TAMIFLU CAPSULES 75MG

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

OSELTAMIVIR PHOSPHATE

Disponible depuis:

ROCHE (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

OSELTAMIVIR PHOSPHATE

Unités en paquet:

10Capsule Capsules

Fabriqué par:

Delpharm Milano s.r.l

Notice patient

TAMIFLU
®
Capsules
Oseltamivir 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 it
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 is used for the treatment of
influenza in children 6 to 12 months
of
age
during
pandemic
influenza
outbreak, for treatment of influenza
in adults and children age 1 year and
above. Tamiflu is also indicated for
post exposure prevention in adults
and children age 1 year and above
following
contact
with
clinically
diagnosed
influenza
case
when
influenza virus is circulating in the
community.
How Tamiflu works
Tamiflu contains oseltamivir which
belongs
to
a
group
of
medicines
named
neuraminidase
inhibitors.
These
medicines
prevent
the
influenza virus from spreading inside
the
body.
They
help
to
ease
or
prevent
the
symptoms
of
the
influenza virus infection.
Influenza, usually called flu, is an
infection
caused
by
a
virus.
The
signs of flu often include a sudden
fever
(more
than
37.8°C),
cough,
runny
or
stuffy
nose,
headaches,
muscle aches and extreme tiredness.
These symptoms can also be caused
by other infections. True influenza
infection only occurs during annual
outbreaks
(epidemics)
when
flu
viruses
are
spreading
in
the
local
community.
Outside
epidemic
periods,
flu-like
symptoms are usually caused by a
different type of illness.
Tamiflu is not a flu vaccine
Tamiflu is not a vaccine: it treats
infection, or prevents the flu virus
spreading. A vaccine gives you
antibodies against the virus. Tamiflu
will not change the effectiveness of a
flu
vaccine,
and
you
might
be
prescribed both by your doctor.
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.
Talk
to
your doctor if this appli

Résumé des caractéristiques du produit

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