PAIDOMICINA 0.3% Krople do oczu, roztwór

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1. PAIDOMICINA “0.3% ear drops, solution”
2. PAIDOMICINA “0,3% ear drops, solution”

PAIDOMICINA “0,3% collirio, soluzione”
TOBRAMICINA
Medicinale equivalente
Flacone contagocce da 5 ml

PHARMACOTHERAPEUTIC CATEGORY
Antibiotic of the aminoglycoside family

INDICATIONS
PAIDOMICINA 0,3% collirio, soluzione is indicated in adults and children one year of age and older
for the treatment of eye and adnexal infections caused by bacteria sensitive to
tobramycin: acute, sub-acute and chronic catarrhal conjunctivitis; blepharitis; bacterial keratitis;
dacryocystitis; pre- and post-operative prophylaxis in surgeries on the anterior segment .
CONTRAINDICATIONS
Do not use PAIDOMICINA 0,3% collirio if you are allergic (hypersensitive) to tobramycin or to
any of the other components of this medicine (listed in paragraph “Composition”).

PRECAUTIONS FOR USE

• In some patients, sensitization to aminoglycoside antibiotics administered topically may occur. If hypersensitivity develops during use of the medicine, treatment should be discontinued and other drugs should be used (see paragraph “Undesirable effects”).
• Cross-hypersensitivity to other aminoglycosides may occur, therefore the possibility that patients sensitized to topically administered tobramycin may also be sensitive to other aminoglycosides administered topically and/or systemically should be considered.
• In patients treated with tobramycin systemically, serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred. Although these effects have not been reported following topical ophthalmic use of tobramycin, caution is advised when it is administered concurrently with systemic therapy.
• As with other antibiotics, the use of tobramycin topically to the eye (especially in case of prolonged or repeated therapy) may induce the growth of abnormal organisms not susceptible, including fungi. If a superinfection occurs, appropriate therapy should be instituted.
• It is recommended not to wear contact lenses during the treatment of an eye infection.
• PAIDOMICINA collirio contains benzalkonium chloride, which can cause eye irritation and is known to be able to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses before applying PAIDOMICINA collirio and wait at least 15 minutes after instillation of the dose before reinserting them.

INTERACTIONS
Inform your doctor or pharmacist if you are taking or have recently taken other
medicines, including those without a prescription.

Incompatibilities
The tyloxapol component contained in the eye drops is incompatible with tetracycline.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In case of pregnancy or possible conception, or if you are breastfeeding, ask your
doctor before using this medicine.
Pregnancy
There are no adequate data regarding the topical ophthalmic use of tobramycin in pregnant women.
Animal studies have shown reproductive toxicity. Tobramycin is not recommended
during pregnancy.
Breastfeeding
It is not known whether tobramycin is excreted in human milk; however, the risk to infants cannot
be excluded. The decision to discontinue breastfeeding or discontinue
therapy with tobramycin should be made considering the benefit of breastfeeding for the child and the
benefit of therapy for the woman.

Driving and using machines
For a certain period of time after using PAIDOMICINA 0,3% collirio, blurred vision may occur.
Do not drive or operate machinery until this effect has worn off.

Important information relating to an excipient contained in PAIDOMICINA 0,3% collirio,
solution
PAIDOMICINA 0,3% collirio contains a preservative (benzalkonium chloride) that can cause
eye irritation and is known to discolor soft contact lenses. If you
wear contact lenses, remove them before using PAIDOMICINA 0,3% collirio and wait 15
minutes before putting them back in.
The use of contact lenses is not recommended during the treatment of an eye
infection.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Instill two drops into the conjunctival sac four times a day in acute forms and three times a
day in chronic forms, as prescribed by your doctor.
Paediatric population
PAIDOMICINA 0,3% collirio can be used in children from one year of age at the same
doses as adults. Safety and efficacy have not been established in children under one year of age and no data are available.
If a drop does not enter the eye, try again.
If you are using other eye drops or ointments, allow at least 5 minutes to pass between
instilling each medicine.

OVERDOSE
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 than prescribed until the time for your next dose.

IF YOU FORGET TO TAKE A DOSE
If you forget to use PAIDOMICINA 0,3% collirio, continue treatment with the next
dose as scheduled. However, if it is almost time to administer the next dose, it is
best to skip the missed 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.
SIDE EFFECTS
Like all medicines, PAIDOMICINA 0,3% collirio can cause side effects, although
not everyone gets them.
The following side effects have been reported with the use of tobramycin 0,3% collirio:
Common side effects (affecting 1 to 10 users out of 100)

• Eye effects: eye discomfort, redness. Uncommon side effects (affecting 1 to 10 users out of 1,000)
• Eye effects: inflammation of the surface of the eye, corneal damage, disorders of the white part of the eye, impaired vision, blurred vision, redness of the eyelid, swelling of the eye and eyelid, eyelid disorder, eye pain, dry eye, eye discharge, eye itching, foreign body sensation in the eyes, increased tearing.
• General side effects: allergy (hypersensitivity), headache, hives, skin inflammation, decreased growth or number of eyelashes, skin discoloration, itching, dry skin. Side effects of unknown frequency (frequency cannot be estimated on the basis of available data)
• Eye effects: eye allergy, eye irritation, eyelid itching.
• General side effects: rash.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can also be reported directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili .
Reporting side effects helps to provide more information on the
safety of this medicine.

