Efferalgan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

EFFERALGAN (EFFERALGANMED)

500 mg, effervescent tablets

Paracetamol
EFFERALGAN and EFFERALGANMED are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If the pain does not subside in adults after 5 days, and symptoms of cold and flu or fever after 3 days, or if the pain, symptoms of cold and flu, or fever do not subside in children and adolescents after 3 days, or if the patient feels worse, they should contact a 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. Package contents and other information

1. What is Efferalgan and what is it used for

Efferalgan is a pain-relieving and antipyretic drug. It lowers elevated body temperature that occurs during illness, without lowering normal temperature.
Paracetamol, to a lesser extent than salicylates, irritates the gastric mucosa.
Indications for use:

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Symptomatic treatment of flu-like conditions and colds.
• Fever.

2. Important information before taking Efferalgan

When not to take Efferalgan

• if the patient has been diagnosed with hypersensitivity (allergy) to paracetamol or any other component of Efferalgan,
• in children with a body weight of less than 17 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active, uncontrolled liver disease,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase,
• if the patient is being treated with MAO inhibitors (drugs used, among others, in depression) and during the 14 days after treatment,

• in the case of concurrent use with painkillers with agonist-antagonist action: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

• Efferalgan contains paracetamol and should be used taking into account the concurrent use of other paracetamol-containing drugs (including prescription and over-the-counter drugs) to avoid taking a daily dose greater than recommended (see section 3).
• Do not take higher doses than recommended. Taking higher doses than recommended carries the risk of very severe liver damage. Symptoms of damage usually appear 1 to 2 days after paracetamol overdose, with maximum severity usually occurring after 3-4 days.
• Paracetamol may cause severe skin reactions (see section 4), such as acute generalized pustular psoriasis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. The doctor should be informed about skin reactions and the use of the drug should be discontinued in case of skin rash or any other symptom of allergy.

Before taking Efferalgan, the doctor should be consulted if the patient has any of the following conditions:

• liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic disease, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, or body wasting,
• long-term malnutrition,
• low glutathione reserves in the liver associated with, for example, appetite disorders, cystic fibrosis, HIV infection, in patients who are starving or wasting, with sepsis,
• dehydration,
• hypovolemia (reduced blood volume).

In case of overdose or accidental ingestion of the drug, a doctor should be consulted immediately.
The doctor should be informed about the use of this drug if the doctor orders a test for uric acid or blood sugar levels.

Efferalgan and other drugs

The doctor should be told about all recently taken drugs, including those available without a prescription.
Concurrent use of Efferalgan may change the action of the following drugs or the use of the following drugs may change the action of concurrently used Efferalgan:

• MAO inhibitors - should not be used concurrently with MAO inhibitors and within 2 weeks after treatment with these drugs due to the possibility of excitement and high fever.
• Drugs containing salicylamide (a pain reliever also used in feverish conditions) - concurrent use prolongs the elimination of paracetamol.
• Drugs that increase liver metabolism - concurrent use of paracetamol and drugs such as St. John's wort, antiepileptic drugs, barbiturates (drugs used mainly in epilepsy), rifampicin (a drug used in tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol (see "Using a higher dose of Efferalgan than recommended" in section 3). Caution should be exercised when using concurrently.
• Isoniazid (a drug used in tuberculosis) and zidovudine (an antiviral drug used in HIV infection) - caution should be exercised when using these drugs concurrently.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - concurrent use increases the risk of kidney function disorders.

• Oral anticoagulant drugs - concurrent use of paracetamol with anticoagulant drugs from the coumarin group, including warfarin, may lead to minor changes in INR values. In such cases, the doctor may increase the frequency of INR value monitoring during concurrent use, as well as for a week after discontinuing paracetamol.
• Phenytoin (a drug used in epilepsy) - concurrent administration may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, large doses of paracetamol and (or) long-term paracetamol doses should be avoided. These patients should be constantly monitored for signs of liver damage.
• Probenecid (a drug used in gout) - reduces paracetamol elimination. During concurrent use with paracetamol, the doctor will consider reducing the paracetamol dose.

Using Efferalgan with alcohol

During treatment with the drug, alcohol should not be consumed or drugs containing alcohol should not be taken, due to the increased risk of toxic liver damage. Particular risk of liver damage exists in starving individuals and those who regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

Efferalgan can be administered to pregnant women if necessary. The lowest effective dose should be used to relieve pain or reduce fever, and the drug should be taken 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 drug, a doctor should be consulted.
There is no sufficient data to indicate whether paracetamol affects fertility.

Driving vehicles and operating machines

Efferalgan does not affect psychophysical fitness. There are no contraindications to driving vehicles and operating machines.

Efferalgan contains sodium, sodium benzoate, and sorbitol

Due to the content of 412.4 mg of sodium (17.9 mEq) in one effervescent tablet. This should be taken into account in patients with reduced kidney function and in patients controlling sodium intake in their diet.
The drug contains 60.606 mg of sodium benzoate in each effervescent tablet.
If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the drug.

3. How to take Efferalgan

The tablet should be dissolved in a glass of water and drunk. Do not chew or swallow an undissolved tablet.
The dose is determined based on the patient's body weight.
The recommended dose of Efferalgan is:

Adults and adolescents with a body weight over 50 kg (over 15 years old)
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight every 4 to 6 hours, the maximum daily dose of paracetamol is 75 mg/kg body weight/day, totaling no more than 4 g of paracetamol per day.
The recommended single dose of Efferalgan is 500 mg or 1 g of paracetamol (one or two effervescent tablets), every 4 to 6 hours, totaling no more than 3 g of paracetamol, i.e., 6 effervescent tablets per day.
However, in the case of severe pain, the daily dose can be increased to a maximum daily dose of 4 g of paracetamol, i.e., 8 effervescent tablets per day. At least a 4-hour interval should always be maintained between doses.

