Tobramycin and dexamethasone Doc Generici

PATIENT LEAFLET: INFORMATION FOR THE USER

TOBRAMYCIN AND DEXAMETHASONE DOC Generics 3 mg/ml + 1 mg/ml eye drops, solution

Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may 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 TOBRAMYCIN AND DEXAMETHASONE DOC Generics is and what it is used for
2. What you need to know before using TOBRAMYCIN AND DEXAMETHASONE DOC Generics
3. How to use TOBRAMYCIN AND DEXAMETHASONE DOC Generics
4. Possible side effects
5. How to store TOBRAMYCIN AND DEXAMETHASONE DOC Generics
6. Contents of the pack and other information

1. What TOBRAMICINA E DESAMETASONE DOC Generici is and what it is used for

TOBRAMICINA E DESAMETASONE DOC Generici contains dexamethasone, a corticosteroid,
and tobramycin, an antibiotic effective against a broad spectrum of bacteria that can infect
the eye.
It is used to prevent and treat inflammation and potential infections of the eye in adults and
children aged 2 years and older.

2. What you need to know before using TOBRAMICINA E DESAMETASONE DOC Generici

Do not take TOBRAMICINA E DESAMETASONE DOC Generici:

• if you are allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6)
• if you have or think you may have fungal (mycosis) or viral eye infections. The use of corticosteroids may worsen the infection
• if your eye produces sticky discharge
• if you have red eyes and have not been examined by a doctor
• if the pressure inside your eye is high
• if you have a swollen eyelid resembling a boil, often accompanied by pain or discomfort, which may indicate acute inflammation of the sebaceous glands at the base of the eyelashes (hordeolum)

Consult your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using TOBRAMICINA E DESAMETASONE DOC Generici:

• if you have a condition that may cause thinning of the eye tissues, such as rheumatoid arthritis, Fuchs' dystrophy, or after corneal transplantation. Corticosteroids may cause further thinning of the tissues and possibly even perforation.

If you experience allergic reactions such as eyelid itching, swelling, or redness of the eyes with TOBRAMICINA E DESAMETASONE DOC Generici, stop treatment and consult your doctor. This allergic sensitivity may also occur with other topical or systemic antibiotics of the aminoglycoside class.
Contact your doctor if you experience blurred vision or other visual disturbances.
If symptoms worsen or suddenly reappear, consult your doctor. You may become more susceptible to eye infections while using this medicine.
If you are taking another antibiotic, even orally, together with TOBRAMICINA E DESAMETASONE DOC Generici, consult your doctor. If you are already taking other antibiotics belonging to the same family as tobramycin (aminoglycosides) while using TOBRAMICINA E DESAMETASONE DOC Generici, your doctor may perform tests to monitor the total blood concentration of these antibiotics.
If you use TOBRAMICINA E DESAMETASONE DOC Generici for a prolonged period, you may become more susceptible to eye infections, experience increased intraocular pressure, or develop cataracts. The risk of increased pressure is higher in predisposed patients, for example, those with diabetes.
If you notice 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 TOBRAMICINA E DESAMETASONE DOC Generici. 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.
You may still use TOBRAMICINA E DESAMETASONE DOC Generici, but discuss it with your doctor first.
Frequent monitoring of intraocular pressure is necessary, especially in children under 6 years of age receiving products containing dexamethasone.
Children
The use of TOBRAMICINA E DESAMETASONE DOC Generici in children under 2 years of age is not recommended because safety and efficacy in this patient group have not been established.
Other medicines and TOBRAMICINA E DESAMETASONE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TOBRAMICINA E DESAMETASONE DOC Generici should not be used simultaneously with other ophthalmic medicines containing tetracycline (another antibiotic).
If TOBRAMICINA E DESAMETASONE DOC Generici is used for prolonged periods, it may cause infection and delay wound healing. Local anti-inflammatory agents may also delay wound healing.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase the blood levels of dexamethasone.
If you are using other eye drops or ointments, wait at least 5 minutes between each. Ointments should be used last.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of TOBRAMICINA E DESAMETASONE DOC Generici is not recommended during pregnancy.
If you are breastfeeding, do not use TOBRAMICINA E DESAMETASONE DOC Generici without first discussing it with your doctor. Your doctor will advise whether to discontinue breastfeeding or stop treatment with TOBRAMICINA E DESAMETASONE DOC Generici.
Driving and using machines
If temporary blurred vision occurs after using TOBRAMICINA E DESAMETASONE DOC Generici, wait until these symptoms have disappeared before driving or operating machinery.
Important information if you wear contact lenses
Wearing contact lenses is not recommended during treatment for eye infection or inflammation.
TOBRAMICINA E DESAMETASONE DOC Generici contains benzalkonium chloride.
TOBRAMICINA E DESAMETASONE DOC Generici contains a preservative (benzalkonium chloride) that may cause eye irritation and may discolor soft contact lenses.
If you wear soft contact lenses, remove them before applying TOBRAMICINA E DESAMETASONE DOC Generici and wait at least 15 minutes before reinserting them.

