Tobrosopt-dex

Leaflet attached to the packaging: patient information

Tobrosopt-DEX, (3 mg + 1 mg)/ml, eye drops, suspension

Tobramycin + Dexamethasone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tobrosopt-DEX and what is it used for
• 2. Important information before using Tobrosopt-DEX
• 3. How to use Tobrosopt-DEX
• 4. Possible side effects
• 5. How to store Tobrosopt-DEX
• 6. Package contents and other information

1.

What is Tobrosopt DEX and what is it used for
Tobrosopt-DEX is a combination medicine that contains two active substances -
tobramycin (an antibacterial medicine) and dexamethasone (an anti-inflammatory, antiallergic, and antipruritic medicine).
Tobrosopt-DEX is used to prevent and treat inflammatory conditions and to prevent eye infections after cataract surgery.
Tobrosopt-DEX can be used in adults and children over 2 years of age.

2.

Important information before using Tobrosopt DEX
When not to use Tobrosopt DEX

• if the patient is allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has herpes simplex virus keratitis;
• if the patient has keratitis caused by the varicella-zoster virus, chickenpox, or other viral diseases of the cornea or conjunctiva;
• if the patient has fungal eye infections or untreated parasitic eye infections;
• if the patient has ocular tuberculosis;
• if the patient has untreated purulent (bacterial) eye infections;
• if the patient has had a foreign body removed from the cornea (part of the eye) and no complications are present.

Warnings and precautions

Before starting treatment with Tobrosopt-DEX, discuss it with your doctor or pharmacist.

• If the patient experiences an allergic reaction (hypersensitivity) in the form of eyelid itching, swelling, or eye redness, treatment should be discontinued and a doctor consulted. Such an allergic reaction may occur when using other topical or systemic antibiotics from the aminoglycoside group.
• If the patient experiences worsening of symptoms or sudden recurrence of symptoms, they should consult a doctor. During treatment with the medicine, the patient may be more susceptible to eye infections.
• If the patient is using other antibiotics, including those taken orally, while using Tobrosopt-DEX, they should consult a doctor.
• If the patient uses Tobrosopt-DEX for a long time, they may experience:
• increased susceptibility to eye infections,
• increased eye pressure (glaucoma),
• development of cataracts.
• If the patient experiences persistent corneal ulceration while using the medicine, they should consult a doctor as soon as possible, as this may be a sign of a fungal eye infection.
• Long-term use of the medicine increases the risk of secondary infection caused by fungi, bacteria, and viruses. It may also lead to delayed healing of eye injuries.
• During long-term treatment, the doctor may recommend ophthalmic examinations (intraocular pressure measurement). Regular eye pressure checks are recommended, especially in children.
• The risk of developing ocular hypertension caused by corticosteroids and cataract formation is higher in children and patients with other diseases (e.g., diabetes).
• Corticosteroid eye drops may cause delayed healing of eye injuries. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may slow down and delay the healing process. Concurrent use of topical NSAIDs and corticosteroids may increase the risk of eye healing problems.
• If the patient has a disease that causes thinning of the eye tissues, they should consult a doctor or pharmacist.
• If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.

Patient should consult a doctor if they experience swelling and weight gain, especially on the torso and face, as these are usually the first symptoms of a disease called Cushing's syndrome. Adrenal insufficiency may occur after discontinuation of long-term or intensive use of Tobrosopt-DEX. Patient should consult a doctor before deciding to stop treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
Tobrosopt DEX and other medicines
Patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patient should especially tell their doctor if they are using non-steroidal anti-inflammatory drugs (NSAIDs).
Concurrent use of a steroid medicine and a non-steroidal anti-inflammatory drug (NSAID) may cause problems with eye healing.
If the patient is using other eye drops or ointments, they should leave at least a 5-minute interval between administrations of the different medicines. Eye ointments should be used last.
Patient should tell their doctor about taking ritonavir or cobicistat, as these medicines may increase the amount of dexamethasone in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Tobrosopt-DEX is not recommended during pregnancy and breastfeeding.

Driving and using machines

Tobrosopt-DEX has no or negligible influence on the ability to drive and use machines.
For a while after administering Tobrosopt-DEX, vision may be blurred. Patient should not drive or operate machines until this symptom subsides.
Tobrosopt DEX contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per ml. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Patient should remove contact lenses before administering the drops and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact a doctor.
Patient should not wear contact lenses if they have an eye infection.

3.

How to use Tobrosopt DEX
This medicine should always be used exactly as prescribed by the doctor. In case of doubts, patient should consult a doctor or pharmacist.

