Pulvinal Beclometasone Dipropionate 100micrograms/dose dry powder inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Beclometasone dipropionate

Available from:

Chiesi Ltd

ATC code:

R03BA01

INN (International Name):

Beclometasone dipropionate

Dosage:

100microgram/1dose

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 03020000; GTIN: 5028613002278

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PULVINAL BECLOMETASONE DIPROPIONATE 100 micrograms/metered dose
inhalation powder
PULVINAL BECLOMETASONE DIPROPIONATE 200 micrograms/metered dose
inhalation powder
PULVINAL BECLOMETASONE DIPROPIONATE 400 micrograms/metered dose
inhalation powder
beclometasone dipropionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm
them even if their symptoms are the same as yours
-
If any of the side effects become serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT PULVINAL BECLOMETASONE DIPROPIONATE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE PULVINAL BECLOMETASONE DIPROPIONATE
3.
HOW TO USE PULVINAL BECLOMETASONE DIPROPIONATE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PULVINAL BECLOMETASONE DIPROPIONATE
6.
FURTHER INFORMATION
1. WHAT PULVINAL BECLOMETASONE DIPROPIONATE IS AND WHAT IT IS USED FOR
Pulvinal Beclometasone Dipropionate inhalation powder is used to help
PREVENT the symptoms of
asthma.
The active ingredient, beclometasone dipropionate, is one of a group
of medicines called
corticosteroids which are often referred to simply as steroids.
Steroids have an anti-inflammatory
action reducing the swelling and irritation in the walls of the small
air passages in the lungs, and so
ease breathing problems.
2. BEFORE YOU USE PULVINAL BECLOMETASONE DIPROPIONATE
DO NOT USE PULVINAL BECLOMETASONE DIPROPIONATE:
•
if you are allergic to beclometasone dipropionate or any of the other
ingredients contained in
your inhaler
•
to treat a sudden attack of breathlessness. It will not help. Use a
quick-acting ‘reliever’
inhaler for this purpose and carry it with you at all times.
TAKE SPECIAL CARE WITH PULVINAL BECLOMETASONE DIPROPIONATE AND ALWAYS
TELL YOUR DOCTOR IF:
•
you a

Summary of Product characteristics

PULVINAL BECLOMETASONE 100 MICROGRAM INHALER
Summary of Product Characteristics Updated 21-Aug-2015 | Chiesi
Limited
1. Name of the medicinal product
Pulvinal Beclometasone Dipropionate 100 micrograms/metered dose
inhalation powder.
2. Qualitative and quantitative composition
Pulvinal Dipropionate 100: Each actuation provides beclometasone 100
micrograms (metered dose) or 95
micrograms as emitted dose.
3. Pharmaceutical form
Inhalation powder administered from a multidose powder inhaler.
4. Clinical particulars
4.1 Therapeutic indications
Pulvinal Beclometasone Dipropionate is indicated in the treatment of
persistent bronchial asthma.
4.2 Posology and method of administration
Pulvinal Beclometasone Dipropionate 100 micrograms/metered dose
inhalation powder is for respiratory
use only. Each inhalation provides 100 micrograms of beclometasone
dipropionate.
STARTING DOSE
Adults
In mild asthma the starting dose is 200 - 400 micrograms per day. In
moderate and severe asthma, the
starting dose can be 800 to 1600 micrograms per day.
Children aged above 6 years
The starting dose is 100 micrograms 2 to 4 times daily according to
the clinical response.
MAXIMUM DOSE
The maximum daily dose for adults is 2000 micrograms and 400
micrograms in children aged above 6
years.
No dose adjustment is required in elderly patients or in those with
renal or hepatic impairment.
Instructions for use
Do not remove the cap protecting the inhaler until the moment of use.
Unscrew the protective cap and before twisting the inhaler, hold it
upright and tap it gently against a hard
surface to level the powder in the chamber.
Press the dark brown button and rotate the inhaler body anti-clockwise
until the red mark on the body
shows through the hole in the mouthpiece (dose-loading position).
While still holding the inhaler upright, rotate the inhaler body
clockwise until the green mark on the body
shows through the hole in the mouthpiece (dose-delivery position).
Breathe out deeply. While still holding the inhaler upright, put the
mouthpiece betwee