Paracetamol biofarm

Package leaflet: Information for the user

Paracetamol Biofarm
Paracetamolum
1000 mg, coated tablets
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult a doctor.

Table of contents:

1. What Paracetamol Biofarm is and what it is 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. Contents of the pack and other information

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

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

Indications
Pain of various origins and intensities, particularly such as:

• headaches,
• migraines,
• rheumatic pain,
• joint, muscle, and bone pain,
• back pain,
• neuralgia,
• menstrual pain,
• toothache.
  Fever associated with cold or flu.

If there is no improvement after 3 days, or if you feel worse, consult a doctor.

2. Important information before using Paracetamol Biofarm

When not to use Paracetamol Biofarm

• if the patient is allergic to paracetamol or any of the other ingredients of this 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 currently taking monoamine oxidase inhibitors (MAO inhibitors) or within 2 weeks after discontinuation of such treatment – see section "Other medicines and Paracetamol Biofarm".

Warnings and precautions
This medicine contains paracetamol.
Do not take Paracetamol Biofarm together with other medicines containing paracetamol due to the risk of overdose and serious adverse 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 section 3 below, "Overdose of Paracetamol Biofarm").
Before starting treatment with Paracetamol Biofarm, consult 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 affecting liver function (see section "Other medicines and Paracetamol Biofarm"),
• if the patient regularly consumes alcohol, is alcohol-dependent, or has alcoholic liver disease,
• if the patient is dehydrated,
• if the patient is chronically undernourished, which may result from alcohol dependence, lack of appetite, or poor nutrition,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme essential for normal red blood cell function),
• in case of haemolytic anaemia (breakdown of red blood cells),
• if the patient is taking various painkillers for a prolonged period, as this may lead to occurrence or worsening of headaches. In such a case, the patient should contact a doctor for advice,
• if the patient is allergic to acetylsalicylic acid, as there is an increased risk of cross-allergy to paracetamol. Patients with bronchial asthma should be particularly cautious (risk of bronchospasm).

Do not drink alcohol while taking paracetamol, as this may cause liver damage. The risk of liver damage is particularly high in fasting individuals, regular alcohol drinkers, and patients with alcoholic liver disease without cirrhosis.
Do not misuse or take Paracetamol Biofarm for longer than 3 days.
Without consulting a doctor or dentist, do not take Paracetamol Biofarm together with other pain-relieving or antipyretic medicines due to the risk of kidney damage (see section "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 children within this age group, paracetamol intended for paediatric use (e.g. suspension, syrup, or suppositories) or tablets with a lower paracetamol dose should be used.

Paracetamol Biofarm and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
In particular, inform your doctor about the use of the following medicines:

• monoamine oxidase inhibitors (MAO inhibitors), used e.g. in depression and Parkinson's disease. Concomitant use of these medicines with paracetamol may cause agitation, high fever, and is contraindicated. Paracetamol Biofarm should not be used earlier than 14 days after discontinuation of MAO inhibitor therapy. A minimum 7-day interval should be maintained between stopping paracetamol and starting MAO inhibitor treatment.
• metoclopramide and domperidone (medicines used to treat nausea and vomiting), as they may enhance the effect of paracetamol,
• propanteline (a medicine delaying gastric emptying) and cholestyramine (used to reduce cholesterol levels), as they may reduce the effect of paracetamol,
• medicines that may impair liver function, such as:
• sedatives, antiepileptics (e.g. phenobarbital, phenytoin, carbamazepine),
• rifampicin (an antibiotic),
• isoniazid (used in tuberculosis treatment);
• probenecid, used in the treatment of gout, as the doctor may need to reduce the paracetamol dose when both are used together,
• oral anticoagulants (e.g. warfarin), as paracetamol enhances their effect, increasing the risk of bleeding,
• salicylamide (used for fever and mild pain), as it may delay paracetamol elimination from the body,
• other anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen), as their concomitant use with paracetamol increases the risk of kidney function disorders,
• caffeine, as it enhances the effect of paracetamol,
• zidovudine (an antiviral medicine used in HIV infection), as concomitant use with paracetamol increases the risk of bone marrow dysfunction. This medicine may be used together with zidovudine only after consultation with a doctor.

Paracetamol Biofarm may affect the results of certain laboratory tests, such as serum uric acid levels and blood glucose concentration.

