Imidazyl

Patient Information Leaflet

Imidazyl 1 mg/ml eye drops, solution

naphazoline nitrate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

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

Contents of this leaflet:

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

1. What Imidazyl is and what it is used for

Imidazyl contains the active substance naphazoline nitrate, which belongs to a group of
medicines called decongestants.
Imidazyl is used to treat eye allergies and inflammations of the conjunctiva, characterised by a burning sensation – also caused by external agents – associated with excessive tearing, discomfort to light, and redness.
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

Do not use Imidazyl

• if you are allergic to naphazoline nitrate or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines belonging to the same class as Imidazyl; in particular xylometazoline, oxymetazoline, tetrihydrozoline
• if you have a disease caused by high pressure inside the eye (narrow-angle glaucoma) or other serious eye diseases
• if you are currently taking certain medicines used to treat depression (monoamine oxidase inhibitors) (see section “Other medicines and Imidazyl”)
• in children under 12 years of age.

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

• if you have high blood pressure (hypertension);
• if you have heart disorders;
• if you have overactivity of a gland called the thyroid (hyperthyroidism);
• if you have high blood sugar levels (hyperglycaemia, diabetes);
• if you have breathing difficulties (bronchial asthma).

Imidazyl is not suitable for the treatment of infections, mechanical (trauma), chemical or thermal injuries, or for removing foreign bodies from the eye.
Caution for athletes: The product contains substances banned for doping.
Any use differing from the recommended dosage regimen or route of administration is prohibited.

Children
Imidazyl is contraindicated in children under 12 years of age.
Keep Imidazyl out of the reach of children, as accidental ingestion may cause toxic effects (see section “If you use more Imidazyl than you should”).

Other medicines and Imidazyl
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Do not use Imidazyl if you are taking medicines for depression (belonging to the class of monoamine oxidase inhibitors) or within two weeks after stopping such treatment, as this may cause a significant increase in blood pressure (severe hypertensive crises).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Imidazyl should be used during pregnancy and breastfeeding only after consulting your doctor and carefully evaluating together the risks and benefits of the treatment.

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

Imidazyl (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 eyes or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak to your doctor.
If you are allergic to preservatives or wear soft contact lenses, you may use Imidazyl Eye Drops in single-dose containers, which do not contain preservatives.

Imidazyl (single-dose container 0.5 ml and 10 ml bottle) contains phosphate buffer
Imidazyl in 0.5 ml single-dose container contains 0.91 mg of phosphate in 0.5 ml of solution.
Imidazyl in 10 ml bottle contains 0.45 mg of phosphate per 1 ml of solution.
If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment.

3. How to use Imidazyl

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The recommended dose is 1-2 drops instilled drop by drop directly into the affected eye.
Apply the medicine 1-2 times daily into the open eye.
Warning: Do not exceed the recommended doses without medical advice. Higher doses, even if applied locally and for a short period of time, may cause serious adverse effects on the whole organism.
Do not use Imidazyl for more than 4 consecutive days unless otherwise prescribed by a doctor, as there is a risk of adverse effects occurring.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.

Imidazyl 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: 1. press down 2. simultaneously unscrew
To close: 3. screw cap back tightly

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

Imidazyl 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 the body of the single-dose container and let the eye drops drip into the eye as described above.

Imidazyl 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 is contraindicated in children under 12 years of age.

If you use more Imidazyl than you should
If accidentally ingested or used excessively over a long period, this medicine may cause toxic effects.
Significantly exceeding the recommended dose of Imidazyl, for example by accidental ingestion, may cause serious adverse 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, hypotonia), and coma.
If adverse effects occur, or in case of accidental ingestion/overdose of Imidazyl, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Imidazyl
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 pressure of the eye,
• nausea,
• headache,
• general effects on the body such as
  • increased blood pressure,
  • heart disorders,
  • increased blood sugar (glucose) levels.

Rarely, allergic reactions (hypersensitivity) may occur; in this case, stop treatment and consult your doctor.
Following the instructions contained in this leaflet reduces the risk of side effects.
These side effects are generally temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the 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

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Imidazyl 1 mg/ml eye drops, solution (10 ml bottle)
Validity after first opening the bottle: 30 days.
Imidazyl 1 mg/ml eye drops, solution (single-dose container)
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 packaging after "Expiry". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 keep the medicine information available; therefore, retain both the packaging and the leaflet.

6. Package contents and other information

What Imidazyl contains
10 ml bottle

• The active substance is naphazoline nitrate. Each ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline).
• The other components are benzalkonium chloride, sodium chloride, disodium edetate, monobasic dihydrate sodium phosphate, dibasic dihydrate sodium phosphate, water for injections, pH adjusters (sodium hydroxide, hydrochloric acid to pH 5.5).

Single-dose container

• The active substance is naphazoline nitrate. Each ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline).
• The other components are dibasic dihydrate sodium phosphate, monobasic dihydrate sodium phosphate, sodium chloride, water for injections.

Description of the appearance of Imidazyl and the contents of the package
Imidazyl is an ophthalmic solution (eye drops) for topical ophthalmic use (administered drop by drop directly into the open eye).
The package 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 S.r.l. - Via Modena, 15 – 40019 Sant’Agata Bolognese (BO), Italy.