Active ingredients: Inbuprofen
Cibalgina Due Fast 200 mg gastro-resistant tablets
Why is Cibalgina due Fast used? What is it for?
Cibalgina Due Fast contains the active substance ibuprofen, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Cibalgina Due Fast works by reducing pain, inflammation and fever. Cibalgina Due Fast is indicated for the treatment of pain of various origins and nature, including:
- headache
- toothache
- neuralgia
- pain in the bones and joints
- pain in the muscles
- menstrual pain The medicine is also indicated as an adjunct therapy in the treatment of fever and flu symptoms.
Talk to your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.
Contraindications When Cibalgina due Fast should not be used
Do not take Cibalgina Due Fast
- if you are allergic to ibuprofen, or any of the other ingredients of this medicine;
- if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics), fever (antipyretics) such as non-steroidal anti-inflammatory drugs (NSAIDs), particularly when the allergy is associated with swelling of the nasal mucosa (polyposis nasal) or asthma, and presents with an asthmatic reaction (bronchospasm), hives or severe cold (acute rhinitis) (see section "Warnings and precautions");
- if you have ever had a severe ulcer in the stomach or the upper part of the intestine
- if you have an ongoing "ulcer
- if you have ever had bleeding or ulcer that occurred repeatedly (two or more distinct episodes of proven ulceration or bleeding)
- if you have ever had stomach and / or bowel bleeding (haemorrhage) or perforation after previous treatment with other medicines
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding
- if you have severe liver or kidney failure
- if you have severe heart failure
- if you have a "change in the production of blood cells, the cause of which is unknown
- if you are in the last 3 months of pregnancy (see section "Pregnancy, breast-feeding and fertility")
- if the patient is a child under the age of 12.
Precautions for use What you need to know before taking Cibalgina due Fast
Talk to your doctor or pharmacist before taking Cibalgina Due Fast.
Anti-inflammatory / pain-relieving drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your therapy with your doctor or pharmacist before taking Cibalgina Due Fast if you have:
- heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blocked arteries) or any type of stroke ( including "mini-stroke" or "TIA", transient ischemic attack);
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.
Take special care and ask your doctor or pharmacist for advice:
- if you are a woman and are planning to become pregnant
- if you are a woman and have fertility problems or are undergoing fertility investigations, why should you stop taking Cibalgina Due Fast
- if the patient is a teenager with dehydration problems, as in this case the medicine can cause kidney problems
- if you have asthma
- if you have an allergic seasonal cold (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
- if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
- if you have liver, kidney or heart problems unless you have severe liver, kidney or heart failure because in these latter cases you should not take Cibalgina Due Fast (see section 2 "Do not take Cibalgina Due Fast "). If you are unsure, ask your doctor.
- if you have liver porphyria
- if you have or have had ulcerative colitis or Crohn's disease as these conditions may get worse
- if you are using medicines that increase urine production (diuretics) or other medicines that can affect the way your kidneys work
- if you have a low volume of body fluids (for example before or after major surgery)
- if you are due to undergo or have had major surgery
- if you have problems with your stomach or intestines, unless you have one or more conditions for which you should not take Cibalgina Due Fast (see section "Do not take Cibalgina Due Fast")
- if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids given by mouth, by injection or rectally (e.g. cortisone), blood thinners (e.g. warfarin) , selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Cibalgina Due Fast")
- if you have an autoimmune disease eg. Lupus erythematosus or connective tissue diseases
In these cases, your doctor will monitor you closely and periodically re-evaluate the need for treatment with Cibalgina Due Fast. In addition, your doctor may have you have periodic tests (such as monitoring your kidney function) to evaluate your condition during treatment with Cibalgina Due Fast.
