TALMINEX oseltamivir (as phosphate) 45 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Accelagen Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; croscarmellose sodium; povidone; sodium stearylfumarate; Gelatin; pregelatinised maize starch; iron oxide black; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; potassium hydroxide

Administration route:

Oral

Units in package:

10 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TALMINEX 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.,TALMINEX 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: Size 4 hard gelatin capsules with grey opaque body with black band, imprinted with M and grey opaque cap imprinted with 45 mg.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-02-25

Patient Information leaflet

TALMINEX Consumer Medicine Information
Talminex CMI Ver 2.0
1
TALMINEX CAPSULES
Oseltamivir phosphate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Talminex 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 Talminex 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 TALMINEX IS USED FOR
Talminex is an antiviral medicine containing the active ingredient
oseltamivir.
Talminex 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.
Talminex belongs to a group of medicines called neuraminidase
inhibitors. These medicines attack the
influenza virus and prevent it from spreading inside your body.
Talminex is absorbed to the key sites of influenza infection and
treats the cause. Taking Talminex 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 TALMINEX HAS BEEN
PRESCRIBED FOR YOU.
Talminex 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.
TALMINEX Consumer Medicine Information
Talminex CMI Ver 2.0
2
BEFORE YOU TAKE TALMINEX
When you must not take it
DO NOT TALMINEX 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 incl

Summary of Product characteristics

Talminex PI Ver 3.0
1
AUSTRALIAN PRODUCT INFORMATION – TALMINEX (OSELTAMIVIR PHOSPHATE)
1.
NAME OF THE MEDICINE
Oseltamivir phosphate
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
TALMINEX is available as hard gelatin capsules for oral use.
Each 75 mg hard capsule of TALMINEX contains 98.5 mg oseltamivir
phosphate, equivalent
to 75 mg of oseltamivir.
Each 45 mg hard capsule of TALMINEX contains 59.1 mg oseltamivir
phosphate, equivalent
to 45 mg of oseltamivir.
Each 30 mg hard capsule of TALMINEX contains 39.4 mg of oseltamivir
phosphate,
equivalent to 30 mg of oseltamivir.
Gelatin capsules contain sulphites. For the full list of excipients,
see Section 6.1 LIST OF
EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Hard capsule.
30 mg: Size “4” hard gelatin capsules with light yellow opaque
colour body with black colour
band, imprinted with “M” and light yellow opaque colour cap
imprinted with “30 mg”
45 mg: Size “4” hard gelatin capsules with grey opaque colour body
with black colour band,
imprinted with “M” and grey opaque colour cap imprinted with “45
mg”.
75 mg: Size “2” hard gelatin capsules with grey opaque colour body
with black colour band,
imprinted with “M” and light yellow opaque colour cap imprinted
with “75 mg”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TALMINEX 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.
TALMINEX 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
TALMINEX may be taken with or without food (see Section 5.2
PHARMACOKINETIC
PROPERTIES). However, taking with food may enhance tolerability in
some patients.
TREATMENT OF INFLUENZA
Treatment should begin within the first or se