Melabiorym B6 MAX, 6 mg + 20 mg, 30 tablets

Melabiorytm B6 MAX contains two active substances – melatonin and pyridoxine hydrochloride (vitamin B6).

Melatonin is a hormone produced in the body by the pineal gland, located in the central nervous system. This hormone plays an important role in regulating the biological circadian rhythm. It regulates the hours of sleep and wakefulness during the day. Vitamin B6 is involved in the body’s metabolic processes. A dose of 20 mg of pyridoxine hydrochloride is greater than the daily requirement for vitamin B6. Vitamin B6 deficiency is associated with a significant decrease in the production of melatonin in the body, while the administration of vitamin B6 stimulates the secretion of melatonin.

Melabiorytm B6 MAX is indicated as an aid in sleep disorders related to time zone changes or shift work.

The active substances of the drug are: melatonin, pyridoxine hydrochloride. Each tablet contains 6 mg of melatonin and 20 mg of pyridoxine hydrochloride.

The other ingredients are: microcrystalline cellulose, sorbitol, macrogol, sodium stearyl fumarate.

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

The lowest effective dose of melatonin should be used and, if necessary, another melatonin medicine should be used that provides the option of taking a different (e.g. lower) dose.

The tablets should be taken orally with water. The tablet can be divided into equal doses.

Adults
For time-zone sleep disorders:
half a tablet or 1 tablet once daily, after dark, starting on the first day
of travel. Continue treatment for 2 to 3 more days after the end of travel.

In circadian sleep-wake rhythm disorders associated with, for example, shift work:
half a tablet or 1 tablet an hour before bedtime.

The effects of the drug are observed gradually, sometimes only after two weeks of use.

Patients with liver or kidney problems
This medicine should not be used in patients with liver or kidney problems.

Elderly people
Dose adjustment is not necessary in elderly people (over 65 years of age).

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

Taking more than the recommended dose of Melabiorytm B6 MAX
If you take more than the recommended dose of the drug, you should immediately contact your doctor or pharmacist.
Taking more than the recommended daily dose of the drug may in individual cases cause drowsiness, disorientation or psychosis.
Taking large doses of vitamin B6 may lead to gastrointestinal disorders, folic acid deficiency and cause skin reactions.

If you miss a dose of Melabiorytm B6 MAX
Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

This medicine should not be used in children and adolescents aged 0 to 18 years.

When not to take Melabiorytm B6 MAX:

• if you are allergic to melatonin, pyridoxine hydrochloride or any of the other ingredients of this medicine;
• in children and adolescents up to 18 years of age;
• during pregnancy and breastfeeding;
• if you have liver or kidney problems;
• if you have depression;
• if you have Parkinson’s disease and are treated with L-dopa without using a peripheral levodopa decarboxylase inhibitor.