Stop treatment and tell your doctor if during treatment with Cibalgina Due Fast you develop:
- gastrointestinal bleeding or ulceration
- sudden or severe skin reactions, as severe skin reactions which can be fatal have been reported very rarely
- mucosal lesions or any other signs of an allergic reaction
- fluid retention and swelling from fluid accumulation (edema)
- signs and symptoms of liver problems or if your liver function parameters are abnormal (visible in blood tests)
- unusual symptoms in the stomach and intestines especially at the beginning of treatment with Cibalgina Due Fast
- fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound tiredness, unexplained bruising and bleeding because you may have a decrease in white blood cells (agranulocytosis)
- neck tension, headache, nausea, vomiting, fever, disorientation because you may be suffering from aseptic meningitis. Patients with autoimmune diseases (Systemic Lupus Erythematosus, connective tissue disease) appear to be more prone to developing aseptic meningitis
- symptoms of an "infection (eg headache, fever) or if you notice an infection worsening" as Cibalgina Due Fast can hide the signs and symptoms of the infection
In these cases, the doctor will decide whether to continue or stop treatment with Cibalgina Due Fast.
Other important information:
- During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulceration or perforation may occur, which can also cause death, and can occur at any time during treatment, with or without warning symptoms or a previous history. serious gastrointestinal events You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity and your doctor may prescribe medicines (eg misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
- Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 "How to take Cibalgina Due Fast").
- Avoid the use of ibuprofen during treatment with other NSAIDs given by mouth, by injection and rectally, including selective cyclo oxygenase-2 inhibitors, as it increases the chance that you will have side effects.
- Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more likely in patients with lupus erythematosus or connective tissue disease.
Children
Cibalgina Due Fast is contraindicated in children under 12 years of age.
Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or bowel bleeding and perforation, which are usually more serious and can be fatal.
If you are elderly you should take the lowest dosage of Cibalgina Due Fast.
As a precaution, your doctor may have you check your kidney function and prescribe medicines that work by protecting the gastrointestinal mucosa such as misoprostol or proton pump inhibitors.
Tell your doctor about any unusual stomach and bowel symptoms especially at the start of treatment with this medicine.
Interactions Which drugs or foods can modify the effect of Cibalgina due Fast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take special care and tell your doctor if you have to take Cibalgina Due Fast and you are already taking one or more of the medicines listed below, your doctor will monitor you and have you tested.
Cibalgina Due Fast can affect or be affected by other medicines. Eg:
- acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, corticosteroids)
- lithium (medicine for mood disorders)
- cardiac glycosides (medicines for the heart)
- medicines that have an anticoagulant effect (i.e. substances that thin the blood by preventing the formation of clots, e.g. aspirin / acetylsalicylic acid, warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
- diuretics, including potassium-sparing, particularly if you have kidney problems
- antidepressants such as selective serotonin reuptake inhibitors (medicines for depression)
- sulfonylureas (diabetes medicine)
- methotrexate (cancer medicine)
- cyclosporine and tacrolimus (immunosuppressants used to change the response of the body's immune system)
- medicines to fight bacterial infections of the quinolone class
- phenytoin (anti-epilepsy medicine)
- colestipol and cholestyramine (medicines to lower cholesterol)
- sulfinpyrazone, fluconazole and voriconazole
- zidovudine (medicine to treat AIDS).
Also some other medicines can influence or be affected by the treatment with Cibalgina Due Fast. Therefore, always consult your doctor or pharmacist before using Cibalgina Due Fast with other medicines.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
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.
Conception, first and second trimester of pregnancy
Do not take Cibalgina Due Fast during the first and second trimester of pregnancy without consulting your doctor. Your doctor will consider whether the benefits to you clearly outweigh the risks to the fetus.
If Cibalgina Due Fast is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
Third trimester of pregnancy
Cibalgina Due Fast is contraindicated during the third trimester of pregnancy because it can cause serious harm to the mother and baby.
Feeding time
Ibuprofen passes into breast milk in small amounts, however no effects on the baby are known to date.
However, do not use Cibalgina Due Fast while breastfeeding unless you have consulted your doctor first.
Fertility
Anti-inflammatories, including Cibalgina Due fast, can cause a reduction in fertility in women, which returns to normal after stopping treatment.
