Tobral

Package leaflet: Information for the patient

TOBRAL 0.3% eye drops, solution

tobramycin
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, contact 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 using 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 substance tobramycin, an antibiotic belonging to 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 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); eyelid inflammations; inflammations of the cornea (the transparent membrane covering the colored part of the eye); and inflammations of the lacrimal sac.
TOBRAL is also used before and after surgical procedures 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

• Consult your doctor before using TOBRAL.
• 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 these symptoms occur while using TOBRAL, stop treatment and consult your doctor. Also note that this allergic sensitivity may also occur with other antibiotics belonging to the aminoglycoside class, whether administered in the eyes or systemically (by injection).
• Consult your doctor if you have or have ever had conditions such as severe myasthenia gravis or Parkinson's disease. This type of antibiotic may worsen muscle weakness.
• 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 TOBRAL together with systemic tobramycin (by injection).
• As with other antibiotics, prolonged use of TOBRAL may make you more susceptible to eye infections, including those caused by fungi. If your symptoms worsen or suddenly reappear, consult your doctor.
• Do not wear contact lenses during treatment for an eye infection (also read the section “TOBRAL contains benzalkonium chloride”).

Other medicines and TOBRAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Incompatibility
The ingredient tyloxapol contained in the eye drops is incompatible with tetracycline. Do not use TOBRAL
together with other eye products containing tetracycline.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.
Pregnancy
Data on the use of tobramycin in the eyes during pregnancy are lacking or limited in number. 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 after 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 TOBRAL eye drops on human fertility.
Driving and use of machines
TOBRAL does not affect or only transiently affects the ability to drive and use machines.
For a certain period after instillation of TOBRAL, blurred vision or other visual disturbances may occur, which could affect your ability to drive and use machinery. If these effects occur, wait until your vision clears before driving or operating machinery.
TOBRAL contains 0.5 mg of benzalkonium chloride per 5 ml, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your 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 an abnormal sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use TOBRAL

Use TOBRAL only for instillation into the eyes.
Always use this medicine exactly as instructed by 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 for acute conditions and three times a day for chronic conditions, according to your doctor's instructions. Use the product for the length of time specified by your doctor.
The following procedure helps reduce the amount of medicine absorbed 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 instillation of each medicine. 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 and no data are available in this population.
Due to the content of boric acid, in children aged between 1 and 2 years, the maximum number of drops that may be administered per day is 14 drops. Higher doses may impair fertility in the future.
In children over 2 years of age, TOBRAL may be used at the same doses as in 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 detached collar from the cap before using the product.
• Hold the bottle 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 1).
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip to avoid contaminating the remaining drops 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 required (Figure 2).
• If instilling drops into both eyes, repeat the same procedure for the other eye.
• Immediately replace the cap after use, screwing it back tightly.
• If a drop misses the eye, try again.

If you use more TOBRAL than you should
If you use more medicine than you should, immediately rinse the eye 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 TOBRAL
If you forget to use TOBRAL, do not worry; instill it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult 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 surface of the eye (keratitis), corneal damage (the transparent membrane covering the colored part of the eye), visual impairment, blurred vision, eye swelling, eyelid swelling, eyelid redness, dry eye, increased tearing, eye pain, eye itching, eye discharge; allergic reactions, urticaria, skin inflammation (dermatitis), reduced growth or number of eyelashes, loss of skin pigmentation, itching, dry skin, headache.

Not known (frequency cannot be estimated from the 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website [insert address].
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 below 25°C.
Do not use this medicine after the expiry date stated on the vial and carton after “Exp.”.
The expiry date refers to the last day of that month. The expiry date refers to the product kept in its
original, unopened packaging and stored correctly.
Do not use the product more than 30 days after first opening the container.
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 TOBRAL contains

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

Description of the appearance of TOBRAL and contents of the pack
TOBRAL is a clear, colourless liquid. One pack contains a plastic dropper bottle containing 5 ml of eye drops.

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

Concessionaire 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
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Patient information leaflet

TOBRAL 0.3% eye ointment

tobramycin
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 effects, including those not listed in this leaflet, consult 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 using 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 substance tobramycin, an antibiotic belonging to 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 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); eyelid inflammations; corneal inflammations (the transparent membrane covering the coloured part of the eye); lacrimal sac inflammations.
TOBRAL is also used before and after surgical procedures on the anterior part of the eye.

