TOBRAL 0.3% Krople do oczu, roztwór

Treść ulotki

1. TOBRAL 0.3% ophthalmic ointment
   1. What TOBRAL is and what it is used for
   2. What you need to know before using TOBRAL
   3. How to use TOBRAL
   4. Possible side effects
   5. How to store TOBRAL
   6. Contents of the pack and other information
2. TOBRAL 0.3% eye drops, solution
   1. What TOBRAL is and what it is used for
   2. What you need to know before using TOBRAL
   3. How to use TOBRAL
   4. Possible side effects
   5. How to store TOBRAL
   6. Contents of the pack and other information
3. TOBRAL 0.3% ear drops, solution
   1. What is TOBRAL and what is it used for
   2. What you need to know before using TOBRAL
   3. Contents of the pack and other information

TOBRAL 0.3% ophthalmic ointment

tobramycin
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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What TOBRAL is and what it is used for

TOBRAL 0.3% ophthalmic ointment contains the active ingredient tobramycin, an antibiotic from the
aminoglycoside family, which acts against various bacteria that can cause eye infections.
TOBRAL is used in adults and children from one year of age to treat eye and
adnexal infections caused by bacteria sensitive to tobramycin: acute, sub-acute and
chronic catarrhal inflammations of the conjunctiva (the transparent membrane lining the white part of the eye and the inside of the
eyelids); eyelid inflammations; corneal inflammations (the transparent membrane covering the
colored part of the eye); lacrimal sac inflammations.
Tobral is also used before and after surgical interventions on the anterior part of the eye.

2. What you need to know before using TOBRAL

DO NOT use TOBRAL

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

Warnings and precautions

• Talk to your doctor before using TOBRAL
• 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 TOBRAL, stop treatment and see your doctor. Also, keep in mind that this allergic sensitivity can occur even with other antibiotics belonging to the same class of aminoglycosides, administered both to the eyes and systemically (by injection).
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics can worsen muscle weakness.
• 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 TOBRAL together with tobramycin taken systemically (by injection).
• As with other antibiotics, if you use TOBRAL for a long time, you may become more susceptible to eye infections, even those caused by fungi. If your symptoms worsen or suddenly reappear, see your doctor.
• Do not wear contact lenses during the treatment of an eye infection.

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

Pregnancy, breastfeeding and fertility
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. Studies in animals 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 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 therapy with tobramycin.
Fertility
No studies have been conducted to evaluate the effect on human fertility of topical
ocular administration of TOBRAL eye ointment.

Driving and using machines
TOBRAL does not alter or transiently alters the ability to drive vehicles and use machinery.
For a certain period of time after application of TOBRAL, blurred vision or other visual disturbances may occur that can affect the ability to drive vehicles and
use machinery. If these effects occur, wait until your vision returns to normal before driving
vehicles and using machinery.

3. How to use TOBRAL

Use TOBRAL only for application to the eyes.
Use this medicine following exactly the instructions of the doctor. If you have doubts, consult your doctor
or pharmacist.

Recommended dose
Apply the ointment to the conjunctival sac two to four times a day, 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 to 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. The ophthalmic ointment should be used last.

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

How to apply TOBRAL

• Wash your hands
• Take the tube of TOBRAL and unscrew the cap.
• Tilt your head back. Lower the eyelid with a clean finger to form a pouch between the eyelid and the eye. The ointment should be applied in this location.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the tip of the tube to avoid infecting the remaining ointment in the tube.
• If you apply the ointment to both eyes, repeat the same operation for the other eye.
• Immediately replace the cap after use, screwing it on tightly.

If you use more TOBRAL 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 of the medicine until the time scheduled for the next administration.

If you forget to use TOBRAL
If you forget to use TOBRAL, 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 a missed dose.

