NOTICE
ANSM - Last updated: 26/09/2013
Name of the medicinal product
DRAGEES FUCA, coated tablet
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 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 DRAGEES FUCA, coated tablet AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE DRAGEES FUCA, coated tablet?
3. HOW TO TAKE DRAGEES FUCA, coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DRAGEES FUCA, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS DRAGEES FUCA, coated tablet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
STIMULANT LAXATION
(A: digestive system and metabolism)
Therapeutic indications
This medication is a stimulant laxative (it stimulates intestinal evacuation).
It is indicated in the short-term treatment of occasional constipation of the adult.
2. BEFORE YOU TAKE DRAGEES FUCA, coated tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
This medicinal product should NOT be used in the following cases:
· certain diseases of the intestine and colon
· in case of abdominal pain (stomach pains)
· in the case of chronic constipation (long-lasting constipation)
· in children under 10 years of age.
This medication is GENERALLY NOT RECOMMENDED unless your doctor advises you in the following cases:
· in combination with certain diuretics or some medicines for the heart ( see chapter interactions )
· in children aged 10 to 15 years.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Special warnings
The use of this medication is not recommended in patients with intolerance to fructose, galactose, Lapp lactase deficiency or glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains "Parahydroxybenzoate" and may cause allergic reactions.
Do not exceed 8 to 10 days of treatment.
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 should not be treated with a stimulant laxative.
It can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...)
· an increase in the consumption of water and fruit juices
· an increase in physical activities (sports, walking ...)
· rehabilitation of defecation reflex
· sometimes, the addition of sound to food
It is helpful to seek advice from your doctor or pharmacist.
Special case of the child :
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right quantities of water with infant milk powders, a diet rich in vegetable products, addition of juice of fruits.
Interaction with other medicines
Taking 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.
Particularly if you take amiodarone, astemizole, bepridil, bretylium, disopyramide, erythromycin IV, halofantrine, pentamidine, quinidinic, sparfloxacin, sotalol , sultopride, terfenadine, vincamine.
Interactions with food and beverages
Not applicable
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
This medication is not recommended during pregnancy and lactation.
Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before using any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Glucose, lactose, sucrose, soda methylated parahydroxybenzoate (E 219), soda propyl parahydroxybenzoate (E 217).
3. HOW TO TAKE DRAGEES FUCA, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS
1 to 2 tablets maximum per day.
Method and route of administration
ORAL TRACK
Duration of treatment
This treatment should only be taken for a short period (maximum 8 to 10 days).
If the effect of the treatment is insufficient, do not increase the dose or prolong the use but ask your doctor or pharmacist.
Symptoms and Instructions for Overdose
Not applicable
Instructions for omission of one or more doses
Do not take a double dose to make up for a missed dose. Continue your treatment normally .
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, DRAGEES FUCA, coated tablet is likely to have undesirable effects, although not everyone is subject to it:
Possibility of diarrhea, abdominal pain.
In this case, stop taking and seek advice from your doctor.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE DRAGEES FUCA, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not exceed the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
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 DRAGEES FUCA contains, coated tablet
The active substances are:
Bourdaine (dry hydroalcoholic extract titrated from) .......................................... ................................... 100.00 mg *
Cascara (dry hydroalcoholic extract titrated from) .......................................... ...................................... 100.00 mg *
Fucus (dry aqueous extract of) ........................................... .................................................. ........... 50.00 mg
For a coated tablet
* A coated tablet contains 12.5 mg of anthracene glycosides expressed as glucofrangulin A.
The other components are:
Microcrystalline cellulose, glycerol dibehenate, magnesium stearate, lactose monohydrate, gum arabic, sucrose, liquid glucose, sodium bicarbonate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, talc, charcoal, brown iron oxide, beeswax yellow.
Pharmaceutical form and content
Coated tablet, box of 15 or 45.
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
HEPATOUM LABORATORY
1 bis, rue de Plaisance
94130 NOGENT-SUR-MARNE
exploiting
HEPATOUM LABORATORY
1, rue du Pont
03270 SAINT-YORRE
Maker
HEPATOUM Laboratories
1, rue du Pont
03270 SAINT YORRE
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product 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 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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.