Efferalgan

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language

Efferalgan(Efferalgan 80 mg)

80 mg, suppositories

Paracetamol
Efferalgan and Efferalgan 80 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Efferalgan and what is it used for
• 2. Important information before taking Efferalgan
• 3. How to take Efferalgan
• 4. Possible side effects
• 5. How to store Efferalgan
• 6. Contents of the packaging and other information

1. What is Efferalgan and what is it used for

Efferalgan is a medicine with analgesic and antipyretic effects. It lowers elevated body temperature that occurs during illness, without lowering normal temperature.
Indications for use:

• fever,
• symptomatic treatment of flu-like and cold conditions,
• pains of various origins.

2. Important information before taking Efferalgan

When not to take Efferalgan

• if you are allergic to paracetamol, propacetamol hydrochloride (a precursor to paracetamol), or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver failure or active, uncontrolled liver disease,
• if you have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), which may lead to hemolytic anemia,
• if you are being treated with MAO inhibitors (medicines used, among other things, in depression) and for 14 days after stopping treatment,
• if you have recently had proctitis, proctocolitis, or rectal bleeding.

The medicine contains soybean oil. Do not take if you are hypersensitive to peanuts or soy.

Warnings and precautions

Before starting to take Efferalgan, you should discuss it with your doctor, pharmacist, or nurse.
Efferalgan contains paracetamol. To avoid overdose, you should check if other medicines (including those prescribed and over-the-counter) you are taking contain paracetamol.
Overdose can lead to severe liver damage and death.
The medicine can be used in children under 2 years of age only on the advice of a doctor. If a child is taking a paracetamol dose of 60 mg/kg body weight/day, you may consider using other antipyretic medicines only if the effect is insufficient.
When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with the duration of treatment, frequency of use, and dose of the medicine.
Do not take doses higher than recommended. Taking paracetamol doses higher than recommended carries a risk of very severe liver damage.
Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.
You should inform your doctor about any skin reactions.
You should consult your doctor before taking Efferalgan if you have any of the following conditions:

• liver failure, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• severe kidney failure,
• alcoholic disease,
• eating disorders: anorexia, bulimia, or cachexia,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration,
• reduced blood volume.

During long-term (more than 3 months) use of painkillers in patients with chronic headache, when taken every other day or more frequently, there may be an increased risk of developing or worsening headache. Headache caused by overuse of painkillers (Medication-Overuse Headache, MOH) should not be treated by increasing the dose. In such cases, in agreement with your doctor, you should stop taking painkillers.

Efferalgan and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking Efferalgan at the same time may change the effect of the following medicines or taking the following medicines may change the effect of Efferalgan taken at the same time:
MAO inhibitors (a group of medicines used in the treatment of depression) – should not be taken at the same time as MAO inhibitors and for 2 weeks after stopping treatment with these medicines due to the possibility of excitement and high fever.
Medicines containing salicylamide (a painkiller also used in feverish conditions) – concurrent use may prolong the elimination of paracetamol.
Enzyme-inducing substances: caution should be exercised when taking paracetamol and medicines that increase liver metabolism, such as antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (a medicine used in tuberculosis), and isoniazid (a medicine used in tuberculosis). This may lead to liver damage, even when taking the recommended doses of paracetamol (see "Taking a higher dose of Efferalgan than recommended" in section 3).
Nonsteroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.
Oral anticoagulants – concurrent use of paracetamol with anticoagulant medicines from the coumarin group, including warfarin, may lead to minor changes in INR values. In such cases, your doctor will increase the frequency of monitoring INR values during concurrent use and for one week after stopping paracetamol.
Phenytoin (a medicine used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or long-term doses of paracetamol. Your doctor should monitor these patients for signs of hepatotoxicity.
Probenecid (a medicine used in gout) – reduces the excretion of paracetamol. When taking this medicine with probenecid, your doctor should consider reducing the dose of paracetamol.
Flucloxacillin – caution should be exercised when taking flucloxacillin at the same time as paracetamol due to the increased risk of developing a disorder affecting blood and body fluids (metabolic acidosis with a large anion gap), especially in patients with risk factors for glutathione deficiency, such as severe kidney dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with a large anion gap is a serious disease that requires urgent treatment.
You should inform your doctor about taking this medicine if your doctor prescribes a test for uric acid or blood sugar.

