Paracetamol Biofarm

Leaflet attached to the packaging: patient information

Paracetamol Biofarm

Paracetamol

500 mg, tablets

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

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 cause stomach irritation. The medicine does not have anti-inflammatory effects. 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 in the course of a cold and/or flu.

2. Important information before taking Paracetamol Biofarm

When not to take 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 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. You should not take Paracetamol Biofarm at the same time as other medicines containing paracetamol, due to the risk of overdose and severe side effects. You should avoid frequent use of medicines containing paracetamol. You should not exceed the maximum daily dose of paracetamol (i.e., no more than 10-15 mg of paracetamol per kilogram of 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 than recommended"). Before starting to take Paracetamol Biofarm, you should discuss it with your doctor:

• 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, causing 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 allergic to acetylsalicylic acid, as there is a higher risk of allergy to paracetamol as well.
• 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 contact their doctor for advice.
• in case of hemolytic anemia (red blood cell breakdown);

During the use of Paracetamol Biofarm, you should immediately inform your doctor: 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 these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid and deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. Cases of liver failure have been reported in patients with reduced glutathione levels, especially in severely malnourished patients, with anorexia, low body mass index (BMI), and alcoholic liver disease (see also "Paracetamol Biofarm with food, drink, or alcohol" below). You should exercise caution when using Paracetamol Biofarm in patients with reduced glutathione levels (such as sepsis). The use of paracetamol may increase the risk of metabolic acidosis. The symptoms of metabolic acidosis include:

• deep, rapid, and difficult breathing,
• feeling of nausea, vomiting, and loss of appetite,
• general poor well-being. You should immediately contact your doctor if the patient experiences the above symptoms simultaneously.

During the use of paracetamol, you should 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. During the treatment with paracetamol, life-threatening skin reactions have been reported. If such symptoms occur (e.g., progressive skin rash, often with blisters or mucosal lesions), you should stop taking Paracetamol Biofarm and immediately go to the hospital. Without consulting a doctor or dentist, you should not take Paracetamol Biofarm at the same time as 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, there are other medicines containing paracetamol in a pharmaceutical form intended for children. 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".

Paracetamol Biofarm and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. In particular, you should tell your doctor if you are taking the following medicines:

• other medicines containing paracetamol - see above;
• monoamine oxidase inhibitors (MAOIs) used, among others, in depression and Parkinson's disease. The simultaneous 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 the use of an MAOI. Between stopping paracetamol and starting treatment with an MAOI, you should maintain a break of at least 7 days;
• 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 it 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;
• probenecid used to treat gout, when paracetamol is used with probenecid, the doctor will reduce the dose of paracetamol;
• oral anticoagulants (e.g., warfarin), as paracetamol enhances the effect of these medicines, which increases 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 used simultaneously with paracetamol;
• caffeine, as it enhances the effect of paracetamol;
• zydovudine (an antiviral medicine used in HIV infection), as it increases the risk of bone marrow disorders when taken with paracetamol. This medicine can be used simultaneously with zidovudine only after consulting a doctor.
• flucloxacillin (an antibiotic) due to a serious blood and body fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

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

Paracetamol Biofarm with food, drink, or alcohol

You should not drink alcohol while taking Paracetamol Biofarm. Taking the medicine during a meal may delay the onset of paracetamol action.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. Paracetamol Biofarm can be given to pregnant women if necessary. You should use the lowest possible dose that effectively relieves pain or reduces 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, you should consult your 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 the ability to drive and use machines.

3. How to take Paracetamol Biofarm

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult a doctor or pharmacist.

Dosage

Adults and adolescents from 12 years of age

• Single dose: 500 mg to 1000 mg of paracetamol (1 to 2 tablets).
• In persistent pain: single dose 500 mg to 1000 mg (1 to 2 tablets), 2 to 4 times a day, not more often than every 4 hours.
• In cancer pain: 10 mg/kg body weight/dose every 4 hours, usually in combination with other analgesics with a different mechanism of action.

The maximum allowed daily dose is 8 (eight)tablets (4000 mg of paracetamol). You should not take it for more than 3 days without consulting a doctor. You should use the lowest possible effective dose of the medicine. You should not take a dose higher than recommended. Taking doses higher than recommended may lead to a risk of severe liver damage.

Use in children and adolescents

Children aged 6 to 12 years Half or one tablet (no more than 10-15 mg of paracetamol per kilogram of body weight) If necessary, the dose can be repeated no more often than every 4 hours, up to 4 times a day. Maximum daily dose of paracetamol: 60 mg of paracetamol per kilogram of body weight per day, given in divided doses as above. Children under 6 years of age For this group of patients, there are other medicines containing paracetamol in a pharmaceutical form intended for children. Special patient groups In patients with liver failure, kidney failure, and Gilbert's syndrome, the doctor will determine the appropriate dose and frequency of administration of the medicine.

Method of administration

Oral administration. The tablet should be swallowed, washed down with a small amount of liquid (preferably boiled water). Taking the medicine during a meal may delay the onset of paracetamol action. The tablet can be divided into two equal doses.

Taking a higher dose of Paracetamol Biofarm than recommended

If you have taken a higher dose of Paracetamol Biofarm than recommended, you should immediately contact your doctor (even if you feel well), as there is a risk of severe, delayed liver damage or even death. Overdose of the medicine may cause, within a few or several hours, nausea, vomiting, excessive sweating, drowsiness, and general weakness. In every case of taking paracetamol in a single dose of 5 g or more, you can provoke vomiting if it has not been more than an hour since ingestion, and immediately contact your doctor. You should take 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of Paracetamol Biofarm

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

Stopping the use of Paracetamol Biofarm

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should immediately stop taking Paracetamol Biofarm and contact your doctor if you experience:

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

Rarely(in 1 to 10 out of 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 rarely(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(frequency cannot be estimated from the available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +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 the medicine.

5. How to store Paracetamol Biofarm

Store in a temperature below 25°C. The medicine should be stored in a place that is invisible and inaccessible to children. You should not use this medicine after the expiry date (EXP) stated on the blister and carton. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Biofarm contains

• The active substance of the medicine is paracetamol. One tablet contains 500 mg of paracetamol.
• The other ingredients are: maize starch, crospovidone, povidone, stearic acid, magnesium stearate.

What Paracetamol Biofarm looks like and what the pack contains

White tablets, oblong, biconvex, with a dividing line on one side. The tablet can be divided into two equal doses. Blisters of aluminum/PVC foil, placed in a cardboard box. Packaging used only in hospitals:1000 or 2000 tablets Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o. Wałbrzyska Street 13 60-198 Poznań phone: +48 61 66 51 500 fax: +48 61 66 51 505 e-mail: biofarm@biofarm.pl

Date of the last update of the leaflet: