Paracetamol Aflofarm

Leaflet attached to the packaging: patient information

Paracetamol Aflofarm

120 mg/5 mL, oral suspension
Paracetamolum

Please read carefully the contents of the 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 leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 3 days of use, or in the case of cold symptoms after 2 days, there is no improvement or the child feels worse, a doctor should be consulted.

THE MEDICINE CONTAINS PARACETAMOL

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 medicine with analgesic and antipyretic effects in the form of a strawberry-flavored suspension. The medicine contains the active substance paracetamol.

Indications for use

Fever, e.g. in the course of a cold and flu.
Pains of various origins of mild and moderate intensity:

• headache;
• toothache;
• teething pain;
• pain after dental and surgical procedures;
• muscle pain, bone and joint pain.

The medicine is indicated for use in children from 3 months to 12 years of age.
If after 3 days there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before taking Paracetamol Aflofarm

When not to take Paracetamol Aflofarm

• -if other medicines containing paracetamol are being taken at the same time;
• -if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• in case of severe liver and/or kidney failure in the child.

Warnings and precautions

The medicine contains paracetamol. The medicine should not be taken at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms. Paracetamol overdose can lead to severe liver damage.
Before starting to take Paracetamol Aflofarm, the patient should discuss this with a doctor or pharmacist:

• if the patient has kidney and/or liver function disorders;
• if the patient has a deficiency of the enzyme dehydrogenase glucose-6-phosphate and methemoglobin reductase (rare hereditary diseases);
• if the patient is underweight or malnourished and suffers from anorexia;
• if the patient regularly consumes alcohol (it may be necessary to completely stop taking this medicine or reduce the dose). The patient should consult a doctor if they suffer from chronic headaches. If the symptoms of the disease persist, the patient should consult a doctor. The dose should not be exceeded.

During the use of Paracetamol Aflofarm, the doctor should be informed immediately if:

• the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (blood and body fluid disorder), which must be treated urgently (see section 2).
  Taking paracetamol may cause false results in some laboratory tests (e.g. blood glucose measurement).
  If the patient is not sure whether they are taking any of the above-mentioned medicines, they should contact a doctor or pharmacist.

Children

In children under 2 years of age, the medicine should be used in consultation with a doctor.

Paracetamol Aflofarm and other medicines

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

• metoclopramide, domperidone (anti-emetic and anti-vomiting medicines);
• cholestyramine (used to reduce high cholesterol levels in the blood);
• sleeping pills and antiepileptic drugs (e.g. phenobarbital, phenytoin, carbamazepine);
• antitubercular drugs;
• rifampicin (an antibiotic used to treat infections), as it may lead to liver damage when taken with Paracetamol Aflofarm;
• zidovudine (an antiviral medicine);
• anticoagulant medicines, in case of long-term use of painkillers;
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid, ibuprofen, diclofenac;
• monoamine oxidase inhibitors (MAOIs) used to treat depression, as paracetamol taken with MAOIs may cause excitement and high fever;
• flucloxacillin (an antibiotic), due to the high risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

(called metabolic acidosis), which must be treated urgently (see section 2).
Taking paracetamol may cause false results in some laboratory tests (e.g. blood glucose measurement).
If the patient is not sure whether they are taking any of the above-mentioned medicines, they should contact a doctor or pharmacist.

Paracetamol Aflofarm with alcohol

This medicine is intended for children.

Pregnancy and breastfeeding

This medicine is intended for children. Other medicines containing paracetamol as an active substance are available for adults.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
Pregnant or breastfeeding women may only take this medicine if, in the doctor's opinion, it is clinically justified.

Driving and using machines

The medicine is intended for children. Paracetamol Aflofarm has no influence or negligible influence on the ability to drive and use machines.
Paracetamol Aflofarm contains cochineal red, sucrose, sodium, sodium benzoate,
ethanol, propylene glycol (E 1520), and benzyl alcohol

Cochineal red

The medicine may cause allergic reactions.

Sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
The medicine contains 3100 mg of sucrose in each 5 mL of suspension. This should be taken into account in patients with diabetes.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium in each 5 mL of suspension, which means the medicine is considered "sodium-free".

Sodium benzoate

The medicine contains 7.44 mg of sodium benzoate in each 5 mL of suspension.

Etanol

This medicine contains 2.13 mg of alcohol (ethanol) in each 5 mL of suspension, which is equivalent to 0.04% (v/v). The amount of alcohol in 5 mL of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

Propylene glycol (E 1520)

The medicine contains 3.44 mg of propylene glycol in each 5 mL of suspension.

