Loperamide HCl Mylan 2 mg, lyophilisaat voor oraal gebruik

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LOPERAMIDEHYDROCHLORIDE 2 mg/stuk SAMENSTELLING overeenkomend met ; LOPERAMIDE 1,85 mg/stuk

INN (Algemene Internationale Benaming):

LOPERAMIDEHYDROCHLORIDE 2 mg/stuk SAMENSTELLING overeenkomend met ; LOPERAMIDE 1,85 mg/stuk

farmaceutische vorm:

Lyofilisaat voor oraal gebruik

Samenstelling:

ASPARTAAM (E 951) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; PEPERMUNT SMAAKSTOF 76175-51 GIVAUDAN ; POLYSORBAAT 80 (E 433) ; PULLULAN (E 1204), ASPARTAAM (E 951) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; PEPERMUNT SMAAKSTOF 76175-51 GIVAUDAN ; POLYSORBAAT 80 (E 433) ; PULLULAN (E 1204), ASPARTAAM (E 951) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; PEPERMUNT SMAAKSTOF 76175-51 GIVAUDAN ; POLYSORBAAT 80 (E 433) ; PULLULAN (E1204)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

BIJSLUITER
Loperamide HCl Mylan 2 mg
RVG 125439
Versie: mei 2022
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPERAMIDE HCL MYLAN 2 MG, LYOPHILISAAT VOOR ORAAL GEBRUIK
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 Loperamide HCl Mylan is and what it is used for
2.
What you need to know before you take Loperamide HCl Mylan
3.
How to take Loperamide HCl Mylan
4.
Possible side effects
5.
How to store Loperamide HCl Mylan
6.
Contents of the pack and other information
1.
WHAT LOPERAMIDE HCL MYLAN 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 LOPERAMIDE HCL MYLAN
DO NOT TAKE LOPERAMIDE HCL MYLAN
- if you have a known hypersensitivity to loperamide hydrochloride or
to any of the excipients (listed in
section 6)
- if children are aged less than 2 years of age
- if you suffer from acute dysentery, which is characterised by blood
in stools and elevated body
temperature.
- if you suffer from acute ulcerative colitis
- if you suffer from bacterial enterocolitis caus

Productkenmerken

SAMENVATTING VAN DE PRODUCTKENMERKEN
Loperamide HCl Mylan 2 mg
RVG 125439
Versie: januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Loperamide HCl Mylan 2 mg, lyophilisaat voor oraal gebruik
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: _
SAMENVATTING VAN DE PRODUCTKENMERKEN
Loperamide HCl Mylan 2 mg
RVG 125439
Versie: januari 2024
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:
The oral lyophilisate should be placed on your tongue, where it