Active ingredients: Nafazolina (Nafazolina nitrate), Tonzilamina (Tonzilamina hydrochloride)
IMIDAZYL Antihistamine 1 mg / ml + 1 mg / ml eye drops, solution (naphazoline nitrate + tonzylamine hydrochloride) bottle of 10 ml
Box of 10 single-dose containers of 0.5 ml
Why is Imidazyl Antihistamine used? What is it for?
WHAT IS IT
Imidazyl antihistamine is an ocular mucosal decongestant and antiallergic.
WHY IT IS USED
IMIDAZYL ANTISTAMINICO is used in allergic and inflammatory states of the conjunctiva accompanied by photophobia (hypersensitivity to light), lacrimation, sensation of foreign bodies, pain.
Contraindications When should not be used Imidazyl Antihistamine
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 disease.
Simultaneous treatment with monoamine oxidase inhibitors (antidepressants).
In children under the age of 12.
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). (See It is important to know that).
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 if you suspect pregnancy or wish to plan a maternity leave.
Precautions for use What you need to know before taking Imidazyl Antihistamine
Those who show hypersensitivity to the preservative should use the IMIDAZYL Antihistamine 1 mg / ml + 1 mg / ml eye drops solution, single-dose container that does not contain preservatives.
Since the single-dose container does not contain preservatives, each single-dose container, once opened, must be thrown away after use, even if only partially used.
Interactions Which drugs or foods can modify the effect of Imidazyl Antihistamine
Although the action of IMIDAZYL Antihistamine 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.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
Although the action of IMIDAZYL Antihistamine occurs mainly in the eye, in patients suffering from: hypertension (high blood pressure), coronary heart disease, hyperthyroidism (excessive thyroid activity) and hyperglycemia (diabetes) it should only be used after having consulted your doctor and have evaluated with him the risk / benefit ratio in your case.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
The product is not suitable for treating infections, mechanical (trauma), chemical or heat damage or for eliminating foreign bodies in the eye.
Dose, Method and Time of Administration How to use Imidazyl Antihistamine: 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 2-3 times a day.
Do not use for more than 4 consecutive days, unless otherwise prescribed, given 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 Antihistamine 1 mg / ml + 1 mg / ml eye drops solution
INSTRUCTIONS FOR OPENING THE BOTTLE
Safety cap
To prevent accidental opening by children
1. press down 2. at the same time unscrew 3. screw back down
The closure is child-resistant if you hear a click when you unscrew the cap without pressing it.
IMIDAZYL Antihistamine 1 mg / ml + 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.
Overdose What to do if you have taken an overdose of Imidazyl Antihistamine
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), coma.
In case of accidental ingestion / intake of an excessive dose of IMIDAZYL Antihistamine, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Imidazyl Antihistamine
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.
Request and fill in the Undesirable Effects report form available at the pharmacy (form B).
Expiry and Retention
See the expiration date indicated on the package; this date is intended for the product in intact packaging, properly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
IMIDAZYL Antihistamine 1 mg / ml + 1 mg / ml eye drops, solution - 10 ml bottle Store below 30 ° C in the original container. Shelf-life after first opening the bottle: 30 days.
IMIDAZYL Antihistamine 1 mg / ml + 1 mg / ml eye drops, solution - single-dose container
Store below 30 ° C in the original container.
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.
Keep this medicine out of the reach 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 eye drops contains:
Active principles:
Naphazoline nitrate 1 mg (equivalent to Naphazoline 770 micrograms)
Tonzilamina hydrochloride 1 mg (equivalent to Tonzilamina 890 micrograms)
Excipients:
benzalkonium chloride, sodium citrate, sodium chloride, hydroxypropylmethylcellulose, sodium fluorescein, methylene blue, purified water.
Single-dose container
1 ml of eye drops contains:
Active principles:
Naphazoline nitrate 1 mg (equivalent to Naphazoline 770 micrograms)
Tonzilamina hydrochloride 1 mg (equivalent to Tonzilamina 890 micrograms)
Excipients:
sodium monobasic phosphate monohydrate, sodium chloride, sodium hydroxide, water for injections.