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

4. Possible side effects

Like all medicines, TOBRAL can cause side effects, although not everybody gets them.
Side effects reported with the use of TOBRAL are listed below.
Common (may affect up to 1 in 10 people)

• Effects on the eyes: eye discomfort, redness. Uncommon (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, swelling of the eye and eyelid, redness of the eyelids, dry eye, increased tearing, eye pain, eye itching, eye discharge.
• General side effects: allergy (hypersensitivity), headache, hives, skin inflammation (dermatitis), decreased growth or number of eyelashes, loss of skin pigmentation, itching, dry skin. Not known (frequency cannot be estimated from available data)
• Effects on the eyes: ocular allergy, eye irritation, eyelid itching.
• General side effects: anaphylactic reactions, rash, severe skin reactions (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/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store TOBRAL

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C. Do not refrigerate.
Do not use this medicine after the expiry date which is stated on the tube and the package after “Exp.”. The
expiry date refers to the last day of the month. The expiry date refers to the product in
intact packaging, correctly stored.
The product must not be used for more than 28 days after the first opening of the container.
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 TOBRAL contains

• The active ingredient is tobramycin. 1 gram of ointment contains 3 mg of tobramycin.
• The other ingredients are chlorobutanol, liquid paraffin, petrolatum.

Description of the appearance of TOBRAL and contents of the pack
Tobral is an ointment of colour from white to off-white. One pack contains an aluminium tube of
3.5 g with an ophthalmic tip in HDPE/LDPE or in HDPE.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy

Distributor for sale
Fidia farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (PD)
Italy

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

TOBRAL 0.3% eye drops, solution

tobramycin
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 their symptoms are the same as yours, 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 TOBRAL is and what it is used for
• 2. What you need to know before you use TOBRAL
• 3. How to use TOBRAL
• 4. Possible side effects
• 5. How to store TOBRAL
• 6. Contents of the pack and other information

1. What TOBRAL is and what it is used for

TOBRAL 0.3% eye drops, solution contains the active ingredient tobramycin, an antibiotic from the
aminoglycoside family, which acts against various bacteria that can cause eye infections.
TOBRAL is used in adults and children from one year of age to treat eye and
adnexal infections caused by bacteria sensitive to tobramycin: acute, sub-acute and
chronic catarrhal inflammations of the conjunctiva (the transparent membrane that lines the white part of the eye and the inside of the
eyelids); eyelid inflammations; corneal inflammations (the transparent membrane that covers the
colored part of the eye); lacrimal sac inflammations.
Tobral is also used before and after surgical interventions on the anterior part of the eye.

2. What you need to know before using TOBRAL

DO NOT use TOBRAL

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

Warnings and precautions

• Talk to your doctor before using TOBRAL.
• 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 you experience these symptoms during the use of TOBRAL, stop treatment and consult your doctor. Also, keep in mind that this allergic sensitivity can also occur with other antibiotics belonging to the same class of aminoglycosides, administered both to the eyes and systemically (by injection).
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics may worsen muscle weakness.
• In patients who have taken tobramycin systemically (by injection), serious adverse effects on the nervous system, ears and kidneys have occurred. Be careful and consult your doctor if you are using TOBRAL together with tobramycin taken systemically (by injection).
• As with other antibiotics, if you use TOBRAL for a long time, you may become more susceptible to eye infections, even those caused by fungi. If your symptoms worsen or suddenly reappear, consult your doctor.
• Do not wear contact lenses during the treatment of an eye infection (see also the section “Tobral contains benzalkonium chloride”).

Other medicines and TOBRAL
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 TOBRAL
together with other eye products that contain tetracycline.

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
Data relating to the application of tobramycin to the eyes in pregnant women are non-existent or
limited in number. Studies in animals 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 therapy with tobramycin.
Fertility
No studies have been conducted to evaluate the effect on human fertility of topical ocular
administration of TOBRAL eye drops.

Driving and using machines
TOBRAL does not alter or transiently alters the ability to drive vehicles and use machinery.
For a certain period of time after the instillation of TOBRAL, blurred vision or other visual disturbances may occur that can affect the ability to drive vehicles and
use machinery. If you experience these effects, wait until your vision returns to normal before driving
vehicles and using machinery.

