Mexalen 500 mg - Tablets

How is it applied?

What are Mexalen 500 mg tablets and what are they used for?

Mexalen 500 mg tablets contain the analgesic and antipyretic paracetamol.

Mexalen 500 mg tablets are used for:

• mild to moderately severe pain (such as headache, toothache, menstrual pain)
• Fever and pain in colds and flu infections
.

If you do not feel better or even worse after 3 days, consult your doctor.

What should you pay attention to before taking it?

What precautions should you take before using Mexalen 500 mg Tablets?

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. other ingredients mentioned in section 6 of this medicine
- if you have a severe impairment of liver function
- if you have a certain hereditary metabolic disorder (glucose-6-phosphate dehydrogenase deficiency)
- if you are a chronic alcoholic
- of children under 6 years of age (see section 3 "How to take Mexalen 500 mg tablets").")

Warnings and Precautions
Please talk to your doctor or pharmacist before taking Mexalen 500 mg Tablets
:
- if you drink alcohol excessively (increasing the liver-damaging effect)
- if you have an impairment of liver function, such as liver inflammationliver inflammation or a congenital disease with jaundice (Gilbert's syndrome)
- in the case of pronounced kidney dysfunction
- in the case of chronic malnutrition or malnutrition
- in the case of malnutrition
- the occurrence of certain urinary stones (due to an increase in oxalic acid in the urine)

As medical supervision is required in these cases during the use of Mexalen 500 mg Tablets, please inform the doctor accordingly if necessary.
To avoid the risk of overdose, ensure that any medicinal products taken at the same time do not contain paracetamol.

Exceeding the recommended dose may cause kidney damage and very severe liver damage. An antidote must then be given as soon as possible (see section 3).

In patients with glutathione deficiency (certain metabolic disorder), the use of paracetamol may increase the risk of metabolic acidosis (over-acidification of the body).

General information on painkillers:

Possible concomitant diseases
If fever persists, signs of a (second) infection or symptoms persist for more than three days, medical supervision is required.

Painkiller headache
Prolonged high-dose, non-intended use of painkillers may cause headache, which must not be treated by increased doses of the medicine.

Kidney damage
In general, habitual use of painkillers, especially when combined with several analgesic agents, can lead to permanent kidney damage with the risk of kidney failure.

Discontinuation of painkillers
If discontinued abruptly after prolonged high-dose (not intended) use of painkillers, headaches as well as fatigue, muscle pain, nervousness and vegetative symptoms (such as e.g. tendency to sweat, dizziness) may occur.(e.g. tendency to sweat, dizziness, trembling, palpitations). These complaints subside within a few days. Until then, do not take painkillers again and do not take them again without medical advice.

Taking Mexalen 500 mg Tablets with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Combination of paracetamol (the active substance

Drugs which, due to their properties
have an effect on the liver such as
liver damage
tuberculosis drugs (rifampicin ) or drugs
against epilepsy

Certain medicines for pain and fever
(salicylamides) delayed excretion of paracetamol

The breakdown of paracetamol may be slowed Certain medicine for gout
, the dose of Mexalen 500 mg should therefore be (probenecid)
reduced.

Determined antibiotic = medicine against
The breakdown of the antibiotic may be delayed infections (chloramphenicol )
(increased side effects possible).

The tendency to a reduction in white blood cells (neutropenia) is increased. Certain medicines for infections with
Mexalene should therefore only be taken with zidovudine
on the advice of a doctor.

Determined medicinal product for gastrointestinal
increased blood levels of paracetamol
ulcers (nizatidine)

Determined medicinal product for gastrointestinal
increased availability of paracetamol complaints (cisapride)

Determined medicine for epilepsy or
depression (lamotrigine) decreased availability of lamotrigine

Medicines to delay
absorption and onset of action of paracetamol gastric emptying (e.g. propantheline)may be delayed.

Medicinal products that lead to an acceleration of the
absorption and onset of action of paracetamol stomach emptying (e.g. Metoclopramide)
may be accelerated.

Determined agent for lowering increased
absorption and effectiveness of paracetamol blood fat levels (cholestyramine)
may be decreased.

