Spasmonal 60mg

1. Name Of The Medicinal Product

SPASMONAL 60 mg

2. Qualitative And Quantitative Composition

Each capsule contains 60mg alverine citrate.

3. Pharmaceutical Form

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

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

Paralytic ileus or known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Possible side effects may include nausea, headache, dizziness, itching, rash, and allergic reactions. There have been isolated reports of jaundice due to hepatitis, which may have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize Starch

Magnesium Stearate

Capsule Shell:

Gelatin, E132, E171, E172

6.2 Incompatibilities

None stated.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Norgine Limited

Chaplin House

Widewater Place

Moorhall Road

Harefield

UXBRIDGE

Middlesex UB9 6NS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00322/5014R

9. Date Of First Authorisation/Renewal Of The Authorisation

June 1998

10. Date Of Revision Of The Text

Date: June 2009

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