Reuprofen 200mg x 10cpr film Helcor

Reuprofen 200mg x 10cpr film Helcor

Therapeutic indications
Reuprofen ® is indicated for:

• symptomatic treatment of painful conditions: headache, migraine (treatment and prophylaxis), toothache, dysmenorrhea, osteoarticular and muscle pain (including tendinitis, bursitis, dislocations, sprains);
• symptomatic treatment of fever.

Contraindications

• Hypersensitivity to ibuprofen or any of the product's excipients;
• Active or previous peptic ulcer, gastrointestinal bleeding, ulcerative colitis, serious liver and/or kidney disorders. Because cross-reactivity between acetylsalicylic acid and other non-steroidal anti-inflammatory drugs has been reported, Reuprofen ® is contraindicated in patients with allergic reactions such as bronchial asthma, urticaria, rhinitis, nasal polyps and angioneurotic edema to this group of drugs;
• Systemic lupus erythematosus or other collagenoses.

Composition

Reuprofen 200 mg
One film-coated tablet contains ibuprofen 200 mg, excipients.

Doses and method of administration
Adults and children over 15 years: 200-400 mg ibuprofen, repeated as needed at 6-8 hour intervals, without exceeding 1200 mg ibuprofen.
Filmed tablets are swallowed whole, with a little water, preferably with meals.
In children under 15 years of age, the use of appropriate pharmaceutical forms is recommended.

Precautions

Patients who experience visual disturbances when taking Reuprofen ® should stop treatment and perform an ophthalmological examination.

Interactions

Diuretics : in some patients Reuprofen ® can reduce the natriuretic effects of thiazides or other diuretics, probably due to sodium retention associated with the inhibition of renal prostaglandin synthesis by Reuprofen ® or other non-steroidal anti-inflammatory drugs.

Anticoagulants : since ibuprofen can increase the effects of oral anticoagulants, the prothrombin time should be monitored during the first weeks of concomitant treatment. It may be necessary to change the dose of the anticoagulant.

Ticlopidine : since ibuprofen increases its antiplatelet activity, it is recommended to monitor the bleeding time.
Antihypertensives: antagonism of nonsteroidal anti-inflammatory drugs against the antihypertensive effect of beta-adrenergic blockers has been reported.

Glucocorticoids : the concomitant use of glucocorticoids may increase the ulcerogenic risk.

Acetylsalicylic acid: simultaneous administration of Reuprofen ® and acetylsalicylic acid or other non-steroidal anti-inflammatory drugs should be avoided.

Digoxin, phenytoin and lithium : individual cases of increased plasma concentrations of digoxin, phenytoin and lithium have been reported in case of concomitant treatment with ibuprofen.

Methotrexate: ibuprofen may increase the hematological toxicity of methotrexate by decreasing its urinary elimination.
Ibuprofen can reduce the effectiveness of intrauterine contraceptive devices.

Special warnings

Because occasionally severe gastrointestinal bleeding and peptic ulcers have been reported in some patients using ibuprofen, Reuprofen ® should be administered under strict medical supervision in patients with active gastrointestinal tract disease or a history of such disease.
The same precautions should be taken into account for patients with a history of bronchospasm, especially if it was the result of medication administration, as well as for patients with impairment of renal and/or hepatic or cardiac functions. In these patients, clinical and laboratory parameters should be monitored periodically, especially if long-term treatment is necessary.

Reuprofen ® should be administered with caution to patients with a history of heart failure or high blood pressure, as cases of hydrosaline retention with edema have been reported.
Because ibuprofen, like other non-steroidal anti-inflammatory drugs, may prolong bleeding time, it should be used with caution in patients with intrinsic coagulation deficiencies and in patients receiving anticoagulant therapy.

Pregnancy and breastfeeding

During the first 5 months of pregnancy, ibuprofen will be administered only if absolutely necessary and only under strict medical supervision. Starting from the 6th month, the administration of ibuprofen is contraindicated.
The use of Reuprofen ® during breastfeeding is not indicated.

Ability to drive vehicles or use machinery
Due to the adverse reactions it produces - drowsiness, dizziness or depression - Reuprofen ® can influence the ability to drive vehicles or use machinery.

Adverse reactions

Gastrointestinal tract

• The most common side effects due to ibuprofen are gastrointestinal disorders: heartburn, anorexia, nausea, vomiting, dyspepsia, abdominal discomfort, diarrhea, active ulcer and gastrointestinal bleeding.

Central nervous system

• Headache, confusion, tinnitus and drowsiness - are less frequently reported than gastrointestinal effects.
• Cases of psychotic disorders and depressive reactions have been reported as well as individual cases of severe headache, nausea, vomiting, fever, stiff neck muscles, sensory disturbances (early signs of meningitis).

Sense organs

• Reversible ocular reactions such as: toxic amblyopia, blurred vision and color vision disorders have been observed.

Skin/hypersensitivity reactions

• Skin rashes such as urticaria, exanthema and purpura have been reported. These reactions may be accompanied by pruritus and Stevens-Johnson syndrome.
• General hypersensitivity reactions are rare. Symptoms can be: fever with skin rashes, abdominal pain, headache, nausea and vomiting, abnormal values ​​of liver tests, meningism and anaphylactic reactions.
• Systemic lupus erythematosus or other collagen diseases may increase the risk of general hypersensitivity reactions.
• Rarely, ibuprofen can cause bronchospasm in predisposed patients.

Blood

• Doses greater than 1000 mg/day may prolong bleeding time.
• The following were reported: thrombocytopenia, granulocytopenia, agranulocytosis, hemolytic anemia and aplastic anemia. Such blood dyscrasias were mainly observed after long-term administration of high doses.

Liver

• Abnormal values ​​of liver tests (increased values ​​of serum transaminases) and jaundice were reported.

Kidney

• Phenomena of hydrosaline retention with the appearance of edema have been reported. There were cases of dysuria and acute interstitial nephritis. Renal function impairment can have varying degrees of severity, especially after long-term administration of high doses.
• In the case of general hypersensitivity reactions, renal failure may occur.
• Cases of kidney damage (renal papillary necrosis) have been reported.

Other unwanted effects

• Stomatitis, menstrual disorders, increased serum urate values ​​can be encountered occasionally.
• In case of the occurrence of adverse reactions, it is necessary to stop the administration immediately and institute the appropriate treatment.