NOTICE
ANSM - Updated: 26/09/2013
Name of the drug
VEGETABLE DRYING REX, film-coated tablet
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· 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.
Summary notice
In this notice :
1. WHAT IS VEGETABLE REX DRYING, film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE VEGETABLE DRESSES REX, film-coated tablet?
3. HOW TO TAKE VEGETABLE DRYING REX, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PLANT VEGETABLE REX, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS VEGETABLE REX DRYING, film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
STIMULATING LAXATIVE
Therapeutic indications
This medicine is a stimulant laxative. (It stimulates intestinal evacuation).
It is recommended in occasional constipation. It usually works in 8 to 12 hours.
2. BEFORE YOU TAKE VEGETABLE DRESSES REX, film-coated tablet?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take VEGETABLE DRAGEES REX, film-coated tablets in the following cases:
· certain diseases of the intestine and colon,
· in case of abdominal pain (stomach pain),
· in case of chronic constipation (long-term constipation),
· in children under 12 years old without the prescription of a doctor.
Precautions for use; special warnings
Take care with REX VEGETABLE DRAGEES, film-coated tablets:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Occasional constipation: It may be related to a recent lifestyle change (travel). The drug can be a help in short treatment. Any recent constipation unexplained by the change in lifestyle, any constipation accompanied by pain, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation): It should not be treated with a stimulant laxative.
It can be related to two causes:
· a bowel disease that requires management by the doctor,
· an imbalance in bowel function due to dietary habits and lifestyle.
The treatment includes among others:
· an increase in dietary intake of plant products (green vegetables, raw vegetables, wholemeal bread, fruit ...),
· an increase in the consumption of water and fruit juice,
· an increase in physical activities (sport, walking ...),
· a reeducation of the defecation reflex,
· sometimes, the addition of sound to the diet.
It is helpful to consult your doctor or pharmacist.
Special case of the child: In the child the treatment of the constipation is based on measures of hygiene of life and dietetics: in particular use of the right quantity of water with the infant milk powders, food rich products of vegetable origin, addition of fruit juice.
Treatment with a stimulant laxative without medical advice is contraindicated. (Regular laxatives at a young age may hinder the normal functioning of the defecation reflex).
Precautions for use
This medicine may cause a loss of potassium. The combination with other medications (such as certain diuretics or heart medications) can be dangerous.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable
Interactions with herbal products or alternative therapies
Not applicable
Use during pregnancy and lactation
It is best not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Lactose.
3. HOW TO TAKE VEGETABLE DRYING REX, film-coated tablet?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
1 to 3 tablets after the evening meal starting with one tablet.
Duration of the treatment
Treatment should be short-lived (8 to 10 days maximum).
Symptoms and instructions in case of overdose
If you have used more REX VEGETABLE DRESSES, film-coated tablets than you should:
Consult your doctor or your pharmacist.
Instructions for omitting one or more doses
If you forgot to use DRAGEES VEGETALES REX, film-coated tablet :
Do not take a double dose to make up for the dose you forgot to take. Continue your treatment normally.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, DRAGEES VEGETALES REX, film-coated tablets can cause side effects, although not everybody gets them:
Possibility of diarrhea, abdominal pain.
In this case stop the treatment and ask your doctor for advice.
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.
5. HOW TO STORE PLANT VEGETABLE REX, film-coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use REX VEGETABLE DRAGEES, film-coated tablets after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does DRAGEES VEGETALES REX, film-coated tablet contain?
The active substances are:
Hydroalcoholic dry extract from Bourdaine ............................................. .......................................... 20,000 mg
Aqueous dry extract of Cascara ............................................. .................................................. ..... 24,000 mg
For a film-coated tablet.
The other components are:
Lactose monohydrate, microcrystalline cellulose (Avicel pH 102), hydrated colloidal silica, silicic acid (Tixosil 33 J), magnesium stearate, regular opaglos NA-7150 (1) , opadry II BROWN 85F36637 (2) .
(1)Composition of Opaglos regular NA-7150 : Shellac, povidone.
(2)Composition of Opadry II BROWN 85F36637 : Black iron oxide, red iron oxide, talc, macrogol, polyvinyl alcohol.
Pharmaceutical form and content
What is DRAGEES VEGETALES REX, film-coated tablet and contents of the pack?
Coated tablet. Box of 40 tablets under pads.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
exploiting
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
Maker
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
Names of the drug in the member states of the European Economic Area
This medicine 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 this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (www.ansm.sante.fr).
Information reserved for health professionals
Not applicable.
Other
Not applicable.