PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Efferalgan
500 mg, effervescent tablets
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet or as your
doctor, pharmacist or nurse has advised.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
If in adults pain persists beyond 5 days, or cold, flu symptoms or fever persist beyond 3 days, and in children and adolescents if pain, cold, flu symptoms or fever persist beyond 3 days, or if the patient feels worse, consult a doctor.

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 occurring during illness, but does not lower normal body temperature. Paracetamol irritates the gastric mucosa less than salicylates.

Indications:

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

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 less than 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, for depression) and within 14 days after stopping such treatment,
when used concomitantly with analgesics having agonist-antagonist activity: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions
Before starting to use Efferalgan, discuss it with your doctor, pharmacist, or nurse.
Efferalgan contains paracetamol and should be used taking into account simultaneous intake of other medicines containing paracetamol (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3).
Do not exceed the recommended doses. Taking higher than recommended doses carries a risk of severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring after 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 may be fatal. Inform your doctor if skin reactions occur and discontinue the medicine if a skin rash or any other sign of hypersensitivity develops.
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),
alcoholic liver disease or excessive alcohol consumption (consuming 3 or more alcoholic drinks daily),
anorexia, bulimia, or physical wasting,
prolonged malnutrition,
low hepatic glutathione reserves due to, for example, eating disorders, cystic fibrosis, HIV infection, fasting or wasting conditions, sepsis,
dehydration,
hypovolemia (reduced circulating blood volume).

Efferalgan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant 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 – do not use simultaneously with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of excitation and high fever.
Medicines containing salicylamide (an analgesic also used in feverish conditions) – concomitant use prolongs the elimination time of paracetamol.
Medicines increasing hepatic metabolism – concomitant use of paracetamol with medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), 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 concomitant use.
Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised when used concomitantly with these medicines.
Non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of kidney function disorders.
Oral anticoagulants – concomitant use of paracetamol with coumarin-type anticoagulants, including warfarin, may lead to minor changes in INR values. In such cases, the doctor may increase the frequency of INR monitoring during concomitant use and for one week after stopping paracetamol.
Phenytoin (used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. During phenytoin treatment, high doses of paracetamol and/or prolonged use should be avoided. These patients should be continuously monitored for signs of liver damage.
Probenecid (used in gout) – reduces paracetamol elimination. When used concomitantly with paracetamol, the doctor may consider reducing the paracetamol dose.
Flucloxacillin – caution is advised when using flucloxacillin simultaneously with paracetamol due to increased risk of developing blood and body fluid disorders (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 blood uric acid or blood glucose levels.
Using Efferalgan with alcohol
Do not drink alcohol or take medicines containing alcohol while using this medicine, due to increased risk of toxic liver damage. The risk of liver damage is particularly high in fasting individuals and those who regularly consume alcohol.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Efferalgan may be given to pregnant women if necessary. Use the lowest effective dose sufficient to relieve pain or reduce fever, and take the medicine for the shortest possible duration.
If pain is not relieved or fever does not subside, or if more frequent dosing becomes necessary, consult your doctor.
There are insufficient data available to determine whether paracetamol affects fertility.
Driving and operating machinery
Efferalgan does not affect psychomotor performance. There are no contraindications to driving vehicles or operating machinery.
Efferalgan contains sodium, sorbitol, and sodium benzoate.
Each effervescent tablet contains 412.4 mg of sodium (main component of table salt). This corresponds to 21% of the maximum recommended daily sodium intake in the diet of adults. If 1 or more effervescent tablets are taken daily for a prolonged period, patients—especially those monitoring sodium intake—should consult their doctor or pharmacist.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose) has been diagnosed in the patient (or their child), the patient should consult their doctor before taking the medicine or giving it to the 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 life) whose mothers used this medicine during pregnancy.

