Paracetamol Biofarm

Leaflet attached to the packaging: patient information

Paracetamol Biofarm

Paracetamolum

1000 mg, coated tablets

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 this patient leaflet, or as directed by a doctor or pharmacist.

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

Table of contents of the leaflet:

• 1. What is Paracetamol Biofarm and what is it used for
• 2. Important information before taking Paracetamol Biofarm
• 3. How to take Paracetamol Biofarm
• 4. Possible side effects
• 5. How to store Paracetamol Biofarm
• 6. Package contents and other information

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

Paracetamol Biofarm contains the active substance paracetamol, which has analgesic and antipyretic effects. The medicine does not have anti-inflammatory effects. It irritates the stomach less than non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid).

Indications for use:

• various types of pain and different intensities, especially:
• headaches,
• migraines,
• rheumatic pain,
• joint, muscle, and bone pain,
• back pain,
• neuralgia,
• menstrual pain,
• toothache. Fever in the course of a cold or flu.

If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor.

2. Important information before taking Paracetamol Biofarm

When not to take Paracetamol Biofarm

• if the patient is allergic to paracetamol or any other component of the medicine (listed in section 6),
• if the patient has severe liver function disorders,
• if the patient has severe kidney function disorders,
• if the patient is taking monoamine oxidase inhibitors (MAOIs) and for 2 weeks after stopping their use - see "Other medicines and Paracetamol Biofarm".

Warnings and precautions

The medicine contains paracetamol.

Do not take Paracetamol Biofarm with other medicines containing paracetamol, due to the risk of overdose and severe side effects.

Avoid frequent use of medicines containing paracetamol.

Do not exceed the maximum daily dose of paracetamol. Taking Paracetamol Biofarm in doses higher than recommended may cause severe liver damage (see below, section 3 "Taking a higher dose of Paracetamol Biofarm than recommended").

Before taking Paracetamol Biofarm, discuss it with your doctor or pharmacist:

• if the patient has kidney function disorders (mild to moderate),
• if the patient has:
• liver function disorders (mild to moderate),
• Gilbert's syndrome (a disorder of bilirubin metabolism in the liver, causing periodic jaundice),
• hepatitis;
• if the patient is taking medicines that affect liver function (see "Other medicines and Paracetamol Biofarm");
• if the patient regularly consumes alcohol, is addicted to alcohol, or has liver disease caused by alcohol abuse;
• if the patient is dehydrated;
• if the patient is chronically malnourished, which may be caused by, for example, alcohol addiction, lack of appetite, or poor nutrition;
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (an enzyme responsible for the proper functioning of red blood cells);
• in the case of hemolytic anemia (red blood cell breakdown);
• if the patient is taking various painkillers for a longer period, as this may lead to the occurrence or worsening of headaches. In such a situation, the patient should consult their doctor for advice.
• if the patient is allergic to acetylsalicylic acid, as there is a higher risk of allergy to paracetamol as well. Particular caution should be exercised by patients with asthma (risk of bronchospasm).

While taking paracetamol, do not drink alcohol, as it may cause liver damage. There is a particular risk of liver damage in people who are fasting, regularly drinking alcohol, and patients with alcoholic liver disease without cirrhosis.

Do not abuse Paracetamol Biofarm and take it for a period longer than 3 days.

Without consulting a doctor or dentist, do not take Paracetamol Biofarm with other medicines that have analgesic or antipyretic effects - due to the risk of kidney damage (see "Other medicines and Paracetamol Biofarm").

Children and adolescents

Paracetamol Biofarm, 1000 mg coated tablets, should not be given to children under 12 years of age. In this age group, paracetamol can be used in a form intended for children (e.g., suspension, syrup, or suppositories) or tablets containing a smaller dose of paracetamol.

Paracetamol Biofarm 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.

In particular, tell your doctor about taking the following medicines:

• monoamine oxidase inhibitors (MAOIs) used, among others, in depression and Parkinson's disease. Concurrent use of these medicines with paracetamol may cause excitement, high fever, and is contraindicated. Paracetamol Biofarm can be taken no earlier than 14 days after stopping MAOI treatment. Between stopping paracetamol and starting MAOI treatment, a break of at least 7 days should be maintained.
• metoclopramide and domperidone (medicines used to treat nausea and vomiting), as they may enhance the effect of paracetamol;
• propantheline (a medicine that delays stomach emptying) and cholestyramine (used to reduce cholesterol levels), as they may weaken the effect of paracetamol;
• medicines that may affect liver function, such as:
• sleeping pills, antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine),
• rifampicin (an antibiotic),
• isoniazid (used to treat tuberculosis);
• probenecid used to treat gout, as the doctor will reduce the dose of paracetamol when taken with probenecid;
• oral anticoagulants (e.g., warfarin), as paracetamol enhances the effect of these medicines, increasing the risk of bleeding;
• salicylamide (used for fever and mild pain), as it may delay the excretion of paracetamol from the body;
• other anti-inflammatory and analgesic medicines (e.g., acetylsalicylic acid, ibuprofen), as they increase the risk of kidney function disorders when taken with paracetamol;
• caffeine, as it enhances the effect of paracetamol;
• zydovudine (an antiviral medicine used to treat HIV infection), as it increases the risk of bone marrow disorders when taken with paracetamol. This medicine can be taken with zydovudine only after consulting a doctor.

Paracetamol Biofarm may affect the results of some laboratory tests, such as uric acid and blood glucose measurements.

Taking Paracetamol Biofarm with food, drink, or alcohol

Do not drink alcohol while taking Paracetamol Biofarm.

