Paracetamol Filofarm

Leaflet attached to the packaging: patient information

Paracetamol Filofarm

500 mg, tablets

Paracetamolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Paracetamol Filofarm and what is it used for

Paracetamol Filofarm contains the active substance paracetamol, which has analgesic and antipyretic effects. By inhibiting cyclooxygenase of arachidonic acid, it prevents the formation of prostaglandins in the central nervous system. The reduction of prostaglandin levels in the hypothalamus causes an antipyretic effect. The analgesic effect is similar to that of non-steroidal anti-inflammatory drugs (NSAIDs), but paracetamol, unlike these drugs, does not inhibit peripheral prostaglandin synthesis. Therefore, it does not have an anti-inflammatory effect and does not cause typical NSAID side effects. Paracetamol does not affect platelet aggregation. It is a drug of choice for the treatment of pain and fever.

Paracetamol Filofarm is used:

• for pains of various etiologies: headaches, muscle pains, toothaches, joint pains, neuralgia, menstrual pains;
• for fever, e.g. in the course of a cold or flu.

This medicine is intended for patients over 12 years of age.

2. Important information before taking Paracetamol Filofarm

When not to take Paracetamol Filofarm

• if the patient is hypersensitive (allergic) to paracetamol or any of the other ingredients of this medicine (listed in section 6). Due to the risk of overdose, you should check if other medicines being taken contain paracetamol;
• if the patient has severe liver or kidney failure;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or hemolytic anemia;
• if the patient has a congenital deficiency of methemoglobin reductase;
• if the patient is taking monoamine oxidase inhibitors (MAOIs) (e.g. selegiline - a medicine used to treat depression and low blood pressure), and for up to 2 weeks after their withdrawal.

Warnings and precautions

While taking Paracetamol Filofarm, the patient should immediately inform their doctor if:

• they have mild to moderate liver failure (including Gilbert's syndrome), acute liver inflammation, are being treated with other medicines that affect liver function, abuse alcohol, or have inadequate nutrition, as there is a risk of liver damage;
• they have kidney failure;
• they have bronchial asthma;
• they have severe diseases, including severe kidney or liver disorders, or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or are taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol in regular doses for a longer period or have taken paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

The patient should consult a doctor, even if the above warnings refer to past situations.

The medicine contains paracetamol. Due to the risk of overdose, it should not be taken with other medicines containing paracetamol, and therefore, the patient should check if other medicines being taken contain paracetamol.

Children and adolescents

The medicine is not intended for use in children under 12 years of age and therefore should not be used in this age group.

Paracetamol Filofarm and other medicines

The patient should tell their doctor about all medicines being taken currently or recently, as well as any medicines they plan to take.

The medicine should not be taken at the same time as other medicines containing paracetamol.

Paracetamol may enhance the effect of anticoagulant medicines (warfarin, coumarin).

Concomitant administration with rifampicin (an antibiotic), isoniazid (an anti-tuberculosis medicine), barbiturates (a sleeping medicine), antiepileptic drugs, diflunisal (a non-steroidal anti-inflammatory medicine), sulfinpyrazone (a medicine used to treat gout), or other medicines with a similar effect on the liver (microsomal enzyme inducers) increases the risk of liver damage.

Paracetamol taken with monoamine oxidase inhibitors (e.g. selegiline - a medicine used to treat depression and low blood pressure) may cause excitement and high fever.

Taking paracetamol with zidovudine (an antiviral medicine) may cause neutropenia (a life-threatening deficiency of neutrophils - a type of white blood cell) and increase the risk of liver damage.

Caffeine enhances the analgesic effect of paracetamol.

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic) due to the risk of a serious blood and fluid disorder (metabolic acidosis), which requires emergency treatment (see section 2).

Paracetamol Filofarm with food, drink, and alcohol

See section 3. During the period of taking the product, the patient should not drink alcohol.

The patient should not drink alcohol while taking Paracetamol Filofarm.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, and also if they suspect they are pregnant or plan to become pregnant, they should consult a doctor or pharmacist before taking Paracetamol Filofarm.

Paracetamol Filofarm can be given to pregnant women if necessary. The patient should use the smallest effective dose to relieve pain or reduce fever and take the medicine for as short a time as possible.

If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, the patient should consult a doctor.

After oral administration, paracetamol passes into breast milk in small amounts. Paracetamol can be used in therapeutic doses in breastfeeding women.

Driving and using machines

Paracetamol Filofarm taken as directed does not affect the ability to drive vehicles, operate machinery, or mental performance.

