Salbutamol 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Salbutamol sulfate

Available from:

Accord-UK 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; GTIN: 5012617008930

Patient Information leaflet

50996926 BBBB0444
50996926 BBBB0444
OPEN TEXT POSITION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• 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 only. Do not pass it on
to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT SALBUTAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALBUTAMOL TABLETS
3. HOW TO TAKE SALBUTAMOL TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SALBUTAMOL TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SALBUTAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
Salbutamol tablets belong to a group of medicines called selective
beta-2-adrenergic agonists, which can be used to relax the muscles of
the airways
and womb. Salbutamol tablets may be used in:
• asthma, to relieve the narrowing of the airways
• chronic bronchitis
•
emphysema.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALBUTAMOL TABLETS
DO NOT TAKE Salbutamol tablets and TELL your doctor if you:
•
are ALLERGIC to salbutamol or any of the other ingredients of this
medicine (listed
in section 6).
•
have THREATENED ABORTION (POTENTIAL MISCARRIAGE) during the FIRST SIX
MONTHS
of pregnancy.
• are taking BETA-BLOCKERS such as propranolol.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST before taking Salbutamol tablets if
you have:
•
an OVERACTIVE THYROID gland (thyrotoxicosis).
• DIABETES.
• a history of HEART DISEASE, IRREGULAR HEART RHYTHM or ANGINA.
Although it is not known exactly how often this happens, some people
occasionally experience chest pain (due to heart problems such as
angina) or
difficulty breathing. Tell your doctor/midwife if you develop these

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 any of the excipients
listed in
section 6.1.
Non-i.v. formulations of salbutamol must not be used to arrest
uncomplicated
premature labour or threatened abortion.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bronchodilators should not be the only or main treatment in patients
with
severe or unstable asthma. Severe asthma requires regular medical
assessment
including lung function testing as patients are at risk of severe
attacks and
even death