Panadol Extra Filmtablet 500 mg 10 pcs

What is Panadol Extra and when is it used?

Panadol Extra contains the pain-relieving active ingredient paracetamol and caffeine. Panadol Extra is used for the short-term treatment of mild to moderate headaches.

What precautions should be taken?

Like all painkillers, Panadol Extra should not be used for longer than 5 days without a doctor's prescription.

Painkillers should not be taken regularly over a long period of time without medical supervision. Long-lasting pain requires a medical evaluation.

The dosage indicated or prescribed by the doctor must not be exceeded.

To prevent the risk of overdose, it should be ensured that other medicines being taken at the same time (e.g. other painkillers, medicines for fever or cold symptoms) do not contain paracetamol.

An overdose of paracetamol can lead to severe liver damage.

It is also important to remember that long-term use of painkillers can itself contribute to headache persistence.

Long-term use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure.

When should Panadol Extra not be used?

Panadol Extra should not be used in the following cases:

• Hypersensitivity to the active ingredients paracetamol and caffeine and related substances (e.g. propacetamol or xanthine) or to one of the excipients (see «What does Panadol Extra contain?»). Such hypersensitivity manifests itself, for example, in asthma, shortness of breath, circulatory problems, swelling of the skin and mucous membranes or skin rashes (nettle fever).
• In severe liver diseases (e.g. acute hepatitis; liver cirrhosis; ascites, ie fluid accumulation in the abdominal cavity).
• In severe kidney disease.
• If you have a hereditary liver disorder (so-called Meulengracht disease).
• In case of alcohol overconsumption.
• Panadol Extra must not be used in children and adolescents under the age of 18.

When is caution required when taking Panadol Extra?

In the following cases, you should consult your doctor before taking:

• with previously damaged liver or kidneys;
• if you have a rare inherited disease of the red blood cells called “glucose-6-phosphate dehydrogenase deficiency”;
• with the simultaneous use of drugs that affect the liver;
• if you have a severe infection (e.g. blood poisoning);
• if you suffer from pulse irregularities (arrhythmia);
• if you are taking the following medicines:
  • blood-thinning medicines (e.g. Marcoumar)
  • cholestyramine (medicine to lower blood lipids)
  • chloramphenicol (medicine against infections)
  • Metoclopramide (medicine for nausea, vomiting)
  • phenytoin, phenobarbital, carbamazepine (medicines for epilepsy (seizures))
  • rifampicin, isoniazid (medicines for tuberculosis)
  • probenecid (medicine for gout)
  • salicylamide (medicine for pain and fever)
  • zidovudine (medicine for HIV infection (AIDS))
  • theophylline or aminophylline (medicines for asthma); the effects and side effects of these medicines are increased. There may be restlessness or palpitations.

It is not advisable to take paracetamol and alcohol at the same time. The risk of liver damage increases, especially if you do not eat at the same time.

Eating disorders such as anorexia, bulimia and severe emaciation as well as chronic malnutrition require caution when using Panadol Extra.

Caution should also be exercised in the event of dehydration and reduced amounts of blood.

Individuals who are hypersensitive to painkillers or antirheumatic drugs may also be hypersensitive to paracetamol (see «What side effects can Panadol Extra have?»).

In very rare cases, paracetamol can cause severe skin reactions (see «What side effects can Panadol Extra have?»).

Excessive consumption of caffeine in the form of coffee, tea or canned drinks containing caffeine should be avoided while taking Panadol Extra.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases
• have allergies or
• use other medicines (including those you bought yourself!)!

Can Panadol Extra be taken during pregnancy or while breastfeeding?

As a precaution, you should avoid taking medicines during pregnancy and breastfeeding or ask your doctor, pharmacist or druggist for advice.

During pregnancy there is an increased risk of spontaneous abortion in connection with the consumption of caffeine. Panadol Extra should therefore not be taken during pregnancy unless your doctor has given you express permission to do so.

Caffeine could affect the infant's condition and behavior and should therefore be avoided during breastfeeding. Talk to your doctor before taking Panadol Extra while breastfeeding.

How do you use Panadol Extra?

Administer single doses no more frequently than every 4 to 6 hours.

The specified maximum daily dose must not be exceeded.

To relieve symptoms, you should always take the lowest effective dose for the shortest possible time.

Adults (over 40 kg body weight):

1 to 2 film-coated tablets as required.

The maximum daily dose is 8 film-coated tablets (= 4 g paracetamol, 520 mg caffeine) within 24 hours.

Take the film-coated tablets with enough liquid after a meal.

Children and young people under the age of 18:

Children and adolescents should not take Panadol Extra.

Follow the dosage given in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Panadol Extra have?

Stop taking Panadol Extra and tell your doctor straight away if you experience one or more of the following symptoms, which may be signs of a rare allergic (hypersensitivity) reaction:

• skin rash (including hives, itching), skin reddening, skin peeling, very rarely up to severe skin reactions,
• swelling of the face, lips, tongue or throat, blistering, sore mouth, nausea,
• wheezing, asthma, shortness of breath, shortness of breath, especially if you have had this before with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• unexpected bruising or bleeding.

In rare cases (affects 1 to 10 users in 10,000) changes in blood counts such as a reduced number of blood platelets (thrombocytopenia) or a severe reduction in the number of certain white blood cells (agranulocytosis) have been observed.

The simultaneous intake of additional caffeine, for example through food, can increase potential side effects of caffeine such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal complaints and palpitations.

If you notice side effects, contact your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What should also be noted?

Durability

The medicinal product may only be used up to the date marked “EXP” on the container.

Storage Notice

Keep out of the reach of children.

Store at room temperature (15-25°C).

More information

In the event of uncontrolled intake (overdose), seek medical help immediately, even if you do not yet have any symptoms. Because of the potential risk of very serious liver damage, prompt medical attention is critical. Nausea, vomiting, abdominal pain, loss of appetite and a general feeling of illness can be an indication of an overdose, but only occur several hours to a day after ingestion.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What is in Panadol Extra?

1 film-coated tablet contains:

Active Ingredients

500 mg paracetamol and 65 mg caffeine.

Excipients

Pregelatinized Starch, Povidone K25, Calcium Carbonate, Crospovidone, Alginic Acid, Magnesium Stearate, Microcrystalline Cellulose, Coating: Titanium Dioxide (E171), Hypromellose, Macrogol 400, Polysorbate 80, Carnauba Wax.

Registration Number

56279 (Swissmedic).

Where can you get Panadol Extra? What packs are available?

In pharmacies and drugstores, without medical prescription.

Packs of 10 film-coated tablets.

Marketing Authorization Holder

GSK Consumer Healthcare Schweiz AG, Risch.