Dulcolax is a stimulant laxative. It is recommended for occasional constipation due to a recent change in lifestyle (e.g. travel) or any unexplained recent constipation.
For warnings, precautions and contraindications, please refer to the package insert.
Dulcolax is a stimulant laxative. It is recommended for occasional constipation due to a recent change in lifestyle (e.g. travel) or any unexplained constipation. For adults and children over 6 years of age. This medicine is also available as Dulcolax suppository in our online pharmacy.
Stimulant laxatives increase muscular contractions in the digestive tract (peristalsis) to move contents faster, facilitating a shorter colonic transit time. Oral stimulants often take between 6 and 10 hours to take effect. In patients suffering from chronic constipation caused by irritable bowel syndrome, stimulants may be the only solution, but should only be taken on a short-term basis.
Taken in the evening (effect 10 hours later), taken in the morning on an empty stomach (effect 5 hours later). For occasional use.
Choose Dulcolax tablets, a fast, effective treatment for temporary constipation. Regain intestinal comfort in the blink of an eye thanks to its gentle, stimulating formula.
Dulcolax tablets are specially designed to provide fast, effective relief from temporary constipation. Thanks to their stimulating formula, the tablets act gently on the intestines to promote rapid, pain-free transit. Don't let constipation spoil your life, opt for Dulcolax and regain intestinal comfort in the blink of an eye.
Dulcolax's unique formula has been specially developed to provide a safe, non-addictive treatment for temporary constipation. The tablets are made with high-quality ingredients, making them ideal for occasional use. Trust Dulcolax to help you return to a healthy, balanced life without worrying about unwanted side effects.
Dulcolax tablets are easy to use and offer precise dosing to ensure you get the results you want. Simply take one tablet with a glass of water to enjoy its beneficial effects on your intestinal transit. The tablets are discreet and easy to carry, so you can take them with you wherever you go for fast relief when you need it.
Oral use
Read package leaflet carefully
Box of 30 gastro-resistant coated tablets.
Warning: this medicine is not like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 20/04/2017
DULCOLAX 5 mg, gastro-resistant coated tablet
bisacodyl
You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 10 days.
In this notice :
1. WHAT IS DULCOLAX 5 mg, coated gastro-resistant tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE DULCOLAX 5 mg gastro-resistant coated tablet?
3. HOW TO TAKE DULCOLAX 5 mg, coated gastro-resistant tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DULCOLAX 5 mg gastro-resistant coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS DULCOLAX 5 mg, coated gastro-resistant tablet AND WHAT IT IS USED FOR?
STIMULANT LAXATION
This medication is recommended for occasional constipation.
2. BEFORE YOU TAKE DULCOLAX 5 mg gastro-resistant coated tablet?
List of information needed before taking the medication
Do not take Dulcolax 5 mg, coated tablets in the following cases:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6,
· severe dehydration,
· in children under 6 years of age,
· certain diseases of the intestine and colon (recto-colitis and other inflammatory disease),
· abdominal pain (stomach pain) of undetermined origin, which may be the sign of a serious illness,
· chronic constipation.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
NO EXTENDED USE (UP TO 10 DAYS) WITHOUT MEDICAL ADVICE
Occasional constipation:
It may be linked to a 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 activity (sports, walking ...),
· a rehabilitation of the defecation reflex,
· sometimes, adding sound to the diet.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Special case in children:
In children the treatment of constipation is based on lifestyle and dietary measures: in particular use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.
Treatment with a stimulatory laxative without medical advice is contraindicated. (Regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex).
Due to the presence of lactose and sucrose, the use of this medication is not recommended in patients with fructose or galactose intolerance, glucose and / or galactose malabsorption syndrome or Lapp lactase deficiency or in sucrase-isomaltase (rare metabolic diseases).
This medicine contains castor oil and can cause digestive problems (mild laxative effect, diarrhea).
Dizzy sensations and syncope, which can occur at the time of defecation, have been reported.
Precautions for use
This medicine may cause loss of potassium.
In patients with precarious water balance (eg kidney failure or elderly patients), DULCOLAX should be discontinued and should be reinstated only under medical supervision, due to the increased risk of dehydration due to intestinal water losses.
Symptoms can be thirsty and decreased in the amount of urine (oliguria).
Patients may have blood in the stool (rectal bleeding), which is usually of mild and spontaneously resolving intensity. In case of rectorrhagia, consult a doctor.
