Picolax 10mg / 3.5g / 12 g Powder for Oral Solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium picosulphate; Magnesium oxide, light ; Citric acid, anhydrous

Предлага се от:

Ferring Ireland Ltd

АТС код:

A06AB; A06AB58

INN (Международно Name):

Sodium picosulphate; Magnesium oxide, light ; Citric acid, anhydrous

дозиране:

10 mg/3.5 g/12 gram(s)

Лекарствена форма:

Powder for oral solution

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Contact laxatives; sodium picosulfate, combinations

Статус Оторизация:

Marketed

Дата Оторизация:

1983-02-24

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
PICOLAX
®
10 MG/ 3.5 G/ 12 G POWDER FOR ORAL SOLUTION
Sodium Picosulfate, Magnesium Oxide, Citric Acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
• 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.
This includes any
possible side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1. What Picolax is and what it is used for
2. What you need to know before you take Picolax
3. How to take Picolax
4. Possible side effects
5. How to store Picolax
6. Contents of the pack and other information
1. WHAT PICOLAX IS AND WHAT IT IS USED FOR
Picolax is a powder that contains sodium picosulfate, a laxative that
works by
increasing the activity of the intestine. Picolax also contains
magnesium citrate,
another type of laxative that works by holding back fluid in the bowel
to provide a
wash-out effect.
Picolax is used for clearance of the bowel prior to examination by
radiography,
endoscopy or surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PICOLAX
DO NOT TAKE PICOLAX IF YOU:
- are allergic (hypersensitive) to sodium picosulfate or any of the
other ingredients of
this medicine (listed in section 6)
- have reduced ability of the stomach to empty (gastric retention)
- have stomach or intestinal ulcers
- have severe problems with your kidneys
- have a blockage or perforation of your bowel
- are currently suffering from feeling or being sick
- have a condition requiring abdominal surgery such as appendicitis
- have been told by a doctor that you have congestive cardiac failure
(the heart is
unable to pump blood efficiently around the body).
- have an active inflammatory bowel disease such as Crohn�

Данни за продукта

Health Products Regulatory Authority
09 March 2021
CRN009W3S
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Picolax 10mg / 3.5g / 12 g Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Sodium Picosulfate
10.0 mg
Magnesium Oxide
3.5 g
Citric Acid (anhydrous)
12.0 g
Each sachet also contains:
Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg)
potassium]
Lactose (60 mg flavour contains 7.5% lactose which equals 4.5 mg per
dosage form)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
White crystalline powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For evacuation of the bowel prior to radiological, endoscopic or
surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Route of administration: Oral.
A low residue diet is recommended on the day prior to the procedure. A
clear liquid diet is recommended on the day of the
procedure. To avoid dehydration it is important to follow the liquid
intake recommendation as advocated together with the
Picolax dosing while the effects of Picolax persist (see section 4.2,
Posology). Apart from the liquid intake together with the
treatment regimen (Picolax + additional liquids), a normal, thirst
driven intake of clear liquids is recommended.
Clear liquids should include a variety of fruit juice without pulp,
soft drinks, clear soup, tea, coffee (without milk, soy or cream)
and water. Liquid intake should not be restricted to only drinking
water.
POSOLOGY
_DIRECTIONS FOR RECONSTITUTION: _
Reconstitute the contents of one sachet in a cup of water
(approximately 150ml). Stir for 2-3 minutes. The solution should now
become an off-white, cloudy liquid with a faint odour of orange. Drink
the solution. If it becomes warm wait until it cools
sufficiently to drink.
_ _
_ _
_ADULTS (INCLUDING ELDERLY)_:
The first Picolax sachet is taken before 8 am the day before the
procedure and the second is taken 6 to 8 hours later.
O