Loperamide capsules

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

loperamide (loperamide hydrochloride)

Commercializzato da:

Arpimed LLC

Codice ATC:

A07DA03

INN (Nome Internazionale):

loperamide (loperamide hydrochloride)

Dosaggio:

2mg

Forma farmaceutica:

capsules

Confezione:

(10/1x10/) in blister

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-09-19

Scheda tecnica

SUMMARY PRODUCT CHARACTERISTIC (SPC)
LOPERAMIDE
2 MG CAPSULES
1.1.
BRAND NAME – LOPERAMIDE
1.2. INTERNATIONAL NON-PROPERTY NAME - LOPERAMIDE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Loperamide 2 mg capsule contains:
_ACTIVE INGREDIENT:_
loperamide hydrochloride – 2 mg;
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
_Loperamide, 2 mg capsules _
Hard gelatin capsules. The capsules have a red body and a pink cap,
and contains white or of white,
odorless granules.
Excipient with known affect: Azorubine - Carmoisine (see section 4.4).
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged 12 years and over.
For the symptomatic treatment of acute episodes of diarrhoea
associated with Irritable Bowel
Syndrome in adults aged 18 years and over following initial diagnosis
by a doctor.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
ACUTE DIARRHOEA
Adults and children over 12:
2 capsules (4 mg) initially followed by 1 capsule (2 mg) after every
loose stool.
The maximum daily dose should not exceed 6 capsules (12 mg).
SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED
WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER
Two capsules (4 mg) to be taken initially, followed by 1 capsule (2
mg) after every loose stool, or as
previously advised by your doctor. The maximum daily dose should not
exceed 6 capsules (12 mg).
_Paediatric population_
Loperamide is contraindicated in children less than 12 years of age.
_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, Loperamide
should be used with caution in such patients because of reduced first
pass metabolism. (see 4.4 Special
warnings and special precautions for use).
Method of administration
Oral use. The capsules should be taken with liquid.
4.3.