MITOBRIN 3 mg /Ml Eye Drops, Solution

Зміст інструкції

1. MITOBRIN 3 mg/ml ear drops, solution
   1. What is MITOBRIN and what is it used for
   2. What you need to know before you use MITOBRIN
   3. How to use MITOBRIN
   4. Possible side effects
   5. How to store MITOBRIN
   6. Contents of the pack and other information
2. MITOBRIN 3 mg/ml eye drops, solution
   1. What is MITOBRIN and what is it 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

MITOBRIN 3 mg/ml ear drops, solution

Tobramycin
Generic Medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could 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 MITOBRIN is and what it is used for
• 2. What you need to know before you use 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 is MITOBRIN and what is it used for

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

2. What you need to know before you use MITOBRIN

Do not use MITOBRIN

• If you are allergic (hypersensitive) to tobramycin or 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, especially if you are an elderly patient, if you suffer from kidney disease, if you are already being treated with antibiotics belonging to the aminoglycoside class, or if you are taking diuretic drugs;
• 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 (see section “Dosage”). In fact, although all aminoglycoside antibiotics are potentially toxic to the kidneys and ears, the risks of toxicity to the ears are associated with the duration of therapy and their administration by parenteral (injection) or local route on wounds and/or ulcers. In the absence of wounds and/or ulcers, these risks should not exist with MITOBRIN, as it is administered locally, at a low daily dose and for a limited number of days. However, pay attention to the appearance of any signs of toxicity such as dizziness, vertigo, ringing in the ears, hearing loss: in these cases, immediately stop treatment and consult your doctor.
• Rarely, cases of hypersensitivity (allergic reaction) may occur. This allergic sensitivity can also occur with other antibiotics belonging to the same class of aminoglycosides, administered both locally and by injection.
• If you are taking tobramycin or other aminoglycoside antibiotics parenterally (by injection) at the same time as using MITOBRIN, your doctor will have you undergo tests to check the total amount of antibiotic present in the blood.

Children
In early infancy, the medicine should only be administered in cases of actual need, under the direct control
of the doctor.

Other medicines and MITOBRIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Incompatibilities
The tyloxapol component contained in the ear drops is incompatible with tetracyclines.
Do not use MITOBRIN together with other ear products that contain tetracyclines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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.
Pregnancy
In pregnant women, the medicine should be administered only in cases of actual need, under the direct
control of the doctor.
Breastfeeding
The product should not be used during breastfeeding. If your doctor deems treatment necessary, they will
have you stop breastfeeding.
Fertility
No studies have been conducted to evaluate the effect on human fertility after the administration of
MITOBRIN ear drops.

Driving and using machines
MITOBRIN does not impair the ability to drive vehicles and operate machinery.

MITOBRIN “3 mg/ml ear 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
equivalent to 0.1 mg/ml.
Benzalkonium chloride may irritate the skin.

3. How to use MITOBRIN

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Apply MITOBRIN ear drops only in the ears.

Recommended dose
Instill four drops into the ear three times a day for 5 - 6 days.
Maximum treatment duration: 7 days (read the “Warnings and precautions” section)

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 you are opening the bottle for the first time, remove the cap detached from the cap before using the product.
• “Ear drops, solution” 20 single-dose containers of 0.25 ml
• Open the aluminum sachet and remove one strip. Remove a single-dose container from the strip and shake it. Unscrew the cap with a slight rotation.
• Hold the bottle/container with the opening facing downwards, holding it with your thumb and middle finger.
• Lie down with the infected ear facing upwards.
• Bring the tip of the bottle/container close to the ear canal.
• Avoid contact of the tip of the bottle/container with the earlobe or the ear canal, the surrounding areas or other surfaces.
• Apply gentle pressure to the base of the bottle/container so as to cause one drop of MITOBRIN to come out at a time.
• If a drop does not enter the ear, try again
• If using the drops in both ears, repeat the procedure for the other ear as well.
• “Ear drops, solution” 1 bottle of 5 ml:
• Immediately replace the cap after use, screwing it on tightly.
• At the end of the expiry period after first opening the bottle (28 days), there will still be MITOBRIN remaining in the bottle. Do not use the remaining medicine in the bottle after completing the treatment cycle. Do not use the ear drops for a period longer than 28 days after first opening the bottle.
• Ear drops, solution” 20 single-dose containers of 0.25 ml:
• Throw away the container and any remaining contents.

