Active ingredients: Allopurinol
Allopurinol Sandoz 100 mg tablets
Allopurinol Sandoz 300 mg tablets
Why is Allopurinol used - Generic Drug? What is it for?
Allopurinol Sandoz 100 mg:
Allopurinol Sandoz is used to reduce uric acid levels in the blood:
in adults whose uric acid levels are too high and cannot be controlled with diet or who have symptoms, especially the following:
- gout
- kidney damage caused by uric acid
- dissolution and prevention of uric acid stones
- prevention of calcium oxalate stones, when uric acid levels are also high;
adults and children weighing 15 kg or more whose uric acid levels are too high and have caused increased uric acid excretion through urination, for example due to:
- radiotherapy
- treatment of a tumor with drugs
- another serious form of cell disintegration;
children weighing 15 kg or more with:
- kidney damage caused by uric acid when treating a blood cancer in the presence of an excessive white blood cell count or an "abnormal white blood cell count
- some particular hereditary disorders of enzyme deficiency, known as Lesch-Nyhan syndrome and adenine-phosphoribosyl-transferase deficiency.
Allopurinol Sandoz 300 mg:
Allopurinol Sandoz is used to reduce uric acid levels in the blood:
in adults whose uric acid levels are too high and cannot be controlled with diet or who have symptoms, especially the following:
- gout
- kidney damage caused by uric acid
- dissolution and prevention of uric acid stones
- prevention of calcium oxalate stones, when uric acid levels are also high;
adults and children weighing 45 kg or more whose uric acid levels are too high and have caused increased uric acid excretion through urination, for example due to:
- radiotherapy
- treatment of a tumor with drugs
- another serious form of cell disintegration
children weighing 45 kg or more with:
- kidney damage caused by uric acid during the treatment of a blood cancer in the presence of an excessive white blood cell count or an abnormal white blood cell count
- some particular inherited disorders of enzyme deficiency, known as Lesch-Nyhan syndrome and adenine-phosphoribosyl-transferase deficiency
Contraindications When Allopurinol - Generic Drug should not be used
Do not take Allopurinol Sandoz Allopurinol Sandoz 100 mg
- if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
This medicine is not suitable for children weighing less than 15 kg.
Allopurinol Sandoz 300 mg
- if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from severe renal impairment with creatinine clearance below 20 ml / min.
This medicine is not indicated for children weighing less than 45 kg.
Precautions for use What you need to know before taking Allopurinol - Generic Drug
Talk to your doctor before taking Allopurinol Sandoz if you suffer from any of the following conditions:
- reduced kidney function. Reduced kidney function is more likely to occur in patients who are taking either drugs to treat high blood pressure containing active substances whose names end in -pril or or diuretics to treat high blood pressure or heart disease
- reduced liver function
- blood formation disorders
In these 3 cases the doctor will carefully monitor the number of blood cells.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Allopurinol Sandoz, initially appearing as red patches in the center or circular patches often with central blisters on the trunk.
Additional signs to report include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk of developing severe skin reactions is within the first few weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of allopurinol, you should no longer restart treatment with Allopurinol Sandoz.
If you get a rash or these skin symptoms, contact a doctor immediately and tell him that you are taking the medicine. Serious skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of alloppinol. , genitals and conjunctivitis (red and swollen eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, widespread aches. The rash may progress with the appearance of diffuse blisters and peeling of the skin. These severe skin reactions may be more common in individuals of Han Chinese or Thai descent.
If you develop a rash or these skin symptoms, you should stop taking allopurinol and contact your doctor immediately. It is important to consider that drug treatment is not necessary if:
- your blood uric acid levels are below 9 mg / 100ml e
- his kidney function is normal and
- follows the dietary recommendations listed under "Allopurinol Sandoz with food and drink and alcohol".
Drink plenty of fluids, enough to produce at least 2 liters of urine per day. This is especially important if you are taking allopurinol to treat:
- renal gout
- uric acid stones.
During therapy with Allopurinol Sandoz it may be useful to increase the pH levels of the urine, in order to increase the excretion of uric acid through urination.
- during radiotherapy, or during treatment with anticancer drugs
- to treat the hereditary enzyme deficiency disorder Lesch-Nyhan syndrome.
Attacks of gout may occur at the start of treatment; therefore, your doctor may prescribe painkillers or colchicine for the first 4 weeks of treatment with Allopurinol Sandoz.
Interactions Which drugs or foods can modify the effect of Allopurinol - Generic Drug
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines can affect (or be affected by) allopurinol:
- 6-mercaptopurine, a drug used to treat blood cancers in the presence of an excessive or "abnormal white blood cell count"
- medicines used to treat aggressive tumors, such as either cyclophosphamide or doxorubicin or bleomycin or procarbazine or alkyl halides
Your doctor will frequently check the number of your blood cells.
- azathioprine, cyclosporine, medicines used to suppress the immune system or to treat other disorders.
Note: Side effects due to cyclosporine may occur more frequently.
- vidarabine, a medicine used to treat viral diseases.
Note: Undesirable effects due to vidarabine may occur more frequently: if this occurs, special attention should be paid
- didanosine, a medicine used to treat HIV infection
- ampicillin, amoxicillin, medicines used to treat bacterial infections. If possible, patients should be given other antibiotics, because allergic reactions are more likely to occur
- salicylates, medicines used to reduce pain, fever or inflammation, for example acetylsalicylic acid
- probenecid, benzbromarone, medicines used to increase uric acid excretion through urination
- chlorpropamide, a drug used to treat diabetes. The chlorpropamide dose may need to be reduced, especially in patients with impaired renal function
- warfarin, phenprocoumon, acenocoumarol, medicines used to prevent normal blood clotting.
Your doctor will check your blood clotting parameters more frequently and reduce the doses of these drugs if necessary
- phenytoin, a medicine used to treat epilepsy or some painful conditions
- theophylline, a drug used to treat asthma and other respiratory disorders. Your doctor will measure plasma levels of theophylline, particularly at the start of treatment with allopurinol or upon any dose changes
- captopril, a medicine used to treat high blood pressure and heart disease. It may increase the risk of skin reactions, particularly if your kidney function is chronically reduced.
