Active ingredients: Lornoxicam
NOXON 8 mg film-coated tablets
Why is Noxon used? What is it for?
Noxon contains the active substance lornoxicam which belongs to a class of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs) which work by reducing pain and inflammation.
Noxon is used to reduce moderate to severe pain and symptoms of rheumatoid arthritis and osteoarthritis, such as joint pain and inflammation.
Contraindications When Noxon should not be used
Do not take Noxon:
- if you are allergic to lornoxicam or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
- if you suffer from gastrointestinal bleeding, rupture and bleeding of a brain vessel or other bleeding problems
- if you have suffered in the past from gastric bleeding or perforation due to previous NSAID therapy
- if you are suffering from an ulcer or have had recurrent ulcers in the stomach or duodenum (two or more episodes of ulceration or bleeding)
- if you have a blood disorder called thrombocytopenia (a low number of platelets in the blood which can increase the risk of bleeding or bruising)
- if you suffer from severe kidney failure
- if you have severe liver failure - if you have severe heart failure
- if you are pregnant or think you are pregnant, breast-feeding or under the age of 18 (see Warnings and precautions)
Precautions for use What you need to know before taking Noxon
Talk to your doctor or pharmacist before taking Noxon Take special care with this medicine if:
- if you have kidney problems
- you are taking other NSAID medicines, including the specific type of NSAID called COX-2 inhibitors. In this case the intake of NOXON should be avoided;
- you are taking other medicines used for inflammation belonging to the corticosteroid family, or medicines used to prevent blood clotting (such as warfarin), or aspirin or medicines for depression called selective serotonin reuptake inhibitors or SSRIs;
- if you have suffered from high blood pressure and / or heart problems in the past
- if you have ulcerative colitis or Crohn's disease
- you are elderly, as you may be more prone to side effects, which can also be serious or life-threatening
- if you have suffered from bleeding
- if you have suffered or are suffering from asthma
- if you have systemic lupus erythematosus (a rare immunological disease).
Consult your doctor or pharmacist:
- if you suffer from heart problems
- if you have already had a stroke
- if you think you may be at risk (for example if you have high blood pressure, diabetes or high cholesterol or if you are a smoker)
- if you have chickenpox, do not take Noxon
- if you need to be treated with Noxon for more than 3 months
- if you have blood clotting disorders
- if you have liver problems
- if you are elderly
Interactions Which drugs or foods can modify the effect of Noxon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed by a doctor.
Do not take Noxon if you are taking other NSAIDs such as acetylsalicylic acid. Ask your doctor or pharmacist if you are unsure.
Noxon can affect or be affected by other medicines: Be especially careful if you are taking any of the following medicines:
- Cimetidine - used to treat heartburn and stomach ulcers
- Anticoagulants such as heparin or phenoprocumon - used to prevent blood clots
- Corticosteroids
- Methotrexate - used in the treatment of tumors and immunological diseases
- Lithium
- Medicines that suppress the immune system, such as cyclosporine or tacrolimus
- Heart medications such as digoxin, ACE inhibitors (such as captopril, enalapril), beta blockers (such as atenolol, sotalol)
- Diuretics
- a type of antibiotics called quinolones
- antiplatelet agents - medicines used to prevent heart attacks and strokes
- acetylsalicylic acid, NSAIDs, including ketorolac
- selective serotonin reuptake inhibitors (SSRIs) - used to treat depression (such as citalopram, fluoxetine)
- glibenclamide and similar medicines, used to treat diabetes
- rifampicin (an antibiotic) or fluconazole (against fungi), as they may have an effect on the effectiveness of Noxon
- some medicines used to treat high blood pressure, kidney problems due to diabetes and heart problems
- Pemetrexed - used in some forms of lung cancer.
Noxon with food, drink and alcohol
Noxon, film-coated tablet, is for oral use. Take the tablets before meals with a sufficient quantity of water. Taking the tablets with a meal can reduce their effectiveness.
Warnings It is important to know that:
Senior citizens
The elderly may be more prone to side effects, particularly bleeding and perforation of the digestive tract, which can be fatal.
