Package leaflet: Information for the user

Panadol Extra, 500 mg + 65 mg, coated tablets
Paracetamolum + Coffeinum
Please read the entire leaflet carefully before using this 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 a doctor, pharmacist, or nurse.

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

Table of contents

What Panadol Extra is and what it is used for
Important information before taking Panadol Extra
How to take Panadol Extra
Possible side effects
How to store Panadol Extra
Contents of the pack and other information

1. What Panadol Extra is and what it is used for

Panadol Extra contains two active substances: paracetamol and caffeine. The therapeutic effect results from the combined action of these active ingredients.
Paracetamol has analgesic and antipyretic properties.
Caffeine exerts a stimulant effect on the central nervous system and enhances the analgesic effect of paracetamol.
Indications for use of Panadol Extra:
The medicine provides analgesic relief in headaches, sore throats, migraines, toothaches, bone, joint, and muscle pain, as well as menstrual pain. It may be used in colds and flu-like conditions. It also has antipyretic properties.

2. Important information before using Panadol Extra

When not to take Panadol Extra:

if the patient is allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6);
in case of alcohol-related illness, severe liver or kidney failure, heart rhythm disorders, or insomnia. This medicine should not be used in children under 12 years of age.

Warnings and precautions

This medicine contains paracetamol.
Do not take more than the recommended dose, as paracetamol overdose may
lead to severe liver damage.
This medicine should not be taken simultaneously with other over-the-counter or prescription medicines
containing paracetamol, such as painkillers, antipyretics, cold and flu remedies, or sleep aids.
Read the leaflet carefully before using the medicine and follow the instructions provided.
During treatment with Panadol Extra, inform your doctor immediately if the patient has any serious medical conditions, including severe kidney disorders, 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). In such cases, patients have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids) when paracetamol was taken regularly over a prolonged period or when paracetamol was taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Consult your doctor before using this medicine if:

the patient has liver or kidney impairment;
the patient has certain enzyme deficiencies (glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency);
the patient is underweight or malnourished due to anorexia;
the patient regularly consumes alcohol. In such cases, it may be necessary to completely stop taking this medicine or reduce the dose.

Consult your doctor before using this medicine if:

the patient has a severe infection;
the patient is underweight or malnourished due to anorexia;
the patient regularly consumes alcohol, as this may increase the risk of liver failure and metabolic acidosis (see information above).

Symptoms of liver failure may include:

loss of appetite, diarrhoea, fever, skin rash;
low blood pressure and rapid heartbeat;
nausea, vomiting, bloating under the right ribs, jaundice, bleeding disorders (skin bruising), and disturbances in consciousness.

Seek immediate medical attention if the patient experiences any of the above symptoms simultaneously.
The use of paracetamol may lead to false results in certain laboratory tests (e.g. blood glucose measurement).

Panadol Extra and other medicines

This medicine contains paracetamol. Due to the risk of overdose, do not take with other medicines
containing paracetamol.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Consult your doctor if the patient is taking any of the following medicines:
metoclopramide, domperidone (used for nausea and vomiting), cholestyramine (used to reduce high blood cholesterol levels), anticoagulants (e.g. warfarin), if long-term pain relief is required, sedatives, antiepileptics, antituberculosis drugs, MAO inhibitors (medicines used in depression), estrogens and progesterone (sex hormones), disulfiram (used, among others, in the treatment of alcoholism), non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid).
This medicine is not recommended for patients taking lithium salts (used, among others, in the treatment of depression and mania).
Paracetamol taken together with MAO inhibitors may cause a state of excitation and high body temperature.
Do not drink alcohol while taking this medicine due to the increased risk of liver damage. The risk of liver damage is particularly high in malnourished patients and those who regularly consume alcohol.
This medicine contains caffeine. During treatment, avoid excessive intake of caffeine (e.g. from coffee, tea, or certain beverages). Excessive caffeine intake may cause difficulty sleeping, tremors, and an unpleasant sensation in the chest due to heart palpitations.
Inform your doctor or pharmacist if the patient is taking:

flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Panadol Extra with food, drink, and alcohol
Do not drink alcohol while taking this medicine due to the increased risk of liver damage.
When Panadol Extra, which contains caffeine, is taken at the recommended dose in combination with dietary sources of caffeine, there may be an increased risk of adverse effects related to higher total caffeine intake, such as: insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disturbances, and heart palpitations.

Children
This medicine is contraindicated in children under 12 years of age.

Pregnancy, breastfeeding, and fertility
Do not use Panadol Extra during pregnancy or breastfeeding.

Driving and operating machinery
Panadol Extra has no effect or negligible effect on the ability to drive and operate machinery.

Warnings regarding excipients
This medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free".
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Panadol Extra

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.
Adults and adolescents over 12 years of age
Orally, 1-2 tablets depending on the severity of symptoms, up to 4 times daily. The medicine should not be taken more frequently than every 4 hours, nor should more than 4 doses (8 tablets) be taken in any 24-hour period.
Do not exceed the recommended dose.
Always use the lowest effective dose for the shortest possible duration.
If symptoms persist, consult a doctor.
Do not use this medicine regularly for more than 3 days without consulting a doctor.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Children
Panadol Extra should not be given to children under 12 years of age.
Overdose of Panadol Extra
Paracetamol overdose may cause liver damage, which can lead to liver transplantation or death. Cases of acute pancreatitis have also been observed, usually associated with impaired liver function and liver damage.
In case of ingestion of more than the recommended dose, seek immediate medical advice even if the person feels well, because potentially life-threatening liver damage may occur, which can lead to liver transplantation or death. If less than one hour has passed since ingestion, induce vomiting. Alternatively, 60–100 g of activated charcoal may be taken orally, preferably mixed with water.
Missed dose of Panadol Extra
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 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 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, shedding of large sheets of the epidermis, and fever;
breathing difficulties, if similar problems occurred previously during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
unexplained bruising or bleeding;
liver function disorders. The above reactions are very rare, occurring in less than 1 in 10,000 patients.

Other adverse reactions.
Frequency of occurrence: "frequency unknown" (cannot be estimated from available data):

dizziness, headache, palpitations, insomnia, psychomotor agitation, anxiety, irritability, nervousness, gastrointestinal disturbances;
metabolic acidosis – a serious condition that may cause blood acidification in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 Extra

Do not dispose of medicines via the wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.

6. Contents of the pack and other information

What Panadol Extra contains

The active substances in this medicine are paracetamol and caffeine. One coated tablet contains 500 mg of paracetamol and 65 mg of caffeine.
The other ingredients are: pregelatinized starch, corn starch, povidone K 25, potassium sorbate, talc, stearic acid, sodium croscarmellose. The film-coat contains: hydroxypropylmethylcellulose, triacetin.

What Panadol Extra looks like and contents of the pack
Panadol Extra is a white, capsule-shaped, film-coated tablet with straight edges, embossed on one side with a triangle and a "+" sign, and smooth on the other side.
The pack contains 8, 10, 12 or 24 film-coated 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

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