Arret 2 mg Hard Capsules

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
LOPERAMIDE HYDROCHLORIDE
Available from:
PCO Manufacturing Ltd.
ATC code:
A07DA; A07DA03
INN (International Name):
LOPERAMIDE HYDROCHLORIDE
Dosage:
2 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Antipropulsives; loperamide
Authorization status:
Authorised
Authorization number:
PPA0465/155/001
Authorization date:
2005-11-28

Arret

®

2 mg Hard Capsules

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 rehydration

therapy which replaces fluids and salts lost during diarrhoea.

2.

What you need to know before you take ARRET Capsules

This medicine is suitable for most people, but a few people should

not use it. If you are in any doubt, talk to your doctor or

pharmacist.

Do not take ARRET Capsules:

If you are allergic to loperamide or any of the other ingredi

ents

of this medicine (listed in section 6)

If it is for a child under 12 years old.

If you have severe diarrhoea after taking antibiotics.

If you are having a flare up of an inflammatory bowel

condition like ulcerative colitis.

If you are constipated or your stomach appears swollen

(particularly in children with severe dehydration).

If you have acute dysentery, the symptoms of which may

include blood in your stools and a high temperature.

If you have had a bacterial infection of the small intestine or

colon.

If you have a blockage of the bowel, including a blockage

due to paralysis of the bowel wall.

If you have an enlargement of the colon, particularly if this

enlargement is very rapid.

If any of these apply to you, get advice from a doctor or

pharmacist without taking ARRET Capsules.

Warnings and Precautions

Talk to your doctor or pharmacist before using ARRET

Capsules.

ARRET Capsules only treats the symptoms of diarrhoea.

Whenever the cause can be identified, it should be treated

appropriately.

If you have AIDS and your stomach becomes swollen, stop

taking the capsules immediately and contact your doctor.

If you suffer from liver problems.

If your diarrhoea lasts for more than 24 hours, please consult

your doctor.

Do not take this product for anything other than its intended

use (see section 1) and never take more than the

recommended amount (see section 3). Serious heart

problems (symptoms of which include fast or irregular

heartbeat) have been reported in patients who have taken too

much loperamide, the active ingredient in ARRET Capsules.

If you have been told by your doctor that you have an

intolerance to some sugars.

If you have severe diarrhoea as your body loses more fluid,

sugars and salts than normal.

Other medicines and ARRET Capsules

If you are taking any other medicines, including:

ritonavir (used to treat HIV) or quinidine (used to treat

abnormal heart rhythms or malaria).

itraconazole or ketoconazole (antifungal medicines)

gemfibrozil (used to treat high cholesterol)

oral desmopressin (used to control thirst and urine

production in patients with diabetic insipidus)

If you are unsure about any of the medicines you are taking, show

the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to

a doctor or pharmacist.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor or

pharmacist for advice before taking this medicine.

Do not take this medicine if you are breast-feeding as small

amounts may get into your milk. Talk to your doctor about a

suitable treatment.

Driving and using machines

This medicine may make you feel dizzy, tired or sleepy. If

affected do not drive or operate machinery.

Other information about this medicine

ARRET Capsules only treat the symptoms of diarrhoea.

When you have diarrhoea, your body can lose large amounts

of fluids and salts. You will need to replace the fluid by

drinking more liquid than usual. Ask your pharmacist about

special powders (known as oral rehydration therapy) which

replace fluids and salts lost during diarrhoea.

The prevention of fluid depletion (dehydration) is of particular

importance in infants, children and frail and elderly people

with acute diarrhoea.

Some of the ingredients can cause problems

This medicine contains lactose. If you have been told by your

doctor that you have an intolerance to some sugars contact

your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per

capsule, that is to say essentially ‘sodium-free'.

3.

How to take ARRET Capsules

Check the tables below to see how much medicine to take.

Swallow the correct number of capsules whole with a drink of

water.

For oral use only.

Do not use more than the stated dose shown in the tables.

Children under 12 years old

Do not give to children under 12 years of age.

Adults and children 12 years and over

To treat sudden short-lived (acute) diarrhoea:

Age

Dose

Adults and children aged 12

years and over

Swallow two capsules initially,

followed by one capsule after

each loose bowel movement.

Do not take more than 5 capsules in any 24 hour period.

If symptoms persist for more than 24 hours talk to your

doctor.