Ulcers, perforations and bleeding in the stomach or intestines
If you have ever had a stomach or intestinal ulcer, particularly if it was complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in your abdomen and report them immediately to your doctor, particularly if these symptoms occur early in the day. Treatment: When gastrointestinal bleeding or ulceration occurs in patients taking NOXON, treatment should be discontinued.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see "Contraindications"), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The risk also increases if certain other medicines are taken at the same time (see "Other medicines and NOXON").
Skin reactions
You should stop taking NOXON at the first sign of a rash, mucosal breakdown or other signs of allergy as this could be the first sign of a serious, sometimes fatal, skin reaction.
Medicines such as Noxon may be associated with a slightly increased risk of heart attacks or strokes which are more likely with high doses and prolonged treatment.
Do not exceed the recommended doses or the duration of the prescribed treatment.
Children and adolescents
Noxon should not be used in children and adolescents under 18 years.
Pregnancy, breastfeeding and fertility
Pregnancy
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.
Do not take Noxon during pregnancy.
Fertility.
Noxon can affect fertility and is therefore not recommended for women planning to become pregnant. Women who have difficulty getting pregnant or who are being treated for infertility should consult their doctor and consider stopping Noxon.
Feeding time
Do not take Noxon while breastfeeding.
Driving and using machines
Noxon may cause sleepiness or dizziness and this may affect the ability to drive and use machines safely.
Noxon contains lactose
If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Noxon: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Noxon tablets can be broken in half, along the pre-break line marked on the tablet.
Adults: start with a dose of 16 mg (2 tablets), followed by a dose of 8 mg (1 tablet), up to a maximum of 32 mg (4 tablets) in the first 24 hours. After that take no more than 16 mg (2 tablets) per day.
Patients with arthritis: take 8 mg to 16 mg (1 or 2 tablets) per day, divided into twice a day. Do not take more than 16 mg (2 tablets) per day.
Patients with moderate liver problems or mild to moderate kidney problems: do not take more than 12 mg (1 tablet and 1/2) per day, divided into two or three times a day.
Patients with gastrointestinal disorders: do not take more than 8 mg (1 tablet) per day.
Children and adolescents: Noxon should not be taken by children and adolescents under 18 years of age.
Swallow the tablets with a sufficient amount of liquid. Do not take Noxon with a meal as food can reduce the effectiveness of the tablets.
If you forget to take Noxon
Take the next tablet at the usual time Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Noxon
If you or someone else has accidentally taken too many tablets, contact your doctor or go to the nearest hospital, taking the pack with you if possible. You may have: nausea, vomiting, dizziness or visual disturbances.
Side Effects What are the side effects of Noxon
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are gastrointestinal in nature. If you experience lesions affecting the gastrointestinal mucosa (peptic ulcers), perforation or bleeding of the digestive tract, stop taking this medicine and contact your doctor immediately.
Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain (dyspepsia), abdominal pain, black stools (melaena), blood in vomit, inflammation of the mucous membrane of the mouth (ulcerative stomatitis), have been reported after administration of NSAIDs. intestinal inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease).
Gastritis has been observed less frequently.
Medicines such as Noxon may be associated with a slightly increased risk of heart attack or stroke.