Allopurinol Sandoz with food and drink and alcohol
Avoid:
- alcohol, especially beer
- foods with high purine content, such as offal - sweetbreads, kidney, brain, heart and tongue - and meat extract.
Warnings It is important to know that:
Pregnancy and breastfeeding and fertility
- Pregnancy
Only take Allopurinol Sandoz during pregnancy if your doctor considers it absolutely necessary, as there are insufficient data.
- Feeding time
You should not take Allopurinol Sandoz while breastfeeding, as the active substance passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Only engage in activities such as driving vehicles, using machines or other potentially dangerous activities if you are sure that Allopurinol Sandoz will not affect your abilities.
In the form of side effects, dizziness, sleepiness and difficulty in controlling movements may occur.
Dose, Method and Time of Administration How to use Allopurinol - Generic Drug: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Allopurinol Sandoz 100 mg
Adults
- Usual starting dose: 1 tablet per day. Your doctor may adjust the dose according to your blood uric acid levels.
- Maximum dose: 9 tablets per day.
Tablets containing 300 mg allopurinol are available for individual dose adjustments.
Children and adolescents under 18 years of age, weighing 15 kg or more
- Usual dose: 10 mg per kilogram of body weight per day, divided into 3 doses.
- Maximum dose: 4 tablets per day.
Patients over 65 years of age
Your doctor will prescribe the minimum dose needed to treat your condition.
Reduced kidney function
Only take Allopurinol Sandoz under the careful supervision of a doctor who will determine the dose.
- Maximum dose for patients with severe renal insufficiency: 1 tablet per day. However, in case of dialysis, your doctor may prescribe 3-4 tablets immediately after each treatment session.
Reduced liver function
The dose will be determined by your doctor.
Method of administration
Take Allopurinol Sandoz
- without chewing the tablet (s)
- with a glass of water
- after a meal e
- always at the same time of day.
Divide the dose and take them throughout the day in the following cases
- if you need to take more than 3 tablets a day oo
- if gastric or intestinal disturbances arise as side effects.
Instructions for dividing the tablet
Divide the tablet as shown in this figure:
Duration of treatment
Treatment with allopurinol is usually required for prolonged periods. Take Allopurinol Sandoz regularly and for as long as your doctor has prescribed.
Consult your doctor regularly for a check-up.
Allopurinol Sandoz 300 mg
Adults
- Usual starting dose: 100 mg per day. Your doctor may adjust the dose according to your blood uric acid levels.
- Maximum dose: 3 tablets per day.
Children and adolescents under 18 years of age, weighing 45 kg or more
- Usual dose: 10 mg per kilogram of body weight per day, divided into 3 doses.
- Maximum dose: 400 mg of allopurinol per day.
Tablets containing 100 mg allopurinol are available for individual dose adjustments.
Patients over the age of 65
Your doctor will prescribe the minimum dose needed to treat your condition.
Children and adolescents under 18 years, weighing less than 45 kg, patients with impaired kidney or liver function
Due to the high active substance content, Allopurinol Sandoz 300 mg is not indicated in this patient group, for whom tablets containing 100 mg of allopurinol are available. After dialysis, your doctor may prescribe 300-400 mg of allopurinol shortly thereafter. each treatment session.
Method of administration
Take Allopurinol Sandoz
- without chewing the tablet (s)
- with a glass of water
- after a meal e
- always at the same time of day
. Divide the dose and take them throughout the day in the following cases
- if you need to take more than 1 tablet a day or
- if gastric or intestinal disturbances arise as side effects.
Instructions for dividing the tablet
Divide the tablet as shown in this figure:
Duration of treatment
Treatment with allopurinol is usually required for prolonged periods. Take Allopurinol Sandoz regularly and for as long as your doctor has prescribed.
Consult your doctor regularly for a check-up.
Overdose What to do if you have taken an overdose of Allopurinol - Generic Drug
If you take more Allopurinol Sandoz than you should
Always consult a doctor. Nausea, vomiting, diarrhea and dizziness may occur as signs of overdose.
If you forget to take Allopurinol Sandoz
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Allopurinol Sandoz
Do not stop treatment without first consulting your doctor: this could compromise the success of the therapy.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Allopurinol - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them
Side effects can occur with the frequencies described below:
Common, may affect up to 1 in 10 people
Skin reactions such as
- itch
- appearance of spots on the skin with small nodules
- peeling of the skin
- spots
- skin bleeding
- peeling of the skin (in rare cases).
These side effects can occur at any time during treatment. If these skin reactions occur, stop taking Allopurinol Sandoz immediately and consult a doctor, as severe hypersensitivity reactions may follow;
Uncommon, may affect up to 1 in 100 people
- nausea
- He retched
- diarrhea
- severe hypersensitivity reactions including fever, rash, joint pain and changes in blood and liver function tests (these may be signs of a multi-organ hypersensitivity disorder)
- increased levels of liver function, in the absence of symptoms
- reduction in platelets, which causes an increased risk of bleeding or bruising
- severe reduction in the number of white blood cells, which makes infections more likely
- reduction in the number of red blood cells, due to a decrease in production, which can cause: o weakness or bruising o o an increase in the likelihood of infections.
