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TRANSISOFT 8.5 G POWDER FOR ORAL SOLUTION IN SACHET

Active substance(s): MACROGOL 3350

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Package leaflet: Information for the patient

TRANSISOFT® 8.5 g powder for oral solution in sachet
macrogol 3350

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 have 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.
• You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
1. What TRANSISOFT® 8.5 g is and what it is used for
2. What you need to know before you take use TRANSISOFT® 8.5 g
3. How to take TRANSISOFT® 8.5 g
4. Possible side effects
5. How to store TRANSISOFT® 8.5 g
6. Contents of the pack and other information

1. WHAT TRANSISOFT® 8.5 g IS AND WHAT IT IS USED
FOR
How it works

It belongs to a group of medicines called osmotic laxatives.This medicine
carries water to your stool, which loosens and increases stool volume,
helping to overcome sluggish bowels. It is not absorbed into the
bloodstream or broken down in the body.

What it is used for

This medicine is used for the treatment of chronic constipation in adults. It
is not recommended for children below 17 years of age.

Pregnancy and breast-feeding

This medicine 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.

Driving and using machines

This medicine has no effect on your ability to drive a car or to operate a
machine.

3. HOW TO TAKE TRANSISOFT® 8.5 g
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.

How many sachets should you take

The recommended dose is 2 sachets per day.

When should you take the sachet(s)

This medicine should be taken as a single dose, preferably in the morning.

How to take your dose

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRANSISOFT® 8.5 g

Dissolve the contents of the sachets in a ½ glass of water (100 mL)
immediately before use and drink the liquid.
The dissolved solution remains as clear as water.

Information on constipation treatment

How long it usually takes to work

The treatment of chronic constipation with any medicine should only be
in addition to a healthy lifestyle and diet, for example:
• increase the proportion of vegetal source products in the diet
(vegetables, bread, fruits),
• increase water and juice fruit intake,
• increase physical activity (sports, walking…),
• rehabilitation of defecation reflex.

Do not take TRANSISOFT® 8.5 g

• If you are allergic (hypersensitive) to the active substance (macrogol =
P.E.G. = polyethylene glycol).
• If you have severe inflammatory bowel disease (such as ulcerative
colitis, Crohn’s disease or toxic megacolon, associated with bowel
narrowing).
• If you have a perforated gut wall or a risk of perforated gut wall.
• If you have a blockage in your intestine (gut obstruction, ileus) or
symptomatic stenosis.
• If you have painful abdominal condition of unknown cause.
Do not take this medicine if any of the above applies to you. If you are not
sure, talk to your pharmacist or doctor before taking the medicine.

Warnings and precautions

• An allergic reaction may occur. The warnings signs of an allergic
reaction and the actions to be taken are stated in section 4. Please read
carefully this section.
• This medicine is sugar free so it can be used if you are diabetic or if you
should follow a galactose-free diet.
As this medicine can sometimes cause diarrhoea, check with a doctor or
pharmacist before taking this medicine if you:
• have impaired liver or kidney function,
• are taking diuretics (water tablets) or are elderly as you may be at risk of
low sodium (salt) or potassium levels in the blood.

Other medicines and TRANSISOFT® 8.5 g

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines may not work as effectively during use with TRANSISOFT®
8.5 g.

This medicine usually takes 24 to 48 hours to work. However talk to a
doctor if symptoms do not improve after 5 days of using TRANSISOFT®
8.5g.

If you take more TRANSISOFT® 8.5 g than you should

• It may cause diarrhoea, which usually disappears when treatment is
stopped or the dose reduced.
• If you suffer from severe diarrhoea or vomiting you should contact a
doctor as soon as possible as you may require treatment to prevent loss
of salts due to fluid loss.

If you forget to take TRANSISOFT® 8.5 g

Do not take a double dose to make up for a forgotten sachet.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Allergic reactions
• The warning signs of an allergic reaction are: difficulty in breathing,
or swelling of the face, lips, tongue or throat, skin rash, itching and
reddening of the skin.
• If you experience one of these side effects, you should stop the
treatment and consult a doctor immediately.
Side effects in adults:
• Very Common (may affect more than 1 in 10 people ): diarrhoea.
• Common (may affect up to 1 in 10 people): abdominal pain, swollen
abdomen (abdominal distention), wind (flatulence), vomiting, feeling
sick (nausea), abnormal liver function tests.
• Uncommon (may affect up to 1 in 100 people): low level of red
blood cells, increased heartrate (tachycardia), hypothyroidism, fatigue,
peripheral oedema, pain, intestinal abcess, viral gastroentiritis, high
level of amylase in the blood, high level of CPK in the blood, high
level of glucose in the blood, increased red blood cell sedimentation
rate, appetite disorder, dehydration, low level of sugar in the blood
(hypoglycaemia), local swelling, muscle twitching, dizziness, altered
sense of taste (dysgueusia), migraine, inflammation of a nerve (neuritis),
pelvic pain, sinus congestion, hiccups, acne, rash, urticaria, high blood

pressure, allergic reactions, low levels of sodium (hyponatreamia) and
potassium (hypokalaemia) in blood especially in elderly patients (over
65 years of age).
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 :
Ireland : HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website : www.hpra.ie
e-mail : medsafety@hpra.ie
United-Kingdom : the Yellow Card Scheme
Website : 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 TRANSISOFT® 8.5 g
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 the sachet. The expiry date refers to the last day of that month.
Reconstituted solution must be used immediately.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What TRANSISOFT® 8.5 g contains

The active substance is macrogol 3350 (Macrogol is also known as
polyethylene glycol or PEG). Each sachet contains 8.5 grams of macrogol
3350.

What TRANSISOFT® 8.5 g looks like and contents of the pack
This medicine is a white or almost white powder in a sachet for making up
a solution.
It is available in packs of 14 or 28 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratoires MAYOLY SPINDLER
6, avenue de l’Europe – B.P. 51
78401 CHATOU CEDEX - France

Manufacturer

Recipharm Höganäs AB
Sporthallsvägen 6
SE-263 34 Höganäs
SWEDEN
This medicinal product is authorised in the Member States of the EEA
under the following names:
Belgium, Ireland, United-kingdom : TRANSISOFT®
France : macrogol 3350 MAYOLY-SPINDLER
This leaflet was last revised in 06/2016
Detailed information on this medicine is available on the website of :
Ireland : HPRA
Website : www.hpra.ie
United-Kingdom : MHRA
Website : www.mhra.gov.uk

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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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