NOTICE
ANSM - Last updated: 17/07/2017
Name of the medicinal product
TRANSILANE, powder for oral suspension in sachet
Seed powder of ispaghul seed
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed 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 pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 3 days.
Do not use this medication for children.
What is in this leaflet?
1. What is TRANSILANE, powder for oral suspension in sachets and in which cases it is used?
2. What should be known before taking TRANSILANE powder for oral suspension in sachets?
3. How to take TRANSILANE powder for oral suspension in sachets?
4. What are the possible side effects?
5. How to store TRANSILANE powder for drinkable suspension in sachets?
6. Package contents and other information.
1. WHAT IS TRANSILANE, Powder for Oral Suspension in PACK AND WHAT IT IS USED FOR?
Laxative of ballast.
Herbal medication indicated in the symptomatic treatment of constipation.
This medication is indicated for adults.
2. BEFORE YOU TAKE TRANSILANE, powder for oral suspension in sachet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine .
Do not take TRANSILANE
· If you are allergic (hypersensitive) to the seed coat of ispaghul or any of the other ingredients of this medication mentioned in section 6.
· If you are allergic to ispaghul seeds. See the paragraph below "Be careful with TRANSILANE"
· If you are suffering from a bowel or large intestine (colon) disease.
· If you have unbalanced diabetes.
· If you suffer from stomach pain you do not know the cause.
· If you have a plug of fecal matter in the intestine (fecaloma).
· If you have bleeding at the anus you do not know the cause.
· If you have difficulty swallowing.
Warnings and Precautions
This medicine contains 2.32 g of sugar per sachet. You should consider this if you are on a low-sugar diet or have diabetes.
This medicine contains a sugar (sucrose). The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains 273 mg of potassium per sachet. You should take this into consideration if your kidneys are not working or if you need to control your potassium dietary intake.
Each sachet is to be taken with at least 90 ml of water. Ingested with insufficient water, this product can swell and block the throat or esophagus. In case of chest pain, vomiting or difficulty in swallowing or breathing, consult a doctor immediately.
If you are being treated with medications that slow down the intestinal transit, you should consult your doctor before taking this medication.
If you are a healthcare professional or caregiver who has long been preparing ispaghul powder products for administration to patients, you may become allergic to these products due to permanent inhalation of the powder. Do not use this medication if you have any of the following symptoms (listed under "What are the possible side effects?") Identified as allergic reactions (see section "Never take TRANSILANE").
Prolonged use is not recommended.
Consult your doctor before taking this medication if you have been immobilized for a long period of time in a bed or if you have very little physical activity.
Tell your doctor if you have kidney disease (kidney failure). Taking this medication may cause an increase in potassium in your blood (hyperkalaemia).
In case of stomach pain or irregular stools during treatment, stop TRANSILANE and ask your doctor for advice.
Children and Youth
In children and adolescents, the treatment of constipation is based on lifestyle and dietary measures such as the use of the right amount of water with milk powders for the child, diet rich in products of vegetable origin, or a consumption of fruit juice.
Long-term treatment with a laxative is not recommended in children because regular intake may interfere with the normal functioning of the defecation reflex.
Other medicines and TRANSILANE
You should tell your doctor or pharmacist if you are taking any medicines that may increase the level of potassium in the blood (hyperkalaemia).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist
The medicines mentioned below should be taken under medical supervision with TRANSILANE
· Minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine, lithium, since their absorption can be decreased. The catch must be shifted by at least 30 minutes.
· thyroid hormones because their dose should be adjusted if necessary.
· Antidiabetic treatments because their dose must be adjusted if necessary.
TRANSILANE with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication will only be used during pregnancy and lactation 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
TRANSILANE contains sucrose and potassium.
3. HOW TO TAKE TRANSILANE, powder for oral suspension in sachet?
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 in doubt.
Dosage
adults
The usual dose is 1 sachet, one to three times a day.
Administration mode
This medication is used orally:
· Pour the powder into a large glass and fill with water.
· Shake and drink immediately.
· Try to avoid inhaling the powder when preparing this product for administration.
Duration of treatment
You should not use this medication for long periods of time without consulting your doctor.
If you take more TRANSILANE than you should :
Immediately consult your doctor or pharmacist.
If you forget to take TRANSILANE :
Do not take a double dose to make up for a missed dose.
If you stop taking TRANSILANE :
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
At the beginning of treatment, bloating, stomach pain, nausea or vomiting can occur and usually disappear during treatment. The frequency is undefined.
Swelling of the belly and risk of oesophageal obstruction or plug of fecal matter can occur especially if the product is swallowed with insufficient amount of fluid. The frequency is undefined.
The seed coat of ispaghul contains substances capable of causing allergic reactions after oral administration of the product, upon contact with the skin and by inhalation when the product is in the form of a powder.
Allergic symptoms may include nasal discharge, redness of the eyes, difficulty breathing, skin reactions, itching and, in some cases, anaphylaxis (a sudden, generalized allergic reaction that can cause a potentially fatal shock). Subjects who regularly prepare the powder are more prone to these reactions (see also section 2, what should be known before taking TRANSILANE ).
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 TRANSILANE powder for oral suspension in sachet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature of + 25 ° C and away from moisture.
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 is contained in TRANSILANE
· The active substance is:
Ispaghul ( Plantago ovata Forssk . ) (Tegument powder of the seed of) ................................. 2.816 g
For a sachet.
· The other ingredients are: potassium bicarbonate, anhydrous citric acid, sodium saccharin, sucrose, lemon flavor.
What TRANSILANE looks like and contents of the pack
TRANSILANE comes in powder form for drinkable suspension in sachets.
Each box contains 20 bags of 7 g.
Marketing Authorization Holder
INNOTECH INTERNATIONAL LABORATORY
22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
Marketing Authorization Operator
INNOTECH INTERNATIONAL LABORATORY
22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
Maker
INNOTHERA CHOUZY
RENE CHANTEREAU STREET
41150 CHOUZY SUR CISSE
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 later by the holder]
MM / YYYY
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Tips for proper use of this medication
There are two types of constipation: constipation of short duration and constipation of long duration. You should follow these guidelines carefully for proper use of this medication.
Short-term constipation (occasional)
It may be related to a recent change in your lifestyle (for example, a trip).
Ask your doctor if constipation is recent and can not be explained by the change in your lifestyle or if you have pain, fever or swelling of the belly.
Long-term (chronic) constipation
It can be linked to two causes:
Either you suffer from a bowel disease that requires management by the doctor.
Either you have an intestinal imbalance related to your eating habits and your way of life.
The treatment includes hygiene and dietetics:
· An increase in vegetable fibers (green vegetables, raw vegetables, whole bread, fruits ...) in your diet.
· Increased consumption of water and fruit juices.
· Sometimes adding sound to your diet.
· An increase in physical activities (sports, walking ...).
· A rehabilitation of the defecation reflex.
In all cases and if you have any doubts, do not hesitate to seek advice from your doctor or pharmacist.