AUDMONAL 60MG CAPSULES
Active substance(s): ALVERINE CITRATE
NAME OF THE MEDICINAL PRODUCT
Audmonal 60 mg Capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60mg alverine citrate
For a full list of excipients, see section 6.1.
Capsule, hard (Capsule).
A Grey/Blue, size '3' hard gelatin capsules printed with ‘AV’ on cap and ‘60’ on
body, containing white to off white powder.
The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome,
painful diverticular disease of the colon and primary dysmenorrhoea
Posology and method of administration
Recommended dose and dosage schedules:
Adults (including the elderly): 1 or 2 capsules one to three times daily.
Children below the age of 12 years: not recommended.
Paralytic ileus or known hypersensitivity to any of the ingredients.
Use during pregnancy and lactation.
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
If any of the following apply do not use Audmonal Capsules; 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 are suffering from severe
- 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.
Interaction with other medicinal products and other forms of interaction
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. Use is
therefore contraindicated during pregnancy and lactation.
Effects on ability to drive and use machines
May cause dizziness. Do not drive or use machinery if affected
Immune system disorders: Allergic reaction, anaphylaxis, dyspnoea and/or
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
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.
Preclinical safety data
Preclinical studies provide evidence that alverine citrate has no significant systemic
toxicity potential at the proposed dosage.
List of excipients
Pregelatinised Starch (Starch 1500)
Capsule shell Cap
Black Iron Oxide
Capsule Shell Body
Printing Ink Composition
Strong Ammonia Solution
Black Iron Oxide (E172)
Special precautions for storage
Do not store above 25°C. Store in the original packaging.
Nature and contents of container
Tablets are packed in Al//PVC/PVdC blisters containing 3, 10, 12, 20, 90 or 100
capsules, in strips of 10 capsules as appropriate. Not all pack size will be marketed.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Auden Mckenzie (Pharma Division) Ltd
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT