Ibuprofen 200 mg. 100 tablets

What Ibuprofen is and what it is used for
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs. It has mild to moderate anti-inflammatory and antipyretic effects.
Ibuprofen is absorbed in the gastrointestinal tract. Peak serum concentration of ibuprofen is reached 1-2 hours after oral administration.
Gastro-intestinal secretagogues and drugs do not impair the absorption of ibuprofen.

Therapeutic indications:
Relieves pain, lowers body temperature and reduces inflammation.
It applies to headaches, neuralgia, toothache, backache, menstrual pains, rheumatic and muscular pains, colds and flu, accompanied by a rise in temperature. The medicine is taken during or after a meal.

2. What you need to know before taking Ibuprofen
Do not take Ibuprofen:

if you are allergic to ibuprofen or any of the other ingredients of this medicine listed in section 6;
if you have or have had an active stomach or duodenal ulcer, perforation or bleeding, including after non-steroidal anti-inflammatory drugs;
if you have severe liver, kidney or heart failure;
if you have or have had hypersensitivity reactions such as inflammation, urticaria or bronchial asthma after taking aspirin or other NSAIDs;
if you are in the last trimester of pregnancy;
if you are taking other NSAIDs, also COX-2 selective inhibitors due to an increased risk of side effects;
if you suffer from haemorrhagic diathesis.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Ibuprofen Polfa.
There is a risk of gastrointestinal haemorrhage, ulceration or perforation, which may be fatal. These incidents occur following warning symptoms, but in some patients such symptoms may be absent. In case of gastrointestinal bleeding or ulceration, treatment with ibuprofen is discontinued. Patients with a history of gastrointestinal disease, especially older, should report to the treating physician any unusual symptoms (especially bleeding). Particular attention is needed in the initial stage of therapy.
Patients should take as low a dose as possible for the shortest possible period of time.
Special care is needed in patients taking ibuprofen and other medications that increase the risk of gastrointestinal bleeding such as corticosteroids and anticoagulants / acecumarol / or anti-aggregates such as aspirin.
Taking ibuprofen, as with other NSAIDs, is associated with a slightly increased risk of a cardiovascular event (myocardial infarction or stroke). This risk is increased by taking high doses over a long period of time. Do not take higher doses for more than 3 days without consulting a doctor.
In case of heart problems, stroke or at a suspected risk of these conditions (eg high blood pressure, diabetes, elevated cholesterol levels, smoking) contact your doctor or pharmacist to discuss the treatment.
The use of this drug in patients with tumors requires caution. Concomitant, long-term use of analgesics may lead to kidney damage and a risk of kidney failure.
Severe skin reactions, some of which fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with NSAIDs. An increased risk of these severe reactions occurs at the beginning of therapy, in the first month in most cases. Treatment should be discontinued at first symptoms such as skin rash, mucosal lesions or other signs of hypersensitivity. An increased risk of developing aseptic meningitis occurs in patients with lupus erythematosus and mixed connective tissue disorders.
Bronchospasm can occur in patients with a history of active bronchial asthma or a history of such an allergic disease.
Ibuprofen may cause visual disturbances - scarred vision and disturbances in color vision. In these cases, the medicine is stopped and an ophthalmologist is consulted.
Ibuprofen has an anticoagulant effect, which should be taken into account when treating patients with blood clotting problems that are being treated with anticoagulants.
This drug belongs to the group of NSAIDs that reversibly affect fertility in women. The effect disappears after discontinuation of treatment.
The lowest effective dose needed to achieve adequate treatment should be used for the shortest possible period of time.
If other disturbing symptoms occur during treatment with ibuprofen, it is necessary to consult a doctor, and the medicine is stopped.

Contact your doctor even if the above warnings refer to situations that have occurred in the past.

Treatment in infancy:
Do not give this medicine to children under 12 years of age.
There is a risk of kidney damage in dehydrated children and adolescents.

Treatment with ibuprofen
You should discuss treatment with your doctor or pharmacist before taking Ibuprofen  if:

have heart problems, including heart failure and angina (chest pain), or have suffered a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to tight or blocked arteries) or any type of stroke including a microinvestigation or a transient ischemic attack);
have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke or if you are a smoker.
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The use of ibuprofen during the first 6 months of pregnancy should be a prescription only.
Do not take ibuprofen during the last 3 months of pregnancy.
Ibuprofen and its metabolites penetrate into breast milk at very low concentrations. It is unusual for ibuprofen at doses recommended for the treatment of pain and fever to have an unwanted effect on the newborn.

Driving and using machines
There is no evidence of a negative effect of ibuprofen on the ability to drive and use machines.

Other medicines and Ibuprofen
Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or are likely to take / use other medicines.

Ibuprofen may affect or be affected by some other medicines.
For example:

Anti-clotting drugs (ie dilute blood / prevent clotting, eg aspirin / acetylsalicylic acid, warfarin, ticlopidine);
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan);
Diuretics: there have been reports of decreased efficacy;
Anticoagulants: There are clinical data indicating that NSAIDs may potentiate the action of anticoagulants; NSAIDs may potentiate the action of anticoagulants such as acecumarol;
Lithium and methotrexate: NSAIDs may increase the plasma concentrations of Lithium and Methotrexate. It is advisable to monitor serum levels;
Zidovudine: there have been reports of prolongation of bleeding time with concomitant use;
Corticosteroids: Concomitant use of NSAIDs increases the risk of side effects, especially on the gastrointestinal tract;
Cardiac glycosides - NSAIDs may exacerbate heart failure and increase the plasma concentration of glycosides;
Mifepristone: NSAIDs used 8-12 days after administration may reduce its effectiveness;
Cyclosporine - Concomitant use increases the risk of nephrotoxicity;
Quinolones - Concomitant use increases the risk of convulsions.
Some other medicines can also affect or be affected by treatment with Ibuprofen Polfa. Therefore, always before using Ibuprofen Polfafe with other medicines, you should consult your doctor or pharmacist.

