VENTOLIN ROTACAP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALBUTAMOL SULFATE

Available from:

Allen and Hanburys Limited

Dosage:

200 mcg Microgram

Pharmaceutical form:

Inhalation Powder, Capsule

Authorization date:

1983-08-05

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin Rotacap 200 micrograms
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule (Rotacap) contains 200
micrograms salbutamol as salbutamol sulphate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Size 3 hard gelatin capsule  with  pale  blue  opaque cap and a  clear body  containing a small amount of  white  powder. 
Each capsule is marked ‘Ventolin 200’, printed in red ink.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Ventolin Rotacaps are indicated in the prophylaxis and
treatment of bronchial asthma and other conditions associated 
with reversible airways obstruction.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Ventolin Rotacaps capsules are for inhalation use only, using
a Ventolin Rotahaler inhaler.
Salbutamol has a duration of action of 4 to 6 hours in
most patients.
Increasing use of beta agonists may be a sign of worsening
asthma. Under these conditions a reassessment of the 
patient's therapy plan may be required and
concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with
excessive dosing, the dosage or frequency of administration
should 
only be increased on medical advice.
_For acute therapy:-_
_For chronic or prophylactic therapy:-_
4.3 CONTRAINDICATIONS
Ventolin Rotacaps are contraindicated in patients with a history
of hypersensitivity to sympathomimetics or any 
component of the preparation.
Adults: 
200 or 400 micrograms as a single dose.
Children: 
200 micrograms as a single dose.
Adults: 
400 micrograms three or four times daily.
Children:
200 micrograms three or four times daily.
2
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 29/08/2005_
_CRN 201420