Toprisan 50mg film coated tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

ITOPRIDE

Dostopno od:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Koda artikla:

A03FA07

INN (mednarodno ime):

ITOPRIDE 50 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

ITOPRIDE 50 mg

Tip zastaranja:

POM

Terapevtsko območje:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Status dovoljenje:

Authorised

Datum dovoljenje:

2016-05-23

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOPRISAN, 50 MG FILM-COATED TABLETS
Itopride hydrochloride
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Toprisan is and what it is used for
2. What you need to know before you take Toprisan
3. How to take Toprisan
4. Possible side effects
5. How to store Toprisan
6. Contents of the pack and other information
1. WHAT TOPRISAN IS AND WHAT IT IS USED FOR
Toprisan belongs to a group of drugs called prokinetic agents.
Prokinetic agents are drugs which
normalise
or
enhance
and
accelerate
bowel
movement
(motility).
Their
administration
results
in
accelerated gastric emptying, accelerated rate of passage of digested
food through the small intestine and
increased tonus of the lower oesophageal sphincter. In addition
Toprisan suppresses vomiting.
Toprisan is indicated for the treatment of symptoms resulting from the
slow gastric emptying, such as
feeling of gastric fullness, upper abdominal pain, lack of appetite,
heartburn, nausea and vomiting in
gastrointestinal disorders, which are not caused by ulcer disease or
organic disease affecting the rate of
passage of digested food through the gastrointestinal tract.
Toprisan is intended for adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPRISAN
DO NOT TAKE TOPRISAN:
-if you are allergic to itopride or any of the other ingredients of
this medicine (listed in section 6)
-if accelerated gastric emptying can be harmful for you, e.g. if you
suffer from gastrointestinal bleeding,
obstruction or perforation.
Toprisan

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Toprisan, 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains itopride hydrochloride 50 mg.
Excipient with known effect: lactose.
Each film-coated tablet contains 58.7 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film- coated tablets with diameter 7mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Toprisan is indicated in adults as atreatment of gastrointestinal
symptoms in functional, non-ulcer
dyspepsia (chronic
gastritis),
such
as:
flatulence, gastric
fullness,
upper
abdominal
pain,
anorexia,
heartburn, nausea and vomiting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended daily dose for adults is 150 mg daily, i.e. 1 tablet 3
times a day before meals. This dose
may be reduced depending on the patient's age and symptoms (see
section 4.4).
_Elderly _
It was shown in clinical studies that the incidence of adverse effects
in patients aged 65 years and older
was not higher than in younger patients. Itopride should be
administered in elderly patients with adequate
precaution because of increased incidence of hepatic and renal
function disorders, other diseases or
treatment with additional drugs.
_Paediatric population _
The safety and efficacy of itopride in paediatric population has not
been established.
_Patients with hepatic or renal impairment _
Itopride is metabolised in liver. Itopride and its metabolites are
excreted mainly via kidneys. Patients with
reduced hepatic or renal functions should be carefully monitored and
in case of adverse reactions it is
necessary to take appropriate measures, as e.g. to reduce the dosage
or to discontinue the therapy.
Duration of treatment
The duration of administration of itopride during clinical studies was
of maximum 8 weeks.
If there is no improvement in gastrointestinal symptoms, Toprisan
should not be used more