Colpermin IBS Relief Capsules

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

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Активный ингредиент:

Peppermint oil

Доступна с:

Imbat Limited

код АТС:

A03A

ИНН (Международная Имя):

Peppermint oil

дозировка:

0.2 millilitre(s)

Фармацевтическая форма:

Gastro-resistant capsule

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Статус Авторизация:

Authorised

Дата Авторизация:

2009-03-06

тонкая брошюра

                                _Page 1 of 2 _
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
COLPERMIN
® IBS RELIEF CAPSULES
(peppermint oil)
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.
•
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 ingredients
of this medicine (listed in
section 6).
•
If you are ALLERGIC TO PEANUTS OR SOYA.
If any of these apply to you, GET ADVICE FROM YOUR DOCTOR OR
PHARMACIST WITHOUT USING
COLPERMIN.
WARNINGS AND PRECAUTIONS

                                
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Характеристики продукта

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colpermin IBS Relief Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.2ml of Peppermint oil.
Excipient: contains refined arachis oil (peanut oil).
For a full list of excipients, see section see 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard
_Product imported from the UK_
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 CHILDREN 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).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who already suffer from heartburn, sometimes experience an
exacerbation of these symptoms when taking the
capsule. Treatment should be discontinued in these patients.
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.
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