Taking Efferalgan with alcohol

You should not drink alcohol due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is intended for children (see section 3).
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Other medicines containing paracetamol as the active substance, intended for adults, have been approved for marketing.
Paracetamol can be given to pregnant women if necessary. You should use the smallest possible dose that effectively relieves pain or reduces fever and take the medicine for as short a time as possible.
If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, you should consult your doctor.
This medicine can be used during breastfeeding only with the consent of a doctor and in individual cases.
There is no sufficient data to determine whether paracetamol affects fertility.

Driving and using machines

The medicine does not affect psychomotor performance. There are no contraindications to driving vehicles and operating machinery.

3. How to take Efferalgan

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If you have any doubts, you should consult your doctor, pharmacist, or nurse.
In children, you should follow the dosage according to body weight, and therefore you should choose Efferalgan with the appropriate strength. The approximate age corresponding to a given body weight is provided only as a guide.
In children, the recommended single dose of paracetamol is about 15 mg/kg body weight. If necessary, it can be given up to 4 times a day, but not more often than every 6 hours. The recommended maximum daily dose of paracetamol is about 60 mg/kg body weight.
Efferalgan, 80 mg, suppositories are intended for infants and children with a body weight of 5 to 10 kg (approximately 2 to 24 months) only on the advice of a doctor.
The recommended single dose is 1 suppository (80 mg of paracetamol). If necessary, the dose can be repeated, but not more often than every 6 hours. Do not take more than 4 suppositories per day (the maximum daily dose of paracetamol is 320 mg).
Patients with kidney function disorders
In patients with severe kidney function disorders, the minimum interval between doses should be in accordance with the following scheme:
Creatinine clearance
Interval between doses
CrCl ≥ 10 ml/min
6 hours
CrCl <10 ml min
8 hours
Patients with liver function disorders
In patients with liver function disorders, you should reduce the dose of the medicine or prolong the intervals between consecutive doses. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight/day (should not exceed 2 g/day):

• in adults with a body weight below 50 kg,
• chronic or compensated active liver disease, mild to moderate liver failure,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholic disease,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration.

Method of administration
Rectal administration. It is not recommended to use suppositories in children with diarrhea.
Frequency of use
Due to the possibility of local irritating effects, it is not recommended to use suppositories more than 4 times a day.
Regular use of the medicine allows you to prevent periodic exacerbations of pain or fever.
In children, you should maintain equal 6-hour intervals between consecutive doses, both during the day and at night.
Duration of treatment
The duration of use of suppositories should be as short as possible. Without consulting a doctor, do not take this medicine for more than 3 days.

Taking a higher dose of Efferalgan than recommended

In case of taking a higher dose than recommended, you should immediately contact your doctor, even if no symptoms have occurred, as this may lead to life-threatening liver damage.
Overdose is particularly dangerous in the elderly, small children, patients with chronic malnutrition, those with liver disease, and patients taking medicines that induce liver enzymes, as these individuals have an increased risk of liver damage.
Overdose of the medicine may cause symptoms to occur within a few to several hours, such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, manifested by abdominal distension, return of nausea, and jaundice.
Rare cases of acute pancreatitis have been observed.

Missing a dose of Efferalgan

You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects listed below is unknown – the frequency cannot be determined based on available data.
Unknown: increased liver enzyme activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of deep skin and subcutaneous tissue layers), diarrhea, abdominal pain; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count); skin redness, rash, erythema, urticaria, papular rash, acute generalized exanthematous pustulosis*, toxic epidermal necrolysis, Stevens-Johnson syndrome.
*Very rare, treatment-requiring cases of hypersensitivity reactions (dyspnea, bronchospasm, excessive sweating) have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Efferalgan

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Efferalgan contains

The active substance of the medicine is paracetamol. Each suppository contains 80 mg of paracetamol.
The other ingredients are solid fat with additives, including lecithin derived from soybean oil.

What Efferalgan looks like and what the packaging contains

Suppository.
Packaging: 2 PVC/PE blisters, in a cardboard box, containing 5 suppositories each.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer:

UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen, France
UPSA SAS
979, avenue des Pyrénées
47520 Le Passage, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20020147

Parallel import authorization number: 265/24

Date of leaflet approval: 01.07.2024

[Information about the trademark]