Liver damage (see section "2. What alcohol
must you be aware of before taking Mexalen 500 mg?")

Effects on laboratory tests:
Taking paracetamol may affect laboratory tests, such as uric acid determination, as well as blood sugar determination.

Taking Mexalen 500 mg Tablets with food, drink and alcohol
You must not drink alcohol while taking Mexalen 500 mg Tablets.
Taking after meals may delay the onset of action.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
If necessary, Mexalen 500 mg Tablets may be taken during pregnancy after strict consideration of the risk-benefit balance. Your doctor will therefore decide whether you should use it during pregnancy. You should use the lowest possible dose that relieves your pain and/or fever and you should use the medicine for the shortest possible period of time and not in combination with other medicines. Contact your doctor or midwife if the pain and/or fever are not relieved or if you need to take the medicine more often.

Lactation:
Paracetamol passes into breast milk. Since adverse effects on the infant have not
been reported, interruption of breast-feeding will not usually be necessary.
However, the dosage should be kept as low as possible and the duration of use as short as possible.

Driving and ability to operate machinery

Paracetamol, the active substance in Mexalen 500 mg Tablets, does not affect the ability to drive or operate machinery. Nevertheless, caution is always advised after taking a painkiller because of possible side effects.

Mexalen 500 mg tablets contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is
almost "sodium-free".

How should the medicine be taken?

How to take Mexalen 500 mg Tablets?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

Dosage

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

The interval between two doses should be at least 6 hours.

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

Adults and adolescents aged 12 years and over (and weighing at least 43 kg):
1 tablet up to a maximum of 4 times daily
The maximum daily dose of 4 tablets (corresponding to 2000 mg paracetamol) must not be exceeded.

Children from the completed 6th to the completed 12th year of age
½ tablet up to 3 times daily.

Children under 6 years
Mexalene 500 mg tablets are not suitable for children under 6 years of age. Suitable other dosage forms with lower active ingredient content are available for them. Please seek advice on this from your doctor or pharmacist.

Older patients (65 years and over)
No special dose adjustment based on age is required. In case of underweight
and organ dysfunction, please follow appropriate instructions.
Patients with liver dysfunction
In patients with liver dysfunction and Gilbert's syndrome (a congenital disease), the dose must be reduced or the dose interval (= the time interval between 2 doses) must be extended.

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

Type and duration of use
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.

If you have taken a larger amount of Mexalen 500 mg tablets than you should

To prevent the risk of an overdose, make sure that other medicines used at the same time do not contain paracetamol!

In the event of an overdose, symptoms such as nausea, vomiting, loss of appetite, paleness and abdominal pain generally occur within 24 hours.

A risk of poisoning exists in particular in elderly people, small children, persons with liver diseases, chronic alcohol abuse, chronic malnutrition or undernourishment and in the simultaneous intake of medicinal products which have an effect on liver function.

If you have taken a larger amount of Mexalen 500 mg Tablets than recommended, call a doctor immediately for help!

For doctors: Information on the treatment of an overdose with paracetamol can be found at the end of this leaflet!

If you forget to take Mexalen 500 mg Tablets
Do not take twice the amount if you have forgotten to take it before.
Take the next dose at the usual time.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How to store Mexalen 500 mg tablets?

No special storage conditions are required for this medicine.

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

HOW TO STORE MEXALEN 500 MG TABLETS?

No special storage conditions are required for this medicine.

Store the medicine out of the reach of children!

You must not use the medicine after the expiry date which is stated on the outer carton after ,,EXP". The expiry date refers to the last day of the month.

The medicinal product must not be disposed of in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

Special notes on the content

Contents of the pack and other information

What Mexalen 500 mg tablets contain

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

The other ingredients are:
Povidone, croscarmellose sodium, maize starch, talc, microcrystalline cellulose, highly dispersed silicon dioxide, magnesium stearate.
What Mexalen 500 mg Tablets look like and contents of the pack

Mexalen 500 mg Tablets are white, round tablets, domed on both sides, with a break notch on one side.
The tablets can be divided into equal doses.

Mexalene 500 mg tablets are available in blister packs of 10, 20, 30, 50 and 60.