Paracetamol Biofarm

Leaflet attached to the packaging: patient information

Paracetamol Biofarm, 500 mg, tablets

Paracetamol

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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a 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. Contents of the packaging 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. Paracetamol does not irritate the stomach.
Indications for use
Pain of various origins and mild to moderate intensity, especially such as:

• headache;
• migraine;
• rheumatic pain;
• joint, muscle, and bone pain;
• back pain;
• neuralgia;
• menstrual pain;
• toothache.

Fever (e.g., in the course of a cold and/or flu).
Paracetamol Biofarm is intended for adults, adolescents, and children over 6 years of age.
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Paracetamol Biofarm

When not to take Paracetamol Biofarm:

• if the patient is hypersensitive 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 taking monoamine oxidase inhibitors (MAOIs) and for 2 weeks after stopping their use - see "Other medicines and Paracetamol Biofarm";
• if the patient has alcoholic liver disease.

Warnings and precautions

The medicine contains paracetamol.
Paracetamol Biofarm should not be taken simultaneously with other medicines containing paracetamol due to the risk of overdose and severe side effects (see also "Taking a higher dose of Paracetamol Biofarm" in section 3).
Frequent use of medicines containing paracetamol should be avoided.
The maximum daily dose of paracetamol should not be exceeded (i.e., no more than 10-15 mg of paracetamol/kg body weight). Taking Paracetamol Biofarm in doses higher than recommended may cause severe liver damage (see section 3, "Taking a higher dose of Paracetamol Biofarm").
The medicine should not be taken for longer than 3 days.
If the following situations apply to the patient, they should consult a doctor before taking Paracetamol Biofarm:

• if the patient has kidney function disorders (mild to moderate), the doctor will recommend a dose reduction (see section 4);
• if the patient has:
• if the patient has liver function disorders (mild to moderate), the doctor will recommend a dose reduction (see section 4);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase (enzymes responsible for the proper functioning of red blood cells)
• Gilbert's syndrome (a disorder of bilirubin metabolism in the liver, leading to periodic jaundice),
• hepatitis;
• if the patient is taking medicines that affect liver function (see "Other medicines and Paracetamol Biofarm");
• if the patient is chronically malnourished, which may be caused by alcohol dependence, lack of appetite, or poor nutrition;
• if the patient is hypersensitive to acetylsalicylic acid, as there is a higher risk of hypersensitivity to paracetamol as well. Particular caution should be exercised by patients with asthma (risk of bronchospasm).
• 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 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 a doctor for advice.
• in case of hemolytic anemia (red blood cell breakdown);

During paracetamol treatment, alcohol should not be consumed, as it may cause liver damage. There is a particular risk of liver damage in individuals who are fasting, regularly drink alcohol, and have alcoholic liver disease without cirrhosis.
Cases of liver failure have been reported in patients with reduced glutathione levels, especially in severely malnourished patients, those with anorexia, and low body mass index (BMI), and those with alcoholic liver disease (see also "Paracetamol Biofarm with food, drink, or alcohol" below).
During Paracetamol Biofarm treatment, the doctor should be informed immediately:

• if the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In such situations, patients have reported severe metabolic acidosis (a blood and body fluid disorder), which occurred when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Caution should be exercised when using paracetamol in patients with reduced glutathione levels (such as sepsis). Paracetamol use may increase the risk of metabolic acidosis.
The symptoms of metabolic acidosis include:

• deep, rapid, and difficult breathing,
• nausea, vomiting, and loss of appetite,
• general poor condition. The doctor should be contacted immediately if the patient experiences the above symptoms simultaneously.

During paracetamol treatment, life-threatening skin reactions have been reported. If such symptoms occur (e.g., progressive skin rash, often with blisters or mucosal lesions), Paracetamol Biofarm should be discontinued, and the patient should go to the hospital immediately.
Paracetamol Biofarm may affect the results of some laboratory tests, such as blood glucose measurement.
Paracetamol Biofarm should not be abused and taken for a longer period than 3 days.
Without consulting a doctor or dentist, Paracetamol Biofarm should not be taken simultaneously with other medicines with analgesic or antipyretic effects - due to the risk of kidney damage (see "Other medicines and Paracetamol Biofarm").