EXPIRY DATE AND STORAGE
Do not use after the expiry date indicated on the outer packaging and the vial.
The expiry date refers to the last day of the month.
No special storage precautions.
The expiry date refers to the product in intact packaging, stored correctly.
The product should not be used more than 28 days after first opening the container.

Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

COMPOSITION
100 ml contain:
Active ingredient: Tobramycin: 0.3 g
Excipients: Tyloxapol, Benzalkonium chloride, Boric acid, Anhydrous sodium sulfate, Sodium chloride, Water
for injections.

PHARMACEUTICAL FORM AND CONTENT
Eye drops, solution
Bottle with dropper from 5 ml

MARKETING AUTHORISATION HOLDER
D.M.G. ITALIA S.R.L.- Via Laurentina Km 26700, 00040 Pomezia (RM)

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

PAIDOMICINA “0,3% collirio, soluzione”
TOBRAMICINA
Medicinale equivalente
20 Single-dose containers of 0.250 ml

PHARMACOTHERAPEUTIC CATEGORY
Antibiotic of the aminoglycoside family

INDICATIONS
PAIDOMICINA 0,3% collirio, soluzione is indicated in adults and children one year of age and older
for the treatment of eye and adnexal infections caused by bacteria sensitive to
tobramycin: acute, sub-acute and chronic catarrhal conjunctivitis; blepharitis; bacterial keratitis;
dacryocystitis; pre- and post-operative prophylaxis in surgeries on the anterior segment .
CONTRAINDICATIONS
Do not use PAIDOMICINA 0,3% collirio if you are allergic (hypersensitive) to tobramycin or to
any of the other components of this medicine (listed in paragraph “Composition”).

PRECAUTIONS FOR USE

• In some patients, sensitization to aminoglycoside antibiotics administered topically may occur. If hypersensitivity develops during use of the medicine, treatment should be discontinued and other drugs should be used (see paragraph “Undesirable effects”).
• Cross-hypersensitivity to other aminoglycosides may occur, therefore the possibility that patients sensitized to topically administered tobramycin may also be sensitive to other aminoglycosides administered topically and/or systemically should be considered.
• In patients treated with tobramycin systemically, serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred. Although these effects have not been reported following topical ophthalmic use of tobramycin, caution is advised when it is administered concurrently with systemic therapy.
• As with other antibiotics, the use of tobramycin topically to the eye (especially in case of prolonged or repeated therapy) may induce the growth of abnormal organisms not susceptible, including fungi. If a superinfection occurs, appropriate therapy should be instituted.
• It is recommended not to wear contact lenses during the treatment of an eye infection.

INTERACTIONS
Inform your doctor or pharmacist if you are taking or have recently taken other
medicines, including those without a prescription.

Incompatibilities
The tyloxapol component contained in the eye drops is incompatible with tetracycline.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In case of pregnancy or possible conception, or if you are breastfeeding, ask your
doctor before using this medicine.
Pregnancy
There are no adequate data regarding the topical ophthalmic use of tobramycin in pregnant women.
Animal studies have shown reproductive toxicity. Tobramycin is not recommended
during pregnancy.
Breastfeeding
It is not known whether tobramycin is excreted in human milk; however, the risk to infants cannot
be excluded. The decision to discontinue breastfeeding or discontinue
therapy with tobramycin should be made considering the benefit of breastfeeding for the child and the
benefit of therapy for the woman.

Driving and using machines
For a certain period of time after using PAIDOMICINA 0,3% collirio, blurred vision may occur.
Do not drive or operate machinery until this effect has worn off.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Instill two drops into the conjunctival sac four times a day in acute forms and three times a
day in chronic forms, as prescribed by your doctor.
Paediatric population
PAIDOMICINA 0,3% collirio can be used in children from one year of age at the same
doses as adults. The safety and efficacy in children under one year of age have not
been established and no data are available.
Before use, make sure the single-dose container is intact.
Hold the single-dose container upright and open by twisting the tab until the container is opened.
The eye drops in single-dose containers should be used immediately after opening. Any residue
should not be reused.
Avoid contact of the container tip with the eye or any other
surface.
If a drop does not enter the eye, try again.
If you are using other eye drops or ointments, allow at least 5 minutes to pass between
instilling each medicine.