3. How to take Paracetamol Filofarm

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.

Recommended dose.

Adults:

Usually, 1 or 2 tablets (corresponding to 500 mg to 1000 mg of paracetamol) are taken orally, if necessary, up to 3 or 4 times a day (maximum 8 tablets in 24 hours, corresponding to 4000 mg of paracetamol).

The patient should maintain an interval of at least 4 hours between consecutive doses.

The medicine should be taken after a meal. The tablet should be swallowed with water.

Maximum duration of use without consulting a doctor - 3 days.

Children over 12 years of age:

Usually, 1 tablet (corresponding to 500 mg of paracetamol) is taken orally, if necessary, up to 3 or 4 times a day (maximum 4 tablets in 24 hours, corresponding to 2000 mg of paracetamol).

The patient should maintain an interval of at least 4 hours between consecutive doses.

The tablet should be swallowed with water.

Maximum duration of use without consulting a doctor - 3 days.

Patients with kidney or liver function disorders

Taking Paracetamol Filofarm in patients with kidney or liver failure is contraindicated.

In patients with liver function disorders or Gilbert's syndrome, the dose of the medicine should be reduced or the intervals between consecutive doses prolonged.

The effective daily dose should not exceed 60 mg/kg per day (the maximum daily dose is 2 g).

Special caution is necessary, as the medicine may have a toxic effect on the liver.

If the patient feels that the effect of Paracetamol Filofarm is too strong or too weak, they should consult a doctor.

Taking a higher dose of Paracetamol Filofarm than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist, even if no symptoms have occurred, as this may lead to life-threatening liver damage.

Paracetamol overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve the next day, despite the fact that liver damage has begun to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.

In every case of taking paracetamol in a single dose of 5 g or more, the patient should induce vomiting if it has not been more than an hour since ingestion and immediately contact a doctor. It is worth administering 60-100 g of activated charcoal orally, preferably mixed with water.

A reliable assessment of the severity of poisoning is provided by measuring the paracetamol concentration in the blood. The value of the concentration in relation to the time elapsed since paracetamol ingestion is an important indicator of whether and how intensive treatment with antidotes should be conducted. Treatment of paracetamol poisoning must be carried out in a hospital, under intensive therapy conditions.

Missing a dose of Paracetamol Filofarm

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Paracetamol Filofarm

In case of any further doubts regarding the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Filofarm can cause side effects, although not everybody gets them.

Rare side effects(occurring in 1 to 10 out of 10,000 treated patients):

nausea, vomiting, digestive disorders, allergic reactions: hives, rash, itching, urticaria, petechiae, anaphylactic shock (a life-threatening insufficient blood supply to organs due to a sudden drop in blood pressure caused by a severe allergic reaction).

Very rare side effects(occurring in less than 1 out of 10,000 treated patients):

hematological disorders, such as thrombocytopenia (a deficiency of platelets in the blood) and agranulocytosis (a complete or almost complete lack of granulocytes - a type of white blood cell).

There have also been reports of very rare cases of severe skin reactions.

Frequency not known(cannot be estimated from the available data):

a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Paracetamol Filofarm taken for a longer period in high doses or overdosed may cause liver and kidney damage.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Jerozolimskie Avenue 181C

02-222 Warsaw

tel: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Paracetamol Filofarm

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Store at a temperature below 25°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Filofarm contains

The active substance of the medicine is paracetamol.

One tablet contains 500 mg of paracetamol.

The excipients are: corn starch, povidone, stearic acid.

What Paracetamol Filofarm looks like and what the packaging contains

Paracetamol Filofarm is a white, round, biconvex tablet for oral administration.

Available packaging:

Tablets in blisters, in a cardboard box:

6 pieces - 1 blister of 6 pieces.

10 pieces - 1 blister of 10 pieces.

20 pieces - 2 blisters of 10 pieces.

50 pieces - 5 blisters of 10 pieces.

60 pieces - 6 blisters of 10 pieces.

100 pieces - 10 blisters of 10 pieces.

120 pieces - 12 blisters of 10 pieces.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Farmaceutyczna Spółdzielnia Pracy FILOFARM

Pułaskiego Street 39

85-619 Bydgoszcz

tel.: 52 342 67 88

fax: 52 342 49 81

Information for the blind and visually impaired: The content of the Paracetamol Filofarm leaflet is available in the Ulotka Audio system at the national free phone number 800 706 848.

Date of last revision of the leaflet: May 2025