Diaretyl 2mg 12 capsules
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  • Diaretyl 2mg 12 capsules

Diaretyl 2mg 12 capsules


€2.39

Indications: Short-term treatment of acute transient diarrhoea in adults (from 15 years of age). This treatment is a complement to dietary measures

48 hours
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In this manual :

1. WHAT IS DIARETYL 2 mg, capsule AND WHAT IS IT USED FOR?

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DIARETYL 2 mg, capsule?

3. HOW DO I TAKE DIARETYL 2 mg, capsule?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE DIARETYL 2 mg, capsule?

6. ADDITIONAL INFORMATION

1. WHAT IS DIARETYL 2 mg, capsule AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

ANTI-DIARRHOEA

(A: digestive system and metabolism)

Therapeutic indications

Short-term treatment of acute transient diarrhoea in adults (15 years and older).

This treatment is a complement to dietary measures.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DIARETYL 2 mg, capsule?

List of information needed before taking the medicine

Not applicable.

Contraindications

Never take DIARETYL 2 mg, capsule:

- if you have chronic bowel and colon disease, especially during acute flare-ups of ulcerative colitis,

- in case of allergy to any of the ingredients of the capsule.

IN CASE OF DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Precautions for use; special warnings

Take care with DIARETYL 2 mg, capsule:

Special warnings

KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.

CAUTION: you must not take this medicine:

- · if you have a fever, vomiting,

- · if you have blood or mucus in your stools,

- · if your diarrhoea occurs during antibiotic treatment (risk of severe colon damage).

You must also stop this treatment and consult your doctor quickly in the following cases:

- in case of fever, vomiting,

- in case of blood or mucus in the stools,

- if there is no improvement after 2 days of treatment,

- in case of constipation or abdominal distension,

- in case of intense thirst or a feeling of dry tongue. Indeed, these signs indicate the beginning of dehydration, i.e. a significant loss of liquid due to diarrhoea. Your doctor will then judge the need to prescribe rehydration, which may be oral or intravenous.

Precautions for use

Use this medicine only with caution (Precautions for use)

TAKE THE ADVICE OF YOUR DOCTOR in case of liver disease, as medical supervision during treatment is necessary

Diarrhea causes loss of fluids and mineral salts.

It is necessary to:

- rehydrate with abundant drinks, salty or sweet, in order to compensate for the loss of fluids due to diarrhoea (drink at least 2 litres)

- eat during the diarrhoea,

o eliminate raw vegetables, fruits, green vegetables, spicy dishes, as well as iced foods or drinks.

o choose grilled meats, rice.

Interactions with other medicines

Taking or using other medications

This medicine contains LOPERAMIDE. Other medicines contain it... Do not combine them, so as not to exceed the maximum recommended doses (see Dosage).

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and breastfeeding

Pregnancy and breastfeeding

If you are pregnant or breastfeeding,

Do not take this medicine without asking your doctor or pharmacist.

This medicine should only be used during pregnancy on the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether or not to continue the treatment.

Breast-feeding is still possible during brief treatment with this medicine.

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

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Driving and using machines

Caution: This drug may cause discrete and transient drowsiness or dizziness which may be dangerous when driving and using certain machines.

List of excipients with a known effect

Not applicable.

3. HOW DO I TAKE DIARETYL 2 mg, capsule?

Instructions for proper use

Not applicable.

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

Do not use in children (under 15 years of age)

Dosage

For adults only (15 years and older).

- Start with 2 capsules in a single dose (i.e. 4 mg of loperamide),

- If diarrhoea continues: after each unformed stool, take 1 additional capsule, but:

o never exceed 6 capsules per day,

o never exceed 2 days of treatment.

Method of administration

Oral use

Swallow the capsules with a glass of water.

Frequency of administration

Take at intervals,

Take 1 capsule after each unmolded bowel movement:

- never exceed 6 capsules per day,

- never exceed 2 days of treatment.

Duration of treatment

The duration of use is limited to 2 days.

Symptoms and instructions in case of overdose

If you have taken more DIARETYL 2 mg, capsule than you should have:

In case of accidental overdose, STOP THE TREATMENT AND CONSULT YOUR DOCTOR ASAP.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, DIARETYL 2 mg, capsule is likely to have side effects, although not everyone is susceptible:

- Constipation and/or distension of the belly,

- Belly pain, bloating, nausea, vomiting, dry mouth,

- Allergic reactions (skin rash, hives and exceptionally severe allergic shock),

- Fatigue, drowsiness, dizziness.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO CONSERVE DIARETYL 2 mg, capsule

Keep out of the reach and sight of children.

Expiry date

Do not use DIARETYL 2 mg, capsule after the expiry date stated on the box.

Storage conditions

STORE THIS MEDICATION at a temperature not exceeding 30°C.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does DIARETYL 2 mg, capsule contain?

The active substance is:

Loperamide hydrochloride .............................................................................................................. 2.00 mg

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

For one capsule.

Other components are:

Corn starch (STARCH 1500), microcrystalline cellulose (AVICEL pH 102), talc.

Capsule shell composition: quinoline yellow, indigotine, patent blue V.

Pharmaceutical form and content

What is DIARETYL 2 mg, capsule and what does it contain?

This medicine is presented in capsule form. Box of 6 or 12 capsules.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

Operator

COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN AUVERT

77020 MELUN

Manufacturer

LABORATOIRES LIPHA

115, AVENUE LACASSAGNE

75003 PARIS

or

DELPHARM

PETIT PARIS FACTORY

91220 BRETIGNY SUR ORGE

or

RHONE POULENC RORER PHARMASPECIALITES

20, AVENUE RAYMOND ARON

92160 ANTONY

or

LABORATOIRES BTT

Z.I. DE KRAFFT

67150 ERSTEIN

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

Not applicable.

Date of approval of the package leaflet

The last date on which this package insert was approved was {date}.

MA under exceptional circumstances

Not applicable.

Internet information

Detailed information on this medicinal product is available on the website of Afssaps (France).

Information for healthcare professionals only

Not applicable.

Other

Not applicable.

3584214

Specific References