IRIDINA 3 mg/1 mg Eye Drop, Suspension

Зміст інструкції

1. Iridina infezioni e infiammazioni 3 mg/ml + 1 mg/ml eye drops, suspension
   1. What is Iridina infections and inflammations and what is it for
   2. What you need to know before using Iridina infections and inflammations
   3. How to use Iridina infections and inflammations
   4. Possible side effects
   5. How to store Iridina infections and inflammations
   6. Contents of the pack and other information

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

Tobramycin/Dexamethasone

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you use 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 is Iridina infections and inflammations and what is it for

Iridina infections and inflammations contains dexamethasone which has an anti-inflammatory effect. Iridina
infections and inflammations also contains tobramycin which is an antibiotic that acts against several bacteria
that can cause infections.
Iridina infections and inflammations is used to prevent and treat eye inflammations and prevent
bacterial infections after cataract surgery in adults and children starting 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 your eyes.
• If you have a red eye that has not been seen by a doctor.

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

• If you have a condition that could cause thinning of eye tissue, such as rheumatoid arthritis, Fuchs' dystrophy or after a corneal transplant, you should inform your doctor. Corticosteroids can cause further thinning and possible perforation.
• If you experience an allergic reaction with Iridina infections and inflammations such as itching of the eyelids, swelling or redness of the eyes, stop using it and see your doctor. This allergic sensitivity may occur with other topical or systemic aminoglycoside-type antibiotics.
• If your symptoms worsen or return suddenly, consult your doctor. You may have 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 cataract formation induced by corticosteroids is greater in diabetic patients.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you feel swelling and weight gain around the torso and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome, consult your doctor. Suppression of adrenal gland function can 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 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 Iridina infections and inflammations with other antibiotic treatments, including oral medications, ask your doctor for advice.
• If you are using Iridina infections and inflammations with other ophthalmic preparations based on non-steroidal anti-inflammatory drugs (NSAIDs), ask your doctor for advice. Concurrent use of eye drops containing non-steroidal anti-inflammatory drugs (NSAIDs) and ophthalmic preparations containing steroids may increase the possibility of healing problems.
• If you use Iridina infections and inflammations for a long period of time, you may become more susceptible to eye infections, have an increase in pressure in the eye/eyes, or develop cataracts.
• Intraocular pressure should be checked 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 can cause eye irritation and changes in the color of soft contact lenses. The use of contact lenses is not recommended during the 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Concurrent use of ophthalmic preparations containing non-steroidal anti-inflammatory drugs (NSAIDs)
and ophthalmic preparations containing steroids may increase the possibility of healing problems.
If you are using other eye drops or ointments, wait at least 5 minutes between administrations. Ointments
should be used last.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase the level of
dexamethasone in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will tell you whether or not you can use Iridina infections and inflammations.

Driving and operating machinery
If you experience temporary blurred vision after using Iridina infections and inflammations, you should
wait until these symptoms disappear before driving and using machinery.

Iridina infections and inflammations contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per ml, equivalent to 0.5 mg/5 ml bottle. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their color. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Iridina infections and inflammations

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

The recommended dose is:
One drop in the 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 can be used in children from 2 years of age at the same dose
as prescribed 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 back and look at the ceiling
• 4. Gently pull down the lower eyelid to form a small pocket
• 5. Press the inverted bottle to let one drop fall 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 parts with the tip of the dropper.
Replace the cap and tighten it after use.

If you use more Iridina infections and inflammations than you should
A topical overdose of Iridina infections and inflammations can be treated with washing with lukewarm
water.

If you forget to use Iridina infections and inflammations
If you forget to instill a dose, instill it as soon as you remember. However, if the next dose is due shortly, skip the forgotten dose and then continue therapy as normal.

If you stop using Iridina infections and inflammations
Your doctor will tell 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 the use of 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 gets them.
The following side effects have been observed

Uncommon side effects

(may affect up to 1 in 100 people)
Effects on the eye: increased pressure in your eyes, redness of the eyelid, swelling of the eyelid,
eye irritation, eye pain, itchy eyes, watery eyes, feeling of discomfort in the eye.
General side effects: headache, nasal secretion and swelling of the throat.

Rare side effects

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

Not known

(frequency cannot be estimated from available data)
Effects on the eye: increased diameter of the pupil, redness of the eyelid, increased production of
tears, inflammation of the surface of the eye.
Hormonal problems: increased growth of hair on the body (especially in women), weakness and atrophy
muscle, purple stretch marks on the skin of the body, increased blood pressure, irregular or
absent 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
paragraph 2, “Warnings and precautions”).
General side effects: allergy (hypersensitivity), dizziness, nausea, abdominal discomfort, rash,
swelling of the face, itching.
If Iridina infections and inflammations is used for more than 24 days, it may cause infections and a slowing
of wound healing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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-tampering seal is broken before first use.
Do not use this medicine after the expiry date which is stated on the package and the bottle after EXP.
The expiry date refers to the last day of that month.

Dispose of the bottle after 28 days from first opening, even if it still contains some of the solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Iridina infezioni e infiammazioni contains

• The active ingredients are tobramycin and desamethasone
• 1 ml of solution contains 3 mg of tobramycin and 1 mg of desamethasone.

The other ingredients are: benzalkonium chloride as a preservative, sodium edetate, hydroxyethylcellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide, tyloxapol.

Description of the appearance of Iridina infezioni e infiammazioni and contents of the pack
Plastic bottle containing 5 ml of a milky white suspension.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
denominations:
Italy
Iridina infezioni e infiammazioni 3 mg/ml + 1 mg/ml eye drops, suspension

Sweden
Toflacort 3 mg/ml + 1 mg/ml eye drops, suspension

Belgium
Detobra 1 mg/ml + 3 mg/ml eye drops in 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