Active ingredients: Nafazolina (Nafazolina nitrate), Tonzilamina (Tonzilamina hydrochloride)
Alpha Antihistamine Eye Drops 0,8 mg / ml + 1 mg / ml eye drops, solution
Why is Alpha Antihistamine Eye Drops used? What is it for?
WHAT IS IT"
Alpha Antihistamine Eye Drops is a decongestant of the ocular mucosa and anti-allergic.
WHY "IT IS USED
Alpha Antihistamine Eye Drops are used in allergic and inflammatory states of the conjunctiva accompanied by photophobia (hypersensitivity to light), lacrimation, sensation of foreign bodies.
Contraindications When antihistamine alpha eye drops should not be used
WHEN IT SHOULD NOT BE USED
Alpha Antihistamine Eye Drops should not be used by people with narrow-angle glaucoma or other serious eye diseases and in children under the age of 10. Hypersensitivity to the components or to other closely related substances from a chemical point of view.
Simultaneous treatment with monoamine oxidase inhibitors (antidepressants).
WHEN IT CAN BE USED ONLY AFTER CONSULTING YOUR DOCTOR
During pregnancy and breastfeeding use only in case of real need, under the direct supervision of the doctor.
It is advisable to consult the doctor even in cases where these disorders have occurred in the past.
Precautions for use What you need to know before taking Alpha antihistamine eye drops
The product, although presenting a very 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, contains benzalkonium chloride, lenses should not be worn during treatment. soft contact.
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.
Interactions Which drugs or foods can modify the effect of Alpha antihistamine eye drops
Although the action of Alpha Antihistamine 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 increase in blood pressure) may arise. If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
Attention for those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.Dose, Method and Time of Administration How to use Alpha antihistamine eye drops: Posology
It is "forbidden" to take other than those reported in terms of dosage schedule and route of administration.
How many
Instill 1-2 drops into the affected eye, up to 2-3 times a day, as needed.
Warning: do not exceed the indicated doses without medical advice. If symptoms persist or worsen after a short period of treatment, consult your doctor.
When and for how long
The product should not be used for more than 4 consecutive days, unless otherwise prescribed, as undesirable effects may occur.
Strictly adhere to the recommended doses.A higher dosage of the product, even if taken topically and for a short period of time, can give rise to severe systemic effects.
Consult your doctor if the complaints occur repeatedly or if you have noticed any recent changes in their characteristics.
Like
Bottle of 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 Antihistamine 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.
Overdose What to do if you have taken an overdose of antihistamine 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. Accidental ingestion of the drug can cause central nervous system (CNS) depression up to coma, especially in children.
In case of accidental ingestion / intake of an excessive dose of Alpha Antihistamine Eye Drops, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Alpha Antihistamine Eye Drops
The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, heart disease, hyperglycemia), increased intraocular pressure, nausea, headache.
Hypersensitivity phenomena may rarely occur.
In this case it is necessary to interrupt the treatment and consult the 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.
It is important to inform the doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the Undesirable Effects report form available at the pharmacy (form B).
Expiry and Retention
See the expiry date indicated on the package: this date refers to the properly stored product in packaging.
Warning: do not use the medicine after the expiry date indicated on the package.
Bottle of 10 ml
Store in the original packaging.
The bottle must be used within 30 days of first opening the bottle.
Single-dose container
Store in the original packaging
Do not store above 25 ° C.
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.
Keep this medicine out of the reach and sight of children
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
COMPOSITION
Bottle 10 ml
1 ml of solution contains:
Active ingredients: Tonzilamina hydrochloride 1 mg; Naphazoline nitrate 0.8 mg.
Excipients: sodium chloride, sodium citrate, monobasic sodium citrate, sodium edetate, benzalkonium chloride, levomentol, ethyl alcohol, water for injections.
Single-dose container
1 ml of solution contains:
Active ingredients: Tonzilamina hydrochloride 1 mg; Naphazoline nitrate 0.8 mg.
Excipients: sodium chloride, sodium citrate, monobasic sodium citrate, sodium edetate, levomentol, ethyl alcohol, water for injections.
HOW IT LOOKS
Alpha Antihistamine Eye Drops comes in the form of eye drops (for ophthalmic use).
The contents of the package are one bottle of 10 ml 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 ANTHISTAMIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
Active principles:
Tonzilamina hydrochloride 1 mg
Naphazoline nitrate 0.8 mg
03.0 PHARMACEUTICAL FORM
Eye drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Allergic and inflammatory states of the conjunctiva, accompanied by photophobia, lacrimation, sensation of foreign bodies.
04.2 Posology and method of administration
Instill 1-2 drops into the affected eye, up to 2-3 times a day, as needed.
Strictly adhere to the recommended doses.
A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects.
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.
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 presenting a very 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.
Keep out of the reach and sight 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 Antihistamine Eye Drops should not be used if you are taking monoamine oxidase inhibitors or if it has been less than two weeks since the last administration of these medicines as severe hypertensive crises can occur.
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.
Accidental ingestion of the drug can cause CNS depression up to coma, especially in children.
In these cases, immediate medical assistance is always required: gastric lavage, sedation with diazepam and general support measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Tonzilamine hydrochloride is a substance with antihistamine activity with local anesthetic properties. As such it determines an attenuation of the inflammatory processes caused by the presence of allergens.
Naphazoline nitrate has a vasoconstrictive action and therefore has a valid decongestant effect on the inflamed mucosa of the conjunctiva.
The association of these two substances therefore tends to reduce subjective symptoms.
05.2 "Pharmacokinetic properties
05.3 Preclinical safety data
Nafazoline nitrate has a LD50 s.c. in the rat equal to 385 mg / kg.
Tonzilamina hydrochloride has a LD50 i.p. equal to 118 mg / kg in the mouse and 493 mg / kg in the guinea pig.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Eye drops, 10 ml bottle
Sodium chloride, sodium citrate, monobasic sodium citrate, sodium edetate, benzalkonium chloride, levomentol, ethyl alcohol, water for injections.
Eye drops, single-dose container
Sodium chloride, sodium citrate, monobasic sodium citrate, sodium edetate, levomentol, ethyl alcohol, water for injections.
06.2 Incompatibility
None known.
06.3 Period of validity
Bottle 10 ml: 3 years
Single-dose container: 2 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 at a temperature not exceeding 30 ° C, in the original package.
The 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.
06.5 Nature of the immediate packaging and contents of the package
Bottle 10 ml
10 ml bottle with dropper in low density polyethylene with screw cap closure in homopolymer polypropylene.
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
Bottle 10 ml
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.
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.
07.0 MARKETING AUTHORIZATION HOLDER
BRACCO - via E.Folli, 50 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Alpha Antihistamine Eye Drops 0,8 mg / ml + 1 mg / ml eye drops, solution
Bottle 10 ml AIC 027837018
Box of 10 single-dose containers of 0.3 ml AIC 027837020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
15.07.1991
10.0 DATE OF REVISION OF THE TEXT
January 2010
