Paracetamol Doz

Leaflet attached to the packaging: information for the user

PARACETAMOL DOZ, 500 mg, tablets

Paracetamolum

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 a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

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

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

Paracetamol DOZ is a pain-relieving and antipyretic medicine. The medicine is used to treat: headache, sore throat, migraine, toothache, bone, joint, and muscle pain, and painful menstruation. Additionally, the medicine can be used for colds and flu-like conditions. If there is no improvement or the patient feels worse after 3 days, they should consult their doctor.

2. Important information before taking Paracetamol DOZ

When not to take Paracetamol DOZ:

• if the patient is hypersensitive (allergic) to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has alcoholic liver disease,
• if the patient has severe liver or kidney failure.

Warnings and precautions

Before taking Paracetamol DOZ, the patient should discuss it with their doctor, pharmacist, or nurse.
When to take special precautions when taking Paracetamol DOZ:

• if the patient has liver or kidney function disorders,
• in patients with a protein deficiency called glucose-6-phosphate dehydrogenase deficiency (which can lead to red blood cell damage) and methemoglobin reductase deficiency,
• the patient should not drink alcohol while taking the medicine, as it may cause liver damage; the risk of liver damage is increased in people who regularly consume alcohol and in people who are fasting,
• due to the risk of paracetamol overdose, the patient should not take other medicines containing paracetamol at the same time.

Paracetamol DOZ and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Medicines that speed up stomach emptying (e.g., metoclopramide, domperidone) may increase paracetamol absorption.
• Cholestyramine (a cholesterol-lowering medicine) may decrease paracetamol absorption.
• Regular daily use of paracetamol may enhance the effect of anticoagulant medicines (from the coumarin group), which can lead to bleeding.
• Concomitant use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptics (e.g., phenobarbital, phenytoin, carbamazepine) and rifampicin (an antibiotic), may lead to liver damage even when taking the recommended doses of paracetamol.
• Salicylamide (an anti-inflammatory, antipyretic, and analgesic medicine) prolongs the elimination of paracetamol from the body.
• Caffeine enhances the analgesic effect of paracetamol.
• Paracetamol used concomitantly with MAO inhibitors (antidepressant medicines) may cause excitement and high temperature.
• Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
• Concomitant administration of paracetamol and nonsteroidal anti-inflammatory medicines (e.g., ibuprofen) increases the risk of kidney function disorders.

Paracetamol DOZ with food, drink, and alcohol

While taking Paracetamol DOZ, the patient should not drink alcohol at the same time.

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 their doctor or pharmacist before taking this medicine.
Paracetamol DOZ can be used during pregnancy if necessary and clinically justified.
The patient should take the smallest possible dose that reduces pain and/or fever, for the shortest time and as infrequently as possible. They should consult their doctor if pain and/or fever do not decrease or if they need to take the medicine more frequently.

Driving and using machines

Paracetamol DOZ does not affect driving or using machines.

3. How to take Paracetamol DOZ

The usual dose of Paracetamol DOZ is:
Adults and children over 12 years old
Orally, 2 tablets. If necessary, the dose can be repeated every 4 hours, up to 4 times a day.
The maximum daily dose of paracetamol is 4 g (8 tablets).
Children from 6 to 12 years old
Orally, half to 1 tablet. If necessary, the dose can be repeated every 4 hours, up to 4 times a day. Do not exceed the dose of 4 tablets in 24 hours.
Do not give the medicine to children under 6 years old unless advised by a doctor.
Do not exceed the recommended dose.
Without consulting a doctor, do not use the medicine for more than 3 days.

Taking a higher dose of Paracetamol DOZ than recommended

In case of taking a higher dose than recommended, the patient should contact their doctor immediately, even if they feel well. Taking a higher dose than recommended may cause liver damage.
Sometimes, before that, nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur.
If the patient is conscious, they should induce vomiting (preferably within the first hour of taking the medicine).
It is worth giving 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of Paracetamol DOZ

Do not take a double dose to make up for a missed dose.

Stopping Paracetamol DOZ

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Paracetamol DOZ can cause side effects, although not everybody gets them.
When taking the medicine in the recommended doses, side effects are rare (may occur in 1 to 10 people out of 10,000). The following may appear:

• allergic reactions, e.g., skin rash,
• burning in the upper abdomen, nausea, vomiting, pancreatitis,
• liver damage, liver enlargement, jaundice.

Very rarely (may occur in less than 1 person out of 10,000), the following may occur:

• decreased platelet count (thrombocytopenia),
• increased methemoglobin levels in the blood (methemoglobinemia),
• life-threatening significant decrease in the number of white blood cells called granulocytes (agranulocytosis),
• severe skin reactions: acute generalized pustular rash on the whole body or blisters and ulcers on the skin, mouth, eyes, and genitals with fever and joint pain or bursting large blisters, extensive ulcers on the skin, shedding of large skin flakes with fever (Stevens-Johnson syndrome, toxic epidermal necrolysis).

After an overdose, liver and/or kidney function disorders may occur.

If any of the side effects get worse or if any side effects not listed in the leaflet occur

the patient should inform their doctor, pharmacist, or nurse.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
e-mail: ndl@urpl.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 DOZ

There are no special precautions for storing the medicinal product in terms of temperature.
Store in the original packaging.
Keep out of sight and reach of children.
Do not use Paracetamol DOZ after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol DOZ contains

• The active substance of the medicine is paracetamol (Paracetamolum).
• The other ingredients of the medicine are povidone K29-32, corn starch, colloidal silica, and magnesium stearate.

What Paracetamol DOZ looks like and what the pack contains

Paracetamol DOZ is a tablet. The tablet can be divided into two halves.
A cardboard box contains:

• 10 tablets (1 blister pack of PVC/Aluminum) or 20 tablets (2 blister packs of PVC/Aluminum) and a patient leaflet, or
• 60 tablets packaged in an HDPE container with a child-resistant closure or an HDPE container with a screw cap and a desiccant, with a patient leaflet.

Marketing authorization holder and manufacturer

Marketing authorization holder:
DOZ S.A.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer:
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Date of last update of the leaflet:07/2019