Active ingredients: Nafazoline (Nafazoline nitrate)
Alfa® eye drops 0.8 mg / ml eye drops, solution
Why is Alpha Eye Drops used? What is it for?
Alpha eye drops contain the active ingredient naphazoline nitrate which belongs to the group of ocular mucosal decongestants. Collirio Alfa is used in case of redness, tearing, burning and itching of the eyes, caused by irritation phenomena (excessive exposure to dust, smoke, etc.).
Talk to your doctor if you do not feel better or if you feel worse after 4 days of treatment.
Contraindications When Alpha eye drops should not be used
Do not use Alpha Eye Drops
- If you are allergic to naphazoline nitrate or any of the other ingredients of this medicine (listed in section 6).
- If you have narrow-angle glaucoma (increased pressure in the eye) or other serious eye diseases.
- In children under twelve years of age.
- If you are taking monoamine oxidase inhibitors (antidepressants).
Precautions for use What you need to know before taking Alpha eye drops
Talk to your doctor before using Alpha Eye Drops:
- if you suffer from hypertension (increased blood pressure), hyperthyroidism (increased thyroid function), heart problems, bronchial asthma and hyperglycaemia (diabetes).
- In case of infections, pus, foreign bodies in the eye, mechanical, chemical or heat damage.
Children and adolescents
Do not use in children under twelve years of age. Take special care to keep this medicine out of the sight and reach of children as it can cause CNS depression (severe sedation or hypotonia, i.e. muscle weakness) if ingested accidentally.
Interactions What medications or foods may change the effect of Alpha Eye Drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Although the action of Alpha Eye Drops occurs mainly in the eye, do not use it if you are taking monoamine oxidase inhibitors (antidepressants) and in the two weeks following such use, as severe hypertensive crises (significant rise in blood pressure) may arise. .
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breastfeeding, use Alpha Eye Drops only if clearly needed and under the direct supervision of your doctor.
Alpha eye drops (bottle) contains benzalkonium chloride
May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reapplying. Note the bleaching action of soft contact lenses.
Alpha eye drops (single-dose container) do not contain benzalkonium chloride
The single-dose containers can be used by contact lens wearers or by those who show hypersensitivity to benzalkonium chloride.
For those who carry out sports activities: this medicine contains ethyl alcohol, the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Alpha eye drops: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Alpha eye drops are for ophthalmic (in the eye) use. It is "forbidden" to take other than those reported in terms of dosage schedule and route of administration.
Dosage
1 or 2 drops in the conjunctival sac (inside the lower eyelid) once or twice a day. Warning: do not exceed the indicated doses without medical advice. Contact your doctor if you do not feel better or if you feel worse afterwards. a short days of treatment.
The product should not be used for more than 4 consecutive days, unless otherwise prescribed, as undesirable effects may occur.A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects.
Consult your doctor if the symptoms occur repeatedly or if you have noticed any recent changes in their characteristics.
Method of administration
Bottle 10 ml
After unscrewing the capsule, the vial is ready for use. Bring it upside down over the eye: press it with your thumb and forefinger. The drops will come out. After use, screw the capsule back on.
Single-dose container
- Open the single-dose container by removing the cap, which can be used, upside down, to temporarily close the container.
- Gently press on the body of the single-dose container and let the eye drops drop into the eye, as described above.
Alpha eye drops, single-dose container does not contain preservatives; for this reason each single-dose container, once opened, must be thrown away after use, even if only partially used.
Use in children and adolescents
It is contraindicated for use in children and adolescents under the age of 12 years
Overdose What to do if you have taken too much alpha eye drops
Strictly adhere to the recommended doses. The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena, especially in children. In case of accidental ingestion / intake of an overdose of Alpha Eye Drops, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Alpha Eye Drops
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of the product can sometimes cause dilation of the pupil, systemic effects of absorption (hypertension, heart disease, hyperglycemia), increased pressure inside the eye, nausea, headache.
Rarely, hypersensitivity phenomena (difficulty in breathing, lowering of blood pressure or the appearance of skin rashes) may occur. In this case, stop the treatment and notify your doctor so that, if necessary, appropriate therapy can be instituted. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Italian Medicines Agency at: http: // www.agenziafarmaco.gov.it/it/responsabili By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. This date refers to the product in packaging, properly stored.
Bottle of 10 ml
Store in the original packaging. The eye drops in the 10 ml bottle should be used within 30 days. from the first opening of the bottle.
Single-dose container
Store at a temperature not exceeding 30 ° C, store in the original package. The eye drops in the single-dose container do not contain preservatives; for this reason each single-dose container, once opened, must be thrown away after use, even if only partially used.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
What Alpha Eye Drops contains
- The active ingredient is naphazoline hydrochloride. 1 ml of solution contains 0.8 mg of naphazoline nitrate.
- The other ingredients are:
For the eye drops (10 ml bottle): Sodium chloride, Monobasic potassium phosphate, Disodium phosphate dodecahydrate, Benzalkonium chloride, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections.
For the eye drops (single-dose container): Sodium chloride, Monobasic potassium phosphate, Disodium phosphate dodecahydrate, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections.
What Alpha Eye Drops looks like and contents of the pack
Alpha eye drops come in the form of eye drops (for ophthalmic use).