Side effects associated with Noxon are listed below:
Common (may affect up to 1 in 10 people)
- moderate and transient headache or dizziness
- nausea, stomach pain, upset stomach, diarrhea and vomiting
Uncommon (may affect up to 1 in 100 people)
- weight loss (anorexia), weight changes, difficulty sleeping, depression
- eye disorders (conjunctivitis)
- sensation of vertigo, ringing in the ear (tinnitus)
- cardiac arrest, irregular heartbeats, faster heartbeat, feeling flushed
- constipation, wind, belching, dry mouth, stomach inflammation, stomach or duodenal ulcer, upper stomach pain, duodenal ulcer, mouth ulcers
- increased liver function test values (found in blood tests) and feeling unwell (malaise)
- rash, itching, increased sweating, redness of the skin (erythema), angio-edema (rapid swelling of the deeper layers of the skin, usually of the face), hives, edema, stuffy nose like an allergy (rhinitis)
- hair loss
- joint pain (arthralgia)
Rare (may affect up to 1 in 1,000 people)
- sore throat
- decreased number of red blood cells (anemia) and white blood cells (thrombocytopenia and leukopenia), weakness
- hypersensitivity, anaphylactoid reaction and anaphylaxis (usually manifested by swelling of the face, flushing, difficulty in breathing and dizziness)
- confusion, nervousness, agitation, feeling sleepy, tingling sensation, altered sense of taste, tremors, headache, disturbed vision
- increased blood pressure, flushing
- bleeding, bruising, increased bleeding time
- difficulty in breathing, cough, bronchospasm
- perforated ulcer, vomiting with blood, gastrointestinal bleeding, tar-colored stools
- inflammation of the mouth, inflammation of the esophagus (oesophagitis), gastroesophageal reflux, difficulty in swallowing, mouth ulcers, inflammation of the tongue
- skin disorders, such as eczema, rash, purpura (red or purple spots)
- pain of bones, muscles, muscle cramps
- urinary problems such as needing to urinate frequently during the night, increased levels of urea and creatinine in the blood
- kidney disorders, including inflammation of the kidneys
Very rare (may affect up to 1 in 10,000 people)
- liver damage, hepatitis (inflammation of the liver), jaundice, cholestasis (interruption of the flow of bile from the liver)
- hematoma, edema (swelling), severe skin problems (Steven-Johnson syndrome, toxic epidermal necrolysis)
- aseptic meningitis in patients suffering from systemic lupus erythematosus and other connective tissue disorders
- changes in blood composition, bleeding under the skin (bruising)
- renal toxicity
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 http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Protect from moisture
Do not use this medicine after the expiry date which is stated on the package after EXP :.
The expiry date refers to the last day of that month.
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.
Deadline "> Other information
What Noxon contains
The active ingredient is: lornoxicam.
Each tablet contains 8 mg of lornoxicam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate macrogol 6000, titanium dioxide (E171), talc, hypromellose.
What Noxon looks like and contents of the pack
Noxon tablets are film-coated with a pre-break line Noxon is packaged in blister packs. The pack contains 30 film-coated tablets.
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 -
NOXON 8 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each tablet contains:
active ingredient: lornoxicam 8 mg.
Excipients: lactose monohydrate:
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM -
Film-coated tablets.
The tablet can be divided into equal halves
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
• Treatment of moderate and severe pain.
• Symptomatic treatment of pain and inflammation associated with inflammatory or degenerative rheumatic diseases.
04.2 Posology and method of administration -
Treatment of moderate and severe pain: a starting dose of 16 mg followed by a dose of 8 mg, up to a maximum of 32 mg in the first 24 hours. Subsequent daily doses should not exceed 16 mg.
Inflammatory and degenerative rheumatic affections
The appropriate dosing regimen should be established based on the patient's individual response. The recommended daily dose is 8-16 mg usually divided into two doses.
The use of the product is reserved for the treatment of adult patients.
Under treatment, the patient will have to be followed to define the optimal dosage schedule. The duration of treatment depends on the time and duration of the disease.
Undesirable effects can be minimized with the use of the shortest possible duration of treatment needed to control symptoms (see section 4.4).
The maximum recommended dose in patients with mild to moderate renal impairment or moderate hepatic impairment is 12 mg / day in 2 or 3 administrations (see section 4.4).
The maximum recommended dose in patients with gastrointestinal disorders is 8 mg / day. NOXON should be taken with a sufficient amount of liquid before meals.
In the treatment of elderly patients (see section 4.4), the posology must be carefully established by the physician, who will have to evaluate a possible reduction of the dosages indicated above.
Instructions for Use
NOXON tablets have a central incision line on one of the two sides, which allows them to be easily divided into two parts by simply pressing on the side bearing the incision.
