Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Efferalgan, 500 mg, effervescent tablets
Paracetamolum
Please read this leaflet carefully 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.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
If in adults the pain persists beyond 5 days, or if cold and flu symptoms or fever persist beyond 3 days, and in children and adolescents if pain, cold and flu symptoms, or fever persist beyond 3 days, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet

What Efferalgan is and what it is used for
Important information before taking Efferalgan
How to take Efferalgan
Possible side effects
How to store Efferalgan
Contents of the pack and other information

1. What Efferalgan is and what it is used for

Efferalgan is an analgesic and antipyretic medicine. It reduces elevated body temperature. Paracetamol irritates the gastric mucosa less than salicylates.
Indications for use:

Pain of various origins (headache, toothache, joint pain, muscle pain, menstrual pain, neuralgia, and others).
Symptomatic treatment of influenza-like conditions and colds.
Fever.

This medicine is intended for use in adults, adolescents, and children with body weight above 17 kg (i.e., approximately 6 years of age and older).

2. Important information before using Efferalgan

When not to use Efferalgan

if the patient is allergic to paracetamol, propacetamol hydrochloride (a paracetamol precursor), or any of the other ingredients of this medicine (listed in section 6),
in children with body weight below 17 kg,
in women during the first trimester of pregnancy,
if the patient has severe liver failure or active, decompensated liver disease,
if the patient has glucose-6-phosphate dehydrogenase deficiency,
if the patient is being treated with MAO inhibitors (medicines used, among others, in depression) and within 14 days after stopping such treatment.

Warnings and precautions
Before starting to use Efferalgan, consult your doctor, pharmacist, or nurse.
Efferalgan contains paracetamol and should be used taking into account the simultaneous intake of other medicines containing paracetamol (including prescription or over-the-counter drugs) to avoid exceeding the recommended daily dose (see section 3).
Do not exceed the recommended doses. Taking higher than recommended doses may result in severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring around days 3–4.
Paracetamol may cause serious skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor if any skin reaction occurs and discontinue the medicine if a skin rash or any other sign of hypersensitivity appears.
Consult your doctor before using Efferalgan if the patient has any of the following conditions:

liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
kidney function disorders (see section 3),
alcohol-related disease,
anorexia, bulimia, or severe malnutrition,
chronic undernutrition (low glutathione reserves in the liver),
dehydration,
hypovolemia (reduced circulating blood volume).

Do not consume alcohol during treatment, nor take medicines containing alcohol.
Prolonged use (over 3 months) of painkillers in patients with chronic headache, taken on alternate days or more frequently, may lead to development or worsening of headache. Headache caused by overuse of painkillers (Medication-Overuse Headache, MOH) should not be treated by increasing the dose. In such cases, treatment with painkillers should be discontinued in consultation with a doctor.

Efferalgan and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Concurrent use of Efferalgan may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan taken simultaneously:

MAO inhibitors – concurrent use with MAO inhibitors and within 2 weeks after stopping such treatment is contraindicated due to the risk of excitation and high fever.
Medicines containing salicylamide (an analgesic also used in fever) – concurrent use prolongs paracetamol elimination time.
Medicines increasing hepatic metabolism – concurrent use of paracetamol with drugs such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), or rifampicin (used in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used (see "Use of higher than recommended dose of Efferalgan" in section 3). Caution is advised during concurrent use.
Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised during concurrent use with these medicines.
Non-steroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.
Oral anticoagulants – concurrent use of paracetamol with coumarin anticoagulants, including warfarin, may lead to slight changes in INR values. In such cases, the doctor may increase the frequency of INR monitoring during and for one week after discontinuation of paracetamol.
Phenytoin (used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, high doses and/or prolonged use of paracetamol should be avoided. These patients should be continuously monitored for signs of liver damage.
Probenecid (used in gout) – reduces paracetamol elimination. During concurrent use, the doctor may consider reducing the paracetamol dose.
Flucloxacillin – caution is advised when using flucloxacillin simultaneously with paracetamol due to increased risk of developing a blood and body fluid disorder (metabolic acidosis with high anion gap), especially in patients with risk factors for glutathione deficiency such as severe kidney dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

Inform your doctor about using this medicine if your doctor orders tests for uric acid or blood sugar levels.

Use of Efferalgan with alcohol
Do not consume alcohol or take medicines containing alcohol during treatment due to increased risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Efferalgan may be given to pregnant women if necessary. The lowest effective dose that adequately relieves pain or reduces fever should be used, for the shortest possible duration and as infrequently as possible.
Paracetamol may be used during breastfeeding only with a doctor's approval and in individual cases. Caution is advised during use in the lactation period.
If pain is not relieved or fever does not subside, or if more frequent dosing is required, consult a doctor.
There are no sufficient data available to demonstrate the effect of paracetamol on fertility.

Driving and operating machinery
Efferalgan does not affect psychophysical performance. There are no contraindications to driving or operating machinery.