Driving and using machines
Cibalgina Due Fast may cause dizziness, tiredness and visual disturbances which may affect the ability to drive and use machines.
If you have these symptoms, avoid driving a vehicle or using machines.
Dose, Method and Time of Administration How to use Cibalgina due Fast: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults, elderly patients and adolescents over 12 years
- The recommended dose is 1-2 gastro-resistant tablets 2-3 times a day.
- Take the tablets with or after a meal, particularly if you have stomach problems. Cibalgina Due Fast tablets dissolve quickly in the mouth without leaving any unpleasant taste, pressing them with the tongue against the palate. You can drink water or another liquid after taking them if you wish.
Take care not to exceed the recommended dose and in any case do not exceed the maximum dose of 6 tablets (1200 mg) per day. Use this medicine for short periods of time only. If you are elderly you should use the lowest possible dose above.
Consult your doctor:
- if after 2-3 consecutive days of treatment with Cibalgina Due Fast you do not notice appreciable results
- if the patient is a teenager who has taken Cibalgina Due Fast for 3 days and it is necessary to continue the treatment
- if you notice worsening of the symptoms of the disease
Talk to your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.
If you forget to take Cibalgina Due Fast
Do not take a double dose to make up for a forgotten dose.
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 an overdose of Cibalgina due Fast
If you take an excessive dosage (overdose) of ibuprofen you may most commonly experience the following symptoms: nausea, vomiting, stomach pain, deep sleep with reduced response to normal stimuli (lethargy), sleepiness, headache, dizziness, buzzing in the ears (tinnitus), uncontrolled body movements (convulsions), lightheadedness and loss of consciousness. Symptoms of an overdose can occur within 4 to 6 hours of taking ibuprofen.
Rarely it may present: uncontrolled eye movements (nystagmus), increased acid in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney effects, stomach and bowel bleeding, profound loss of consciousness ( coma), momentary interruption of breathing (apnea), blue discoloration of the skin and mucous membranes (cyanosis), diarrhea, decreased activity of the nervous system (central nervous system depression) and respiratory activity (respiratory system depression).
In addition, it can also manifest: disorientation, a state of excitement, fainting, low blood pressure (hypotension), decreased or increased heartbeat (bradycardia or tachycardia), worsening of a pre-existing respiratory problem (asthma).
If you take too much ibuprofen it can cause severe kidney and liver damage. In case of accidental ingestion / intake of an excessive dose of Cibalgina Due Fast, notify your doctor immediately or contact the nearest hospital.
If you have any further questions on the use of Cibalgina Due Fast, ask your doctor or pharmacist.
Side Effects What are the side effects of Cibalgina due Fast
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms. Undesirable effects are dose dependent and may vary from patient to patient.
Should one of these effects appear during treatment with Cibalgina Due Fast, it is advisable to stop using the medicine and consult your doctor.
The most commonly observed adverse events are affecting the stomach and / or intestines. Ulcers of the stomach or the first part of the intestine (peptic ulcer), perforation or bleeding from the stomach and / or intestines may occur, which may be also fatal, particularly in the elderly.
In particular, the risk of bleeding from the stomach and / or intestine depends on the dose and duration of treatment.
In addition to the side effects listed below, dark bloody stools (melaena) and bloody vomiting (haematemesis) due to bleeding from the stomach, esophagus and duodenum have been reported after administration of Cibalgina Due Fast.
Medicines such as Cibalgina Due Fast may be associated with a modest increased risk of heart attack (heart attack) or stroke (see section "Warnings and precautions").
