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BISACODYL CRISTERS 5mg Laxative 30 tablets

Name: BISACODYL CRISTERS 5mg Laxatif 30 comprimés
Brand: Marque Verte
SKU: 19406
Price: 3.89 EUR
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Brand : Marque Verte

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BISACODYL CRISTERS 5mg Laxative 30 tablets

Bisacodyl Cristers 5 mg Laxatix 30 tablets is a medicine is recommended in case of occasional constipation .

Description of BISACODYL CRISTERS 5mg Laxative 30 tablets

Bisacodyl is a local action laxative belonging to the family of phenylmethane derivatives.
It increases colonic motility and intestinal secretion of water, electrolytes and proteins; this results in a stimulation of the defecation , a reduction of the transit time and a softening of the stools .

Advice for use and dosage

Dosage
In adults: 1 or 2 tablets maximum per day.

Comment on the recommendations for use and dosage of BISACODYL CRISTERS 5mg Laxative 30 tablets with our partner Avis checked after your purchase.

Composition

The active substance is :

Bisacodyl ...................... 5 mg
For a gastro-resistant coated tablet.

The other components are :

Lactose monohydrate, microcrystalline cellulose, hyprolose, pregelatinized starch, magnesium stearate.
Coating: hypromellose, triethyl citrate, talc, eudragit L100, eudragit S100, sucrose, magnesium stearate, titanium dioxide, yellow iron oxide, Carnauba wax.

Precaution of use

Never take this medicine :

if you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6,
severe dehydration,
in children under 6,
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 serious illness,
chronic constipation.

Presentation of BISACODYL CRISTERS 5mg Laxative

Bisacodyl comes in a box of 30 tablets.

Our advice and expert advice in pharmacy

Constipation is usually defined as a slowing down of the intestinal transit , causing a drop in the frequency of stool emission, which will appear dehydrated.
When constipation, that is to say the delay of the passage to the saddle lasts only a few weeks (up to less than 3 stools weekly ), it is called transient constipation (or occasional constipation).
Constipation is most often the result of poor nutrition. In case of constipation, doctors advise to take foods high in fiber . Most people with constipation, according to the specialists, have not eaten enough fiber-containing foods (ie less than 25-50 grams per day). While these facilitate intestinal transit . So, which foods facilitate transit? What are the natural laxatives?

Fiber can be found in green vegetables, cabbage, Swiss chard, spinach or salad.
Banana is also a food rich in fiber and contains in addition potassium, a trace element essential for health.
The apple is also interesting because of its richness in pectin which stimulates the intestine.
Plums and prunes will purify the intestine and stimulate it, they are also rich in potassium, iron and vitamins.
Sprouted seeds as well as oilseeds such as almonds and nuts are rich in enzymes facilitating digestion and omega 3 which will help lubricate the stool.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated: 19/03/2018

Name of the drug

BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet

bisacodyl

framed

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Talk to your pharmacist for any advice or information.

· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse after 10 days.

What does this booklet contain ?

1. What is BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet and when is it used?

2. What you need to know before taking BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

3. How to take BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

4. What are the possible side effects?

5. How to store BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

6. Contents of the package and other information.

1. WHAT IS BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: LAXATIVE STIMULANT, ATC code: A06AB02.

This medication is recommended for occasional constipation.

2. BEFORE YOU TAKE BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

Do not take BISACODYL CRISTERS 5 mg, enteric coated tablets:

· if you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6,

· severe dehydration,

· in children under 6,

· 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 serious illness,

· chronic constipation.

Warnings and precautions

Talk to your doctor or pharmacist before taking BISACODYL CRISTERS 5 mg, enteric coated tablet.

Special warnings

It can be related to a change in lifestyle (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,

· or an imbalance of 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 activity (sport, walking ...),

· a reeducation of the defecation reflex,

· sometimes, the addition of sound to the diet.

Special case in children:

In children the treatment of constipation is based on lifestyle and dietetic measures: including the use of the right amount of water with infant milk powders, diet rich in plant products, addition of 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).

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.

In patients with precarious fluid balance (eg, renal failure or elderly patients), BISACODYL CRISTERS should be discontinued and should be reinstituted only under medical supervision, due to the increased risk of dehydration due to intestinal water loss.

Symptoms can be of the type of thirst and a decrease in the amount of urine (oliguria).

Patients may have blood in the stools (rectorrhagia), which is usually of mild intensity and spontaneously resolving. In case of occurrence of rectorragies, consult a doctor.

This medicine SHOULD NOT BE USED unless directed otherwise by your doctor in association with: amiodarone, bretylium, disopyramide, quinidine, sotalol, astemizole, bepridil, erythromycin IV, halofantrine , pentamidine, sultopride, terfenadine, vincamine.

Child and teenagers

Not applicable.

Other medicines and BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet with food and drink

Not applicable.

Pregnancy and breast feeding

Pregnancy

The use of this drug is not recommended during pregnancy.

feeding

The use of this medicine is possible during breastfeeding. If you are pregnant or breastfeeding, contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The effects of BISACODYL CRISTERS 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 spasms, avoid potentially dangerous activities such as driving and using machines.

BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet contains lactose monohydrate and sucrose

If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine.

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).

The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.

3. HOW TO TAKE BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

Dosage

· In adults : 1 or 2 tablets maximum 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: 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 to the dose to obtain regular bowel movements.

Do not exceed the maximum daily dose.

You should avoid taking products that reduce the acidity of your stomach, such as alkaline medications, antacids, proton pump inhibitors, or milk, so you do not prematurely dissolve the stomach. coating of the tablet.

Administration mode

The tablets should be swallowed without being chewed.

Frequency of administration

Take the evening (effect 10 hours after) or the morning on an empty stomach (effect 5 hours after).

Duration of treatment

No prolonged use, more than 10 days without medical advice.

Use in children and adolescents

Not applicable.

If you take more BISACODYL CRISTERS 5 mg, enteric coated tablets than you should:

A correction of the hydroelectrolytic disorders in case of very important fluid loss may be necessary. This is particularly important for the elderly and young people. The administration of antispasmodics may be useful.

If you forget to take BISACODYL CRISTERS 5 mg, enteric coated tablet:

Not applicable.

If you stop taking BISACODYL CRISTERS 5 mg, enteric coated tablet:

Not applicable.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly reported side effects during treatment are abdominal pain and diarrhea.

The assessment of adverse reactions is based on the following frequencies:

Very common: affects more than 1 patient in 10

Frequent: affects 1 to 10 patients in 100

Uncommon: affects 1 to 10 patients in 1,000

Rare: affects 1 to 10 patients in 10,000

Very rare: affects less than 1 patient in 10,000

Not known: can not be estimated from the available data

Immune system disorders

· Rare: Anaphylactic Reactions, Quincke's Edema

Affection of skin and subcutaneous tissue

· Rare: Generalized pruritus (allergic reaction)

Metabolism and nutrition disorders

· Rare: Dehydration

· Not known: Decrease in blood potassium

Nervous system disorders

· Uncommon: Dizziness

· Rare: Syncope

Taking bisacodyl can lead to abdominal pain associated with abdominal spasms and / or defecation that can lead to dizziness or syncope.

Gastrointestinal disorders

· Common: Abdominal pain, diarrhea, nausea

· Uncommon: Bloody stool (rectorrhagia), anorectal discomfort (burning sensation and anorectal pain), vomiting

· Rare: Colitis

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system : National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr .

By reporting side effects, you can help provide more information about the safety of the medicine.

5. HOW TO STORE BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.

This medicine does not require any special storage precautions.

Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What BISACODYL CRISTERS contains 5 mg, gastro-resistant coated tablet

· The active substance is:

Bisacodyl ................................................. .................................................. ...................... 5 mg

For a gastro-resistant coated tablet.

· The other components are:

Lactose monohydrate, microcrystalline cellulose, hyprolose, pregelatinized starch, magnesium stearate.

Coating : hypromellose, triethyl citrate, talc, eudragit L100, eudragit S100, sucrose, magnesium stearate, titanium dioxide, yellow iron oxide, Carnauba wax.

What is BISACODYL CRISTERS 5 mg, gastro-resistant coated tablet and package contents?

This medication is a gastro-resistant, yellow, round, biconvex, coated tablet. Box of 20, 25, 30 tablets under plate (PVC / Aluminum) or (PVC / PVDC opaque white / Aluminum).

Not all presentations may be marketed.

Marketing Authorization Holder

Cristers

22 QUAI GALLIENI

92150 SURESNES

Operator of the marketing authorization

Cristers

22 QUAI GALLIENI

92150 SURESNES

Maker

MEDREICH PLC

Warwick House, Plane Tree Crescent

Feltham, TW13 7HF

Names of the drug in the member states of the European Economic Area

Not applicable.

The last date this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Vidal file

VIDAL OF THE FAMILY

BISACODYL CRISTERS

Laxative stimulant

This medicine is a generic of DULCOLAX tablet.

. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS ^(summary)

BISACODYL Cristers: compressed enteric (yellow); box of 30.
Not refunded - Free price -

Cristers Laboratory

COMPOSITION ^(summary)

	p cp
bisacodyl	5 mg
Lactose	+

INDICATIONS ^(summary)

This medicine contains a stimulant laxative . It increases secretions and motility of the intestine.
It is used in the symptomatic treatment of constipation.

CONTRAINDICATIONS ^(summary)

This medicine should not be used in the following cases:

inflammatory bowel diseases
constipation or abdominal pain due to obstruction of the digestive tract: intestinal narrowing, fecal impaction (stool stopper);
significant dehydration, especially if it is associated with a loss of minerals ( sodium , potassium );
child under 6 years old.

ATTENTION ^(summary)

This medicine can be bought without a prescription. Nevertheless, it should be used only episodically and in very short cure, not more than 8 to 10 days.
Its regular use may result in:

an addiction ,
serious bowel disorders,
loss of minerals, especially potassium , which can cause serious heart rhythm disorders .

It should be used only exceptionally in children and only on medical prescription in children under 12 years.
Stop treatment if you have diarrhea or abdominal pain.

DRUG INTERACTIONS ^(summary)

This medication may interact with drugs 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 BREASTFEEDING ^(summary)

Pregnancy :
The effect of this medication during pregnancy is poorly understood. Its use is not recommended for pregnant women.

Breastfeeding:
This medicine does not pass into breast milk. It can be used to treat constipation in breastfeeding women.

DIRECTIONS AND DOSAGE ^(summary)

The tablets should be swallowed without being chewed with a large glass of water.
The laxative effect is not immediate. It usually occurs about 10 hours after taking the drug at bedtime and 5 hours after taking it in the morning.

Usual dosage:

Adult: 1 or 2 tablets a day.
Child over 6 years old: 1 tablet a 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 lifestyle and dietary measures: high fiber intake, abundant drinks, regular physical activity and time for bowel movements.

ADVERSE POSSIBLE EFFECTS ^(summary)

Frequent (1 to 10% of patients): diarrhea, abdominal pain, nausea.
Uncommon (less than 1% of patients): vomiting, burning or anal pain, rectal bleeding (resulting in blood in the stool and requiring medical advice), abdominal spasm that may result in dizziness or discomfort.
Rare: itching, allergic reaction , dehydration.

LEXICON ^(summary)

corticosteroids
Substance close to cortisone. Natural corticosteroids, necessary for the functioning of the body, are manufactured 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 state can be accompanied, at the end of the catch, of various symptoms, grouped under the term of withdrawal syndrome.

diuretics
Drug allowing an increased elimination of water by the kidneys. 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 more rare conditions.
These drugs cause a loss of sodium and potassium (except for some of them called "potassium sparing"). Their prolonged intake therefore requires regular control of blood potassium, to avoid the cardiac disorders that could result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible consequence, but rarer at usual dosages, from prolonged use of diuretics; it is also detected by a blood test.

fecal impaction
Stool cap in the rectum or colon. It is to be feared in the elderly or constipated, or those who remain long bedridden. 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.

stimulant laxative
Laxative powerful but irritating for the digestive tract, responsible for a loss of minerals (potassium, etc.) by the body. Its prolonged use causes dependence: it is no longer possible to go to the stool without medication. In the long term, definitive lesions of the intestinal lining may appear (laxative disease).

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

allergic reaction
Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.

sodium
Mineral substance that can form salts, especially with chlorine (sodium chloride, or table salt).

torsades de pointes
Serious heart rhythm disorder, promoted by:

hypokalemia or situations that favor it: prolonged and severe diarrhea, repeated use of stimulant laxatives, etc.,
a heart too slow,
a visible predisposition on the electrocardiogram,
taking certain medications

The drugs capable of causing torsades de pointes are the following: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, certain neuroleptics, cisapride, diphémanil, halofantrine, mizolastine, pentamidine, moxifloxacine, erythromycin (route IV).

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

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

way

Path (route of administration) used to administer the 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.

Pharmacist's advice

used for :

occasional constipation, Laxative