Taking Paracetamol Biofarm with food, drink or alcohol
Do not consume 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Paracetamol Biofarm may be administered to pregnant women if clinically justified. The lowest effective dose providing adequate pain relief or fever reduction should be used for the shortest possible duration. If pain persists or fever does not subside, or if more frequent dosing is required, consult a doctor.
Paracetamol Biofarm may be used during breastfeeding only if, in the doctor's opinion, it is clearly necessary.

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

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to use Paracetamol Biofarm

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not take a higher dose of Paracetamol Biofarm than recommended.
Bear in mind that doses of paracetamol higher than recommended may cause severe liver damage.

Dosage
Adults (with body weight greater than 50 kg)
Single dose – 1 (one) coated tablet (1000 mg paracetamol).
Subsequent doses should be taken at intervals of at least 4 to 6 hours.
A minimum of 4 hours must be maintained between doses.
The maximum daily dose is 4 (four) coated tablets (4000 mg paracetamol).
Do not use for longer than 3 days without consulting a doctor.

Special patient groups
To determine the appropriate paracetamol dosage for the following individuals, consult a doctor:

• adults and children aged 12 years and older (with body weight less than 50 kg),
• patients with renal or hepatic impairment (mild to moderate),
• patients with Gilbert's syndrome,
• dehydrated or chronically undernourished patients,
• patients who chronically consume alcohol.
  In these patients, the doctor will reduce the single dose and maximum daily dose of paracetamol, and will extend the interval between doses.

Use in children and adolescents
Children aged 12 years (with body weight greater than 50 kg)
Dosage as in adults.
Children under 12 years of age
Do not use, as Paracetamol Biofarm 1000 mg coated tablets are not intended for use in this patient group.
In children under 12 years of age, tablets containing a lower dose of paracetamol or paracetamol formulations intended for children (e.g. suspension, syrup, or suppositories) may be used.

Method of administration
The medicine is administered orally.
The coated tablet should be swallowed whole with a small amount of liquid (preferably boiled water).
The tablet may be divided into halves.

Overdose of Paracetamol Biofarm
If a dose higher than recommended is taken, contact a doctor immediately (even if the patient feels well), as there is a risk of severe, delayed liver damage or even death.
Symptoms of overdose usually include pain in the liver area and, after two days, jaundice.
Nausea and vomiting may sometimes occur earlier. These symptoms may not reflect the severity of the overdose or the associated risk.

Missed dose of Paracetamol Biofarm
Do not take a double dose to make up for a missed dose.

Discontinuation of Paracetamol Biofarm
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Paracetamol Biofarm and contact your doctor immediately
if you experience symptoms such as swelling of the face, tongue or throat,
difficulty swallowing, red itchy skin rashes, or difficulty breathing.
Rare (in 1 to 10 out of 10,000 patients):

• Platelet disorders (coagulation disorders, which may lead to bleeding), disorders related to stem cells (disorders in blood cell formation in the bone marrow);
• Allergic reactions;
• Depression, confusion, hallucinations;
• Tremor, headache;
• Visual disturbances;
• Edema (swelling);
• Hypotension (low blood pressure);
• Bronchospasm;
• Gastrointestinal bleeding, abdominal or stomach pain, diarrhea, nausea, vomiting;
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis;
• Itching, rash, sweating, urticaria, red skin patches, angioedema with symptoms such as swelling of the face, lips, throat or tongue;
• Dizziness, general malaise, fever, excessive sedation;
• Poisoning.

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

• Blood disorders (reduced number of platelets, white and red blood cells), hemolytic anemia (destruction of red blood cells);
• Decreased glucose (sugar) levels in blood;
• Hepatotoxic effects (liver damage);
• Cloudy, purulent urine and kidney function disorders;
• Severe allergic reactions requiring discontinuation of treatment (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, possibly severe), Stevens-Johnson syndrome (a severe, life-threatening skin disease), laryngeal edema, anaphylactic shock (severe allergic reaction), anemia, liver function disorders and hepatitis, kidney function disorders (severe kidney failure, blood in urine, inability to pass urine), gastrointestinal disorders, and dizziness.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 and packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

Contents of the pack and other information
What Paracetamol Biofarm contains

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

What Paracetamol Biofarm looks like and contents of the pack
White, elongated, biconvex coated tablets with a smooth surface, with a single-scored line, free from spots and chipping.
The tablets are packed in blisters made of PVC/PVDC/Aluminium, with a patient leaflet, and placed in a cardboard box.
Pack sizes:
2 tablets in 1 blister
6 tablets in 1 blister
10 tablets in 1 blister
20 tablets in 2 blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
tel. + 48 61 66 51 500
[email protected]