Children and adolescents with a body weight of up to 50 kg
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight, preferably every 6 to 8 hours, the maximum daily dose of paracetamol is 60 mg/kg body weight/day.

For children with a body weight of 17 to 25 kg (6 to 8 years old), the single dose is 250 mg of paracetamol (half an effervescent tablet). If necessary, the dose can be repeated every 6 hours. Do not take more than 1 g of paracetamol per day (2 effervescent tablets).

For children with a body weight of 25 to 33 kg (8 to 10 years old), the single dose is 250 mg (half an effervescent tablet). If necessary, the dose can be repeated every 4-6 hours. Do not take more than 1.5 g of paracetamol per day (3 effervescent tablets).

For children with a body weight of 33 to 50 kg (10 to 15 years old), the single dose is 500 mg (one effervescent tablet), if necessary, the dose can be repeated every 6 hours, do not take more than 2 g of paracetamol per day (4 effervescent tablets).

The approximate age range depending on body weight is given only as a guide.
Frequency of administration
Regular administration of the drug allows prevention of periodic exacerbations of pain or fever:

• in children, a regular interval should be maintained between doses, both during the day and at night,
• in adults, the interval between doses should not be less than 4 hours.

Elderly patients
No dose modification is necessary.
Patients with kidney function disorders
In patients with kidney function disorders, the recommended single dose is 500 mg (1 effervescent tablet), and the minimum interval between doses should be in accordance with the following schedule:
Creatinine clearance
Interval between doses
CrCl ≥50 ml/min
4 hours
CrCl 10-50 ml/min
6 hours
CrCl <10 ml min
8 hours
Patients with liver function disorders
In patients with liver function disorders, the dose of the drug should be reduced or the intervals between consecutive doses prolonged. 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 controlled active liver disease, especially mild to moderate liver failure, Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholic disease,
• long-term malnutrition,
• dehydration.

Duration of treatment
In adults, the drug should not be used without a doctor's recommendation for more than 5 days in case of pain, and more than 3 days in case of cold and flu or fever. In children and adolescents, the drug should never be used for more than 3 days.

Using a higher dose of Efferalgan than recommended

In case of taking too large a dose or ingesting the drug, a doctor should be consulted to obtain appropriate advice.
Overdose is particularly dangerous in the elderly, small children, patients who are malnourished for a long time, those with liver disease, and patients taking drugs that induce liver enzymes, as these individuals are at increased risk of liver damage.
Drug overdose may cause symptoms such as:

nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may subside the next day, despite the fact that liver damage is beginning to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.
In every case of taking this drug in a single dose of 10 tablets (5 g of paracetamol) or more, vomiting should be induced if no more than an hour has passed since ingestion, and a doctor should be contacted immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. Medical advice should be sought immediately.

Missing a dose of Efferalgan

A double dose should not be taken to make up for a missed dose.
In case of doubts related to the use of the drug, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all drugs, Efferalgan can cause side effects, although they do not occur in everyone.
If any of the side effects worsen or if any side effects not listed in the leaflet occur, a doctor or pharmacist should be informed.
The frequency of side effects listed below is defined as follows:
Rare: in less than 1 in 1,000, but in more than 1 in 10,000 treated patients.
Very rare: in less than 1 in 10,000 treated patients.
Rare: malaise, decreased blood pressure, increased liver transaminase activity.
Very rare: hypersensitivity reactions, tachycardia, diarrhea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), decrease or increase in INR values (blood coagulation factor).

Very rare, treatment-requiring cases of hypersensitivity reactions have been reported:
skin redness, rash, erythema, or urticaria, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), dyspnea, bronchospasm, excessive sweating, decreased blood pressure, up to symptoms of anaphylactic shock (caused by a severe systemic allergic reaction, its symptoms include: dyspnea, swelling of the larynx and throat, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening) and Quincke's edema, severe skin reactions: acute generalized pustular psoriasis on the entire body or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain, or giant blisters, extensive erosions on the skin, shedding of large skin flakes, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be informed.
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
Jerozolimskie Avenue 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, more information can be collected on the safety of the drug.

5. How to store Efferalgan

There are no special recommendations for storage.
Store in a place invisible and inaccessible to children.
Do not use Efferalgan after the expiration date stated on the packaging.
The expiration date means the last day of the specified month.
Drugs should not be thrown into the sewage system or household waste containers. A pharmacist should be asked how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Efferalgan contains

The active substance of the drug is paracetamol. 1 effervescent tablet contains 500 mg of paracetamol.
The other ingredients of the drug are: sodium benzoate, sodium carbonate, citric acid, sorbitol, sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, povidone.

What Efferalgan looks like and what the package contains

Effervescent tablet
Package:
A package containing 4, 8, or 16 effervescent tablets in Al/PE foil packaging, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in France, the country of export:

UPSA SAS
3 Rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturers:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
French marketing authorization number: 325 699-3
34009 325 699 3 9
325 700-1
34009 325 700 1 0

Parallel import authorization number: 30/17 Date of leaflet approval: 27.01.2022

[Information about the trademark]
End of page 7