1. Name Of The Medicinal Product
SPASMONAL Forte 120 mg, Hard capsules.
2. Qualitative And Quantitative Composition
Each capsule contains 120 mg alverine citrate.
3. Pharmaceutical Form
An opaque, size 1 capsule with a grey cap and blue body, marked “SP120”.
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 capsule 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 Forte 120 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 including anaphylaxis.
There have been isolated reports of jaundice due to hepatitis which 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: gelatine, 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
A box of aluminium foil/UPVC blister strip packs containing 2, 10, 20, 30, 60 or 90 capsules, in strips of 10 capsules as appropriate.
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 00322/0075
9. Date Of First Authorisation/Renewal Of The Authorisation
09 October 1997/ 04 April 2003
10. Date Of Revision Of The Text
June 2009
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