Dompicare 20 mg Filmdragerad tablett

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

domperidon

זמין מ:

NordicInfu Care AB

קוד ATC:

A03FA03

INN (שם בינלאומי):

domperidone

כמות:

20 mg

טופס פרצבטיות:

Filmdragerad tablett

הרכב:

natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; domperidon 20 mg Aktiv substans

סוג מרשם:

Receptbelagt

איזור תרפויטי:

Domperidon

מצב אישור:

Avregistrerad

תאריך אישור:

2013-05-16

מאפייני מוצר

1. NAME OF THE MEDICINAL PRODUCT
Dompicare 20 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg domperidone.
Excipient with known effect:
Contains 116 mg of lactose.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are white, oblong and biconvex with a score
line on one face and of
about 11.2 mm long and 3.9 mm thick.
The tablets can be divided into two equal doses.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Adults
The relief of the symptoms of nausea and vomiting, epigastric sense of
fullness, upper
abdominal discomfort and regurgitation of gastric contents.
Adolescents (over 12 years and weighing 35 kg or more)
The relief of the symptoms of nausea and vomiting.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended to take this medicine before meals. If taken after
meals, absorption of the
drug is somewhat delayed.
_Adults and adolescents (over 12 years and weighing 35 kg or more)_
The initial duration of treatment is four weeks. Patients should be
re-evaluated after four
weeks and the need for continued treatment re-assessed.
10 mg (1/2 tablet) to 20mg (1 tablet) three to four times per day with
a maximum daily dose
of 80 mg.
_Paediatric population_
Dompicare tablets
_ _
are unsuitable for use in children under 12 years of age and weighing
less
than 35 kg.
_Use in patients with hepatic impairment_
No data is available in patients with hepatic impairment. Since
domperidone is highly
metabolised in the liver, this medicinal product should not be used in
patients with hepatic
impairment, see section 4.4.
_Use in patients with renal impairment_
Since very little unchanged drug is excreted via the kidneys, it is
unlikely that the dose of a
single administration needs to be adjusted in patients with renal
insufficiency. However, on
repeated administration, the dosing frequency should be reduced to
once or twice daily
depending on the severity of the impairment, and the dose may n