DULCOLAX 5MG TABLET 30

DULCOLAX 5MG COMPRIMES 30 View larger

3400939069425

Dulcolax is a stimulant laxative. This drug is recommended in cases of occasional constipation related to a recent change in lifestyle (travel) or any recent unexplained constipation.

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For warnings, the precautions and cons-indications, please see the instructions.

Description

Dulcolax is a stimulant laxative. This drug is recommended in cases of occasional constipation related to a recent change in lifestyle (travel) or any recent unexplained constipation.

For adults and children over 6 years

Composition:

  • Bisacodyl 5.00 mg coated tablet.
  • Excipients: lactose monohydrate, corn starch, anhydrous, soluble starch, glycerol (85%), magnesium stearate. Embedding: magnesium stearate, sucrose, arabic gum, titanium dioxide, talc, Macrogol 6000, L 100 and Eudragit S 100, castor oil, yellow iron oxide, white beeswax, carnauba wax, shellac.
  • Excipients with known effect:   lactose, saccharose, castor oil.


Dosage:

  • Adults   : 1-2 tablets per day maximum. Do not make prolonged use (over 10 days).
  • Children 6 to 12 years   : 1 tablet per day for 2 to 10 days maximum

Taken in the evening (10 hours after effect), taken in the morning fasting (5 hours after effect).   Use occasionally.

Cons-indications:

  • Allergy to bisacodyl or any of the excipients.
  • State of severe dehydration
  • Inflammatory bowel disease, ulcerative colitis, Crohn's disease.
  • Abdominal pain syndromes of unknown cause, including severe abdominal pain associated with nausea and vomiting may indicate a more serious condition.
  • Occlusive syndromes or subocclusifs.
  • Children under 6 years.
  • Congenital galactosemia, fructose intolerance, malabsorption of glucose and galactose, or lactase deficiency, or sucrase-isomaltase

Oral

Read carefully the instructions

Packaging
  : Box 30 coated gastro-resistant tablets.

 

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

DULCOLAX tablet

Stimulating laxative

bisacodyl

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

DULCOLAX: Gastro- resistant tablet (yellow); box of 30.
-

Laboratory Boehringer Ingelheim France

COMPOSITION (summary)
p cp
bisacodyl 5 mg
Lactose 35 mg

INDICATIONS (summary)
This medicine contains a stimulant laxative . It increases the secretions and motility of the intestine.
It is used in the symptomatic treatment of constipation.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • inflammatory bowel diseases,
  • abdominal pain of undetermined cause,
  • constipation or abdominal pain due to obstruction of the digestive tract: intestinal constriction, faecaloma (stool plug),
  • child under 6 years of age.
WARNING (Contents)
This medication should be used episodically and in a very brief cure, not more than 8 to 10 days.
Its regular use can result in: The use of laxatives must remain exceptional in children.
Stop treatment in case of diarrhea or abdominal pain.
DRUG INTERACTIONS (summary)
This medicine may interact with medicines that may cause torsades de pointes .
In addition inform your pharmacist or doctor if you are taking corticosteroids (except topical treatment), of diuretics or medications containing digoxin, digitoxin or amphotericin B (by way intravenous).
PREGNANCY AND BREAST-FEEDING (summary)
This medication is not recommended during pregnancy or lactation.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets must be swallowed without being crunched either in the morning on an empty stomach (effect 5 hours after) or in the evening (effect 10 hours later).

Usual dosage:

  • Adult: 1 or 2 tablets per day.
  • Children over 6 years: 1 tablet per day. The duration of the treatment, which should not exceed a few days, is fixed by the doctor.
TIPS (summary)
Avoid simultaneous use of alkaline substances (Vichy water, for example).
The treatment of constipation is essentially based on hygiene measures: high-fiber food, abundant drinks, regular physical activity and time to get to the saddle.
POSSIBLE ADVERSE EFFECTS (summary)
Diarrhea, abdominal pain.
Very rarely: allergic reaction .


GLOSSARY (summary)


corticosteroids
Substance close to cortisone. The natural corticoids, necessary for the functioning of the organism, are made by the adrenal glands. Synthetic corticosteroids, chemical derivatives of cortisone, are used as powerful anti-inflammatory drugs.


addiction
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.


diuretics
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.


fecal impaction
Stool plug in the rectum or in the colon. It is to be feared in the elderly or constipated, or those who remain bedridden for a long time. It exposes to a risk of obstruction of the digestive tract.


enteric
Qualifies certain tablets or capsules in which the active substance is protected from the acidity of the stomach.


stimulating laxative
A powerful but irritating laxative for the digestive tract, responsible for a loss of mineral salts (potassium, etc.) by the body. Its prolonged use causes an addiction: it is no longer possible to go to the saddle without medication. In the long term, definitive lesions of the internal wall of the intestine may appear (laxative disease).


potassium
Mineral element present in large quantities in the body.
See also: kalaemia.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


torsades de pointes
Severe heart rhythm disorder, favored by:
  • hypokalaemia or situations favoring it: significant and prolonged diarrhea, repeated use of stimulant laxative, etc.,
  • a heart too slow,
  • a visible predisposition on the electrocardiogram,
  • taking certain medications.
Drugs that can cause torsades de pointes include quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, certain neuroleptics, cisapride, diphenemil, halofantrine, mizolastine, pentamidine, moxifloxacin and erythromycin.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.


heart rhythm disorders
Severe or benign anomaly of the frequency of contractions of the heart. Extrasystole is contraction occurring just before or after a normal contraction, often perceived as a slight shock in the chest. Fibrillation is an irregular and disorderly contraction. Other disorders include torsades de pointes, Wolf-Parkinson-White syndrome, Bouveret's disease, tachysystolia, flutter and atrioventricular block, etc.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 20/04/2017

Name of the medicinal product

DULCOLAX 5 mg, gastro-resistant coated tablet

bisacodyl

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

Review summary

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?

Pharmacotherapeutic group

STIMULANT LAXATION

Therapeutic indications

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

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Cons-indications

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

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

Pregnancy

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.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using 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?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

· 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.

Risk of withdrawal syndrome

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.

Expiration date

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.

Storage conditions

This medicine does not require special precautions for storage .

If necessary, warnings against visible signs of deterioration

Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

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.

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

SANOFI-AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

exploiting

SANOFI-AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Maker

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 notice

The last date on which this leaflet was revised is {YYYY}.

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.

Cheap Dulcolax in your medicine approved Ars

Dulcolax is a medicament for laxative effect to treat constipation used in the treatment of occasional constipation.

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