TRANSISOFT

Patient Information Leaflet

TRANSISOFT 8.5 g powder for oral solution in sachet

Macrogol 3350
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not feel better or if you feel worse.

Contents of this leaflet

1. What TRANSISOFT 8.5 g is and what it is used for
2. What you need to know before taking 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 adds water to the stools, making them softer and increasing their volume, thereby helping to relieve symptoms associated with sluggish bowel. It is neither absorbed into the bloodstream nor 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 under 17 years of age.

2. What you need to know before taking TRANSISOFT 8.5 g

Information on the treatment of constipation
The treatment of chronic constipation with any medicinal product should only be
complementary to a healthy lifestyle and diet, for example:

• increasing the proportion of plant-based foods in the diet (vegetables, bread, fruit),
• increasing fluid and fruit juice intake,
• increasing physical activity (sports, walking, etc.),
• retraining the 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 suffer from a severe intestinal inflammatory disease (such as ulcerative colitis, Crohn's disease, or toxic megacolon, associated with intestinal narrowing).
• If you have a perforation in the intestinal wall or are at risk of intestinal perforation.
• If you have a blockage in the intestine (intestinal obstruction, ileus) or symptomatic stenosis.
• If you have an abdominal condition with unknown cause causing pain.

Do not take this medicine if any of the conditions described above apply to you. If
you are unsure, consult your pharmacist or doctor before taking the medicine.
Warnings and precautions

• An allergic reaction may occur. Warning signs of an allergic reaction and the measures to be taken are described in section 4. Please read this section carefully.
• This medicine does not contain sugars and can therefore be used if you have diabetes or need to follow a galactose-free diet.

Since this medicine may sometimes cause diarrhoea, consult a doctor or pharmacist
before taking the medicine if:

• you suffer from hepatic or renal insufficiency,
• you are taking diuretics or are elderly, as you may be at risk of low levels of sodium (salt) or potassium in the blood.

Other medicines and TRANSISOFT 8.5 g
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
Some medicines may not work as effectively when taken together with Transisoft.
Pregnancy and breastfeeding
TRANSISOFT 8.5 g may be taken during pregnancy and while breastfeeding.
If you are pregnant, trying to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking TRANSISOFT 8.5 g.
Driving and using machines
This medicine has no effect on the ability to drive vehicles or operate machinery.

3. How to take TRANSISOFT 8.5 g

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 the dose
Dissolve the contents of one sachet in half a glass of water (100 ml) immediately before use and drink the resulting solution.
The dissolved solution remains clear like water.
Usual time required for the medicine to take effect
This medicine generally takes 24–48 hours to work. However, if symptoms do not improve after 5 days of using Transisoft, consult a doctor.
If you take more TRANSISOFT 8.5 g than you should

• It may cause diarrhoea, which usually resolves by stopping treatment or reducing the dose.
• If you experience severe diarrhoea or vomiting, you must contact a doctor as soon as possible, as treatment may be necessary 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 the missed sachet.

4. Possible side effects

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

Allergic reactions

• Warning signs of an allergic reaction include: difficulty breathing, or swelling of the face, lips, tongue or throat, skin rash, itching and redness of the skin.
• If you experience any of these side effects, you must stop 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, abdominal swelling (abdominal distension), flatulence, vomiting, feeling unwell (nausea), abnormal liver function tests.
• Uncommon (may affect up to 1 in 100 people): low red blood cell count, increased heart rate (tachycardia), hypothyroidism, fatigue, peripheral oedema, pain, intestinal abscess, viral gastroenteritis, high levels of amylase in the blood, high levels of creatine phosphokinase (CPK) in the blood, high blood glucose levels, increased erythrocyte sedimentation rate, disturbances in appetite, dehydration, low blood sugar levels (hypoglycaemia), local swelling, muscle contractions, dizziness, altered taste sensation (dysgeusia), headache, inflammation of a nerve (neuritis), pelvic pain, sinus congestion, hiccups, acne, skin rash, urticaria, high blood pressure, allergic reactions, low levels of sodium (hyponatraemia) and potassium (hypokalaemia) in the blood, especially in elderly patients (aged over 65 years).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
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 stated on the carton and sachet. The expiry date refers to the last day of that month.
The reconstituted solution must be used immediately.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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.
Description of the appearance of TRANSISOFT 8.5 g and contents of the pack
This medicine is a white or almost white powder contained in a sachet, to be used for the preparation of a solution.
It is available in packs of 14 or 28 sachets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in EEA Member States under the following names:
Transisoft: Belgium, Germany, Italy, Ireland, and United Kingdom.
Macrogol 3350 Mayoly Spindler: France
More detailed information on this medicinal product is available on the website:
http://www.agenziafarmaco.gov.it