2. What you should 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 in the eyes may occur. This allergic reaction may range from localized itching or skin redness to severe generalized allergic reactions (anaphylactic reactions) or severe skin reactions. If these symptoms occur during the use of TOBRAL, stop treatment and consult your doctor. Also keep in mind that this allergic sensitivity may also occur with other antibiotics belonging to the aminoglycoside class, whether administered in the eyes or systemically (by injection).
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. This type of antibiotic may worsen muscle weakness.
• 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 TOBRAL together with systemic tobramycin (by injection).
• As with other antibiotics, prolonged use of TOBRAL may increase your susceptibility to eye infections, including those caused by fungi. If your symptoms worsen or suddenly reappear, consult your doctor.
• Do not wear contact lenses during treatment for an eye infection.

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might 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 in number. 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 after ocular administration. Tobramycin is excreted in breast milk following systemic administration (by injection). The risk to infants cannot be ruled out. 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 TOBRAL ophthalmic ointment on human fertility.

Driving and using machines
TOBRAL does not affect or only transiently affects the ability to drive and use machinery.
For a certain period after application of TOBRAL, 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 is clear again before driving or operating machinery.

3. How to use TOBRAL

Use TOBRAL only for ocular application.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Apply the ointment into the conjunctival sac two to four times daily, according to your doctor's instructions. Use the product for the length of time specified by your doctor.
The following procedure helps minimize the amount of medicine absorbed into the bloodstream after ocular 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 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 may be used in children from 1 year of age onwards at the same doses as those recommended for adults.
How to apply TOBRAL

• Wash your hands.
• Take the TOBRAL tube and unscrew the cap.
• Tilt your head backward. Gently pull down the eyelid with a clean finger to form a pouch between the eyelid and the eye. The ointment should be applied into this pouch.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the tube to avoid contaminating the remaining ointment in the tube.
• If applying the ointment to both eyes, repeat the same procedure for the other eye.
• Immediately replace the cap after use, screwing it back on tightly.

If you use more TOBRAL than you should
If you use more medicine than recommended, immediately rinse the eye 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 TOBRAL
If you forget to use TOBRAL, do not worry; apply it as soon as you remember. However, if it is almost time for the 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 have any doubts about how to use this medicine, consult 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 disorders: eye discomfort, redness.

Uncommon (may affect up to 1 in 100 people)

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

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

• Eye disorders: allergic reaction in the eye, eye irritation, eyelid itching.
• General side effects: anaphylactic reactions, skin rash, severe skin rashes (Stevens-Johnson syndrome, erythema multiforme).

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 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 below 25°C. Do not refrigerate.
Do not use this medicine after the expiry date stated on the tube and the carton after "Exp.". The expiry date refers to the last day of the stated month. The expiry date applies to the product in its original, unopened packaging, stored correctly.
The product must not be used more than 28 days after first opening the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TOBRAL contains

• The active substance is tobramycin. 1 gram of ointment contains 3 mg of tobramycin.
• The other ingredients are chlorobutanol, liquid paraffin, and petroleum jelly.

Description of the appearance of TOBRAL and contents of the pack
Tobral is an ointment ranging in colour from white to off-white. One pack contains an aluminium tube of 3.5 g with an ophthalmic tip in HDPE/LDPE or HDPE.
Marketing Authorization Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Supplier 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
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Patient information leaflet

TOBRAL 0.3% ear drops, solution

tobramycin
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using 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% ear drops, solution, contains the active substance tobramycin, an antibiotic belonging to the aminoglycoside family, which acts against various bacteria that can cause ear infections.
TOBRAL is indicated for the treatment of infections of the external ear canal (external otitis).

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).
• If you have, or suspect you have, a perforated eardrum.