TOBRAL contains 0.5 mg of benzalkonium chloride per 5 ml which is 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
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 TOBRAL

Use TOBRAL 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 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 to 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. The ophthalmic ointment should be used last.

Use in children and adolescents
Do not use TOBRAL in children under 1 year of age as safety and efficacy have not been established in this population and no data are available.
Due to the content of boric acid, for children between 1 and 2 years of agethe maximum number of
drops that can be administered in a day is 14 drops. Higher dosages may compromise future
fertility.
In children over 2 years of age, TOBRAL can be used at the same doses as prescribed for adults.
If you have any doubts, consult your doctor.

How to apply TOBRAL

1 2

• Wash your hands.
• Take the TOBRAL bottle and unscrew the cap.
• If you are opening the bottle for the first time, remove the ring detached from the cap before using the product.
• Hold the bottle 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 1).
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the dropper tip to avoid infecting the drops remaining in the bottle.
• Gently press the base of the bottle to release one drop of TOBRAL at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is sufficient (figure 2).
• If you instill drops in both eyes, repeat the same operation for the other eye.
• Immediately replace the cap after use, screwing it on tightly.
• If a drop does not enter the eye, try again.

If you use more TOBRAL than you should
If you use more medicine than you should, immediately wash your eye with warm water. However, no adverse
effects are expected.
Do not use more of the medicine until the time scheduled for the next administration.

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

4. Possible side effects

Like all medicines, TOBRAL can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of TOBRAL.
Common (may affect up to 1 in 10 people)

• eye discomfort, eye redness. Uncommon (may affect up to 1 in 100 people)
• inflammation of the eye surface (keratitis), damage to the cornea (the transparent membrane covering the colored part of the eye), impaired vision, blurred vision, eye swelling, eyelid swelling, redness of the eyelids, dry eye, increased tearing, eye pain, eye itching, eye secretion; allergic reactions, hives, skin inflammation (dermatitis), decreased growth or number of eyelashes, loss of skin color, itching, dry skin, headache. Not known (frequency cannot be estimated from available data)
• eye allergy, eye irritation,
• severe allergic reactions, skin rash, severe skin rashes (Stevens-Johnson Syndrome, erythema multiforme).

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 .
By reporting side effects you can help to provide more information on the safety of this
medicine.

5. How to store TOBRAL

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the vial and the packaging box 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.
Do not use the product for more than 30 days after first opening the container.
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 TOBRAL contains

• The active substance is tobramycin. 1ml of eye drops contains 3 mg of tobramycin.
• The other ingredients are: tyloxapol, benzalkonium chloride, boric acid, anhydrous sodium sulfate, sodium chloride, sulfuric acid, sodium hydroxide (to adjust the pH), purified water.

Description of the appearance of TOBRAL and contents of the pack
TOBRAL is a clear and colorless liquid. One pack contains a 5 ml plastic dropper bottle.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Distributor for sale
Fidia farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (PD)
Italy

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcellona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcellona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Norimberga
Germany

TOBRAL 0.3% ear drops, solution

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

1. What is TOBRAL and what is it used for

TOBRAL 0.3% ear drops, solution, contains the active ingredient tobramycin, an antibiotic
of the aminoglycoside family, which acts against various bacteria that can cause ear
infections.
TOBRAL is indicated in the treatment of infections of the external auditory canal (otitis externa).

2. What you need to know before using TOBRAL

DO NOT use TOBRAL

• 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 the presence of a perforated eardrum.

