Panadol rapid
Poland
Table of Contents
Package leaflet: Information for the user
Panadol Rapid
500 mg, effervescent tablets
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 3 days, or if you feel worse, consult your doctor.
Table of contents
- What Panadol Rapid is and what it is used for
- Important information before taking Panadol Rapid
- How to take Panadol Rapid
- Possible side effects
- How to store Panadol Rapid
- Contents of the pack and other information
What Panadol Rapid is and what it is used for
Panadol Rapid effervescent tablets contain paracetamol, a substance with analgesic and antipyretic properties. Due to faster absorption, the action of paracetamol in effervescent tablets may occur more quickly compared to regular paracetamol tablets.
Panadol Rapid is indicated for the relief of mild to moderate pain of various origins, such as headache, including migraine and tension headache, toothache, neuralgia, back pain, rheumatic and muscular pain, menstrual pain, sore throat, as well as fever and pain associated with cold or flu.
2. Important information before taking Panadol Rapid
Do not take Panadol Rapid:
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
- in case of alcohol-related liver disease,
- in case of severe hepatic or renal insufficiency.
Warnings and precautions
This medicine contains paracetamol. Do not exceed the recommended dose.
Overdosing on paracetamol may lead to severe liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or cold and flu remedies.
Read this leaflet carefully before use and follow the instructions provided.
Consult your doctor before taking this medicine if you:
- have liver or kidney insufficiency,
- have deficiency of certain enzymes (glucose-6-phosphate dehydrogenase or methemoglobin reductase),
- are underweight or malnourished due to anorexia,
- regularly consume alcohol (it may be necessary to completely stop taking this product or reduce the dose),
- have a severe infection (sepsis), which may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include:
- deep, rapid, and labored breathing,
- nausea, vomiting, and loss of appetite,
- general malaise.
Seek immediate medical attention if the patient experiences the above symptoms simultaneously.
Consult your doctor if you suffer from chronic headaches.
Do not drink alcohol while taking this medicine, as it increases the risk of liver damage. The risk of liver damage is particularly high in fasting patients and those who regularly consume alcohol. Existing liver disease increases the risk of liver damage associated with paracetamol use.
If symptoms persist, consult your doctor.
Keep the medicine out of sight and reach of children.
Do not exceed the recommended dose.
Children
Not recommended for children under 12 years of age or weighing less than 50 kg, as Panadol Rapid 500 mg effervescent tablets cannot be divided.
Panadol Rapid and other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
Do not take other medicines containing paracetamol at the same time.
Consult your doctor if you are taking any of the following medicines:
metoclopramide, domperidone (used for nausea and vomiting), cholestyramine (used to reduce high blood cholesterol levels), anticoagulants (if long-term pain relief is required), sedatives, antiepileptics, antituberculosis drugs, MAO inhibitors (used in depression), nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid).
Paracetamol may cause false results in certain laboratory tests (e.g., blood glucose measurement).
Concomitant use of paracetamol with MAO inhibitors may cause agitation and high fever.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Panadol Rapid may be used during pregnancy if clinically justified. Use the lowest effective dose needed to relieve pain and (or) fever, for the shortest possible duration and as infrequently as possible.
Consult your doctor if pain and (or) fever do not subside or if you need to take the medicine more frequently. Like other medicines, this medicine should be used during pregnancy only if clearly necessary.
Paracetamol passes into breast milk in clinically insignificant amounts. Available data do not indicate contraindications to breastfeeding during treatment with this medicine. Like other medicines, this medicine should be used during breastfeeding only if clearly necessary.
Driving and using machines
Panadol Rapid has no effect or negligible effect on the ability to drive and operate machinery.
This medicine contains sorbitol and sodium
Sorbitol
This medicine contains 50 mg of sorbitol per tablet. Sorbitol is a source of fructose. If you (or your child) have previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—consult your doctor before taking this medicine or giving it to your child.
Sodium
One tablet contains 427 mg of sodium, which corresponds to 21.4% (42.8% with 2 tablets) of the WHO-recommended maximum daily intake of 2 g sodium for adults.
3. How to use Panadol Rapid
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
For oral use only.
The medicine should be taken orally, dissolved in half a glass of water.
Use in adults and adolescents aged above 12 years (body weight above 50 kg)
1–2 tablets, no more frequently than every 4 hours, not more than 4 doses in 24 hours.
The maximum daily dose of paracetamol is 4000 mg (8 tablets) in divided doses.
Children aged 12 years (body weight 42 kg)
The dose should be determined according to the child's age and body weight.
Single dose: 10–15 mg/kg body weight:
for a child aged 12 years (42 kg) – 1 tablet (500 mg),
no more frequently than every 4 hours, not more than 4 doses in 24 hours.
Maximum daily dose of paracetamol: 60 mg/kg bw/24 h in divided doses as above. Not more than 4 doses in 24 hours.
In case of any doubts regarding dosing, the child's caregiver should consult a doctor.
Children under 12 years of age or with body weight below 50 kg
Not recommended.
If needed, administer Panadol in suspension, intended for children from 3 months of age.
In case of any doubts regarding dosing, consult a doctor.
Do not take a higher than recommended dose, or more frequently than every 4 hours.
Always use the lowest effective dose for the shortest possible duration.
Without consulting a doctor, do not use this medicine regularly for longer than 3 days.
Overdose of Panadol Rapid
In any case of ingestion of a dose higher than recommended, seek immediate medical advice, 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. In every case of ingestion of 5 g or more of paracetamol at once, and if less than one hour has passed since ingestion, vomiting may be induced. Administer 60–100 g of activated charcoal orally, preferably mixed with water.
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 the onset of liver damage, which subsequently becomes evident as upper abdominal discomfort, recurrence of nausea, and jaundice.
Missed dose of Panadol Rapid
Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, Panadol Rapid can cause adverse reactions.
You should stop using the medicine immediately and consult a doctor if any of the following occur:
- allergic reactions (hypersensitivity) such as skin rash or itching, sometimes associated with difficulty breathing or swelling of the lips, tongue, throat or face,
- skin rash or severe skin reaction characterized by sudden widespread blistering 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 sheets of epidermis, and fever,
- breathing difficulties, if similar problems occurred previously during use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
- unexplained bruising or bleeding,
- liver function disorders. These reactions occur very rarely, i.e. in less than 1 in 10,000 patients.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 Panadol Rapid
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep the medicine out of sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.
6. Contents of the packaging and other information
What Panadol Rapid contains
- The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
- The other ingredients are: sorbitol, sodium saccharin, sodium hydrogen carbonate, povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate.
What Panadol Rapid looks like and contents of the pack
Panadol Rapid is a white effervescent tablet.
The pack contains 12 or 24 effervescent tablets.
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
Haleon Ireland Dungarvan Limited
Knockbrack, Lisfennel,
Dungarvan,
Co. Waterford,
X35 RY76,
Ireland
FAMAR S.A.
7 Anthousa Av.
15344 Pallini
Attiki
Greece
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.