ARRET 2mg Milligram Capsule

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LOPERAMIDE HYDROCHLORIDE

Commercializzato da:

McNeil Healthcare (Ireland) Ltd

Codice ATC:

A07DA03

INN (Nome Internazionale):

LOPERAMIDE HYDROCHLORIDE

Dosaggio:

2mg Milligram

Forma farmaceutica:

Capsule

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Antipropulsives

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2008-08-15

Foglio illustrativo

FACE 1
– 1 –
Loperamide Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
■ This medicine is used to treat sudden short-
lived (acute) attacks of diarrhoea in adults
and children aged 12 years and over.
■ DO NOT TAKE THIS MEDICINE:
■ There are some people who should not
use this medicine. To find out if you are
one of them. See Section 2 ▶
■ If you are allergic to loperamide or any of
the other ingredients of this medicine.
■ SPEAK TO YOUR DOCTOR:
■ If you suffer from any of the conditions
mentioned in Section 2 ▶
■ If you are taking any other medicines.
See Section 2 ▶
■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
These are shown in the dosage table.
See Section 3 ▶
NOW READ THIS WHOLE LEAFLET CAREFULLY
BEFORE YOU USE THIS MEDICINE.
■ Keep this leaflet. You may need to read it
again.
■ Ask your pharmacist if you need more
information or advice.
■ If you get any side effects, talk to your
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4 ▶
■ You must talk to a doctor if you do not feel
better or if you feel worse after 24 hours.
WHAT IS IN THIS LEAFLET
1. What ARRET™ Capsules are, and what
they are used for.
2. What you need to know before you take
ARRET™ Capsules.
3. How to take ARRET™ Capsules.
4. Possible side effects.
5. How to store ARRET™ Capsules.
6. Contents of the pack and other information.
1
WHAT ARRET™ CAPSULES
ARE AND WHAT THEY ARE USED
FOR
ARRET™ Capsules is a medicine which is
used to treat sudden short-lived (acute)
attacks of diarrhoea in adults and children
aged 12 years and over.
The capsules contain loperamide hydrochloride
which helps reduce diarrhoea by slowing down
an overactive bowel, which helps the body
to absorb water and salts from the bowel.
ARRET™ Capsules should be used in
conjunction with oral re

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arret 2mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains loperamide hydrochloride 2 mg.
Excipients contain Lactose Monohydrate 127.0 mg per capsule.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (short term: capsule)
Brown and light green hard gelatine capsules containing a white
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the management of acute diarrhoea together with fluid
and electrolyte replacement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. The capsules should be taken with water.
Adults and children over 12 years only:
The usual dose is 2 capsules initially, followed by 1 capsule after
each further episode of diarrhoea up to a maximum of
5 in 24 hours.
Use in Elderly:
No dose adjustment is required for the elderly.
Renal impairment:
No dose adjustment is required for patients with renal impairment.
Hepatic impairment:
Although no pharmacokinetic data are available in patients with
hepatic impairment, Arret should be used with caution
in such patients because of reduced first pass metabolism_ (see 4.4
Special warning and precautions for use)._
Method of Administration:
Oral.
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4.3 CONTRAINDICATIONS
Arret