CosmoCol Half 6.9g powder for oral solution

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

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

Διαθέσιμο από:

Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United

Φαρμακολογική κατηγορία (ATC):

A06AD65

INN (Διεθνής Όνομα):

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

Φαρμακοτεχνική μορφή:

POWDER FOR ORAL SOLUTION

Σύνθεση:

MACROGOL 3350 6.563 gram(s) ; SODIUM CHLORIDE 0.1754 gram(s) ; SODIUM HYDROGEN CARBONATE 0.0893 gram(s) ; POTASSIUM CHLORIDE 0.0233 gram(s)

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

DRUGS FOR CONSTIPATION

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-06-02

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOCOL HALF 6.9 G, POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium
chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you notice 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 CosmoCol Half is and what it is used for
2.
What you need to know before you use CosmoCol Half
3.
How to use CosmoCol Half
4.
Possible side effects
5.
How to store CosmoCol Half
6.
Contents of the pack and other information
1.
WHAT COSMOCOL HALF IS AND WHAT IT IS USED FOR
CosmoCol Half is a laxative.
This medicine is used to:
-
treat chronic constipation.
-
treat impaction. Impaction is persistent constipation, where a large
volume of stools cause a
blockage of the rectum and / or colon.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSMOCOL HALF
_ _
DO NOT TAKE COSMOCOL HALF 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).
-
you have a blockage in your intestine.
-
you have a perforated gut wall.
-
you have a severe inflammatory bowel disease like ulcerative colitis,
Crohn's disease or
toxic megacolon.
WARNINGS AND PRECAUTIONS
If you have heart or kidney problems, an impaired gag reflex or suffer
from heart-burn, talk to your
doctor before taking CosmoCol Half.
OTHER MEDICINES AND COSMOCOL HALF
Some medicines, such as medicines for epilepsy, may be less effective
during use of CosmoCol
Half. Tell your doctor about any other medicines that you are taking.
Do not take other

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CosmoCol Half 6.9 g, powder for oral solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of CosmoCol Half contains the following active ingredients:
Macrogol 3350, 6.563 g
Sodium chloride, 0.1754 g
Sodium hydrogen carbonate, 0.0893 g
Potassium chloride, 0.0233 g
Content of electrolyte ions when one sachet is dissolved in 62.5 mL
water:
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Potassium 5.0 mmol/l
This medicinal product contains sodium, equivalent to 93.87 mg per
sachet. Contains sorbitol. For
the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral solution
Free flowing white powder
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of chronic constipation in adults, adolescents and
the elderly.
For resolving faecal impaction in adults, adolescents and the elderly.
Faecal impaction is defined as
refractory constipation with faecal loading in the rectum and/or colon
confirmed by physical or
radiological examination of the abdomen and rectum.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHRONIC CONSTIPATION
A course of treatment for constipation does not normally exceed two
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 medication,
in particular opioids and
antimuscarinics.
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Adults, Adolescents and the Elderly
2-6 sachets daily in divided doses, accrding to individual response.
For extended use, dose can be adjusted down to 2-4 sachets daily.
FAECAL IMPACTION
Adults, Adolescents and the Elderly
A course of treatment for faecal impaction does not normally exceed 3
days.
Dosage is 16 sachets daily, all of which should be consumed within a
6-hour period.
The above dosage regimen should be stopped