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

WHAT TO DO IF YOU FORGET TO TAKE A DOSE OR MORE DOSES
If you forget to use PAIDOMICINA 0.3% eye drops, continue treatment with the next
dose as scheduled. However, if it is almost time to administer the next dose, it is
best to skip the forgotten dose and return to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

In case of any doubt about the use of this medicine, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, PAIDOMICINA 0.3% eye drops can cause side effects, although not
everyone will experience them.
The following side effects have been reported with tobramycin 0.3% eye drops:
Common side effects (affecting 1 to 10 users out of 100)

• Eye effects: eye discomfort, redness. Uncommon side effects (affecting 1 to 10 users out of 1,000)
• Eye effects: inflammation of the eye surface, corneal damage, disorders of the white part of the eye, impaired vision, blurred vision, eyelid redness, swelling of the eye and eyelid, eyelid disorder, eye pain, dry eye, eye discharge, eye itching, foreign body sensation in the eyes, increased tearing.
• General side effects: allergy (hypersensitivity), headache, hives, skin inflammation, decreased growth or number of eyelashes, loss of skin pigmentation, itching, dry skin. Side effects of unknown frequency (frequency cannot be estimated based on available data)
• Eye effects: eye allergy, eye irritation, eyelid itching.
• General side effects: rash.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
consult your doctor or pharmacist.
Side effects can also be reported directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili .
Reporting side effects helps to provide more information on the
safety of this medicine.

EXPIRY DATE AND STORAGE
Do not use after the expiry date indicated on the packaging.
The expiry date refers to the last day of the month.
No special storage precautions.
The expiry date refers to the product in intact packaging, correctly stored.
The product does not contain preservatives: after administration, the vial should be discarded
even if only partially used.
The product must not be used for more than 28 days after opening the sachet containing the
single-dose containers.

Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

COMPOSITION
One single-dose container contains:
Active ingredient: Tobramycin: 0.750 mg
Excipients: Tyloxapol, Boric acid, Anhydrous sodium sulfate, Sodium chloride, Water for injections.

PHARMACEUTICAL FORM AND CONTENT
Eye drops, solution
20 single-dose containers of 0.250 ml

MARKETING AUTHORISATION HOLDER
D.M.G. ITALIA S.R.L.- Via Laurentina Km 26700, 00040 Pomezia (RM)

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

PAIDOMICINA “0.3% ear drops, solution”

TOBRAMICINA
Equivalent medicine
5 ml dropper bottle

PHARMACOTHERAPEUTIC CATEGORY
Antibiotic of the aminoglycoside family

THERAPEUTIC INDICATIONS
PAIDOMICINA 0.3% ear drops, solution is indicated in the treatment of infections of the
external auditory canal caused by bacteria sensitive to tobramycin.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
As with all antibiotics, prolonged use may allow the growth of resistant microorganisms, including fungi.
Due to the presence of the non-ionic surfactant tyloxapol, the concomitant use of products containing tetracyclines is not recommended.
Although all aminoglycoside antibiotics are potentially nephro- and ototoxic, the risks of
ototoxicity are associated with the duration of therapy and their administration by parenteral or topical route on wounds and/or ulcerations.
In the absence of wounds and/or ulcerations, these risks should not exist with PAIDOMICINA 0.3%
ear drops, as it is administered topically, at a low daily dose and for a
limited number of days.
More careful medical monitoring is required in elderly patients, in patients already in
treatment with aminoglycosides or with impaired renal function and undergoing concomitant treatment
with loop diuretics.
The product must not be injected. PAIDOMICINA 0.3% ear drops, must not be
applied to wounds and ulcerations of the external auditory canal and the middle ear.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
The tyloxapol component is incompatible with tetracycline

SPECIAL WARNINGS
If topical administration of tobramycin is accompanied by systemic treatment
with aminoglycoside antibiotics, the total serum concentration must be carefully monitored.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnant women and young children, the product should be administered only in cases of
real need, under the direct control of the doctor. The product should not be used during
breastfeeding. If the doctor considers the treatment necessary, breastfeeding should be
discontinued.

Effects on ability to drive and use machines
Based on the pharmacodynamic properties, the product should not alter, if at all,
the ability to drive vehicles or operate machinery.
PAIDOMICINA 0.3% ear drops contains benzalkonium chloride, an irritating substance, which may
cause local skin reactions.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Instill four drops into the external auditory canal three times a day for 5-6 days.

OVERDOSE
There are no known cases of overdose.
In case of accidental ingestion of an excessive dose of PAIDOMICINA 0.3% ear drops
immediately notify your doctor or go to the nearest hospital.