This medication MUST NOT BE GENERALLY USED, unless directed to do so by your doctor in association with: amiodarone, bretylium, disopyramide, quinidinic acid, sotalol, astemizole, bepridil, erythromycin IV, halofantrine , pentamidine, sultopride, terfenadine, vincamine.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Other medicines and DULCOLAX 5 mg, gastro-resistant coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
The use of this medication is not recommended during pregnancy.
feeding
Use of this medication is possible during breast-feeding.
Tell your doctor if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
The effects of Dulcolax on the ability to drive and use machines have not been studied.
However, dizziness and / or syncope may occur due to abdominal spasms. In case of abdominal spasm, avoid potentially dangerous activities such as driving and using machines.
List of excipients with known effect
DULCOLAX 5 mg gastro-resistant coated tablet contains
List of excipients with a known effect: lactose, sucrose, castor oil.
3. HOW TO TAKE DULCOLAX 5 mg, coated gastro-resistant tablet?
Not applicable.
· In adults : 1 to 2 tablets per day.
· Children up to 12 years of age with chronic or persistent constipation should be treated only under the direction of a physician.
In children over 6 years of age: the use of a stimulant laxative is exceptional and exclusively on medical prescription: 1 tablet per day for two to ten days.
It is recommended to start treatment with the lowest dose. The dose can then be adjusted up to the dose to obtain regular bowel movements.
Do not exceed the maximum daily dose.
Avoid taking at the same time products that reduce the acidity of the stomach, such as alkaline drugs, antacids, proton pump inhibitors or milk, so as not to prematurely dissolve the acid, coating of the tablet.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION: IT MAY NOT BE ADAPTED TO ANOTHER CASE
DO NOT ADVISE IT TO ANOTHER PERSON
Administration mode
The tablets should be swallowed without being chewed.
Frequency of Administration
Take in the evening (effect 10 hours after) or in the morning on an empty stomach (effect 5 hours after).
Duration of treatment
No prolonged use, greater than 10 days without medical advice.
Symptoms and Instructions for Overdose
If you take more DULCOLAX 5 mg, coated gastro-resistant tablet you should not have:
A correction of the hydroelectrolyte disorders in the event of a very large fluid loss may be necessary. This is particularly important in the elderly and young subjects. Administration of antispasmodics may be useful.
Instructions for omission of one or more doses
Not applicable.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The most common adverse reactions reported during treatment were abdominal pain and diarrhea.
The assessment of adverse reactions is based on the following frequencies:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 patients out of 100
Uncommon: affects 1 to 10 of 1,000 patients
Rare: affects 1 to 10 patients out of 10,000
Very rare: affects less than 1 in 10,000 patients
Not known: can not be estimated from the available data
Immune system disorders
- Rare: Anaphylactic reactions, angioedema
Skin and subcutaneous tissue disorder
- Rare: Generalized itching (allergic reaction)
Metabolism and Nutrition Disorders
- Rare: Dehydration
- Not known: Decreased blood potassium levels
Nervous System Disorders
- Uncommon: Dizziness
- Rare: Syncope
Dulcolax may cause abdominal pain associated with abdominal spasms and / or defecation which may cause dizziness or syncope.
Gastrointestinal disorders
- Common: Abdominal pain, diarrhea, nausea
- Uncommon: Blood in the stool (rectal bleeding), anorectal discomfort (burning sensation and anorectal pain), vomiting
- Rare: Colitis
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.
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 via 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 DULCOLAX 5 mg gastro-resistant coated tablet?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
This medicine does not require special precautions for storage .
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What DULCOLAX 5 mg contains, gastro-resistant coated tablets
· The active substance is:
Bisacodyl ......................................................................................................... ..5.0000 mg
For a coated tablet.
· The other excipients are: lactose monohydrate, anhydrous corn starch, 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, yellow iron oxide, white beeswax, Carnauba wax, shellac.
Pharmaceutical form and content
Aspect of DULCOLAX 5 mg, enteric coated tablet and contents of the pack
This medication is in the form of an enteric coated tablet.
Box of 20, 25 or 30 tablets.
Not all pack sizes may be marketed.
82 AVENUE RASPAIL
94250 GENTILLY
82 AVENUE RASPAIL
94250 GENTILLY
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 notice
The last date on which this leaflet was revised is {YYYY}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Stimulating laxative
bisacodyl
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DULCOLAX: Gastro- resistant tablet (yellow); box of 30.
-
Laboratory Boehringer Ingelheim France
| p cp | |
| bisacodyl | 5 mg |
| Lactose | 35 mg |
Usual dosage:
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