Efferalgan

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Fervex Pain and Fever (Efferalganmed)
500 mg, effervescent tablets
Paracetamolum
Fervex Pain and Fever and Efferalganmed are different trade names for 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
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 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 persists beyond 3 days, or if the patient feels worse, consult a doctor.

Leaflet contents

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

1. What Fervex Pain and Fever is and what it is used for

Fervex Pain and Fever 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 over 50 kg (i.e., over 15 years of age).

2. Important information before using Fervex Pain and Fever

When not to use Fervex Pain and Fever

• 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 50 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active untreated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase deficiency,
• if the patient is being treated with MAO inhibitors (medicines used e.g. for depression) or within 14 days after discontinuation of such treatment.

Warnings and precautions
Before starting to use Fervex Pain and Fever, discuss this with your doctor, pharmacist,
or nurse.
Fervex Pain and Fever contains paracetamol and should be used considering
concomitant use 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 doses higher than recommended carries
a risk of severe liver damage. Symptoms of liver damage usually appear
within 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 allergic symptoms develop.
Consult your doctor before using Fervex Pain and Fever if the patient has any of the
following conditions:

• liver function disorders, including Gilbert's syndrome (hereditary hyperbilirubinemia),
• kidney function disorders (see section 3),
• alcoholic liver disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, or starvation,
• dehydration,
• hypovolemia (reduced circulating blood volume).

During treatment with Fervex Pain and Fever, inform the doctor immediately if the
patient develops serious conditions, including severe kidney disorders or 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
(a disturbance in blood and body fluid balance) when paracetamol was used regularly
for 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 or take medicines containing alcohol.
Long-term (over 3 months) use of painkillers in patients with chronic headache, taken every two days or more frequently, may lead to development or worsening of headache. Medication-overuse headache (MOH) should not be treated by increasing the dose. In such cases, in consultation with a doctor, use of painkillers should be discontinued.
Fervex Pain and Fever and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Concomitant use of Fervex Pain and Fever may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex Pain and Fever taken simultaneously:

• MAO inhibitors – concomitant use with MAO inhibitors is contraindicated, as well as within 2 weeks after discontinuation of such treatment, due to the risk of excitation and high fever.
• Medicines containing salicylamide (an analgesic also used for fever) – concomitant use prolongs the elimination time of paracetamol.
• Medicines increasing hepatic metabolism – concomitant use of paracetamol with medicines such as St. John's wort, antiepileptics, barbiturates (medicines mainly used in epilepsy), or rifampicin (a medicine used in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used (see "Use of doses higher than recommended of Fervex Pain and Fever" in section 3). Caution is advised during concomitant use.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised during concomitant use.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of kidney function disorders.
• Oral anticoagulants – concomitant 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 concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (a medicine used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, high doses of paracetamol and/or prolonged use of paracetamol should be avoided. These patients should be continuously monitored for signs of liver damage.
• Probenecid (a medicine used in gout) – reduces the elimination of paracetamol. During concomitant use with paracetamol, the doctor may consider reducing the paracetamol dose.
• Flucloxacillin (an antibiotic) – inform your doctor or pharmacist if the patient is taking flucloxacillin due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Inform your doctor about using this medicine if your doctor orders tests for blood uric acid
or blood glucose.
Use of Fervex Pain and Fever with alcohol
During treatment, do not consume alcohol or take medicines containing alcohol,
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 a doctor before using this medicine. Fervex Pain and Fever
may be given to pregnant women if necessary. Use the lowest effective recommended dose
that adequately relieves pain or reduces fever, 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 increased dosing frequency becomes necessary, consult a doctor. There are no sufficient available data to demonstrate the effect of paracetamol on fertility.
Driving and operating machinery
Fervex Pain and Fever does not affect psycho-physical performance. There are no contraindications to
driving or operating machinery.
Fervex Pain and Fever contains sodium, sorbitol, sodium benzoate, and in flavoring contains fructose, glucose, and sucrose.
Each effervescent tablet contains 197 mg of sodium (main component of table salt). This corresponds to approximately 10% 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 in their diet, should contact their doctor or pharmacist.
Each effervescent tablet contains 126 mg of sorbitol. Sorbitol is a source of fructose. If the patient 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 contact a doctor before taking the medicine. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Each effervescent tablet contains 50 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 age).
The medicine contains 0.96 mg of fructose in each effervescent tablet. If the patient 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), consult a doctor before taking the medicine.

3. How to use Fervex Pain and Fever

This medicine should always be taken 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 determined 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.

Recommended dose:
Adults and adolescents with body weight above 50 kg (aged over 15 years)
The recommended single dose of Fervex Pain and Fever 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). There must always be at least a 4-hour interval between doses.

Elderly patients
Dose adjustment is usually not necessary.
However, coexisting risk factors, some of which are more common in elderly patients, should be taken into account, as they 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 intervals between doses extended. In the following situations, the maximum daily dose must not exceed 60 mg/kg b.w./day (must not exceed 2 g/day):

• in patients 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,
• chronic malnutrition (low hepatic glutathione reserves),
• dehydration.

Method of administration
Oral use. The effervescent tablet must be dissolved in a glass of water and the resulting solution drunk. Do not chew or swallow the tablets.

Frequency of administration
To prevent periodic exacerbations 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, unless otherwise directed by a doctor. In adolescents, never use the medicine for longer than 3 days.

Overdose of Fervex Pain and Fever
If an excessive dose has been taken or if Fervex Pain and Fever has been 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 diseases, 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, anorexia, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage may already be developing, manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
In any case of single ingestion of 5 g or more of paracetamol, vomiting should be induced if less than one hour has passed since ingestion, and immediate contact with a doctor is required. Administration of 60–100 g of activated charcoal orally, preferably mixed with water, is recommended. Immediate medical advice must 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 Fervex Pain and Fever
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning 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 will experience 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 patients treated,
very rare: in less than 1 in 10,000 patients treated,
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 renal failure.
Not known: 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, generalised acute exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome; bronchospasm, persistent drug-induced rash; serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
Very rare cases of hypersensitivity reactions (skin redness, shortness of breath, bronchospasm, excessive sweating), requiring discontinuation of treatment, have been reported.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-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 Fervex Pain and Fever medicine

Keep the medicine out of sight and reach of children.
No special storage instructions 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 sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex Pain and Fever contains
The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
The other ingredients are: citric acid, sodium carbonate, sodium bicarbonate, sorbitol, sodium saccharin,
sodium lauryl sulfate, povidone, sodium benzoate, citrus flavour (orange-grapefruit) (contains fructose, glucose and sucrose).

What Fervex Pain and Fever looks like and contents of the pack
Effervescent tablet.
White or almost white, flat, round tablet with bevelled edges and a score line; water-soluble, producing an effervescing reaction. The tablet can be divided into equal doses.
Pack: soft aluminium/PE blisters containing 16 effervescent tablets, in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, the country of export:
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer:
UPSA SAS
979, avenue des Pyrénées
47520 Le Passage
France
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

French Marketing Authorisation Number (country of export): 34009 325 700 1 0
325 700-1
Parallel Import Authorisation Number: 88/19