If you use more MITOBRIN than you should
In case of accidental intake of an excessive dose of MITOBRIN, immediately inform your doctor or go to the nearest hospital.
No cases of overdose are known.

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

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

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

4. Possible side effects

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

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 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 bottle and the packaging after “Expiry”. The
expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
This medicine does not require any special storage precautions.
Validity after opening:

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

“Ear drops, solution” 1 bottle of 5 ml
The product must be used within 28 days after the first opening of the bottle.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MITOBRIN contains

Ear drops, solution” 20 single-dose containers of 0.25 ml

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

“Ear drops, solution” 1 bottle of 5 ml

• The active ingredient is tobramycin. One bottle contains 15 mg of tobramycin.
• The other ingredients 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 presented as ear drops, solution.
20 single-dose containers of 0.25 ml
1 dropper bottle of 5 ml

Marketing Authorisation 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)

MITOBRIN 3 mg/ml eye drops, solution

tobramycin
Generic Medicine

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 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 if 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 you use 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 is MITOBRIN and what is it 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 eye and adnexal infections caused by bacteria sensitive to tobramycin:

• acute, sub-acute and chronic catarrhal inflammations of the conjunctiva (transparent membrane that lines the white part of the eye and the inside of the eyelids);
• inflammations of the eyelid;
• inflammations of the cornea (transparent membrane that covers the colored part of the eye);
• inflammations of the lacrimal sac.

MITOBRIN is also used before and after surgical interventions 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Talk to your doctor or pharmacist before using MITOBRIN.
• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin, administered to the eyes, may occur. This allergic reaction can range from localized itching or redness of the skin, to severe general allergic reactions (anaphylactic reactions) or severe skin reactions. If these symptoms occur during the use of MITOBRIN, stop it

treatment and see your doctor. Also, be aware that this allergic sensitivity may occur
even with other antibiotics belonging to the same class of aminoglycosides, administered both to the
eyes

• In patients who have taken tobramycin systemically (by injection), serious adverse effects on the nervous system, ears and kidneys have occurred. Be careful and see your doctor if you are using MITOBRIN together with tobramycin taken systemically (by injection);
• As with other antibiotics, if you use MITOBRIN for a long period of time, you may become more susceptible to eye infections, even those caused by fungi. If your symptoms worsen or suddenly reappear, see your doctor;

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

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

Other medicines and MITOBRIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Incompatibilities
The tyloxapol component contained in the eye drops is incompatible with tetracycline. Do not use
MITOBRIN together with other products for the eyes that contain tetracycline.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data relating to the application of tobramycin to the eyes in pregnant women are non-existent or limited in number.
Animal studies have shown reproductive toxicity. Tobramycin should be used
in pregnancy only if strictly necessary.
Breastfeeding
It is not known whether tobramycin is excreted in breast milk after application to the eyes. Tobramycin is
excreted in breast milk after systemic administration (by injection). The risk to infants cannot be
excluded. Ask your doctor, who will decide whether you should stop breastfeeding or stop the
therapy with tobramycin.
Fertility
No studies have been conducted to evaluate the effect on human fertility of topical ocular administration of
MITOBRIN eye drops.

