Arret 2mg Hard Capsules

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Loperamide hydrochloride

Предлага се от:

Johnson & Johnson (Ireland) Limited

АТС код:

A07DA; A07DA03

INN (Международно Name):

Loperamide hydrochloride

дозиране:

2 milligram(s)

Лекарствена форма:

Capsule, hard

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Antipropulsives; loperamide

Статус Оторизация:

Marketed

Дата Оторизация:

1989-05-03

Листовка

– 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 rehydrati

Данни за продукта

Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 1 of 6
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.
Excipient with known effect - Each capsule contains Lactose
Monohydrate 127.0mg.
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.
4.3 CONTRAINDICATIONS

Arret is contra-indicated in children under 12 years of age
Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 2 of 6

Arret is contrainidicated in patients with a known hypersensitivity to
loperamide hydrochloride or to any of the
excipients

Arret should not be used as the primary therapy:

In patients with acute dysentery, which is characterised by blood in
the stools and high fever.

In patients with acute ulcerative colitis

In patients with bacterial enterocolitis caused by invasive organisms
including Salmonella, Shigella and
Campylobacter.

In patients with Pseudomenbraneous colitis associa