Use in adults

Patient should strictly follow the dosage regimen prescribed by the doctor.
If the doctor does not recommend otherwise, the medicine is usually used as follows:
one to two drops into the conjunctival sac (conjunctival sacs) of the infected eye (eyes) every 4-6 hours. Within the first 24-48 hours, the doctor may increase the dose of the medicine to 1-2 drops every two hours, and then gradually decrease the frequency of use as the symptoms subside. Patient should be careful not to stop treatment too early.
In severe cases, one to two drops are used into the conjunctival sac (conjunctival sacs) of the infected eye (eyes) every hour, until improvement is achieved. The medicine is then used less frequently - 1-2 drops every two hours for three days. Then, 1-2 drops are used every 4 hours for 5-8 days, and finally 1-2 drops once a day for 5 to 8 days, if the doctor considers it necessary.
After cataract surgery, one drop is used four times a day, starting from the day after surgery, for up to 24 days. The doctor may decide to use the medicine one day before surgery, at a dose of one drop four times a day, and then one drop after surgery, and one drop four times a day for the next 23 days. If necessary, the doctor will decide on more frequent use of the medicine: up to one drop every two hours for the first two days of treatment.

Use in children over 2 years of age

The medicine can be used in children over 2 years of age in the same doses as in adults.
The safety and efficacy in children under 2 years of age have not been established, and there are no data available on the use of the medicine in this age group.

Use in patients with liver or kidney impairment

The effect of the medicinal product in the form of eye drops containing tobramycin and dexamethasone has not been studied in these patient populations. However, due to the low systemic absorption of the above-mentioned substances after local administration, it is considered that there is no need to modify the dosage.

Method of administration

Tobrosopt-DEX is intended for external use only - locally into the conjunctival sac.
Patient should not touch the tip of the dropper, as this may contaminate the contents of the bottle.

• 1. Before administering the medicine, patient should wash their hands thoroughly.
• 2. Shake the bottle before use.
• 3. Unscrew the cap on the bottle.
• 4. Tilt the head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 5. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine is released into the eye. The tip of the dropper should not be touched to the eye, eyelids, or any other surface. If the drop does not get into the eye, the next drop should be administered.
• 6. Immediately after administering Tobrosopt-DEX, patient should gently press the inner corner of the eye for about 1 minute. This will help reduce the risk of systemic side effects.
• 7. If the doctor has prescribed the medicine to be administered to the second eye, patient should repeat the actions from points 4, 5, and 6.
• 8. The dropper is designed to accurately measure the drops, so patient should not enlarge the opening of the dropper.
• 9. After administration, the bottle should be screwed back on. However, it should not be screwed too tightly.

Patient should regularly administer the medicine throughout the entire treatment period prescribed by the doctor, even if the symptoms of the eye infection (infections) subside earlier.

Using a higher dose of Tobrosopt-DEX than recommended

Patient should not use higher doses or use the medicine more frequently than prescribed by the doctor. In case of overdose, excess medicine can be rinsed out of the eye with lukewarm water.

Missing a dose of Tobrosopt-DEX

If a dose of the medicine is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped and the next dose should be administered according to the established dosage regimen. Patient should not take a double dose to make up for the missed dose.
Stopping treatment with Tobrosopt DEX
In case of any further doubts about the use of this medicine, patient should consult a doctor or pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tobrosopt-DEX can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or other serious side effects, they should stop using Tobrosopt DEX and immediately contact a doctor or the Emergency Department of the nearest hospital.
Immediately after administering the medicine, mild eye burning or stinging may occur frequently (in 1 to 10 patients out of 100). These symptoms subside after about 5-15 seconds and do not require discontinuation of the medicine.
Uncommon (occurring in 1 to 10 patients out of 1,000):
Eye symptoms: high intraocular pressure, eye pain, eye itching, feeling of discomfort in the eye, eye irritation.
Rare (occurring in 1 to 10 patients out of 10,000):
Eye symptoms: eye allergy, blurred vision, dry eye syndrome, inflammation of the eye surface, redness.
General symptoms: taste disorders.
Unknown (frequency cannot be estimated from the available data):
Eye symptoms: eyelid swelling, eyelid redness, pupil dilation, increased tearing, blurred vision.
General symptoms: severe allergic reactions (hypersensitivity), dizziness, headache, nausea, feeling of discomfort in the stomach, severe skin reactions (erythema multiforme), rash, face swelling, itching.
Hormonal disorders: excessive hair growth on the body (especially in women), muscle weakness and muscle mass loss, purple stretch marks on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain, especially on the torso and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5.

How to store Tobrosopt DEX
Store in a temperature below 30°C.
Store the bottle tightly closed in the outer packaging.
The medicine should be stored out of sight and reach of children.

Shake before use.

Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date stated on the carton and bottle refers to the last day of the stated month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Tobrosopt-DEX can be used for 4 weeks after the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste. Patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tobrosopt DEX contains

• The active substances of the medicine are tobramycin and dexamethasone. Each ml of the drops contains 3 mg of tobramycin and 1 mg of dexamethasone. Each drop contains 120 micrograms of tobramycin and 40 micrograms of dexamethasone.
• The other ingredients are: hydroxyethylcellulose; benzalkonium chloride solution; sodium chloride; anhydrous sodium sulfate (E 514); disodium edetate; tyloxapol; sulfuric acid and/or sodium hydroxide (to adjust pH); purified water.

What Tobrosopt DEX looks like and what the package contains
Tobrosopt-DEX is a sterile eye drop suspension in the form of a white suspension.
The medicine is available in LDPE bottles containing 5 ml of solution with an LDPE dropper and an HDPE cap with a tamper-evident closure, packaged in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: