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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after three days.
What is in this leaflet
1. What Efferalgan is and what it is used for 2. What you need to know before you use Efferalgan 3. How to use Efferalgan 4. Possible side effects 5. How to store Efferalgan 6. Contents of the pack and other information
1. What Efferalgan is and what it is used for
Efferalgan is a medicine indicated for the treatment of mild pain and/or fever. It is meant for alleviating fever and/or pain for example in case of headache, colds, toothache or muscle pain.
2. What you need to know before you use Efferalgan Do not use Efferalgan
■ if you are allergic to paracetamol or any of other ingredients of this medicine (listed in section 6). ■ if you have severe liver disease. ■ if you have diarrhoea. ■ if you have recently had anal or rectal inflammation or you have had bleeding from the rectum.
Warnings and precautions
Talk to your doctor or pharmacist before using paracetamol or giving it to a child as dose reduction or prolongation of intervals between doses may be required so the maximum dose does not exceed 60 mg/kg/day: ■ if you have severe kidney disease. ■ if you have Gilbert's syndrome (familial hyperbilirubinaemia). ■ chronic or compensated active liver disease (mild to moderate liver failure). ■ if you have glucose-6-phospathe dehydrogenase deficiency (risk of developing haemolytic anaemia). ■ if you have anorexia, bulimia, cachexia or chronic malnutrition. ■ if you have significant weight loss (dehydration, hypovolaemia). ■ if the doctor has ordered tests to determine uric acid or sugar content in blood, inform him/her that you are using this medicine. ■ if there are signs of irritation or pain around anus. Paracetamol can cause serious skin reactions. The use of the medicine should be stopped if extensive skin rash or signs of hypersensitivity develop. When higher than recommended doses of paracetamol are administered, severe liver damage may occur. The clinical symptoms of liver damage appear 1-2 days after overdosage. The strongest symptoms of liver damage are usually observed on the 3rd-4th day (see section 3 “If you use more Efferalgan than you should”). Please contact your doctor if the symptoms persist for more than three days.
Other medicines and Efferalgan
Tell your doctor if you are taking or have recently taken any other medicines, including medicines purchased without a prescription. Concurrent use with medicines that activate the function of hepatic cells in a specific way, like certain hypnotics and anticonvulsives (including phenobarbital, phenytoin, carbamazepine) and antibiotics (isoniazid, rifampicin) may cause liver damage at otherwise harmless paracetamol doses. In case of concurrent administration of paracetamol and chloramphenicol the excretion of chloramphenicol may decrease significantly and its toxicity may increase. Concurrent use of paracetamol and zidovudine (AZT) increases the risk of serious blood change (neutropenia). Therefore paracetamol should be used concurrently with zidovudine only by doctor’s recommendation. Continuous simultaneous use of paracetamol with orally administered anticoagulants, including warfarin, may cause changes in INR values and haemorrhage risk. The monitoring of INR value is required during the use of paracetamol and for up to one week after discontinuing it. To avoid overdose, it should be verified that other administrated medications (prescription as well as over-the-counter medicines) do not contain paracetamol. Combining paracetamol with acetylsalicylic acid and other painkillers is not recommended.
Pregnancy and breast-feeding
This medicine is intended for use in children. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine is intended for use in children. No effect on the ability to drive or use machines has been observed.
3. How to use Efferalgan
For rectal administration. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended daily dose of paracetamol is 60 mg/kg that is administered as 4 single doses after equal time intervals, i.e. 15 mg/kg with a 6-hour interval. There should be an at least 6-hour interval between administrations. If you do not know the child’s body weight, you should weigh the child to administer most adequate dose. Paracetamol is available as preparations with different strengths, therefore it is possible to find suitable medicine for each child’s body weight. The approximate age corresponding to body weight may be variable. Efferalgan 80 mg suppositories are suitable for infants and small children with a body weight of 510 kg (approximately 2-24 months old), single dose is one 80 mg suppository that must not be administered more frequently than with a 6-hour interval. Efferalgan 150 mg rectal suppositories are suitable for small children with a body weight of 10-15 kg (approximately 2-3 years old), a single doose is one 150 mg rectal suppository that must not be administered more frequently than with a 6-hour interval.
In case of severe renal failure there should be at least 6-8-hour interval between administrations. Do not exceed the maximum allowed daily dose of 60 mg/kg.
Paracetamol must not be used in the case of acute liver failure. In the case of liver damage, the dosage must be reduced or the intervals between doses prolonged. The maximum daily dosage must not exceed 60 mg/kg/day or 2g/day if: ■ you weigh less than 50 kg ■ the child has a chronic or compensated active liver disease, mainly with mild to moderate liver failure ■ you have Gilbert’s syndrome (familial hyperbihruminemia) ■ you are chronically malnourished ■ you are dehydrated
If you use more Efferalgan than you should
In case of overdose or unintended administration of too large dose consult a doctor immediately or call emergency number. In case of overdose in the beginning (during the first day) nausea, vomiting, sweating, sleepiness and general malaise may occur. Despite possible improvement on the second day the liver damage may continuously and irreversibly worsen.
If you forget to use Efferalgan
Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The post-marketing side effects listed below have been reported: Might occur rarely (1 patient in 1,000 to 10,000) upon using paracetamol: ■ diarrhoea and abdominal pain. ■ increase or decrease of blood coagulation (INR value). ■ increase of the activity of liver enzymes (transaminases). Usually these changes are mild, reversible and do not require treatment discontinuation. Have been described very rarely (less than 1 patient in 10,000) upon using paracetamol: ■ renal impairment has been observed very rarely. ■ skin rashes (urticaria, erythema, pruritus) and allergic reactions like angioedema or anaphylactic shock (anaphylaxis with severe hypotension) and severe skin lesions like acute generalised exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome have been described after paracetamol use. ■ hepatic impairment, liver necrosis, hepatitis. ■ abnormally low count of blood cells (thrombocytopenia, leukopenia, neutropenia) has been reported in association with paracetamol use. This may cause epistaxis or gum bleeding or recurrence of fever or infection signs. If this occurs, stop treatment immediately and inform your doctor. The medicine administered as suppositories may cause rectal or anal irritation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Efferalgan
Keep this medicine out of the sight and reach of children. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the carton and strip after “EXP”. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Efferalgan contains
■ The active substance is paracetamol. One rectal suppository contains either 80 mg or 150 mg of paracetamol, respectively. ■ The other excipient is solid grease.
What Efferalgan looks like and contents of the pack
10 rectal suppositories in a strip in a carton.
Marketing Authorisation Holder
Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövöhaz u. 39 1024, Budapest Hungary
UPSA SAS 304, avenue du Docteur Jean Bru 47000 Agen France or UPSA SAS 979 Avenue des Pyrenees 47520 Le Passage France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Amicus Pharma OÜ Phone: 640 1030 E-mail: email@example.com