Colpermin Gastro-resistant CapsulesPeppermint oil 0.2ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Peppermint oil

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

A03AX

INN (International Name):

Peppermint oil

Dosage:

0.2 millilitre(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other drugs for functional gastrointestinal disorders

Authorization status:

Marketed

Authorization date:

1985-03-08

Summary of Product characteristics

Health Products Regulatory Authority
24 September 2019
CRN008K0J
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colpermin Gastro-resistant CapsulesPeppermint oil 0.2ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.2ml of peppermint oil.
Excipients: each capsule contains 136 mg Arachis oil, refined (peanut
oil).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Capsules, hard.
Size 1, enteric coated hard gelatin capsule coloured light blue/dark
blue, with a blue band between cap and body, containing
an oily mixture with an odour of peppermint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of symptoms of discomfort and of abdominal colic and
distension experienced by patients with irritable
bowel syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ADOLESCENTS 15 YEARS AND OVER:_
One capsule three times a day, taken 30-60 minutes before food with a
small quantity of water. The capsules should not be
taken immediately after food.
The dose may be increased to two capsules, three times a day when
discomfort is more severe.
_CHILDREN UNDER 15 YEARS:_
There is no experience of Colpermin Capsules in children under the age
of 15 years.
The capsules should be taken until symptoms resolve, usually within
one or two weeks. At times when symptoms are more
persistent, the capsules can be continued for longer periods of not
longer than 2 to 3 months per course.
4.3 CONTRAINDICATIONS
This product should not be used in patients who are hypersensitive to
any of its ingredients, including menthol and arachis oil
(peanut oil).
If you are allergic to peanut or soya, do not use this medicinal
product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The capsules should not be broken or chewed because this would release
the peppermint oil prematurely, possible causing
local irritation of the mouth and oesophagus.
Patients who already suffer from heartburn sometimes have an
exacerbation of this symptom after taking Col