Active ingredients: Nafazoline (Nafazoline nitrate)
IMIDAZYL 1 mg / ml EYE DROPS, SOLUTION
Imidazyl package inserts are available for pack sizes:- IMIDAZYL 1 mg / ml EYE DROPS, SOLUTION
- IMIDAZYL 1 mg / ml Nasal spray, solution
Why is Imidazyl used? What is it for?
WHAT IS IT
Sympathomimetic used as a decongestant: used to reduce redness of the eyes.
WHY IT IS USED
IMIDAZYL is used for allergies and inflammation of the eye, characterized by a sense of burning, also caused by external agents, associated with excessive tearing, light discomfort, redness.
Contraindications When Imidazyl should not be used
WHEN IT SHOULD NOT BE USED
Hypersensitivity towards the components of the product or other strictly correlated substances from a chemical point of view; in particular towards xylometazoline, oximetazoline, tetrizoline. Narrow angle glaucoma or other serious eye diseases. Simultaneous treatment with monoamine oxidase inhibitors (antidepressants). Contraindicated in children under 12 years of age.
When it can be used only after consulting your doctor
- Pregnancy and breastfeeding (see What to do during pregnancy and breastfeeding).
- In patients suffering from: hypertension (high blood pressure); heart ailments; hyperthyroidism (excessive thyroid activity); hyperglycemia (diabetes) and bronchial asthma (see It is important to know). It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding, IMIDAZYL should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case. Consult your doctor in case you suspect pregnancy or wish to plan a maternity leave.
Precautions for use What you need to know before taking Imidazyl
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, medical attention is required.
The product should be kept out of the reach of children as accidental ingestion can cause central nervous system depression (marked sedation or hypotonia), coma.
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.
Interactions Which drugs or foods can modify the effect of Imidazyl
Although the action of IMIDAZYL 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. you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
Although the action of IMIDAZYL occurs mainly in the eye, in patients suffering from: hypertension (high blood pressure), coronary heart disease, hyperthyroidism (excessive thyroid activity), bronchial asthma and hyperglycaemia (diabetes) it should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
The product is not suitable for treating infections, mechanical (trauma), chemical or heat damage or for eliminating foreign bodies in the eye.
IMIDAZYL does not change the state of alertness and can therefore also be administered to patients who have to drive cars.
Dose, Method and Time of Administration How to use Imidazyl: Posology
How many
Pour 1-2 drops directly into the affected eye.
Warning: do not exceed the indicated doses without medical advice.
When and for how long
Repeat this operation 1-2 times a day.
Do not use for more than 4 consecutive days, unless otherwise prescribed due to the possibility that unwanted effects may otherwise occur.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Pour drop by drop directly into the open eye.
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.
IMIDAZYL 1 mg / ml Eye drops, solution (10 ml bottle)
INSTRUCTIONS FOR OPENING THE BOTTLE
Safety cap
To prevent accidental opening by children
The closure is child-resistant if you hear a click when you unscrew the cap without pressing it.
IMIDAZYL 1 mg / ml Eye drops, solution (single-dose container)
INSTRUCTIONS FOR OPENING THE 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.
IMIDAZYL 1 mg / ml Eye drops solution, 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 Imidazyl
The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause central nervous system depression: marked sedation (severe drowsiness), hypotonia and coma.
In case of accidental ingestion / intake of an excessive dose of IMIDAZYL, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Imidazyl
The use of the product can sometimes cause dilation of the pupil, increased internal pressure of the eye, general effects such as increased blood pressure, heart disease, increased blood glucose values, nausea, headache (headache). Hypersensitivity phenomena may rarely occur, in this case stop the treatment and institute a suitable therapy.
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 your doctor or pharmacist of any undesirable effects not described in this leaflet.
Expiry and Retention
IMIDAZYL 1 mg / ml Eye drops, solution (10 ml bottle)
Shelf-life after first opening the bottle: 30 days.
IMIDAZYL 1 mg / ml Eye drops, solution (single-dose container)
Once opened, each single-dose container must be thrown away after use, even if only partially used.
Store the container in the cardboard case.
WARNING: Do not use the medicine after the expiry date indicated on the package. 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
IMIDAZYL 1 mg / ml Eye drops, solution (10 ml bottle)
1 ml of eye drops contains:
Active principle:
Naphazoline nitrate 1 mg (equivalent to Naphazoline 770 micrograms)
for a total of 10 mg of Nafazoline nitrate (equal to Nafazoline 7.7 mg) present in the 10 ml bottle.
Excipients:
Benzalkonium chloride, sodium citrate, sodium chloride, disodium edetate, sodium fluorescein, menthol, alcohol, purified water.
IMIDAZYL 1 mg / ml Eye drops, solution (single-dose container)
1 ml of eye drops contains:
Active principle:
Naphazoline nitrate 1 mg (equivalent to Naphazoline 770 micrograms)
for a total of 500 micrograms of Nafazoline nitrate (equal to Nafazoline 385 micrograms) present in the single-dose container of 0.5 ml.
Excipients:
Monobasic sodium phosphate, sodium chloride, water for injections.
