Efferalgan forte

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Efferalgan Forte (Dafalgan 1 g), 1 g, effervescent tablets
Paracetamolum
Efferalgan Forte and Dafalgan 1 g are different brand names of the same medicine.
Please read the entire 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
your doctor, pharmacist, or nurse.

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

Table of contents of the leaflet:

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

1. What Efferalgan Forte is and what it is used for

Efferalgan Forte 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 to a lesser extent than salicylates.
Indications for use:

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Fever.

2. Important information before using Efferalgan Forte

When not to use Efferalgan Forte:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in individuals with body weight less than 50 kg,
• in women during the first trimester of pregnancy,
• in patients with severe hepatic insufficiency or active, decompensated liver disease,
• in patients with glucose-6-phosphate dehydrogenase deficiency,
• in patients being treated with monoamine oxidase inhibitors (MAOIs) (medicines used e.g. in depression) and within 14 days after discontinuation of such treatment,
• when used concomitantly with analgesic drugs having agonist-antagonist opioid activity: buprenorphine, nalbuphine, pentazocine.

Warnings and precautions
Before starting to use Efferalgan Forte, discuss it with your doctor, pharmacist, or nurse.
Due to the content of 1 g of paracetamol per effervescent tablet, Efferalgan Forte should not be used in children and adolescents under 15 years of age.
Efferalgan Forte contains paracetamol and should be used taking into account the 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 use doses higher than recommended. Using higher than recommended doses poses a risk of severe liver damage. Symptoms of liver injury usually appear one to two days after paracetamol overdose, with maximum severity typically occurring on days 3–4.
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 any skin reaction occurs and discontinue use of the medicine if a skin rash or any other sign of hypersensitivity develops.
Consult your doctor before using Efferalgan Forte 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, excessive alcohol consumption (ingestion of 3 or more alcoholic drinks daily),
• anorexia, bulimia, or cachexia,
• prolonged malnutrition,
• low glutathione reserves in the liver due to, for example, eating disorders, cystic fibrosis, HIV infection, fasting or cachectic patients, sepsis,
• dehydration,
• hypovolemia (reduced circulating blood volume).

Efferalgan Forte 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 Forte may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Efferalgan Forte taken simultaneously:

• MAO inhibitors – do not use concurrently with MAO inhibitors or within 2 weeks after discontinuation of treatment with these medicines due to the risk of developing excitation and high fever.
• Medicines containing salicylamide (analgesic, also used in fever) – concurrent use prolongs paracetamol elimination time.
• Drugs increasing hepatic metabolism – concurrent use of paracetamol with drugs 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 Forte" in section 3). Caution is advised during concomitant use.
• Isoniazid (used in tuberculosis) and zidovudine (antiviral medicine, used in HIV infection) – caution is advised during concomitant use with these medicines.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.
• Oral anticoagulants – concurrent use of paracetamol with coumarin-type anticoagulants, including warfarin, may lead to slight changes in INR values. In such cases, the doctor will increase the frequency of INR monitoring during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. During phenytoin treatment, high and/or prolonged doses of paracetamol should be avoided. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces paracetamol excretion. During concomitant use 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.
Use of Efferalgan Forte 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 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 Forte may be given to pregnant women if necessary. The lowest effective dose that adequately relieves pain or reduces fever should be used, and the medicine should be taken for the shortest possible duration.
If pain is not relieved or fever does not subside, or if increased frequency of dosing becomes necessary, consult your doctor.
There are no sufficient available data to indicate whether paracetamol affects fertility.
Driving and operating machinery
Efferalgan Forte does not affect psychophysical performance. There are no contraindications to driving or operating machinery.
Efferalgan Forte contains sodium, sorbitol (E 420), and sodium benzoate (E 211)
Each effervescent tablet contains 567 mg of sodium (the main component of table salt). This corresponds to 28% of the maximum recommended daily sodium intake in the diet for adults. Patients, especially those monitoring sodium intake in their diet, who take 1 or more effervescent tablets daily over a long period, should consult their doctor or pharmacist.
Each effervescent tablet contains 252 mg of sorbitol (E 420). Sorbitol (E 420) 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 (E 420) may cause gastrointestinal discomfort and may have a mild laxative effect.
Efferalgan Forte 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 life) whose mothers used this medicine during pregnancy.

