SPASMONAL 60 mg

Each capsule contains 60mg alverine citrate.

An opaque size 3 capsule with a grey cap and blue body, marked “SP 60”.

The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea

Recommended dose and dosage schedules:

Adults (including the elderly): 1or 2 capsules one to three times daily.

Children below the age of 12 years: not recommended.

• Paralytic ileus

• Known hypersensitivity to any of the ingredients.

• Intestinal obstruction

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 60 mg; 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 your symptoms worsen, or if they do not improve after 2 weeks treatment.

None stated.

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in Preclinical studies is limited.

May cause dizziness. Do not drive or use machinery if affected

Immune system disorders: Allergic reaction, anaphylaxis, dyspnoea and/or wheezing

Nervous system disorders: Headache, dizziness

Gastrointestinal disorders: Nausea

Hepato-biliary disorders: Jaundice due to hepatitis, typically this resolves on cessation of alverine

Skin and subcutaneous tissue disorders: Itching, rash

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

Fatality has occurred following overdose with very high doses.

Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic 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.

The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.

Although preclinical data are limited, those available indicate that alverine citrate has no significant potential for toxicity at the proposed dose level

Alverine citrate acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerably higher doses.

Maize Starch

Magnesium Stearate

Capsule Shell:

Gelatin, E132, E171, E172

None stated.

3 years.

Store in a dry place. Do not store above 25°C.

Plastic containers of 20 or 100 capsules; foil/UPVC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.

None.

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

PL 15142/0240

June 1998

September 2011

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