DISLEP 25 mg solution for injection/infusion

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

LEVOSULPIRIDE

Disponibil de la:

Ferrer Internacional S.A. Gran Vía Carlos III, 94 08028 Barcelona, Spain

Codul ATC:

N05AL07

INN (nume internaţional):

LEVOSULPIRIDE 25 mg/2ml

Forma farmaceutică:

SOLUTION FOR INJECTION/INFUSION

Compoziție:

LEVOSULPIRIDE 25 mg/2ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOLEPTICS

Rezumat produs:

Licence number in the source country: NOT APPLICAPABLE

Statutul autorizaţiei:

Authorised

Data de autorizare:

2021-11-10

Prospect

PATIENT INFORMATION LEAFLET
DISLEP 25 MG SOLUTION FOR INJECTION/INFUSION
Levosulpiride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE AS IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again later.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed only for you. Do not give it to
anyone else. It may harm
them, even if their symptoms are the same as yours.
-
If you experience any side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dislep
is and what it is used for
2.
What you should know before you take Dislep
3.
How to take Dislep
4.
Possible side effects
5.
How to store Dislep
6.
Contents of the pack and other information
1.
WHAT DISLEP
IS AND WHAT IT IS USED FOR
Dislep
contains the active substance levosulpiride which belongs to a group
of medicines
called 'psycholeptics, antipsychotics (neuroleptics)'.
It works by stimulating the motility of the stomach and intestines
(gastrointestinal prokinetic).
This medicinal product is indicated for the
SHORT-TERM
treatment of:
-
_DYSPEPTIC SYNDROME: _
this syndrome, that is a set of various symptoms, referring to poor
digestion, can be due to organic causes, or to lesions of digestive
organs, or due to the
malfunction of these organs, including those caused by poor lifestyle,
without evidence of
lesions in the digestive organs themselves. It is mainly linked to a
difficulty in the stomach to
empty itself. Some bodily disorders (such as delayed gastric emptying
in the case of diabetes,
or some cancers) or psychological disorders (such as anxiety and
depression which can lead
to alterations in gut function) can make digestion difficult. The
stomach struggles to empty
itself, which can lead to: pain and heartburn, loss of appetite
(anorexia), flatulence, stomach
swelling and tension, post-food headaches, belching, diarrhoea and
constipation.
Levosulpiride

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dislep 25mg solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2 ml ampoule contains:
_Active substance: _
levosulpiride 25 mg
Excipients with known effects: sodium
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear colourless solution, without foreign body.
Solution for injection/infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of dyspeptic syndrome (anorexia, meteorism, sense
of
epigastric tension, postprandial headache, heartburn, belching,
diarrhoea,
constipation) from delayed gastric emptying linked to organic
(diabetic
gastroparesis,
neoplasms,
etc.)
and/or
functional
factors
(visceral
somatisation in anxious- depressive subjects) in patients who have not
responded to other therapy.
Symptomatic and short-term treatment of vomiting and nausea induced by
antiblastic drugs following failure of first-line therapy.
Short-term and symptomatic treatment of dizziness, tinnitus and
hearing
loss and nausea associated with Ménière's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (
_according to medical prescription_
):
One 25 mg ampoule (i.m. or i.v.) 2 or 3 times per day.
If patients have severe symptoms with nausea and vomiting and oral
administration is difficult, initiate treatment with Dislep 25 mg
solution for
injection/infusion (i.m. or i.v.) 2 or 3 times per day for a few days
and, when
symptoms become milder, switch to oral administration for 10-15 days.
If
necessary, repeat the course of therapy orally for another 2 or 3
weeks, after
an interruption period of at least 8-10 days. When oral administration
is
needed,
other
medicinal
products
containing
levosulpiride
in
pharmaceutical forms for oral use, should be administered.
Treatment of vomiting: an i.m. or i.v. ampoule, possibly repeated 2-3
times
per day, until symptoms disappear.
If the drug is used in the treatment of antiblastic agent-induced
vomiting
(cisplatin, anthracyclines) a