Tamiflu Capsule 30mg

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

OSELTAMIVIR PHOSPHATE

Disponible desde:

ROCHE (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

OSELTAMIVIR PHOSPHATE

Unidades en paquete:

10Capsule Capsules

Fabricado por:

Delpharm Milano s.r.l

Información para el usuario

TAMIFLU
®
CAPSULES
_Oseltamivir 30mg, 45 mg and 75 mg _
1
_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What Tamiflu is used for
2.
How Tamiflu works
3.
Before you use Tamiflu
4.
How to use Tamiflu
5.
While you are using Tamiflu
6.
Side Effects
7.
Storage and disposal of Tamiflu
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT TAMIFLU IS USED FOR
Tamiflu contains the active
ingredient oseltamivir.
Tamiflu is prescribed to you for
treating or preventing influenza.
HOW TAMIFLU WORKS
Tamiflu belongs to a group of
medicines named “neuraminidase
inhibitors”. These medicines prevent
the influenza virus from spreading
inside the body and so help to ease
or prevent the symptoms arising
from the influenza virus infection.
BEFORE YOU USE TAMIFLU
-
_When you must not take it _
Do not take or receive Tamiflu if:

you are allergic (hypersensitive)
to oseltamivir or any of the other
ingredients of Tamiflu.

the package is torn or shows
signs of tampering

the expiry date (EXP) printed on
the pack has passed.

if you take this medicine after the
expiry date has passed, it may not
work as well.

if you are not sure if you should
be taking Tamiflu, talk to your
doctor.
-
_Use in the elderly _
Although there is limited experience
with use of Tamiflu in patients 65
years and older, the dose
recommended for use in elderly
patients is the same as that
recommended for adults.
-
_Use in children_ _ _
Safety and effectiveness of Tamiflu
in children under 1 year of age has
not been established.
-
_Before you start to take it _
Tell your doctor if:

you are pregnant or plan to
become pregnant
It is not known whether Tamiflu
is harmful to an unborn baby
when taken by a pregnant
woman. If there is a need to take
Tamiflu when you are pregnant,
your doctor will discuss the risks
and benefits to you and the
unborn baby.

you are breast-feeding or plan to
breast-feed. Tamiflu may pass
into breast milk. Your doctor
will discuss the r

Ficha técnica

PACK INSERT FOR MALAYSIA
T a m iflu
®
Oseltamivir phosphate 1. DESCRIPTION 1.1 Therapeutic/Pharmacologic Class of Drug Tamiflu is an antiviral agent 1.2 Type of Dosage Form Capsule, hard. 30 mg capsule consisting of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. The content of the capsule appear as a white powder . 45 mg capsule consisting of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “4 5 mg”. Imprints are blue. The content of the capsule appear as a white powder . 75 mg capsule consisting of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”. Imprints are blue. The content of the appea r as a white powder . 1.3 Route of Administration Oral 1.4 Qualitative and Quantitative Composition Active ingredient: oseltamivir phosphate 30 mg capsules, containing 39.4 mg oseltamivir phosphate equivalent to 30 mg of oseltamivir. 45 mg capsules, containing 59.1 mg oseltamivir phosphate equivalent to 45 mg of oseltamivir. 75 mg capsules, containing 98.5 mg oseltamivir phosphate equivalent to 75 mg of oseltamivir. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indications Treatment of influenza Tamiflu is indicated for the tre atment of influenza in children 6 to 12 months of age during a pandemic influenza outbreak . Tamiflu is indicated for the treatment of influenza in adults and children ≥1 year of age (see sections 2.2.1 Special Dosage Instructions, 2.4 W arnings and Precautions and 3.3 Non clinical Safety). Treatment should commence as soon as possible but no later than forty -eight hours after the onset of the initial symptoms of infe ction. Prophylaxis of influenza Tamiflu is indicated for post exposure prophylaxis in adults and children ≥1 year following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. 2.2 Dosage and Administrati on Tamiflu may be taken with o