DULCOLAX PICO LIQUID 5 MG/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM PICOSULPHATE MONOHYDRATE

Available from:

Boehringer Ingelheim Limited

ATC code:

A06AB08

INN (International Name):

SODIUM PICOSULPHATE MONOHYDRATE

Dosage:

5 MG/5ml

Pharmaceutical form:

Oral Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Contact laxatives

Authorization status:

Authorised

Authorization date:

1996-03-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. You need 
to take Dulcolax Pico Liquid as instructed in this leaflet 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 your pharmacist or doctor if your  
 symptoms worsen or do not improve after five days  
  treatment
•  If a side effect occurs and gets troublesome, or seems  
 serious to you, or if you experience any side effect not
 listed in this leaflet, please tell your pharmacist or doctor
IN THIS LEAFLET:
1. What Dulcolax Pico Liquid is and what it is used for
2. 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. Further 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

Summary of Product characteristics

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:
Methyl Parahydroxybenzoate (E218)
2.5 mg / 5 ml
Propyl Parahydroxybenzoate (E216)
0.5 mg / 5 ml
Ethanol 96%
250 mg / 5 ml
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).
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/03/2016_
_CRN 2170277_
_page number: 1_
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 CONTRAIND