Mitobrin

Package leaflet: Information for the patient

MITOBRIN 3 mg/ml ear drops, solution

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

1. What MITOBRIN is and what it is used for

MITOBRIN 3 mg/ml ear drops, solution, contains the active substance tobramycin, an antibiotic of the aminoglycoside family, which acts against various bacteria that can cause ear infections.
MITOBRIN is indicated for the treatment of infections of the external auditory canal (external otitis).

2. What you need to know before using MITOBRIN

Do not use MITOBRIN

• If you are allergic (hypersensitive) to tobramycin or to any of the other ingredients of this medicine (listed in section 6);
• If you have or suspect a perforation of the eardrum.

Warnings and precautions

• Consult your doctor before using MITOBRIN, particularly if you are elderly, if you have kidney disease, if you are already being treated with antibiotics belonging to the aminoglycoside class, or if you are taking diuretic medicines;
• As with all antibiotics, prolonged use may promote the growth of microorganisms resistant to the medicine, including fungi;
• Do not apply MITOBRIN to wounds or ulcers and do not use it for more than 7 days (read section “Dosage”). Although all aminoglycoside antibiotics are potentially toxic to the kidneys and ears, the risks of ototoxicity are associated with the duration of treatment and their administration via parenteral (injection) or local routes on wounds and/or ulcers. In the absence of wounds and/or ulcers, such risks should not occur with MITOBRIN, since it is administered locally, at a low daily dosage and for a limited number of days. Nevertheless, be alert for any signs of toxicity such as dizziness, vertigo, ringing in the ears, or hearing loss: if these occur, stop treatment immediately and consult your doctor.
• Hypersensitivity reactions (allergic reactions) may rarely occur. This allergic sensitivity may also occur with other antibiotics belonging to the aminoglycoside class, whether administered locally or by injection.
• If you are simultaneously receiving tobramycin or other aminoglycoside antibiotics via parenteral (injection) route while using MITOBRIN, your doctor will perform tests to monitor the total amount of antibiotic in your blood.

Children
In early infancy, this medicine should be administered only when clearly necessary and under the direct supervision of a doctor.
Other medicines and MITOBRIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Incompatibility
The component tyloxapol contained in the ear drops is incompatible with tetracyclines.
Do not use MITOBRIN together with other ear products containing tetracyclines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
In pregnant women, the medicine should be administered only when clearly necessary and under the direct supervision of a doctor.
Breastfeeding
This product should not be used during breastfeeding. If your doctor considers treatment necessary, you will be advised to discontinue breastfeeding.
Fertility
No studies have been conducted to evaluate the effect of MITOBRIN ear drops on human fertility.
Driving and using machines
MITOBRIN does not affect the ability to drive or operate machinery.
MITOBRIN “3 mg/ml ear drops, solution” 1 bottle of 5 ml contains benzalkonium chloride
One 5 ml bottle of MITOBRIN “3 mg/ml ear drops, solution” contains 0.5 mg of benzalkonium chloride, equivalent to 0.1 mg/ml.
Benzalkonium chloride may irritate the skin.

3. How to use MITOBRIN

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply MITOBRIN ear drops only into the ears.

Recommended dose
Instill four drops into the affected ear three times daily for 5–6 days.
Maximum duration of treatment: 7 days (see section “Warnings and precautions”).

How to apply MITOBRIN

• Wash your hands.
• “Ear drops, solution” 1 bottle of 5 ml
• Take the bottle and shake it well before unscrewing the cap.
• If opening the bottle for the first time, remove the detached ring from the cap before using the product.
• “Ear drops, solution” 20 single-dose containers of 0.25 ml
• Open the aluminum pouch and remove one strip. Detach one single-dose container from the strip and shake it. Unscrew the cap with a gentle twisting motion.
• Hold the bottle/container with the opening facing downward, using your thumb and middle finger.
• Lie down with the affected ear facing upward.
• Bring the tip of the bottle/container close to the ear canal.
• Avoid contact between the tip of the bottle/container and the earlobe, ear canal, surrounding areas, or any other surfaces.
• Gently squeeze the base of the bottle/container to release one drop of MITOBRIN at a time.
• If a drop does not enter the ear, try again.
• If treating both ears, repeat the procedure for the other ear.
• “Ear drops, solution” 1 bottle of 5 ml:
• Immediately replace the cap after use, screwing it back on tightly.
• After the expiry period following first opening of the bottle (28 days), some MITOBRIN may remain in the bottle. Do not use any remaining medicine in the bottle after completing the treatment course. Do not use the ear drops for longer than 28 days after first opening the bottle.
• “Ear drops, solution” 20 single-dose containers of 0.25 ml:
• Discard the container and any remaining contents after use.

If you use more MITOBRIN than you should
If you accidentally take too much MITOBRIN, contact your doctor immediately or go to the nearest hospital.
Cases of overdose are not known.

