Kytril 2mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Granisetron hydrochloride

Disponível em:

Atnahs Pharma UK Ltd

Código ATC:

A04AA02

DCI (Denominação Comum Internacional):

Granisetron hydrochloride

Dosagem:

2mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04060000; GTIN: 5000471005905

Folheto informativo - Bula

1
uk-pil-Kytril-clean-161214-1mg-2mg-tabs
PACKAGE LEAFLET: INFORMATION FOR THE USER
KYTRIL 1 MG FILM-COATED TABLETS
KYTRIL 2 MG FILM-COATED TABLETS
Granisetron
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, nurse or
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What Kytril is and what it is used for
2.
What you need to know before you take Kytril
3.
How to take Kytril
4.
Possible side effects
5.
How to store Kytril
6.
Contents of the pack and information
1.
WHAT KYTRIL IS AND WHAT IT IS USED FOR
Kytril contains the active substance granisetron. This belongs to a
group of medicines called ‘5-HT
3
receptor antagonists’ or ‘anti-emetics’. These tablets are only
for use in adults.
Kytril is used to prevent or treat nausea and vomiting (feeling and
being sick) caused by other medical
treatments, such as chemotherapy or radiotherapy for cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KYTRIL
DO NOT TAKE KYTRIL TABLETS
•
if you are allergic (hypersensitive) to granisetron or any of the
other ingredients of Kytril (listed in
section 6: Further information and “Important Information about some
of the ingredients Kytril
below”.
If you are not sure, talk to your doctor, nurse or pharmacist before
taking these tablets.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using these tablets,
especially if you:
•
are having problems with your bowel movements because of a blockage of
your gut (intestines)
•
have heart problems, are being treated for cancer with a medicine that
is known to damage your
heart or have problems with levels

Características técnicas

KYTRIL 2 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 12-Apr-2017 | Roche
Products Limited
1. Name of the medicinal product
Kytril 2 mg film-coated tablets
2. Qualitative and quantitative composition
2.1 GENERAL DESCRIPTION
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg granisetron (as the
hydrochloride).
Excipients with known effect:
Each tablet contains 138.76 mg of lactose monohydrate.
Sodium starch glycolate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
The tablets are white to almost white triangular biconvex tablets
imprinted with K2 on one side.
4. Clinical particulars
4.1 Therapeutic indications
Kytril film-coated tablets are indicated in adults for the prevention
and treatment of acute nausea and
vomiting associated with chemotherapy and radiotherapy.
Kytril film-coated tablets are indicated in adults for prevention of
delayed nausea and vomiting associated
with chemotherapy and radiotherapy.
4.2 Posology and method of administration
Posology
1 mg twice a day or 2 mg once a day for up to one week following
radiotherapy or chemotherapy. The
first dose of Kytril should be administered within 1 hour before the
start of therapy. Dexamethasone has
been used concomitantly at doses up to 20 mg once a day orally.
_Paediatric population_
The safety and efficacy of granisetron tablets in children have not
yet been established.
No data are available.
_Older people and renal impairment_
There are no special precautions required for its use in either
elderly patients or those patients with renal
impairment.
_Hepatic impairment_
There is no evidence to date for an increased incidence of adverse
events in patients with hepatic
disorders. On the basis of its kinetics, whilst no dosage adjustment
is necessary, granisetron should be
used with a certain amount of caution in this patient group (see
section 5.2).
Method of administration
The tablets should be swallowed whole with water.
4.3 Contraindications
Hypersensitivi