Paracetamol Teva

Leaflet attached to the packaging: information for the user

Paracetamol Teva, 1000 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again. 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 tell their doctor or pharmacist. See section 4.
• If after 3 days in the case of fever, and after 5 days in the case of pain, no improvement occurs or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Paracetamol Teva is a medicine that relieves pain and reduces fever (analgesic and antipyretic). Paracetamol Teva is used to treat the following conditions:

• mild to moderate pain
• fever.

Paracetamol Teva, 1000 mg, is suitable for adults and adolescents from 16 years of age (body weight over 50 kg).

2. Important information before taking Paracetamol Teva

When not to take Paracetamol Teva

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

Warnings and precautions

Before starting to take Paracetamol Teva, the patient should discuss it with their doctor or pharmacist:

• if the patient has chronic alcoholism,
• if the patient has liver function disorders (hepatitis, Gilbert's syndrome),
• if the patient has kidney failure,
• if the patient is dehydrated,
• if the patient is chronically malnourished,
• if the patient has a blood infection,
• in patients with asthma sensitive to acetylsalicylic acid,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (enzyme deficiency),
• if the patient has hemolytic anemia (abnormal breakdown of red blood cells).

Patients addicted to alcohol or with liver damage should not take Paracetamol Teva unless prescribed by a doctor. In these patients, the dose of the medicine must be reduced (see section 3 "How to take Paracetamol Teva"). If other painkillers containing paracetamol are taken at the same time, Paracetamol Teva should not be taken without first consulting a doctor or pharmacist. Never take a higher dose of Paracetamol Teva than recommended. Higher doses do not increase the analgesic effect, but may cause severe liver damage (see section 3 "Taking a higher dose of Paracetamol Teva than recommended"). Prolonged, excessive, and improper use of painkillers can lead to the occurrence of headaches that cannot be treated with higher doses of the medicine. In such a situation, the patient should contact a doctor. Usually, habitual use of painkillers, especially combinations of several analgesic substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). Sudden withdrawal of painkillers after long-term use, in high doses, improper use, can cause headaches, fatigue, muscle pain, nervousness, and vegetative symptoms. These withdrawal symptoms will subside within a few days. Until then, the patient should avoid taking painkillers again and not take them without consulting a doctor.

Other medicines and Paracetamol Teva

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken. Medicines that may interfere with the action of Paracetamol Teva include:

• probenecid(a medicine used to treat gout).
• medicines that can damage the liver, such as phenobarbital(sleeping pills), phenytoin carbamazepine primidone(medicines used to treat epilepsy) and rifampicin(a medicine used to treat tuberculosis). Taking these medicines and paracetamol at the same time may cause liver damage.
• isoniazid(a medicine used to treat tuberculosis) and salicylamide(a painkiller) may lead to an increase in paracetamol levels in the body.
• metoclopramide domperidone(medicines used to treat nausea). These medicines may increase the absorption of paracetamol and accelerate its onset of action.
• medicines that slow down gastric emptying. These medicines may delay the absorption of paracetamol and the onset of its action.
• cholestyramine(a medicine used to reduce increased lipid levels in the blood) may reduce the absorption of paracetamol and delay its onset of action. Therefore, cholestyramine should not be taken within the first hour after taking paracetamol.
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin): repeated intake of paracetamol for more than a week increases the risk of bleeding. Therefore, long-term use of paracetamol should only be done under medical supervision. Occasional intake of paracetamol does not have a significant effect on the risk of bleeding.

Medicines whose action may be affected by Paracetamol Teva include:

• lamotrigine(a medicine used to treat epilepsy), the action of lamotrigine may be weakened when taken with paracetamol.

Taking paracetamol and AZT (zidovudine, a medicine used to treat HIV infections) at the same time increases the risk of liver damage and increases the risk of a decrease in the number of white blood cells (neutropenia). This may disrupt the immune system and increase the risk of infections. Therefore, Paracetamol Teva can only be taken with zidovudine after a doctor's recommendation. The use of paracetamol may affect laboratory test results. The results of uric acid and blood sugar measurements may change.

Paracetamol Teva with food and alcohol

Paracetamol Teva should not be taken with alcohol. The tablets can be taken with or without food.

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. Paracetamol Teva can be given to pregnant women if necessary. The lowest possible 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 additional symptoms occur, the patient should consult a doctor. Paracetamol passes into breast milk in small amounts. Since no harmful effects of the medicine on the infant are known, Paracetamol Teva can be used during breastfeeding. However, if the patient is breastfeeding, they should consult a doctor if Paracetamol Teva is to be used more frequently than occasionally.

Driving and using machines

Paracetamol Teva has no or negligible influence on the ability to drive and use machines.

Paracetamol Teva contains sodium.

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

3. How to take Paracetamol Teva

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 patient should consult a doctor or pharmacist. The dosage of Paracetamol Teva depends on the patient's age and body weight. The usual single dose is 10-15 mg of paracetamol per kilogram of body weight, up to a total daily dose of 60 mg/kg of body weight. The maximum dose of 3000 mg of paracetamol per day (which corresponds to 3 tablets of this medicine) should not be exceeded. The patient must take the medicine at intervals of at least 6 hours, which means that the medicine can be taken a maximum of 4 times a day. The patient should remember not to exceed the maximum daily dose. If the pain persists for more than 5 days, the fever lasts for more than 3 days, the symptoms worsen, or additional symptoms occur, the patient should stop taking the medicine and consult a doctor.

