Peglax 10 g powder for oral solution in sachet

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Macrogol 4000

Доступна з:

Casen-Recordati S.L.

Код атс:

A06AD; A06AD15

ІПН (Міжнародна Ім'я):

Macrogol 4000

Дозування:

10 gram(s)

Фармацевтична форма:

Powder for oral solution

Адміністрація маршрут:

Oral use

Одиниць в упаковці:

pack sizes of 10, 20, 50 and 100 sachets

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична група:

Drugs for constipation. Osmotically acting laxatives

Терапевтична области:

Osmotically acting laxatives; macrogol

Терапевтичні свідчення:

Symptomatic treatment of constipation in adults and children aged 8 years and above

Статус Авторизація:

Not marketed

Дата Авторизація:

2013-06-28

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEGLAX 10G POWDER FOR ORAL SOLUTION IN SACHET
MACROGOL 4000
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Peglax is and what it is used for
2.
What you need to know before you take Peglax
3.
How to take Peglax
4.
Possible side effects
5.
How to store Peglax
6.
Contents of the pack and other information
1.
WHAT PEGLAX IS AND WHAT IT IS USED FOR
The name of this medicine is Peglax 10g powder for oral solution in
sachet.
Peglax is considered as osmotic laxative.
Peglax is used for the symptomatic treatment of constipation in adults
and children 8 years old and
over. It should be used with appropriate changes to lifestyle and diet
(see section 2).
You must talk to a doctor if you do not feel better or if you feel
worse.
This medicine contains Macrogol (P.E.G. = polyethylene glycol).
In the case of constipation, the maximum treatment period in children
is 3 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEGLAX
OCCASIONAL CONSTIPATION:
Occasional constipation may be related to a recent change in your
lifestyle. There are medicines that
can be used for short term treatment. Ask the opinion of your doctor
in the case of recent constipation
which cannot be explained by changes in your lifestyle, or in the case
of constipation associated with
pain, fever or abdominal swelling.
CHRONIC CONSTIPATION (LONG TERM CONSTIPATION):
Chronic constipation may be caused by:

Intestinal disease that requires a physician’s advice.

Intestinal dysfu

Характеристики продукта

Health Products Regulatory Authority
30 November 2020
CRN00C23W
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Peglax 10 g powder for oral solution in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10 g of macrogol 4000.
Excipient(s) with known effect: 0.0000018 mg of sulphur dioxide
(E-220) per sachet and less than 1 mmol of sodium per sachet.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
Almost white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in adults and children aged 8
years and above.
An organic disorder should have been ruled out before initiation of
treatment. Peglax should remain a temporary adjuvant
treatment to appropriate lifestyle and dietary management of
constipation, with a maximum 3-months treatment course in
children. If symptoms persist despite associated dietary measures, an
underlying cause should be suspected and treated
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Posology
1 to 2 sachets per day, preferably taken as a single dose in the
morning. It is recommended to drink 125 ml of liquids (e.g.
water) after each dose.
The effect of Peglax becomes apparent within 24 to 48 hours after its
administration.
The daily dose should be adapted according to the clinical effects and
may range from one sachet every other day (especially
in children) up to 2 sachets a day.
Treatment should be stopped gradually and resumed if constipation
recurs.
_Paedriatic population_
1 to 2 sachets per day, preferably taken as a single dose in the
morning. It is recommended to drink 125 ml of liquids (e.g.
water) after each dose.
In children, treatment should not exceed 3 months due to a lack of
clinical data for treatment lasting longer than 3 months.
Treatment-induced restoration of bowel movements will be maintained by
lifestyle and dietary measures.
Method of administration
Each sachet should be dissolved in a glass of water (125 ml
approxi