BUDICORT TURBUHALER 100 MCGDOSE

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

BUDESONIDE

Disponibil de la:

ASTRAZENECA (ISRAEL) LTD

Codul ATC:

R03BA02

Forma farmaceutică:

POWDER FOR INHALATION

Compoziție:

BUDESONIDE 100 MCG/DOSE

Calea de administrare:

INHALATION

Tip de prescriptie medicala:

Required

Produs de:

ASTRA ZENECA AB., SWEDEN

Grupul Terapeutică:

BUDESONIDE

Zonă Terapeutică:

BUDESONIDE

Indicații terapeutice:

Bronchial asthma.

Data de autorizare:

2022-08-31

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
BUDICORT
® BUDICORT
®
100 mcg
200 mcg
TURBUHALER
®
TURBUHALER
®
Powder for Inhalation
Powder for Inhalation
Composition:
Each dose contains:
Budesonide 100 mcg
Budesonide 200 mcg
FOR INACTIVE INGREDIENTS, PLEASE REFER TO SECTION 6 - "FURTHER
INFORMATION".
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Treatment of bronchial asthma.
THERAPEUTIC GROUP:
Corticosteroid.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive to Budesonide or to any of the other ingredients
contained in the
medicine.
SPECIAL WARNINGS REGARDING USE OF BUDICORT TURBUHALER:
BEFORE TREATMENT WITH BUDICORT TURBUHALER TELL YOUR DOCTOR IF:
•
You have a lung infection.
•
You have a cold or chest infection or any problems with breathing.
•
You have or have ever had tuberculosis (TB).
•
You have liver function problems.
If you experience blurred vision or other visual disturbances contact
your doctor.
DRUG INTERACTIONS
IF
YOU
ARE
TAKING,
OR
IF
YOU
RECENTLY
TAKEN,
OTHER
MEDICINES
INCLUDING
NON-
PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR
PHARMACIST.
Especially inform the doctor or pharmacist if you are taking:
•
Steroid medicines.
•
Medicines to treat fungal infections (such as itraconazole and
ketoconazole).
•
Medicines to treat HIV (such as ritonavir or cobicistat-containing
products).
PREGNANCY, BREAST-FEEDING AND FERTILITY:
•
If you are pregnant, breast-feeding, may be pregnant or are planning
pregnancy,
consult your doctor before using Budicort Turbuhaler. Do not use

Caracteristicilor produsului

THIS CONTENT OF THIS LEAFLET HAS BEEN CHECKED AND APPROVED IN JANUARY
2012 AND UPDATED
ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN FEBRUARY 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Budicort
®
Turbuhaler
®
100 micrograms / dose, inhalation powder
Budicort® Turbuhaler® 200 micrograms / dose
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide 100 micrograms/actuation.
Budesonide 200 micrograms/actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Breath-actuated metered dose powder inhaler.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Budicort is recommended in patients with bronchial asthma.
4.2 Posology and method of administration
Posology
The dosage of Budicort Turbuhaler is individual.
Budicort Turbuhaler is for oral inhalation
When transferring patients to Turbuhaler from other devices, treatment
should be individualised, The drug and method
of delivery should be considered.
The dosage should be individualised.
The dose should always be reduced to the minimum needed to maintain
good asthma control.
Adults (including elderly) and children over 12 years of age: When
starting treatment, during periods of severe asthma
and while reducing or discontinuing oral glucocorticosteroids, the
dosage in adults should be 200 - 1600 micrograms
daily, divided into 2-4 administrations.
In less severe cases and children over 12 years of age, 200 - 800
micrograms daily, in divided doses, may be used. During
periods of severe asthma, the daily dosage can be increased to up to
1600 micrograms, in 2-4 divided doses.
Children 6 years-12 years of age: 200 - 800 micrograms daily, in
divided doses. During periods of severe asthma, the
daily dose can be increased up to 800 micrograms.
The maintenance dose should be the lowest possible.
It is possible that the patient will not taste or perceive any
medicine when Budicort Turbuhaler is used; this is because
such a small amount of substance is dispensed.
In patients where an increased therapeutic effec