VARDAMIR 0.3% + 0.1% Eye drops, solution

Зміст інструкції

1. VARDAMIR 0,3% + 0,1% EYE DROPS, SOLUTION
2. VARDAMIR 0.3% + 0.1% EYE DROPS, SOLUTION

VARDAMIR 0,3% + 0,1% EYE DROPS, SOLUTION

Tobramycin and Dexamethasone
Medicinal equivalent
PHARMACOTHERAPEUTIC CATEGORY
Corticosteroids and antimicrobics in association.

INDICATIONS
VARDAMIR is indicated for the treatment of ocular inflammations when a corticosteroid is necessary
and when there is an ocular infection or the risk of ocular infections in adults and in children from two years of
age onwards.

CONTRAINDICATIONS
VARDAMIR is contraindicated in the following cases:
a) Do not use VARDAMIR if you are allergic (hypersensitive) to tobramycin, dexamethasone or any of the
other components of this medicine (listed in paragraph “Composition”).
b) Acute epithelial keratitis due to Herpes Simplex (dendritic keratitis)
c) Smallpox vaccination, chickenpox or other viral infections of the cornea and conjunctiva (except keratitis due
to Herpes Zoster)
d) Fungal infection of the eye
e) Ocular infections from mycobacteria (tuberculosis of the eye)
f) Intraocular hypertension
g) Acute purulent ophthalmias, purulent conjunctivitis and purulent and herpetic blepharitis which may be
masked or aggravated by corticosteroids
h) Hordeolum (stye).

PRECAUTIONS FOR USE
Before using VARDAMIR consult your doctor.

• In some patients, sensitization to topically administered aminoglycoside antibiotics may occur. If hypersensitivity develops during the use of the medicine, treatment should be discontinued.
• 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 systemic aminoglycoside therapy, 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 administered in conjunction with systemic aminoglycoside therapy.
• Prolonged use of corticosteroids may cause ocular hypertension and/or glaucoma with damage to the optic nerve, reduction of visual acuity and visual field defects, and formation of posterior subcapsular cataract. In patients undergoing prolonged ophthalmic therapy with corticosteroids, intraocular pressure should be monitored regularly and frequently. This is particularly important in pediatric patients treated with products containing dexamethasone, as the risk of steroid-induced ocular hypertension may be greater in children under six years of age and may manifest earlier than when it manifests in adults. The frequency and duration of treatment should be carefully evaluated, and intraocular pressure (IOP) should be monitored from the beginning of treatment, considering that the risk of steroid-induced IOP increase is greater and manifests earlier in pediatric patients.
• Prolonged use of corticosteroids can also reduce resistance to ocular infections and promote their development, and mask clinical signs of infection, preventing recognition of antibiotic ineffectiveness. In patients with persistent corneal ulcer, a fungal infection should be suspected. If a fungal infection occurs, corticosteroid therapy should be discontinued.
• As with other antibiotics, topical ocular use of tobramycin (especially with prolonged or repeated therapy) can induce growth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.
• In diseases that cause thinning of the cornea or sclera, perforation may occur with the use of topical corticosteroids.
• Topical ophthalmic corticosteroids may delay healing of corneal wounds.
• It is recommended not to wear contact lenses during the treatment of ocular inflammation or infection.
• Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses before applying VARDAMIR and wait at least 15 minutes after instillation of the dose before reinserting them.

To be used under the direct control of the doctor.
For ophthalmic use only.

INTERACTIONS
Inform your doctor or pharmacist if you are taking or have recently taken other medicines,
including those without a prescription.
Interaction studies have not been conducted.
If you are using more than one medicine for topical ocular use, allow at least 5 minutes between
instillation of each medicine.

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

SPECIAL WARNINGS
Pregnancy, breastfeeding and fertility
Ask your doctor 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 or dexamethasone in
pregnant women. Studies in animals have shown reproductive toxicity following topical administration
of corticosteroids.
VARDAMIR is not recommended during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone for topical ophthalmic use are excreted in breast milk. The
risk to infants cannot be excluded. A decision must be made whether to discontinue breastfeeding
or to discontinue therapy with VARDAMIR, considering the benefit of breastfeeding for the
child and the benefit of therapy for the woman.
Fertility
No data are available on the effect of this medicine on male or female fertility.

Driving and operating machinery
VARDAMIR does not alter or transiently alters the ability to drive vehicles or operate machinery.
However, transient blurring of vision or other visual disturbances may impair the
ability to drive or operate machinery. If blurring of vision occurs after
instillation, the patient should wait until vision returns to clear before driving or operating machinery.

Important information relating to an excipient contained in VARDAMIR 0,3% + 0,1% eye drops, solution
VARDAMIR 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 remove contact lenses before
applying VARDAMIR eye drops and wait at least 15 minutes after instillation of the dose before
reinserting them.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Instill 1 or 2 drops 4-5 times a day as prescribed by your doctor.
Paediatric population
VARDAMIR can be used in children from two years of age at the same doses as for adults.
Safety and efficacy have not been established in children under two years of age and no data are
available.

