Ephedrine hydrochloride 30mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Ephedrine hydrochloride

Tilgjengelig fra:

A A H Pharmaceuticals Ltd

ATC-kode:

R03CA02

INN (International Name):

Ephedrine hydrochloride

Dosering :

30mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 03010102; GTIN: 5025903005704

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER EPHEDRINE HYDROCHLORIDE 30 MG TABLETS
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 Ephedrine Tablets are and what they are 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.
Further 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 THESE TABLETS IF YOU:

are allergic to ephedrine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
An allergic reaction may be recognised as a rash, itching, swollen
face
or lips, or shortness of breath.

have coronary heart disease with narrowing of the blood vessels that
supply blood and
oxygen to the heart.

have an overactive thyroid gland.

are being treated for depression with monoamine oxidase inhibitors
(MAOIs) or have
only recently stopped taking them (within the last two weeks)

suffer from high blood pressure.

suffer from any prostate gland problems.
CHILDREN
The tablets are not recommended for children under one year of age.
WARNINGS AND PRECAUTIONS
SPEAK TO YOUR DOCTOR

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride 30 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of Ephedrine Hydrochloride.
Excipient(s) with known effect: Also contains 35mg of Lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Plain, white, bi-convex tablet, free from any visible contamination.
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 _
The adult dose is 15 - 60mg three times a day depending on response.
_Elderly _
The elderly dosage should be substantially reduced. Initial therapy
should be
50% of adult dose. _ _
_Children _
For children under 1 year: Not recommended
For children 1 - 5 years: 15 mg three times a day.
For children 6 - 12 years: 30 mg three times a day.
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 man. 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, the
Lapp
lactase deficiency