Colpermin Gastro-resistant Capsules Peppermint oil 0.2ml

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Peppermint oil

Доступна с:

Johnson & Johnson (Ireland) Limited

код АТС:

A03AX

ИНН (Международная Имя):

Peppermint oil

дозировка:

0.2 millilitre(s)

Фармацевтическая форма:

Gastro-resistant capsule, hard

Терапевтические области:

Other drugs for functional gastrointestinal disorders

Статус Авторизация:

Marketed

Дата Авторизация:

2006-03-10

тонкая брошюра

COLPERMIN®
GASTRO-RESISTANT CAPSULES
PEPPERMINT OIL 0.2ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However you still
need to take Colpermin
carefully to get the best results from it.
■
Keep this leaflet. You may need to read it again.
■
Treatment should not be commenced without a prior diagnosis of
Irritable Bowel Syndrome
by your doctor.
■
Speak to your doctor or pharmacist if you suffer from any of the
conditions mentioned in
Section 2 or if you are taking any other medicines. (See Section 2)
■
Ask your pharmacist if you need more information or advice.
■
You must contact a doctor if your symptoms worsen or do not improve
after 2 weeks.
■
If any of the side effects get serious or if you notice any side
effects not listed in this leaflet,
please contact your doctor or pharmacist.
IN THIS LEAFLET
1. What Colpermin is and what it is used for.
2. Before you take Colpermin
3. How to take Colpermin
4. Possible side-effects
5. How to store Colpermin
6. Further information
1 WHAT COLPERMIN IS AND WHAT IT IS USED FOR
Colpermin is an antispasmodic which is used to relieve the bloating,
painful spasms and cramps
which
occur
in
the
large
bowel
in
Irritable
Bowel
Syndrome
(IBS).
The
capsules
contain
peppermint oil, which relaxes the spasm of the bowel wall. This
relieves pain and allows pockets
of gas, which may have made you feel bloated, to pass along the bowel
and out of the body.
Irritable Bowel Syndrome is a condition in which there is pain, spasm
and bloating at almost any
point between the groin, the navel and the sides, sometimes
accompanied by diarrhoea and
constipation. The symptoms may be more noticeable when you are feeling
stressed and anxious.
2 BEFORE YOU TAKE COLPERMIN
This medicine is suitable for most people but a few people should not
use it. If you are in any
doubt, talk to your doctor or pharmacist.
DO NOT TAKE THIS MEDICINE…
■
If you are allergic to peppermint oil, or any of the other ingredie

Характеристики продукта

Health Products Regulatory Authority
28 June 2021
CRN00CD98
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colpermin Gastro-resistant Capsules Peppermint 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 with opaque blue cap,
opaque light blue body and a dark 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 af