04.3 Contraindications -
NOXON is contraindicated in the following cases:
• hypersensitivity to the active substance or to any of the excipients;
• hypersensitivity (symptoms such as asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs);
• gastrointestinal, cerebrovascular or other bleeding phenomena
• previous episodes of gastrointestinal bleeding or perforation associated with previous NSAID therapy
• previous or ongoing episodes of haemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding)
• thrombocytopenia;
• severe renal insufficiency (serum creatinine> 700 μmol / L)
• severe hepatic insufficiency;
• Known or suspected pregnancy, lactation, pediatric age (see section 4.6).
• severe heart failure.
04.4 Special warnings and appropriate precautions for use -
In the presence of the following situations, lornoxicam should only be administered after careful risk-benefit assessment:
• Renal insufficiency: Lornoxicam should be administered with caution in patients with mild (serum creatinine 150-300 μmol / L) to moderate (serum creatinine 300 - 700 μmol / L) renal insufficiency as maintenance of renal blood flow is dependent on prostaglandins kidney. In such patients the maximum recommended daily dosage is 12 mg, divided into 2 or 3 administrations. Should deterioration of renal function be observed during treatment, the administration of lornoxicam should be discontinued.
• Renal function should be monitored in patients undergoing major surgery, heart failure, treatment with diuretics or concomitant treatment with medicinal products that are suspected or known to cause renal damage.
• Patients with bleeding disorders: Close clinical monitoring and careful evaluation of laboratory tests (eg APTT) is recommended.
• Hepatic insufficiency (eg cirrhosis of the liver): in patients with hepatic insufficiency, clinical monitoring and evaluation of laboratory tests should be instituted at regular intervals since, following treatment with daily doses of 12-16 mg, an accumulation of lornoxicam (increased AUC). Accumulation phenomena aside, hepatic insufficiency does not appear to affect the pharmacokinetic parameters of lornoxicam, which are however comparable to those observed in healthy subjects. In patients with moderate hepatic insufficiency, the maximum recommended daily dosage is 12 mg, divided into 2 or 3 doses.
• Prolonged treatment (over 3 months): regular laboratory tests are recommended, indicative of hematology (hemoglobin), renal function (creatinine) and liver enzymatic activity.
• Elderly patients over 65 years of age: monitoring of renal and hepatic function is recommended. Precautions should be extended in the case of elderly patients who have recently undergone surgery. Noxon should be administered with caution in the elderly as gastrointestinal adverse effects are less tolerated in these patients.
The use of NOXON should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and underlying gastrointestinal and cardiovascular risks).
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3) and in elderly patients, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Clinical monitoring at regular intervals is recommended.
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking NOXON, the treatment should be discontinued.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). Adequate monitoring and instruction are required in patients with a history of hypertension and / or heart failure. mild to moderate congestive since fluid retention and edema have been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke). There are insufficient data to exclude such a risk for lornoxicam.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with lornoxicam after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). In the early stages of therapy, patients appear to be higher risk: the onset of the reaction occurs in most cases within the first month of treatment. NOXON should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Caution is needed in patients with a previous or concomitant history of bronchial asthma, as NSAIDs can precipitate bronchospasm in this category of subjects.
There may be an increased risk of aseptic meningitis in patients with systemic lupus erythematosus and various connective tissue disorders.
.
Like any other NSAID, NOXON also reduces platelet aggregation by lengthening the bleeding time. Therefore careful attention is required when administering NOXON to patients with an increased bleeding tendency.
In the "setting of" spinal or epidural anesthesia, concomitant treatment with NSAIDs and heparin increases the risk of spinal / epidural hematoma (see section 4.5).
The risk of nephrotoxicity may increase in case of concomitant treatment with NSAIDs and tacrolimus as a consequence of limited renal synthesis of prostacyclin. Therefore, renal function should be closely monitored in patients undergoing such combination therapy.
As with many NSAIDs, occasional increases in serum transaminase levels, increases in serum bilirubin or other liver parameters, increases in serum creatinine and blood urea nitrogen and other laboratory abnormalities have been reported. are significant or persist over time, lornoxicam administration should be discontinued and appropriate investigations prescribed.
The use of NOXON, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. NOXON administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations. .
