Paracetamol Olimp

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Paracetamol OLIMP, 500 mg, coated 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.

• The 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 or the patient feels worse after 3 days, they should consult a doctor.

Table of contents of the leaflet

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

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

Paracetamol OLIMP contains paracetamol, which has analgesic and antipyretic effects.
Paracetamol OLIMP is indicated for the symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and/or to reduce fever.
If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.

2. Important information before taking Paracetamol OLIMP

Do not take Paracetamol OLIMP

• if the patient is hypersensitive to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Read the leaflet before taking the medicine and follow the instructions.
The medicine contains paracetamol.Do not take more than the recommended dose. Taking paracetamol in higher doses can cause severe liver damage.
Do not take this medicine at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat cold and flu symptoms.
Taking the recommended daily dose at one time can cause serious liver damage; in such a case, immediate medical attention should be sought.
Before taking the medicine, consult a doctor or pharmacist if:

• the patient has liver or kidney disease, Gilbert's syndrome
• hemolytic anemia
• the patient is dehydrated due to vomiting, diarrhea, or insufficient water intake
• the patient has a deficiency of certain enzymes (glucose-6-phosphate dehydrogenase or methemoglobin reductase), has low glutathione reserves (a protein involved in liver metabolism)
• the patient regularly consumes alcohol; patients who drink alcohol during paracetamol treatment are at increased risk of liver damage (it may be necessary to completely stop taking this medicine or reduce the dose)
• the patient is underweight (body weight below 50 kg) or malnourished
• if the patient is taking medicines that may accelerate liver metabolism of paracetamol (see section 4.5)
• the patient has mild joint inflammation but needs to take painkillers daily
• the patient has a severe infection (sepsis) that can lead to metabolic acidosis. Symptoms of metabolic acidosis include:
• deep, rapid, and labored breathing
• nausea, vomiting, and loss of appetite
• general malaise. If the patient experiences any of these symptoms, they should immediately consult a doctor. During Paracetamol OLIMP treatment, the doctor should be informed immediately if the patient experiences severe diseases, including severe kidney dysfunction 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). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Consult a doctor if the patient has chronic headaches.
There is a special risk of overdose leading to life-threatening liver damage in patients who are malnourished and regularly consume alcohol. Existing liver disease increases the risk of liver damage associated with paracetamol use.
Tell the doctor if the patient is taking other medicines containing paracetamol. The doctor will check the dosage to minimize the risk of overdose.
If the patient stops taking painkillers after a long period of use (especially in high doses), they may experience a phenomenon of increased pain and/or increased frequency of headaches, as well as transient, mild discomfort, including fatigue and weakness. These phenomena are characteristic of most painkillers; the discomfort is usually mild and transient and does not require additional treatment.
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), the medicine should be discontinued, and the patient should immediately go to the hospital.
If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.
The medicine should be stored out of sight and reach of children.

Paracetamol OLIMP and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Paracetamol OLIMP at the same time as other medicines containing paracetamol.

Before taking paracetamol, consult a doctor if the patient is taking:

• medicines that enhance peristalsis (movement of food and digestive products in the digestive tract), such as metoclopramide or domperidone (medicines used to treat nausea and vomiting). These medicines cause accelerated absorption of paracetamol
• medicines that inhibit peristalsis or absorption in the digestive tract, such as cholestyramine (a medicine used to reduce elevated lipid levels in blood serum)
• anticoagulant medicines (such as warfarin or other coumarin derivatives), especially if paracetamol is to be taken for a long time
• medicines that increase liver metabolism and/or reduce glutathione reserves, such as certain sedatives or certain medicines used to treat epilepsy (e.g., phenobarbital, phenytoin, carbamazepine) and rifampicin (used to treat bacterial infections) or isoniazid (used to treat tuberculosis), which may lead to liver damage, even at recommended paracetamol doses
• monoamine oxidase inhibitors (MAOIs) (medicines used in psychiatry and neurology, e.g., phenelzine). Taking these medicines with paracetamol may increase the risk of excitement and fever.
• salicylamide
• nonsteroidal anti-inflammatory drugs (e.g., acetylsalicylic acid)
• herbal medicines containing St. John's wort (used to treat depression)
• medicines used to treat HIV infection (zidovudine): the tendency to reduce the number of white blood cells (neutropenia) increases. Taking paracetamol at the same time as zidovudine is possible only after consulting a doctor
• probenecid (used to treat gout), the patient may need to reduce the paracetamol dose
• chloramphenicol (an antibiotic)

