Despasm

INSTRUCTIONS TO THE PATIENT

- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

- The doctor and the pharmacist are experts in medicine, its benefits and risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

Council of Arab Health Ministers

Union of Arab Pharmacists

RESTRICTIONS ON USE :

Contraindications

Hypersensitivity to Mebeverine.

Effects on the capacity to drive vehicles or use machines

Occasionally, Mebeverine may cause dizziness which effect on the ability to

drive vehicles or use machines.

Use in pregnancy and lactation

It should be administered with caution during pregnancy. Mebeverine is not

excreted in milk of lactating women after therapeutic doses.

ADVERSE EFFECTS :

In general Mebeverine is well tolerated. In very rare cases allergic reactions

appear as exanthem or urticaria and dizziness have been reported.

OVERDOSAGE :

Mebeverine may cause CNS excitability in case of overdosage. Gastric lavage

and symptomatic treatment is recommended.

STORAGE INSTRUCTIONS:

Despasm Tablets : Store below 30oC in a dry place.Protect from light.

Despasm Retard Capsules : Store below 25oC in a dry place.Protect from

light.

PRESENTATIONS:

Despasm Tablets : Blister pack of 20 tablets and hospital packs of

different sizes.

Despasm Retard Capsules : Blister pack of 20 capsules and hostpital pack

of different sizes.

COMPOSITION :

Despasm :

Each f/c tablet contains : Mebeverine HCl B.P. 135 mg.

Despasm Retard :

Each Capsule contains : Mebeverine HCl 200 mg

(as sustained release pellets).

DESCRIPTION:

Despasm (Mebeverine HCl) is an antispasmodic with direct action on the

smooth muscle of the gastro-intestinal tract. Its action not mediated by the

autonomic nervous system and the anticholinergic side effects not occur. It is

completely metabolised by hydrolysis and the metabolites are excreted in the

urine. Despasm tablets rapidly absorbed after oral doses with peak plasma

concentrations occuring in 1 to 3 hours and 75% of Mebeverine bound to

albumin in plasma.

Despasm Retard capsules are prolonged release formulation.

INDICATIONS:

- Symptomatic treatment of abdominal pain and cramps.

- Intestinal discomfort related to irritable bowel syndrome.

- Gastro-intestinal spasm.

DOSAGE AND ADMINISTRATION:

Despasm tablets : The usual dose is one tablet three times daily, taken 20

minutes before meals with water.