MICROLAX SODIUM CITRATE 450 & 45 MG/5ml Rectal Solution

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Descargar Fitxa tècnica (SPC)
28-04-2016

ingredients actius:

SODIUM CITRATE, SODIUM LAURYL SULFOACETATE

Disponible des:

McNeil Healthcare (Ireland) Ltd

Codi ATC:

A06AG11

Designació comuna internacional (DCI):

SODIUM CITRATE, SODIUM LAURYL SULFOACETATE

Dosis:

450 & 45 MG/5ml

formulario farmacéutico:

Rectal Solution

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

LAURILSULFATE, INCL COMBINATIONS

Estat d'Autorització:

Transfer Pending

Data d'autorització:

2005-04-29

Informació per a l'usuari

                                Rectal Solution
Sodium Citrate 450 mg / 5 ml
Sodium Lauryl Sulphoacetate 45 mg / 5 ml
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 Microlax 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. 
•  If any of the side effects get serious or if you notice 
any side effects not listed in this leaflet, please talk 
to your doctor or pharmacist.
IN THIS LEAFLET
1. What Microlax is and what it is used for.
2. Before you use Microlax
3. How to use Microlax
4. Possible side effects
5. How to store Microlax
6. Further information
1.  WHAT MICROLAX IS AND WHAT IT IS USED FOR
Microlax enema is a laxative used to empty the 
large bowel in constipation, or prior to surgical 
and diagnostic procedures or in obstetrics prior to 
delivery. The enema acts as a laxative by softening 
the stools and by its lubricating properties.
This medicine is for use in adults and children.
2.  BEFORE YOU USE MICROLAX
 This medicine is suitable for most children and adults 
but a few people should not use it. If you are in any 
doubt, talk to your doctor or pharmacist.
 DO NOT USE THIS MEDICINE…
If you have ever had a hypersensitivity reaction 
(e.g. rash, swelling of the face and throat, difficulty 
breathing) to any of the ingredients. See Section 6.
 TAKE SPECIAL CARE WITH MICROLAX...
If you have ulcers or inflammation of your large 
bowel or any other part of your intestine.
Prolonged use may lead to irritation of the anal 
canal.
The nozzle should only be inserted to half its length 
when used in children under 3 years old.
Seek medical advice if symptoms persist and avoid 
prolonged use. Speak to your doctor or pharmacist 
before using Microlax if you are taking sodium 
polystyrene sulphonate (a medicin
                                
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Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Microlax Rectal Solution
Sodium Citrate 450mg/5ml
Sodium Lauryl Sulphoacetate 45mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml unit dose contains sodium citrate 450mg and sodium lauryl sulphoacetate 45mg.
Excipient: Contains Sorbic acid (E200) 5mg/5ml unit dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal solution (enema)
A colourless, viscous liquid, containing small air bubbles, supplied in disposable 5 ml white low density capped
polyethylene microenema tubes with elongated nozzles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The Microlax enema acts as a laxative through its faecal softening and lubricant properties.
For evacuation of the colon in constipation, or prior to surgical and diagnostic procedures or in obstetrics prior to
delivery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rectal.
Recommended dosage schedules.
Adults
- One Microenema administered as necessary.
Children - As adults unless below the age of 3, when the nozzle should be inserted only half its length.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged usage of the microenema may lead to irritation of the anal canal.
When used in children under 3 years old, the nozzle should be inserted only to half its length.
When used in patients with inflammatory or ulcerative conditions of the large bowel, or with acute gastrointestinal
conditions, extreme caution should be exercised.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/04/2016_
_CRN 2174835_
_page number: 1_
Lubricate the nozzl
                                
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