PARA-DENK 500 Tablet

- If you or your child are allergic to paracetamol or any of the other ingredients of this medicine.

Hepatobiliary disorders

Reports of a slight rise in certain liver enzymes (serum transaminase) were rare.

Immune system disorders

In very rare cases, there may be allergic reactions that are manifested by a simple rash or urticaria, and eventually shock. In the case of an allergic shock reaction, ask your nearest doctor to come to your assistance.

Another very rare occurrence is the triggering of a constriction of the respiratory tract (analgesic-induced asthma) in predisposed people.

Blood and lymphatic system disorders

Changes in blood count have been reported on very rare occasions as have a reduced number of blood platelets (thrombocytopenia) or a reduction in the number of certain white blood cells (agranulocytosis).

Skin and subcutaneous tissue disorders

Very rare cases of serious skin reactions have been reported.

Interactions are possible with:

- Drugs to treat gout, such as probenecide

- Sleeping pills, such as phenobarbital; drugs to treat epilepsy, such as phenytoin, carbamazepine; drugs to treat tuberculosis (rifampicin) and other drugs that may cause damage to the liver

- Drugs to reduce elevated serum lipids (cholestyramine)

- Drugs given for HIV infections (zidovudine)

- Drugs for nausea (metoclopramide and domperidone)

- Concomitant intake of substances that delay gastric emptying.

- Laboratory tests: Uric acid and blood sugar determination may be affected.

- This tablet should not be taken or administered with alcohol.

Pregnancy

This tablet should only be used during pregnancy after careful consideration of the potential benefits and risks.

This tablet should not be taken over a long period of time during pregnancy, in high doses or in combination with other drugs, as its safety has not been proven in such cases.

Breast-feeding

Paracetamol passes into human milk. As it is not known to be harmful for the infant, discontinuation of breast-feeding is generally not necessary.

- If you or your child suffer from chronic alcoholism

- If you or your child suffer from impaired liver function (such as inflammation of the liver, Gilbert’s syndrome)

- If you or your child have pre-existing kidney damage

- If you or your child suffer from diseases accompanied by reduced glutathione levels (if necessary dose adjustment e.g. for diabetes mellitus, HIV, Down syndrome, tumors).

If the symptoms get worse or if you do not notice an improvement after 3 days or if you develop a high temperature, then you or your child must consult your doctor.

In order to avoid the risk of an over-dose, one should make sure that other medication being taken concurrently does not contain paracetamol.

Prolonged, incorrect use of high doses of painkillers, particularly in combination with other painkillers, may lead to permanent kidney damage associated with the risk of renal failure (analgesic nephropathy).

If high doses of painkillers, that have been incorrectly used for prolonged periods of time, are discontinued abruptly, headache, fatigue, muscle pain, nervousness or vegetative symptoms may occur. These withdrawal symptoms abate within a few days. Until then, painkillers should not be used and should not be taken again without consulting your doctor beforehand.

This tablet should not be used over long periods or in high doses without consulting your doctor or dentist.

Pharmacotherapeutic group: Analgesic and antipyretic, anilide.

The analgesic and antipyretic mechanism of action of paracetamol has not been clearly resolved. A central and peripheral effect is probable. Pronounced inhibition of cerebral prostaglandin synthesis is only mildly inhibited. Furthermore, paracetamol inhibits the effect of endogenous pyrogen on the hypothalamic temperature regulation centre.