3. How to use Efferalgan Forte

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

The dose is based on the patient's body weight. 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.

Recommended dose:
Adults and adolescents with body weight above 50 kg (aged over 15 years)
The recommended single dose of Efferalgan Forte is 1 effervescent tablet (1 g paracetamol) every 4 to 6 hours, up to 3 times daily, not exceeding 3 effervescent tablets (3 g paracetamol) in total. However, in cases of severe pain, the dose may be increased to the maximum daily dose of 4 g paracetamol (4 effervescent tablets). Always maintain at least a 4-hour interval between doses.

Elderly patients
Dose adjustment is not necessary.

Patients with renal impairment
For patients with impaired renal function, the recommended single dose is 500 mg, and the minimum interval between doses should follow the scheme below:

| Creatinine clearance | Dosing interval | |----------------------|----------------| | CrCl ≥ 50 ml/min | 4 hours | | CrCl 10–50 ml/min | 6 hours | | CrCl < 10 ml/min | 8 hours |

Efferalgan Forte should not be used in patients with renal impairment, as reduced doses are required. Efferalgan 500 mg effervescent tablets are available for such patients.

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 (and should not exceed 2 g/day):

• 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 (low glutathione reserves in the liver),
• dehydration.

Method of administration
Oral use.
Dissolve the tablet in a glass of water and drink the resulting solution. Do not chew or swallow the tablets whole.

Frequency of use
Regular use of the medicine helps prevent recurrent episodes of pain or fever.
The interval between doses should be 6 hours and must not be shorter than 4 hours under any circumstances.

Duration of use
In adults, do not use this medicine for longer than 5 days without medical advice, or for fever for longer than 3 days. In adolescents, do not use the medicine for longer than 3 days.

Overdose of Efferalgan Forte
If an excessive dose is taken or if Efferalgan Forte 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 patients 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 following day, even though liver damage may already be developing, manifesting as 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, vomiting should be induced if less than one hour has passed since ingestion, and immediate medical advice must be sought. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water. Immediate medical consultation is essential.

Missed dose of Efferalgan Forte
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 experiences them.
The frequency 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 patients treated
very rare: in less than 1 in 10,000 patients treated.
Rare: malaise, hypotension, increased hepatic aminotransferase activity.
Very rare: hypersensitivity reactions, tachycardia, diarrhoea, abdominal pain, nausea, vomiting,
renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (reduced platelet count),
leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of
white blood cell), decrease or increase in INR values (blood coagulation index).
Very rare, treatment-requiring cases of hypersensitivity reactions have been reported: skin
erythema, 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 severe systemic allergic reaction; symptoms include: dyspnoea, laryngeal and
pharyngeal swelling, skin itching and redness, headache, feeling of "pressure", dizziness, significant
weakness, up to loss of consciousness; in severe cases may be life-threatening) and Quincke's oedema,
severe skin reactions: acute generalized exanthematous pustulosis over the entire body or blisters and
erosions on the skin, in the oral cavity, eyes and genital organs, fever and joint pain or rupturing large
blisters, extensive skin erosions, peeling of large skin sheets, and fever (toxic epidermal necrolysis,
Stevens-Johnson syndrome).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist,
or nurse. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Efferalgan Forte

Keep this medicine out of sight and reach of children.
Store below 25°C.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Efferalgan Forte contains

• The active substance is paracetamol. Each effervescent tablet contains 1 g of paracetamol.
• Other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), sodium lauryl sulfate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan Forte looks like and contents of the pack
Effervescent tablet.
Pack: Al/PE soft blisters containing 8 tablets, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Portugal, the country of export: 3851987
Parallel import authorisation number: 250/23