Imidazyl antihistamine

Package leaflet: Information for the patient

Imidazyl Antihistamine 1 mg/ml + 1 mg/ml eye drops, solution

naphazoline nitrate + antazoline hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after 4 days of treatment.

Contents of this leaflet:

1. What Imidazyl Antihistamine is and what it is used for
2. What you need to know before using Imidazyl Antihistamine
3. How to use Imidazyl Antihistamine
4. Possible side effects
5. How to store Imidazyl Antihistamine
6. Contents of the pack and other information

1. What Imidazyl Antistaminico is and what it is used for

Imidazyl Antistaminico contains the active substances naphazoline nitrate, which belongs to a group of medicines called decongestants, and tonzylamine hydrochloride, which belongs to a group of medicines called antihistamines.
Imidazyl Antistaminico is used to treat eye allergies and eye inflammation (conjunctiva) accompanied by light sensitivity (photophobia), tearing, sensation of foreign bodies, and pain.
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using Imidazyl Antistaminico

Do not use Imidazyl Antistaminico

• if you are allergic to naphazoline nitrate or tolonazine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines of the same class as naphazoline nitrate and tolonazine hydrochloride; in particular xylometazoline, oxymetazoline, tetriazoline
• if you have a disease caused by high pressure within the eye (narrow-angle glaucoma) or if you have other serious eye diseases
• if you are concurrently taking certain medicines used to treat depression (monoamine oxidase inhibitors) (see section "Other medicines and Imidazyl Antistaminico")
• in children under 12 years of age
• during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using Imidazyl Antistaminico:

• if you suffer from high blood pressure (hypertension)
• if you have heart disorders
• if you suffer from overactivity of a gland called the thyroid (hyperthyroidism)
• if you have high blood sugar levels (hyperglycaemia, diabetes)

The use, especially prolonged, of locally applied medicines may cause allergic reactions (sensitization phenomena). In such case, discontinue treatment and contact your doctor.
Imidazyl Antistaminico is not suitable for the treatment of infections, mechanical (trauma), chemical or thermal injuries, or for removal of foreign bodies from the eye.
Caution for those engaged in sports activities: the product contains substances prohibited for doping.
Any use differing from the dosage regimen and route of administration indicated is prohibited.
Children
Imidazyl Antistaminico is contraindicated in children under 12 years of age.
Accidental ingestion of Imidazyl Antistaminico, particularly in children, may cause toxic effects (see section "If you use more Imidazyl Antistaminico than you should").

Other medicines and Imidazyl Antistaminico
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Imidazyl Antistaminico if you are taking medicines for depression (belonging to the class of monoamine oxidase inhibitors) and during the two weeks following such treatment, as a significant increase in blood pressure (severe hypertensive crises) may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Imidazyl Antistaminico should be used during pregnancy and breastfeeding only after consulting your doctor and evaluating with him the risks and benefits of the treatment.

Driving and using machines
Imidazyl Antistaminico does not impair the ability to drive or operate machinery.

Imidazyl Antistaminico (10 ml bottle) contains benzalkonium chloride (preservative)
This medicine contains 0.10 mg of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the most superficial transparent layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak with your doctor.
If you are allergic to the preservative, you may use Imidazyl Antistaminico in single-dose containers which do not contain preservatives.

Imidazyl Antistaminico (single-dose container 0.5 ml and 10 ml bottle) contains phosphate buffer
Imidazyl Antistaminico in 0.5 ml single-dose container contains 0.17 mg of phosphate in 0.5 ml of solution.
Imidazyl Antistaminico in 10 ml bottle contains 0.45 mg of phosphate in 1 ml of solution.
If you have severe damage to the outermost transparent layer of the eye (cornea), phosphates may very rarely cause corneal opacities due to calcium deposits during treatment.

3. How to use Imidazyl Antistaminico

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops instilled drop by drop directly into the affected eye.
Apply the medicine 2-3 times a day into the open eye.
Warning: Do not exceed the stated doses without medical advice. A higher dose, even if applied locally and for a short period of time, may cause serious undesirable effects on the entire organism.
Do not use Imidazyl Antistaminico for more than 4 consecutive days unless otherwise prescribed by a doctor, as undesirable effects may occur.
Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics.

