Meda Health Sales

Spasmonal 60mg hard Capsules

Spasmonal contains the following active ingredient:

Alverine Citrate 60 mg per capsule

For a full list of excipients see section 6.1

Hard capsules.

Hard gelatin size 3 capsules for oral administration. Each blue/grey opaque capsule is marked 'SP60'

Spasmonal is indicated for 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:

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

Use during pregnancy and lactation.

Additional warnings to be included on 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 60mg; 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 of treatment.

None known

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 acetylcholine, histamine or 5-hydroxytryptamine. It acts selectively on gut and uterine muscle, only affecting the heart, blood vessels and tracheal muscle at considerable 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 (El32)

Titanium Dioxide (El71)

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 packs containing 3 or 100 capsules.

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 1332/41/1

Date of first authorisation: 18th October 1993

Date of last renewal: 18th October 2008

February 2012