HOW IT LOOKS
IMIDAZYL comes in the form of eye drops, a solution for ophthalmic use (to be poured drop by drop directly into the open eye).
The contents of the IMIDAZYL 1 mg / ml Eye drops solution pack is 10 ml.
The contents of the pack of IMIDAZYL 1 mg / ml Eye drops solution, single-dose container is 0.5 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
IMIDAZYL 1 MG / ML EYE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 1 mg of naphazoline nitrate (equal to 770 mcg of naphazoline).
Excipient with known effects:
10 ml bottle: 1 ml of solution contains 0.10 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Eye drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
In allergic and inflammatory states of the conjunctiva characterized by a sense of burning, also by external agents, associated with excessive lacrimation, photophobia, hyperemia.
04.2 Posology and method of administration
Instill 1-2 drops into the affected eye, 1-2 times a day.
Do not exceed the recommended dose. 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 due to the possibility that unwanted effects may otherwise 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 serious systemic effects.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other closely related substances from a chemical point of view; in particular towards xylometazoline, oximetazoline, tetrizoline.
Narrow angle glaucoma or other serious eye disease.
Children under 12 years old.
Concurrent 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, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disorders, bronchial asthma and hyperglycemia (diabetes).
The product should be kept out of the reach of children since accidental ingestion can cause depression of the CNS (marked sedation and hypotonia), coma. In these cases, immediate medical assistance is always required.
The product is not suitable for treating infections, mechanical (trauma), chemical or heat damage, or for eliminating foreign bodies in the eye. These situations require medical attention.
Imidazyl 10ml bottle contains benzalkonium chloride. May cause eye irritation during treatment, soft contact lenses should not be worn.
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
Imidazyl should not be used if you are taking monoamine oxidase inhibitor drugs or if it has been less than two weeks since the last administration of these drugs as severe hypertensive crises can occur.
04.6 Pregnancy and lactation
There are no known teratogenic and embryotoxic effects of the component the specialty, in topical use. However, in pregnant women and during lactation the product should be used only in case of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Imidazyl does not affect the ability to drive or use machines.
04.8 Undesirable effects
The use of the product can sometimes lead to pupillary dilation, systemic effects of absorption (hypertension, cardiac disorders, hyperglycemia), increased intraocular pressure, nausea, headache. Hypersensitivity phenomena may rarely occur. suitable therapy.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "Street address www.aifa.gov.it/responsabili
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. Accidental ingestion of the drug, especially in children, can cause central nervous system depression: marked sedation (severe drowsiness), hypotonia and coma. If this happens: gastric lavage, sedation with diazepam and general supportive measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: ophthalmologicals - sympathomimetics used as decongestants.
ATC code: S01GA01.
Naphazoline in its quality of imidazoline derivative with alpha stimulating activity, determines an evident local vasoconstrictor effect without systemic actions. Its remarkable receptor affinity guarantees a powerful and prolonged ischemic action. The absence of beta-stimulating effect ensures a reduced vasodilator effect only of the reflex type.
05.2 Pharmacokinetic properties
In animal studies, Imidazyl demonstrated excellent local pharmacokinetics, showing a rapid and consistent vasoconstrictor effect. Studies relating to systemic absorption, evaluated with the presence of the effects of adrenergic stimulation, have highlighted the excellent tolerability of the drug. Imidazyl has shown a very poor systemic absorption, which however occurs mainly in the gastrointestinal tract.
05.3 Preclinical safety data
The active principle has a very low toxicity especially with the topical route and its LD 50 by intraperitoneal route in mice was equal to 54 mg / kg.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Imidazyl bottle of 10 ml
Benzalkonium chloride
Sodium chloride
Disodium edetate
Sodium monobasic phosphate dihydrate
Disodium phosphate dihydrate
Purified water.
Imidazyl single-dose container
Monobasic sodium phosphate
Sodium chloride
Water for injections.
06.2 Incompatibility
Not known.
06.3 Period of validity
Imidazyl bottle of 10 ml
4 years.
Validity after first opening: 30 days.
Imidazyl single-dose container
3 years.
Imidazyl 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.
06.4 Special precautions for storage
Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package
Imidazyl bottle of 10 ml
10 ml plastic bottle.
Imidazyl single-dose container
10 single-dose containers of 0.5 ml, enclosed in PE-Al sachets.
06.6 Instructions for use and handling
Instructions for Use:
Imidazyl bottle of 10 ml
Container with child resistant closure: press and hold the cap to unscrew.
Imidazyl single-dose container
Open the container by twisting and pulling the cap.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
RECORDATI Chemical and Pharmaceutical Industries S.p.A. - Via M. Civitali, 1 - 20148 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
Imidazyl 1 mg / ml eye drops, solution - bottle 10 ml A.I.C. n. 003410026
Imidazyl 1 mg / ml eye drops, solution - 10 single-dose containers 0.5 ml A.I.C. n. 003410065
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Imidazyl bottle of 10 ml
Date of first authorization: 30 May 1950
Date of most recent renewal: May 31, 2010
Imidazyl single-dose container
Date of first authorization: 23 February 1987
Date of most recent renewal: 31 May 2010
10.0 DATE OF REVISION OF THE TEXT
21/10/2015