Imidazyl Antistaminico 1 mg/ml + 1 mg/ml eye drops, solution (10 ml bottle)
INSTRUCTIONS FOR OPENING THE BOTTLE
Child-resistant cap
To prevent accidental opening by children
To open To close

1. Press down 2. Simultaneously unscrew 3. Screw back tightly

The closure is child-resistant if, when unscrewing the cap without pressing, you hear a click.

Imidazyl Antistaminico 1 mg/ml + 1 mg/ml eye drops, solution (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 reclose the container.
2. Gently press on the body of the single-dose container and instil the eye drops into the eye as described above.

Imidazyl Antistaminico 1 mg/ml + 1 mg/ml eye drops, solution (single-dose container) does not contain preservatives; therefore, each single-dose container must be discarded after use, even if only partially used.

Use in children
Imidazyl Antistaminico is contraindicated in children under 12 years of age.

If you use more Imidazyl Antistaminico than you should
If accidentally ingested or used in excessive doses over a prolonged period, the medicine may cause toxic effects.
Significantly exceeding the recommended dose of Imidazyl Antistaminico, for example in case of accidental ingestion, may cause serious undesirable effects on the heart and circulatory system. Symptoms may include: reduced heart rate (bradycardia), severe headache, nausea, vomiting, breathing difficulties, increased heart rate (tachycardia), and chest pain.
Accidental ingestion of the medicine, especially in children, may cause depression of the central nervous system: marked drowsiness (pronounced sedation), coma.
If undesirable effects occur or in case of accidental ingestion/overdose of Imidazyl Antistaminico, contact your doctor immediately or go to the nearest hospital.

If you forget to use Imidazyl Antistaminico
Do not use a double dose to make up for the forgotten dose.

If you stop using Imidazyl Antistaminico
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The use of this medicine may sometimes cause:

• dilation of the pupil,
• increased internal eye pressure,
• nausea,
• headache (cephalalgia),
• general effects on the body such as
  • increased blood pressure,
  • heart disorders,
  • increased blood sugar (glucose) levels.

Rarely, allergic reactions (hypersensitivity) may occur; if this happens, discontinue treatment and consult your doctor.
Following the instructions provided in this leaflet reduces the risk of side effects.
These side effects are usually temporary. If any of these occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imidazyl Antistaminico

Keep this medicine out of the sight and reach of children.
Store below 30°C in the original packaging.
Imidazyl Antistaminico 1 mg/ml + 1 mg/ml eye drops, solution (10 ml bottle)
Usable for 30 days after first opening of the bottle.
Imidazyl Antistaminico 1 mg/ml + 1 mg/ml eye drops, solution (single-dose container)
The single-dose container does not contain preservatives; therefore, each single-dose container must be discarded after use, even if only partially used.
Do not use this medicine after the expiry date stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always have medicine information available; therefore, keep both the carton and the package leaflet.

6. Package contents and other information

What Imidazyl Antistaminico contains
10 ml bottle

• The active substances are naphazoline nitrate and tetryzoline hydrochloride. 1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline) and 1 mg of tetryzoline hydrochloride (equivalent to 890 micrograms of tetryzoline).
• The other components are benzalkonium chloride, sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, water for injections, pH adjusters (sodium hydroxide, hydrochloric acid to pH 5.5).

Single-dose container

• The active substances are naphazoline nitrate and tetryzoline hydrochloride. 1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline) and 1 mg of tetryzoline hydrochloride (equivalent to 890 micrograms of tetryzoline).
• The other components are sodium dihydrogen phosphate monohydrate, sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of Imidazyl Antistaminico and contents of the pack
Imidazyl Antistaminico is an ophthalmic solution presented as eye drops to be instilled drop by drop into the open eye.
The pack contains either one 10 ml bottle or 10 single-dose containers of 0.5 ml each.

Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milan, Italy.

Manufacturer
10 ml bottle
Tubilux Pharma S.p.A. - via Costarica, 20/22 - Pomezia (Rome), Italy.
Single-dose container
Farmigea S.p.A. - via G. Battista Oliva, 8 - Ospedaletto (Pisa), Italy.
COC Farmaceutici Italia S.r.l. - Via Modena, 15 – 40019 Sant’Agata Bolognese (BO), Italy.