Taking the medicine with food may delay the onset of its action.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Paracetamol Biofarm can be given to pregnant women if it is clinically justified. The smallest effective dose should be used, and the medicine should be taken for the shortest possible time. 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 their doctor.

Paracetamol Biofarm can be used during breastfeeding only if, in the doctor's opinion, it is absolutely necessary.

Driving and using machines

Paracetamol does not affect or has a negligible effect on the ability to drive and use machines.

The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means that the medicine is considered "sodium-free".

3. How to take Paracetamol Biofarm

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

Do not take a higher dose of Paracetamol Biofarm than recommended.

Remember that higher doses of paracetamol than recommended may cause very severe liver damage.

Dosage

Adults (with a body weight over 50 kg)

Single dose - 1 (one) coated tablet (1000 mg of paracetamol).

Subsequent doses of the medicine should be taken at intervals of at least 4 to 6 hours.

There should be at least a 4-hour interval between taking individual doses.

The maximum allowed daily dose is 4 (four)coated tablets (4000 mg of paracetamol).

Do not take for more than 3 days without consulting a doctor.

Special patient groups

To determine the appropriate dose of paracetamol for the following individuals, consult a doctor:

• adults and children over 12 years old (with a body weight less than 50 kg),
• patients with kidney or liver failure (mild to moderate),
• patients with Gilbert's syndrome,
• dehydrated or chronically malnourished patients,
• patients who regularly consume alcohol. In these patients, the doctor will reduce the single dose and maximum daily dose of paracetamol and extend the time between taking subsequent doses of paracetamol.

Use in children and adolescents

Children over 12 years old (with a body weight over 50 kg)

Dosage is the same as for adults.

Children under 12 years old

Do not use, as Paracetamol Biofarm, 1000 mg coated tablets, are not intended for this patient group.

In children under 12 years old, paracetamol can be used in a form intended for children (e.g., suspension, syrup, or suppositories) or tablets containing a smaller dose of paracetamol.

Method of administration

The medicine is taken orally.

Swallow the coated tablet with a small amount of liquid (preferably boiled water).

The tablet can be divided into halves.

Taking a higher dose of Paracetamol Biofarm than recommended

If a higher dose of Paracetamol Biofarm than recommended is taken, immediately consult a doctor (even if the patient feels well), as there is a risk of severe, delayed liver damage or even death.

Symptoms of overdose are usually pain in the liver area, jaundice after two days. Sometimes, nausea and vomiting occur earlier. These symptoms may not reflect the severity of the overdose or the associated risk.

Missing a dose of Paracetamol Biofarm

Do not take a double dose to make up for a missed dose.

Stopping Paracetamol Biofarm treatment

If you have any further doubts about taking 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.

Stop taking Paracetamol Biofarm and immediately consult your doctor

if you experience symptoms such as:facial swelling, tongue or throat swelling, difficulty swallowing, red, itchy skin changes, and breathing difficulties.

Rarely(in 1 to 10 out of 10,000 patients):

• blood disorders (coagulation disorders, which may cause bleeding), disorders related to stem cells (disorders of blood cell production in the bone marrow);
• allergic reactions;
• depression, confusion, hallucinations;
• tremors, headaches;
• vision disturbances;
• edema;
• hypotension (low blood pressure);
• bronchospasm;
• gastrointestinal bleeding, abdominal pain or stomach pain, diarrhea, nausea, vomiting;
• liver function disorders, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis;
• itching, rash, sweating, urticaria, red spots on the skin, angioedema with symptoms such as facial swelling, lip swelling, throat or tongue swelling.
• dizziness, general malaise, fever, excessive sedation;
• poisoning.

Very rarely(less than 1 in 10,000 patients):

• blood disorders (reduced platelet count, white and red blood cell count), hemolytic anemia (red blood cell breakdown);
• reduced blood glucose levels;
• toxic liver damage (liver damage);
• cloudy, purulent urine and kidney function disorders;
• severe allergic reactions requiring treatment discontinuation (see above);
• severe skin reactions.

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

Toxic epidermal necrolysis (a life-threatening skin disease), erythema multiforme (an allergic reaction, may be severe), Stevens-Johnson syndrome (a severe, life-threatening skin disease), laryngeal edema, anaphylactic shock (a severe allergic reaction), anemia, liver function disorders and hepatitis, kidney function disorders (severe kidney failure, blood in urine, inability to urinate), gastrointestinal disorders, and dizziness.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, 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

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

By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Paracetamol Biofarm

Do not store above 25°C.

Keep the medicine out of sight and reach of children.

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

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

Package contents and other information

What Paracetamol Biofarm contains

• The active substance of the medicine is paracetamol. One coated tablet contains 1000 mg of paracetamol.
• Other ingredients are: tablet core: cornstarch, crospovidone, povidone, stearic acid, sodium croscarmellose, magnesium stearate; tablet coating (AquaPolish clear 09.03VF): hypromellose 6cP, talc, glycerol.

What Paracetamol Biofarm looks like and what the pack contains

White, oblong, biconvex coated tablets with a smooth surface, with a single break line on one side, without stains or cracks.

The tablets are packaged in PVC/PVDC/Aluminum blisters, which, along with the patient leaflet, are placed in a cardboard box.

Package sizes:

2 tablets in 1 blister

6 tablets in 1 blister

10 tablets in 1 blister

20 tablets in 2 blisters

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Poland

tel. +48 61 66 51 500

biofarm@biofarm.pl

Date of last revision of the leaflet: