TAPAMOL

Package leaflet: Information for the patient

TAPAMOL
240 mg/5 mL, oral suspension
Paracetamolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, contact the doctor.

Table of contents

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

1. What TAPAMOL is and what it is used for

TAPAMOL oral suspension is an antipyretic and analgesic medicine intended for use in infants and children, containing paracetamol as the active substance.
Indications
Fever and pain of various origins (e.g. after surgical procedures, teething pain, mild to moderate headache), as well as symptoms associated with the body's reaction to vaccination (pain, fever, local reaction).
TAPAMOL is indicated for symptomatic treatment of fever lasting no longer than 3 days and mild to moderate pain in infants from 0 to 3 months of age (with body weight up to 4 kg).
In children under 3 months of age, use only on medical advice.
Do not use for more than 3 days without consulting a doctor.

2. Important information before using TAPAMOL

When not to use TAPAMOL:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in patients with severe hepatic insufficiency or viral hepatitis,
• in patients with severe renal insufficiency,
• in alcoholic liver disease.

Warnings and precautions
Before starting to use Tapamol, discuss this with your doctor or pharmacist.
Do not use together with other medicines containing paracetamol due to the risk of overdose. In case of overdose, consult a doctor immediately, even if the patient feels well.
Taking a multiple daily dose of paracetamol at once may lead to severe liver damage; in such cases, loss of consciousness does not occur. However, immediate medical advice must be sought.
Do not use for longer than 3 days without consulting a doctor.
Do not take doses higher than recommended.
This medicine should be used with caution in patients with hepatic or renal insufficiency. There is an increased risk of liver damage in malnourished individuals. Caution should be exercised when using paracetamol in patients with reduced glutathione levels (e.g. in sepsis).
Paracetamol use may increase the risk of metabolic acidosis. Caution is advised when using paracetamol in patients with glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency.
During treatment with Tapamol, immediately inform the doctor if the patient has severe illnesses, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and fluid imbalance) has been reported in patients taking paracetamol regularly over a long period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
In patients with asthma who are allergic to salicylates (e.g. acetylsalicylic acid), allergy to paracetamol may occur.
Available study results suggest that administering paracetamol may be a risk factor for the development of asthma and allergic diseases in children.

TAPAMOL 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.
This medicine should not be taken together with centrally acting analgesics or alcohol, as it enhances their effects. When used concomitantly with barbiturates, antiepileptic drugs (e.g. glutethimide, phenobarbital, phenytoin, carbamazepine), or rifampicin, the harmful effect of paracetamol on the liver is increased. Paracetamol increases the toxicity of chloramphenicol.
Long-term use of high-dose paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Concurrent use of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of kidney function disorders. Paracetamol used simultaneously with monoamine oxidase (MAO) inhibitors may cause agitation and high fever.
The absorption of paracetamol is accelerated by drugs that speed up gastric emptying (e.g. metoclopramide, domperidone) and delayed by drugs that slow gastric emptying (e.g. cholestyramine).
Using paracetamol in combination with zidovudine may cause neutropenia. Salicylamide prolongs the elimination time of paracetamol.
Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).
Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic), due to a serious blood and fluid imbalance (called metabolic acidosis), which requires urgent treatment (see section 2).

TAPAMOL and alcohol
Medicine intended for children.
Do not consume alcohol while taking this medicine.

Pregnancy and breastfeeding
Medicine intended for children.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Women who are pregnant or breastfeeding may use this medicine when, in the doctor's opinion, it is necessary.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

TAPAMOL contains 3.7 g of sucrose in 5 mL of suspension
This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

TAPAMOL contains sodium metabisulfite
Sodium metabisulfite may, in rare cases, cause severe hypersensitivity reactions and bronchospasm.

TAPAMOL contains 7.0659 mg of sodium benzoate in 5 mL of suspension
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

TAPAMOL contains less than 1 mmol (23 mg) of sodium per 5 mL of suspension, meaning the medicine is considered "sodium-free".

TAPAMOL contains 10.575 mg of propylene glycol in 5 mL of suspension
Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicinal products containing propylene glycol or alcohol.

3. How to use the medicine TAPAMOL

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally. An oral syringe is provided with the package.
Shake well before use to obtain a uniform suspension.
Recommended dosage:
The average single dose of paracetamol is 10 mg to 15 mg per kilogram of body weight.
If necessary, the dose may be repeated no more frequently than every 4 to 6 hours, and no more than 4 times per day, i.e., a maximum of 60 mg/kg body weight/day.
In children under 3 months of age, use only on medical advice.
Do not use for longer than 3 days without consulting a doctor.
Do not exceed the maximum daily dose. The medicine should be taken as needed when symptoms occur.
If high fever, signs of secondary infection, or prolonged symptoms occur, consult a doctor.
The table below provides an example dosing regimen for the medicine:

5 mL of oral suspension contains 240 mg of paracetamol (full oral syringe).
Dosage instructions using the oral syringe:

• before first use, the syringe must be washed thoroughly in warm (not boiling) water with detergent,
• after removing the cap, attach the syringe to the stopper located in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, then gently push the plunger downwards to draw the suspension into the syringe to the desired volume indicated on the scale,
• return the bottle to its upright position and carefully remove the syringe from the stopper (see figure),

• place the tip of the syringe into the child's mouth, then slowly press the plunger to gently empty the contents of the syringe (the child should be held in an upright or sitting position),
• after use, close the bottle and wash the syringe in warm (not boiling) water with detergent, then dry it thoroughly.

No special recommendations regarding administration with food.
OVERDOSE OF TAPAMOL
If more than the recommended dose of the medicinal product has been taken, seek immediate advice from a doctor or pharmacist, even if the patient feels well.
Severe poisoning may occur in children after ingestion of 200 mg paracetamol/kilogram body weight/day.
Accidental or intentional paracetamol 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 next day, despite slowly developing severe liver damage, manifested by a feeling of fullness in the upper abdomen, nausea, and jaundice.
Treatment of paracetamol poisoning must be carried out in hospital under intensive medical care. If less than one hour has passed since paracetamol ingestion, induce vomiting and administer activated charcoal.
MISSING A DOSE OF TAPAMOL
The medicinal product should be taken as directed in section 3.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rarely (in 1 to 10 patients out of 10,000):
skin allergic reactions: urticaria, erythema, dermatitis.
Very rarely (occurring in less than 1 patient out of 10,000):
reduced platelet count (thrombocytopenia),
reduced white blood cell count (leukopenia, agranulocytosis),
nausea, vomiting, diarrhoea,
liver function disorders.
Frequency not known (cannot be estimated from available data):
a serious condition which may cause the blood to become more acidic (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Prolonged or overdosed use of the medicine may cause liver and kidney damage as well as methemoglobinemia with symptoms of cyanosis (bluish discolouration of the skin).
There have been reports of very rare cases of severe skin reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 181 C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the safety of the medicine.

5. How to store TAPAMOL

Store below 25°C. Store the bottle in an upright position.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
After first opening, the medicine remains stable for 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TAPAMOL contains

• The active substance is paracetamol. 5 mL of suspension contains 240 mg of paracetamol.
• The other ingredients (excipients) are: sucrose, xanthan gum (E 415), monohydrate citric acid (E 330), sodium benzoate (E 211), sodium metabisulfite (E 223), natural strawberry flavour AR 2143 (containing natural flavouring substances, including d-limonene and propylene glycol), purified water.

What TAPAMOL looks like and contents of the pack
A milky to light yellow coloured suspension with a strawberry odour.
The pack contains 100 mL or 85 mL of oral suspension.
Bottle made of amber glass type III with a HDPE screw cap, security ring and LDPE adapter for oral syringe, together with an oral syringe made of LDPE/PS with a capacity of 5 mL, graduated in 0.25 mL increments, in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicines Information
tel.: 22 742 00 22
e-mail: [email protected]