SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ephedrine 1.0%w/v Nasal Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains Ephedrine Hydrochloride 10mg/ml See 6.1 for excipients.

3    PHARMACEUTICAL FORM

Nasal Drops.

Ephedrine 1% Nasal Drops are a clear colourless solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of nasal congestion

4.2    Posology and method of administration

Instil the drops into each nostril.

Adults (including the elderly) and children over 12 years

1-2 drops to be put into each nostril as required up to 4 times a day

Children under 12 and infants Not recommended.

In all cases the drops should not be used for longer than 7 days.

4.3 Contraindications

Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors, or within two weeks of stopping such treatment. It should also be avoided in patients with cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed- angle glaucoma and urinary retention.

Patients receiving halogenated anaesthetics (see section 4.5).

Children under 12 years

4.4 Special warnings and precautions for use

Asthmatics should consult their doctor before using ephedrine nasal drops.

Avoid excessive or prolonged use due risk of tolerance with diminished effect and risk of rebound congestion.

4.5 Interaction with other medicinal products and other forms of interaction

The effects of ephedrine are diminished by guanethidine, reserpine, and probably methyldopa, and may be diminished or enhanced by tricyclic antidepressants. Ephedrine may also diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients

Patients anaesthetised with inhalation anaesthetics but particularly cyclopropane and halothane can develop cardiac arrhythmias if given sympathomimetics

4.6 Pregnancy and lactation

All drugs should be avoided if possible during pregnancy and lactation. Medical advice should be sought before use. Ephedrine has been reported to cause irritability and disturbed sleep when used during breast feeding.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Undesirable effects which may arise in patients with idiosyncrasy to ephedrine include anxiety, restlessness, nausea, muscular weakness and tremors, sweating and thirst and sometimes dermatitis. In patients with prostate enlargement, it may cause increased difficulty with micturition. Continued use of drops may aggravate the condition and lead to rebound congestion and drug induced rhinitis. It may also lead to tolerance.

Undesirable effects associated with the use of this product also include local irritation, headache and cardiovascular effects.

4.9 Overdose

The estimated minimal lethal dose of ephedrine in children up to 2 years of age is 200mg and for adults 2g, but fatalities due to ephedrine overdose are rare and not likely to occur following administration of nasal drops. Single doses of up to 400mg of ephedrine have been given without serious toxic effects. In large doses ephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Paranoid psychosis, delusions and hallucinations may follow overdosage. Treatment of overdosage should include supportive and symptomatic treatment. In severe cases the stomach should be emptied by aspiration and lavage. Diazepam may be given to control central nervous system stimulation.

Chlorpromazine may be given for excitement or the management of hallucinations. A beta-adrenoceptor blocking agent may be required to control cardiac arrhythmias.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Ephedrine hydrochloride is applied locally to relieve congestion of mucous membranes in acute sinusitis and hay fever. It has a stimulant action on the respiratory centre. Ephedrine releases norepinephrine from storage sites in the sympathetic nerves to the effector organ. It exhibits tachyphylaxis, repeated infusions become less effective as the releasable stores of norepinephrine are depleted.

Ephedrine redistributes the blood flow and causes cardiac stimulation without markedly raising the blood pressure.

Sympathomimetic drugs exert their effect by vasoconstriction of the mucosal blood vessesls, which in turn reduces the thickness of the nasal mucosa. However they can give rise to a rebound phenomenon as their effects wear off, due to secondary vasodilation with a subsequent temporary increase in nasal congestion.

5.2    Pharmacokinetic properties

Ephedrine is rapidly and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine together with small amounts of metabolites produced by hepatic metabolism. Ephedrine has been variously reported to have a plasma half-life ranging from 3 to 6 hours depending on urinary pH; elimination is enhanced and halflife accordingly shorter in acid urine.

5.3    Preclinical safety data

No additional data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride Benzalkonium chloride Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

3 years (36 months)

Discard any drops 2 months after first opening.

6.4 Special precautions for storage

Do not store above 25°C keep container in outer carton.

6.5 Nature and contents of container

Polyethylene dropper bottle with tamper evident cap. Pack size 10ml.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd Bampton Road,

Romford,

RM3 8UG England.

8    MARKETING AUTHORISATION NUMBER(S)

PL 0156/0035

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/04/2010

10 DATE OF REVISION OF THE TEXT

29/04/2010