Tell the doctor or pharmacist if the patient is taking:

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

Paracetamol affects laboratory test results.

Before performing laboratory tests, the patient should tell the doctor that they are taking a medicine containing paracetamol. Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement, uric acid measurement).

Paracetamol OLIMP with food and drink

Alcohol may increase the risk of toxic liver damage. During paracetamol treatment, the patient should not consume alcohol.

Pregnancy and breastfeeding

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.
Pregnancy
Paracetamol OLIMP can be given to pregnant women if necessary. The lowest effective dose should be used 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. Like other medicines, this medicine should be taken during pregnancy only if absolutely necessary.
Breastfeeding
Paracetamol is excreted in small amounts into breast milk. Available data do not indicate any contraindications to breastfeeding during treatment with this medicine. The lowest possible dose should be used for the shortest possible time with the lowest possible frequency.
Like other medicines, this medicine should be taken during breastfeeding only if absolutely necessary.

Driving and using machines

Paracetamol OLIMP does not affect the ability to drive and use machines.

Paracetamol OLIMP contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, per single dose, and per maximum daily dose, which means that the medicine is considered "sodium-free".

3. How to take Paracetamol OLIMP

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.
Recommended dose
Adults, including the elderly and adolescents over 12 years old (with a body weight over 50 kg):
The recommended single dose is 1 to 2 tablets. If necessary, the dose can be repeated no more than every 4 hours, up to 4 times a day. The maximum daily dose of paracetamol is 4 g (8 tablets).
Adults, including the elderly and adolescents over 12 years old (with a body weight of 40-50 kg):
The recommended single dose is 1 tablet. If necessary, the dose can be repeated no more than every 4 hours, up to 6 times a day. The maximum daily dose of paracetamol is 3 g (6 tablets).
Children aged 11 (with a body weight of 40 kg)
The dose is determined based on the child's age and body weight.
The single dose is 10 to 15 mg/kg of body weight.
For a child aged 11 (40 kg), 1 tablet (500 mg) can be taken, no more than every 4 hours, no more than 4 doses per day.
In case of doubt about the dosage, the child's caregiver should consult a doctor.
Children under 11 years old or with a body weight below 40 kg
Paracetamol OLIMP should not be taken, as the tablets cannot be divided into smaller doses.
The paracetamol dose depends on body weight and age; usually, 10-15 mg/kg of body weight is taken at a time.
The medicine should not be taken regularly for more than 3 days without consulting a doctor.
Do not exceed the recommended maximum daily dose.
Use the lowest effective dose for the shortest possible period.
Tablets should be swallowed with water.
Children
Paracetamol OLIMP is not intended for children under 11 years old.
Special patient groups:
Patients with kidney disorders and mild kidney failure
In patients with liver or kidney dysfunction and Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged.
Do not exceed the total daily dose of 2 g without medical advice.
Patients with severe kidney failure
In severe kidney failure (creatinine clearance <10 ml min), the interval between doses must be at least 8 hours.
Elderly patients
Dose adjustment in elderly patients is not necessary. However, in frail, bedridden elderly patients with liver or kidney dysfunction, it may be necessary to reduce the dose or prolong the intervals between doses.
Without medical advice, do not exceed the maximum daily dose of 60 mg/kg of body weight (maximum 2 g/day) in patients with:

• body weight below 50 kg,
• chronic alcoholism,
• dehydration,
• chronic malnutrition.