3. How to take ibuprofen
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults and children over 12 years of age
Initially 2 tablets taken with water. Then - 1 - 2 tablets every 4 hours, if necessary.
Do not take more than 6 tablets a day.
Do not take the medicine for more than 3 days without consulting a doctor.
If, despite treatment, pain and temperature worsen or new symptoms develop after the first 2 days, contact a doctor.
Consult a doctor if ibuprofen is to be used for more than 3 days in children from 6 months of age (between 6 months and 12 years) or adolescents (between 12 and 18 years of age) and in case of deterioration symptoms.
If you have the impression that the effect of Ibuprofen Polfa is stronger or weaker, talk to a doctor.

If you take more Ibuprofen than you should
The following symptoms may occur with NSAIDs at doses higher than recommended: nausea, vomiting, abdominal pain or diarrhea in rare cases. Tinnitus, headache, dizziness or gastrointestinal bleeding may also occur. Severe poisoning affects the central nervous system, which is manifested by drowsiness or agitation, disorientation or coma in very rare cases. Very rarely convulsive seizures are observed. Metabolic acidosis and prothrombin time (INR) may increase in severe intoxication. Acute kidney failure and liver lesions, shortness of breath, sudden drop in blood pressure, bradycardia or tachycardia and atrial fibrillation may occur. Sharpening of asthma symptoms may occur in patients with bronchial asthma.
If you take too much ibuprofen, talk to your doctor who will help you throw away
If you forget to take Ibuprofen 
Do not take a double dose to make up for the missed tablet.
Take the next dose according to the established treatment schedule.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects are listed by frequency and location, starting with the most common side effects, with the following convention: very common (=> 1/10), common (=> 1/100 to 1/10), uncommon (=> 1/1 000 to 1/100), rare (=> 1 / 10,000 to 1 / 1,000) and very rare (<1 / 10,000).

Gastrointestinal diseases

Uncommon: Dyspepsia, abdominal pain, nausea, epigastric pain, elastic abdominal pain, epigastric discomfort, heartburn;
Rare: Diarrhea, constipation, vomiting and gastritis;
Very rare: Bleeding from the gastrointestinal tract, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
Stomach and / or duodenal ulcer, perforation and bleeding, sometimes fatal, especially in older patients.
Diseases of the nervous system

Uncommon: headache;
Rare: Dizziness, dizziness, insomnia or drowsiness, agitation, nervousness and fatigue;
Very rare: Aseptic meningoencephalitis, disorders of consciousness.
Psychiatric disorders

Very rare: Depression and emotional disturbances.
Diseases of ear and labyrinth

Very rare: tinnitus and hearing disorders.
Eye diseases

Uncommon: Scots, blurred vision, diplopia, and color vision disorders.
Diseases of the kidneys and urinary tract

Very rare: Azotemia, haematuria, renal failure, including acute renal failure, papillary necrosis, creatinine clearance reduction, polyuria, oliguria and hypernatraemia (sodium retention).
Liver and biliary diseases

Very rare: Hepatic function abnormalities, positive liver function tests, especially in prolonged use, hepatitis and jaundice.
Diseases of blood and lymph

Very rare: agranulocytosis, aplastic anemia, haemolytic anemia, sometimes with a positive Coomb test, eosinophilia, leucopenia, neutropenia, thrombocytopenia with or without purpura, reduction in hemoglobin concentration or hematocrit levels.
Skin and connective tissue diseases

Common: Rash, including maculopapular;
Uncommon: Urticaria, pruritus and alopecia;
Very rare: Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Metabolic and nutritional disorders

Common: Loss of appetite.
Diseases of the immune system

Uncommon: Sickness syndrome, including abdominal pain, fever, fever, nausea and vomiting;
Very rare: Acute hypersensitivity reactions - swelling of the face, tongue and larynx, dyspnoea, hypotension, tachycardia or acute shock, bronchospastic reactions, exacerbation of bronchial asthma or bronchospasm.
Heart diseases

Edema, hypertension or heart failure have been reported with high doses of NSAIDs;
Clinical and epidemiological studies suggest that the use of Ibuprofen, especially at high doses (over 2400 mg / day) and prolonged treatment, may be associated with a slightly increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).
Other:

Uncommon: Dry mouth, gum ulceration and rhinitis.
Packaging content and additional information
What Ibuprofen Polpha contains
Active substance: ibuprofen 200 mg.

The other ingredients (excipients) are:
Core:

Povidone (25) - 4.5 mg;
Lactose monohydrate - 65.0 mg;
Potato starch - 50.0 mg;
Talc - 7.0 mg;
Silica, colloidal anhydrous - 1.0 mg;
Magnesium stearate - 2.5 mg.
Coverage:

Sucrose - 149.85 mg;
Talc - 44.5 mg;
Arabic gum (dry spray) - 5.0 mg;
Carnauba wax - 0.1 mg;
White wax - 0.05 mg;
Cochinil red - 0.5 mg.
Blister of PVC / AL foil and contains 10 coated tablets. The pack contains 20 or 100 tablets in a cardboard box.

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