Macrolief 13.8g sachet, powder for oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MACROGOL, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE

Available from:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350 13.125 g SODIUM CHLORIDE 0.3507 g SODIUM HYDROGEN CARBONATE 0.1785 g POTASSIUM CHLORIDE 0.0466 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

MACROGOL 3350 13.125 g SODIUM CHLORIDE 0.3507 g SODIUM HYDROGEN CARBONATE 0.1785 g POTASSIUM CHLORIDE 0.0466 g

Prescription type:

OTC

Therapeutic area:

DRUGS FOR CONSTIPATION

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACROLIEF 13.8G SACHET, POWDER FOR ORAL SOLUTION
macrogol 3350 / sodium chloride / sodium hydrogen carbonate /
potassium chloride
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Macrolief is and what it is used for
2. What you need to know before you take Macrolief
3. How to take Macrolief
4. Possible side effects
5. How to store Macrolief
6. Contents of the pack and other information
1. WHAT MACROLIEF IS AND WHAT IT IS USED FOR
_ _
Macrolief is a laxative used for the treatment of constipation
(especially if constipation lasts a long
time) in adults, adolescents and elderly. It is not recommended for
children below 12 years of age.
It is also used to treat a build up of hard faeces in your bowel which
may be a result of long-term
constipation (this is known as faecal impaction).
Macrogol 3350 makes your faeces softer and easier to pass, giving you
relief from constipation. The
electrolytes (salts) help to maintain your body’s normal levels of
sodium, potassium and water while
you are being treated for constipation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MACROLIEF
DO NOT TAKE MACROLIEF
-
if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium
chloride, or any of the other ingredients in
_ _
this medicine (listed in section 6)
-
if you have a perforated gut (bowel) wall
-
if you have a blockage in your intestine (gut obstruction, ileus)
-
if you have severe inflammatory bowel disease such as ulcerative
coliti

Summary of Product characteristics

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SUMMARY
OF
PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Macrolief 13.8g sachet, powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350
13.125 g
Sodium chloride
0.3507 g
Sodium hydrogen carbonate
0.1785 g
Potassium chloride
0.0466 g
The content of electrolyte ions per sachet following reconstitution in
125 ml of water is equivalent to:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate (bicarbonate)
17 mmol/l
Potassium
5 mmol/l
Excipient(s) with known effect
Each sachet contains 0.8 mg sorbitol (E 420), 8.2 mmol (188 mg) sodium
and 0.6 mmol (24.4 mg)
potassium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
Single-dose sachet containing a white crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of chronic constipation. Macrolief is also effective
in resolving faecal impaction,
defined as refractory constipation with faecal loading of the rectum
and/or colon.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Chronic constipation:_
_ _
A course of treatment for chronic constipation with
_ _
Macrolief does not normally exceed 2 weeks,
although this can be repeated if required.
As for all laxatives, prolonged use is not usually recommended.
Extended use may be necessary in the
care of patients with severe chronic or resistant constipation,
secondary to multiple sclerosis or
Parkinson's disease, or induced by regular constipating medicinal
product in particular opioids and
antimuscarinics.
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Adults, adolescents and the elderly: 1-3 sachets daily in divided
doses, according to individual
response. For extended use, the dose can be adjusted down to 1 or 2
sachets daily.
Children below 12 years old: Not recommended.
_Faecal impaction_
:
A course of treatment for faecal impaction with Macrolief does not
normally exceed 3 days.
Adults, adolescents and the elderly: 8 sachets daily, all o