PARACETAMOL FARMALIDER

Package leaflet: Information for the user

Paracetamolum Farmalider, 1000 mg, tablets
Paracetamolum
Read this leaflet carefully before taking the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Paracetamolum Farmalider is and what it is used for
Paracetamol belongs to a group of analgesic and antipyretic medicines. Paracetamol is indicated for the symptomatic treatment of mild to moderate pain (e.g. headache, toothache, menstrual pain) and fever.

2. Important information before taking Paracetamolum Farmalider
When not to take Paracetamolum Farmalider:

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Paracetamolum Farmalider, discuss with your doctor or pharmacist if you have:

• kidney disease,
• liver disease (including Gilbert's syndrome and alcoholic liver disease),
• acute hepatitis,
• are taking other medicines that may affect liver function,
• glucose-6-phosphate dehydrogenase deficiency,
• haemolytic anaemia.

During treatment with Paracetamolum Farmalider, immediately inform your doctor if:

• you have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).

Severe metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients taking paracetamol regularly for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Do not take any other medicines containing paracetamol at the same time.

In case of overdose, seek immediate medical help due to the risk of delayed, serious liver damage.

Do not exceed the recommended dose.

Do not exceed 4 g (4 tablets) within 24 hours.

Paracetamol may affect the results of the following laboratory tests:

• serum uric acid levels when using phosphotungstic acid,
• blood glucose levels when using glucose oxidase and peroxidase.

Children
Do not use in children under 16 years of age. For children under 16 years of age, consult your doctor or pharmacist, as other dosage forms with doses adjusted for this patient group are available.

Paracetamolum Farmalider and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2). Before starting treatment with the tablets, tell your doctor or pharmacist if you are taking prescription medicines, especially metoclopramide or domperidone (for nausea or vomiting), cholestyramine (to lower blood cholesterol levels), opioids (for severe pain), or chloramphenicol (for bacterial infections).

If you are taking anticoagulant medicines ( blood thinners such as warfarin) and need to take a painkiller regularly, you should discuss this with your doctor due to the risk of bleeding. However, occasional doses of Paracetamolum Farmalider may be taken together with anticoagulants.

Taking Paracetamolum Farmalider with food, drink and alcohol
Taking paracetamol in patients who regularly consume alcohol (more than three alcoholic drinks per day – beer, wine, vodka, etc.) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Paracetamolum Farmalider may be used during pregnancy if necessary.

Take the lowest recommended dose that reduces pain and (or) fever, for the shortest possible duration and as infrequently as possible.

Consult your doctor if pain and (or) fever do not subside or if you need to take the medicine more frequently.

Driving and using machines
Paracetamol has no or negligible effect on the ability to drive and operate machinery.

3. How to take Paracetamolum Farmalider
Always take this medicine exactly as your doctor or pharmacist has advised. If in doubt, consult your doctor or pharmacist.

Recommended dose:
Adults (including elderly) and adolescents over 16 years of age: one tablet up to four times daily as needed.

Do not take more frequently than every 4 hours.

Do not take more than 4 tablets within 24 hours.

Use in children
Do not use in children and adolescents under 16 years of age.

If you think that the effect of Paracetamolum Farmalider is too strong or too weak, consult your doctor or pharmacist.

If a dose of less than 1000 mg paracetamol is required, use other strengths of the medicine appropriate for the needed dose.

Taking more Paracetamolum Farmalider than recommended
Seek immediate advice from your doctor or pharmacist. In case of overdose or accidental ingestion, go immediately to hospital or call the toxicology information centre, providing the name of the medicine and the amount taken.

If you overdose on this medicine, go to hospital immediately, even if there are no symptoms.

Symptoms of overdose within the first 24 hours include: pallor, nausea, vomiting, loss of appetite and abdominal pain.

Treatment of overdose is most effective within the first 4 hours after ingestion.

In case of overdose, seek immediate medical help due to the risk of delayed, serious liver damage.

If symptoms persist or headache becomes persistent, consult your doctor.

Missed dose of Paracetamolum Farmalider
Do not take a double dose to make up for a missed tablet. Take the missed dose as soon as you remember, and take the next doses at the prescribed intervals (at least 6 hours apart).

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine may cause the following side effects:

Rare (may occur in up to 1 in 1,000 people): feeling of discomfort, drop in blood pressure (hypotension), breathing difficulties (bronchospasm), asthma and increased blood levels of aminotransferases.

Very rare (may occur in up to 1 in 10,000 patients): kidney disorders, cloudy urine, allergic skin rash (skin eruption), jaundice, blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), angioedema (swelling), anuria and haematuria, interstitial nephritis.

Unknown frequency (cannot be estimated from available data): Serious condition that may cause the blood to become more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Taking paracetamol in high doses or during long-term treatment may cause liver damage.

If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist.

Very rare cases of severe skin reactions have been reported.

Reporting of side effects
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to:

Department of Monitoring of Adverse Drug Reactions
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
e-mail: [email protected]

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Paracetamolum Farmalider
Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.

No special storage conditions required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the pack and other information
What Paracetamolum Farmalider contains
The active substance is paracetamol. Each tablet contains 1000 mg of paracetamol.

The other ingredients are: pregelatinised starch, maize (gluten-free), stearic acid (type 50), povidone (K-30), crospovidone (type A), microcrystalline cellulose and magnesium stearate.

What Paracetamolum Farmalider looks like and contents of the pack
Paracetamolum Farmalider is supplied as an oral tablet in packs containing: 1, 6, 8, 10, 12, 16, 18, 20, 30, 32 and 100 tablets.

Not all pack sizes may be marketed.

Tablet dimensions: 21.0 ± 0.2 mm (length) x 10.0 ± 0.2 mm (width) x 8.1 ± 0.2 mm (thickness). The score line on the tablet is only intended to facilitate breaking for ease of swallowing.

Marketing Authorisation Holder
Farmalider S.A.
C/ La Granja, 1, Alcobendas
28108 Madrid
Spain

Manufacturer/Importer:
Toll Manufacturing Services S.L
C/ Aragoneses, 2, Alcobendas
28108 Madrid
Spain
FROSST IBÉRICA, S.A.
Vía Complutense, 140, Alcalá de Henares
28805 Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information, please contact the local representative of the marketing authorization holder.