Package leaflet: Information for the patient

Paracetamol Aflofarm
500 mg, tablets
Paracetamolum
Please read carefully the entire leaflet before taking the medicine, as it contains important
information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days of treatment for pain, 3 days for fever, or 2 days for cold symptoms, or if you feel worse, you should consult a doctor.

Table of contents

What Paracetamol Aflofarm is and what it is used for
Important information before taking Paracetamol Aflofarm
How to take Paracetamol Aflofarm
Possible side effects
How to store Paracetamol Aflofarm
Contents of the pack and other information

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

Paracetamol Aflofarm is an analgesic and antipyretic medicine. It contains the active substance paracetamol.
Indications
Short-term treatment of mild to moderate pain, such as:

headaches;
muscle pain;
bone and joint pain;
menstrual pain;
toothache;
post-dental and post-surgical pain.

Fever, for example, associated with cold or influenza.

2. Important information before taking Paracetamol Aflofarm

When not to take Paracetamol Aflofarm

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 and/or kidney failure;
if the patient has viral hepatitis;
in case of alcohol-related disease;
in children under 6 years of age.

Warnings and precautions
This medicine contains paracetamol. Due to the risk of overdose and toxic effects of paracetamol, Paracetamol Aflofarm should not be used simultaneously with other medicines containing paracetamol.
Before starting treatment with Paracetamol Aflofarm, discuss the following with your doctor or pharmacist:

if the patient has impaired kidney and/or liver function;
if the patient is allergic to acetylsalicylic acid, as there is a risk of cross-allergy to paracetamol;
if the patient has glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency (rare inherited disorders).

Before undergoing laboratory tests, the patient should inform the doctor that they are taking Paracetamol Aflofarm, as it may interfere with the results of certain tests (e.g. blood glucose or uric acid levels).
Alcohol should not be consumed during treatment with this medicine (see section: Paracetamol Aflofarm and alcohol).
During treatment with Paracetamol Aflofarm, the patient should immediately inform the doctor if:

the patient has serious underlying conditions, including severe kidney dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic). In such cases, severe metabolic acidosis (a disturbance in blood and body fluid balance) has been reported in patients taking paracetamol regularly over a prolonged period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
Paracetamol Aflofarm should not be given to children under 6 years of age.
Paracetamol Aflofarm with other medicines
Tell your 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.
Before using Paracetamol Aflofarm, the patient should inform the doctor or pharmacist if they are taking:

metoclopramide (an antiemetic medicine), as it may increase the absorption of paracetamol;
propantheline (an antispasmodic medicine), as it may delay the absorption of paracetamol;
sedatives and anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), as concomitant use with Paracetamol Aflofarm may lead to liver damage;
rifampicin (an antibiotic used to treat infections), as its use together with Paracetamol Aflofarm may lead to liver damage;
zidovudine (a medicine used in the treatment of HIV infection), as paracetamol may enhance its toxic effect on bone marrow;
anticoagulants such as coumarin and indandione derivatives, e.g. acenocoumarol, warfarin (medicines used to reduce blood clotting), as Paracetamol Aflofarm may enhance their effect and increase the risk of bleeding;
non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, diclofenac, due to the risk of kidney damage, kidney cancer, or bladder cancer;
monoamine oxidase inhibitors (MAOIs) used in the treatment of depression, as paracetamol taken together with MAOIs may cause agitation and high fever. Paracetamol Aflofarm should not be used earlier than 14 days after discontinuation of MAOI treatment;
flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

If the patient is unsure whether they are taking any of the medicines listed above, they should contact their doctor or pharmacist.
Paracetamol Aflofarm and alcohol
Alcohol should not be consumed during treatment with Paracetamol Aflofarm, as it may cause liver damage. The risk of liver damage is particularly high in malnourished individuals and those who regularly consume alcohol.
Pregnancy and breastfeeding
Women who are pregnant or breastfeeding should use this medicine only if clinically justified by a doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Paracetamol Aflofarm may be given to pregnant women if necessary. The lowest effective dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible duration. If pain is not relieved or fever does not subside, or if more frequent dosing becomes necessary, medical advice should be sought.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to take Paracetamol Aflofarm

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Paracetamol Aflofarm for longer than 5 days for pain, 3 days for fever, or 2 days for cold symptoms, unless advised by a doctor.
The tablets should be taken orally, swallowed with water.

Recommended dose
Adults and adolescents over 12 years of age:
Single dose of 1 to 2 tablets (500 mg to 1000 mg paracetamol).
The dose may be repeated every 4 to 6 hours, no more than 4 times in 24 hours.
Typically, 1 tablet (500 mg paracetamol) is taken 4 times daily, every 4 to 6 hours.
Do not exceed 8 tablets in 24 hours (4 g paracetamol).

Children aged 6 to 12 years:
Single dose of half a tablet (250 mg paracetamol).
The dose may be repeated every 4 to 6 hours, no more than 4 times in 24 hours.
Do not exceed 4 tablets in 24 hours.
The tablet may be divided into halves.

Children
Do not use in children under 6 years of age.

Taking more than the recommended dose of Paracetamol Aflofarm
If more than the recommended dose of Paracetamol Aflofarm has been taken, contact a doctor immediately, even if the patient feels well. Overdose may cause severe liver damage.

Symptoms of overdose include: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may improve the next day, even though liver damage may already be developing, which may present as abdominal discomfort, return of nausea, and jaundice (yellowing of the skin and whites of the eyes).

If a patient has taken 10 paracetamol tablets (5 g) or more at once, and less than one hour has passed since ingestion, induce vomiting and take the patient to hospital immediately.

Missed dose of Paracetamol Aflofarm
Do not take a double dose to make up for a missed dose. Continue treatment as usual without increasing the next dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop using the medicine immediately and consult a doctor if any of the following occur:

allergic reaction, such as: skin rash or itching, sometimes associated with swelling of the lips, tongue, throat or face, causing difficulty in breathing;
angioedema (sudden swelling of the face, limbs or joints without itching or pain);
breathing difficulties, wheezing (bronchial asthma attack);
liver function disorders, jaundice (yellowing of the skin and whites of the eyes).

Rare (occurs in 1 to 10 people in 10,000):

itching;
erythema (red-purple skin patches, sometimes with blisters);
urticaria (pinkish, itchy wheals on the skin);
rash (itchy red bumps on the skin);
shortness of breath;
sweating;
low blood pressure, up to shock symptoms (a clinical condition caused by insufficient oxygenation of vital organs);
nausea, vomiting;
liver function disorders, jaundice (yellowing of the skin and whites of the eyes).

Very rare (occurs in less than 1 person in 10,000):

thrombocytopenia (decreased number of blood platelets – increased risk of bleeding and bruising);
agranulocytosis, granulocytopenia (decreased number of granulocytes – a type of white blood cells, leading to increased susceptibility to infections);
methemoglobinemia (blood loses its ability to carry oxygen to body cells, resulting in bluish discoloration of the skin and easy fatigue);
renal colic, renal papillary necrosis, acute kidney failure.

Frequency unknown (cannot be estimated from available data):

serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Paracetamol Aflofarm

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
Lot: means batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Aflofarm contains

The active substance is paracetamol. One tablet contains 500 mg of paracetamol.
Other ingredients are: pregelatinized starch, povidone, crospovidone, stearic acid.

What Paracetamol Aflofarm looks like and contents of the pack
Paracetamol Aflofarm is a prolonged, biconvex tablet with a score line on one side.
Pack contents: 2, 10, 20, 30 or 50 tablets.
Marketing authorisation holder and manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: + 48 42 22-53-100