IMODIUMCAPS 2MG CAPSULES 12

NOTICE

ANSM - Last updated: 31/05/2017

Name of the medicinal product

IMODIUMCAPS 2 mg capsule

Loperamide Hydrochloride

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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 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 2 days.

What is in this leaflet?

1. What is IMODIUMCAPS 2 mg, capsule and in which cases it is used?

2. What should I know before taking IMODIUMCAPS 2 mg capsule?

3. How to take IMODIUMCAPS 2 mg capsule?

4. What are the possible side effects?

5. How to store IMODIUMCAPS 2 mg capsule?

6. Package contents and other information.

1. WHAT IS IMODIUMCAPS 2 mg, hard capsule AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: ANTI-DIARRHEA - ATC code: A07DA03 (A: digestive system and metabolism).

Short-term treatment of acute transient diarrhea in adults and children from 15 years.

This treatment is a complement to the dietary measures: read carefully the chapter "Warnings and Precautions".

You should contact your doctor if you experience no improvement or feel less well after 2 days.

2. BEFORE YOU TAKE IMODIUMCAPS 2 mg, capsule?

Do not take IMODIUMCAPS 2 mg, capsule:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· if blood is present in your stool and / or in case of high fever.

· if you are suffering from chronic bowel and colon disease, especially during acute outbreaks of ulcerative colitis (inflammatory bowel disease with bleeding).

· if you suffer from inflammation of the intestine with diarrhea and pain following the use of antibiotics (pseudomembranous colitis).

· if you suffer from inflammation of the intestine due to an invasive bacteria ( bacterial enterocolitis ).

· in children under 15 years of age.

This medication should not be used when stopping or decreasing intestinal transit should be avoided.

Treatment should be discontinued in the event of constipation, abdominal distention or intestinal occlusion.

IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking IMODIUMCAPS 2 mg capsule.

You should stop treatment and consult your doctor promptly if:

· if you do not notice improvement after 2 days of treatment,

· in the event of fever or vomiting during treatment,

· in the presence of blood or mucus in the stools,

· in case of intense thirst, sensation of dry tongue. Indeed, these signs show an onset of dehydration, that is to say a significant loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.

· if you are infected with the Human Immunodeficiency Virus (HIV), immediately stop treatment at the 1 ^st abdominal distension signs (resulting in swelling of the abdomen).

In case of liver failure (liver malfunction), tell your doctor; a close medical supervision may be necessary if this medication is used.

You should follow the following dietary rules during treatment:

· rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (the adult's average daily water intake is 2 liters),

· you feed enough time of diarrhea,

o avoiding certain intakes and especially milk, raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.

o favoring grilled meats, rice.

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).

Take this product only for the intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (symptoms may include a rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient of IMODIUMCAPS.

Other medicines and IMODIUMCAPS 2 mg capsule

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines, including:

- itraconazole or ketoconazole (used to treat infections caused by fungi),

- gemfibrozil (used to treat high levels of fat in the blood),

- of desmopressin by the oral route (used in particular to limit thirst and urine production in patients suffering from diabetes insipidus).

IMODIUMCAPS 2 mg, capsule with food and beverages

Not applicable.

Pregnancy and breast feeding

If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

Breast-feeding is not recommended when taking this medication.

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

Driving and using machines

Be careful. Do not drive without reading the instructions.

This medication may cause drowsiness, dizziness, or fatigue. Due to these risks, caution is advised when driving vehicles or using machines.

IMODIUMCAPS 2 mg, capsule contains lactose.

3. HOW TO TAKE IMODIUMCAPS 2 mg capsule?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

Reserved for adults and children from 15 years.

Start with 2 capsules in a single dose (4 mg of loperamide hydrochloride).

If diarrhea continues: after each unmolded saddle, take 1 extra capsule, but:

· never exceed 6 capsules per day,

· never exceed 2 days of treatment.

Administration mode

Oral use.

Swallow the capsules with a glass of water.

Duration of the treatment

The duration of use is limited to 2 days.

If you take more IMODIUMCAPS 2 mg capsule than you should:

If you have taken too much IMODIUMCAPS, seek immediate medical advice or a hospital. Symptoms may include: increased heart rate, irregular heartbeat, changes in your heart rate (these symptoms may have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty passing urine or respiratory distress, decreased vigilance, shrinking of the pupil, bloating or constipation.

In this case, you should go to the hospital where an antidote (naloxone) can be given to you. Hospital monitoring should be maintained for at least 48 hours. Children react more strongly to high doses of IMODIUMCAPS than adults. If a child takes too much or has any of the above symptoms, contact a doctor immediately.

If you forget to take IMODIUMCAPS 2 mg capsule:

Do not take a double dose to make up for the missed dose.

If you stop taking IMODIUMCAPS 2 mg capsule:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

The most common side effects (more than 1 in 100 patients) are constipation, flatulence, headache and nausea.

The following side effects have also been reported with loperamide:

· Allergic reactions that may include breathing difficulties or swallowing, swelling of the face or skin reactions (rash, hives, itching).

· Vomiting, difficulty digesting, dry mouth, severe constipation, stomach pain or swelling, abdominal discomfort, intestinal obstruction, tongue pain.

· Sometimes severe cutaneous eruptions.

· Tired.

· Difficulty in urinating.

· Dizzy sensations, somnolence, loss or diminution of consciousness, stupor, increase in muscle tone, difficulty in coordinating its movements.

· Pupil narrowing (myosis).

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 IMODIUMCAPS 2 mg capsule?

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 or label. The expiry date refers to the last day of that month .

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 IMODIUMCAPS contains 2 mg capsule

· The active substance is:

Loperamide Hydrochloride ............................................... .............................................. 2.00 mg

Amount corresponding to loperamide base ............................................. 1.86 mg

For a capsule.

· The other components are:

Lactose monohydrate, corn starch, talc, magnesium stearate.

Capsule envelope composition : gelatin, indigotine, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), erythrosine.

What is IMODIUMCAPS 2 mg, capsule and contents of the pack

This medication is in the form of a capsule. Box of 6 or 12.

Not all pack sizes may be marketed.

Marketing Authorization Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Marketing Authorization Operator

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Maker

JANSSEN CILAG

DOMAIN OF MAIGREMONT

27100 VAL-DE-REUIL

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).

Health Education Council:

Diarrhea causes loss of liquids and mineral salts.

This medicine treats the symptoms of acute diarrhea in adults, but does not provide rehydration, accompanied by dietary hygiene.

It is therefore necessary to drink plenty of sugary drinks (fruit juices) and salted broths to compensate for these losses. Avoid milk, green vegetables, raw vegetables, fruits, spices until diarrhea disappears.

VIDAL OF THE FAMILY

IMODIUMCAPS