Peptomet tablets film-coated

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

domperidone

Disponível em:

Remedica Ltd.

Código ATC:

A03FA03 վերարտադրված դեղ, պարզ ընթացակարգով

DCI (Denominação Comum Internacional):

domperidone

Dosagem:

10mg (30/3x10/) in blister

Forma farmacêutica:

tablets film-coated

Unidades em pacote:

10mg (30/3x10/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2018-06-08

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
PEPTOMET 10 MG FILM-COATED TABLETS
DOMPERIDONE
This
medicine
is
subject
to
additional
monitoring.
This
will
allow
quick
identification of new safety information. You can help by reporting
any side effects,
you may get. See the end of section 4 for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1. What Peptomet is and what it is used for
2. What you need to know before you take Peptomet
3. How to take Peptomet
4. Possible side effects
5. How to store Peptomet
6. Contents of the pack and other information
1. WHAT PEPTOMET IS AND WHAT IT IS USED FOR
Peptomet is a medicine which contains domperidone. It belongs to a
group of medicines
called ‘dopamine antagonists’έ
This medicine is used in adults and in adolescents to treat nausea
(feeling sick) and
vomiting (being sick).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPTOMET
This medicine is suitable for most adults and adolescents 12 years of
age and older with
a body weight of 35 kg or more, but a few people should not use it. If
you are in any
doubt, talk to your doctor or pharmacist.
DO NOT TAKE PEPTOMET
if you are allergic (hypersensitive) to domperidone or any of the
other ingredients of
Peptomet 10 mg Film-Coated Tablets (listed in section 6: Contents of
the pack and
other information). Signs of an allergic reaction include: a rash,
swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
if you have a tumour o

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report
any suspected adverse reactions. See section 4.8 for how to report
adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Peptomet 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains domperidone 10 mg.
Excipient(s) with known effect
This product contains 60.9 mg lactose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Peptomet is indicated for the relief of the symptoms of nausea and
vomiting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Peptomet should be used at the lowest effective dose for the shortest
duration necessary
to control nausea and vomiting.
Usually, the maximum treatment duration should not exceed one week.
See section 4.4 for further information.
Adults and adolescents (12 years of age and older and weighing 35 Kg
or more):
One 10 mg film-coated tablet up to three times per day with a maximum
dose of 30 mg
per day.
_Neonates, infants, children (less than 12 years of age) and
adolescents weighing less _
_than 35 Kg _
_ _
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Due to the need for accurate dosing, Peptomet tablets are unsuitable
for use in children
and adolescents weighing less than 35 Kg.
Hepatic Impairment
Peptomet is contraindicated in moderate or severe hepatic impairment
(see section 4.3).
Dose modification in mild hepatic impairment is however not needed
(see section 5.2).
Renal Impairment
Since the elimination half-life of Peptomet is prolonged in severe
renal impairment, on
repeated administration, the dosing frequency of Peptomet should be
reduced to once
or twice daily depending on the severity of the impairment, and the
dose may need to
be reduced. Suc