Body weight and age of the patient

Single dose Maximum daily dose (24 hours)

over 50 kg:
adolescents from 16 years of age and adults
½ tablet - 1 tablet
(which corresponds to 500-1000 mg
of paracetamol)
3 tablets (which corresponds to 3000 mg
of paracetamol)

Method of administration

The tablets should be swallowed without chewing, with a sufficient amount of liquid. The tablet can be divided into equal doses.

Special patient groups

Renal impairment
In patients with impaired liver or kidney function, the dose should be reduced or the intervals between doses prolonged. The patient should consult a doctor or pharmacist.
Chronic alcoholism or liver function disorders
Long-term alcohol consumption or liver function disorders may lower the toxicity threshold of paracetamol. In such patients, the dose should be reduced or the intervals between doses prolonged. The patient should consult a doctor or pharmacist.
Elderly patients
In elderly patients, no dose adjustment is necessary.
Children and adolescents with low body weight
Paracetamol Teva tablets, 1000 mg, are not suitable for children under 16 years of age and with a body weight below 50 kg, as the strength of the medicine is not suitable for this age group. For this group of patients, other pharmaceutical forms and strengths are available.

Taking a higher dose of Paracetamol Teva than recommended

The total daily dose of paracetamol should not exceed 60 mg/kg of body weight per day and should not be higher than 3000 mg. The effects of an overdose of the medicine can be very serious and, in rare cases, may even lead to death. If a higher dose of Paracetamol Teva than recommended is taken, the patient should immediately contact a doctor, even if they feel well! There is a risk of delayed, severe liver damage. To avoid liver damage, it is essential that the doctor administers an antidote as soon as possible.

Missing a dose of Paracetamol Teva

The patient should not take a double dose to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Teva can cause side effects, although not everybody gets them.

The patient should stop taking Paracetamol Teva and immediately contact their nearest available doctor in the following cases:

Rare: may affect up to 1 in 1,000 people

• symptoms of angioedema, such as facial swelling, tongue or throat swelling, difficulty swallowing, hives, and difficulty breathing
• overdose and poisoning

Very rare: may affect up to 1 in 10,000 people

• hepatotoxicity (liver damage caused by medicines)
• hypersensitivity reactions (severe allergic reaction)
• Very rare cases of severe skin reactions (drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) have been reported.
• Paracetamol may cause a decrease in the number of white blood cells and a decrease in resistance to infections. If an infection occurs with symptoms such as fever and severe deterioration of the general condition or fever with local symptoms of infection such as sore throat/mouth or urinary tract disorders, the patient should immediately contact a doctor. To assess possible agranulocytosis (a decrease in the number of white blood cells), a blood test should be performed. It is essential to tell the doctor about taking Paracetamol Teva.

Frequency not known: frequency cannot be estimated from the available data

• anaphylactic shock
• erythema multiforme (severe allergic reaction or skin infection)

Other side effects:

Rare: may affect up to 1 in 1,000 people

• itching, skin rash, hives, petechiae (small bleeding under the skin), bronchospasm with dyspnoea, similar to asthma (analgesic asthma) in sensitive patients
• blood disorders, coagulation disorders
• abdominal pain, bleeding, diarrhea, nausea, vomiting
• dizziness, malaise, fever, sweating, sedation
• tremors, headaches, vision disorders
• depression, disorientation, hallucinations
• abnormal liver function, liver failure, jaundice, increased activity of certain liver enzymes in the blood (aminotransferases).

Very rare: may affect up to 1 in 10,000 people

• thrombocytopenia (decrease in platelet count), leukopenia (decrease in white blood cell count), hemolytic anemia (abnormal breakdown of red blood cells)
• hypoglycemia (low blood sugar)
• cloudy urine and kidney function disorders (e.g., kidney failure)

Frequency not known: frequency cannot be estimated from the available data

• interstitial nephritis (inflammation of the kidney tissue) after long-term use of high doses

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, more information can be collected on the safety of the medicine.

5. How to store Paracetamol Teva

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Teva contains

• The active substance is paracetamol. Each tablet contains 1000 mg (= 1 g) of paracetamol.
• The other ingredients are: povidone K-30, sodium croscarmellose, corn starch, talc, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate.

What Paracetamol Teva looks like and contents of the pack

White, oblong, biconvex tablets with a dividing line on both sides. Paracetamol Teva is available in packs containing 10 tablets.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands, tel.: (22) 345 93 00

Manufacturer

Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary, Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

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

Germany, Paracetamol-ratiopharm 1000 mg Tabletten, Finland, Paracetamol ratiopharm 1000 mg tabletti, Luxembourg, Paracetamol-ratiopharm 1000 mg Tabletten, Netherlands, Paracetamol Teva 1000 mg, tabletten, Poland, Paracetamol Teva, Portugal, Paracetamol ratiopharm

Date of last revision of the leaflet: August 2021