Prix de DULCOLAX 10 mg, suppositoire

Pharmacotherapeutic group: STIMULANT LAXATIVE – ATC code: A06AB02

Stimulant laxatives work by stimulating the lower part of the intestine.

This medication is recommended for certain forms of constipation and as preparation for certain examinations (rectoscopy).

Dulcolax does not help you lose weight; it does not affect the absorption of calories or nutrients.

Never take DULCOLAX 10 mg, suppository:
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,
certain diseases of the intestine and colon (ulcerative colitis and other inflammatory diseases),
abdominal pain (belly pain) of unknown origin, which may be a sign of a serious illness,
chronic constipation.
IF IN DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Warnings and precautions

Talk to your doctor or pharmacist before taking DULCOLAX 10 mg, suppository .

Special warnings

NO PROLONGED USE (GREATER THAN 10 DAYS) WITHOUT MEDICAL ADVICE

Occasional constipation:

It may be related to a change in lifestyle (travel). The drug can be an aid in short-term treatment. Any recent constipation unexplained by the change in lifestyle, any constipation accompanied by pain, fever, swelling of the stomach should lead to seeking the advice of the doctor.

Chronic constipation (long-term constipation):

It should not be treated with a stimulant laxative (such as DULCOLAX).

It can be linked to two causes:

· either an intestinal disease that requires medical treatment,

· or an imbalance in intestinal function due to dietary 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, etc.),

· an increase in the consumption of water and fruit juice,

· an increase in physical activity (sport, walking, etc.),

· re-education of the defecation reflex,

· sometimes, the addition of bran to the diet.

IF IN DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Dizziness and syncope, which may occur during defecation, have been reported.

Precautions for use

In case of diarrhea or abdominal pain, the medication should be stopped.

In patients with compromised fluid balance (e.g. renal insufficiency or elderly patients), DULCOLAX should be discontinued and only restarted under medical supervision, due to the increased risk of dehydration through intestinal fluid loss.

Symptoms may include thirst and decreased urine output (oliguria).

Patients may experience blood in the stool (rectal bleeding), which is usually mild and self-limiting. If rectal bleeding occurs, consult a doctor.

Using other laxatives at the same time as DULCOLAX may increase the gastrointestinal effects of DULCOLAX.

This medication SHOULD GENERALLY NOT BE USED, unless advised otherwise by your doctor, in combination with: amiodarone, bretylium, disopyramide, quinidines, sotalol, astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sultopride, terfenadine, vincamine.

It is preferable not to use DULCOLAX suppositories in cases of hemorrhoidal flare-ups, anal fissures, ulcerative colitis.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Children

Not applicable.

Other medicines and DULCOLAX 10 mg, suppository

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

DULCOLAX 10 mg, suppository with food and drink

Not applicable.

Pregnancy and breastfeeding

Pregnancy

The use of this medicine is not recommended during pregnancy.

Breastfeeding

The use of this medicine is possible during breastfeeding.

If you are pregnant or breastfeeding, notify your doctor.

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

Driving vehicles and using machines

The effects of Dulcolax on the ability to drive and use machines have not been studied.

However, dizziness and/or fainting may occur due to abdominal spasms. If abdominal spasms occur, avoid potentially hazardous activities such as driving and using machinery.

DULCOLAX 10 mg, suppository contains

Not applicable.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

FOR ADULTS ONLY

1 suppository per day, half an hour before the time chosen for bowel movements.

The maximum daily dose should not be exceeded.

Mode and route of administration

Rectal route.

Suppositories should be removed from their packaging and placed in the rectum, flat end first (to prevent rejection) with the tapered tip pointing down.

Frequency of administration

The suppository should be used half an hour before the time chosen for bowel movements.

Suppositories usually take effect within 10 to 30 minutes.

Duration of treatment

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

If you take more DULCOLAX 10 mg suppository than you should

Correction of hydroelectrolytic disorders in cases of very significant fluid loss may be necessary. This is particularly important in the elderly and young subjects. Administration of antispasmodics may be useful.

If you forget to take DULCOLAX 10 mg, suppository

Not applicable.

If you stop taking DULCOLAX 10 mg suppository

Not applicable.

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 in 10 people

Common: affects 1 to 10 people in 100

Uncommon: affects 1 to 10 people in 1,000

Rare: affects 1 to 10 in 10,000 people

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

Frequency not known: cannot be estimated from the available data.

Immune system disorders

Rare: Anaphylactic reactions, Quincke’s edema.

Skin and subcutaneous tissue disorders

Rare: Generalized pruritus (allergic reaction)

Metabolism and nutrition disorders

Rare: Dehydration

Frequency not known: decreased blood potassium level

Nervous system disorders

Uncommon: Dizziness

Rare: Syncope

Taking Dulcolax may cause abdominal pain related to abdominal spasms and/or defecation which may cause dizziness or fainting.

Gastrointestinal disorders

Common: Abdominal pain, diarrhea, nausea.

Uncommon: blood in stools (rectorrhagia), anorectal discomfort (burning sensation and anorectal pain), vomiting.

Rare: Colitis including ischemic colitis (insufficient blood supply to the colon which can lead to tissue death).

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, please tell your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, talk to . This also applies to any adverse reactions 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 Pharmacovigilance Centers – Website: www.ansm.sante.fr

By reporting side effects you can help provide more information on the safety of this medicine.

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 after EXP.

The expiration date refers to the last day of that month.

Store at a temperature not exceeding 30°C .

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

What DULCOLAX 10 mg, suppository contains

The active substance is:
Bisacodyl ………………………………………….. ………………………………………….. ……………….. 0.01 g

Other excipients are: Solid semi-synthetic glycerides (Witepsol W 45).
What DULCOLAX 10 mg, suppository looks like and contents of the pack

Marketing Authorization Holder

OPELLA HEALTHCARE FRANCE SAS
157 Charles de Gaulle Avenue

92200 Neuilly-sur-Seine

Marketing Authorization Operator

OPELLA HEALTHCARE FRANCE SAS
157 Charles de Gaulle Avenue

92200 Neuilly-sur-Seine

Manufacturer

ISTITUTO DE ANGELI SRL

LOCALITA PRULLI

REGGELLO (FI)

ITALY

Names of the medicine in the Member States of the European Economic Area

Not applicable.

The last date this notice was revised is:

[to be completed later by the holder]

Others

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