Paracetamol aflofarm

Package leaflet: Information for the patient

Paracetamol Aflofarm
120 mg/5 mL, oral suspension
Paracetamolum
Please read the entire leaflet carefully before taking this 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.

• Keep this leaflet for possible future reference.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of use, or after 2 days in the case of cold symptoms, or if the child feels worse, consult a doctor.

THIS MEDICINE CONTAINS PARACETAMOL
Table of contents of the leaflet

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

Paracetamol Aflofarm is an analgesic and antipyretic medicine presented as a strawberry-flavoured oral suspension. The medicine contains paracetamol as the active substance.

Therapeutic indications
Fever, e.g. associated with colds and influenza.
Mild to moderate pain of various origins:

• headache;
• toothache;
• pain associated with teething;
• pain following dental and surgical procedures;
• muscular pain, bone and joint pain.

This medicine is indicated for use in children from 3 months of age up to 12 years.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before taking Paracetamol Aflofarm

When not to take Paracetamol Aflofarm

• if you are taking other medicines containing paracetamol 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 children.

Warnings and precautions
This medicine contains paracetamol. It should not be taken simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat symptoms of flu and colds. Paracetamol overdose may lead to severe liver damage.
Before starting to take Paracetamol Aflofarm, consult your doctor or pharmacist if:

• the patient has impaired kidney and/or liver function;
• the patient has glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency (rare inherited disorders);
• the patient is underweight or malnourished due to anorexia;
• the patient regularly consumes alcohol (it may be necessary to completely stop taking this medicine or reduce the dose). Consult your doctor if the patient suffers from chronic headaches. If symptoms persist, consult a doctor. Do not take a dose higher than recommended.

While taking Paracetamol Aflofarm, inform your doctor immediately if:

• the patient has severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
Paracetamol Aflofarm should be used in children under 2 years of age only under medical supervision.
Paracetamol Aflofarm and 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 taking Paracetamol Aflofarm, the patient should inform the doctor or pharmacist if they are taking:

• metoclopramide, domperidone (medicines for nausea and vomiting);
• cholestyramine (used to reduce high blood cholesterol levels);
• sedatives and antiepileptic medicines (e.g. phenobarbital, phenytoin, carbamazepine);
• anti-tuberculosis medicines;
• rifampicin (an antibiotic used to treat infections), as its simultaneous use with Paracetamol Aflofarm may lead to liver damage;
• zidovudine (an antiviral medicine);
• anticoagulants, if long-term pain relief is required;
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid, ibuprofen, diclofenac;
• monoamine oxidase inhibitors (MAO inhibitors) used to treat depression, because paracetamol taken together with MAO inhibitors may cause excitation and high fever;
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).
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
This medicine is intended for children.
Pregnancy and breastfeeding
This medicine is intended for children. Other paracetamol-containing medicines intended for adults have been authorized for use.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Women who are pregnant or breastfeeding may use this medicine only if, in the doctor's opinion, it is clinically justified.
Driving and operating machinery
This medicine is intended for children. Paracetamol Aflofarm has no effect or has a negligible effect on the ability to drive and operate machinery.
Paracetamol Aflofarm contains carmine, sucrose, sodium, sodium benzoate, ethanol, propylene glycol (E 1520), and benzyl alcohol
Carmine
This medicine may cause allergic reactions.
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this 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, meaning the medicine is considered "sodium-free".
Sodium benzoate
The medicine contains 7.44 mg of sodium benzoate in each 5 mL of suspension.
Ethanol
This medicine contains 2.13 mg of alcohol (ethanol) in each 5 mL of suspension, equivalent to 0.04% (w/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 cause 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 and patients with liver or kidney disease should consult their doctor before using this medicine, as larger amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Paracetamol Aflofarm

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Shake well before use for at least 30 seconds.
This medicine is for oral use only.
An oral dosing device is provided with the packaging to assist in accurate dosing. A full dose of 15 mL (filled up to the upper mark) contains 360 mg of paracetamol.
Recommended dose
Children
The dose should be calculated according to the child's body weight (typically 10–15 mg/kg per single dose) or according to the following schedule. The doses listed below are single doses.
Children aged:

• from 3 months to 12 months: 2.5 to 5 mL (60 to 120 mg paracetamol)
• from 1 to 6 years: 5 to 10 mL (120 to 240 mg paracetamol)
• from 6 to 12 years: 10 to 20 mL (240 to 480 mg paracetamol)
  Note: Paracetamol Aflofarm should be used in children under 2 years of age only under medical supervision.

