Panadol Extra

Panadol Extra contains 2 active ingredients: paracetamol and caffeine. The therapeutic effect of the preparation is the result of the combined action of active substances. Paracetamol has an analgesic and antipyretic effect. Caffeine stimulates the central nervous system and enhances the analgesic effect of paracetamol.

Effects

The drug has an analgesic effect in headaches, sore throats, migraines, toothaches, bone, joint and muscle pains and menstrual pains. Panadol Extra can be used in colds and flu-like conditions. It has an antipyretic effect.

Active substance: Coffeinum, Paracetamolum

Composition

The active substance	Each film-coated tablet contains 500 mg of paracetamol and 65 mg of caffeine.
the other ingredients	pregelatinized starch, corn starch, povidone (K 25), potassium sorbate, talc, stearic acid, croscarmellose sodium. The coating contains: hydroxypropyl methylcellulose, triacetin.

Dosage

Always use this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

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. Do not take the medicine more frequently than every 4 hours or take more than 4 doses (8 tablets) in 24 hours.
• Do not use more than the recommended dose.
• Always use the lowest effective dose for the shortest possible time.
• Without consulting a doctor, the drug should not be used regularly for more than 3 days.

If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

Usage in children

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

Contraindications

When not to take Panadol Extra:

• if you are allergic to paracetamol, caffeine or any of the other ingredients of this medicine
• in the case of alcoholism, severe liver or kidney failure, heart rhythm disorders, insomnia.

Do not give the drug to children under 12 years of age.

Contents

12 film-coated tablets

Storage method

15°C-25°C

Manufacturer

GLAXOSMITHKLINE

Warnings

This is medicine. For safety, use it according to the leaflet attached to the package. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Do not use a higher dose than recommended because an overdose of paracetamol can lead to severe liver damage.

The drug should not be used simultaneously with other drugs available without a prescription or with a doctor’s prescription containing paracetamol, such as analgesics, antipyretics, used to treat the symptoms of flu and colds, to help falling asleep.

Read the leaflet before using the medicine and follow the instructions contained therein.

Before using the drug, consult a doctor in the case of:

• liver and kidney failure,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• patients who are underweight or malnourished, suffering from anorexia,

• patients who regularly consume alcohol.

You may need to stop taking this medicine altogether or reduce your dose.

Before using the drug, consult a doctor in the case of:

• severe infection
• patients who are underweight or malnourished, suffering from anorexia,
• patients who regularly consume alcohol as this may increase the risk of hepatic failure and metabolic acidosis.

Symptoms of liver failure include:

• loss of appetite, diarrhoea, fever, skin rash
• low blood pressure and fast heart rate
• nausea, vomiting, distension under the ribs on the right side of the abdomen, jaundice, blood clotting disorders (petechiae on the skin), impaired consciousness

Symptoms of metabolic acidosis include:

• deep, fast and labored breathing
• feeling sick, vomiting and loss of appetite,
• feeling generally unwell.

Contact your doctor immediately if you experience any of the above symptoms at the same time.

Panadol Extra with food, drink and alcohol

Do not drink alcohol while taking the product due to the increased risk of liver damage.

If Panadol Extra containing i.a. caffeine will be administered in the recommended dosage in combination with caffeine contained in food, it is possible to increase the side effects associated with the increase in the total dose of caffeine, such as: insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disorders, palpitations.

Pregnancy and breastfeeding
Panadol Extra should not be used during pregnancy and breastfeeding.

Driving
Panadol Extra has no or negligible influence on the ability to drive and use machines.

Overdosage

Paracetamol overdose can cause liver damage, which may result in liver transplantation or death. Cases of acute pancreatitis, usually associated with hepatic dysfunction and liver injury, have also been reported.

If you take more than the recommended dose, seek medical advice immediately, even if you feel well, as life-threatening liver damage may occur, which may result in liver transplantation or death. Vomiting should be induced if less than an hour has elapsed since ingestion. You can also take 60-100 g of activated charcoal
orally, preferably mixed with water.

Interactions with other drugs

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

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to use.

• Consult your doctor if you are taking the following medicines: metoclopramide, domperidone (used to treat nausea and vomiting), cholestyramine (used to reduce high blood cholesterol), anticoagulants (including warfarin) if you need long-term pain relief medicine, sleeping pills, anti-epileptic drugs, anti-tuberculosis drugs, MAO inhibitors (drugs used in depression), estrogens and progesterone (sex hormones), disulfiram (used, among others, in the treatment of alcoholism), non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).
• This medicine is not recommended for people taking lithium salts (used, among others, to treat depression, mania).
• The use of paracetamol may cause false results in some laboratory tests (e.g. determination of blood glucose).
• Paracetamol used simultaneously with MAO inhibitors can cause a state of agitation and high temperature.
• You should not drink alcohol while taking this medicine due to the increased risk of liver damage. Patients who are malnourished and regularly drink alcohol are at particular risk of liver damage.
• The medicine contains caffeine. Excessive consumption of caffeine (e.g. contained in coffee, tea or some beverages) should be avoided while using the drug. Excessive caffeine consumption can cause difficulty falling asleep, jitteriness and an uncomfortable feeling in the chest due to palpitations. If symptoms persist, consult your doctor.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using the medicine immediately and contact your doctor if you experience:

• allergic reaction such as skin rash or itchy skin, sometimes with difficulty breathing or swelling of the lips, tongue, throat or face
• skin rash or severe skin reaction with severe generalized pustular rash or blisters and sores on the skin, mouth, eyes and genitals, fever and joint pain or giant blisters bursting under the skin, widespread sores on the skin, peeling of large patches of skin and fever ,
• breathing problems if you have had similar problems in the past while taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
• unexplained bruising or bleeding
• liver dysfunction.

These reactions are very rare, i.e. less than 1 in 10,000 patients.

Other side effects:

• dizziness, headache, palpitations, insomnia, restlessness, anxiety, irritability, nervousness, gastrointestinal disorders.

These reactions occur at an unknown frequency (cannot be estimated from the available data).

Reporting Adverse Reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.