Exceptionally, chickenpox can be at the origin of serious infectious complications of the skin and soft tissues. To date, an active role of NSAIDs in the worsening of these infections cannot be excluded.
Therefore, it is advisable to avoid the use of lornoxicam in case of chickenpox.
In the absence of data on safety and efficacy, the use of lornoxicam is not recommended in children and adolescents under 18 years of age.
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not be treated with this medicinal product.
04.5 Interactions with other medicinal products and other forms of interaction -
The concomitant intake of NOXON and:
• Cimetidine: increased serum concentrations of lornoxicam
- Anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin (see section 4.4) with an increased risk of bleeding. Careful monitoring of the INR should be undertaken.
• Phenprocoumon: decreases the effect induced by Phenprocoumon.
• Antiplatelet agents: increased risk of bleeding
• Heparin and low molecular weight heparins: increased risk of bleeding: NSAIDs increase the risk of spinal or epidural hematomas when administered concomitantly with heparin as part of a spinal or epidural anesthesia.
• Loop diuretics and thiazide diuretics: decreases the diuretic effect and antihypertensive efficacy of loop diuretics and thiazides
• Potassium-sparing diuretics: decreases the diuretic effect and antihypertensive efficacy, hyperkalaemia or possible nephrotoxicity
• ACE inhibitors: the antihypertensive effects of ACE inhibitors may decrease
• Beta-blockers: reduction of the antihypertensive efficacy
• Angiotensin II antagonists: I reduction of the antihypertensive efficacy
• Digoxin: reduction of the renal clearance of digoxin (toxicity: nausea, vomiting, arrhythmia).
• Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
• Quinolone antibiotics (Quinolone): increases the risk of seizures
• Acetylsalicylic acid, NSAID including ketorolac, increased risk of gastrointestinal bleeding.
• Methotrexate: increases the serum concentration of methotrexate. It can increase toxicity. When it is necessary to use combination therapy, careful monitoring should be performed.
• Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)
• Lithium, can increase lithemia beyond toxicity limits. Therefore, especially at the initiation of therapy, serum lithium levels should be monitored to correct or discontinue treatment.
• Ciclosporin: increases the serum concentration of cyclosporine. The nephrotoxicity of cyclosporine may be increased by a prostaglandin-mediated renal effect. Renal function should be monitored during combination therapies.
• Sulfonylureas, can increase their hypoglycemic effect.
• Tacrolimus: due to the limited synthesis of prostacyclin in the kidney, the risk of nephrotoxicity increases. Renal function should be monitored during concomitant treatment.
• Pemetrexed: the renal clearance of pemetrexed decreases, increasing its serum concentration, causing myelosuppression, renal and gastrointestinal toxicity).
Food intake can decrease absorption by about 20% and increase Tmax values.
04.6 Pregnancy and breastfeeding -
Pregnancy
Lornoxicam is contraindicated in the third trimester of pregnancy and should not be taken during the first and second trimester of pregnancy (including delivery), as no clinical data in these conditions are available.
There are insufficient data on the use of lornoxicam in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Inhibition of prostraglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation after use of a prostraglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with increasing dosage and duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has been shown to increase embryo loss before and after implantation and embryo-fetal lethality.
During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be given unless clearly needed.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and to renal dysfunction, which can progress to renal failure and therefore to a reduced amount of amniotic fluid. At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and fetus to prolonged bleeding time and inhibition of uterine contractions resulting in delayed or prolonged labor. Therefore, the use of lornoxicam is contraindicated during pregnancy. the third trimester of pregnancy (see section 4.3)
Feeding time
There are no data on the excretion of lornoxicam in human milk. Lornoxicam is excreted in the milk of rats at relatively high concentrations. Therefore NOXON should not be administered during lactation.
04.7 Effects on ability to drive and use machines -
Patients who experience dizziness and / or drowsiness under treatment with NOXON should refrain from driving vehicles or operating dangerous machinery.
04.8 Undesirable effects -
The most commonly observed adverse events with NSAIDs are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of NSAIDs (see section 4.4). Gastritis has been observed less frequently.