HOW IT LOOKS
IMIDAZYL ANTHISTAMIN comes in the form of eye drops (solution for ophthalmic use). The contents of the package are one bottle of 10 ml or 10 single-dose containers of 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 ANTHISTAMIN 1 MG / ML + 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) and 1 mg of tonzylamine hydrochloride (equal to 890 mcg of tonzylamine).
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 accompanied by photophobia, lacrimation, foreign body sensation, pain.
04.2 Posology and method of administration
Instill 1-2 drops in the affected eye, 2-3 times a day. Do not exceed the recommended dose.
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.
In case of persistence or worsening of symptoms after a short period of treatment, invite the patient to consult the doctor. In any case, the product should not be used for more than 4 consecutive days, unless otherwise prescribed, given the possibility that unwanted effects may otherwise occur.
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.
Pregnancy and lactation (see section 4.6).
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, cardiac disorders and hyperglycemia (diabetes).
Accidental ingestion can cause central nervous system depression: marked sedation (severe drowsiness), 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.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
Imidazyl Antihistamine 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 Antihistamine 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
There are no known teratogenic and embryotoxic effects of the two components of the specialty, in topical use. However, in pregnant and lactating women the use of Imidazyl Antihistamine requires the approval of the doctor.
04.7 Effects on ability to drive and use machines
Imidazyl Antihistamine 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
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: severe sedation (severe drowsiness), 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 in combination.
ATC code: S01GA51.
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 a beta-stimulating effect ensures a reduced vasodilator effect only of the reflex type. Tonzilamina has shown a valid blocking activity of histaminergic H1 receptors and, therefore, prevention of allergic phenomena.
05.2 Pharmacokinetic properties
In animal studies, Imidazyl Antihistamine has shown excellent local pharmacokinetics, showing a rapid, consistent and complete antiallergic effect.
Studies relating to systemic absorption, evaluated with the presence of the effects of adrenergic stimulation, have highlighted the excellent tolerability of the drug which has shown very poor systemic absorption.
05.3 Preclinical safety data
The active principles have a very low toxicity especially with the topical route and its LD 50 of the intraperitoneal route in mice was equal to 54 mg / kg (naphazoline) 49 mg / kg (tonzylamine).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Imidazyl Antihistamine 10 ml bottle
Benzalkonium chloride
Sodium chloride
Disodium edetate
Sodium monobasic phosphate dihydrate
Disodium phosphate dihydrate
Purified water.
Imidazyl Antihistamine single-dose container
Monobasic sodium phosphate monohydrate
Sodium chloride
Sodium hydroxide
Water for injections.
06.2 Incompatibility
Not known.
06.3 Period of validity
Imidazyl Antihistamine 10 ml bottle
5 years.
Validity after first opening: 30 days.
Imidazyl Antihistamine single-dose container
3 years.
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.
06.4 Special precautions for storage
Store below 30 ° C in the original package.
06.5 Nature of the immediate packaging and contents of the package
Imidazyl Antihistamine 10 ml bottle
10 ml plastic bottle.
Imidazyl Antihistamine single-dose container
10 single-dose containers of 0.5 ml in plastic, in PE-Al sachets.
06.6 Instructions for use and handling
Instructions for Use:
Imidazyl Antihistamine 10 ml bottle
Container with child resistant closure: press and hold the cap to unscrew.
Imidazyl Antihistamine 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 Antihistamine 1 mg / ml + 1 mg / ml eye drops, solution - 10 ml bottle
A.I.C. n. 035469016
Imidazyl Antihistamine 1 mg / ml + 1 mg / ml eye drops, solution - 10 single-dose containers of 0.5 ml
A.I.C. n. 035469028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 08 August 2002
Date of most recent renewal: 08 August 2007
10.0 DATE OF REVISION OF THE TEXT
21/10/2015
