Efferalgan

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
EFFERALGAN (EFFERALDOL)
500 mg, effervescent tablets
Paracetamolum
EFFERALGAN and EFFERALDOL are different brand names of the same medicine.
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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. See section 4.
• If pain in adults persists beyond 5 days or fever beyond 3 days, and in adolescents if pain or fever persists beyond 3 days, or if the patient feels worse, consult a doctor.

Table of contents

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

1. What Efferalgan is and what it is used for

Efferalgan is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature. Paracetamol irritates the gastric mucosa to a lesser extent than salicylates.
Indications:

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

This medicine is intended for short-term use in adults and adolescents with body weight above 50 kg (i.e. aged over 15 years).

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 50 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 discontinuation of such treatment.

Warnings and precautions
Before starting to use Efferalgan, discuss it with your doctor, pharmacist, or nurse.
Efferalgan contains paracetamol, and it 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 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 around 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 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 (hereditary hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcohol-related disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, wasting syndrome, or starvation,
• dehydration,
• hypovolemia (reduced circulating blood volume).

During treatment with Efferalgan, immediately inform your doctor if the patient develops any serious illness, including severe kidney disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In such cases, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when paracetamol was used regularly over a prolonged period or when paracetamol was taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
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, the discontinuation of painkillers should be considered in consultation with a doctor.

Efferalgan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 is contraindicated, as well as 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 fever) – concurrent use prolongs the elimination time of paracetamol.
• Medicines enhancing hepatic metabolism – concurrent 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 doses higher than recommended of Efferalgan" in section 3). Caution is advised during concurrent use.
• Isoniazid (used in tuberculosis) and zidovudine (an antiviral drug used in HIV infection) – caution is advised when used concomitantly 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-type 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. High doses and/or prolonged use of paracetamol should be avoided during phenytoin treatment. Patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces paracetamol elimination. The doctor may consider reducing the paracetamol dose during concurrent use.
• Flucloxacillin (an antibiotic) – inform your doctor or pharmacist if the patient is taking flucloxacillin due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Inform your doctor that you are taking 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 effects on 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 recommended dose should be used to relieve pain or reduce fever, for the shortest possible duration and as infrequently as possible.
Paracetamol may be used during breastfeeding only with a doctor's approval and on an individual basis. Caution should be exercised when using the medicine during lactation.
If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.
There are no sufficient available data to demonstrate an effect of paracetamol on fertility.

Driving and operating machinery
Efferalgan does not affect psychomotor 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 (a 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 over a long period, patients, especially those monitoring dietary sodium intake, should contact 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 does not break down fructose) has been diagnosed in the patient (or their child), 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 61 mg of 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 taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist or nurse. If in doubt, consult your 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 (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 with body weight above 50 kg (aged over 15 years)
The recommended single dose of Efferalgan is 500 mg or 1000 mg paracetamol (one or two effervescent tablets), every 4 to 6 hours, not exceeding a total of 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). Always maintain at least a 4-hour interval between doses.

Elderly patients
Dose adjustment is usually not necessary.
However, concomitant risk factors, some of which are more common in elderly patients, should be taken into account and may require dose adjustment.

Patients with renal impairment
In patients with impaired renal function, the minimum interval between doses and the maximum daily dose should be adjusted according to the following scheme:

| Creatinine clearance | Dosing interval | Maximum daily dose | |----------------------|-----------------|--------------------| | CrCl 10–50 ml/min | 6 hours | 3000 mg (3 g) | | CrCl <10 ml/min | 8 hours | 2000 mg (2 g) |

Patients with hepatic impairment
In patients with impaired liver function, the dose should be reduced or the dosing intervals 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 with body weight below 50 kg,
• chronic or compensated active liver disease, especially mild to moderate liver failure,
• 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, the interval between doses should be 6 hours and must not be shorter than 4 hours.

Duration of treatment
In adults, do not use this medicine for longer than 5 days for pain or 3 days for fever without medical advice. In adolescents, do not use this 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 patients, young children, chronically malnourished patients, patients with alcohol-related disease, patients with liver disease, and patients taking drugs that induce liver enzymes, as these patients are at increased risk of liver damage.

Paracetamol overdose may cause symptoms such as nausea, vomiting, anorexia, pallor, excessive sweating, drowsiness and general weakness within a few to several hours. These symptoms may resolve 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 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 activated charcoal orally is recommended, preferably mixed with water. Immediate medical advice should be sought.

The following events have been observed after paracetamol overdose:

• acute renal failure,
• disseminated intravascular coagulation,
• rare cases of acute pancreatitis.

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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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,
not known: frequency cannot be estimated from the available data.
Rare: low blood pressure.
Very rare: tachycardia; nausea, vomiting; renal colic, renal papillary necrosis,
acute kidney failure.
Not known: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of deep skin layers and subcutaneous tissue);
diarrhoea, abdominal pain; increased hepatic aminotransferase activity; thrombocytopenia
(decreased platelet count), leukopenia (decreased white blood cell count), neutropenia
(decreased neutrophil count – a type of white blood cell); rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome; bronchospasm, persistent drug eruption; serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
Very rare, treatment-requiring cases of hypersensitivity reactions (skin redness, shortness of breath, bronchospasm, excessive sweating) have been reported, requiring discontinuation of treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Efferalgan

Keep this medicine out of the 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 docusate, povidone, sodium saccharin, sodium benzoate (E 211).

What Efferalgan looks like and contents of the pack
Effervescent tablet.
White effervescent tablet with a score line and bevelled edges.
The score line is not intended for breaking the tablet into equal doses.
Pack:
Pack containing 8 or 16 effervescent tablets in soft Al/LDPE blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France
Manufacturer:
UPSA
979, avenue des Pyrénées
47520 Le Passage, France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing authorisation number in Spain, the country of export: 933564.9
Parallel import authorisation number: 111/23