In this manual :
1. WHAT IS DULCOLAX 5 mg, Gastro-resistant Coated Tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DULCOLAX 5 mg gastro-resistant coated tablet
3. HOW DO I TAKE DULCOLAX 5 mg, Gastro-resistant Coated Tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE DULCOLAX 5 mg, Gastro-resistant Coated Tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS DULCOLAX 5 mg, Gastro-resistant Coated Tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
STIMULANT LAXATIVE
This medicine is recommended in cases of occasional constipation.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DULCOLAX 5 mg, Gastro-resistant coated tablet
List of information needed before taking the medicine
Not applicable.
Never take DULCOLAX 5 mg gastro-resistant coated tablet in the following cases:
- known allergy to any of the components of the product,
- severe dehydration,
- in children under 6 years of age,
- certain diseases of the intestine and colon (recto-colitis and other inflammatory diseases),
- abdominal pain (belly pain) of undetermined origin, which may be a sign of a more serious disease,
- chronic constipation.
This medicine MUST NOT BE USED in the following cases, unless otherwise advised by your doctor in combination with: amiodarone, bretylium, disopyramide, quinidinics, sotalol, astemizole, bepridil, erythromicin IV, halofantrine, pentamidine, sultopride, terfenadrine, vincamine.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take caution with DULCOLAX 5 mg, enteric coated tablet:
Special Warnings
DO NOT USE FOR PROLONGED PERIODS (MORE THAN 10 DAYS) WITHOUT MEDICAL ADVICE.
Occasional constipation:
It may be related to a recent change in lifestyle (travel). The drug can be a help in short treatment. Any recent constipation unexplained by a change in lifestyle, any constipation accompanied by pain, fever, swelling of the abdomen should be referred to a doctor.
Chronic constipation (long-term constipation):
It should not be treated with a stimulant laxative.
It can be related to two causes:
- or a bowel disease that requires management by the doctor,
- or to an imbalance of the intestinal function due to eating habits and lifestyle.
The treatment includes among other things:
- an increase in dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit...),
- an increase in the consumption of water and fruit juice,
- an increase in physical activity (sport, walking, etc.),
- reeducation of the defecation reflex,
- sometimes adding bran to the food.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Special case in children:
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 plant-based products, and the addition of fruit juice.
Treatment with a stimulant laxative without medical advice is contraindicated. (Regular use of laxatives in early life can impair the normal functioning of the defecation reflex).
Due to the presence of lactose and sucrose, this medicine should not be used in patients with galactosemia, fructose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency or sucrase-isomaltase deficiency (rare metabolic diseases).
This medicine contains castor oil and may cause digestive disorders (mild laxative effect, diarrhea).
Dizziness and syncope, which may occur at the time of defecation, have been reported.
Precautions for use
This medicine may cause a loss of potassium.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
The use of this medicine should be avoided during pregnancy or while breastfeeding. If you are pregnant or breastfeeding, tell your doctor.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: lactose, sucrose, castor oil.
3. HOW TO TAKE DULCOLAX 5 mg, Gastro-resistant Coated Tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
- In adults: 1 or 2 tablets maximum per day.
- In children over 6 years of age: the use of an irritant laxative is exceptional and only on medical prescription: 1 tablet per day for two to ten days.
THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN A SPECIFIC SITUATION:
- IT MAY NOT BE SUITABLE FOR ANOTHER CASE.
- DO NOT ADVISE IT TO ANOTHER PERSON.
How to take it
The tablets should be swallowed without chewing.
Frequency of administration
Take in the evening (effect 10 hours later) or in the morning on an empty stomach (effect 5 hours later).
Duration of treatment
Do not use for longer than 10 days without medical advice.
Symptoms and instructions in case of overdose
If you have taken more DULCOLAX 5 mg Gastro-resistant Coated Tablets than you should have, you should not take more than the recommended dose:
Correction of fluid and electrolyte disturbances may be necessary in the event of very large fluid losses. This is particularly important in the elderly and young. The administration of antispasmodics may be helpful.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DULCOLAX 5 mg, enteric-coated tablet is likely to have side effects, although not everyone is subject to them, such as: cramps, diarrhea, abdominal pain, decrease in blood potassium levels.
Very rare cases of allergic reactions including anaphylactoid reactions have been reported.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE DULCOLAX 5 mg, Gastro-resistant Coated Tablet
Keep out of the reach and sight of children.
Do not use DULCOLAX 5 mg gastro-resistant coated tablets after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DULCOLAX 5 mg gastro-resistant coated tablet contain?
The active substance is:
Bisacodyl .................................................................................................................................... 5.0000 mg
For one coated tablet.
The other components are:
Lactose monohydrate, maize starch anhydrous, soluble starch, glycerol (85%), magnesium stearate.
Coating: magnesium stearate, sucrose, gum arabic, titanium dioxide, talc, macrogol 6000, eudragit L 100, eudragit S 100, castor oil, iron oxide yellow, white beeswax, carnauba wax, shellac.
Pharmaceutical form and content
What is DULCOLAX 5 mg, enteric coated tablet and what does it contain?
This medicine is presented as a gastro-resistant coated tablet.
Box of 20, 25 or 30 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOEHRINGER INGELHEIM FRANCE
14, rue Jean Antoine de Baif
75013 PARIS
Operator
BOEHRINGER INGELHEIM FRANCE
14, rue Jean Antoine de Baif
75013 PARIS
Manufacturer
DELPHARM REIMS
10 RUE COLONEL CHARBONNEAUX
51100 REIMS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information for healthcare professionals only
Not applicable.
Not applicable.
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