Efferalgan contains sodium, sorbitol (E 420), and sodium benzoate (E 211)
Each effervescent tablet contains 412 mg of sodium (main component of table salt), equivalent to 21% of the maximum recommended daily sodium intake in adults. Patients, especially those monitoring sodium intake, who take 1 or more effervescent tablets daily over a long period, should consult their doctor or pharmacist.
Each effervescent tablet contains 300 mg of sorbitol (E 420). Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose), the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan contains sodium benzoate (E 211), 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
your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
The dose is based on the patient's body weight. The approximate age corresponding to a given body
weight is provided only as a guideline.
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight (b.w.), every
4 to 6 hours, up to a maximum daily dose of 75 mg/kg b.w. The total daily dose of paracetamol must not exceed 4 g.
The recommended dose is:
Adults and adolescents weighing over 50 kg (aged above 15 years)
The recommended single dose of Efferalgan is 500 mg or 1 g paracetamol (one or two effervescent
tablets), every 4 to 6 hours, for a total of no more than 3 g paracetamol (6 effervescent tablets per
day). However, in the case of severe pain, the daily dose may be increased to the maximum dose of
4 g paracetamol (8 effervescent tablets per day). There must always be at least a 4-hour interval between doses.
Children and adolescents weighing up to 50 kg
The recommended single dose of paracetamol is 10 to 15 mg/kg b.w., preferably every 6 to 8 hours,
with a maximum daily dose of 60 mg/kg b.w./day.
Children weighing 17 to 25 kg (aged 6 to 8 years): the single dose is 250 mg
paracetamol (half an effervescent tablet). The dose may be repeated if necessary every 6 hours. Do
not administer more than 1 g paracetamol per day (2 effervescent tablets).
Children weighing 25 to 33 kg (aged 8 to 10 years): the single dose is 250 mg (half an
effervescent tablet). The dose may be repeated if necessary every 4-6 hours. Do not
administer more than 1.5 g paracetamol per day (3 effervescent tablets).
Children weighing 33 to 50 kg (aged 10 to 15 years): the single dose is 500 mg (one
effervescent tablet), which may be repeated if necessary every 6 hours; do not administer
more than 2 g paracetamol per day (4 effervescent tablets).
Elderly patients
Dose adjustment is not necessary.
Patients with renal impairment
In patients with impaired renal function, the recommended single dose is 500 mg (1 effervescent
tablet), and the minimum interval between doses should follow the scheme below:
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 hepatic impairment
In patients with impaired liver function, the dose should be reduced or the intervals between doses
extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg b.w./day (should not exceed 2 g/day):

in patients weighing less than 50 kg,
chronic or compensated active liver disease, especially mild to moderate hepatic insufficiency,
Gilbert's syndrome (familial non-haemolytic hyperbilirubinaemia),
chronic alcohol-related disease,
chronic malnutrition (low hepatic glutathione reserves),
dehydration.

Method of administration
Oral use. The effervescent tablet should be dissolved in a glass of water and the resulting solution
drunk. Do not chew or swallow the tablets.
Frequency of administration
To prevent recurrent episodes of pain or fever:

in children, maintain regular dosing intervals both during the day and night,
in adults, the interval between doses must not be less than 4 hours.

Duration of treatment
In adults, do not use Efferalgan for longer than 5 days for pain, or for more than 3 days for cold,
flu, or fever, unless advised by a doctor. In children and adolescents, never use the medicine for
longer than 3 days.
Taking more Efferalgan than recommended
If an excessive dose is taken or Efferalgan is taken by mistake, contact your doctor immediately for
appropriate advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished
patients, those with alcohol-related disease, liver disease, or patients taking medicines that induce
liver enzymes, as these individuals are at increased risk of liver damage.
Overdose may cause symptoms within a few to several hours, such as:
nausea, vomiting, anorexia, pallor, excessive sweating, drowsiness, and general weakness. These
symptoms may subside the next day, even though liver damage may have started, manifesting as
upper abdominal discomfort, recurrence of nausea, and jaundice.
In any case where this medicine has been taken in a single dose of 5 g paracetamol or more,
induce vomiting if less than one hour has passed since ingestion, and contact a doctor
immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably
mixed with water. Seek medical advice immediately.
Rare cases of acute pancreatitis have been observed.
Missing a dose of Efferalgan
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of occurrence of the adverse reactions 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,
unknown: frequency cannot be estimated based on available data.

Rare: lowering of blood pressure.

Very rare: tachycardia; nausea, vomiting; renal colic, renal papillary necrosis, acute renal failure.

Unknown: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of deep skin layers and subcutaneous tissue); diarrhoea, abdominal pain; increased liver aminotransferase activity; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of white blood cell); rash, erythema, urticaria, purpura, generalized pustular rash, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Very rare, treatment-requiring cases of hypersensitivity reactions (skin redness, dyspnoea, bronchospasm, excessive sweating) have been reported.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Efferalgan

Keep this medicine out of sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Efferalgan contains

The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
Other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium docecyl sulfate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan looks like and contents of the pack
Effervescent tablet.
Pack: Al/LDPE soft blisters containing 8 or 16 effervescent tablets, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer:
UPSA, 979, Avenue des Pyrénées, 47520 Le Passage, France
UPSA, 304, Av. Dr. Jean Bru, 47000 Agen, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, country of export: 933564.9
Parallel Import Licence Number: 68/24