Do not administer the medicine more frequently than every 4 hours, with a maximum of 4 doses per day (do not exceed 60 mg paracetamol/kg body weight/24 hours).
Do not administer to children for longer than 3 days without consulting a doctor, or in case of cold symptoms, for longer than 2 days.

Accidental overdose of Paracetamol Aflofarm
Paracetamol overdose may lead to liver damage. Immediate medical advice should be sought, even if the patient feels well and no symptoms of poisoning are observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. If a larger than recommended dose of paracetamol has been taken and less than one hour has passed since ingestion, induce vomiting. Activated charcoal 60–100 g may also be administered orally, preferably mixed with water.
There are no well-defined data regarding paracetamol overdose in children.
Symptoms during the first two days of acute paracetamol poisoning may not reflect the severity of intoxication. Most signs of liver damage, such as jaundice, hypoglycaemia (low blood glucose levels), and metabolic acidosis (see section 2), may appear only after 2 days. Overdose may cause symptoms within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the following day, despite the onset of liver damage, which may later manifest as upper abdominal discomfort, recurrence of nausea, and jaundice.

Missed dose of Paracetamol Aflofarm
Do not take a double dose to make up for a missed 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 they do not occur in everyone.
You must stop taking the medicine immediately and consult a doctor if any of the following symptoms occur:

• allergic reaction, such as: skin rash or itching, sometimes accompanied by swelling of the lips, tongue, throat or face, causing difficulty in breathing – very rare, i.e. less frequently than in 1 out of 10,000 people;
• angioedema (sudden swelling of the face, limbs or joints without itching or pain) – rare, i.e. less frequently than in 1 out of 1,000 people;
• skin rash or severe skin reaction, manifesting as acute generalized vesicular rash or blisters and erosions on the skin, in the mouth, eyes, and genital organs, fever and joint pain, or rupturing large subcutaneous blisters, extensive skin erosions, peeling of large skin sheets, and fever – very rare;
• difficulty breathing, wheezing (asthma attack) – rare;
• breathing problems, if similar problems occurred previously during use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs – very rare;
• bruising or bleeding of unknown cause – very rare;
• liver function disorders, jaundice (yellowing of the skin and whites of the eyes) – rare.

Rare (occurring in fewer than 1 out of 1,000 people):

• itching;
• erythema (red-blue skin patches, sometimes with blisters);
• urticaria (bright pink, itchy wheals on the skin);
• rash (itchy, red bumps on the skin);
• dyspnoea;
• sweating;
• hypotension, up to shock symptoms (a clinical condition caused by insufficient oxygenation of vital organs);
• nausea, vomiting.

Very rare (occurring in fewer than 1 out of 10,000 people):

• 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 skin cyanosis 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 reactions occur, including any 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 at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Paracetamol Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the bottle and the carton.
The expiry date refers to the last day of the stated month.
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 pack and other information

What Paracetamol Aflofarm contains

• The active substance is paracetamol. 5 mL of oral suspension contains 120 mg of the active substance paracetamol.
• The other ingredients are: polysorbate 80, sucrose, xanthan gum, sodium saccharin, sodium benzoate, citric acid, carmine red (E 124), strawberry flavour AR0012/F (containing, 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 colour, with a strawberry taste and odour.
The medicine pack consists of: a brown glass bottle containing 100 mL of suspension, with a white aluminium screw cap, supplied with a measuring device, all contained in a cardboard box.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 42 22-53-100

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