See your doctor immediately if you experience symptoms of infection, such as:
- fever and general malaise
- fever with symptoms of local infections, such as inflammation of the throat, pharynx and mouth
- urinary disorders;
Rare, may affect up to 1 in 1,000 people
If you experience any of these symptoms, stop taking the tablets and tell your doctor immediately:
- fever and chills, headache, body aches (flu-like symptoms) and general feeling of unwell
- any changes in the skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blistering and peeling of the skin
- liver disorders, which can range from either inflammation of the liver, including the destruction of liver cells to, in extreme cases, complicated inflammation of the liver tissue;
Very rare, may affect up to 1 in 10,000 people
- life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2)
- different allergic reactions or fever or skin reactions or chills or joint pains or reversible increases in liver enzymes transaminase and alkaline phosphatase or inflammation of the bile ducts or xanthine stones in the urinary tract
- life-threatening allergic shock reactions
- disturbances of the lymph nodes (angioimmunoblastic lymphadenopathy), which disappear after the end of treatment with allopurinol
- vomiting of blood
- increased excretion of fat in the stool
- gastric and intestinal disorders
- changes in the number of white blood cells or less than 4000 white blood cells per microliter of blood or more than 10,000 white blood cells per microliter of blood or an increase in the number of white blood cells called granulocytes or an increase in the number of white blood cells known as eosinophilic granulocytes
- deficiency of red blood cells, due to reduced or abnormal production in the bone marrow
- feeling of weakness
- general feeling of being unwell
- painful, deep and complicated inflammation of the hair follicles, caused by bacteria
- loss of consciousness
- increased blood pressure
- blood in the urine
- increase in the size of one or both breasts in men (gynecomastia)
- severe and painful swelling of the deep layers of the skin, mainly affecting the face
- sensory disturbances, such as numbness or tingling
- inflammation of the lining of the mouth
- increased blood fat levels
- changes in taste
- difficulty in controlling movements
- hair loss
- throat inflammation
- impotence
- headache
- abnormal increase of substances in the blood, which usually occurs in the urine due to a decrease in kidney function
- paralysis
- muscle aches
- nerve disorders, including inflammation of the nerves in the arms or legs
- drowsiness
- dizziness
- depression
- ejaculation during sleep
- vision impairment
- opacity of the ocular lens
- some eye disorders with degeneration of the center of the inner lining of the eye, which can result in loss of central vision
- infertility
- hair discoloration
- slow heart rate
- increased accumulation of water in the tissues
- diabetes mellitus.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the plastic / aluminum tablet blister / container and carton, after "EXP". The expiry date refers to the last day of that month.
Storage of this medicinal product does not require any special precautions.
Container of tablets
Validity after first opening: 6 months.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Allopurinol Sandoz Allopurinol contains
Sandoz 100 mg
- The active ingredient is allopurinol. Each tablet contains 100 mg of allopurinol.
- The other ingredients are: microcrystalline cellulose, powdered cellulose, crospovidone, macrogol 4000, magnesium stearate, povidone K25, talc.
Allopurinol Sandoz 300 mg
- The active ingredient is allopurinol. Each tablet contains 300 mg of allopurinol.
- The other ingredients are: microcrystalline cellulose, powdered cellulose, crospovidone, macrogol 4000, magnesium stearate, povidone K25, talc.
What Allopurinol Sandoz looks like and contents of the pack
Allopurinol Sandoz 100 mg
White tablets, rounded on the top and bottom, with a single score line. The tablets can be divided into equal halves.
The following packs of the medicine are available:
- blisters containing 1, 7, 10, 25, 28, 30, 50, 90 and 100 tablets
- containers containing 50, 100, 250, 500 and 1000 tablets.
Allopurinol Sandoz 300 mg
White to off-white, oblong, rounded tablets on the top and bottom, with a score line on both sides. The tablets can be divided into equal halves.
The following packs of the medicine are available:
- blisters containing 1, 7, 10, 20, 28, 30, 50, 90, 100 and 105 tablets
- containers containing 20, 30, 50, 100, 105, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ALLOPURINOL SANDOZ TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Allopurinol Sandoz 100 mg tablets
Each tablet contains 100 mg of allopurinol.
Allopurinol Sandoz 300 mg tablets
Each tablet contains 300 mg of allopurinol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
Allopurinol Sandoz 100 mg tablets
Round, biconvex, white tablets, scored on one side only. The tablets can be divided into equal halves.
Allopurinol Sandoz 300 mg tablets
Round, biconvex, white to ivory-white tablets with a score line on both sides. The tablets can be divided into equal halves.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Allopurinol Sandoz 100 mg
Adults
• For all forms of hyperuricemia that cannot be controlled with diet, with serum uric acid values in the range of 535 mcmol / l (9 mg / 100 ml) and above and in the clinical complications of hyperuricemia states, in particular manifest gout , uratic nephropathy, for the dissolution and prevention of uric acid stones, as well as for the prevention of calcium oxalate stone formation in conjunction with hyperuricemia.
Adults, children and adolescents with a body weight ≥15 kg
• secondary hyperuricemia of different origin.
Children and adolescents weighing ≥15 kg
• uric acid nephropathy during the treatment of leukemia
• hereditary disorders of enzyme deficiency, Lesch-Nyhan syndrome (partial or total hypoxanthine-guanine-phosphoribosyl-transferase deficiency) and adenine-phosphoribosyl-transferase deficiency.
Allopurinol Sandoz 300 mg
Adults
• For all forms of hyperuricemia that cannot be controlled with diet, with serum uric acid values in the range of 535 mcmol / l (9 mg / 100 ml) and above and in the clinical complications of hyperuricemia states, in particular manifest gout , uratic nephropathy, for the dissolution and prevention of uric acid stones, as well as for the prevention of calcium oxalate stone formation in conjunction with hyperuricemia.
Adults, children and adolescents with a body weight ≥45 kg
• secondary hyperuricemia of different origin.
Children and adolescents weighing ≥45 kg
• uric acid nephropathy during the treatment of leukemia
• hereditary disorders of enzyme deficiency, Lesch-Nyhan syndrome (partial or total hypoxanthine-guanine-phosphoribosyl-transferase deficiency) and adenine-phosphoribosyl-transferase deficiency.
04.2 Posology and method of administration
Allopurinol Sandoz 100 mg tablets
Dosage in adults
Allopurinol should be introduced in low doses, for example 100 mg / day, in order to reduce the risk of adverse reactions and the dose should only be increased if the serum urate response is unsatisfactory. Particular care should also be taken if renal function is poor (see "Dosage in" renal insufficiency ").
The following dosage schedules are suggested:
100 mg to 200 mg per day in mild conditions,
300 mg to 600 mg per day in moderately severe conditions,
700 mg to 900 mg per day in severe conditions.
