Paracetamol Aflofarm

Package Leaflet: Information for the Patient

Paracetamol Aflofarm

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 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days for pain, 3 days for fever, or 2 days for cold symptoms there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Paracetamol Aflofarm is a pain reliever and antipyretic. The medicine contains the active substance paracetamol.

Indications for Use

Short-term treatment of mild to moderate pain, such as:

• headaches;
• muscle aches;
• bone and joint pain;
• menstrual cramps;
• toothaches;
• pain after dental and surgical procedures. Fever, for example, in the course of a cold or flu.

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 or kidney failure;
• if the patient has viral hepatitis;
• in case of alcoholism;
• in children under 6 years of age.

Warnings and Precautions

The medicine contains paracetamol. Due to the risk of overdose and toxic effects of paracetamol, Paracetamol Aflofarm should not be taken at the same time as other medicines containing paracetamol.
Before starting to take Paracetamol Aflofarm, the patient should discuss it with their doctor or pharmacist:

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

Before performing laboratory tests, the patient should tell their doctor that they are taking Paracetamol Aflofarm, as it may affect the results of some tests (e.g., glucose or uric acid levels in the blood).
During treatment with Paracetamol Aflofarm, the patient should not drink alcohol (see section: Paracetamol Aflofarm with alcohol).
During the use of Paracetamol Aflofarm, the patient should immediately inform their doctor if:

• they have severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Children

Paracetamol Aflofarm should not be given to children under 6 years of age.

Paracetamol Aflofarm and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Before taking Paracetamol Aflofarm, the patient should inform their doctor or pharmacist if they are taking:

• metoclopramide (a medicine with anti-emetic action), as it may increase the absorption of paracetamol;
• propenteline (a medicine with antispasmodic action), as it may delay the absorption of paracetamol;
• sedatives and antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), as their concurrent use with Paracetamol Aflofarm may lead to liver damage;
• rifampicin (an antibiotic used to treat infections), as it may lead to liver damage when used concurrently with Paracetamol Aflofarm;
• zidovudine (a medicine used to treat HIV infection), as paracetamol may increase its toxic effect on the bone marrow;
• anticoagulant medicines derived from coumarin and indandione, e.g., acenocoumarol, warfarin (medicines used to reduce blood clotting), as Paracetamol Aflofarm may increase 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 or bladder cancer;
• monoamine oxidase inhibitors (MAOIs) used to treat depression, as paracetamol taken concurrently with MAOIs may cause a state of excitement and high fever. Paracetamol Aflofarm can be used no earlier than 14 days after the end of treatment with MAOIs;
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

If the patient is unsure whether they are taking any of the above medicines, they should contact their doctor or pharmacist.

Paracetamol Aflofarm with Alcohol

During treatment with Paracetamol Aflofarm, the patient should not drink alcohol, as it may cause liver damage. There is a particular risk of liver damage in malnourished individuals who regularly drink alcohol.

Pregnancy and Breastfeeding

Pregnant or breastfeeding women may use this medicine only when, in the doctor's opinion, it is clinically justified.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Paracetamol Aflofarm can be given to pregnant women if necessary. The lowest effective dose should be used 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.

Driving and Operating Machines

The medicine does not affect the ability to drive or operate machines.

3. How to Take Paracetamol Aflofarm

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 their doctor or pharmacist.
Without consulting a doctor, Paracetamol Aflofarm should not be taken for more than 5 days for pain, 3 days for fever, or 2 days for cold symptoms.
The tablets should be taken orally, with water.

Recommended Dose

Adults and adolescents over 12 years of age:
1 to 2 tablets (500 mg to 1000 mg of paracetamol) at a time.
If necessary, the dose can be repeated every 4 to 6 hours, but no more than 4 times a day.
Usually, 1 tablet (500 mg of paracetamol) is taken 4 times a day, every 4 to 6 hours.
No more than 8 tablets (4 g of paracetamol) should be taken per day.
Children from 6 to 12 years of age:
half a tablet (250 mg of paracetamol) at a time.
The dose can be repeated every 4 to 6 hours, but no more than 4 times a day.
No more than 4 tablets should be taken per day.
The tablet can be divided into halves.

Children

Paracetamol Aflofarm should not be used in children under 6 years of age.

Taking a Higher Dose of Paracetamol Aflofarm Than Recommended

In case of taking a higher dose of Paracetamol Aflofarm than recommended, the patient should immediately contact their doctor, even if they do not feel any discomfort. Overdose may cause severe liver damage.
Overdose symptoms: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage is developing, which is manifested by abdominal distension, return of nausea, and jaundice (yellow discoloration of the skin and whites of the eyes).
If the patient has taken 10 tablets of paracetamol (5 g) or more at a time, and no more than an hour has passed since ingestion, they should induce vomiting and be taken to the hospital.

Missing a Dose of Paracetamol Aflofarm

The patient should not take a double dose to make up for a missed dose. They should continue taking the medicine without increasing the next dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

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

The Patient Should Stop Taking the Medicine and Consult Their Doctor If:

• an allergic reaction occurs, such as a skin rash or itching, sometimes accompanied by swelling of the lips, tongue, throat, or face, making breathing difficult;
• angioedema (sudden swelling of the face, limbs, or joints without itching or pain);
• breathing difficulties, wheezing (asthma attack);
• liver function disorders, jaundice (yellow discoloration of the skin and whites of the eyes).

Rarely(occurring in 1 to 10 people out of 10,000):

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

Very Rarely(occurring in less than 1 person out of 10,000):

• thrombocytopenia (decreased platelet count - increased risk of bleeding and bruising);
• agranulocytosis, granulocytopenia (decreased granulocyte count - one of the types of white blood cells, making the patient more susceptible to infections);

methemoglobinemia (the blood loses its ability to carry oxygen to the body's cells, leading to cyanosis and easy fatigue);

• renal colic, renal papillary necrosis, acute kidney failure.

Frequency Not Known (Cannot Be Estimated from the Available Data):

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

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Aflofarm

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date stated is the last day of the month.
Batch: means batch number.
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 Aflofarm Contains

• The active substance of the medicine is paracetamol. 1 tablet contains 500 mg of paracetamol.
• The other ingredients are: gelatin starch, povidone, crospovidone, stearic acid.

What Paracetamol Aflofarm Looks Like and What the Pack Contains

Paracetamol Aflofarm is an oblong, biconvex tablet with a dividing line on one side.
The pack contains: 2, 10, 20, 30, or 50 tablets.

Marketing Authorization Holder and Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Date of Last Revision of the Leaflet: