Paracetamol Teva

Leaflet attached to the packaging: patient information

Paracetamol Teva, 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 the patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their 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 contains paracetamol, which belongs to a group of medicines called analgesics
(pain relievers). Paracetamol Teva is used to relieve mild to moderate pain and reduce fever.
Paracetamol Teva can be used to treat headache, toothache, menstrual cramps, muscle pain, and fever associated with the common cold.

2. Important information before taking Paracetamol Teva

When not to take Paracetamol Teva

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

Warnings and precautions

Paracetamol Teva should not be taken in combination with alcohol, as this may cause severe liver damage. The effect of alcohol will not be enhanced by the addition of paracetamol.
Before starting to take Paracetamol Teva, the patient should discuss this with their doctor:

• If the patient has kidney or liver disease (including Gilbert's syndrome, a hereditary non-hemolytic jaundice, or hepatitis).
• If the patient regularly consumes large amounts of alcohol. The patient may require smaller doses of the medicine and limitation of the treatment period, as otherwise, the liver may be damaged.
• If the patient is dehydrated or has a nutritional disorder, e.g., due to alcohol dependence, lack of appetite, or poor nutrition.
• If the patient has hemolytic anemia (abnormal breakdown of red blood cells).
• If the patient has a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.
• If the patient is taking other medicines that may affect liver function.
• If the patient is taking other medicines containing paracetamol, as this may lead to severe liver damage.
• If the patient frequently takes painkillers for a long period, as long-term use may cause severe and frequent headaches. The patient should not increase the dose of the painkiller but should consult their doctor for advice.
• If the patient has asthma and is sensitive to acetylsalicylic acid.
• If the patient has a severe infection, such as sepsis, which may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include deep, rapid, and severe breathing, nausea, vomiting, loss of appetite. If these symptoms occur together, the patient should immediately consult their doctor.

Warning:taking higher doses than recommended is associated with a risk of severe liver damage. Therefore, do nottake a dose larger than the maximum daily dose of paracetamol. Caution should also be exercised when taking other medicines that also contain paracetamol. See also section 3 "Taking a higher dose of Paracetamol Teva than recommended".
In case of high fever or infection symptoms lasting more than 3 days of treatment or if the pain persists after 5 days of treatment, the patient should consult their doctor.

Paracetamol Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. This is especially important when taking:

• chloramphenicol(used to treat infections), as Paracetamol Teva may delay the elimination of the medicine from the body
• metoclopramideor domperidone(used to treat nausea and vomiting), as they may enhance the effect of Paracetamol Teva
• cholestyramine(used to lower cholesterol) and medicines that delay gastric emptying, as they may reduce the effect of Paracetamol Teva
• probenecid(used to treat gout). The patient may require a reduced dose of Paracetamol Teva
• anticoagulant medicines(blood thinners, e.g., warfarin), if the patient requires daily and long-term use of Paracetamol Teva
• salicylamide(used to treat fever and mild pain), as it may delay the elimination of Paracetamol Teva from the body
• lamotrigine(used to treat epilepsy), as Paracetamol Teva may reduce its effect
• medicines that may potentially damage the liver, such as:
• barbituratesor carbamazepine(used to treat mental illnesses and epilepsy)
• rifampicin(used to treat bacterial infections)
• isoniazid(used to treat tuberculosis)
• phenytoin(used to treat epilepsy)
• St. John's Wort(Hypericum perforatum) (used to treat depression)
• flucloxacillin(an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking the maximum daily doses of paracetamol.
  Paracetamol Teva may affect the results of some laboratory tests, such as uric acid and blood glucose measurements.

Paracetamol Teva with alcohol

The patient should avoid taking Paracetamol Teva and drinking alcohol at the same time.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Paracetamol Teva can be given to pregnant women if necessary. The patient should use the lowest effective dose for the shortest possible duration. 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 their doctor.
Paracetamol Teva can be taken in recommended doses during breastfeeding.

Driving and using machines

Paracetamol does not affect the ability to drive or use machines.

3. How to take Paracetamol Teva

Instructions for use
The tablet should be swallowed with a glass of water.
Dosage
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Do not take a dose larger thanrecommended. The patient should remember that higher doses than recommended may cause a risk of severe liver damage.
The dose for children and adolescents should be determined based on body weight and the appropriate pharmaceutical form should be used. The information about the age of children within each weight group is for guidance only.
Adults and adolescents with a body weight over 50 kg
The usual dose is 1 to 2 tablets (500 mg to 1000 mg), which can be repeated every 4 to 6 hours, up to a maximum of 6 tablets (3 g) per day.
Children and adolescents with a body weight of 43 kg to 50 kg (approximately 12-15 years)
The usual dose is 1 tablet (500 mg), which can be repeated every 4 hours, up to a maximum of 5 tablets (2.5 g) per day.
Children with a body weight of 34 kg to 43 kg (approximately 11-12 years)
The usual dose is 1 tablet (500 mg), which can be repeated every 6 hours, up to a maximum of 4 tablets (2 g) per day.
Children with a body weight of 26 kg to 34 kg (approximately 8-11 years)
The usual dose is half a tablet (250 mg), which can be repeated every 4 hours, or 1 tablet (500 mg), which can be repeated every 6 hours, up to a maximum of 3 tablets (1.5 g) per day.
Paracetamol Teva, 500 mg is not intended for use in children with a body weight below 26 kg.

