TRANSULOSE Gelée orale en pot Pot 150g

NOTICE

ANSM - Last updated: 24/02/2017

Name of the medicinal product

TRANSULOSE, potted jelly

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is TRANSULOSE, potted jelly and in which cases it is used

2. What information should be known before taking TRANSULOSE, oral jelly pot?

3. How to take TRANSULOSE, oral jelly in pot?

4. What are the possible side effects?

5. How to store TRANSULOSE, oral jelly in a pot?

6. Package contents and other information.

1. WHAT IS TRANSULOSE, potted jelly AND WHAT IT IS USED FOR?

Lubricating laxative.

This medication is indicated for the symptomatic treatment of constipation in adults.

You should talk to your doctor if you do not feel better or feel less well

2. BEFORE YOU TAKE TRANSULOSE, JELLY POT IN JAPAN?

Do not take TRANSULOSE, potted jelly:

· If you are allergic to the active ingredients or to any of the ingredients of this medication mentioned in section 6.

· Certain diseases of the intestine and colon, such as rectocolitis, Crohn's disease, intestinal occlusion.

· In case of abdominal pain (stomach pains).

· In case of digestive perforation or suspicion of perforation.

· In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame

Warnings and Precautions

Talk to your doctor or pharmacist before taking TRANSULOSE, oral jelly in po t.

IN THE CONTEXT OF CONSTIPATION NO LONGER USE (OVER 8 DAYS) WITHOUT MEDICAL ADVICE.

Occasional constipation

It may be related to a recent change in lifestyle (eg travel).

The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.

Chronic constipation (long-term constipation)

It can be linked to two causes:

· a bowel disease that requires a physician to take care of;

· or an imbalance in intestinal function due to dietary habits and lifestyle.

Treatment includes:

· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);

· increased consumption of water and fruit juices;

· an increase in physical activities (sports, walking, etc.);

· rehabilitation of the defecation reflex;

· sometimes, adding sound to the diet.

The administration of paraffin oil in persons who are elongated or have difficulty in swallowing should be cautious because of the risk of bronchial inhalation.

This medication should be used with caution in case of liver or kidney disease and in patients treated with diuretics.

children

Not applicable.

Other medicines and TRANSULOSE, oral jelly in pot

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

TRANSULOSE, potted jelly with food and beverages

Not applicable.

Pregnancy and lactation and fertility

It is best not to use this medication during pregnancy. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice.

Sport

Not applicable.

Driving and using machines

Not applicable.

TRANSULOSE, potted jelly contains aspartame

3. HOW TO TAKE TRANSULOSE, oral jelly in pot?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage

Attack treatment: 2 to 3 teaspoons (5 ml) per day.

Maintenance treatment: 1 to 3 teaspoons per day.

Method and route of administration

Oral use.

Duration of treatment

The duration of treatment varies according to the symptomatology.

If you take more than TRANSULOSE, oral jelly in pot you should:

Immediately consult your doctor or pharmacist.

If you forget to take TRANSULOSE, oral jelly pot:

Not applicable.

If you stop taking TRANSULOSE, oral jelly in jar:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

The following side effects may occur:

· Bloating, semi-fluid stools.

· These phenomena can occur at the beginning of treatment, they cease after adjustment of the dosage.

· Rare cases of itching, anal pain and moderate slimming.

· The use of paraffin oil exposes the risk of anal seepage and sometimes peri-anal irritation.

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 via 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 TRANSULOSE, oral jelly in pot?

Keep this medicine out of the reach and sight of children.

Do not use after the expiry date stated on the package after EXP: MM / YYYY. The expiry date refers to the last day of that month.

This medication should be stored at a temperature not exceeding 30 ° C.

The shelf life after first opening is 4 weeks.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Contains TRANSULOSE, oral jelly in pot

· The active substances are:

Lactulose ................................................. .................................................. ......................... 35.00 g

Special solidified paraffin oil

Quantity corresponding to:

- Vaseline ................................................ .................................................. ......................... 21.45 g

- Liquid paraffin ............................................... .................................................. 42.91 g

For 100 g.

· The other components are: Aspartam, cholesterol, lactic acid, bixin oil, mandarin essential oil, lemon essential oil, sweet orange essential oil.

What is TRANSULOSE, potted jelly and contents of the pack

This medication is in the form of oral jelly: 150 g and 200 g glass jar or 100 g, 150 g or 200 g polypropylene jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder

TEVA HEALTH

100-110, esplanade of the General de Gaulle

92931 Paris la defense cedex

la France

Marketing Authorization Operator

TEVA HEALTH

100-110, esplanade of the General de Gaulle

92931 Paris la defense cedex

la France

Maker

CHEMINEAU LABORATORIES

93 ROAD OF CURRENCY

37210 VOUVRAY

or

SANOFI WINTHROP INDUSTRIE

6 boulevard de l'Europe

21800 QUETIGNY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[To be completed at a later date by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

VIDAL OF THE FAMILY

TRANSULOSE