If you forget to use MITOBRIN
If you forget to use MITOBRIN, do not worry—apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using MITOBRIN
Do not stop treatment without first consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Reactions of ear toxicity (ototoxicity) have occurred following local use of aminoglycoside antibiotics; the frequency of these is unknown.
As with all aminoglycoside antibiotics applied to the ears, local intolerance or hypersensitivity reactions (allergy) may occur. In such cases, discontinue treatment and consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MITOBRIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer packaging, following "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
This medicine does not require any special storage precautions.

Shelf-life after opening:

“Ear drops, solution” 20 single-dose containers of 0.25 ml
The product does not contain preservatives: after administration, discard the container even if it has been only partially used.
After opening the pouch, the remaining containers must be used within 28 days.

“Ear drops, solution” 1 bottle of 5 ml
The product must be used within 28 days after first opening the bottle.

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 MITOBRIN contains
Otic drops, solution 20 single-dose containers of 0.25 ml

• The active substance is tobramycin. Each single-dose container contains 0.75 mg of tobramycin.
• The other components are: tyloxapol, boric acid, anhydrous sodium sulfate, sodium chloride, water for injections.

Otic drops, solution 1 5-ml dropper bottle

• The active substance is tobramycin. Each bottle contains 15 mg of tobramycin.
• The other components are: tyloxapol, benzalkonium chloride (see section 2), boric acid, anhydrous sodium sulfate, sodium chloride, water for injections.

Description of the appearance of MITOBRIN and package contents
MITOBRIN is an otic solution.
Packaged as: 20 single-dose containers of 0.25 ml
1 5-ml dropper bottle
Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD), Italy
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

Patient Information Leaflet: Information for the Patient

MITOBRIN 3 mg/ml eye drops, solution

tobramycin
Generic Medicine
Please read this entire 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MITOBRIN is and what it is used for

MITOBRIN 3 mg/ml eye drops, solution contains the active substance tobramycin, an antibiotic of the aminoglycoside family, which acts against various bacteria that can cause eye infections.
MITOBRIN is used in adults and children from one year of age onwards to treat infections of the eye and associated structures caused by bacteria sensitive to tobramycin:

• Acute, subacute, and chronic catarrhal inflammations of the conjunctiva (the transparent membrane covering the white part of the eye and the inner surface of the eyelids);
• Inflammations of the eyelid;
• Inflammations of the cornea (the transparent membrane covering the colored part of the eye);
• Inflammations of the lacrimal sac.

MITOBRIN is also used before and after surgical procedures on the anterior part of the eye.

2. What you need to know before using MITOBRIN

Do not use MITOBRIN

• if you are allergic to tobramycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Consult your doctor or pharmacist before using MITOBRIN.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin administered in the eyes may occur. This allergic reaction may range from localized itching or redness of the skin to severe generalized allergic reactions (anaphylactic reactions) or serious skin reactions. If you experience these symptoms while using MITOBRIN, stop treatment immediately and consult your doctor. Also note that this allergic sensitivity may occur with other antibiotics belonging to the same aminoglycoside class, even when administered in the eyes.

• In patients who have received tobramycin systemically (by injection), serious adverse effects affecting the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using MITOBRIN together with systemic tobramycin (by injection).

• As with other antibiotics, prolonged use of MITOBRIN may increase susceptibility to eye infections, including fungal infections. If your symptoms worsen or suddenly reappear, consult your doctor.

MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml

• Do not wear contact lenses during treatment of an eye infection (also read the section “MITOBRIN ‘3 mg/ml eye drops, solution’ 1 bottle of 5 ml contains benzalkonium chloride”).

Other medicines and MITOBRIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Incompatibilities
The component tyloxapol contained in the eye drops is incompatible with tetracycline. Do not use MITOBRIN together with other eye products containing tetracycline.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Data on the use of tobramycin in the eyes during pregnancy are lacking or limited. Animal studies have shown reproductive toxicity. Tobramycin should be used during pregnancy only if strictly necessary.

Breastfeeding
It is not known whether tobramycin is excreted in breast milk following ocular administration. Tobramycin is excreted in breast milk after systemic administration (by injection). The risk to breastfed infants cannot be excluded. Consult your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with tobramycin.

Fertility
No studies have been conducted to evaluate the effect of topical ocular administration of MITOBRIN eye drops on human fertility.

Driving and using machines
MITOBRIN does not affect, or affects only transiently, the ability to drive or operate machinery. However, for a certain period after instillation of MITOBRIN, blurred vision or other visual disturbances may occur, which could affect your ability to drive or use machinery. If these effects occur, wait until your vision clears before driving or operating machinery.

MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml contains benzalkonium chloride
A 5 ml bottle of MITOBRIN “3 mg/ml ear drops, solution” contains 0.5 mg of benzalkonium chloride per bottle, equivalent to 0.1 mg/ml.
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 unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use MITOBRIN

Use MITOBRIN eye drops, solution only for instillation into the eyes.
Always use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Instill two drops into the conjunctival sac (inner part of the eyelid) four times a day for acute forms and three times a day for chronic forms, as directed by your doctor.
Use the product for the length of time specified by your doctor.

