Panadol Extra

Leaflet attached to the packaging: information for the user

Panadol Extra, 500 mg + 65 mg, coated tablets

Paracetamol + Caffeine

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, you may need to read it again.
• 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 their doctor.

Table of contents of the leaflet

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

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

Panadol Extra contains two active substances: paracetamol and caffeine. The therapeutic effect is the result of the combined action of the active substances.
Paracetamol has analgesic and antipyretic effects.
Caffeine has a stimulating effect on the central nervous system and enhances the analgesic effect of paracetamol.

Indications for use of Panadol Extra:

The medicine has an analgesic effect in headaches, throat pain, migraines, toothaches, bone, joint, and muscle pain, as well as menstrual pain. It can be used in colds and flu-like conditions. It has an antipyretic effect.

2. Important information before taking 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 alcoholism, severe liver or kidney failure, heart rhythm disorders, insomnia. The medicine should not be taken by children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol.

Do not take a higher dose than recommended, asparacetamol overdose can lead to severe liver damage.
The medicine should not be taken at the same time as other medicines available without a prescription or on a doctor's prescription, containing paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms, or sleep aids.
One should read the leaflet before taking the medicine and follow the recommendations contained therein.
During the use of Panadol Extra, the doctor should be informed immediately if the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2).

Before taking the medicine, consult a doctor in the following cases:

• liver or kidney failure,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• patients with low body weight or malnourished, suffering from anorexia,
• patients who regularly consume alcohol. It may be necessary to completely stop taking this medicine or reduce the dose.

Before taking the medicine, consult a doctor in the following cases:

• severe infection,
• patients with low body weight or malnourished, suffering from anorexia,
• patients who regularly consume alcohol, as this may increase the risk of liver failure and metabolic acidosis (see above).

Symptoms of liver failure include:

• loss of appetite, diarrhea, fever, skin rash,
• low blood pressure and rapid heart rate,
• nausea, vomiting, abdominal pain, jaundice, blood clotting disorders (bruises on the skin), changes in consciousness.

One should contact a doctor immediately if the patient experiences any of the above symptoms at the same time.
Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Panadol Extra and other medicines

The medicine contains paracetamol. Due to the risk of overdose, do not take with other medicines containing paracetamol.

One should tell the doctor or pharmacist about all medicines being taken by the patient, including those taken recently or planned to be taken.
One should consult a doctor when taking the following medicines:
metoclopramide, domperidone (used against nausea and vomiting), colestyramine (used to reduce high cholesterol levels in the blood), anticoagulant medicines (e.g., warfarin), in case of a need for long-term use of a painkiller, sleeping pills, antiepileptic medicines, anti-tuberculosis medicines, MAO inhibitors (medicines used in depression), estrogens, and progesterone (sex hormones), disulfiram (used in the treatment of alcoholism), non-steroidal anti-inflammatory medicines (e.g., acetylsalicylic acid).
This medicine is not recommended for people taking lithium salts (used in the treatment of depression, mania).
Paracetamol taken with MAO inhibitors may cause a state of excitement and high temperature.
One should not drink alcohol while taking this medicine due to the increased risk of liver damage. There is a particular risk of liver damage in malnourished patients and those who regularly drink alcohol.
The medicine contains caffeine. During the use of the medicine, one should avoid excessive consumption of caffeine (e.g., contained in coffee, tea, or some drinks). Excessive caffeine consumption may cause difficulty sleeping, tremors, and unpleasant feelings in the chest due to heart palpitations.
One should inform the 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 must be treated urgently (see section 2).

Panadol Extra with food, drink, and alcohol

One should not drink alcohol while taking this product due to the increased risk of liver damage.
In case the Panadol Extra medicine containing caffeine is taken in the recommended dose in combination with caffeine contained in food, it is possible to enhance the side effects associated with the increase in the total dose of caffeine, such as: insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disorders, heart palpitations.

Children

Panadol Extra should not be given to children under 12 years of age.

Pregnancy, breastfeeding, and fertility

Panadol Extra should not be taken during pregnancy and breastfeeding.

Driving and using machines

Panadol Extra has no influence or negligible influence on the ability to drive and use machines.
Warnings about excipients
The medicine contains less than 1 mmol (39 mg) of potassium per dose, which means that the medicine is considered "potassium-free".
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Panadol Extra

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

Adults and adolescents over 12 years of age

Orally, depending on the severity of the symptoms, 1-2 tablets, up to 4 times a day. The medicine should not be taken more often than every 4 hours or more than 4 doses (8 tablets) in 24 hours.
Do not take a higher dose than recommended.
One should always use the lowest effective dose of the medicine for the shortest possible time.
If the symptoms persist, one should consult a doctor.

Without consulting a doctor, the medicine should not be taken regularly for more than 3 days.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.
Children
Panadol Extra should not be given to children under 12 years of age.

Taking a higher dose of Panadol Extra than recommended

Paracetamol overdose may cause liver damage, which may result in liver transplantation or death. Cases of acute pancreatitis have also been observed, usually associated with liver dysfunction and liver damage.
In case of taking a higher dose than recommended, one should immediately seek medical advice, even if the patient's condition is good, as it may lead to life-threatening liver damage, which may result in liver transplantation or death. If it has been less than an hour since ingestion, one should induce vomiting. One can also take 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of Panadol Extra

One should 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.
One should stop taking the medicine and consult a doctor if:

• an allergic reaction (hypersensitivity) occurs, such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• a skin rash or severe skin reaction occurs, 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, widespread erosions on the skin, and fever,
• breathing problems occur, in case similar problems have occurred in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines,
• bruises or bleeding of unknown cause occur,
• liver function disorders occur. The above reactions are very rare, i.e., they occur in less than 1 in 10,000 patients.

Other side effects.
Frequency of occurrence: "frequency not known" (cannot be estimated from the available data):

• dizziness, headache, heart palpitations, insomnia, restlessness, anxiety, irritability, nervousness, gastrointestinal disorders;
• metabolic acidosis - a serious condition that can cause blood acidification, in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, one should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 to gather more information on the safety of the medicine.

5. How to store Panadol Extra

Medicines should not be disposed of via wastewater or household waste. One should ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The medicine should be stored out of sight and reach of children.
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 month stated.
Store in a temperature below 25°C.

6. Contents of the pack and other information

What Panadol Extra contains

• The active substances of the medicine are paracetamol and caffeine. One coated tablet contains 500 mg of paracetamol and 65 mg of caffeine.
• The other ingredients are: gelatin starch, corn starch, povidone K 25, potassium sorbate, talc, stearic acid, sodium croscarmellose. The coating contains: hypromellose, triacetin.

What Panadol Extra looks like and contents of the pack

Panadol Extra is a white, coated, capsule-shaped tablet with a flat edge, with a triangular embossing and a "+" sign on one side, and a smooth surface on the other.
The pack contains 8, 10, 12, or 24 coated tablets.

Marketing authorization 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

Date of last revision of the leaflet:

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