MIOREL GE Capsule

This medicine is a muscle relaxant. It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions. It is to be used for acute conditions related to spinal column.

Dosage

8mg every 12 hours. The treatment duration is limited to 7 consecutive days.

Do not exceed the recommended doses and treatment duration.

This medicine should not be used for long-term treatment.

Use in children and adolescents

Do not give this medicine to children and adolescents below 16 years old because of safety concerns.

If your doctor has informed you that you are intolerant to certain sugars, contact him or her before taking this medicine.

- if you are allergic to thiocolchicoside, colchicine, or any of the other ingredients of this medicine.

- if you are pregnant might become pregnant or think you may be pregnant.

- if you are woman of childbearing potential not using contraception.

- if you are breast feeding.

Common

- Digestive problems such as diarrhoea and stomach pain.

- Drowsiness.

Uncommon

- Digestive problems such as nausea and vomiting.

- Drowsiness.

Rare

- Allergic reactions such as hives.

Unknown

- Allergic reactions such as Quincke’s oedema (sudden swelling of the neck and face that can make it difficult to breathe). It can also cause anaphylactic shock (severe allergic reaction endangering the patient with sudden discomfort and a significant drop in blood pressure, which can be preceded by a rash of pimples, itching, redness on the skin, difficulty breathing, swelling of the face and/or neck).

- Convulsions or recurrences of seizures in epileptic patients.

- Liver damage *hepatitis).

Contraindicated. (See the package insert about the details.)

Use with caution in the event of a history of epilepsy or convulsions.

If convulsive episodes occur, the treatment must be discontinued.

If you notice symptoms that could indicate liver damage while being treated with MIOREL (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice, pruritus), you must stop taking MIOREL and immediately seek medical advice if one of the symptoms occurs.

You should not use this medicine at higher dose or for longer than 7 days. This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes). This has been shown in studies in animals and in laboratory studies. In humans, this type of damage to cells is a risk factor for cancer, harm to unborn child, and impairment of male fertility.

Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy.

Notify your doctor if you have:

- seizures.

- diarrhoea. Your doctor might adjust the dosage.

- stomach pain, nausea, vomiting.

Pharmacotherapeutic group: muscle relaxant.