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Package leaflet
Information for use, please, read carefully!
FENEFRIN® 10%
(Phenylephrini hydrochloridum)
Eye drops, solution.
Marketing authorisation holder:
UNIMED PHARMA, JSC, Bratislava, Slovak Republic.
Composition:
Active substance:
Phenylephrini hydrochloridum (phenylephrine hydrochloride) 100 mg, corresponding
to phenylephrinum (phenylephrine) 80.3 mg in one mL of solution.
1 mL = 36 drops.
Excipients:
Dinatrii edetas dihydricus (dihydrate of edetane disodium), benzalkonii chloridum
(benzalkonium chloride), acidum hydrochloridum 1% (hydrochloric acid q.s.), aqua ad
iniectabilia (water for injections).
Pharmacotherapeutic group: Ophthalmic, alpha-sympathomimetic agent.
Characteristics: Phenyephrine is an alpha1-sympathomimetic agent. It acts as a
mydriatic substance in the eye that dilates pupils, and as a potent vasoconstrictor
that narrows eye vessels.
Indications: FENEFRIN® 10% is used in desirable rapid and pronounced dilation of
the pupil (a pupil will become unusually large), in prevention of development or
destruction of already developed adhesions between the iris and the lens (in
inflammation of the uveal tract), and for dilation of the pupil before intraocular (eye)
surgery.
Contraindications: Hypersensitivity to the active substance, or to any of the other
ingredients of the preparation.
Narrow-angle glaucoma, rhinitis sicca (dry inflammation of nasal mucosa),
vascular aneurysm (a balloon-like swelling in the wall of an artery), pregnancy and
lactation. The preparation is contraindicated for use in children.
The potential risk of using this preparation must be weighed against the
benefit it might produce in patients with cardiovascular disease, high blood pressure,
heart function disturbances, irregular heartbeat (arrhythmia), arteriosclerosis,
overactivity of the thyroid gland, insulin-dependent diabetes.
FENEFRIN® 10% can be used in above conditions only with special caution
and physician supervision. It is important to consult a doctor also in situations when
any of these conditions took place in the past, or occurred during the use of
FENEFRIN® 10%.
Undesirable effects:
Ocular side effects
Conjunctival hyperaemia (excess of blood), eye redness, sensation of burning in the
eye, impairment of visual acuity persisting over several hours (and inability to focus)
are possible. Dilating of pupils enables to be dazzled easily.
Long-term use may lead to conjunctival redness, thickening of the cornea due
to oedema, keratinisation of the conjunctiva, closure of the tear duct. Permanent use
may result in narrowing of pupils in elderly patients.
Systemic side effects
Increase in blood pressure, pounding heartbeat, increased pulse rate, severe
headache are possible. These systemic effects occur more often in patients with
conjunctival hyperaemia and corneal or conjunctival damage.
FENEFRIN® 10% may even aggravate the narrowing of chamber angle, thus,
it may provoke glaucoma attack.
If you notice above mentioned undesirable effects, or any other unusual
reactions, please inform your doctor.
Interactions: The effects of FENEFRIN® 10% and those of other drugs used
simultaneously may interact with each other. Your doctor should therefore be
informed about all drugs you are currently taking or you intend to take, either those
on medical prescription, or over-the-counter products. Should another doctor
prescribes you a new drug, inform him/her that you use FENEFRIN® 10% eye drops,
solution. If you receive also other ophthalmic agents, discuss the suitability of their
concomitant use with your ophthalmologist. Undesirable effects of FENEFRIN® 10%
may by potentiated by simultaneous use of monoaminoxidase inhibitors, tricyclic
antidepressants, certain anaesthetics, insulin, methyldopa, atropine and betasympatholytics (e.g. propranolol). Prominent elevation of blood pressure may develop
after co-administration of guanethidine or reserpine. This data may apply also to
medicines you used recently, or you will use soon after you have stopped using
FENEFRIN® 10%.
Dosage: The preparation is indended to be used by adults. One drop (as a single
dose) is applied into the conjuctival sac when rapid and pronounced dilating of the
pupil is to be achieved. For therapeutic reasons, in order to destruct adhesions, one
drop of the preparation is instilled into the conjuctival sac of the eye (or both eyes)
once a day. Therapy should not last longer than 5 days; prolonged therapy requires
medical supervision. For dilating the pupil during operation, the preparation can be
applied 30-60 minutes prior to intraocular surgery.
Dosage in elderly patients
Caution is required when FENEFRIN® 10% is administered to older people; this
preparation is used only in cases when possibility of use of another drug with lower
phenylephrine concentration was considered.
Mode of use
A patient leans his/her head back slightly, pulls the lower lid down and instills gently
one drop into the conjuctival sac by squeezing a bottle. It is important not to touch the
dropper tip to the eye. After application, the bottle should be closed again.
Like with all eye drops, it is recommended to press a finger against the
lacrimal sac (the inner corner of eye) before instillation to reduce systemic
absorption, and to release pressure 2-3 minutes after applying the drops.
Special warnings: Patients who are treated with this preparation should not wear
soft contact lenses at all (benzalkonium chloride, which is deposited in them for a
long time, may damage the cornea). Patients can wear rigid contact lenses under
medical supervision, however, the lenses have to be removed before application of
the drops and not reinserted earlier than 15 minutes after use. Regular medical
examinations during therapy are essential.
FENEFRIN® 10% causes dilation of pupils. Vision is blurred, in addition there
is a risk of dazzle that lasts even several hours. A patient has to avoid driving motor
vehicles and operating machines for a period of a few hours after instillation of the
preparation. His/her ability to react quickly and reasonably may be impaired.
Overdosage (e.g. incidental ingestion of the contents of a bottle) may present with
increase in blood pressure, pounding heartbeat, headache, vomiting, feeling of fear,
trembling, pulse rate is increased first, then it may be slowed down. After application
of a high dose into the eye, the conjunctival sac has to be rinsed with water
immediately in order to remove the medicine. In accidental overdosage or ingestion
of the preparation, a nearest doctor should be contacted at once. If possible, to give
activated charcoal before medical visit is advisable. Phentolamine is administered as
a peripheral alpha-receptor blocker in dangerously increased blood pressure. In case
of a missed dose, a next usual dose is applied when it is due (do not apply a double
dose to make up for a missed one).
Precautions: Preparation must not be used after the expiry date shown on the
pack. Use an open bottle within 28 days. Tighten the cap of the bottle after instillation
right away. Keep out of reach of children.
Package: 1 x 5 mL, 1 x 10 mL, 3 x 5 mL.
Storage: Do not refrigerate/freeze. Protect to light.
Date of last text revision: August 2005
Oriešková 11, 821 05 Bratislava
Slovak Republic