Phenylephrine Eye Drops Bpc 10% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenylephrine Eye Drops BPC 10%w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine Hydrochloride BP 100mg/ml
3 PHARMACEUTICAL FORM
Eye Drops
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A mydriatic agent to dilate the pupil for diagnosis and treatment.
4.2. Posology and Method of Administration
For topical ocular use only.
Adults
Administer 1 drop in each eye. If necessary repeat once after 1 hour. Children and the elderly Not recommended
4.3. Contra-indications
Patients with closed angle glaucoma, cardiac disease, hypertension, diabetes, tachycardia, thyrotoxicosis and hypersensitivity to any component of the preparation. Also patients taking MAOI’s, tricyclic antidepressants and antihypertensive agents including beta blockers.
4.4. Special Warnings and Precautions for Use
Corneal clouding may occur with phenylephrine if corneal epithelium has been denuded or damaged. Use with caution in patients with cerebral arteriosclerosis. Not to be used by patients who continue to wear soft contact lenses.
4.5. Interactions with other Medicaments and other forms of Interaction
Do not use in conjunction with the following:
Monoamine oxidase inhibitors (where interactions may occur within 4 weeks of stopping treatment), due to an increased risk of adrenergic reactions.
Tricyclic antidepressants (where interactions may occur within several days of stopping treatment), due to the risk of raised blood pressure and cardiac arrhythmia.
Anti-hypertensives due to potential reversal of action by using topical phenylephrine with possible fatal consequences
Cyclopropane and halothane due to the increased risk of ventricular fibrillation Cardiac glycosides and quinidine due to an increased risk of arrhythmias
4.6. Pregnancy and Lactation
Safety has not been established and therefore it should only be used in pregnancy if considered essential by the physician.
4.7. Effects on Ability to Drive and Use Machines
May cause stinging and transient blurring of vision. Do not drive or operate machinery until vision is clear.
4.8. Undesirable Effects
Eye pain and stinging may be experienced on instillation but can be overcome by use of a topical anaesthetic. May cause photophobia, conjunctival sensitisation, allergy and cardiac related reactions such as hypertension with pulmonary oedema and with arrhythmias have been reported.
4.9. Overdose
If overdose occurs by topical instillation, symptoms would be those of acute hypertension. An adrenergic blocking agent such as 5-10mg phentolamine mesylate should be administered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Phenylephrine is a sympathomimetic agent with direct effects on adrenergic receptors. It has alpha-adrenergic activity without significant stimulating effects on the central nervous system.
5.2. Pharmacokinetic Properties
As a mydriatic or conjunctival decongestant the effects last for several hours. Concentrations of greater than 2% may cause intense local iritation.
5.3. Preclinical Safety Data
None of relevance to the prescriber
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium metabisulphite BP/Ph Eur Sodium Citrate BP/ Ph Eur Benzalkonium chloride Purified Water BP/Ph Eur
6.3.
6.4.
6.5.
7
May contain sodium hydroxide or hydrochloric acid
Special Precautions for Storage Store between 2 and 8°C
Nature and Contents of Container
10ml low density polyethylene dropper bottle with integral eye dropper and tamper evident high density polyethylene cap. The product is supplied with a patient leaflet and packed in a cardboard carton. Pack size 1 x 10ml.
MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd Bampton Road,
Romford,
RM3 8UG England
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6 June 1997
10 DATE OF REVISION OF THE TEXT
October 2000