The following procedure helps reduce the amount of medicine that passes into the bloodstream after eye application:

• Keep the eyelid closed and, at the same time, apply gentle pressure with a finger at the inner corner of the eye near the nose for at least 2 minutes.
• If you are using other eye drops or ophthalmic ointments, wait at least 5 minutes between instilling each medicine. Ophthalmic ointment should be used last.

Use in children and adolescents
Do not use MITOBRIN in children under 1 year of age, as safety and efficacy have not been established in this population and no data are available.
MITOBRIN may be used in children from 1 year of age at the same doses as recommended for adults.

How to apply MITOBRIN
Instructions for use

• Wash your hands.
• If you wear contact lenses, remove them before instilling the eye drops and wait at least 15 minutes before reinserting them.
• For eye drops, solution in multidose bottle:
  • Take the bottle and shake it well before unscrewing the cap.
  • If you are using the bottle for the first time, remove the broken ring from the cap before using the product.
• For eye drops, solution in single-dose containers:
  • Open the aluminum pouch and remove one strip (Figure 1). Remove one single-dose container from the strip and shake it. Unscrew the cap with a slight twisting motion.
• Hold the bottle/container upside down between your thumb and middle finger.
• Tilt your head backward. Pull down the eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Figure 2).
• Bring the tip of the bottle/container close to the eye.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle/container.
• Gently press the base of the bottle/container to release one drop of Mitobrin at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is needed (Figure 3).
• If a drop does not enter the eye, try again.
• After using MITOBRIN, keep your eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose, for at least one minute (Figure 4). This helps prevent MITOBRIN from spreading throughout the rest of the body.
• If you are instilling drops into both eyes, repeat the same procedure for the other eye.

MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml:

• Immediately replace the cap after use, screwing it back on tightly.
• After the expiry period following first opening of the bottle (28 days), there may still be MITOBRIN remaining in the bottle. Do not use any remaining medicine in the bottle after completing the treatment course. Do not use the eye drops for longer than 28 days after first opening the bottle.

MITOBRIN “3 mg/ml eye drops, solution” 20 single-dose containers of 0.250 ml:

• Before use, ensure the single-dose container is intact.
• Use the eye drops in single-dose containers immediately after opening. Do not reuse any leftover solution. Discard the container and any remaining contents.
• The product must be used within 28 days of opening the aluminum pouch.

If you use more MITOBRIN than you should
If you use more medicine than you should, rinse your eye immediately with lukewarm water. However, no adverse effects are expected.
Do not use the medicine again until the next scheduled dose.

If you forget to use MITOBRIN
If you forget to use MITOBRIN, do not worry. Instill it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the missed dose.

If you stop using MITOBRIN
Do not stop treatment without first consulting your doctor.

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 everyone experiences them.

Common side effects (may affect up to 1 in 10 people)

• Eye-related effects: eye irritation, eye redness.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye-related effects: inflammation of the eye surface, corneal damage (the transparent membrane covering the coloured part of the eye), impaired vision, blurred vision, eyelid redness, eye and eyelid swelling, eye pain, dry eye, eye discharge, eye itching, increased tearing.
• General side effects: allergy (hypersensitivity), headache, urticaria, skin inflammation (dermatitis), reduced growth or number of eyelashes, loss of skin pigmentation, itching, dry skin.

Side effects of unknown frequency (frequency cannot be determined from the available data)

• Eye-related effects: ocular allergy, eye irritation, eyelid itching.
• General side effects: severe allergic reactions, skin rash, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MITOBRIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, stored correctly.
This medicine does not require any special storage precautions.

Shelf-life after opening:
MITOBRIN “3 mg/ml eye drops, solution” 20 single-dose containers of 0.250 ml
The product does not contain preservatives: after administration, discard the container even if it has been only partially used.
After opening the pouch, any remaining containers should be used within 28 days.

MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml
The product should be used within 28 days after first opening the bottle.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MITOBRIN contains
MITOBRIN “3 mg/ml eye drops, solution” 20 single-dose containers of 0.250 ml

• The active substance is tobramycin. Each single-dose container contains 0.75 mg of tobramycin.
• The other components are: tyloxapol, boric acid, anhydrous sodium sulfate, sodium chloride, water for injections.
  MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml
• The active substance is tobramycin. Each bottle contains 15 mg of tobramycin.
• The other components are: tyloxapol, benzalkonium chloride (see section 2), boric acid, anhydrous sodium sulfate, sodium chloride, water for injections.

Description of the appearance of MITOBRIN and contents of the pack
MIToBRIN is a solution for eye drops.
20 single-dose containers of 0.250 ml
1 dropper bottle of 5 ml

Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD), Italy

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)