The contents of the Alpha Eye Drops pack are one 10 ml bottle or 10 single-dose containers of 0.3 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
EYE DROPS ALPHA 0,8 MG / ML EYE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
EYE DROPS ALPHA 0.8 mg / ml eye drops, solution
1 ml of solution contains:
Active principle:
Naphazoline nitrate 0.8 mg
For excipients see point 6.1
03.0 PHARMACEUTICAL FORM
Eye drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Redness, tearing, burning and itching of the eyes caused by irritation phenomena (excessive exposure to dust, smoke, etc.).
04.2 Posology and method of administration
Eye drops
1-2 drops in the conjunctival sac once or twice a day.
Strictly follow the recommended doses.
If symptoms persist or worsen after a short period of treatment, consult your doctor. In any case, the product should not be used for more than 4 consecutive days, unless otherwise prescribed, as undesirable effects may occur.
A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects.
04.3 Contraindications
It should not be used by people with narrow-angle glaucoma or other serious eye diseases.
Hypersensitivity to the components or to other closely related substances from a chemical point of view.
It should not be used in children under the age of twelve.
Simultaneous treatment with monoamine oxidase inhibitors (see section 4.5).
04.4 Special warnings and appropriate precautions for use
The product, although having poor systemic absorption, should be used with caution in patients suffering from hypertension, hyperthyroidism, cardiac disorders, bronchial asthma and hyperglycemia (diabetes).
Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require medical attention.
The product should be kept out of the reach of children as accidental ingestion can cause CNS depression (marked sedation or hypotonia).
Since the product, in the 10 ml bottle pack, contains benzalkonium chloride, soft contact lenses should not be worn during treatment.
Since benzalkonium chloride is not present in the single-dose package, this can be used by contact lens wearers, or by those who show hypersensitivity to benzalkonium chloride.
04.5 Interactions with other medicinal products and other forms of interaction
Alpha eye drops should not be used in people undergoing treatment with antidepressant drugs (MAOIs) and in the two weeks following such treatment as severe hypertensive crises can arise.
04.6 Pregnancy and lactation
During pregnancy and breastfeeding use only in case of real need, under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Nothing to report.
04.8 Undesirable effects
The use of the product can sometimes cause pupillary dilation, systemic effects of absorption (hypertension, heart disease, hyperglycaemia), increased intraocular pressure, nausea, headache. Hypersensitivity phenomena may rarely occur. doctor so that, where necessary, appropriate therapy can be instituted.
The patient is invited to report any undesirable effects not described above to the attending physician or pharmacist.
04.9 Overdose
Strictly adhere to the recommended doses.
The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena, especially in children.
If this happens: gastric lavage, sedation with diazepam and general supportive measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Naphazoline nitrate is an active ingredient with sympathomimetic action, used as a vasoconstrictor and decon-managing agent for local application on the nasal and ocular membranes.
It acts on the adrenergic receptors causing a depressive effect on the central nervous system, rather than an excitatory one.
05.2 "Pharmacokinetic properties
Nafazoline nitrate has a LD50 s.c. in the rat equal to 385 mg / kg.
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Eye drops (10 ml bottle):
Sodium chloride, Monobasic potassium phosphate, Disodium phosphate dodecahydrate, Benzalkonium chloride, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections.
Eye drops (single-dose container)
Sodium chloride, Monobasic potassium phosphate, Disodium phosphate dodecahydrate, Hamamelis Virginiana concentrated distilled water, Ethyl alcohol, Camphor, Water for injections.
06.2 Incompatibility
None known.
06.3 Period of validity
Eye drops (10 ml bottle): 3 years
Eye drops (single-dose container): 3 years
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Eye drops (10 ml bottle)
Store in the original packaging.
Validity after first opening: 30 days.
Eye drops (single-dose container)
Store in the original packaging.
Store at a temperature not exceeding 30 ° C.
It does not contain preservatives; for this reason each single-dose container, once opened, must be thrown away after use, even if only partially used.
06.5 Nature of the immediate packaging and contents of the package
Eye drops (10 ml bottle)
10 ml dropper bottles in plastic material.
Base body and dropper in low density polyethylene, screw cap in polypropylene.
Eye drops (single-dose container)
10 single-dose containers of 0.3 ml in 2 strips of 5 single-dose containers
06.6 Instructions for use and handling
Eye drops (10 ml bottle)
After unscrewing the cap, the vial is ready for use.
Bring it upside down over the eye; press it with your thumb and forefinger. Drops will come out. After use screw the capsule back on.
Eye drops (single-dose container)
Instructions for opening the single-dose container
1. Open the single-dose container by removing the cap, which can be used, upside down, to temporarily close the container.
2. Gently press on the body of the single-dose container and let the eye drop drop into the eye.
07.0 MARKETING AUTHORIZATION HOLDER
BRACCO s.p.a. - Via E. Folli, 50 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Alpha eye drops 0,8 mg / ml eye drops - 10 ml bottle A.I.C. 003235049
Alpha eye drops 0.8 mg / ml eye drops - 10 single-dose containers 0.3 ml A.I.C. 003235076
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
15.04.1950/
10.0 DATE OF REVISION OF THE TEXT
January 2010
