Meda Health Sales

Spasmonal Forte 120mg Hard capsules

Each capsule contains 120mg alverine citrate.

For a full list of excipients see Section 6.1.

Hard capsules

Hard gelatin size 1 capsule for oral administration. Each blue/grey opaque capsule is marked 'SP120'.

Spasmonal Forte 120mg is indicated for the use in the relief of smooth muscle spasm, in conditions such as irritable bowel syndrome and painful diverticular disease of the colon.

Recommended dose and dosage schedules:

Adults (including the elderly): 1 capsule one to three times daily.

Children below the age of 12 years: not recommended.

Cases of Paralytic ileus or known hypersensitivity to any of the ingredients.

Use during pregnancy and lactation.

Additional warnings to be included in the Patient Information Leaflet:

If this is the first time you have had these symptoms, consult your doctor before using any treatment.

If any of the following apply do not use SPASMONAL FORTE 120mg; it may not be the right treatment for you. See your doctor as soon as possible if:

− you are aged 40 years or over

− you have passed blood from the bowel

− you are feeling sick or vomiting

− you have lost your appetite or lost weight

− you are looking pale and feeling tired

− you are suffering from severe constipation

− you have a fever

− you have recently travelled abroad

− you are or may be pregnant

− you have abnormal vaginal bleeding or discharge

− you have difficulty or pain passing urine

−

Consult your doctor if you have developed new symptoms, or if you or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

None stated.

Use contraindicated during pregnancy and lactation.

None.

Possible side effects may include nausea, headache, dizziness, itching, rash, and allergic reactions, including anaphylaxis.

There have been isolated cases of jaundice due to hepatitis, which may have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.

Can produce hypotension and atropine-like toxic effects. Management is as for atropine poisoning with supportive therapy for hypotension.

Alverine citrate is a spasmolytic effective on smooth muscle of the alimentary tract. It is non-specific in that it is equally effective in reducing muscular contractions induced by acetyl choline, histamine or 5-hydroxytryptamine. It acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.

After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites.

There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing

Preclinical studies provide evidence that alverine citrate has no significant systemic toxicity potential at the proposed dosage.

Maize Starch

Magnesium Stearate

Capsule shell:

Gelatin

Indigo Carmine - (E132)

Titanium Dioxide - (E171)

Black Iron Oxide - (E172)

Not applicable.

3 years.

Do not store above 25°C. Store in the original container in order to protect from light.

Cartons of aluminium foil UPVC/PVDC blister strips containing 2, 10, 20, 30, 60 or 90 capsules, in strips of 10 capsules as appropriate.

Not all pack sizes may be marketed.

No special requirements.

Meda Health Sales Ireland Limited

Unit 34/35 Block A,

Dunboyne Business Park

Dunboyne

Co. Meath

PA 1332/41/2

Date of first authorisation: 14 April 2000

Date of last renewal: 18 October 2008

January 2012