SPIRIVA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TIOTROPIUM BROMIDE

متاح من:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC رمز:

R03BB04

الشكل الصيدلاني:

INHALATION POWDER HARD CAPSULES

تركيب:

TIOTROPIUM BROMIDE 18 MCG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

المجموعة العلاجية:

TIOTROPIUM BROMIDE

المجال العلاجي:

TIOTROPIUM BROMIDE

الخصائص العلاجية:

Tiotropium is a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

تاريخ الترخيص:

2020-09-30

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
THIS MEDICINE IS TO BE SUPPLIED BY PHYSICIAN’S PRESCRIPTION ONLY
SPIRIVA
®
Inhalation powder, hard capsules
Each Spiriva capsule contains 18 mcg Tiotropium (as bromide
monohydrate).
Each Spiriva capsule also contains 5.5 mg lactose monohydrate.
Inactive ingredients and allergens in the medicine - See section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains essential information about
this medicine. If you have any further questions, refer to the
physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it
seems to you that their illness is similar.
This medicine is not intended for children and adolescents under the
age of 18.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Spiriva is indicated for the maintenance treatment of chronic
obstructive pulmonary disease (COPD) (a lung
disease that causes shortness of breath and coughing).
THERAPEUTIC GROUP
:
Anticholinergics.
More about the medicine
Spiriva helps patients with COPD to breathe more easily. COPD is a
chronic lung disease causing shortness of
breath and coughing. The medical condition of COPD is associated with
chronic inflammatory states of the
airways (bronchitis) and emphysema. Since COPD is a chronic disease,
you should take Spiriva every day, and
not only when you experience breathing problems or other COPD
symptoms.
Spiriva is a long acting bronchodilator assisting in the opening of
airways, thus making it easier to get air in and
out of the lungs. Regular use of Spiriva may help you when you suffer
from shortness of breath resulting from
your disease, and may also help to minimize the effects of the disease
on your everyday life. Regular use of
Spiriva will also help you to be more active. Daily use of Spiriva
will also help to prevent sudden and short term
worsening of COPD symptoms, which may last for several days. The
medicine is active for more than

خصائص المنتج

SPIRIVA
INHALATION POWDER, HARD CAPSULES
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
SPIRIVA, inhalation powder, hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.5 microgram tiotropium bromide monohydrate
equivalent to 18 microgram
tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
HandiHaler device) is 10 microgram
tiotropium.
Excipient: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Light green hard capsules with the product code TI 01 and company logo
printed on the capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tiotropium is a bronchodilator for the maintenance treatment of
chronic obstructive pulmonary
disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
THE MEDICINAL PRODUCT IS INTENDED FOR INHALATION USE ONLY.
The recommended dosage of tiotropium bromide is inhalation of the
contents of one capsule once
daily with the HandiHaler device at the same time of day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation and not for oral
intake.
Tiotropium bromide capsules must not be swallowed.
Tiotropium bromide should only be inhaled with the HandiHaler device.
Special Populations:
Geriatric patients can use tiotropium bromide at the recommended dose.
Renally impaired patients can use tiotropium bromide at the
recommended dose. For patients with
moderate to severe impairment (creatinine clearance

50 ml/min) (see section 4.4 and section 5.2).
Hepatically impaired patients can use tiotropium bromide at the
recommended dose (see section 5.2 ).
Paediatric population
_COPD _
There is no relevant use in the paediatric population (below 18 years)
in the indication stated under
section 4.1.
_Cystic fibrosis _
The safety and efficacy of Spiriva 18 microgram in children and
adolescents has not been established.
No data are available.
Method of administration:
To ensure proper administration of the me