Benzyl alcohol

The medicine contains 0.087 mg of benzyl alcohol in each 5 mL of suspension.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Paracetamol Aflofarm

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Before use, shake vigorously for at least 30 seconds.

The medicine is for oral use.
A measuring cup is attached to the packaging to facilitate dosing. A full measuring cup of 15 mL (filled to the top line) contains 360 mg of paracetamol.

Recommended dose

Children

The dose is determined based on the child's body weight (on average, 10-15 mg/kg body weight) or according to the following scheme. The given doses are single doses.
Children aged:

• from 3 months to 12 months: 2.5 to 5 mL (60 to 120 mg of paracetamol)
• from 1 to 6 years: 5 to 10 mL (120 to 240 mg of paracetamol)
• from 6 to 12 years: 10 to 20 mL (240 to 480 mg of paracetamol) Note: In children under 2 years of age, the medicine should be used in consultation with a doctor.

The medicine should not be given more often than every 4 hours, up to a maximum of 4 doses per day (do not exceed the dose of 60 mg of paracetamol/kg body weight/24 hours).
Without consulting a doctor, the medicine should not be given to children for more than 3 days, and in the case of cold symptoms, no longer than 2 days.

Taking a higher dose of Paracetamol Aflofarm than recommended

Paracetamol overdose can lead to liver damage. Medical advice should be sought immediately, even if the patient's condition is good and no symptoms of poisoning have been observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. If a higher dose of paracetamol than recommended is taken, and it has not been more than an hour since ingestion, vomiting should be induced. Activated charcoal can also be given orally, preferably mixed with water.
There is a lack of well-defined data on paracetamol overdose in children.
Symptoms within the first two days of acute paracetamol poisoning do not reflect the severity of the poisoning. Most symptoms of liver damage, such as jaundice, hypoglycemia (low blood glucose levels), and metabolic acidosis (see section 2), may only appear after 2 days of overdose. Overdose of the medicine may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few, dozen hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Paracetamol Aflofarm

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The medicine should be stopped immediately and a doctor consulted if the following symptoms occur:

• allergic reaction, such as: skin rash or itching, sometimes accompanied by swelling

of the lips, tongue, throat, or face, making breathing difficult – very rare, i.e. less than 1 in 10,000 people;

• angioedema (sudden swelling of the face, limbs, or joints without itching and pain) - rare, i.e. less than 1 in 1,000 people;
• skin rash or severe skin reaction, manifested by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or bursting giant blisters under the skin, extensive erosions on the skin, and fever - very rare;
• breathing difficulties, wheezing (asthmatic attack) - rare;
• breathing problems, if similar problems have occurred in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs - very rare;
• bruises or bleeding of unknown cause - very rare;
• liver function disorders, jaundice (yellowing of the skin and whites of the eyes) - rare.

Rare(occurring in less than 1 in 1,000 people):

• 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 shock symptoms (a clinical condition caused by insufficient oxygenation of vital organs);
• nausea, vomiting.

Very rare(occurring in less than 1 in 10,000 people):

• agranulocytosis, granulocytopenia (reduced number of granulocytes - one type of white blood cell, making the patient more susceptible to infections);
• methemoglobinemia (blood loses its ability to transport oxygen to body cells, leading to cyanosis and easy fatigue);
• kidney colic, renal papillary necrosis, acute kidney failure.

Frequency not known(cannot be estimated from the available data):

• a serious disease 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 those not listed in this leaflet, the doctor or pharmacist should be informed.
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
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.
Reporting side effects will help to gather more information 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. Do not freeze. Store in the original packaging.
Do not use this medicine after the expiry date stated on the bottle and carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. 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. 5 mL of oral suspension contains 120 mg of paracetamol.
• The other ingredients are: polysorbate 80, sucrose, xanthan gum, sodium saccharin, sodium benzoate, citric acid, cochineal red (E 124), strawberry flavor AR0012/F (contains, among others, ethanol, propylene glycol (E 1520), and benzyl alcohol), purified water.

What Paracetamol Aflofarm looks like and contents of the pack

Paracetamol Aflofarm is an oral suspension, pink-red in color, with a strawberry flavor and aroma.
The packaging of the medicine is: a brown glass bottle containing 100 mL of suspension, with a white aluminum cap, with a measuring cup, placed in a cardboard box.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów

Date of last revision of the leaflet: