CONTALAX CONSTIPATION CPR 30

CONTALAX CONSTIPATION CPR 30 View larger

3400930251539

Omega Pharma Omega Pharma

Contalax 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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Used for : occasional constipation

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For warnings, precautions for use and cons-indications, please refer to the user guide.

Description

Contalax 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

Contalax 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 Contalax:

  • 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.

Warnings against Contalax:

  • 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 instructions carefully Contalax

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

CONTALAX

Stimulating laxative

bisacodyl

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

PRESENTATIONS (summary)

CONTALAX: compressed enteric (white); box of 30.
-

Omega Pharma Laboratory

COMPOSITION (summary)
p cp
bisacodyl 5 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,
  • constipation or abdominal pain due to obstruction of the digestive tract: intestinal constriction, faecaloma (stool plug),
  • especially if it is associated with a loss of mineral salts ( sodium , potassium ).
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: It should only be used in exceptional cases 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)
This medication is taken preferably at bedtime. Swallow the tablets without chewing them with a large glass of water.
The laxative effect is not immediate. It usually occurs about 10 hours after taking the drug.

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.


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.


sodium
An inorganic substance which can form salts, especially with chlorine (sodium chloride, or table salt).


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 (respiratory tract), 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: 14/11/2016

Name of the medicinal product

CONTALAX, gastro-resistant 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 medication exactly as prescribed 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 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.

Do not use this medication for children.

What is in this leaflet?

1. What is CONTALAX, an enteric-coated tablet and in which cases it is used?

2. What do you need to know before taking CONTALAX Gastro-Resistant Tablets?

3. How to take CONTALAX Gastro-Resistant Tablets?

4. What are the possible side effects?

5. How to store CONTALAX Gastro-resistant tablets?

6. Package contents and other information.

1. WHAT CONTALAX is a gastro-resistant tablet AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group - ATC code: A06AB02

STIMULANT LAXATION

(A: digestive system and metabolism)

This medication is indicated in the short-term treatment of occasional constipation.

2. BEFORE YOU TAKE CONTALAX, Gastro-Resistant Tablets?

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

Do not take CONTALAX, gastro-resistant tablets:

· if you are allergic (hypersensitive) to bisacodyl or to any of the other ingredients of this medication mentioned in section 6.

· if you have bowel and / or colon disease, such as ulcerative colitis, Crohn's disease, intestinal occlusion.

· if you have abdominal pain (stomach pains).

· if you suffer from severe dehydration.

This medication SHOULD NOT BE USED unless your doctor tells you otherwise during pregnancy or in combination with certain medications that cause certain heart problems (peak torsade).

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

Warnings and Precautions

Talk to your doctor or pharmacist before taking CONTALAX, an enteric-coated tablet.

Special warnings

IN THE CONTEXT OF CONSTIPATION, NO EXTENDED USE (ABOVE 8-10 DAYS) WITHOUT MEDICAL ADVICE.

Occasional constipation

It may be related to a recent change in lifestyle (eg 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 can be linked to two causes:

· a bowel disease that requires a physician to take care of;

· or an imbalance in intestinal function due to dietary habits and lifestyle.

Treatment includes:

· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);

· increased consumption of water and fruit juices;

· an increase in physical activities (sports, walking, etc.);

· rehabilitation of the defecation reflex;

· sometimes, adding sound to the diet.

Precautions for use

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

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, of fruit juice.

Other drugs and CONTALAX, gastro-resistant tablet

IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, especially medicines with certain cardiac disorders (torsade de pointe), INFORM YOUR DOCTOR OR PHARMACIST IF YOU TAKE, HAVE RECENTLY TAKEN OR MAY TAKE ANY OTHER MEDICINE.

CONTALAX, gastro-resistant tablets with food and beverages

Not applicable.

Pregnancy and breast feeding

The use of this medication is not recommended during pregnancy and lactation. If you discover that you are pregnant during treatment, quickly consult your doctor alone will be able to adapt the treatment to your condition.

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

Sport

Not applicable.

Driving and using machines

Not applicable.

CONTALAX, gastro-resistant tablet contains lactose.

3. HOW TO TAKE CONTALAX, Gastro-resistant tablet?

Dosage

Adults : 1 to 2 tablets per day.

If diarrhea occurs, decrease dosage.

Administration mode

Oral use.

The tablets should be swallowed with a little water, without chewing them.

Frequency of Administration

This medication should preferably be given at bedtime.

Duration of treatment

The duration of treatment is limited to 8-10 days.

Use in children

Children over 6 years : 1 tablet per day.

If diarrhea occurs, decrease dosage.

If you take more CONTALAX, gastric-resistant tablet than you should:

Immediately consult your doctor or pharmacist.

If you forget to take CONTALAX, gastro-resistant tablet:

Not applicable.

If you stop taking CONTALAX, gastro-resistant tablet:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

· Risk of diarrhea and abdominal pain, especially in subjects suffering from irritable bowel.

· Hypokalemia (decreased potassium in the blood.

· Abnormal staining of urine.

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 CONTALAX, gastro-resistant tablet?

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

Do not use this medicine after the expiry date which is stated on the carton.

No special storage conditions.

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What CONTALAX contains, gastro-resistant tablets

The active substance is:

Bisacodyl ................................................. .................................................. .......................... 5.0 mg

For a gastro-resistant tablet.

The other components are:

Lactose, modified starch (Starx 1500), anhydrous colloidal silica, magnesium stearate, cellulose acetate phthalate, ethyl phthalate.

What is CONTALAX, gastro-resistant tablets and contents of the pack

This medication is in the form of a gastro-resistant tablet. Box of 30.

Marketing Authorization Holder

LABORATOIRES OMEGA PHARMA FRANCE

20 STREET ANDRE GIDE

92320 CHATILLON

Marketing Authorization Operator

LABORATOIRES OMEGA PHARMA FRANCE

20 STREET ANDRE GIDE

92320 CHATILLON

Maker

OPODEX INDUSTRIE LABORATORIES

36-42, AVENUE MARC SANGNIER

92390 VILLENEUVE-LA-GARENNE

or

DELPHARM REIMS

10 RUE COLONEL CHARBONNEAUX

51100 REIMS

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which 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).

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