Taking a higher dose of Paracetamol OLIMP than recommended

Consult a doctor immediately if a higher dose of Paracetamol OLIMP than recommended is taken. Paracetamol overdose can lead to severe liver damage, which can result in liver transplantation or death. Cases of acute pancreatitis have been reported, usually associated with liver dysfunction (including acute liver failure) and toxic liver effects. To avoid possible liver damage, it is essential that the doctor assess the patient's condition and, if necessary, administer an antidote as soon as possible. If more than 5 g of paracetamol is taken at one time and it has been less than an hour since ingestion, vomiting can be induced. 60-100 g of activated charcoal can be given orally, preferably mixed with water. Symptoms of overdose usually occur within 24 hours of taking the medicine and may include: nausea, vomiting, loss of appetite, pallor, abdominal pain, and diarrhea. In case of paracetamol overdose, immediate measures are necessary, even if no symptoms are observed.

Missing a dose of Paracetamol OLIMP

Do not take a double dose to make up for a missed dose.
If there are any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and consult a doctor if:

• an allergic reaction (hypersensitivity) occurs, which may include: skin rash, itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face
• anaphylactic shock (a severe allergic reaction characterized by dizziness, impaired consciousness, rapid heartbeat, and low blood pressure)
• skin rash or severe skin reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or large blisters

subcutaneous, extensive skin erosions, and fever

• breathing difficulties, if similar problems have occurred in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
• unexplained bruising or bleeding, various rare changes in blood morphology, such as decreased platelet count (thrombocytopenia) or significant decrease in the number of certain white blood cells (agranulocytosis)
• nausea, loss of appetite, short-term weight loss, yellow eyes, and skin

The above side effects are very rare, i.e., less common than 1 in 10,000 treated patients, except for severe skin reactions and allergic reactions (anaphylactic shock), whose frequency cannot be determined based on available data.

Other possible side effects are listed below by frequency:

Rare (may affect up to 1 in 1000 patients)

• allergic reactions, including itching, rash, hives
• abdominal pain, diarrhea, nausea, vomiting, dyspepsia (indigestion)
• headache
• slight increase in activity of certain liver enzymes (aminotransferase in serum)
• liver dysfunction, including liver failure, liver necrosis, jaundice
• skin reactions: itching, rash, hives, sweating, angioedema (swelling of the skin and soft tissues)
• dizziness, malaise
• overdose and poisoning

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

• blood diseases: thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), pancytopenia (decreased red and white blood cell count, as well as platelet count), neutropenia (low neutrophil count), hemolytic anemia (abnormal breakdown of red blood cells), agranulocytosis (significant decrease in white blood cell count)
• severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), or acute generalized exanthematous pustulosis (AGEP)
• presence of white blood cells in urine (cloudy urine)
• hepatotoxicity

Unknown (frequency cannot be determined based on available data)

• severe kidney diseases caused by long-term use of high doses (interstitial nephritis, renal tubular necrosis)
• anemia (decreased red blood cell count)
• hepatitis
• a serious condition that can make the blood more acidic (i.e., 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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 492 13 01; fax +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Paracetamol OLIMP

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging and blister (after the EXP symbol). The expiration date refers to the last day of the given month.
There are no special instructions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol OLIMP contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients (excipients) are: tablet core: microcrystalline cellulose, povidone K90, purified water, colloidal silica, sodium croscarmellose, sodium stearyl fumarate, coating: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium carbonate.

What Paracetamol OLIMP looks like and what the packaging contains

Coated tablet, oblong, biconvex, white or almost white.
PVC/Aluminum blister in a cardboard box.
The packaging contains 12 or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
Tel. +48 14 680 32 00
{logo of the marketing authorization holder}

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:
Panaprex
Poland:
Paracetamol OLIMP

Date of last revision of the leaflet: 23.01.2025