VENTOLIN TABLETS 2 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

SALBUTAMOL AS SULFATE

Dostupné z:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kód:

R03AC02

Forma lieku:

TABLETS

Zloženie:

SALBUTAMOL AS SULFATE 2 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ASPEN BAD OLDESLOE GMBH, GERMANY

Terapeutické skupiny:

SALBUTAMOL

Terapeutické oblasti:

SALBUTAMOL

Terapeutické indikácie:

Relief of bronchospasm in bronchial asthma of all types, chronic bronchitis, emphysema.

Dátum Autorizácia:

2011-08-31

Príbalový leták

VENTOLIN TABLETS -
Ventolin Tablets are white, circular, flat-faced tablets with
bevelled edges, engraved on one side with a code.
Ventolin Tablets are packaged in double foil blister packs,
which contain 100 or 500 tablets.
Not all pack sizes may be marketed.
LICENSE HOLDER: GlaxoSmithKline (Israel) Ltd., 25 Basel
St., Petach Tikva.
MANUFACTURER:
VENTOLIN SYRUP - Farmaclair, Herouville-Saint-Clair,
France.
VENTOLIN TABLETS - Aspen Bad Oldesloe GmbH, Bad
Oldesloe, Germany.
This leaflet was checked and approved by the Ministry of
Health in July 2015.
Registration number of the medicine in the National Drug
Registry of the Ministry of Health:
VENTOLIN SYRUP - 050-54-24044
VENTOLIN TABLETS - 050-78-24043
VENTOLIN SYRUP -
•
Protect from light.
•
If your pharmacist has diluted your syrup (with purified
water):
-
store it below 25
o
C
-
do not use after 28 days
-
follow the instructions on the pharmacist's label.
•
Wipe the neck of the bottle after use.
6. ADDITIONAL INFORMATION
IN ADDITION TO THE ACTIVE INGREDIENT THE MEDICINE ALSO
CONTAINS:
VENTOLIN SYRUP –
Citric acid monohydrate, hydroxypropyl methylcellulose
2910, the preservative sodium benzoate, sodium citrate,
sodium chloride, saccharin sodium, orange flavour IFF
17.42.8187 and purified water.
VENTOLIN TABLETS –
Lactose monohydrate, maize starch, starch pregelatinised,
magnesium stearate and purified water.
WHAT DOES THE MEDICINE LOOK LIKE AND WHAT IS THE CONTENT
OF THE PACKAGE:
VENTOLIN SYRUP -
Ventolin Syrup comes in an amber-coloured glass bottle.
It is sealed with an aluminium cap or with a child-resistant
plastic cap.
Each bottle contains 150 ml of syrup.
Each bottle contains 2 mg of salbutamol in each 5 ml of
undiluted syrup.
_Ven Syr-Tab PT v4_
_Ven Syr-Tab PT v4_
DO NOT EXCEED THE RECOMMENDED DOSE
OPENING INSTRUCTIONS - TO REMOVE THE CAP, PRESS DOWN,
WHILE SIMULTANEOUSLY TURNING COUNTERCLOCKWISE.
IF YOU ACCIDENTALLY HAVE TAKEN A HIGHER DOSAGE
If you took an overdose or if a child has accidentally
swallowed the medicine, refer immediately to a

Súhrn charakteristických

Page 1 of 9
_ _
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in July 2015_
VENTOLIN
TM SYRUP
VENTOLIN
TM TABLETS 2 MG
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin
Syrup
Ventolin
Tablets 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin
Syrup: Each 5 ml contains 2 mg Salbutamol (as Sulfate).
Excipient with known effect: Sodium
Ventolin
Tablets 2 mg: Each tablet contains 2 mg Salbutamol (as Sulfate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ventolin
Syrup: Syrup
Ventolin
Tablets 2 mg: Tablets
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Syrup and Ventolin Tablets are indicated for the relief of
bronchospasm in bronchial asthma of all types, chronic bronchitis and
emphysema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Ventolin syrup and Ventolin Tablets are suitable oral therapy for
children and
adults who are unable to use an inhaler device.
Bronchodilators should not be the only or main treatment in patients
with
severe or unstable asthma. Severe asthma requires regular medical
assessment
as death may occur. Patients with severe asthma have constant symptoms
and
frequent exacerbations, with limited physical capacity, and PEF values
below
60% predicted at baseline with greater than 30% variability, usually
not
returning entirely to normal after a bronchodilator. These patients
will require
a high dose inhaled (e.g. >1mg/day) beclomethasone dipropionate) or
oral
corticosteroid therapy. Sudden worsening of symptoms may require
increased
Page 2 of 9
costicosteroid dosage which should be administered under urgent
medical
supervision.
Adults
Ventolin
Syrup:
The minimum starting dose is 2 mg three times a day given as 5 ml
syrup. The
usual effective dose is 4 mg (10 ml syrup) three or four times a day,
which
may be increased to a maximum of 8 mg (20 ml syrup) three or four
times a
day if adequate bronchodilation is not obtained.
Ventolin Tablets:
The minimum starting dose is 2 mg t