Dulcolax Pico Liquid 5mg/5ml oral solution

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Aktīvā sastāvdaļa:

SODIUM PICOSULFATE

Pieejams no:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

ATĶ kods:

A06AB08

SNN (starptautisko nepatentēto nosaukumu):

SODIUM PICOSULFATE 5 mg/5ml

Zāļu forma:

ORAL SOLUTION

Kompozīcija:

SODIUM PICOSULFATE 5 mg/5ml

Receptes veids:

OTC

Ārstniecības joma:

DRUGS FOR CONSTIPATION

Autorizācija statuss:

Authorised

Autorizācija datums:

2006-08-30

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
DULCOLAX® PICO LIQUID 5MG/5ML ORAL SOLUTION
(sodium picosulfate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. Always take Dulcolax
Pico Liquid exactly as described
in this leaflet or as your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse after five days.
WHAT IS IN THIS LEAFLET:
1. What Dulcolax Pico Liquid is and what it is used for
2. What you need to know before you take Dulcolax Pico Liquid
3. How to take Dulcolax Pico Liquid
4. Possible side effects
5. How to store Dulcolax Pico Liquid
6. Contents of the pack and other information
1.
WHAT DULCOLAX PICO LIQUID IS AND WHAT IT IS USED FOR
Dulcolax Pico Liquid contains a medicine called sodium picosulfate.
This belongs to a group of
medicines called laxatives.
Dulcolax Pico Liquid is used for relief of constipation. This medicine
does not help with weight loss.
Dulcolax Pico Liquid gently stimulates the muscles of the bowel (large
intestine). This brings predictable,
overnight relief from constipation, helping to return the body to its
natural rhythm.
WHAT IS CONSTIPATION?
Normal and regular bowel movement is important for most people.
However, what is “normal and
regular” varies from person to person. Some may have a bowel
movement every day, others less often.
Whatever it is like for you, it is best that your bowel movement has a
regular pattern.
•
Constipation is an occasional problem for some people. For others, it
may happen more often
•
It happens when the normal muscle actions in the bowel (large
intestine) slow down. This can
mean that material is not

Produkta apraksts

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dulcolax
Pico Liquid 5 mg/5 ml, oral solution
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution containing 5 mg of sodium picosulfate (as monohydrate)
in each 5 ml.
Excipients with known effect
Methyl Parahydroxybenzoate (E218)
2.5 mg / 5 ml
Propyl Parahydroxybenzoate (E216)
0.5 mg / 5 ml
Ethanol 96%
250 mg / 5 ml
Each 5 ml dose contains 1.18 mg sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to yellowish or slightly yellowish-brown, slightly
viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term management of constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The following dosages are recommended to be taken at night to produce
evacuation the
following morning.
It is recommended to start with the lowest dose. The dose may be
adjusted up to the
maximum recommended dose to produce regular stools. The maximum
recommended
daily dose should not be exceeded.
Adults and children over 10 years of age:
One to two 5 ml spoonfuls (5-10 mg) per day.
Children under 10 years of age:
Not to be taken by children under 10 years of age without medical
advice.
Children aged 4-10 years:
Half to one 5 ml spoonful (2.5-5 mg) per day.
Children aged 2-4 years:
The recommended dosage is 0.25 mg per kilogram body weight per day (1
ml of Dulcolax
Pico Liquid contains 1 mg sodium picosulfate).
Page 2 of 6
In the management of constipation, once regularity has been restarted
dosage should be
reduced and can usually be stopped.
Diluent: Can be diluted with purified water.
4.3
CONTRAINDICATIONS
DULCOLAX PICO is contraindicated in patients with:
•
Ileus or intestinal obstruction
•
Severe painful and/or feverish acute abdominal conditions (e.g.
appendicitis)
potentially associated with nausea and vomiting
•
Acute inflammatory bowel diseases
•
Severe dehydration
•
Known hypersensitivity to sodium picosulfate or any other comp