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AUDMONAL 60MG CAPSULES

Active substance(s): ALVERINE CITRATE / ALVERINE CITRATE / ALVERINE CITRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Audmonal 60 mg Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60mg alverine citrate
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
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.

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): 1 or 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.

Intestinal obstruction
Use during pregnancy and lactation.

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 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
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. Use is
therefore contraindicated during pregnancy and lactation.

4.7

Effects on ability to drive and use machines
May cause dizziness. Do not drive or use machinery if affected

4.8

Undesirable effects
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

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
suspected
adverse
reactions
via
Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
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.

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.

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
Pregelatinised Starch (Starch 1500)
Magnesium Stearate
Capsule shell Cap
Gelatin
Black Iron Oxide
Titanium Dioxide
Capsule Shell Body
Gelatin
Brilliant Blue
Titanium Dioxide
Printing Ink Composition
Shellac
Dehydrated Alcohol
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol
Strong Ammonia Solution
Black Iron Oxide (E172)
Potassium Hydroxide

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25°C. Store in the original packaging.

6.5

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.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Auden Mckenzie (Pharma Division) Ltd
Whiddon Valley
Barnstaple
North Devon
EX32 8NS
United Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 17507/0148

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/09/2009

10

DATE OF REVISION OF THE TEXT
01/06/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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