1. Name Of The Medicinal Product
Colofac Tablets 135 mg
Mebeverine Tablets 135mg
Fomac Tablets 135 mg
Colofac IBS
Boots Pharmacy IBS Relief 135mg Tablets
2. Qualitative And Quantitative Composition
Mebeverine hydrochloride 135mg.
For excipients, see section 6.1
3. Pharmaceutical Form
Coated tablets.
Round white sugar coated tablets, with no superficial markings.
4. Clinical Particulars
4.1 Therapeutic Indications
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac Tablets 135mg:
For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Colofac is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
Colofac IBS/ Boots Pharmacy IBS Relief 135mg Tablets: For the symptomatic relief of Irritable Bowel Syndrome.
4.2 Posology And Method Of Administration
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac Tablets 135mg:
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks, when the desired effect has been obtained, the dosage may be gradually reduced.
Paediatric Population
Mebeverine 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
Colofac IBS/Boots Pharmacy IBS Relief 135mg Tablets:
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals.
If symptoms persist for more than 2 weeks, consult your doctor.
Warning: Do not exceed the stated dose.
Paediatric Population
Mebeverine 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
Since Mebeverine coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Colofac IBS / Boots Pharmacy IBS Relief 135mg Tablets :
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 mebeverine. It may not be the right treatment for you. See your doctor as soon as possible.
- you are aged 40 years or over
- you have passed blood form the bowel
- you are feeling sick or vomiting
- 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
No interaction studies have been performed. .
4.6 Pregnancy And Lactation
No clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
There is insufficient information on the excretion of mebeverine in human or animal breast milk. Physico-chemical and available pharmacodynamic data on mebeverine point to excretion in breast milk and a risk to the suckling child cannot be excluded. Mebeverine should not be used during breast-feeding.
4.7 Effects On Ability To Drive And Use Machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable Effects
Allergic reactions mainly but not exclusively limited to the skin have been observed (A frequency cannot be estimated from the available data)
Immune system disorders:
Hypersensitivity
Skin and subcutaneous tissue disorders:
Urticaria, angioedema, erythematous rash
4.9 Overdose
Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible.
No specific antidote is known; gastric lavage and symptomatic treatment is recommended.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC-Code: A03AA04
Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.
5.2 Pharmacokinetic Properties
Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such, but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.
5.3 Preclinical Safety Data
During its development phase the entity mebeverine was extensively tested in several animal species in acute, (sub) chronic and reproduction investigations.
The oral LD50 ranged from 902 - 1995 mg/kg.
The main symptoms in the animals, after very high oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation.
The dosages used in animal studies exceeded several times the dosages used for humans (40 mg/kg for animal dosing versus 6 mg/kg for humans).
No mutagenic or clastogenic effects were found in in vitro and in vivo studies with mebeverine.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose, starch (potato or maize), povidone, talc, magnesium stearate, sucrose, gelatin, acacia, carnauba wax.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
5 years.
6.4 Special Precautions For Storage
Do not store above 30°C. Store in the original package.
6.5 Nature And Contents Of Container
Boxes containing 10, 15, 84 or 100 tablets in blister strips.
HDPE tamper-evident tablet container with snap on cap containing 500 tablets.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Abbott Healthcare Products Limited/Abbott Healthcare Products Limited trading as Boots Pharmacy
Mansbridge Road
West End
Southampton
SO18 3JD
8. Marketing Authorisation Number(S)
PL 00512/0044
9. Date Of First Authorisation/Renewal Of The Authorisation
14 March 1978/21 April 2005
10. Date Of Revision Of The Text
31/03/2011
LEGAL STATUS
Colofac Tablets/ Mebeverine Tablets 135 mg/Fomac 135 mg: POM
Colofac IBS/ Boots Pharmacy IBS Relief 135mg Tablets: P
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