Molative oral powder 13.8g sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Available from:

Viatris UK Healthcare Ltd

ATC code:

A06AD65

INN (International Name):

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Dosage:

65mmol/1litre ; 53mmol/1litre ; 5.4mmol/1litre ; 17mmol/1litre ; 105gram/1litre

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060400; GTIN: 5016695007168 5016695007151 5016695007144

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOLATIVE 13.8 G 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.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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 Molative is and what it is used for
2.
What you need to know before you take Molative
3.
How to take Molative
4.
Possible side effects
5.
How to store Molative
6.
Contents of the pack and other information
1.
WHAT MOLATIVE IS AND WHAT IT IS USED FOR
Molative is a laxative (a medicine used to help you pass stools) for
the treatment of long-term
(chronic) constipation in adults, adolescents and elderly. It is not
recommended for children below 12
years of age.
Molative helps you to have a comfortable bowel movement even if you
have been constipated for a
long time.
Molative is also used for the treatment of faecal impaction (a
condition where large amounts of stool
builds up in the rectum and/or colon which cannot be passed easily).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLATIVE
DO NOT TAKE MOLATIVE:
-
if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium
chloride or any of the other ingredients of this medicine (listed in
section 6).
-
if you have a blockage in your intestine (gut obstruction, ileus)
-
if you have a perforated gut (bowel) wall
-
if you have severe inflammatory bowel disease such as ulcerative
colitis, Crohn’s disease or
toxic megacolon.
If any of these apply to you, please talk to your doctor or pharmacist
for further advice.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pha

Summary of Product characteristics

OBJECT 1
MOLATIVE 13.8 G POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 05-Jun-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Molative 13.8 g 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
350.7 mg
Sodium Hydrogen Carbonate
178.5 mg
Potassium Chloride
46.6 mg
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
Bicarbonate
17 mmol/l
Potassium
5 mmol/l
Excipient with known effect:
Each sachet contains sorbitol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution
Single-dose sachet containing a free flowing white crystalline powder.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of chronic constipation in adults and adolescents
aged 12 years and over.
Molative 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 constipation with Molative 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 medication in
particular opioids and
antimuscarinics.
_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. Alternative macrogol
products are available for
children.
FAECAL IMPACTION
A course of treatment for faecal impaction with Molative does not
normally exceed 3 days.