Doses above 300 mg should be administered in divided doses not exceeding 300 mg at a time. If administration based on the mg / kg body weight ratio is required, a dose of 2-10 mg / kg body weight / day should be used.
Pediatric population with body weight ≥15 kg
The daily dose is 10 mg of allopurinol per kilogram of body weight (for a maximum of 400 mg per day), divided into 3 doses.
Older people
As no specific data are available for the use of allopurinol in elderly patients, this group of patients should be treated with the lowest therapeutically justifiable dose. The possibility of impaired renal function, particularly in patients, should also be considered. older patients.
Posology in impaired renal function
Since allopurinol and its metabolites are excreted by the kidney, overdose may occur in cases of impaired renal function if the dose is not properly adjusted.
Therefore, in order to minimize this risk, an adjustment of the recommended dose is indicated. In cases of severe renal impairment, a maximum dose of 100 mg allopurinol should be administered per day, or single doses of 100 mg should be administered at intervals of more than one day. The respective doses should only be increased if the effects are inadequate. The serum oxypurinol level should not exceed 15.2 mcg / mL.
The following table constitutes a guideline for determining doses in the case of renal insufficiency:
In the case of hemodialysis, 300 to 400 mg of allopurinol can be administered immediately after each treatment session (eg 2 or 3 times per week).
Posology in impaired hepatic function
Doses should be reduced in patients with hepatic impairment. During the initial stages of therapy it is recommended that liver function tests be performed periodically.
Treatment of conditions of high urate turnover, eg neoplasm, Lesch-Nyhan syndrome
Before initiating cytotoxic therapy, it is advisable to use allopurinol to correct existing hyperuricemia and / or hyperuricosuria. It is important to ensure adequate hydration to maintain optimal diuresis and to attempt alkalization of the urine to increase the solubility of urinary urate / uric acid. The allopurinol dose should be the lowest of the recommended dosing regimens.
If renal function has been impaired by urate nephropathy or other pathology, the recommendations given forposology in patients with impaired renal function.
These precautions can reduce the risk of xanthine and / or oxypurinol deposition and the consequent complication of the clinical situation. See also section 4.5.
Tips for monitoring :
Dosage should be adjusted by monitoring serum urate concentrations and urinary urate / uric acid levels at appropriate intervals.
Allopurinol Sandoz 300 mg tablets
Dosage in adults
Allopurinol should be introduced in low doses, for example 100 mg / day, in order to reduce the risk of undesirable effects and the dose should only be increased if the serum urate response is unsatisfactory. Special care should also be taken in the treatment. case of poor kidney function (see "Dosage in patients with hepatic or renal insufficiency").
The following dosage schedules are suggested:
100 mg to 200 mg per day in mild conditions,
300 mg to 600 mg per day in moderately severe conditions,
700 mg to 900 mg per day in severe conditions.
Doses above 300 mg should be administered in divided doses not exceeding 300 mg at a time. If administration based on mg / kg body weight is required, 2-10 mg / kg body weight / day should be used.
Pediatric population with body weight ≥45 kg
The daily dose is 10 mg of allopurinol per kilogram of body weight (for a maximum of 400 mg per day), divided into 3 doses.
Senior citizens
Since specific data on the use of allopurinol in elderly patients are not available, this group of patients should be treated with the lowest therapeutically justifiable dose. The possibility of impaired renal function, particularly in patients, should also be considered. older patients.
Posology in patients with impaired renal or hepatic function
Due to the high content of active ingredient, Allopurinol Sandoz 300 mg is not indicated in patients with impaired renal or hepatic function.
In case of hemodialysis 300 to 400 mg of allopurinol can be administered immediately after each treatment session (eg 2 or 3 times per week).
Treatment of conditions of high urate turnover, eg neoplasm, Lesch-Nyhan syndrome
Before initiating cytotoxic therapy, it is advisable to use allopurinol to correct existing hyperuricemia and / or hyperuricosuria. It is important to ensure adequate hydration to maintain optimal diuresis and to attempt alkalization of the urine to increase the solubility of urinary urate / uric acid. The allopurinol dose should be the lowest of the recommended dosing regimens.
If renal function has been impaired by urate nephropathy or other pathology, the recommendations given forposology in patients with impaired renal function.
These precautions can reduce the risk of xanthine and / or oxypurinol deposition and the consequent complication of the clinical situation. See also section 4.5.
Tips for monitoring :
Dosage should be adjusted by monitoring serum urate concentrations and urinary urate / uric acid levels at appropriate intervals.
Allopurinol Sandoz 100 mg and 300 mg
Methods and duration of the processing
The tablets should be taken without chewing, with plenty of liquid and after a meal. If the dose of 300 mg allopurinol per day is exceeded, or if symptoms of gastrointestinal intolerance occur, the dose should be divided and administered in several doses throughout the day.
The duration of treatment depends on the underlying disease. In order to prevent the formation of calcium oxalate and uric acid stones and in cases of hyperuricemia and primary gout, long-term therapy will be necessary in most cases. In case of secondary hyperuricaemia, transient treatment is recommended in accordance with the duration of the increase in uric acid values.
04.3 Contraindications
Allopurinol Sandoz 100 mg
• hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• children of body weight
Allopurinol Sandoz 300 mg
• hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• severe renal dysfunction, with creatinine clearance less than 20 ml / min
• children of body weight
04.4 Special warnings and appropriate precautions for use
Life-threatening skin reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of allopurinol.
Patients should be informed of the signs and symptoms and monitored closely for skin reactions. The highest risk of developing SJS and TEN occurs in the first eight weeks of treatment. If symptoms or signs of SJS or TEN occur (e.g. progressive skin rash often with blistering or mucosal lesions), treatment with Allopurinol Sandoz should be discontinued. The best results in the management of SJS and TEN are obtained with an early diagnosis and immediate discontinuation of therapy with any suspect drug. Early discontinuation is associated with a better prognosis.If the patient has developed SJS or TEN with the use of Allopurinol Sandoz, Allopurinol Sandoz should no longer be used in this patient.
