Iridina infections and inflammations

Package leaflet: Information for the patient

Iridina infezioni e infiammazioni 3 mg/ml + 1 mg/ml eye drops, suspension

Tobramycin/Desamethasone
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Iridina infezioni e infiammazioni is and what it is used for
Iridina infezioni e infiammazioni contains desamethasone, which has an anti-inflammatory effect. Iridina infezioni e infiammazioni also contains tobramycin, an antibiotic active against various bacteria that can cause infections.
Iridina infezioni e infiammazioni is used to prevent and treat eye inflammation and to prevent bacterial infections after cataract surgery in adults and children from 2 years of age.

2. What you need to know before using Iridina infections and inflammations

Do not use Iridina infections and inflammations:

• If you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6).
• If you have or think you may have an eye infection.
• If you have sticky discharge from the eyes.
• If you have a red eye that has not been examined by a doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using Iridina infections and inflammations.

• If you have a medical condition that could cause thinning of an eye tissue, such as rheumatoid arthritis, Fuchs' dystrophy, or if you have had a corneal transplant, inform your doctor. Corticosteroids may cause further thinning and possible perforation.
• If you experience an allergic reaction with Iridina infections and inflammations, such as eyelid itching, swelling, or redness of the eyes, stop using it and consult your doctor. This allergic sensitivity may occur with other topical or systemic antibiotics of the aminoglycoside class.
• If symptoms worsen or suddenly return, consult your doctor. You may become more susceptible to infections with the use of this product.
• If you are diabetic, consult your doctor. The risk of increased intraocular pressure and/or corticosteroid-induced cataract formation is higher in diabetic patients.
• Contact your doctor if blurred vision or other visual disturbances occur.
• Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Iridina infections and inflammations. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat.
• Consult your doctor if you have neuromuscular disorders such as myasthenia gravis or Parkinson's disease. This medicine may worsen muscle weakness.
• If you are using other antibiotic treatments together with Iridina infections and inflammations, including oral medications, ask your doctor for advice.
• If you are using other ophthalmic preparations containing non-steroidal anti-inflammatory drugs (NSAIDs) together with Iridina infections and inflammations, seek medical advice. Concomitant use of eye drops containing non-steroidal anti-inflammatory drugs (NSAIDs) and ophthalmic preparations containing steroids may increase the risk of healing problems.
• If you use Iridina infections and inflammations for a long period of time, you may become more susceptible to eye infections, may experience increased pressure in the eye(s), or may develop cataracts.
• Intraocular pressure should be monitored frequently; this is particularly important in children under 6 years of age receiving products containing dexamethasone.
• If you wear soft contact lenses, remove them before using this medicine and wait at least 15 minutes before reinserting them. This product contains benzalkonium chloride as a preservative, which may cause eye irritation and changes in the color of soft contact lenses. Wearing contact lenses is not recommended during treatment of eye infections and inflammations.

Children
Do not use Iridina infections and inflammations in children under 2 years of age, as safety and efficacy have not been established in this population.
Other medicines and Iridina infections and inflammations
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of ophthalmic preparations containing non-steroidal anti-inflammatory drugs (NSAIDs) and ophthalmic preparations containing steroids may increase the risk of healing problems.
If you are using other eye drops or eye ointments, wait at least 5 minutes between administrations. Eye ointments should be used last.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will advise you whether or not you can use Iridina infections and inflammations.
Driving and using machines
If you experience temporary blurred vision after using Iridina infections and inflammations, you must wait until these symptoms have disappeared before driving or operating machinery.
Iridina infections and inflammations contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per ml, equivalent to 0.5 mg per 5 ml vial. Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. 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 transparent outermost layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. How to use Iridina infections and inflammations

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
One drop in the affected eye(s) every 4–6 hours during the day. During the first 48 hours, your doctor may
increase the dosage to one drop every 2 hours. Do not use for more than 24 days.
Use in children and adolescents
Iridina infections and inflammations may be used in children from the age of 2 years at the same dose
recommended for adults.
Always wash your hands before using the eye drops.
Use the eye drops as follows:

1. Shake the bottle well.
2. Remove the protective cap.
3. Tilt your head backwards and look at the ceiling.
4. Gently pull down the lower eyelid to form a small pocket.
5. Squeeze the inverted bottle to release one drop into the eye.
6. While closing the treated eye, press with your finger against the inner corner of the eye (the point where the eye meets the nose) for 1 minute.

Avoid touching the eye or other surfaces with the dropper tip.
Replace and tighten the cap after use.
If you use more Iridina infections and inflammations than you should
Topical overdose of Iridina infections and inflammations can be treated by rinsing with warm water.
If you forget to use Iridina infections and inflammations
If you forget to instill a dose, do so as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
If you stop using Iridina infections and inflammations
Your doctor will advise you when to stop treatment with Iridina infections and inflammations.
Inform your doctor if you need to stop treatment.
If you have any doubts about how to use the product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Iridina infections and inflammations can cause side effects, although not everybody will experience them.
The following side effects have been observed:

Uncommon side effects
(may affect up to 1 in 100 people)
Eye effects: increased pressure in the eyes, redness of the eyelid, swelling of the eyelid, eye irritation, eye pain, eye itching, watery eyes, sensation of ocular discomfort.
General side effects: headache, nasal discharge, swelling of the throat.

Rare side effects
(may affect up to 1 in 1,000 people)
Eye effects: eye redness, blurred vision, dry eyes, eye allergy, inflammation on the surface of the eye.
General side effects: altered taste.

Not known
(frequency cannot be estimated from the available data)
Eye effects: increased pupil diameter, eyelid redness, increased tear production, inflammation on the surface of the eye.
Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
General side effects: allergy (hypersensitivity), dizziness, nausea, abdominal discomfort, rash, facial swelling, itching.

If Iridina infections and inflammations is used for more than 24 days, it may cause infections and delayed wound healing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 Iridina infections and inflammations

Keep this medicine out of the sight and reach of children.
Do not use the bottle if its anti-counterfeiting seal is broken before first use.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP.
The expiry date refers to the last day of that month.
Discard the bottle 28 days after first opening, even if some of the solution remains.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Iridina infections and inflammations contains

• The active substances are tobramycin and dexamethasone.
• 1 ml of solution contains 3 mg of tobramycin and 1 mg of dexamethasone.

The other components are: benzalkonium chloride as preservative, edetate sodium, hydroxyethylcellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide, tyloxapol.
Description of the appearance of Iridina infections and inflammations and contents of the pack
Plastic bottle containing 5 ml of a white milky suspension.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A.
Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
00071 Pomezia (RM)
Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy
Iridina infections and inflammations 3 mg/ml + 1 mg/ml eye drops, suspension
Sweden
Toflacort 3 mg/ml + 1 mg/ml ögondroppar, suspension
Belgium
Detobra 1 mg/ml + 3 mg/ml collyre en suspension
Detobra 1 mg/ml + 3 mg/ml oogdruppels, suspensie
Detobra 1 mg/ml + 3 mg/ml Augentropfen, Suspension
Luxembourg
Detobra 1 mg/ml + 3 mg/ml collyre en suspension
Detobra 1 mg/ml + 3 mg/ml oogdruppels, suspensie
Detobra 1 mg/ml + 3 mg/ml Augentropfen, Suspension