Ephedrine hydrochloride 30mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Ephedrine hydrochloride

Beschikbaar vanaf:

Wockhardt UK Ltd

ATC-code:

R03CA02

INN (Algemene Internationale Benaming):

Ephedrine hydrochloride

Dosering:

30mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 03010102; GTIN: 5012727900926

Bijsluiter

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Removal of ref. to the 60mg strength tabs
in the patient information leaflet/QRD update
PACKAGE LEAFLET:
INFORMATION FOR THE
USER
EPHEDRINE
HYDROCHLORIDE 15MG
AND 30MG TABLETS
EPHEDRINE
HYDROCHLORIDE
READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU
START USING 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 side
effects not listed in this
leaflet. See section 4.
The name of your
medicine is Ephedrine
Hydrochloride 15mg or
30mg Tablets. In the rest
of this leaflet it is called
Ephedrine Tablets.
WHAT IS IN THIS LEAFLET:
1. What Ephedrine
Tablets are and what
are they used for
2. What you need to
know before you take
Ephedrine Tablets
3. How to take
Ephedrine Tablets
4. Possible side effects
5. How to store
Ephedrine Tablets
6. Contents of the pack
and other information
1.
WHAT EPHEDRINE
TABLETS ARE AND
WHAT THEY ARE USED
FOR
The active ingredient in
Ephedrine Tablets is
ephedrine hydrochloride,
which belongs to a
group of medicines
called bronchodilators,
which open up the
airways in your lungs and
prevent or relieve
wheezing.
Ephedrine Tablets are
used to prevent or
relieve wheezing
associated with asthma.
2.
WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE EPHEDRINE
TABLETS
DO NOT TAKE EPHEDRINE
TABLETS IF YOU:
• are allergic to
ephedrine
hydrochloride or any of
the other ingredients
contained in Ephedrine
Tablets (see list under
heading “What
Ephedrine Tablets
contain” in section 6)
• have coronary heart
disease with narrowing
of the blood vessels
that supply blood and
oxygen to the heart
• suffer from high blood
pressure
• have an over

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride Tablets BP 30mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg of ephedrine hydrochloride
Excipients with known effect
Each tablet contains 23.33mg of lactose
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, circular tablets marked E30 on one face and CP on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ephedrine tablets are indicated for the treatment or prevention of
attacks of
bronchospasm in asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
15 – 60mg three times daily
Children
under 1 year
not recommended
1 – 5 years
15mg three times daily
6 – 12 years
30mg three times daily
Elderly
Dosage should be substantially reduced. Initial therapy should
be 50% of adult dose.
Method of administration
Take the tablets with a glass of water.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Ischaemic heart disease
•
Hypertension
•
Thyrotoxicosis
•
Prostatic hypertrophy
Ephedrine has positive inotropic and chronotropic effects on the heart
and its
use should be avoided in patients with ischaemic heart disease.
Ephedrine increases blood pressure in humans. Over the counter
acquisition
of sympathomimetics should always be considered in hypertensive
patients
whose blood pressure control has suddenly deteriorated.
Patients with hyperthyroidism may be susceptible to the effects of
ephedrine.
Ephedrine may precipitate acute urinary retention in patients with
prostatic
hypertrophy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ephedrine should be given with care to patients with hyperthyroidism,
diabetes mellitus, angle-closure glaucoma and renal impairment.
Ephedrine has potentially life threatening effects in its acute
cardiovascular
and central stimulant effects.
Patients with rare hereditary problems of galactose intolerance, total
lactase
deficiency or glucose-gal