Hypersensitivity syndrome, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
Hypersensitivity reactions to allopurinol can manifest in very different ways, including maculo-papular rash, hypersensitivity syndrome (also known as DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS / TEN). These reactions are clinical diagnoses; their appearance forms the basis for the clinical decision. If such reactions occur at any time during treatment, allopurinol should be discontinued immediately. Re-challenge should not be undertaken in patients with hypersensitivity syndrome and SJS / TEN. Corticosteroids may be useful for overcome hypersensitivity skin reactions.
Allele HLA-B * 5801
The HLA-B * 5801 allele has been shown to be associated with the risk of developing allopurinol-related hypersensitivity syndrome and SJS / TEN. The frequency of the HLA-B * 5801 allele varies widely between ethnic groups: up to 20% in the Han Chinese population, about 12% in the Korean population, and 1-2% in individuals of Japanese or European descent. genotyping, as a screening tool for deciding whether or not to initiate allopurinol treatment, has not been established. If the patient is a known carrier of HLA-B * 5801, the use of allopurinol may be considered if the benefits are considered to outweigh the risks. Additional vigilance is required for signs of hypersensitivity syndrome or SJS / TEN and the patient should be informed of the need to stop treatment immediately at the first appearance of symptoms.
According to recent recommendations in the literature, treatment with medicines is not necessary if uric acid levels are below 535 mcmol / l (equivalent to 9 mg / 100 ml), as long as dietary recommendations are followed and there is no kidney damage. . Foods with a high purine content (for example offal, such as sweetbreads, kidney, brain, liver, heart and tongue, as well as meat extract) and alcohol (especially beer, as this involves the intake of guanosine, a ribonucleoside that markedly elevates the level of uric acid) should be avoided.
If hypersensitivity reactions (e.g. rash) occur, Allopurinol Sandoz should be discontinued immediately.
The treating physician should exercise particularly careful monitoring in the case of impaired renal or hepatic function or pre-existing haematopoiesis disorders. In patients with impaired renal or hepatic function the relevant dosing recommendations should be considered (see section 4.2). Allopurinol should be administered with caution especially in patients treated for example with ACE inhibitors or diuretics due to hypertension or heart failure, as patients in this group may suffer from renal insufficiency.
In the treatment of renal gout and uric acid stones, the volume of urine produced should be at least 2 liters per day.
In order to avoid high concentrations of uric acid in serum or urine (as can occur in radiotherapy or chemotherapy of cancer, as well as in Lesch-Nyhan syndrome), in addition to the administration of allopurinol, copious amounts of fluids should be taken to ensure sufficient diuresis. Furthermore, the alkalinization of the urine, used to improve the dissolution of urate / uric acid, can help to increase the excretion of these substances.
If urate nephropathy or any other pathological change has already caused renal impairment, the dose should be adjusted based on renal function parameters (see section 4.2).
Allopurinol treatment should not be initiated until an acute attack of gout has been fully remedied, to avoid the onset of further attacks.
An acute attack of gouty arthritis may occur in the initial stages of allopurinol treatment, as with uricosuric agents: therefore it is advisable to administer prophylaxis with an appropriate anti-inflammatory agent or colchicine for at least one month. For detailed information regarding appropriate doses, precautions and warnings, consult the literature.
If acute attacks develop in patients receiving allopurinol, treatment should continue at the same dose, while the acute attack should be treated with an appropriate anti-inflammatory agent.
Adequate allopurinol therapy can result in the dissolution of large uric acid stones in the renal pelvis, with the remote possibility of occlusion in the ureter.
04.5 Interactions with other medicinal products and other forms of interaction
6-mercaptopurine and azathioprine
Azathioprine is metabolised to 6-mercaptopurine, which is inactivated by the action of xanthine oxidase. When 6-mercaptopurine or azathioprine is administered concomitantly with allopurinol, only a quarter of the normal dose of 6-mercaptopurine or azathioprine should be administered, because inhibition of xanthine oxidase prolongs their activity.
Vidarabine (adenine arabinoside)
Evidence suggests that the plasma half-life of vidarabine increases in the presence of allopurinol. When the two products are used concomitantly, further attention is required to be able to recognize the increased toxic effects. There is no unequivocal evidence that allopurinol potentiates the activity of other cytotoxic drugs.
Salicylates and uricosuric agents
Oxipurinol, the metabolite of allopurinol itself therapeutically active, is excreted by the kidneys in a similar way to urates. Therefore drugs with uricosuric activity, such as probenecid or high doses of salicylates, can accelerate the excretion of oxypurinol; this could in turn reduce the therapeutic activity of allopurinol, but the clinical significance of this phenomenon must be evaluated case by case.
Chlorpropamide
If allopurinol is administered concomitantly with chlorpropamide in the presence of poor renal function, the risk of prolonged hypoglycaemic activity may be increased, because allopurinol and chlorpropamide may compete for excretion in the renal tubule.
Coumarin anticoagulants
There have been rare reports of an increased effect of warfarin and other coumarin anticoagulants when these are co-administered with allopurinol. Therefore it is necessary to carefully monitor all patients taking anticoagulants.
Phenytoin
Allopurinol may inhibit the hepatic oxidation of phenytoin, but the clinical significance of this phenomenon has not been demonstrated.
Theophylline
Inhibition of theophylline metabolism has been reported. The mechanism of interaction can be explained by the fact that in humans xanthine oxidase is involved in the biotransformation of theophylline. In patients starting therapy with allopurinol or increasing its dose, theophylline levels should be monitored.
Ampicillin / amoxicillin
An increased frequency of skin reactions has been reported in patients taking ampicillin or amoxicillin concomitantly with allopurinol compared to patients not receiving both drugs. The cause of this association is unknown, however it is recommended that alternative therapy to ampicillin or amoxicillin be used when available for patients receiving allopurinol.