Common side effects (may affect up to 1 in 10 people)
- difficulty digesting (dyspepsia)
- pain in the abdomen
- nausea
- He retched
Uncommon side effects (may affect up to 1 in 100 people)
- allergic reactions including skin rash, hives, itching and asthma attacks
- headache
- dizziness
- insomnia
- agitation
- irritability
- fatigue
- rash on the skin
Rare side effects (may affect up to 1 in 1,000 people)
- ringing and ringing in the ears (tinnitus)
- impaired hearing
- ulcer of the stomach or upper part of the intestine (peptic ulcer)
- perforation or bleeding from the stomach and / or intestines
- inflammation of the lining of the mouth with ulceration (ulcerative stomatitis)
- stomach inflammation (gastritis)
- worsening of inflammation of the colon (colitis)
- worsening of a chronic inflammatory disease of the digestive system (Crohn's disease)
- failure of the kidneys
- damage to kidney tissue (papillary necrosis) (particularly in long-term therapy)
- increased concentration of uric acid in the blood
Very rare side effects (may affect up to 1 in 10,000 people)
- worsening of inflammation associated with infection (e.g. development of necrotizing fasciitis)
- reduction in the number of platelets in the blood (thrombocytopenia)
- anemia
- reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis)
- reduction in the number of all cells in the blood (pancytopenia)
- severe allergic reaction (anaphylactic reaction)
- swelling due to fluid accumulation (angioedema)
- aseptic meningitis (infection of the meninges, membranes of the brain)
- changes in tests to evaluate liver function
- liver problems, eg. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
- liver damage, especially in long-term therapy
- reactions of the skin and mucous membranes, including severe (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Not known side effects (frequency cannot be estimated from the available data)
- mental changes (psychotic reactions)
- depression
- visual disturbances
- irregular heartbeat (palpitations)
- swelling (edema)
- heart failure
- heart attack
- high blood pressure (hypertension)
- inflammation of the esophagus (esophagitis)
- inflammation of the pancreas (pancreatitis)
- narrowing of the intestine (diaphragmatic intestinal strictures)
- gas (flatulence)
- diarrhea
- constipation (constipation)
- edema formation particularly in patients with high blood pressure or kidney problems (renal failure, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure
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 www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
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 package after Expiry. 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.
Other information
What Cibalgina Due Fast contains
- The active ingredient is ibuprofen. Each tablet contains 200 mg of ibuprofen.
- The other ingredients are ethyl cellulose, phthalate cellulose acetate, maize starch, microcrystalline cellulose, saccharin, croscarmellose sodium, strawberry flavor, fumaric acid, silicon dioxide, magnesium stearate, anhydrous dibasic calcium phosphate.
Description of the appearance of Cibalgina Due Fast and contents of the pack
Each pack of Cibalgina Due Fast contains 12 or 24 gastro-resistant tablets in blister packs.
A blister holder is included in the pack of 24 gastro-resistant 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
CIBALGINA DUE FAST 200 MG GASTRORESISTANT TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains - Active ingredient: ibuprofen 200 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablets.
Round white or almost white tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pain of various origins and nature (headache, toothache, neuralgia, osteo-joint and muscle pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.
04.2 Posology and method of administration
Dosage:
Adults, seniors and adolescents over 12 years: 1-2 gastro-resistant tablets 2-3 times a day.
Do not exceed the dose of 6 tablets (1200 mg) within 24 hours.
Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above.
If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
Method of administration: the tablets dissolve quickly in the mouth without leaving any unpleasant taste, pressing them with the tongue against the palate. Follow up, if necessary, with a glass of water.
It is advisable to take the medicine with or after meals, particularly in the presence of gastric disorders.
Use only for short periods of treatment.
After 2-3 days of treatment without appreciable results, consult your doctor.
04.3 Contraindications
Do not administer under 12 years of age.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma, and presents with bronchospasm, urticaria or acute rhinitis (see also section 4.4).
Severe or active peptic ulcer.
History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Hematopoietic disorders of unknown origin.
Cerebrovascular or other haemorrhage.
Severe hepatic or renal insufficiency.
Severe heart failure.
Third trimester of pregnancy (see section 4.6)
04.4 Special warnings and appropriate precautions for use
General informations
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks).
The use of Cibalgina Due Fast, like any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. The administration of Cibalgina Due Fast should be suspended in women who have fertility problems or who are undergoing fertility investigations.
There is a risk of impaired renal function in dehydrated adolescents.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Like other NSAIDs, ibuprofen can mask the signs and symptoms of infection due to its pharmacodynamic properties.