Warnings and precautions

• Consult your doctor before using TOBRAL, especially if you are elderly, suffer from kidney disease, are already being treated with antibiotics belonging to the aminoglycoside class, or are taking diuretic medicines.
• Consult your doctor if you have or have ever had conditions such as severe myasthenia or Parkinson's disease. This type of antibiotic may worsen muscle weakness.
• Serious adverse effects on the nervous system, ears, and kidneys have occurred in patients who have received tobramycin systemically (by injection). Be cautious and consult your doctor if you are using TOBRAL together with systemically administered (by injection) tobramycin.
• As with all antibiotics, prolonged use may allow the growth of microorganisms against which the medicine is no longer effective, including fungi.
• Do not apply the medicine on wounds or ulcers and do not use it for more than 7 days (read section “Recommended dose”). Although all aminoglycoside antibiotics are potentially toxic to the kidneys and ears, the risks of ototoxicity are associated with the duration of therapy and parenteral (injection) or local administration on wounds and/or ulcers. In the absence of wounds and/or ulcers, such risks should not occur with TOBRAL, as it is administered locally, at a low daily dose, and for a limited number of days. However, be vigilant for any signs of toxicity such as dizziness, vertigo, ringing in the ears, or hearing loss: in such cases, stop treatment immediately and consult your doctor.
• Rarely, cases of hypersensitivity (allergic reaction) may occur. This allergic sensitivity may also occur with other antibiotics belonging to the aminoglycoside class, administered either locally or by injection.
• If you are simultaneously receiving tobramycin or other aminoglycoside antibiotics by parenteral (injection) route while using TOBRAL, your doctor will arrange blood tests to monitor the total amount of antibiotic in your blood.

Children
TOBRAL 0.3% ear drops, solution must not be used in children aged 2 years or younger due to its boron content (see “TOBRAL contains boron”).
Your doctor will assess the need to prescribe TOBRAL 0.3% ear drops, solution for children older than 2 years.

Other medicines and TOBRAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Incompatibilities
The ingredient tyloxapol contained in the ear drops is incompatible with tetracyclines. Do not use TOBRAL together with other ear products containing tetracyclines.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
This medicine should be administered to pregnant women only when clearly needed and under direct medical supervision.

Breastfeeding
This product should not be used during breastfeeding. If your doctor considers treatment necessary, you will be advised to stop breastfeeding.

Fertility
No studies have been conducted to evaluate the effect on human fertility following administration of TOBRAL ear drops.

TOBRAL contains 0.5 mg of benzalkonium chloride per 5 ml, equivalent to 0.1 mg/ml.
Benzalkonium chloride may cause skin irritation.

TOBRAL contains boron. Do not administer to children under 2 years of age, as this medicine contains boron, which may impair fertility in the future.

3. How to use TOBRAL

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Apply TOBRAL ear drops only into the ears.

Recommended dose
Instill four drops into the affected ear three times a day for 5–6 days.
Maximum duration of treatment: 7 days (see section “Warnings and precautions”).
If in doubt, 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 downward, using your thumb and middle finger.
• Lie down with the affected ear facing upward (Figure 1).
• Bring the tip of the bottle close to the ear canal.
• Avoid contact between the dropper tip and the earlobe, ear canal, surrounding areas, or any other surfaces: this could contaminate the drops.
• 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 slight pressure at the bottom is sufficient (Figure 2).
• If treating both ears, repeat the procedure for the other ear.
• Immediately after use, securely screw the cap back onto the bottle and keep the container tightly 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—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 a forgotten dose.

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

4. Possible side effects

Like all medicines, TOBRAL can cause side effects, although not everybody gets them.
Following local use of aminoglycoside antibiotics, cases of ear toxicity (ototoxicity) have been reported; the frequency is unknown.
As with all aminoglycoside antibiotics applied to the ears, local intolerance or hypersensitivity reactions (allergy) may occur. In such 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 may also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects 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 below 25°C.
Do not use this medicine after the expiry date stated on the bottle and carton after “Exp.”. The expiry date refers to the last day of that month. The expiry date applies to the product if unopened and stored correctly.
Do not use the product more than 30 days after first opening the container.
Do not dispose of medicines 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 TOBRAL contains

• The active substance is tobramycin. 1 ml of ear drops contains 3 mg of tobramycin.
• The other components 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, colourless liquid. The pack contains one plastic dropper bottle of 5 ml.

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

Selling Agent
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