TAMIFLU oseltamivir (as phosphate) 45 mg capsule blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oseltamivir phosphate, Quantity: 59.1 mg (Equivalent: oseltamivir, Qty 45 mg)

Available from:

Roche Products Pty Ltd

INN (International Name):

Oseltamivir phosphate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: povidone; croscarmellose sodium; purified talc; sodium stearylfumarate; pregelatinised maize starch; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; iron oxide black; indigo carmine; butan-1-ol; ethanol; Shellac; methanol

Administration route:

Oral

Units in package:

10 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tamiflu is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,Tamiflu is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Product summary:

Visual Identification: Hard gelatin capsule with a grey body and cap; ROCHE is printed in blue ink on the body and 45 mg is printed in blue ink on the cap.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 10 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-08-08

Patient Information leaflet

TAMIFLU
®
_CAPSULES_
_contains the active ingredient oseltamivir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tamiflu capsules.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tamiflu
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAMIFLU IS USED
FOR
Tamiflu is an antiviral medicine
containing the active ingredient
oseltamivir.
Tamiflu is used for the treatment and
prevention of influenza (an infection
caused by the influenza virus). It has
no effect on the common cold or
other respiratory virus infections.
Tamiflu belongs to a group of
medicines called neuraminidase
inhibitors. These medicines attack
the influenza virus and prevent it
from spreading inside your body.
Tamiflu is absorbed to the key sites
of influenza infection and treats the
cause. Taking Tamiflu means you
feel better faster.
You will also be less likely to
develop complications of influenza,
such as bronchitis, pneumonia and
sinusitis.
Typical symptoms of influenza
include fever, headache, muscle
aches, sore throat, cough and
generally feeling unwell.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TAMIFLU HAS
BEEN PRESCRIBED FOR YOU.
Tamiflu is not addictive.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR ABOUT HAVING THE
INFLUENZA VACCINATION.
Vaccination every year is the best
way to prevent influenza.
BEFORE YOU TAKE
TAMIFLU
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TAMIFLU IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO OSELTAMIVIR OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tong

Summary of Product characteristics

Tamiflu 20210430
1
AUSTRALIAN PRODUCT INFORMATION
TAMIFLU
® (OSELTAMIVIR PHOSPHATE)
1.
NAME OF THE MEDICINE
Oseltamivir phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAMIFLU CAPSULES
Tamiflu 75 mg capsule contains of 98.5mg of oseltamivir phosphate
equivalent to 75mg
oseltamivir.
Tamiflu 45 mg capsule contains 59.1 mg oseltamivir phosphate,
equivalent to 45 mg of
oseltamivir.
Tamiflu 30 mg capsule contains 39.4 mg of oseltamivir phosphate,
equivalent to 30 mg of
oseltamivir.
TAMIFLU 6MG/ML POWDER FOR ORAL SUSPENSION
Each bottle, with 13 g powder for oral suspension, contains 0.5122 g
of oseltamivir
phosphate and when constituted with 55 mL water results in a
concentration of 6 mg/mL of
oseltamivir.
Excipients with known effect
_Tamiflu 6mg/mL powder for oral suspension _
5 ml oseltamivir suspension delivers 0.9 g of sorbitol.
7.5 ml oseltamivir suspension delivers 1.3 g of sorbitol.
10 ml oseltamivir suspension delivers 1.7 g of sorbitol.
12.5 ml oseltamivir suspension delivers 2.1 g of sorbitol.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
TAMIFLU CAPSULES
Hard capsules
Tamiflu 75 mg capsules has a light yellow/opaque cap and a grey/opaque
body. "ROCHE" is
printed in blue ink on the grey body and "75 mg" is printed in blue
ink on the light yellow cap.
Tamiflu 45 mg capsules has a grey/opaque cap and a grey/opaque body.
"ROCHE" is printed
in blue ink on the grey body and "45 mg" is printed in blue ink on the
grey cap.
Tamiflu 30 mg capsules has a light yellow/opaque cap and a light
yellow/opaque body.
"ROCHE" is printed in blue ink on the yellow body and "30 mg" is
printed in blue ink on the
light yellow cap.
Tamiflu 20210430
2
TAMIFLU 6MG/ML POWDER FOR ORAL SUSPENSION
Powder for oral suspension.
The powder is a granulate or clumped granulate with a white to light
yellow colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tamiflu is indicated for the treatment of infections due to influenza
A and B viruses in adults
and children including full-term n