The use of Cibalgina Due Fast should be avoided in conjunction with other NSAIDs, including selective COX-2 inhibitors (see section 4.5).
Gastrointestinal effects
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including ibuprofen, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
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.
When gastrointestinal bleeding or ulceration occurs in patients taking Cibalgina Due Fast the treatment should be discontinued.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), 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. For these patients and also for patients taking concomitant low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events, concomitant therapy with gastroprotective agents (misoprostol or proton pump inhibitors) should be considered (see below and section 4.5).
Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic 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 Cibalgina Due Fast, 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).
Hepatic effects
When ibuprofen is prescribed to patients with impaired liver function, close medical surveillance is required, as their condition may be exacerbated.
As with other NSAIDs, including ibuprofen, the values of one or more liver enzymes may increase. If ibuprofen is prescribed for an extended period of time, regular monitoring of liver function is indicated as a precautionary measure. If persistence or worsening of abnormal liver function values is observed, signs or symptoms consistent with the development are observed. development of liver disease or if other manifestations occur (eg eosinophilia, rash), treatment with ibuprofen should be discontinued. Hepatitis without prodromal symptoms may develop with the use of ibuprofen. Ibuprofen is contraindicated in severe hepatic insufficiency (see section 4.3).
Caution is required when ibuprofen is administered to patients with hepatic porphyria as the drug could trigger an attack.
Kidney effects
Since fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen, particular caution is required in patients with impaired cardiac and renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that may significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery. In these cases when ibuprofen is administered, monitoring of renal function is recommended as a measure Precautionary. Discontinuation of treatment is usually followed by a return to the pre-treatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency (see section 4.3).
Skin effects
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including ibuprofen (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment.
Cibalgina Due Fast should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Cardiovascular and cerebrovascular effects
Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (eg. or stroke) In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg / day) are associated with an increased risk of myocardial infarction.
Caution is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.
Pre-existing respiratory diseases
In patients with asthma, seasonal allergic rhinitis, edema of the nasal mucosa (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to those of allergic rhinitis), reactions to NSAIDs as exacerbation of asthma, Quincke's edema or urticaria are more frequent than in other patients. Particular caution is recommended in these (emergency-ready) patients.
Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma (see section 4.3).
Systemic lupus erythematosus (SLE) and mixed connective tissue disease
There may be an increased risk of aseptic meningitis in patients with SLE and mixed connective tissue disorders (see below and section 4.8).
Aseptic meningitis
Aseptic meningitis has been observed very rarely in patients treated with ibuprofen. Although this is likely to occur more likely in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in individuals without an underlying chronic disease.
04.5 Interactions with other medicinal products and other forms of interaction
Use caution in patients treated with any of the following medicines, as interactions have been reported in some patients.
Acetylsalicylic acid: As with other NSAIDs, co-administration of ibuprofen and acetylsalicylic acid is not recommended because it may increase the risk of adverse events (unless low-dose aspirin, not exceeding 75 mg / day, has been recommended. to the doctor).
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and uncertainties relating to their application to the clinical situation do not allow to draw firm conclusions for continued use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).
Other NSAIDs including selective COX-2 inhibitors: avoid concomitant use of two or more NSAIDs as this leads to an increased risk of adverse effects (see section 4.4).
Lithium: Ibuprofen can increase plasma concentrations of lithium, due to reduced elimination of the latter. Therefore, monitoring of serum lithium levels is recommended.
Cardiac glycosides: Ibuprofen, like other NSAIDs, can exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma concentrations of glycosides. Monitoring of serum glycoside levels is therefore recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, the concomitant use of ibuprofen with diuretics or antihypertensive agents (eg beta-blockers, ACE inhibitors, angiotensin II antagonists) may cause a reduction in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should undergo periodic blood pressure monitoring. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant treatment with diuretics Potassium sparing may be associated with increased serum potassium levels, which therefore should be monitored frequently (see section 4.4).