3. How to take TOBRAMICINA E DESAMETASONE DOC Generici

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one or two drops into the affected eye(s) 4-5 times a day, as directed by your doctor.

Use in children and adolescents
TOBRAMICINA E DESAMETASONE DOC Generici may be administered to children over 2 years of age at the same dose as adults.

Instructions for use

• Always wash your hands before using the eye drops
• Unscrew the cap
• Hold the bottle upside down between thumb and index finger
• Tilt your head backward
• Pull down the lower eyelid to create a small pocket between the eyelid and the eye. The drop should fall into this pocket
• Bring the dropper tip close to the eye. Do this in front of a mirror if it helps
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the drops
• Gently press the base of the bottle to release one drop at a time
• Do not squeeze the bottle; a gentle pressure on the bottom is sufficient
• If drops are to be used in both eyes, repeat the steps for the other eye. Close the bottle tightly immediately after use

If a drop does not enter the eye, try again.

If you use more TOBRAMICINA E DESAMETASONE DOC Generici than you should, rinse the eye with lukewarm water.

If you forget to use TOBRAMICINA E DESAMETASONE DOC Generici, do not worry—use it as soon as you remember. Do not use a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

Uncommon (may affect up to 1 in 100 people):

• Eye effects: increased eye pressure, eye pain, eye itching, eye discomfort, eye irritation
• General side effects: headache, runny nose, sore throat, laryngospasm (a pathological condition whose symptoms include lowered voice, sensation of suffocation, inspiratory difficulty, and sharp breathing noises)

Rare (may affect up to 1 in 1,000 people):

• Eye effects: inflammation of the eye surface, eye allergy, blurred vision, dry eye, eye redness
• General side effects: bad taste

Not known (frequency cannot be estimated from the available data):

• Eye effects: eyelid swelling, eyelid redness, increased pupil size, increased tear production
• General side effects: allergy, dizziness, nausea, abdominal discomfort, rash, facial swelling, itching
• 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 levels of proteins and calcium in the body, delayed growth in children and adolescents, and body and facial swelling with weight gain (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).

In some patients, administration of tobramycin by injection, infusion, or inhalation (systemic route) has caused serious damage to the nervous system, ear, and kidney. These effects have not occurred after administration of tobramycin as eye drops. Therefore, your doctor will closely monitor you if you need to take tobramycin systemically at the same time as using it as eye drops.

Ocular use of steroids (such as dexamethasone) may cause increased intraocular pressure, cataract formation, and vision disturbances. Prolonged use of eye drops may promote the development of fungal infections or other eye infections.

In very rare cases, some patients with severe damage to the outermost transparent layer of the eye (the cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment.

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 the national reporting system at 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 TOBRAMICIN AND DEXAMETHASONE DOC Generici

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
EXP. The expiry date refers to the last day of that month.
Stop using the bottle 4 weeks after first opening to avoid infection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Do not give this medicine to other people, even if their symptoms are the same as yours, as it could be harmful.

6. Package contents and other information

What TOBRAMICINA E DESAMETASONE DOC Generici contains

• The active substances are tobramycin 3 mg/mL and dexamethasone sodium phosphate 1.316 mg/mL (equivalent to dexamethasone 1 mg/mL).
• The other components are: tyloxapol, benzalkonium chloride, disodium edetate, sodium sulfate, sodium chloride, sulfuric acid (to adjust pH), water for injections.

Description of the appearance of TOBRAMICINA E DESAMETASONE DOC Generici and contents of the pack
TOBRAMICINA E DESAMETASONE DOC Generici is a solution in a pack containing one 5 ml low-density polyethylene bottle with a screw cap.
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer responsible for batch release
Genetic S.p.A., Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA)