Tobi Podhaler

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Tobramycin

Available from:

Viatris Healthcare Limited

ATC code:

J01GB01

INN (International Name):

tobramycin

Therapeutic group:

Antibacterials for systemic use,

Therapeutic area:

Cystic Fibrosis; Respiratory Tract Infections

Therapeutic indications:

Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

2011-07-20

Patient Information leaflet

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOBI PODHALER 28 MG INHALATION POWDER, HARD CAPSULES
tobramycin
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TOBI Podhaler is and what it is used for
2.
What you need to know before you take TOBI Podhaler
3.
How to take TOBI Podhaler
4.
Possible side effects
5.
How to store TOBI Podhaler
6.
Contents of the pack and other information
Instructions for use with the Podhaler device (
_overleaf_
)
1.
WHAT TOBI PODHALER IS AND WHAT IT IS USED FOR
WHAT TOBI PODHALER IS
TOBI Podhaler contains a medicine called tobramycin which is an
antibiotic. This antibiotic belongs
to a class called aminoglycosides.
WHAT TOBI PODHALER IS USED FOR
TOBI Podhaler is used in patients aged 6 years and older who have
cystic fibrosis to treat lung
infections caused by bacteria called
_Pseudomonas aeruginosa._
For the best results from this medicine, please use it as this leaflet
instructs you.
HOW TOBI PODHALER WORKS
TOBI Podhaler is a powder for inhalation that is filled into capsules.
When you inhale TOBI Podhaler,
the antibiotic can enter directly into your lungs to fight against the
bacteria causing the infection and to
improve your breathing.
WHAT IS _PSEUDOMONAS AERUGINOSA_
It is a very common bacterium that infects the lungs of nearly
everyone with cystic fibrosis at some
time during their lives. Some people do not get this infection until
later on in their lives, while others
get it very young. It is one of the most damaging bacteria for p

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TOBI Podhaler 28 mg inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 28 mg tobramycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Clear colourless capsules containing a white to almost white powder,
with “MYL TPH” printed in
blue on one part of the capsule and Mylan logo printed in blue on the
other part of the capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOBI Podhaler is indicated for the suppressive therapy of chronic
pulmonary infection due to
_Pseudomonas aeruginosa_
in adults and children aged 6 years and older with cystic fibrosis.
See sections 4.4 and 5.1 regarding data in different age groups.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of TOBI Podhaler is the same for all patients within the
approved age range, regardless of
age or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg
capsules), administered twice
daily for 28 days. TOBI Podhaler is taken in alternating cycles of 28
days on treatment followed by
28 days off treatment. The two doses (of 4 capsules each) should be
inhaled as close as possible to
12 hours apart and not less than 6 hours apart.
_ _
_Missed doses _
In case of missed dose with at least 6 hours until the next dose, the
patient should take the dose as soon
as possible. Otherwise, the patient should wait for the next dose and
not inhale more capsules to make
up for the missed dose.
_Duration of treatment _
Treatment with TOBI Podhaler should be continued on a cyclical basis
for as long as the physician
considers the patient is gaining clinical benefit from the treatment
with TOBI Podhaler. If clinical
deterioration of pulmonary status is evident, additional or
alternative anti-pseudomonal therapy should
be considered. See also information on clini