Corticosteroids: Concomitant administration of ibuprofen and corticosteroids may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Sulfonylureas: NSAIDs may potentiate the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen.
Methotrexate: NSAIDs can reduce the clearance of methotrexate through inhibition of tubular secretion. The administration of ibuprofen 24 hours before or after the administration of methotrexate can lead to an increase in the concentration of methotrexate and an increase in its toxic effect. , concomitant use of NSAIDs and high doses of methotrexate should be avoided. If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity. Furthermore, the potential risk of interactions should also be considered in low dose methotrexate treatment (
Ciclosporin and tacrolimus: The risk of a nephrotoxic effect due to cyclosporin and tacrolimus, due to reduced prostaglandin synthesis in the kidney, is increased by concomitant administration of some non-steroidal anti-inflammatory drugs, including ibuprofen. Therefore, ibuprofen should be given at lower doses than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored.
Fluoroquinolone antibacterials: There have been isolated cases of seizures which may have been induced by the concomitant use of fluoroquinolone and NSAIDs.
Phenytoin: When phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase. Therefore, monitoring of phenytoin plasma concentrations is recommended.
Colestipol and cholestyramine: when given concomitantly with ibuprofen, they can delay or decrease the absorption of the latter. Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after colestipol / cholestyramine administration.
Potent CYP2C9 inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitory agents (such as sulfinpyrazone, fluconazole and voriconazole) requires caution as it may lead to a significant increase in peak plasma concentrations and ibuprofen exposure due to inhibition. the metabolism of ibuprofen. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in S (+) - ibuprofen exposure from approximately 80 to 100% was shown. Therefore, a dose reduction of ibuprofen should be considered when administered concomitantly with potent CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.
Zidovudine: There is an increased risk of haematological toxicity when administered concomitantly with NSAIDs. There is evidence of an increased risk of haemarthroses and hematomas in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen.
04.6 Pregnancy and breastfeeding
Pregnancy:
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of embryo-fetal mortality.
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 first and second trimester of pregnancy, Cibalgina Due Fast should not be administered except in strictly necessary cases.
If Cibalgina Due Fast is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can exhibit:
• the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
• the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, Cibalgina Due Fast is contraindicated during the third trimester of pregnancy.
Feeding time:
Ibuprofen passes into breast milk in small amounts. Although no undesirable effects in the infant are known to date, caution should be exercised when ibuprofen is administered to a nursing woman.
Fertility:
There is evidence showing that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause a reduction in female fertility by effect on ovulation. This event is, however, reversible upon discontinuation of treatment.
04.7 Effects on ability to drive and use machines
Undesirable effects such as dizziness, fatigue and visual disturbances are possible after taking NSAIDs. If present, patients should not drive or operate machinery.
04.8 Undesirable effects
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
Side effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal bleeding is dose-dependent and duration of treatment.
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 Cibalgina Due Fast (see section 4.4).
Gastritis has been observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke) (see Section 4.4).
Adverse reactions are listed below by organ system class and frequency. Frequencies are defined as: very common (≥1 / 10); common (≥1 / 100,
1 This is probably related to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an "infection or worsening" infection appear during treatment with ibuprofen, it is recommended that the patient seek medical attention without delay. It will therefore be necessary to assess whether there is a need for anti-infective / antibiotic therapy.
2 The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bruising and bleeding.
3 The first symptoms are: neck tension, headache, nausea, vomiting, fever, disorientation. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed (see section 4.4).
4 Particularly in long-term therapy
04.9 Overdose
Symptoms:
Symptoms of overdose include central nervous system disorders such as headache, dizziness, tinnitus, lightheadedness and loss of consciousness (including myoclonic seizures in children), as well as abdominal pain, nausea, vomiting and diarrhea. Gastrointestinal bleeding and acute renal failure and liver damage are also possible. Hypotension, respiratory depression, cyanosis may also appear. An "exacerbation of the condition is possible in asthmatic patients."
Treatment:
There is no specific antidote for ibuprofen.