Approximately 20% of patients treated with lornoxicam may experience adverse reactions. The most frequent adverse events of lornoxicam include nausea, dyspesia, indigestion, abdominal pain, vomiting and diarrhea. Based on the available studies, these symptoms were generally observed in less than 10% of patients.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Clinical and epidemiological studies suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke) (see section 4.4) There are insufficient data to rule out such a risk with lornoxicam.
Very common (≥1 / 10), Common (≥1 / 100,
Infections and infestations:
Rare: pharyngitis.
Disorders of the blood and lymphatic system:
Rare: anemia; thrombocytopenia; leukopenia, increased clotting time,
Very rare: bruising. NSAIDs, as a class effect, can cause potentially serious haematological disorders, such as neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia.
Immune system disorders:
Rare: hypersensitivity, anaphylaxis, anaphylactoid reactions.
.
Metabolism and eating disorders:
Uncommon: anorexia, weight changes
Psychiatric disorders:
Uncommon: insomnia, depression.
Rare: confusion, nervousness, agitation.
Nervous system disorders:
Common: mild and transient headache, dizziness
Rare: drowsiness, paraesthesia, changes in taste, tremors, migraines.
Very rare: aseptic meningitis in patients with systemic lupus erythematosus and various connective tissue disorders.
Eye disorders:
Uncommon: conjunctivitis
Rare: vision disturbances.
Ear and labyrinth disorders:
Uncommon: dizziness, tinnitus
Cardiac disorders:
Uncommon: palpitations, tachycardia, edema, heart failure
Vascular disorders:
Uncommon: redness, edema
Rare: hypertension, hot flashes, haemorrhage, hematoma
Respiratory, thoracic and mediastinal disorders:
Uncommon: rhinitis
Rare: dyspnoea, cough, bronchospasm
Gastrointestinal disorders:
Common: nausea, abdominal pain, dyspesia, diarrhea, vomiting
Uncommon: constipation, flatulence, belching, dry mouth, gastric ulcer, gastritis, upper abdominal pain, duodenal ulcer and mouth ulceration
Rare: melaena, haematemesis, stomatitis, oesophagitis, gastroesophageal reflux, dysphagia, aphthous stomatitis, glossitis, gastrointestinal haemorrhage, perforated peptic ulcer.
Hepatobiliary disorders:
Uncommon: increased levels of liver function parameters, SGPT (ALT) or SGOT (AST)
Very rare: hepatotoxicity, including e.g. liver failure, hepatitis, jaundice and cholestasis.
Skin and subcutaneous tissue disorders:
Uncommon: rash, pruritus, increased sweating erythematous rash, angioedema and urticaria, alopecia.
Rare: dermatitis, eczema, purpura.
Very rare: edema, bullous reactions such as erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders:
Uncommon: arthralgia
Rare: bone pain, muscle spasms, myalgia
Renal and urinary disorders:
Rare: nocturia, interstitial nephritis, nephrotic syndrome, papillary necrosis, membranous nephropathy, urination disturbances, increased blood urea nitrogen and creatinine levels.
Very rare: lornoxicam can precipitate "acute renal failure in patients with pre-existing renal impairment and whose maintenance of renal blood flow depends on renal prostaglandin (see section 4.4). Nephrotoxicity in various forms, including nephritis and nephrotic syndrome, has been associated with NSAIDs as a class effect.
General disorders and administration site conditions:
Uncommon: malaise, face edema.
Rare: asthenia
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose -
Currently there is no clinical experience on overdose to allow a definition of the consequences, or to identify specific remedies. However, following lornoxicam overdose, the onset of the following symptoms can be expected: nausea, vomiting, brain symptoms (dizziness, disturbed vision). Severe symptoms are ataxia which can progress to coma, cramps, liver damage and kidney and possible bleeding disorders.
In the event of an actual or suspected overdose, the drug should be discontinued.
Lornoxicam is rapidly excreted due to its short half-life. The drug is not dialysable. No specific antidote is currently known.
Measures should be taken to reduce the absorption of the substance (such as the immediate administration of charcoal or cholestyramine); gastric lavage can also be considered.
