Mexalen 500 mg tablets

Mexalen 500 mg tablets contain the active ingredient paracetamol, which relieves pain and reduces fever.

Mexalen 500 mg tablets are used in:

• mild to moderate pain (such as headache, toothache, period pain)
• Fever and pain associated with colds and flu infections

If you do not feel better or if you feel worse after 3 days, contact your doctor

Contraindications

Mexalen 500 mg tablets must not be taken:

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe liver impairment
• if you suffer from a certain hereditary metabolic disorder (deficiency of glucose6-phosphate dehydrogenase)
• if you are chronically alcoholic
• by children under 6 years of age (see section 3 “How to take Mexalen 500 mg tablets?”)

interactions

Combination of paracetamol (the active substance in Mexalen 500 mg tablets) with: Possible interactions

• Medicines that have an effect on the liver due to their properties, such as: tuberculosis medicines (rifampicin) or medicines for epilepsy liver damage
• Anticoagulants (“anticoagulants”) such as warfarin or fluindione The anticoagulant effect can be increased with prolonged use (more than a week).
• Certain medicines for pain and fever (salicylamide) delay the elimination of paracetamol
• Certain medicines for gout (Probenecid) The breakdown of paracetamol may be slowed down; the dose of Mexalen 500 mg should therefore be reduced.
• Certain antibiotics = drugs against infections (chloramphenicol) The breakdown of the antibiotic can be delayed (increased side effects possible).
• Certain medicines used to treat HIV infection (zidovudine) The tendency to have a reduced number of white blood cells (neutropenia) is increased. Mexalen should therefore only be taken concomitantly with zidovudine on medical advice.
• Certain medicines for stomach ulcers (nizatidine) increased blood levels of paracetamol
• Certain medicines for gastrointestinal complaints (cisapride) increase the availability of paracetamol
• Certain medicines for epilepsy or depression (lamotrigine) reduced availability of lamotrigine
• Drugs that delay gastric emptying (e.g. propantheline) The absorption and onset of action of paracetamol can be delayed.
• Drugs that accelerate gastric emptying (e.g. metoclopramide) The absorption and onset of action of paracetamol can be accelerated.
• Certain medicines used to lower high levels of fat in the blood (cholestyramine) Paracetamol absorption and effectiveness may be reduced.
• Alcohol Liver damage (see section "2. What you need to know before you take Mexalen 500 mg?")

Effects on laboratory tests:
Taking paracetamol can affect laboratory tests such as uric acid tests and blood sugar tests.

Taking Mexalen 500 mg tablets with food, drink and alcohol
Do not drink alcohol while taking Mexalen 500 mg tablets. Taking it after meals may delay the onset of action.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
If necessary, Mexalen 500 mg tablets can be taken during pregnancy after careful consideration of the risk/benefit ratio. Your doctor will therefore decide whether to use it during pregnancy. You should use the lowest dose that relieves your pain and/or fever and you should use the medicine for the shortest possible time and not in combination with other medicines. Contact your doctor or midwife if the pain and/or fever does not go away or you need to take the medicine more often.

Breast-feeding:
Paracetamol passes into breast milk. Since adverse consequences for the infant have not yet become known, it will not usually be necessary to interrupt breastfeeding. However, the dosage should be kept as low as possible and the duration of use should be kept as short as possible. 

application

In principle, painkillers should be dosed as little as is necessary for a sufficient effect - in order to keep the risk of the occurrence of undesirable effects as small as possible.

The time interval between two intakes should be at least 6 hours.

Unless otherwise prescribed by the doctor, the recommended dose is:

Adults and adolescents from 12 years (and at least 43 kg body weight):
1 tablet up to 4 times a day
. The maximum daily dose of 4 tablets (equivalent to 2000 mg paracetamol) must not be exceeded.

Children from the age of 6 up to the age of 12
½ tablet up to 3 times a day.

Children under 6 years of age
Mexalen 500 mg tablets are not suitable for children under 6 years of age. Other suitable dosage forms with a lower active ingredient content are available for them. Please ask your doctor or pharmacist for advice on this.

Elderly (65 years and older)
No specific dose adjustment is required based on age. In the case of underweight and organ dysfunction, please follow the relevant instructions.

Patients with liver dysfunction
In patients with liver dysfunction and Gilbert's syndrome (an inherited disease), the dose must be reduced or the dose interval (= the interval between 2 doses) increased.

Patients with renal dysfunction
In the case of severe renal dysfunction, a dosing interval (= the interval between 2 intakes) of at least 8 hours must be observed.

Type and duration of administration Take the
tablets with sufficient liquid (preferably a glass of drinking water).

The duration of use should be limited to the duration of the illness.
If the symptoms persist for more than 3 days, a doctor must be consulted. 

side effects

Rare side effects (may affect up to 1 in 1,000 people)

• Increase in certain liver values

Very rare side effects (may affect up to 1 in 10,000 people)

• changes in blood counts (reduction in all blood cells, reduction in the number of blood platelets, or severe reduction in the number of certain white blood cells); certain disorders of the red blood pigment (methaemoglobinemia)
• in sensitive people, asthma-like narrowing of the airways, hypersensitivity reactions ranging from simple reddening of the skin or urticaria (nettle rash) to a shock reaction with circulatory failure.
• Serious inflammatory skin reactions with blistering such as acute generalized exanthematous pustulosis (AGEP), erythema multiforme (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome)

Side effects with frequency not known (cannot be estimated from the available data)

• liver damage
• skin rash

composition

The active substance is: paracetamol
1 tablet contains 500 mg paracetamol.

The other ingredients are: povidone, croscarmellose sodium, maize starch, talc, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

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