Children and adolescents

The medicine should not be given to children under 6 years of age. For this age group, other paracetamol-containing medicines are available in a pediatric formulation.
Detailed information on the use of this medicine in children and adolescents can be found in section 3, "Dosage" and "Use in children and adolescents".

• "Dosage" and "Use in children and adolescents".

Paracetamol Biofarm and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed if the patient is taking the following medicines:

• other medicines containing paracetamol - see warnings above;
• monoamine oxidase inhibitors (MAOIs) used in depression and Parkinson's disease. Concurrent use of these medicines with paracetamol may cause a state of excitement and high fever; Paracetamol Biofarm can be used no earlier than 14 days after stopping MAOI use. A 7-day interval should be maintained between stopping paracetamol and starting MAOI treatment;
• 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:
• sedatives, antiepileptics (e.g., phenobarbital, phenytoin, carbamazepine),
• rifampicin (an antibiotic);
• isoniazid;
• probenecid used in the treatment of gout; when paracetamol is used with probenecid, the doctor will reduce the paracetamol dose;
• 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 paracetamol elimination from the body;
• nonsteroidal anti-inflammatory drugs (e.g., acetylsalicylic acid, ibuprofen), as concurrent use with paracetamol increases the risk of kidney function disorders;
• caffeine, as it enhances the analgesic effect of paracetamol;
• zydovudine (an antiviral medicine used in HIV infection), as concurrent use with paracetamol increases the risk of bone marrow disorders. This medicine can be used concurrently with zydovudine only after consulting a doctor.
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (metabolic acidosis), which require urgent treatment (see section 2).
• 2).

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

Paracetamol Biofarm with food, drink, or alcohol

During Paracetamol Biofarm treatment, alcohol should not be consumed due to the increased risk of toxic liver damage (see also "Warnings and precautions" and "When not to take Paracetamol Biofarm").
Taking the medicine with food may delay the onset of paracetamol 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 a doctor or pharmacist before taking this medicine.
Paracetamol Biofarm can be used during pregnancy if necessary. The lowest effective dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible time.
If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult a doctor.
Paracetamol passes into breast milk in amounts that are not clinically significant. Available data do not indicate any contraindications to breastfeeding during paracetamol treatment.
As with other medicines, this product should be used during pregnancy and breastfeeding only if necessary, for a short time, and longer treatment is possible only after consulting a doctor.

Driving and using machines

Paracetamol has no or negligible influence on the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means the medicine is considered "sodium-free".

3. How to take Paracetamol Biofarm

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

Dosage

The lowest effective dose of the medicine should be used.
Paracetamol Biofarm should not be taken regularly for longer than 3 days without consulting a doctor.
A higher dose than recommended should not be taken. Taking higher doses than recommended may lead to a risk of severe liver damage.
Adults and adolescents over 12 years
A single dose is 1 to 2 tablets (corresponding to 500 mg to 1000 mg of paracetamol).
If necessary, the dose can be repeated at intervals of no less than 4 hours, up to 4 times a day.
The maximum daily dose is 8 tablets (4000 mg of paracetamol).

Use in children and adolescents

Children aged 6 to 12 years
A single dose is half or one tablet (corresponding to 250 mg or 500 mg of paracetamol), not more than 10-15 mg of paracetamol/kg body weight.
If necessary, the dose can be repeated at intervals of no less than 4 hours, up to 4 times a day.
The maximum daily dose of paracetamol is 60 mg of paracetamol/kg body weight/day, given in divided doses as above.
It is particularly important to follow the dosage instructions based on the child's body weight.
Children under 6 years
The medicine should not be given to children under 6 years of age. For this age group, other paracetamol-containing medicines are available in a pediatric formulation.
Special patient groups
Patient with liver or kidney failure, as well as those with Gilbert's syndrome, should consult a doctor to determine the appropriate dose and frequency of administration.

