Summary of Product Characteristics (SmPC) - Audmonal 60 mg capsules
1 NAME OF THE MEDICINAL PRODUCT
Alverine Citrate 60 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60mg alverine citrate
For the 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
Posology
Adults (including the elderly)
1 or 2 capsules one to three times daily.
Children below the age of 12 years
Not recommended.
Method of administration
For oral use
4.3 Contraindications
- Paralytic ileus
- Intestinal obstruction
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 Alverine Citrate 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 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 Fertility, 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
May cause dizziness. Do not drive or use machinery if affected
4.8 Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data)
The following undesirable effects were observed:
Immune system disorders
Not known anaphylaxis, allergic reaction
Nervous system disorders
Not known dizziness, headache
Respiratory, thoracic and mediastinal disorders
Not known dyspnoea and/or wheezing
Gastrointestinal disorders
Not known nausea
Hepatobiliary disorders
Not known jaundice due to hepatitis (typically this resolves on cessation of alverine), liver function test abnormal
Skin and subcutaneous tissue disorders
Not known rash, itching
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
Symptoms
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
Pharmacotherapeutic group: Other drugs for functional gastrointestinal disorders, ATC code: A03AX08.
Alverine citrate is an antispasmodic with a direct action on smooth muscle.
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
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.
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 may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/2253
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/09/2009
10 DATE OF REVISION OF THE TEXT
29/09/2023