REFLAD 50 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Itopride hydrochloride

Dostępny od:

PRO.MED.CS Praha a.s.

Kod ATC:

A03FA07

INN (International Nazwa):

Itopride hydrochloride

Forma farmaceutyczna:

Film-coated tablet

Dziedzina terapeutyczna:

itopride

Data autoryzacji:

2022-05-20

Ulotka dla pacjenta

1/4
PACKAGE LEAFLET: INFORMATION FOR THE USER
REFLAD 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 REFLAD is and what it is used for
2.
What you need to know before you take REFLAD
3.
How to take REFLAD
4.
Possible side effects
5.
How to store REFLAD
6.
Contents of the pack and other information
1.
WHAT REFLAD IS AND WHAT IT IS USED FOR
REFLAD belongs to a group of drugs called prokinetic agents.
Prokinetic agents are drugs which
normalise or enhance and accelerate bowel movement (motility).
REFLAD is indicated for the treatment of symptoms resulting from the
slow gastric emptying, such as
feeling of gastric fullness up to upper abdominal pain, lack of
appetite, heartburn, nausea and
vomiting, which are not caused by ulcer disease or organic disease
affecting the rate of passage of
digested food through the gastrointestinal tract.
REFLAD is intended for adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REFLAD
DO NOT TAKE REFLAD
-
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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine.
Itopride hydrochloride enhances the action of acetylcholine and
caution should be exercised when
administering REFLAD.
In case side effects occur in elderly patients doctor takes
appropriate measu

Charakterystyka produktu

Health Products Regulatory Authority
01 November 2023
CRN00DRYL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REFLAD 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of itopride hydrochloride.
Excipient with known effect
Each film-coated tablet contains 70.95 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to almost white round biconvex film-coated tablets with score
line, diameter 7 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of gastrointestinal symptoms of functional dyspepsia caused
by reduced gastrointestinal motility.
The medicinal product is intended for adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults is 1 tablet 3 times a day before meal,
corresponding to 150 mg of itopride daily. The
maximum daily dose is 150 mg of itopride.
This dose can be reduced if required in the course of disease. The
exact dosage and duration of treatment depends on the
clinical state of the patient. REFLAD should not be used for more than
8 weeks (see section 5.1).
_Paediatric population_
Safety of this product in children under the age of 16 has not been
established.
_Hepatic or renal impairment_
Itopride is metabolised in liver. Itopride and its metabolites are
excreted mainly via kidneys (see section 5.2). 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.
_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 caution because of increased incidence of
hep