Cyclophosphamide, doxorubicin, bleomycin, procarbazine, mecloroetamine
In patients with neoplastic diseases (except leukemia), increased bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported in the presence of allopurinol. However, in a well-controlled study in patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and / or mecloroetamine (mustine hydrochloride), allopurinol did not appear to increase the toxic reaction of these cytotoxic agents.
Cyclosporine
Some reports suggest that the plasma concentration of ciclosporin may be increased during concomitant treatment with allopurinol. Therefore, in case of concomitant administration of the two drugs, the possibility of increased cyclosporine toxicity should be taken into account.
Didanosine
In healthy volunteers and HIV patients receiving didanosine, concomitant treatment with allopurinol (300 mg daily) resulted in an increase in plasma Cmax and AUC of didanosine by approximately double, without however affecting the terminal half-life. co-administration of these two drugs is generally not recommended. If concomitant use is unavoidable, a dose reduction of didanosine may be required, and patients should be carefully monitored.
Captopril
Concomitant administration of allopurinol and captopril may increase the risk of skin reactions, particularly in cases of chronic renal failure.
04.6 Pregnancy and lactation
Pregnancy
There are insufficient data on the use of allopurinol during pregnancy. Animal studies have shown reproductive toxicity (see section 5.3). Because it interferes with purine metabolism and the potential risk to humans is unknown, allopurinol should not be used during pregnancy unless absolutely necessary.
Breastfeeding
The data indicate that allopurinol and oxipurinol are excreted in human breast milk. Concentrations of 1.4 mg / liter of allopurinol and 53.7 mg / liter of oxypurinol were detected in the milk of a woman who was taking 300 mg of allopurinol per day. However, there are no data on the effects of allopurinol or its metabolites on the breastfed infant. Due to very limited experience, allopurinol should not be used during the breastfeeding period.
04.7 Effects on ability to drive and use machines
Since there have been reports of adverse reactions such as somnolence, dizziness and ataxia in patients taking allopurinol, patients should exercise caution before driving, operating machinery or performing hazardous activities until they are reasonably certain that the " allopurinol has no negative influence on their performance.
04.8 Undesirable effects
There is no up-to-date clinical documentation for this medicine that can be used as an aid in determining the frequency of side effects. Undesirable effects may vary in their incidence depending on the dose received and whether the drug is administered in combination with other therapeutic agents.
The frequency categories assigned to the adverse drug reactions below are estimates: for most reactions no suitable data are available to calculate the incidence. Adverse drug reactions identified through post-marketing monitoring are considered rare or very rare. The following convention was used for frequency classification:
very common (≥1 / 10);
common (≥1 / 100 to
uncommon (≥1 / 1000 to
rare (≥1 / 10,000 to
very rare (
not known (frequency cannot be estimated from the available data).
Adverse reactions associated with allopurinol are rare in the overall treated population and are mostly mild in severity. The incidence is higher in the presence of renal and / or hepatic disorders.
Infections and infestations
Very rare: furunculosis.
Disorders of the blood and lymphatic system
Very rare: agranulocytosis,
aplastic anemia,
thrombocytopenia,
altered blood counts such as leukopenia, leukocytosis, granulocytosis and eosinophilia.
Very rare cases of thrombocytopenia, agranulocytosis and aplastic anemia have been reported, particularly in subjects with renal and / or hepatic insufficiency; reinforcing the need for special attention for this patient group.
Disorders of the immune system
A multi-organ delayed hypersensitivity disorder (known as hypersensitivity syndrome or DRESS) with fever, rash, vasculitis, lymphadenopathy, pseudo-lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, abnormal liver function tests and disappearance syndrome intrahepatic bile ducts (destruction and disappearance of intrahepatic bile ducts), manifests itself in various combinations. Other organs may also be involved (e.g. liver, lungs, kidneys, pancreas, myocardium and colon). If such reactions occur at any time during treatment, allupyrinol treatment should be discontinued immediately and permanently.
When generalized hypersensitivity reactions occurred, renal and / or hepatic changes were generally present, particularly when the outcome was fatal.
Uncommon: hypersensitivity reactions
Very rare: angioimmunoblastic lymphadenopathy
Corticosteroids may be useful for treating hypersensitivity skin reactions. When generalized hypersensitivity reactions have occurred, renal and / or hepatic changes have usually occurred, particularly in the event of a fatal outcome.
Angioimmunoblastic lymphadenopathy has been described very rarely following biopsy for generalized lymphadenopathy. This appears to be reversible after discontinuation of allopurinol.
Metabolism and nutrition disorders
Very rare: diabetes mellitus,
hyperlipidemia.
Psychiatric disorders
Very rare: depression.
Nervous system disorders
Very rare: coma,
paralysis,
ataxia,
neuropathy,
paraesthesia,
drowsiness,
headache,
changes in taste,
peripheral neuritis,
dizziness.
Eye disorders
Very rare: cataracts,
visual disturbances,
macular changes.
Ear and labyrinth disorders
Very rare: dizziness.
Cardiac pathologies
Very rare: bradycardia,
angina.
Vascular pathologies
Very rare: hypertension.
Gastrointestinal disorders
Uncommon: nausea,
He retched,
diarrhea.
Very rare: recurrent haematemesis,
steatorrhea,
stomatitis,
alterations of the alvo.
In early clinical trials, cases of nausea and vomiting were reported. More recent data suggests that these reactions are not a significant problem and can be avoided by taking allopurinol after meals.
Hepatobiliary disorders
Uncommon: asymptomatic increase in liver function test values.
Rare: hepatitis (including hepatic necrosis and granulomatous hepatitis).
Hepatic dysfunction has been reported with no clear evidence of increased generalized hypersensitivity.
Skin and subcutaneous tissue disorders
Common: rash.
Very rare: Serious skin adverse reactions (SCARs) have been reported: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (see section 4.4),
alopecia,
hair discoloration,
angioedema,
fixed drug eruption,
Quincke's edema.
Skin reactions are the most common reactions and can occur at any time during treatment. They can be itchy, maculopapular, sometimes scaly, sometimes purpuric, and rarely exfoliative, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS / TEN).
