Microlax Rectal Solution Sodium Citrate 450mg/5ml Sodium Lauryl Sulphoacetate 45mg/5ml

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Sodium citrate; Sodium lauryl sulfoacetate

متاح من:

Johnson & Johnson (Ireland) Limited

ATC رمز:

A06AG; A06AG11

INN (الاسم الدولي):

Sodium citrate; Sodium lauryl sulfoacetate

جرعة:

450 mg/ 5 ml +45 mg/5ml

الشكل الصيدلاني:

Rectal solution

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Enemas; laurilsulfate, incl. combinations

الوضع إذن:

Marketed

تاريخ الترخيص:

1998-01-23

نشرة المعلومات

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.
X 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
medicine used to treat high blood levels of
potassium).
! PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before
using this product if yo

خصائص المنتج

Health Products Regulatory Authority
10 June 2022
CRN00CYS6
Page 1 of 4
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.
Lubricate the nozzle tip with some of the contents to aid insertion.
Seek medical advice if symptoms persist and avoid prolonged use.
Health Products Regulatory Authority
10 June 2022
CRN00CYS6
Page 2 of 4
Microlax contains sorbic acid which may cause local skin reactions,
e.g. contact dermatitis which is a local irritation at the site of
use.
4.5 INTERACTION WITH OTHER