NOTICE
ANSM - Updated on: 16/02/2015
Name of the medicinal product
TRANSIPEG 5.9 g, powder for oral solution in sachet
Macrogol 3350
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet. You might 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 give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
Review summary
In this notice :
1. WHAT IS TRANSIPEG 5.9 g, powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE TRANSIPEG 5.9 g powder for oral solution in sachet?
3. HOW TO TAKE TRANSIPEG 5.9 g, powder for oral solution in sachet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE TRANSIPEG 5.9 g powder for oral solution in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS TRANSIPEG 5.9 g, powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
TRANSIPEG 5.9 g, powder for oral solution in a sachet belongs to a group of medicines called osmotic laxatives. Osmotic laxatives are drugs that keep water in your gut.
Therapeutic indications
This medication is indicated for the symptomatic treatment of constipation in adults.
2. BEFORE YOU TAKE TRANSIPEG 5.9 g powder for oral solution in sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take TRANSIPEG 5.9 g, powder for oral solution in sachet:
· If you are allergic (hypersensitive) to the active ingredient (macrogol 3350) or any of the other ingredients of TRANSIPEG 5.9 g, powder for oral solution in sachet ( see section "6. Additional Information" ).
· If you have a bowel disease (and especially a colon).
· If you have a perforation or if you are going to puncture your gut.
· If you have pain in your tummy.
· If you have a hereditary disease called phenylketonuria because TRANSIPEG 5.9 g, powder for oral solution contains aspartame ( see also "Important information about some of the ingredients of TRANSIPEG 5.9 g, powder for oral solution in sachet " ).
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with TRANSIPEG 5.9 g powder for oral solution in sachet:
If you are using this medication for the first time and you are not getting better after 2 weeks of treatment, ask your doctor.
TRANSIPEG 5.9 g, powder for oral solution in sachet and constipation:
Occasional constipation : It may be related to a recent change in lifestyle (eg travel). TRANSIPEG 5.9 g, powder for oral solution in sachet can be a short treatment aid. You should consult your doctor for any recent constipation that is not due to a change in lifestyle or for any constipation accompanied by pain, fever or swelling of the belly.
Chronic constipation (long-lasting constipation) : It can be related to two causes:
· Either you suffer from a bowel disease. Your doctor will then prescribe a specific treatment for this situation;
· Either you have an imbalance in your intestine related to your eating habits and your lifestyle.
The treatment of your constipation should be accompanied by the following recommendations on your eating habits and lifestyle:
· an increase in vegetable fibers (green vegetables, raw vegetables, whole bread, fruits ...) in your diet;
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· rehabilitation of the defecation reflex;
· sometimes, adding sound to your diet.
It is important to consult a doctor if there is no improvement.
Interaction with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
TRANSIPEG 5.9 g powder for oral solution in sachet can be used during pregnancy only on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
feeding
TRANSIPEG 5.9 g, powder for oral solution in sachets can be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of TRANSIPEG 5.9 g powder for oral solution in sachet:
TRANSIPEG 5.9 g, powder for oral solution contains several ingredients you should consider before using this medicine:
· of aspartam (source of phenylalanine). It can be dangerous for people with a hereditary disease called phenylketonuria.
· of sucrose. If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
· of sodium (290 mg per sachet). You should consider this if you are on a salt-free or low-salt diet.
· potassium (about 40 mg per sachet). You should consider this if you have kidney failure or if you are on a controlled potassium diet.
3. HOW TO TAKE TRANSIPEG 5.9 g, powder for oral solution in sachet?
Instructions for proper use
TRANSIPEG 5.9 g powder for oral solution in sachets should be taken only for a short period of time.
The effect of TRANSIPEG 5.9 g, powder for oral solution in a sachet is manifested within 24 to 48 h after setting.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Always take the dose recommended by your doctor. In case of doubt consult your doctor or pharmacist.
The usual dose is 1 to 2 sachets per day to be taken at one time, preferably in the morning.
Method of administration
TRANSIPEG 5.9 g, powder for oral solution in sachet is used orally. Each sachet must be dissolved in 100 ml of water (half a glass of water, preferably non-gaseous). Once the sachet is dissolved, take this medication quickly.
If you feel that the effect of TRANSIPEG 5.9 g powder for oral solution is too strong or too weak, talk to your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you take more than TRANSIPEG 5.9 g powder for oral solution in a sachet you should:
Consult your doctor or pharmacist immediately ( see also section "4. What are the possible side effects?" ).
Instructions for omission of one or more doses
If you forget to take TRANSIPEG 5.9 g, powder for oral solution in sachet:
Do not take a double dose to make up for the single dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, TRANSIPEG 5.9 g powder for oral solution in a sachet is liable to have undesirable effects, although not everyone is subject to it.
· Very rare cases of anaphylactic reactions (severe allergic reaction causing breathing difficulties, swelling) and allergic to urticaria (red patches), rash, pruritus (itching) or edema (swelling) have been reported reported. If these reactions occur, stop treatment immediately and seek advice from your doctor.
· Abdominal pain and bloating have also been reported frequently, especially in patients with intestinal disorders.
· The occurrence of mild to moderate diarrhea or fluid stools is a common side effect, especially in the case of a high dose.
These effects generally disappear within 24 to 48 hours after discontinuation of therapy. The treatment can then be resumed at a lower dose.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE TRANSIPEG 5.9 g powder for oral solution in sachet?
Keep out of the reach and sight of children.
Expiration date
Do not use TRANSIPEG 5.9 g powder for oral solution in sachets after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does TRANSIPEG contain 5.9 g, powder for oral solution in sachets?
The active substance is macrogol 3350 (5.9 g per sachet).
The other ingredients are sodium chloride, anhydrous sodium sulfate (E514), potassium chloride (E508), sodium bicarbonate (E500), aspartame (E951), potassium acesulfame, aroma lemon.
The lemon flavor contains: maltodextrin, sucrose, lemon flavor, gum arabic (E414), lecithin (E322) and silicon dioxide (E551).
Pharmaceutical form and content
What is TRANSIPEG 5.9 g, powder for oral solution in sachet and contents of the pack?
This medication is in the form of white to whitish powder to be dissolved in water. This medication is packaged in boxes containing 10, 20, 30, 50, 60 or 200 sachets.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
Maker
LABORATORIES M. RICHARD
RUE DU PROGRES
ZI OF REYS DE SAULCE
26270 SAULCE -SUR-RHONE
or
LAMPS. PROSPERO SPA
Via Della Pace, 25 / A
41030 SAN PROSPERO (MO)
Italy
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.