| Section 4.2
From:
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac Tablets 135mg:
Adults (including the elderly) and children 10 years and over:
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.
Children under 10 years: Not applicable.
Colofac IBS/Boots Pharmacy IBS Relief 135mg Tablets:
Adults (including the elderly) and children 10 years and over:
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.
Children under 10 years: Not applicable.
To:
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.
Section 4.3:
From:
Hypersensitivity to any component of the product.
To:
Hypersensitivity to the active substance or to any of the excipients.
Section 4.4:
From:
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac 135 mg:
None.
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.
To:
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.
Section 4.5:
From:
None known.
To:
No interaction studies have been performed.
Section 4.6:
From:
Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.
To:
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.
Section 4.7:
From:
None.
To:
No studies on the effects on the ability to drive and use machines have been performed.
Section 4.8:
From:
In very rare cases allergic reactions have been reported, in particular erythematous rash, urticaria and angioedema.
To:
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
Section 4.9:
From:
On theoretical grounds it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended.
To:
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.
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