parol-pedifen@dafra.be

Administration mode

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• The bottle of Pedifen® suspension must be shaken before use;

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For oral use

• Optimal efficacy of Pedifen® is achieved when the product is taken either on an empty stomach or before meals.

• In sensitive stomach patients, however, it is advisable to take Pedifen® during a meal.

• Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Contraindications

• Ibuprofen is contraindicated in the following cases:

  • history of hypersensitivity to ibuprofen

  • history of allergy to acetylsalicylic acid or any of the non-steroidal anti-inflammatory agents

• Chronic administration of NSAIDs, particularly at high doses, may be complicated by gastrointestinal ulcer, hemorrhage or perforation without there being any warning signs.

• Since ibuprofen is mainly eliminated by the kidneys, it can accumulate in the body of patients who have reduced kidney function.

  • In patients with reduced renal perfusion, NSAIDs may precipitate acute renal failure by suppressing the supportive role of renal prostaglandins in maintaining renal circulation.

  • This risk is present in patients with reduced kidney, liver and heart function and in patients taking diuretics.

Precautions  : Although the effect is short-lived and reversible, ibuprofen has an anti-aggregation effect on the function of thrombocytes. It should be used with caution in patients with bleeding phenomena and in those taking anticoagulants.

In general, Pedifen® is well tolerated. The most common side effects are:

• Nausea, epigastric pain, heartburn, diarrhoea, constipation, flatulence, edema, dizziness, rash, pruritus, tinnitus

Pregnancy and breast feeding

• Pregnancy  :

  • Ibuprofen is not recommended for pregnant women.

  • NSAIDs can cause premature closure of the ductus arteriosus* if administered late in pregnancy.

*In the developing fetus, the ductus arteriosus is a shunt connecting the pulmonary artery to the aorta that allows most of the blood from the right ventricle to bypass the fluid-filled lungs of the fetus. During fetal development, this shunt prevents the lungs from being overloaded and allows the right ventricle to strengthen. Closure of the duct before birth can lead to right ventricular failure. The canal usually closes at birth.

• Breastfeeding :

  • It is not known whether ibuprofen passes into human milk.

  • However, given the potential adverse effects of NSAIDs on the child, consideration should be given to discontinuation of either breast-feeding or treatment with ibuprofen.