Efferalgan

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Efferalgan

500 mg, effervescent tablets

Paracetamol

It is necessary to 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 directed by a doctor, pharmacist, or nurse.

• 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If in adults the pain does not subside after 5 days, and symptoms of cold and flu or fever after 3 days, and in children and adolescents, pain, symptoms of cold and flu, or fever do not subside after 3 days, or 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. 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 the elevated body temperature that occurs during illness, without lowering normal body temperature. Paracetamol is less irritating to the stomach lining than salicylates.

• 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

• in children with a body weight of less than 17 kg,
• in women during the first trimester of pregnancy,
• in the case of concomitant use with analgesic medicines with agonist-antagonist action: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions

Before starting to take Efferalgan, the patient should discuss it with their doctor, pharmacist, or nurse.

Efferalgan contains paracetamol and should be taken with consideration of concomitant use of other medicines containing paracetamol (including those available on prescription or over-the-counter), so as not to exceed the recommended daily dose (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 liver damage usually appear within one to two days after paracetamol overdose, with maximum severity usually occurring within 3-4 days.

Paracetamol may cause severe skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. The patient should inform their doctor about any skin reactions and stop taking the medicine in case of a skin rash or any other sign of an allergic reaction.

The patient should consult their doctor before taking Efferalgan if they have any of the following conditions:

• liver function disorders, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic liver disease, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, or cachexia,
• prolonged malnutrition,
• low glutathione reserves in the liver associated with, for example, anorexia, cystic fibrosis, HIV infection, in fasting or cachectic patients, with sepsis,
• dehydration,
• hypovolemia (reduced blood volume).

Efferalgan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Concomitant use of Efferalgan may alter the effects of the following medicines or the use of the following medicines may alter the effects of Efferalgan:

• MAO inhibitors - should not be taken concomitantly with MAO inhibitors and for 2 weeks after the end of treatment with these medicines, due to the possibility of excitement and high fever.
• Medicines containing salicylamide (a pain reliever also used in feverish conditions) - concomitant use prolongs the elimination of paracetamol.
• Medicines that increase liver metabolism - concomitant use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (a medicine 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 concomitantly.

The patient should inform their doctor about the use of this medicine if the doctor prescribes a test for uric acid or blood sugar.

Using Efferalgan with alcohol

While taking the medicine, the patient should not drink alcohol or take medicines containing alcohol, due to the increased risk of toxic liver damage. Particular risk of liver damage exists in individuals who are fasting and regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Efferalgan can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time.

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, the patient should consult their doctor.

There is no sufficient data to determine whether paracetamol affects fertility.

Driving and using machines

Efferalgan does not affect psychophysical abilities. There are no contraindications to driving vehicles and operating machinery.

Efferalgan contains sodium, sorbitol, and sodium benzoate.

Each effervescent tablet contains 412.4 mg of sodium (the main component of common salt). This corresponds to 21% of the maximum recommended daily intake of sodium in the diet for adults.

Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the patient's body does not break down fructose), the patient should consult their doctor before taking the medicine or giving it to their child.

Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Efferalgan contains sodium benzoate, which may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age) whose mothers used this medicine during pregnancy.

3. How to take Efferalgan

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

The dose is determined based on the patient's body weight. The approximate age corresponding to a given body weight is provided only as a guide.

The recommended single dose of paracetamol is 10 to 15 mg/kg body weight, every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg body weight. The total daily dose of paracetamol should not exceed 4 g.

The recommended dose is:

Adults and adolescents with a body weight over 50 kg (over 15 years of age)

The recommended single dose of Efferalgan is 500 mg or 1 g of paracetamol (one or two effervescent tablets), every 4 to 6 hours, for a total of no more than 3 g of paracetamol (6 effervescent tablets per day).

However, in the case of severe pain, the daily dose can be increased to a maximum of 4 g of paracetamol (8 effervescent tablets per day). The patient should always maintain at least a 4-hour interval 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, with a maximum daily dose of 60 mg/kg body weight per day.

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).

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).

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

Elderly patients

There is no need to modify the dose.

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 scheme:

Creatinine clearance

Interval between doses

CrCl ≥ 50 ml/min

4 hours

CrCl 10-50 ml/min

6 hours

CrCl <10 ml min< p>

8 hours

Patients with liver function disorders

In patients with liver function disorders, the dose of the medicine should be reduced or the intervals between doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight per day (should not exceed 2 g/day):

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

Method of administration

Oral administration. The tablet should be dissolved in a glass of water and the prepared solution should be drunk. The tablets should not be chewed or swallowed.

Frequency of administration

Regular use of the medicine allows for the 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.

Duration of use

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

Using a higher dose of Efferalgan than recommended

In the event of taking too high a dose or accidentally taking Efferalgan, the patient should contact their doctor for 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 medicines that induce liver enzymes, as these individuals are at increased risk of liver damage.

Overdose of the medicine 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, manifested by abdominal distension, return of nausea, and jaundice.

In every case of taking this medicine in a single dose of 10 tablets (5 g of paracetamol) or more, the patient should induce vomiting if it has not been more than an hour since ingestion and contact their doctor immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. The patient should seek medical advice immediately.

Missing a dose of Efferalgan

The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Efferalgan can cause side effects, although not everybody gets them.

The frequency of side effects listed below is defined as follows:

rare: in less than 1 in 1,000 but 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 (blood coagulation factor) values.

Very rare, requiring withdrawal of treatment, cases of hypersensitivity reactions have been reported:

skin redness, rash, flushing, 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 exanthematous pustulosis on the entire body or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or bursting giant blisters, extensive erosions on the skin, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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,

phone: +48 22 49 21 301,

fax: +48 22 49 21 309,

website: https://smz.ezdrowie.gov.pl.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Efferalgan

The medicine should be stored in a place that is out of sight and reach of children.

There are no special precautions for storage.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 effervescent tablet contains 500 mg of paracetamol.
• The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan looks like and what the packaging contains

Effervescent tablet.

Packaging:

Soft Al/LDPE blisters containing 8 or 16 tablets in a cardboard box.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer:

UPSA 979

Avenue des Pyrénées - Le Passage

47520

France

UPSA 304

Av. Dr. Jean Bru

Agen

France

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

CEFEA Sp. z o.o. Sp. komandytowa

ul. Działkowa 56

02-234 Warsaw

SHIRAZ PRODUCTIONS Sp. z o.o.

ul. Tymiankowa 24/28

95-054 Ksawerów

CANPOLAND SPÓŁKA AKCYJNA

ul. Beskidzka 190

91-610 Łódź

Marketing authorization number in Spain, the country of export: 933564.9

Parallel import authorization number: 104/23

Date of leaflet approval: 07.06.2023

[Information about the trademark]