3. How to use Efferalgan

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
The dose is determined based on the patient's body weight. 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 (bw), every 4 to 6 hours, up to
a maximum daily dose of 75 mg/kg bw. The total daily dose of paracetamol must not exceed 4 g.
Recommended doses:
Adults and adolescents with body weight above 50 kg (over 15 years of age)
The recommended single dose of Efferalgan is 500 mg or 1 g paracetamol (one or two effervescent tablets),
every 4 to 6 hours, with a total of no more than 3 g paracetamol (6 effervescent tablets per day).
However, in cases 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 with body weight up to 50 kg
The recommended single dose of paracetamol is 10 to 15 mg/kg bw, preferably every 6 to 8 hours, with a
maximum daily dose of 60 mg/kg bw/day.
Children with body weight from 17 to 25 kg (aged 6 to 8 years): single dose is 250 mg paracetamol
(half an effervescent tablet). The dose may be repeated if necessary every 6 hours. Do not exceed
1 g paracetamol per day (2 effervescent tablets).
Children with body weight from 25 to 33 kg (aged 8 to 10 years): single dose is 250 mg (half an effervescent
tablet). The dose may be repeated if necessary every 4–6 hours. Do not exceed 1.5 g paracetamol per day
(3 effervescent tablets).
Children with body weight from 33 to 50 kg (aged 10 to 15 years): single dose is 500 mg (one effervescent
tablet), which may be repeated if necessary every 6 hours; do not exceed 2 g paracetamol per day
(4 effervescent tablets).
Elderly patients
No dose adjustment is necessary.
Patients with renal function 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 function 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 bw/day
(should not exceed 2 g/day):

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

Method of administration
Oral administration. The tablet should be dissolved in a glass of water and the resulting solution consumed.
Do not chew or swallow the tablets.
Frequency of administration
Regular use of the medicine helps prevent periodic exacerbations of pain or fever:

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

Duration of use
In adults, do not use this medicine for longer than 5 days for pain, or for more than 3 days for cold, flu, or
fever, without medical advice. In children and adolescents, never use the medicine for longer than 3 days.
Use of a higher than recommended dose of Efferalgan
If an overdose is taken or Efferalgan is taken by mistake, contact a doctor immediately for appropriate
advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished
patients, those with alcohol-related disease, liver disorders, and patients taking drugs that induce liver
enzymes, as these individuals have an increased risk of liver damage.
Overdose may cause symptoms within a few to several hours, such as: nausea, vomiting, loss of appetite,
pallor, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day,
even though liver damage may already be developing, manifesting as abdominal discomfort, recurrence of
nausea, and jaundice.
In any case where this medicine is taken in a single dose of 10 tablets (5 g paracetamol) or more, vomiting
should be induced if less than one hour has passed since ingestion, and immediate medical attention must
be sought. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with
water. Immediate medical advice should be sought.
Missed dose of Efferalgan
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The frequency of occurrence of the adverse 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, hypotension (low blood pressure), increased liver aminotransferase activity.
Very rare: hypersensitivity reactions, tachycardia, diarrhoea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type of white blood cells), decrease or increase in INR values (blood coagulation index).

Very rare, treatment-terminating cases of hypersensitivity reactions have been reported: skin redness, rash, erythema or urticaria, angioedema (swelling of deep skin layers and subcutaneous tissue), dyspnoea, bronchospasm, excessive sweating, hypotension up to symptoms of anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: dyspnoea, laryngeal and pharyngeal oedema, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases may be life-threatening), as well as Quincke's oedema, severe skin reactions: acute generalized pustular rash over the entire body or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing giant blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse effects 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 required.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium docecynate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan looks like and contents of the pack
Effervescent tablet.
Pack:
Soft Al/LDPE blisters containing 8 or 16 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder 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 - Le Passage
France
UPSA 304
Av. Dr. Jean Bru
Agen
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
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 JOINT STOCK COMPANY
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation number in Spain, country of export: 933564.9
Parallel import authorisation number: 104/23