Product information
Pain and fever of various origins.
Symptomatic treatment of flu-like conditions and colds.
Contraindications:
Hypersensitivity to the active substance or to the excipients listed in section 6.1. Severe renal and/or hepatic impairment. Alcoholic disease.
Side effects:
Rare side effects (≥ 1/10,000 to < 1/1,000): Skin and subcutaneous tissue disorders such as pruritus, urticaria, rash, erythema, angioedema.
Very rare side effects (< 1 / 10,000):
blood and lymphatic system disorders such as: changes in the blood count (thrombocytopenia with symptoms of thrombocytopenic purpura); hepatobiliary disorders such as: impaired liver function; kidney and urinary disorders such as: impaired kidney function.
Reporting suspected side effects:
Reporting suspected adverse reactions after authorization of the medicinal product is important. This allows continuous monitoring of the benefit/risk balance of the medicinal product. Medical professionals should report any suspected adverse reactions to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl or the responsible entity.
Interactions:
Liver enzyme enhancers such as carbamazepine, phenobarbital, phenytoin, omeprazole, rifampicin, zidovudine, St John’s wort and ethanol may increase the hepatotoxicity of paracetamol. Probenecid may delay the elimination of paracetamol and increase its half-life. Paracetamol used for a long time in high doses increases the effect of coumarin anticoagulants (e.g. warfarin), causing the risk of bleeding.
Dosage:
Paracetamol Farmina, 250 mg, suppositories is intended for rectal administration in children. The recommended single dose is 10 to 15 mg per kilogram of the child’s body weight. One suppository may be administered 3 to 4 times a day (maximum 60 mg/kg/day). Use no more than every 4 hours.
Paracetamol Farmina, 500 mg, suppositories is intended for rectal administration.
Adults and children over 50 kg (over 12 years of age): 1 to 2 suppositories every 4 to 6 hours. The recommended single dose in children is 10 to 15 mg/kg of the child’s body weight.
One suppository may be administered 3 to 4 times a day (maximum 60 mg/kg/day). Do not exceed the maximum daily dose of 4 g per day, including all paracetamol-containing medicines.
Note: do not use other medicines containing paracetamol at the same time.
Precautions:
The medicinal product should be used with caution in patients with renal and/or hepatic impairment.
Paracetamol should be used with caution in people with glucose-6-phosphate dehydrogenase deficiency.
There is also an increased risk of liver damage in patients who are fasting and regularly drinking alcohol.
Less than 5% of patients allergic to acetylsalicylic acid derivatives may be allergic to paracetamol.
Driving:
The drug does not affect the ability to drive and use machines.
Overdose:
Overdose of the drug may cause symptoms such as nausea, vomiting, excessive sweating and drowsiness as well as general weakness within a few hours. They may subside the next day, although liver damage begins to develop, manifested by abdominal distention, nausea and jaundice returning. If you take 5 g or more of paracetamol, contact your doctor immediately.
A reliable assessment of the severity of poisoning is provided by determining the paracetamol concentration in the blood. The value of the concentration in relation to the time that has elapsed since taking paracetamol is an important guide as to whether and how intensively treatment with antidotes is necessary. If such testing is impracticable and the likely dose of paracetamol is high, more intensive antidote treatment should be instituted: at least 2.5 g of methionine should be administered and treatment with acetylcysteine and/or methionine continued (already in the hospital), which are very effective in first 10-12 hours after poisoning, but are probably also useful after 24 hours. Treatment of paracetamol poisoning must take place in a hospital in an intensive care setting.
Pregnancy:
Paracetamol Farmina, 250 mg, suppositories: not applicable. The medicinal product is intended for children.
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