Allopurinol should be discontinued immediately when such reactions occur. After recovery from mild reactions, if desired, allopurinol can be re-introduced at a low dose (eg 50 mg / day) and gradually increased. If the rash recurs, allopurinol must be permanently discontinued as more severe hypersensitivity reactions may occur (see Immune system disorders).
The HLA-B * 5801 allele has been identified as a genetic risk factor for allopurinol-related SJS / TEN in retrospective, case-control pharmacogenetic studies in Han Chinese, Japanese and European patients. Up to 20-30% of some Han Chinese, African and Indian populations carry the HLA-B * 5801 allele while only 1-2% of Northern European, US and Japanese patients are estimated to be carriers of HLA- B * 5801. However, the use of genotyping as a screening tool for the decision to initiate treatment with allopurinol has not been established.
The clinical diagnosis of SJS / TEN remains the basis for decision making. If such reactions occur at any time during treatment, allopurinol treatment should be discontinued immediately and permanently.
Angioedema has been observed to occur with and without signs and symptoms of an increased generalized hypersensitivity reaction to allopurinol.
Renal and urinary disorders
Very rare: haematuria,
uremia.
Diseases of the reproductive system and breast
Very rare: gynaecomastia,
male infertility,
erectile dysfunction.
General disorders and administration site conditions
Very rare: general malaise,
asthenia,
edema,
fever.
Fever has been reported to occur with and without signs and symptoms of a generalized increased hypersensitivity reaction to allopurinol (see Immune system disorders).
Musculoskeletal and connective tissue disorders
Very rare: muscle aches.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There is no known specific antidote. After taking a single 20 g dose, one patient experienced symptoms such as nausea, vomiting, diarrhea and dizziness. In another patient a 22.5 g dose did not cause any side effects.
If intoxication is suspected, especially in cases of concomitant treatment with azathioprine or 6-mercaptopurine, the patient may be given activated charcoal (only when intake is within one hour).
Marked absorption of allopurinol can considerably inhibit the activity of xanthine oxidase: this has no adverse effects, unless it affects the effects of other concomitantly administered medicinal products, in particular azathioprine or 6-mercaptopurine. In this case it must be recognized. the risk of an increase in business.
Maximal diuresis stimulates the excretion of allopurinol and its metabolites. If necessary, hemodialysis can be done.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antigout preparations; preparations that inhibit the production of uric acid.
ATC code: M04 AA01.
Allopurinol and its main metabolite (oxipurinol) reduce the production of uric acid by inhibiting the enzyme xanthine oxidase, which plays an important role in the oxidation of hypoxanthine to uric acid. This results in a decrease in acid levels. uric acid and urate in body fluids and urine.
In addition to the inhibition of purine metabolism, biosynthesis in some patients from scratch of purines is suppressed by the inhibition of the hypoxanthine-guanine-phosphoribosyl-transferase.
05.2 "Pharmacokinetic properties
Allopurinol is active when administered orally and is rapidly absorbed from the upper gastrointestinal tract. Some studies have detected allopurinol in the blood 30-60 minutes after administration. Estimates of bioavailability range from 67% to 90%. Plasma levels. Maximal allopurinol usually occurs approximately 1.5 hours after oral administration of allopurinol, but decreases rapidly and is difficult to detect after 6 hours. Maximum oxipurinol levels generally occur 3-5 hours after oral administration of allopurinol and are much more consistent. Allopurinol binds negligibly to plasma proteins and therefore changes in protein binding are not expected to significantly alter clearance. The apparent volume of distribution of allopurinol is approximately 1.6 liters / kg, which suggests relatively consistent tissue uptake. Tissue concentrations of allopurinol have not been reported in humans but it is likely that both allopurinol and oxipurinol are present in higher concentrations in the liver and intestinal mucosa, where the activity of xanthine oxidase is high.
About 20% of the amount of allopurinol ingested is excreted in the faeces. Elimination of allopurinol occurs primarily via metabolic conversion to oxypurinol by xanthine oxidase and aldehyde oxidase, with less than 10% of the drug excreted unchanged in the urine.
Allopurinol has a plasma half-life of approximately 1-2 hours.
Oxipurinol is a less potent xanthine oxidase inhibitor than allopurinol, but the plasma half-life of oxipurinol is much longer: for humans, estimates range from 13 to 30 hours. For this reason, with a single daily dose of allopurinol is maintained an effective inhibition of xanthine oxidase for a period of 24 hours. Patients with normal renal function gradually accumulate oxypurinol until a steady-state plasma concentration of oxypurinol is reached. Typically, taking 300 mg of allopurinol per day, such patients will have plasma concentrations of oxypurinol of 5-10 mg / liter .
Oxipurinol is eliminated unchanged in the urine, but has a long elimination half-life, as it undergoes tubular reabsorption. The reported values for the elimination half-life range from 13.6 to 29 hours. Significant discrepancies in these values may be justified by different types of studies and / or creatinine clearance in patients.
Pharmacokinetics in patients with renal impairment
The clearance of allopurinol and oxypurinol is markedly reduced in patients with impaired renal function, resulting in elevated plasma levels during chronic therapy. Following prolonged treatment with allopurinol 300 mg per day, patients with renal impairment, with creatinine clearance values between 10 and 20 ml / min, had plasma concentrations of oxypurinol of approximately 30 mg / liter. This concentration is approximately equal to that which would be achieved by patients with normal renal function receiving doses of 600 mg / day. A reduction in the dose of allopurinol is therefore required in patients with renal impairment.
Older people
Apart from those due to deterioration of renal function, the pharmacokinetic properties of the medicinal product are not expected to be affected by any other changes (see section "Pharmacokinetics in patients with renal impairment").
05.3 Preclinical safety data
A. Mutagenesis
Cytogenesis studies have shown that allopurinol does not induce chromosomal aberrations in human blood cells in vitro at concentrations up to 100 mcg / ml and in vivo at doses up to 600 mg / day for a mean period of 40 months.
Allopurinol does not produce nitrous compounds in vitro, nor does it negatively affect lymphocyte transformation in vitro.