Method of administration

The medicine should be taken orally.
The tablet should be swallowed with a small amount of liquid (preferably boiled water).
Taking the medicine with food may delay the onset of paracetamol action.
The tablet can be divided into two equal doses.

Taking a higher dose of Paracetamol Biofarm

In case of taking a higher dose of Paracetamol Biofarm, the doctor should be contacted immediately (even if the patient feels well), as there is a risk of severe, delayed liver damage, which may result in liver damage or even death.
Overdose of the medicine may cause nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. In each case of taking a single dose of paracetamol of 5 g or more, vomiting can be induced if it has not been more than an hour since ingestion, and the doctor should be contacted immediately. 60-100 g of activated charcoal should be administered orally, preferably mixed with water.

Missing a dose of Paracetamol Biofarm

A double dose should not be taken to make up for a missed dose.

Stopping Paracetamol Biofarm treatment

In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Paracetamol Biofarm can cause side effects, although not everybody gets them.
Paracetamol Biofarm treatment should be stopped immediately, and the doctor should be contacted without delay if the following occur:

• Angioedema, sometimes associated with difficulty breathing or swelling of the lips, tongue, throat, or face, difficulty breathing, excessive sweating, nausea, blood pressure drop, shock, anaphylactic shock (very rare: less than 1 in 10,000 patients).
• Allergic reactions, such as: skin rash, itching, urticaria (rare: between 1 in 1,000 and 1 in 10,000 patients).
• Skin rashes or severe skin reactions characterized by acute generalized pustular rash or blisters and mucosal lesions, fever, and joint pain or large blisters under the skin, widespread skin peeling, and fever (very rare).
• Breathing difficulties, if similar problems have occurred in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (very rare).
• Bruising or bleeding caused by thrombocytopenia, platelet disorders, thrombocytopenic purpura, or hemolytic anemia (rare).
• Inclination to infections and general weakness caused by agranulocytosis (rare) or pancytopenia (reduction in blood cell count) (very rare).
• Liver function disorders, liver damage, jaundice (yellowing of the skin and eyes), liver cell death (rare), hepatotoxicity (liver damage caused by chemicals) (very rare).
• Overdose and poisoning (rare).
• Low blood sugar levels (very rare).
• Pyelonephritis, severe kidney damage, interstitial nephritis, blood in urine, inability to urinate (very rare).

Other side effects:
Rare(between 1 in 1,000 and 1 in 10,000 patients):

• Blood disorders, including leukopenia and bone marrow disorders.
• Depression, disorientation, hallucinations.
• Tremors, headache.
• Visual disturbances.
• Edema.
• Abdominal pain, gastrointestinal bleeding, diarrhea, nausea, vomiting.
• Dizziness, malaise, fever, drowsiness, interactions with other medicines.
• Sweating.
• Purpura.

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

• Very rare cases of severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis) have been reported.

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

• Paracetamol-induced skin diseases - drug-induced dermatoses.
• A serious condition that can cause blood acidification (metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Paracetamol Biofarm

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the blister pack and carton after EXP.
The expiration date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Biofarm contains

• The active substance of the medicine is paracetamol. One tablet contains 500 mg of paracetamol.
• The other ingredients are: cornstarch, povidone K30, crospovidone, sodium croscarmellose, microcrystalline cellulose, stearic acid 50, magnesium stearate.

What Paracetamol Biofarm looks like and contents of the pack

White or almost white, oblong, biconvex tablets with a break line on one side.
The tablet can be divided into equal doses.
The tablets are packaged in aluminum/PVC blisters, placed in a cardboard box.
Package sizes:
2, 6, 10, 20, 30, or 50 tablets
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
email: biofarm@biofarm.pl

Date of last revision of the leaflet: