HELCOR

REUPROFEN 400MG X 10 FILM-COATED TABLETS

Composition

Each film-coated tablet contains 400 mg ibuprofen. The other ingredients are: core-microcrystalline cellulose (type 101), sodium starch glycolate (type A), povidone (K 30), talc, magnesium stearate, colloidal anhydrous silicon dioxide; Film (Reuprofen 400 mg)-Opadry II Red 85F25305, consisting of: partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350/macrogol 4000, titanium dioxide (E 171), Ponceau 4R (E 124), sunset yellow (E 110).

Therapeutic indications

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by changing the body's response to pain, inflammation and high temperature.

Reuprofen is used for:

• Relieving mild to moderate pain, such as headache, dental pain;
• Reducing fever and pain associated with the common cold.

Dosage and method of administration

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless your doctor has recommended otherwise, the usual standard doses are:

Adults and adolescents weighing approximately 40 kg:

Initial dose: take 200 mg or 400 mg ibuprofen with water. If necessary, take further doses of 200-400 mg ibuprofen, but do not exceed a total dose of 1200 mg in any 24-hour period. The interval between doses should not be less than 4 hours for the 200 mg dose and 6 hours for the 400 mg dose.

Children weighing between 20 and 39 kg (approximately 6 years of age):

Reuprofen should only be used in children who weigh at least 20 kg. The maximum total daily dose of ibuprofen is 20-30 mg per kg body weight, divided into 3 to 4 single doses. The interval between doses should not be less than 6 hours. Do not exceed the maximum recommended daily dose. It is recommended that a total dose of 30 mg ibuprofen/kg, in a 24-hour period, should not be exceeded.

Precautions

Take special care with Reuprofen:

• if you have certain skin conditions [systemic lupus erythematosus (SLE) or mixed connective tissue disease]. If you experience serious skin reactions, such as: exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Reuprofen should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of allergic reaction;
• if you have an inherited blood cell formation disorder (acute intermittent porphyria);
• if you have or have had bowel disease (ulcerative colitis or Crohn's disease);

Special warnings

Pregnancy, breast-feeding, 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.

Do not take this medicine during the last three months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy, unless your doctor recommends otherwise. This medicine passes into breast milk, but it can be used during breast-feeding if taken at the recommended dose and for the shortest possible time.

This medicine belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible on stopping the medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines, if used short-term and at the recommended doses.

Packaging

Reuprofen 400 mg film-coated tablets are available in a box with 1 PVC/Al blister, containing 10

film-coated tablets.

 

Page updated on: 09.06.2021