In case of any doubt on the use of this medicine, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, PAIDOMICINA 0.3% ear drops can cause side effects
although not everyone experiences them.
Rarely, cases of hypersensitivity have occurred. In these cases, discontinue treatment and
consult your doctor. Considering the route of administration, the doses used and the
duration of therapy, signs of ototoxicity and systemic signs of tobramycin toxicity are unlikely.
If any of the side effects worsen, or if you notice any side effect

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
The expiry date refers to the last day of the month.
Caution: do not use the medicine after the expiry date stated on the packaging.
No special precautions for storage.
Validity after opening:
After first opening, the bottle must be used within 28 days
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Keep the medicine out of the sight and reach of children.
COMPOSITION
100 ml of solution contains:
Active ingredient:
Tobramycin: 0.3 g
Excipients: Tyloxapol, Benzalkonium chloride, Boric acid, Anhydrous sodium sulfate, Sodium chloride, Water
for injections.

PHARMACEUTICAL FORM AND CONTENT
Ear drops, solution
5 ml dropper bottle

MARKETING AUTHORISATION HOLDER
D.M.G. ITALIA S.R.L.- Via Laurentina Km 26700, 00040 Pomezia (RM)

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

PAIDOMICINA “0,3% ear drops, solution”

TOBRAMICIN
Equivalent medicinal product
20 Single-dose containers of 0.250 ml

PHARMACOTHERAPEUTIC CATEGORY
Antibiotic of the aminoglycoside family

THERAPEUTIC INDICATIONS
PAIDOMICINA 0.3% ear drops, solution is indicated in the treatment of infections of the
external auditory canal caused by bacteria sensitive to tobramycin.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
As with all antibiotics, prolonged use may allow the growth of resistant microorganisms,
including fungi.
Due to the presence of the non-ionic surfactant tyloxapol in the formulation, concomitant use of
products containing tetracyclines is not recommended.
Although all aminoglycoside antibiotics are potentially nephro- and ototoxic, the risk of
ototoxicity is associated with the duration of therapy and their administration by parenteral or topical
route on wounds and/or ulcerations.
In the absence of wounds and/or ulcerations, these risks should not exist with PAIDOMICINA 0.3%
ear drops, as administered topically, at a low daily dose and for a
limited number of days.
More careful medical monitoring is required in elderly patients, in patients already in
treatment with aminoglycosides or with impaired renal function and undergoing concomitant
treatment with loop diuretics.
The product must not be injected. PAIDOMICINA 0.3% ear drops should not be
applied to wounds and ulcerations of the external auditory canal and middle ear.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even
those without a prescription.
The tyloxapol component is incompatible with tetracycline

SPECIAL WARNINGS
If topical administration of tobramycin is accompanied by systemic treatment
with aminoglycoside antibiotics, the total serum concentration must be carefully monitored.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnant women and young children, the product should be administered only in cases of
real need, under the direct control of the doctor. The product should not be used during
breastfeeding. If your doctor deems treatment necessary, breastfeeding should be
suspended.

Effects on ability to drive and use machines
Based on the pharmacodynamic properties, the product should not alter, if at all,
the ability to drive vehicles or use machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Instill four drops into the external auditory canal three times a day for 5-6 days.
Before use, make sure that the single-dose container is intact.
Hold the single-dose container in a vertical position and open by rotating the tab until the container
opens.
The ear drops in single-dose containers must be used immediately after opening.
Any residue must not be reused.

OVERDOSE
There are no known cases of overdose.
In case of accidental ingestion of an excessive dose of PAIDOMICINA 0.3% ear drops,
immediately inform your doctor or go to the nearest hospital.

In case of any doubt on the use of this medicine, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, PAIDOMICINA 0.3% ear drops can cause side effects
although not everyone experiences them.
Rarely, cases of hypersensitivity have been reported. In these cases, discontinue treatment and
consult your doctor. Considering the route of administration, the doses used and the
duration of therapy, signs of ototoxicity and systemic signs of tobramycin toxicity are unlikely.
If any of the side effects worsen, or if you notice any side effect

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
The expiry date refers to the last day of the month.
Caution: do not use the medicine after the expiry date indicated on the packaging.
No special precautions for storage.
Validity after opening:
The product does not contain preservatives: after administration, the vial must be discarded
even if only partially used.
After opening the sachet, the remaining vials must be used within 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Keep the medicine out of the sight and reach of children.
COMPOSITION
One single-dose container contains:
Active ingredient:
Tobramycin: 0.750 mg
Excipients: Tyloxapol, Boric acid, Anhydrous sodium sulfate, Sodium chloride, Water for injections.

PHARMACEUTICAL FORM AND CONTENT
Ear drops, solution
20 single-dose containers of 0.250 ml

MARKETING AUTHORISATION HOLDER
D.M.G. ITALIA S.R.L.- Via Laurentina Km 26700, 00040 Pomezia (RM)

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