Loperamide 2mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Teva UK Ltd

ATC code:

A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 5017007388135 5017007388166

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIARRHOEA RELIEF CAPSULES
LOPERAMIDE 2 MG CAPSULES
LOPERAMIDE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Diarrhoea Relief Capsules
Loperamide 2 mg Capsules carefully to get the best results from them.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.

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 doctor or 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 DIARRHOEA RELIEF CAPSULES Loperamide 2 mg Capsules ARE AND WHAT
THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIARRHOEA RELIEF CAPSULES
Loperamide 2 mg Capsules
3.
HOW TO TAKE DIARRHOEA RELIEF CAPSULES Loperamide 2 mg Capsules
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DIARRHOEA RELIEF CAPSULES Loperamide 2 mg Capsules
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DIARRHOEA RELIEF CAPSULES Loperamide 2 mg Capsules ARE AND
WHAT THEY ARE USED FOR
Diarrhoea Relief Capsules Loperamide 2 mg Capsules contain Loperamide,
which belongs to a group of drugs
called antidiarrhoeals.
Diarrhoea Relief Capsules Loperamide 2 mg Capsules are used to treat
the symptoms of sudden short-lived
(acute) cases of diarrhoea in adults and children aged 12 years and
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIARRHOEA RELIEF CAPSULES
Loperamide 2 mg Capsules
DO NOT TAKE DIARRHOEA RELIEF CAPSULES Loperamide 2 mg Capsules IF YOU:

are allergic (hypersensitive) to loperamide or any of the other
ingredients of this medicine (listed in
section 6)

have acute dysentery, which is characterised by blood in your st

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diarrhoea Relief Capsules
Loperamide 2 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg Loperamide Hydrochloride.
Excipient(s) with known effect:
This product contains lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Green and dark grey, size 4 capsules containing a fine white powder.
Printed
'LOP2'.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Loperamide hydrochloride is indicated for the symptomatic treatment of
acute
diarrhoea in adults and children aged 12 years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The capsules should be taken with liquid.
Adults and Children 12-17 years
The initial dose is 2 capsules (4 mg) for adults and 1 capsule (2 mg)
for children;
followed by 1 capsule (2 mg) after every subsequent loose stool.
Further investigation into the cause of the diarrhoea should be
considered if there is no
improvement within 24 hours of starting treatment with loperamide
hydrochloride.
The maximum dose is 6 capsules (12 mg) daily for adults and children
aged 12-17 years.
Paediatric Populations
The capsules should not be used in children under 12 years of age.
Elderly
No dose adjustment is required for the elderly.
Patients with Renal Impairment
No dose adjustment is required for patients with renal impairment.
Patients with Hepatic Impairment
Although no pharmacokinetic data are available in patients with
hepatic impairment
loperamide HCl should be used with caution in such patients because of
reduced first
pass metabolism (see Section 4.4).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
•
Not to be used in children under 12 years of age.
•
Not for use when inflammatory bowel disease is present.
•
Loperamide HCl should not be used as the primary therapy:
•
in patients with acute dysentery, which is characterised by blood in
stools and
high fever,