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MOLATIVE 13.8 G POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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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.

TBC

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 pharmacist before
taking Molative.
If you have a heart condition and are taking
this medicine for faecal impaction, you
must follow the specific instructions on how
to take this medicine, which are given in
section 3 of this leaflet.

During treatment

If you have possible signs of changes to
electrolyte levels in the blood such as fluid
retention in the body, shortness of breath,
tiredness, dehydration or heart problems,
stop taking Molative and talk to your
doctor immediately (see section 4 “Possible
side effects”).

Description Macrogol 3350 13.8 g 50 x 2,50,100,20,30
Component Type Leaflet
Affiliate Item Code 872092
Superceded Affiliate Item Code 804920
TrackWise PR No. 872092
MA No. PL 04569/1677
Packing Site/Printer NA
Supplier Code NA

Pharma Code TBC
SAP No. NA
Vendor Job No. 278933
Trackwise Proof No. 1
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Children

Do not give this medicine to children below
the age of 12 years.

Other medicines and Molative

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
Some medicines, e.g. medicines to treat
epilepsy, may not work as effectively during
use with Molative.

Pregnancy and breast-feeding

Molative can be taken during pregnancy
and whilst breast-feeding.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.

Molative contains potassium, sodium
and sorbitol

This medicine contains 0.63 mmol (24 mg)
of potassium per sachet. This should be
taken into consideration if you take more
than one sachet daily and you have reduced
kidney function, or if you are on a controlled
potassium diet.
This medicine contains 8.1 mmol (187 mg)
of sodium per sachet. This should be taken
into consideration if you are on a controlled
sodium diet.
The lemon lime flavour in Molative contains
sorbitol. If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking
this medicine.

3. How to take Molative
Always take this medicine exactly as
described in this leaflet or as your doctor or
pharmacist have told you. Check with your
doctor or pharmacist if you are not sure.

Adults, children (aged 12 years and above)
and the elderly:
The recommended dose for constipation is
one sachet taken one to three times daily.

This medicine can be taken at any time with
or without food or drink.
Constipation:
A dose of Molative is 1 sachet.
Take this 1 –3 times a day according to the
severity of your constipation.
Faecal impaction:
A dose is 8 sachets a day of Molative is needed
for the treatment of faecal impaction.
The 8 sachets should be taken within
24 hours for up to 3 days if required.
If you have a heart condition do not take
more than 2 sachets within an hour.

TBC

Package leaflet: Information for the patient

How to mix:
Open the sachet and pour the contents into
a glass. Add about 125ml or ¼ pint of water
to the glass. Stir well until all the powder has
dissolved and the Molative solution is clear
or slightly hazy, then drink it.
If you are taking Molative for faecal
impaction, it may be easier to dissolve
8 sachets in 1 litre of water. You should cover
the solution and keep it in a refrigerator
for up to 24 hours, after which any unused
solution should be thrown away.

Duration of treatment

Constipation:
Treatment with Molative usually lasts for
about 2 weeks.
If you need to take Molative for longer,
please see your doctor.

Date: 18 Apr 2016
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Time: 13:46
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Usually for long term treatment, the dose
can be lowered to either 1 or 2 sachets a day.
Faecal impaction:
Treatment with Molative can be for up to
3 days.

If you take more Molative than you should
This can cause severe pain and swelling
in your abdomen (stomach), vomiting
(sickness) or diarrhoea. If this happens,
contact your doctor or pharmacist.

TBC

You may develop excessive diarrhoea,
which can lead to dehydration. If this occurs,
stop taking Molative and drink plenty of
fluids. If you are worried contact your doctor
or pharmacist.

If you forget to take Molative

If you forget to take a dose, take it as soon
as you remember and then continue on
as before.
Do not take a double dose to make up for a
forgotten dose.

If you stop taking Molative

To get the most benefit from Molative,
always finish the course of treatment
according to the directions in this package
leaflet. This will make sure that your
constipation is cleared, otherwise your
condition may persist.
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody
gets them.

If you notice any of the following side
effects, stop taking this medicine and
contact your doctor immediately or
go to the nearest hospital emergency
department straight away:
Frequency not known (cannot be
estimated from the available data)
• serious allergic reaction which causes
sudden signs of allergy such as shortness
of breath, difficulty in breathing, or
swelling of the face, lips, tongue, throat
or other parts of the body (anaphylaxis,
angioedema)
• changes to electrolyte levels in the
blood. You may experience tiredness,
dehydration, shortness of breath, swelling
of the feet and legs due to fluid build up or
heart problems.

Other possible side effects
Frequency not known (cannot be
estimated from the available data)
• skin rash, itching, reddening of the skin or
a nettle rash
• swollen hands, feet or ankles
• shortness of breath
• headaches
• high or low levels of potassium in the blood
• indigestion, stomach ache or rumbles,
feeling bloated (swollen stomach), wind
• feeling sick (nausea) or being sick (vomiting)
• soreness of the rectum and anus (bottom)
• diarrhoea. You may experience mild
diarrhoea when taking Molative. This side
effect generally get better if you reduce
the amount Molative you take.

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5. How to store Molative
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry date
which is stated on the carton and sachet. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice that
any of the sachets are damaged.
Store the reconstituted solution in a
refrigerator (2°C to 8°C), and use within
24 hours. After 24 hours, any unused
solution should be thrown away.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
any medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Molative contains

The active substances in each 13.8 g
sachet are:
Macrogol 3350 
13.125 g
Sodium chloride
350.7 mg
Sodium hydrogen carbonate
178.5 mg
Potassium chloride
46.6 mg
When made into a drink with 125 ml of
water, each sachet provides:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
Potassium
5 mmol/l
The other ingredients are colloidal
anhydrous silica, saccharin sodium, orange
flavour (orange flavour contains: flavouring
substances and flavouring preparations,
maltodextrin, acacia gum, alpha-tocopherol)
and lemon lime flavour (lemon lime
flavour contains: flavouring preparations,
maltodextrin, mannitol, gluconolactone,
sorbitol (see section 2, “Molative contains
potassium, sodium and sorbitol”), acacia
gum, colloidal anhydrous silica).

What Molative looks like and contents of
the pack

Molative is a white powder.
Each sachet contains 13.8 g of powder and is
packed in cartons containing 20, 30, 50 and
100 sachets or in a multipack of 100 comprising
of 2 cartons, each containing 50 sachets.
Not all of these pack sizes are marketed.

TBC

If your constipation is caused by an illness such
as Parkinson’s disease or multiple sclerosis
(MS), or if you take medicines that cause
constipation, your doctor may recommend
that you take Molative for longer than 2 weeks.

Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom.

Manufacturer

Klocke Pharma-Service GmbH,
Strassburger Strasse 77, 77767 Appenweier,
Germany.
Hermes Pharma Ges.m.b.H., Allgäu 36,
9400 Wolfsberg, Austria.
This leaflet was last revised in 04/2016
872092

Description Macrogol 3350 13.8 g 50 x 2,50,100,20,30
Component Type Leaflet
Affiliate Item Code 872092
Superceded Affiliate Item Code 804920
TrackWise PR No. 872092
MA No. PL 04569/1677
Packing Site/Printer NA
Supplier Code NA

Pharma Code TBC
SAP No. NA
Vendor Job No. 278933
Trackwise Proof No. 1
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Date: 18 Apr 2016
No. of colours

1

Time: 13:46
Page Count

Colours

Black

Non-Print
Colours

codes

2/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 297 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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