In case of high fever or infection symptoms lasting more than 3 days of treatment or if the pain persists for more than 5 days of treatment, the patient should consult their doctor.

Patients with kidney or liver disorders
The dose must be reduced or the intervals between doses prolonged in patients with kidney or liver disorders and in patients with Gilbert's syndrome. In patients with severe kidney disorders, the intervals between doses of Paracetamol Teva should be at least 8 hours. The patient should consult their doctor or pharmacist for advice.
Elderly patients
Dose adjustment in elderly patients is not necessary.
Patients with chronic alcoholism
Chronic alcohol consumption may increase the risk of paracetamol toxicity. The interval between doses should be at least 8 hours. The patient should not exceed 2 g of paracetamol per day.

Taking a higher dose of Paracetamol Teva than recommended

The patient should immediately consult their doctor in case of overdose, even if they feel well, as there is a risk of delayed severe liver damage. To avoid possible liver damage, it is essential that the doctor administers an antidote as soon as possible.
Symptoms of liver damage usually do not appear until several days later. Symptoms of overdose may include nausea, vomiting, loss of appetite, pallor, and abdominal pain. These symptoms usually occur within 24 hours of taking the medicine.

4. Possible side effects

Like all medicines, Paracetamol Teva can cause side effects, although not everybody gets them.
If the patient experiences the following symptoms: difficulty breathing, swelling of the face, lips, throat, or tongue (severe allergic reactions) they should stop taking this medicineand immediatelyseek medical advice.
Rarely(may affect up to 1 in 1000 people):

• blood platelet disorders (coagulation disorders), bone marrow disorders (disorders of blood cell production in the bone marrow)
• allergic reactions
• depression, confusion, hallucinations
• tremors, headache
• vision disorders
• edema (abnormal fluid accumulation under the skin)
• abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting
• abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver cell death (necrosis)
• rash, itching, sweating, urticaria, red spots on the skin
• dizziness, general malaise, fever, sedation, drug interactions
• overdose and poisoning.

Very rarely(may affect up to 1 in 10,000 people):

• blood disorders (reduced platelet count, white blood cell count, and neutrophil count in the blood, hemolytic anemia)
• low blood glucose levels
• hepatotoxicity (liver damage caused by chemicals)
• cloudy urine and kidney disorders.

Very rare cases of severe skin reactions have been reported.
Unknown(frequency cannot be estimated from the available data):
Stevens-Johnson syndrome (allergic reaction or skin infection), fluid accumulation in the larynx,
anaphylactic shock (severe allergic reaction), anemia (reduced red blood cell count in the blood), liver function disorders and hepatitis, kidney function disorders (severe kidney failure, blood in the urine, inability to urinate), stomach and intestine disorders, dizziness.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 to gather more information on the safety of the medicine.

5. How to store Paracetamol Teva

The medicine should be stored out of the sight and reach of children.
PVC/Aluminum blisters: Do not store above 25°C.
HDPE container: No special precautions for storage temperature.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. "Expiry date" or "EXP" means the last day of the month stated.
The batch number on the packaging is stated after "Batch number (Lot)" or "Lot".
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 required. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Teva contains

• The active substance is paracetamol. Each coated tablet contains 500 mg of paracetamol.
• The other ingredients are: tablet core:maize starch, hydroxypropylcellulose, talc, and magnesium stearate; tablet coatingOpadry II Clear 85F29116: polyvinyl alcohol, macrogol 3350, and talc.

What Paracetamol Teva looks like and contents of the pack

White coated capsule-shaped tablet, 17 mm x 7.2 mm in size, with a score line on one side. The tablet can be divided into equal doses.
Package sizes:
Blister:6, 12, 24, and 50 coated tablets
Container:100 and 200 coated tablets

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw

Manufacturer/Importer

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Orifice Medical AB
Aktergatan 2, 4 och 5
271 55 Ystad
Sweden

To obtain more detailed information on the medicine and its names in the European Economic Area, the patient should contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of leaflet approval: November 2022