Gastrointestinal disorders can be treated with a prostaglandin analog or ranitidine.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Therapeutic drug category: anti-inflammatory and antirheumatic, non-steroidal, oxicam.
ATC code: M01AC05
Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID), with analgesic properties and belonging to the class of oxicams. The mechanism of action is mainly linked to the blocking of prostaglandin synthesis through the inhibition of cyclooxygenase, which leads to the desensitization of peripheral nociceptors and the inhibition of inflammation. A central effect on nociception has also been hypothesized which appears to be independent of the anti-inflammatory effects.
Lornoxicam has no effect on vital signs (e.g. body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).
The analgesic properties of lornoxicam have been successfully demonstrated in several studies conducted during the clinical development of the drug.
Due to local gastrointestinal irritation and a systemic ulcerogenic effect related to inhibition of prostaglandin (PG) synthesis, gastrointestinal sequelae are common undesirable effects observed following treatment with lornoxicam, as also evidenced with other NSAIDs.
05.2 "Pharmacokinetic properties -
Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentration values are reached after approximately 1-2 hours. The absolute bioavailability (calculated as AUC) of NOXON is 90-100%. A first pass effect was not observed. The mean elimination half-life is 3-4 hours and is almost unchanged in elderly patients and in those with hepatic or renal insufficiency. Except for the accumulation phenomena that occur in patients with chronic liver disease treated for 7 days with doses daily of 12 and 16 mg, no significant changes in the kinetic profile of NOXON were observed in elderly patients and in those with hepatic or renal insufficiency.
Lornoxicam is present in the plasma in unchanged form and to a lesser extent as a hydroxylated metabolite, devoid of pharmacological activity. The plasma protein binding, especially with the albumin fraction, is 99% and is independent of the plasma concentration. It is also found in synovial fluid after repeated administration. Tmax is approximately 1-2 hours after oral administration.
Lornoxicam is completely metabolised: approximately 2/3 is eliminated via the liver and 1/3 via the kidney as an inactive substance. In animal model tests, NOXON did not induce hepatic enzyme induction.
Based on clinical data, there is no evidence of accumulation of lornoxicam after repeated dosing at recommended doses. The concomitant intake of lornoxicam with food reduces the Cmax values by about 30%, increases the Tmax values from 1.5 to 2.3 hours and decreases the absorption by up to 20% (calculated on AUC).
Simultaneous administration of antacids does not change the kinetics of lornoxicam.
05.3 Preclinical safety data -
Based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential, preclinical data demonstrate the absence of particular hazards for humans.
In several species, lornoxicam caused renal toxicity and gastrointestinal ulceration in single and repeated dose toxicity studies.
In animals, administration of prostaglandin synthesis inhibitors has been shown to increase embryo loss before and after implantation and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular malformations, have been reported in animals given prostaglandin synthesis inhibitors during the organ genetic period.
In the rat, lornoxicam interfered with fertility (effects on ovulation and implantation), and had consequences during pregnancy and parturition. In rabbits and rats, due to inhibition of the cyclo-oxygenase, lornoxicam induced premature closure of the arterial duct.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose, lactose monohydrate, macrogol 6000, titanium dioxide (E 171), talc, hypromellose.
06.2 Incompatibility "-
Not applicable.
06.3 Period of validity "-
5 years.
06.4 Special precautions for storage -
Store away from humidity.
06.5 Nature of the immediate packaging and contents of the package -
PVC / PVDC / aluminum blisters.
Pack sizes: 30 8 mg film-coated tablets
06.6 Instructions for use and handling -
Not applicable.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
GRÜNENTHAL ITALIA S.r.l. - Via Carlo Bo, 11 - 20143 Milan
Under license from: Nycomed Austria GmbH - Linz (Austria)
08.0 MARKETING AUTHORIZATION NUMBER -
NOXON 8 mg Film-coated tablets: 30 tablets - AIC n. 029294030
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
February 19, 2011
10.0 DATE OF REVISION OF THE TEXT -
April 2, 2015