Treatment should be symptomatic and supportive and includes maintaining a patent airway and monitoring cardiac and vital signs until stabilization. Gastric emptying or oral administration of activated charcoal is indicated if the patient presents within one hour of ingestion of more than 400 mg / kg body weight. If ibuprofen has already been absorbed, alkaline substances should be administered to promote the excretion of ibuprofen in the urine. If frequent and prolonged, seizures should be treated with diazepam or IV lorazepam. Bronchodilators should be given for asthma. There is no specific antidote available.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Non-steroidal anti-inflammatory / antirheumatic drugs. ATC code: M01AE01.
Ibuprofen is a synthetic analgesic-anti-inflammatory, also endowed with a marked antipyretic activity. Chemically it is the progenitor of phenylpropionic derivatives. The analgesic activity is non-narcotic and is 8-30 times higher than that of acetylsalicylic acid. L "Ibuprofen is a potent inhibitor of prostaglandin synthesis and exerts its activity by inhibiting their synthesis.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
05.2 Pharmacokinetic properties
Absorption
Ibuprofen is rapidly absorbed from the gastrointestinal tract.
Peak blood concentrations occur between 1 and 2 hours after dosing.
Ibuprofen pharmacokinetics are linear at therapeutic doses.
Bioavailability is not affected by simultaneous food intake but when ibuprofen is taken immediately after a meal, there is a reduction in the rate of absorption but no significant reduction in the extent of absorption.
Cibalgina Due Fast comes in the form of gastro-resistant tablets, consisting of microencapsulated ibuprofen: the microgranules of ibuprofen are coated with cellulose acetophthalate which makes them resistant to the acid pH of the stomach, thus improving gastric tolerability. Once in the intestine, the microgranules dissolve and release the ibuprofen which is absorbed by the body.
Distribution
Ibuprofen is rapidly distributed throughout the body and the percentage of plasma protein binding is approximately 90-99%.
Biotransformation
Ibuprofen is not an enzyme inducer. Approximately 90% of a dose is metabolised by the liver (oxidation) as two inactive metabolites and eliminated primarily via the kidneys.
Elimination
Ibuprofen is rapidly excreted in the urine; 45 to 79% of the administered dose is eliminated within 24 hours in the form of metabolites or their glucuronide conjugates and a small amount of the drug is excreted via the bile.
In the urine, the percentages of free and conjugated ibuprofen are approximately 1 and 14%; the rest of the drug is eliminated in the faeces both as metabolites and as unabsorbed drug.
Ibuprofen has an elimination half-life of approximately 2-4 hours.
05.3 Preclinical safety data
In animal studies, the subchronic and chronic toxicity of ibuprofen was mainly characterized by lesion and ulcers in the gastrointestinal tract. In-vitro and in-vivo studies produced no clinically relevant evidence of mutagenic effects of ibuprofen. Studies in rats and mice revealed no carcinogenic effects on ibuprofen. Ibuprofen inhibited ovulation in rabbits and caused implantation disturbances in various animal species (rabbit, rat and mouse). Experimental studies in rats and rabbits showed that ibuprofen crosses the placental barrier. After administration of toxic maternal doses, there was an increased incidence of malformations (ventricular septal defects) in the rat offspring.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ethylcellulose; cellulose acetate phthalate; cornstarch; microcrystalline cellulose; saccharin; croscarmellose sodium; strawberry flavor; fumaric acid; silicon dioxide; magnesium stearate; anhydrous dibasic calcium phosphate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Rigid Polyamide / Aluminum / PVC blister welded to aluminum foil using a polyvalent heat-sealing lacquer.
Blister packs of 12 and 24 gastro-resistant tablets. A blister holder is also included in the pack of 24 tablets.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Consumer Health S.p.A. - Largo U. Boccioni 1, Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
12 gastro-resistant tablets - AIC: 029500030
24 gastro-resistant tablets - AIC: 029500055
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: January 2007
10.0 DATE OF REVISION OF THE TEXT
15 July 2014