Evidence from biochemical and other cytological studies strongly suggests that allopurinol has no adverse effects on DNA at any stage of the cell cycle and is not mutagenic.
B. Carcinogenesis
No evidence of carcinogenicity was demonstrated in mice and rats treated with allopurinol for up to 2 years.
C. Teratogenicity
A study in mice treated with intraperitoneal doses of 50 or 100 mg / kg on day 10 and 13 of gestation demonstrated fetal abnormalities, but in a similar study in rats with doses of 120 mg / kg on day 12 of gestation. gestation no abnormalities were observed. Extensive studies conducted with high doses of allopurinol, administered orally, in mice up to 100 mg / kg / day, in rats up to 200 mg / kg / day and in rabbits up to 150 mg / kg / day from the 8th on the 16th day of gestation they showed no teratogenic effects.
A study in vitro conducted on salivary glands of cultured mouse fetuses to detect embryotoxicity indicated that allopurinol is not expected to cause embryotoxicity without also causing maternal toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Powdered cellulose
Povidone K25
Macrogol 4000
Crospovidone
Talc
Magnesium stearate
Microcrystalline cellulose
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
Shelf life after first opening of the HDPE container: 6 months.
06.4 Special precautions for storage
Storage of this medicinal product does not require any special precautions.
06.5 Nature of the immediate packaging and contents of the package
Allopurinol Sandoz 100 mg
PVC / aluminum and PP / aluminum blisters containing 1, 7, 10, 25, 28, 30, 50, 90, 100 tablets.
HDPE container with PE closing cap containing 50, 100, 250, 500, 1000 tablets.
Allopurinol Sandoz 300 mg
PVC / aluminum and PP / aluminum blisters containing 1, 7, 10, 20, 28, 30, 50, 90, 100, 105 tablets.
HDPE container with PE closing cap containing 20, 30, 50, 100, 105, 250, 500, 1000 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Sandoz Spa - Largo U. Boccioni 1 - 21040 Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
100 mg tablets 1 tablet in PVC / AL AIC blister n. 039060013
100 mg tablets 7 tablets in PVC / AL AIC blister n. 039060025
100 mg tablets 10 tablets in PVC / AL AIC blister n. 039060037
100 mg tablets 25 tablets in PVC / AL AIC blister n. 039060049
100 mg tablets 28 tablets in PVC / AL AIC blister n. 039060052
100 mg tablets 30 tablets in PVC / AL AIC blister n. 039060064
100 mg tablets 50 tablets in PVC / AL AIC blister n. 039060076
100 mg tablets 90 tablets in PVC / AL AIC blister n. 039060088
100 mg tablets 100 tablets in PVC / AL AIC blister n. 039060090
100 mg tablets 1 tablet in blister PP / AL AIC n. 039060102
100 mg tablets 7 tablets in blister PP / AL AIC n. 039060114
100 mg tablets 10 tablets in blister PP / AL AIC n. 039060126
100 mg tablets 25 tablets in blister PP / AL AIC n. 039060138
100 mg tablets 28 tablets in blister PP / AL AIC n. 039060140
100 mg tablets 30 tablets in blister PP / AL AIC n. 039060153
100 mg tablets 50 tablets in blister PP / AL AIC n. 039060165
100 mg tablets 90 tablets in blister PP / AL AIC n. 039060177
100 mg tablets 100 tablets in blister PP / AL AIC n. 039060189
100 mg tablets 50 tablets in HDPE AIC bottle n. 039060191
100 mg tablets 100 tablets in HDPE AIC bottle n. 039060203
100 mg tablets 250 tablets in HDPE AIC bottle n. 039060215
100 mg tablets 500 tablets in HDPE AIC bottle n. 039060227
100 mg tablets 1000 tablets in HDPE AIC bottle no. 039060239
300 mg tablets 1 tablet in PVC / AL AIC blister n. 039060241
300 mg tablets 7 tablets in PVC / AL AIC blister n. 039060254
300 mg tablets 10 tablets in PVC / AL AIC blister n. 039060266
300 mg tablets 20 tablets in PVC / AL AIC blister n. 039060278
300 mg tablets 28 tablets in PVC / AL AIC blister n. 039060280
300 mg tablets 30 tablets in PVC / AL AIC blister n. 039060292
300 mg tablets 50 tablets in PVC / AL AIC blister n. 039060304
300 mg tablets 90 tablets in PVC / AL AIC blister n. 039060316
300 mg tablets 100 tablets in PVC / AL AIC blister n. 039060328
300 mg tablets 105 tablets in PVC / AL AIC blister n. 039060330
300 mg tablets 1 tablet in blister PP / AL AIC n. 039060342
300 mg tablets 7 tablets in blister PP / AL AIC n. 039060355
300 mg tablets 10 tablets in blister PP / AL AIC n. 039060367
300 mg tablets 20 tablets in blister PP / AL AIC n. 039060379
300 mg tablets 28 tablets in blister PP / AL AIC n. 039060381
300 mg tablets 30 tablets in blister PP / AL AIC n. 039060393
300 mg tablets 50 tablets in blister PP / AL AIC n. 039060405
300 mg tablets 90 tablets in blister PP / AL AIC n. 039060417
300 mg tablets 100 tablets in blister PP / AL AIC n. 039060429
300 mg tablets 105 tablets in blister PP / AL AIC n. 039060431
300 mg tablets 20 tablets in HDPE AIC bottle n. 039060443
300 mg tablets 30 tablets in HDPE AIC bottle n. 039060456
300 mg tablets 50 tablets in HDPE AIC bottle n. 039060468
300 mg tablets 100 tablets in HDPE AIC bottle n. 039060470
300 mg tablets 105 tablets in HDPE AIC bottle No. 039060482
300 mg tablets 250 tablets in HDPE AIC bottle n. 039060494
300 mg tablets 500 tablets in HDPE AIC bottle n. 039060506
300 mg tablets 1000 tablets in HDPE AIC bottle n. 039060518
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
25/08/2009 - 27/02/2014
10.0 DATE OF REVISION OF THE TEXT
March 2015
