NOTICE
ANSM - Last updated: 30/06/2017
Name of the medicinal product
PARAPSYLLIUM powder for oral suspension in sachets
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 your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS PARAPSYLLIUM Powder for Oral Suspension in PACK AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE PARAPSYLLIUM, powder for oral suspension in sachets?
3. HOW TO TAKE PARAPSYLLIUM powder for oral suspension in sachets?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PARAPSYLLIUM powder for oral suspension in sachets?
6. ADDITIONAL INFORMATION
1. WHAT IS PARAPSYLLIUM Powder for Oral Suspension in PACK AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
LAXATIF DE LAT / LAXATIVE LUBRICANT
(A: digestive system and metabolism)
Therapeutic indications
This medication is indicated for the symptomatic treatment of constipation.
2. BEFORE YOU TAKE PARAPSYLLIUM, powder for oral suspension in sachets?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take PARAPSYLLIUM powder for oral suspension in sachets in the following cases:
· intestinal occlusion (stopping intestinal transit),
· abdominal pain of indeterminate cause,
· fecal matter (fecal plug).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with PARAPSYLLIUM powder for oral suspension in sachets:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
Occasional constipation
It may be related to a recent change in lifestyle (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.
Special cases of the child
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of 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.
Precautions for use
Use this medicine with caution in case of:
· diabetes: take account of the presence of sorbitol (3.284 g per sachet);
· obstruction of the biliary tract;
· concomitant administration of vitamins A, D, E and K, the absorption of which may be decreased;
· alteration of intestinal motility;
· prolonged bedtime: risk of fecal matter (plug of fecal matter);
Elderly people should be sure to drink plenty.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
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 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: sorbitol.
3. HOW TO TAKE PARAPSYLLIUM, powder for oral suspension in sachets?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
1 sachet per day.
Administration mode
Oral use.
Pour the contents of a sachet into a large glass of water or fruit juice.
Shake and drink immediately.
Frequency of Administration
To be taken once a day, in the evening at bedtime.
Duration of the treatment
The duration of treatment varies according to the symptomatology.
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, PARAPSYLLIUM powder for oral suspension in sachets is likely to cause side effects, although not everybody gets them.
Risk of abdominal bloating in the beginning, treatment.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE PARAPSYLLIUM powder for oral suspension in sachets?
Keep out of the reach and sight of children.
Expiration date
Do not use PARAPSYLLIUM powder for oral suspension in sachets after the expiry date which is stated on the carton.
Storage conditions
This medication should be stored away from moisture.
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 PARAPSYLLIUM, powder for oral suspension in sachet contain?
The active substances are:
Pulverized mucilaginous seed of Psyllium seeds (1) ........................................ .......................... 3.333 g
Microencapsulated liquid paraffin ............................................... .................................................. ..... 3.333 g
Quantity corresponding to:
- Light liquid paraffin .............................................. .................................................. ...................... 2.87 g
- Gelatin ................................................ .................................................. ........................................ 0.28 g
- Silicon dioxide (Syloïd 244) .......................................... .................................................. ............ 0.14 g
- Sorbic acid ............................................... .................................................. ................................ 0.03 g
For a bag of 10 g.
(1)Mucilaginous seed coat pulverized with Psyllium seeds: Ispaghul seed powder ( Psyllium husk ) obtained from " Plantago ovata " Forsk seeds.
The other components are:
Sorbitol, mango flavor, apricot flavor, anhydrous colloidal silica.
Pharmaceutical form and content
What is PARAPSYLLIUM, powder for oral suspension in sachets and contents of the pack?
This medicinal product is in powder form for oral suspension in sachets. Box of 10, 30 or 200.
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
ALFASIGMA FRANCE
14 BOULEVARD DES FRERES VOISIN
92130 ISSY-LES-MOULINEAUX
exploiting
ALFASIGMA FRANCE
14 BOULEVARD DES FRERES VOISIN
92130 ISSY-LES-MOULINEAUX
Maker
OPODEX INDUSTRIE LABORATORIES
36-42 AVENUE MARC SANGNIER
92390 VILLENEUVE LA GARENNE
or
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
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.