Warnings and precautions

• Consult your doctor before using TOBRAL, 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.
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics can worsen muscle weakness.
• In patients who have taken tobramycin systemically (by injection), serious adverse effects have occurred at the level of the nervous system, ears and kidneys. Be careful and consult your doctor if you are using TOBRAL together with tobramycin taken systemically (by injection).
• As with all antibiotics, prolonged use can allow the growth of microorganisms against which the medicine is no longer effective, including fungi.
• Do not apply the medicine to wounds or ulcerations and do not use it for more than 7 days (see section “Recommended dose”). In fact, although all aminoglycoside antibiotics are potentially toxic to the kidneys and ears, the risk of ear toxicity is associated with the duration of therapy and their administration by parenteral (injection) or local route on wounds and/or ulcerations. In the absence of wounds and/or ulcerations, these risks should not exist with TOBRAL, 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 TOBRAL, your doctor will have you undergo tests to check the total amount of antibiotic present in the blood.

Children
TOBRAL 0.3% ear drops, solution should not be used in children under or
equal to 2 years of age due to the content of boron (see “TOBRAL contains boron”).
The doctor will assess the need to prescribe TOBRAL 0.3% ear drops, solution in children
over 2 years of age.

Other medicines and TOBRAL
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 TOBRAL 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 when absolutely necessary,
under direct medical supervision.
Breastfeeding
The product should not be used during breastfeeding. If your doctor deems treatment necessary,
she will have you stop breastfeeding.
Fertility
No studies have been conducted to evaluate the effect on human fertility after administration
of TOBRAL ear drops.

TOBRAL contains 0.5 mg of benzalkonium chloride per 5 ml which is equivalent to 0.1 mg/ml.
Benzalkonium chloride can irritate the skin.

TOBRAL contains boron.Do not administer to children under 2 years of age because this
medicine contains boron and may compromise fertility in the future.

3How to use TOBRAL
Use this medicine following exactly the instructions of your doctor. If you have doubts consult
your doctor or pharmacist.
Apply TOBRAL ear drops only to the ears.

Recommended dose
Instill four drops into the ear three times a day for 5 - 6 days.
Maximum duration of treatment: 7 days (see section “Warnings and precautions”).
If you have doubts, consult your doctor.

How to apply TOBRAL

1 2

• Wash your hands.
• Take the bottle and unscrew the cap.
• Hold the bottle, with the opening facing down, holding it with your thumb and middle finger.
• Lie down with the infected ear facing up (figure 1).
• Bring the tip of the bottle close to the ear canal.
• Avoid contact of the dropper with the earlobe or ear canal, surrounding areas or other surfaces: they could infect the drops.
• Apply gentle pressure to the base of the bottle so as to cause one drop of TOBRAL to come out at a time.
• Do not squeeze the bottle; it is designed so that a slight pressure on the bottom is sufficient (figure 2).
• If using the drops in both ears, repeat the procedure for the other ear as well.
• Screw the cap back on the bottle tightly immediately after use and keep the bottle well closed when not in use.
• If a drop does not enter the ear, try again.

If you forget to use TOBRAL
If you forget to use TOBRAL, do not worry and apply 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 schedule of
administration.
Do not use a double dose to make up for the missed dose.

If you have any doubts about using this medicine, ask your doctor or pharmacist.
4Possible side effects
Like all medicines, TOBRAL can cause side effects, although not everyone
will experience them.
Following local use of aminoglycoside antibiotics, toxicity reactions to the
ear (ototoxicity) have occurred, the frequency of which 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 experience any side effects, including 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/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of
this medicine.

5How to store TOBRAL
Keep the medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the bottle and the box after
“Expiry.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, stored correctly.
Do not use the product more than 30 days after first opening the container.
Do not dispose of any medicine in waste water 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 TOBRAL contains

• The active ingredient is tobramycin. 1 ml of ear drops contains 3 mg of tobramycin.
• The other ingredients are: tyloxapol, benzalkonium chloride, boric acid, sodium chloride, anhydrous sodium sulfate, sodium chloride, purified water.

Description of the appearance of TOBRAL and contents of the pack
TOBRAL is a clear and colorless liquid. One pack contains a 5 ml plastic dropper bottle.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Distributor for sales
Fidia farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (PD)
Italy

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany