Loperamide hydrochloride 2 mg Oral Lyophilisate

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loperamide Hydrochloride

Available from:

Tenshi Kaizen B.V.

ATC code:

A07DA03

INN (International Name):

Loperamide Hydrochloride

Pharmaceutical form:

Oral lyophilisate

Therapeutic area:

loperamide

Authorization date:

2022-03-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
[NATIONALLY COMPLETED NAME]
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, pharmacist or nurse has
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, pharmacist or
nurse. 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 2 days.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name]is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME]IS AND WHAT IT IS USED FOR
This medicine contains loperamide hydrochloride which helps to stop
diarrhoea by making the stools more
solid and less frequent. This medicine is used for the treatment of
sudden short-lived (acute) attacks of
diarrhoea in adults and adolescents over 12 years of age.
THIS MEDICINE MUST NOT BE USED FOR MORE THAN
2 DAYS WITHOUT MEDICAL ADVICE AND SURVEILLANCE.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME], IF:
- patients with a known hypersensitivity to loperamide hydrochloride
or to any of the excipients (listed in
section 6);
- children aged less than 2 years of age
- patients with acute dysentery, which is characterised by blood in
stools and elevated body temperature.
- patients with acute ulcerative colitis
- patients with bacterial enterocolitis caused by invasive organisms
including Salmonella, Shigella and
Cam

Summary of Product characteristics

Health Products Regulatory Authority
02 August 2022
CRN00CY30
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loperamide hydrochloride 2 mg Oral Lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide hydrochloride 2 mg equivalent to loperamide 1.85 mg per
oral lyophilisate
Excipients with known effect: 1.0 mg aspartame (E951)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
oral lyophilisate.
White to off-white, round, tablets, debossed with T on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of acute diarrhoea in adults and adolescents
aged 12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Two oral lyophilisates (4 mg) initially followed by 1 oral
lyophilisate (2 mg) after every loose stool, not earlier than 1 hour
after
the initial dose. The usual dose is 3-4 oral lyophilisates (6 mg-8 mg)
daily; the maximum daily dose should not exceed 6 oral
lyophilisates (12 mg).
_Adolescents aged 12 years and older _
One oral lyophilisate (2 mg) initially followed by 1 oral lyophilisate
(2 mg) after every loose stool, not earlier than 1 hour after
the initial dose.
The maximum daily dose should not exceed 4 oral lyophilisates (8 mg).
The maximum duration of treatment without consultation with a doctor
is 2 days.
_Children_
This medicinal product is not intended for children between 2 and 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, this medicine should be used with caution
in such patients because of reduced first pass metabolism (see section
4.4).
Method of administration:
Health Products Regulatory Authority
02 August 2022
CRN00CY30
Page 2 of 7
The oral lyophilisate should be placed on your tongue, where it
dissolves and can be swallowed with the saliva. No liquid inta