NOTICE
ANSM - Last updated: 28/11/2016
Name of the medicinal product
POLY-KARAYA, granulated
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS POLY-KARAYA, granulated AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE POLY-KARAYA, granulated?
3. HOW TO TAKE POLY-KARAYA, granulated?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE POLY-KARAYA, granulated?
6. ADDITIONAL INFORMATION
1. WHAT IS POLY-KARAYA, granulated AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medicine is indicated for the symptomatic treatment of non-organic colopathies (colonic disease): diarrhea, constipation, meteorism (bloating due to gas accumulation).
2. BEFORE YOU TAKE POLY-KARAYA, granulated?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take POLY-KARAYA, granulated in case of stenosing stenosis of the digestive tract (permanent narrowing of part or the entire digestive tract).
Precautions for use; special warnings
Take special care with POLY-KARAYA, granulated:
Because of the presence of sucrose, it should NOT be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
In case of megacolon (dilation of part or all of the large intestine), this drug will be used with caution.
This medicinal product contains 3.55 g of sucrose per sachet (maximum daily quantity 10.65 g): take it into account in the daily diet in the case of a low-sugar diet or diabetes.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and 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
List of excipients with a known effect: sucrose (3.55 g per sachet).
3. HOW TO TAKE POLY-KARAYA, granulated?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
3 sachets per day in 3 doses.
Administration mode
Oral use.
To swallow without chewing with a little water, at the beginning of the meals.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, POLY-KARAYA, Granulated is likely to have side effects, although not everyone is subject to it.
· Sometimes, at the beginning of treatment, a transient sensation of intestinal bloating.
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 POLY-KARAYA, granulated?
Keep out of the reach and sight of children.
Expiration date
Do not use POLY-KARAYA, granulated after the expiry date stated on the carton.
Storage conditions
Store at a temperature not exceeding 30 ° C.
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 POLY-KARAYA contain, granulated?
The active substances are:
Gum karaya ................................................ .................................................. .................................... 4 g
Polyvinylpolypyrrolidone ................................................. .................................................. ....................... 2 g
For a bag of 10 g.
The other components are:
Gum, saccharose, gelatin, gum arabic, talc, titanium oxide (E 171), powdered compound flavor no. 27864.
Pharmaceutical form and content
What is POLY-KARAYA, granulate and contents of the pack?
This medication is in the form of sachets. Box of 30 sachets of 10 g.
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
CHEPLAPHARM ARZNEIMITTEL GMBH
BAHNHOFSTRASSE 1A
17498 MESEKENHAGEN
GERMANY
exploiting
CHEPLAPHARM France
105, RUE ANATOLE France
92300 LEVALLOIS-PERRET
Maker
DELPHARM DIJON
6 BOULEVARD OF EUROPE
21800 QUETIGNY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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.