Use in the elderly, patients with kidney or liver problems.

No dose adjustment is required for the elderly or patients with

kidney problems. However, if you have liver problems you should

speak to your doctor or pharmacist before taking this medicine.

If you take more ARRETCapsules than you should

If you have taken too many ARRET Capsules, immediately contact

a doctor or hospital for advice. Symptoms may include: increased

heart rate, irregular heartbeat, changes to your heartbeat (these

symptoms can have potentially serious, life-threatening

consequences), muscle stiffness, uncoordinated movements,

drowsiness, difficulty urinating, or weak breathing.

Children react more strongly to large amounts of ARRET

Capsules than adults. If a child takes too much or shows any of

the above symptoms, call a doctor immediately.

If you forget to take ARRET Capsules

You should only take this medicine as required following the

dosage instructions above carefully. If you forget to take a dose,

take a dose after the next loose stool (bowel movement). Do not

take a double dose.

4.

Possible side effects

Like all medicines, ARRET Capsules can cause side effects,

although not everybody gets them.

If you experience any of the following, stop using the

medicine and seek immediate medical help:

Allergic reactions including unexplained wheezing, shortness

of breath, passing out or swelling of face and throat.

Skin rashes which may be severe and include blistering or

peeling of the skin.

Loss of consciousness or reduced level of consciousness.

If you experience any of the following, stop using the

medicine and talk to your doctor

Common: may affect up to 1 in 10 people

Headache

Constipation

Nausea

Flatulence

Uncommon: may affect up to 1 in 100 people.

Dizziness or drowsiness.

Feeling sick, vomiting and indigestion

Tiredness

Dry mouth

Stomach discomfort

Rash

Rare: less than 1 in 1,000 people are affected

Itchiness or hives.

Difficulties passing water.

Stomach pain or swollen stomach.

Severe constipation.

Hypertonia (muscle tension).

Miosis (constriction of the eye pupil).

Ileus (blockage of the bowel, this may be due to paralysis of

the bowel wall)

Megacolon (enlargement of the colon, this may be rapid)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on

the safety of this medicine.

5.

How to store ARRET Capsules

Do not store above 25 °C. Store in the original package.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the date which is stated on the

carton and blister. The expiry date refers to the last day of that

month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no

longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What ARRET Capsules contains

The active substance is loperamide hydrochloride. Each hard

capsule contains 2 mg loperamide hydrochloride.

The other ingredients are: lactose monohydrate, maize starch,

talc, magnesium stearate, titanium dioxide (E171), yellow ferric

oxide (E172), indigotin, gelatin, erythrosine sodium.

What ARRET Capsules looks like and contents of the pack

Each hard capsule has a green cap and purple body and contains

a white odourless powder

ARRET 2 mg Hard Capsules are available in blister packs of

6 and 12 capsules, contained in an outer cardboard carton.

Not all pack sizes may be marketed.

Parallel Product Authorisation Number:

PPA 465/155/1

Manufacturer

Famar ABE (Plant B), Anthousis Avenue, 15344 Anthousa,

Greece.

Product procured from within the EU, repackaged and

distributed by the Parallel Product Authorisation holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath, Ireland.

ARRET is a registered trademark of Janssen-Cilag Ltd.

Date of leaflet preparation by PCO Manufacturing:

December 2018

Health Products Regulatory Authority

04 January 2019

CRN008N33

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Arret 2 mg Hard Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 2 mg loperamide hydrochloride.

Excipient with known effect

Each capsule contains lactose monohydrate

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Hard capsule

Product imported from Greece

Purple and green hard gelatin capsules containing a white powder.

4 CLINICAL PARTICULARS

As per PA0330/042/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0330/042/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Maize starch

Talc

Magnesium stearate

Titanium dioxide (E171)

Yellow ferric oxide (E172)

Indigotin

Gelatin

Erythrosine sodium

Health Products Regulatory Authority

04 January 2019

CRN008N33

Page 2 of 2

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date of this product is the date shown on the container and outer

package of the product on the market in the country of origin.

6.4 Special precautions for storage

Do not store above 25 °C.

Store in the original package.

6.5 Nature and contents of container

Blister packs of 6 and 12 capsules contained in an outer cardboard carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/155/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28 November 2005

Date of last renewal: 28 November 2010

10 DATE OF REVISION OF THE TEXT

January 2019

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