Driving and operating machinery
MITOBRIN does not alter or transiently alters the ability to drive vehicles and operate machinery.
For a certain period of time after instillation of MITOBRIN, blurred
vision or other visual disturbances may occur that can affect the ability to drive vehicles and operate machinery.
If these effects occur, wait for vision to clear before driving vehicles and 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 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 re-applying 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 MITOBRIN

Use MITOBRIN eye drops, solution only for instillation into the eyes.
Use this medicine following exactly the instructions of your doctor. 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 in acute forms
and three times a day in chronic forms, as directed by your doctor.
Use the product for the period of time specified by your doctor.
The following operation is useful to limit the amount of medicine that passes into the blood after application
into the eyes:

• keep the eyelid closed and at the same time apply gentle pressure with a finger on the inner corner of the eye near the nose for at least 2 minutes. If you are using other eye drops or ophthalmic ointments, allow at least 5 minutes to pass between the instillation of 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 can be used in children from one year of age onwards at the same doses as for adults.
How to apply MITOBRIN

Instructions for use

• Wash your hands
• If you wear contact lenses, remove the lenses before instilling the eye drops and wait at least 15 minutes before re-applying them. Eye drops, solution in a multi-dose bottle:
• Take the bottle and shake it well before unscrewing the cap
• If you are opening the bottle for the first time, remove the cap detached from the cap before using the product. Eye drops, solution in single-dose containers:
• Open the aluminum pouch and extract a strip (figure 1). Remove a single-dose container from the strip and shake it. Unscrew the cap with a slight rotation.
• Hold the bottle/container upside down between your thumb and middle finger.
• Tilt your head back. Lower the eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled in this area (figure 2).
• Bring the tip of the bottle/container close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the tip of the bottle/container.
• Gently press the base of the bottle/container, releasing one drop of Mitobrin at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is sufficient (figure 3).
• If a drop does not enter the eye, try again
• After using MITOBRIN, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose for at least one minute (figure 4). This helps to prevent MITOBRIN from spreading throughout the body.
• If you instill drops in both eyes, repeat the same operation for the other eye. MITOBRIN “3 mg/ml eye drops, solution” 1 bottle of 5 ml:
• Immediately replace the cap after use, screwing it on tightly.
• At the end of the expiry period after the first opening of the bottle (28 days), there will still be MITOBRIN in the bottle. Do not use the remaining medicine in the bottle after completing the course of treatment. Do not use the eye drops for a period longer than 28 days after the first opening of the bottle. MITOBRIN “3 mg/ml eye drops, solution” 20 single-dose containers of 0.250 ml:
• Before use, make sure the single-dose container is intact
• Use the eye drops in single-dose containers immediately after opening. Do not reuse any residue. Throw away 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, immediately wash your eye with lukewarm water. However, no adverse effects are expected.
Do not use more medicine until the time scheduled for the next administration.

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

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)

• Effects on the eyes: eye discomfort, redness.

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

• Effects on the eyes: inflammation of the eye surface, damage to the cornea (the transparent membrane covering the colored part of the eye), impaired vision, blurred vision, redness of the eyelids, swelling of the eye and eyelid, eye pain, dry eye, eye discharge, eye itching, increased tearing.
• General side effects: allergy (hypersensitivity), headache, hives, skin inflammation (dermatitis), decreased growth or number of eyelashes, loss of skin color, itching, dry skin. Side effects of unknown frequency (frequency cannot be estimated based on available data)
• Effects on the eyes: ocular allergy, eye irritation, eyelid itching.
• General side effects: severe allergic reactions, rash, severe skin eruptions (Stevens-Johnson Syndrome, erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor
or pharmacist. You can also report side effects directly through 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 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 refers to the product in intact packaging, correctly stored.
This medicine does not require any special storage precautions.
Validity 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 vial even if only partially used.
After opening the sachet, the remaining vials must be used within 28 days.

MITOBRIN “3 mg/ml eye 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 in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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. One single-dose container contains 0.75 mg of tobramycin.
• The other ingredients 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. One bottle contains 15 mg of tobramycin.
• The other ingredients 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 presented as eye drops, solution.
20 single-dose containers of 0.25 ml
1 dropper bottle of 5 ml

Marketing Authorisation 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)