Salbutamol 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Salbutamol sulfate

Available from:

Approved Prescription Services Ltd

ATC code:

R03CC02

INN (International Name):

Salbutamol sulfate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101

Patient Information leaflet

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Details
________________________________________________________________________________________
Version 2
01.11.2017
SALBUTAMOL 4MG 28 TABLETS LABEL LEAFLET - UK
03
Black
pms 464
R.Paul
25.07.2019
05-08-19
RH
BBBA5634
30 x 115
7pts
Accord Barnstaple
n/a
n/a
Profile
Braille
Print free areas
FMD
PRINT
FREE
Print free areas required
for FMD.
PRINT FREE AREAS
50974057 BBBA5634
50974057 BBBA5634
Each tablet contains 4.8mg salbutamol sulfate equivalent
to 4mg salbutamol. For oral administration.
Also contains lactose, E122-see leaflet for details.
Use as directed by physician. Keep out of the sight
and reach of children. Read the package leaflet before use.
Store below 25°C in a dry place.
PL 0142/0486
TABLETS
SALBUTAMOL
4
MG
Accord, Barnstaple, EX32 8NS, UK
_28 TABLETS_
_For oral use_
TABLETS
SALBUTAMOL
Accord, Barnstaple, EX32 8NS, UK
4
MG
_28 TABLETS_
_For oral use_
Each tablet contains 4.8mg salbutamol
sulfate equivalent to 4mg salbutamol.
For oral administration. Also contains lactose,
E122-see leaflet for details. Use as directed by physician.
Keep out of the sight and reach of children.
Read the package leaflet before use.
Store below 25°C in a dry place.
PL 0142/0486
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BEC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Salbutamol Tablets BP 4mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4.8mg salbutamol sulfate equivalent to 4mg
salbutamol.
Excipients with known effect:
Each 4mg tablet contains:
-
120.10mg Lactose monohydrate
-
Carmoisine (E122)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Salbutamol Tablets are indicated in adults, adolescents and children
aged 2 to
12 years.
1. For the relief of bronchospasm in bronchial asthmas of all types.
2. Chronic bronchitis.
3. Emphysema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
The usual effective dose is 4mg three or four times per day. If
adequate
bronchodilation is not obtained each single dose may be gradually
increased to
as much as 8mg. However, it has been established that some patients
obtain
adequate relief with 2mg three or four times daily. In elderly
patients or in
those known to be unusually sensitive to beta-adrenergic stimulant
drugs, it is
advisable to initiate treatment with 2mg three or four times per day.
_ _
_Children:_
The following doses should be administered three or four times daily.
2-6 years: 1-2mg
6-12 years: 2mg
Over 12 years: 2-4mg
The product is not recommended for children under 2 years of age. The
drug
is well tolerated by children so that, if necessary, these doses may
be
cautiously increased.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Salbutamol should not be used for threatened abortion during the first
or
second trimester of pregnancy.
Salbutamol and beta-blocking drugs such as propranolol should not
usually be
prescribed together.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bronchodilators should not be the only or main treatment in patients
with
severe or unstable asthma.
Increasing use of bronchodilators in particular shor