PANADOL 500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Panadol Menthol Active
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Panadol Menthol Active and what is it used for
   1. Panadol Menthol Active is used for the short-term treatment of flu or
4. Important information before taking Panadol Menthol Active
   1. When not to take Panadol Menthol Active:
   2. Do not take with other medicines containing paracetamol,
   3. Warnings and precautions
   4. Panadol Menthol Active and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Panadol Menthol Active
   1. Use in adults and children over 12 years of age (with a body weight over 50 kg)
   2. Taking a higher dose of Panadol Menthol Active than recommended
   3. Missing a dose of Panadol Menthol Active
6. Possible side effects
   1. Reporting side effects
7. How to store Panadol Menthol Active
   1. Store the medicine out of sight and reach of children.
8. Contents of the packaging and other information
   1. What Panadol Menthol Active contains
   2. What Panadol Menthol Active looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: August 2023
   6. Other sources of information

Leaflet attached to the packaging: information for the user

Panadol Menthol Active

500 mg, powder for oral solution preparation
Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Panadol Menthol Active contains paracetamol, which has analgesic and antipyretic effects.

Panadol Menthol Active is used for the short-term treatment of flu or

cold symptoms such as: fever, sore throat, headache, muscle aches.

2. Important information before taking Panadol Menthol Active

When not to take 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 alcoholism,
• if the patient has severe liver or kidney failure.

Do not take with other medicines containing paracetamol,

Do not give to children under 12 years of age or with a body weight below 50 kg.

Warnings and precautions

The medicine contains paracetamol.Do not take more than the recommended dose.
Overdose of paracetamol can lead to severe liver damage.
Do not take this medicine at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms.
Read the leaflet before taking the medicine and follow the instructions in it.
Before taking the medicine, consult a doctor if:

• you have kidney or liver disease, including alcoholic liver disease,
• you have chronic headaches,
• you are underweight or malnourished, suffering from anorexia,
• you regularly consume alcohol (you may need to completely stop taking this product or reduce the dose),
• you have a severe infection (sepsis) that may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include:
• deep, rapid, and labored breathing,
• nausea, vomiting, and loss of appetite,
• general poor condition. You should contact a doctor immediately if you experience any of these symptoms. You should consult a doctor if you have chronic headaches. Existing liver disease increases the risk of liver damage associated with paracetamol use. If symptoms persist, consult a doctor. Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement). The medicine should be stored out of sight and reach of children.

Panadol Menthol Active and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Consult a doctor if you are taking:

• metoclopramide, domperidone(used for nausea and vomiting),
• cholestyramine(used to reduce high cholesterol levels in the blood),
• anticoagulant medicines(such as warfarinor other coumarin derivatives) in case of prolonged use of painkillers,
• liver metabolism-enhancing medicines, e.g., some sleeping pills or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine) and rifampicin, as liver damage may occur even when taking the recommended doses of paracetamol,
• MAO inhibitors(medicines used to treat depression),
• salicylamide.Concurrent use of paracetamol and acetylsalicylic acidincreases the risk of kidney function disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Panadol Menthol Active can be used during pregnancy if clinically justified. Take the smallest possible dose that reduces pain and (or) fever, for the shortest possible time and as infrequently as possible.
Consult a doctor if pain and (or) fever do not decrease or if you need to take the medicine more frequently. Like other medicines, this medicine should be used during pregnancy only if necessary.
Paracetamol passes into breast milk in amounts that are not clinically significant. Available data do not indicate any contraindications to breastfeeding during treatment with this medicine. Like other medicines, this medicine should be used during breastfeeding only if necessary.

Driving and using machines

Panadol Menthol Active has no influence or negligible influence on the ability to drive and use machines.
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 some 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 its 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 taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis). 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 (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 toxicity accumulation (metabolic acidosis).
• One sachet contains 0.009 mg of ethanol. The amount of ethanol in a dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol 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 intake of 2 g of sodium for adults.
• The medicine contains azo dyes: carmoisine (E122), orange yellow (E110), and brilliant black (E151). The medicine may cause allergic reactions. One sachet contains 0.05 mg of propylene glycol (E1520) (in the composition of Blackcurrant Flavor 502 009 AP 0551).
• The medicine contains glucose in glucose syrup (Blackcurrant Flavor ingredient). If the patient has previously been diagnosed with intolerance to some 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 children over 12 years of age (with a body weight over 50 kg)

Orally, 1 or 2 sachets, if necessary, every 4-6 hours.
Dissolve the contents of the sachet in hot water, mix well, and drink.
Do not take more than 4000 mg in 24 hours.
Without consulting a doctor, do not use the medicine regularly for more than 3 days.

• Do not take more frequently than every 4 hours.
• Do not take more than the recommended dose.
• Do not take more than 8 sachets in 24 hours.
• Always use the lowest effective dose of the medicine for the shortest possible time.
• Do not give the medicine to children under 12 years of age or with a body weight below 50 kg.

Taking a higher dose of Panadol Menthol Active than recommended

In any case of taking a higher dose than recommended, seek medical advice 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. In any case of taking a single dose of paracetamol of 5 g or more and if no more than an hour has passed since ingestion, vomiting can be induced. Administer 60-100 g of activated charcoal orally, preferably mixed with water.
Accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day, despite the fact that liver damage has begun to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Panadol Menthol Active

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and consult a doctor if you experience:

• an allergic reaction (hypersensitivity), such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, extensive erosions on the skin, and fever,
• breathing problems, if you have experienced similar problems in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory medicines,
• bruises or bleeding of unknown cause;
• liver function disorders characterized by nausea, loss of appetite, weight loss, abdominal distension, and yellowing of the eyes and skin.

These reactions are very rare.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
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
Jerozolimskie Avenue 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 gather more information on the safety of the medicine.

5. How to store Panadol Menthol Active

Store the 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 after EXP. The expiry date refers to the last day of the month.
Dispose of the packaging in an appropriate manner. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Panadol Menthol Active contains

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

What Panadol Menthol Active looks like and what the packaging contains

The medicine is a light pink powder in a sachet made of paper/PE/Aluminum/PE laminate, in a cardboard box. The packaging contains 5, 6, 10, 12, 15, 20, or 24 sachets. Not all pack sizes may be marketed.

Marketing authorization holder

Haleon Poland Sp. z o.o.
Rzymowskiego 53
02-697 Warsaw
phone: 800 702 849

Manufacturer

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

Date of last revision of the leaflet: August 2023

Other sources of information

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