Package leaflet: Information for the user

Panadol Menthol Active
500 mg, effervescent powder for oral solution
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 information leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or additional information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 3 days, you should consult your doctor.

Contents of the leaflet

What Panadol Menthol Active is and what it is used for
What you need to know before taking Panadol Menthol Active
How to take Panadol Menthol Active
Possible side effects
How to store Panadol Menthol Active
Contents of the pack and other information

1. What Panadol Menthol Active is and what it is used for

Panadol Menthol Active contains paracetamol, which has analgesic and antipyretic properties.
Panadol Menthol Active is used for the short-term treatment of symptoms of flu or
common cold such as: fever, sore throat, headache, and muscle pain.

2. Important information before using Panadol Menthol Active

When not to use Panadol Menthol Active:

if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
if the patient has alcoholic disease,
if the patient has severe liver or kidney impairment.

Do not use simultaneously with other medicines containing paracetamol.
Do not give this medicine to children under 12 years of age or weighing less than 50 kg.
Warnings and precautions
This medicine contains paracetamol. Do not take more than the recommended dose.
Paracetamol overdose can lead to severe liver damage.
This medicine should not be used concurrently with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat symptoms of flu and colds.
Read the leaflet carefully before use and follow the instructions provided.
Consult a doctor before using the medicine if the patient:

has kidney or liver disease, including alcoholic liver disease,
suffers from chronic headaches,
is underweight or malnourished due to anorexia,
regularly consumes alcohol (it may be necessary to completely stop taking this product or reduce the dose),
has 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 feeling of being unwell. Contact a doctor immediately if the patient experiences the above symptoms simultaneously.
  Consult a doctor if the patient suffers from chronic headaches.
  Existing liver disease increases the risk of liver damage associated with paracetamol use.
  If symptoms persist, consult a doctor.
  Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).
  Keep the medicine out of sight and reach of children.

Panadol Menthol Active and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Consult a doctor if taking the following medicines:

metoclopramide, domperidone (used against nausea and vomiting),
cholestyramine (used to reduce high blood cholesterol levels),
anticoagulants (such as warfarin or other coumarin derivatives), if long-term painkiller treatment is required,
medicines that increase hepatic metabolism, e.g. certain sedatives or antiepileptics (e.g. phenobarbital, phenytoin, carbamazepine) and rifampicin, as liver damage may occur even when taking recommended doses of paracetamol,
MAO inhibitors (medicines used to treat depression),
salicylamide.
Concomitant use of paracetamol and acetylsalicylic acid increases the risk of kidney function disorders.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Panadol Menthol Active may be used during pregnancy if clinically justified. The lowest effective dose that reduces pain and/or fever should be taken for the shortest possible duration and as infrequently as possible.
Consult a doctor if pain and/or fever do not subside or if more frequent dosing is needed. As with other medicines, this medicine should only be used during pregnancy if clearly necessary.
Paracetamol passes into breast milk in clinically insignificant amounts. Available data do not indicate any contraindications to breastfeeding during treatment with this medicine. As with other medicines, it should only be used during breastfeeding if clearly necessary.

Driving and using machines
Panadol Menthol Active has no effect or negligible effect on the ability to drive and operate machinery.

Warnings about excipients
Panadol Menthol Active contains: sucrose, aspartame, azo dyes, sodium, ethanol, benzyl alcohol, propylene glycol, glucose.

One sachet contains 2000 mg of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
One sachet contains 50 mg of aspartame (E951). Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
One sachet contains 3 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Large volumes of benzyl alcohol should be administered with caution and only if necessary, especially in patients with impaired kidney or liver function due to the risk of toxic accumulation (so-called metabolic acidosis).
One sachet contains 0.009 mg of alcohol (ethanol). The amount of alcohol in 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.
One sachet contains 118 mg of sodium, which corresponds to 5.9% of the WHO-recommended maximum daily sodium intake of 2 g for adults.
The medicine contains azo dyes: carmoisine (E122), sunset yellow (E110), and brilliant black (E151). The medicine may cause allergic reactions. One sachet contains 0.05 mg of propylene glycol (E1520) (in the Blackcurrant flavour component).
The medicine contains glucose in glucose syrup (component of Blackcurrant flavour). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

3. How to take Panadol Menthol Active

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.

Use in adults and adolescents over 12 years of age (body weight above 50 kg)
Orally, 1 or 2 sachets, if necessary, every 4–6 hours.
Dissolve the contents of the sachet in hot water, stir well, and drink.
Do not exceed 4000 mg within 24 hours.
Without consulting a doctor, this medicine should not be used regularly for longer than 3 days.

Do not take more often than every 4 hours.
Do not exceed the recommended dose.
Do not take more than 8 sachets in 24 hours.
Always use the lowest effective dose for the shortest possible duration.
Do not give this medicine to children under 12 years of age or weighing less than 50 kg.

Overdose of Panadol Menthol Active
In any case of overdose, 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. If a dose of paracetamol of 5 g or more has been taken and less than one hour has passed, vomiting may be induced. Administer 60–100 g of activated charcoal orally, preferably mixed with water.

Accidental or intentional overdose of paracetamol 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, even though liver damage may have started to develop, later presenting as upper abdominal pain, recurrence of nausea, and jaundice.

Missed dose of Panadol Menthol Active
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 skin itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat or face,
skin rash or severe skin reaction presenting as acute generalized pustular 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,
breathing problems, if similar problems occurred previously during use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
unexplained bruises or bleeding;
liver function disorders manifested by nausea, loss of appetite, weight loss, bloating in the upper abdomen, and yellowing of the eyes and skin.

The above reactions occur very rarely.
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 Reactions of Medicinal Products, 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 provide more information on the safety of this medicine.

5. How to store Panadol Menthol Active

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use the medicine after the expiry date stated on the sachet and outer packaging following EXP. The expiry date refers to the last day of the stated month.
Dispose of the packaging at the appropriate collection point. 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 packaging and other information

What Panadol Menthol Active contains

The active substance is paracetamol. Each sachet contains 500 mg of paracetamol.
The other ingredients are: sucrose, aspartame (E951), tartaric acid, sodium citrate, menthol flavour E 41580, blackcurrant flavour 502 009 AP 0551 (containing, among others: benzyl alcohol, propylene glycol (E1520), ethanol, glucose syrup, sodium), red dye (Rojo conacert M659) containing carmoisine (E122), sunset yellow (E110) and brilliant black (E151), sodium chloride as standardizing agent.

What Panadol Menthol Active looks like and contents of the pack
The medicine is a light pink powder contained in sachets made of paper/PE/Aluminium/PE laminate, packed in a cardboard box. The pack contains 5, 6, 10, 12, 15, 20 or 24 sachets. Not all pack sizes may be available on the market.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
Rzymowskiego 53 Street
02-697 Warsaw
Tel.: 800 702 849

Manufacturer
SmithKline Beecham S.A.,
Carretera de Ajalvir, km 2.500,
28806 Alcala de Henares,
Madrid,
Spain

Further information
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.