OVERDOSE
Considering the route of administration, topical ocular, it is unlikely that cases of
overdose will occur. However, if this should happen, wash the eye thoroughly with water
current.
Do not use the medicine again 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 VARDAMIR, 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 FURTHER QUESTIONS ON THE USE OF THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, VARDAMIR can cause side effects, although not everybody
experience them.
The following side effects have been reported with tobramycin eye drops:
Common side effects (affect 1 to 10 users out of 1,000)
Eye effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort,
eye irritation.
Rare side effects (affect 1 to 10 users out of 10,000)
Eye effects: allergy, blurred vision, dry eye, abnormal eye sensitivity, eye inflammation,
redness.
Side effects of unknown frequency (frequency cannot be estimated based on available data)
Eye effects: swelling of the eyelids, increased pupil size, increased
tear production.
General side effects: headache, nausea, abdominal discomfort, skin rash, skin inflammation,
redness or itching, facial swelling.

Reporting of side effects
If you get any side effects, talk to 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
1 ml of eye drops contains:

Active ingredients: tobramycin 3 mg, dexamethasone sodium phosphate 1.316 mg (equivalent to dexamethasone 1 mg).

Excipients: tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric
acid (pH adjuster), water for injections.

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

MARKETING AUTHORISATION HOLDER
OMIKRON ITALIA S.R.L.
VIALE BRUNO BUOZZI, 5

• 00197 - ROME (RM)

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

VARDAMIR 0.3% + 0.1% EYE DROPS, SOLUTION

Tobramycin and Dexamethasone
Medicinal equivalent
PHARMACOTHERAPEUTIC CATEGORY
Corticosteroids and antimicrobics in association.

INDICATIONS
VARDAMIR is indicated for the treatment of ocular inflammations when a corticosteroid is necessary
and when there is an ocular infection or the risk of ocular infections in adults and in children from two years of
age onwards.

CONTRAINDICATIONS
VARDAMIR is contraindicated in the following cases:
i) Do not use VARDAMIR if you are allergic (hypersensitive) to tobramycin, dexamethasone or any of the
other components of this medicine (listed in paragraph “Composition”).
j) Acute epithelial keratitis due to Herpes Simplex (dendritic keratitis)
k) Smallpox vaccination, varicella or other viral infections of the cornea and conjunctiva (except keratitis due to
Herpes Zoster)
l) Fungal infection of the eye
m) Ocular infections due to mycobacteria (tuberculosis of the eye)
n) Intraocular hypertension
o) Acute purulent ophthalmias, purulent conjunctivitis and purulent blepharitis and herpetic infections that may be
masked or aggravated by corticosteroids
p) Stye.

PRECAUTIONS FOR USE
Before using VARDAMIR consult your doctor.

• In some patients, sensitization to topically administered aminoglycoside antibiotics may occur. If hypersensitivity develops during use of the medicine, treatment should be discontinued.
• 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 systemic aminoglycoside therapy, 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 administered concurrently with systemic aminoglycoside therapy.
• Prolonged use of corticosteroids may cause ocular hypertension and/or glaucoma with damage to the optic nerve, reduction of visual acuity and visual field defects, and formation of posterior subcapsular cataract. In patients undergoing prolonged ophthalmic therapy with corticosteroids, intraocular pressure should be monitored regularly and frequently. This is particularly important in pediatric patients treated with products containing dexamethasone, as the risk of steroid-induced ocular hypertension may be greater in children under six years of age and may manifest earlier than when it manifests in adults. The frequency and duration of treatment should be carefully evaluated, and intraocular pressure (IOP) should be monitored from the start of treatment, considering that the risk of steroid-induced IOP increase is greater and manifests earlier in pediatric patients.
• Prolonged use of corticosteroids can also reduce resistance to ocular infections and promote their development, and mask the clinical signs of infection, preventing recognition of the ineffectiveness of the antibiotic. In patients with persistent corneal ulcer, a fungal infection should be suspected. If a fungal infection occurs, corticosteroid therapy should be discontinued.
• As with other antibiotics, topical ocular use of tobramycin (especially with prolonged or repeated therapy) may induce growth of non-susceptible organisms, including fungi. If a superinfection occurs, appropriate therapy should be instituted.
• In diseases that cause thinning of the cornea or sclera, perforation may occur with the use of topical corticosteroids.
• Topical ophthalmic corticosteroids may delay healing of corneal wounds.
• It is recommended not to wear contact lenses during the treatment of an eye inflammation or infection.

To be used under the direct control of the doctor.
For ophthalmic use only.

INTERACTIONS
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.
No interaction studies have been performed.
If you are using more than one medicine for topical ocular use, allow at least 5 minutes between
instillation of each medicine.

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

SPECIAL WARNINGS
Pregnancy, breastfeeding and fertility
Ask your doctor 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 or dexamethasone in
pregnant women. Animal studies have shown reproductive toxicity following topical administration
of corticosteroids.
VARDAMIR is not recommended during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone for topical ophthalmic use are excreted in breast milk. The
risk to infants cannot be excluded. A decision must be made whether to discontinue breastfeeding
or to discontinue therapy with VARDAMIR, taking into account the benefit of breastfeeding for the
child and the benefit of therapy for the woman.
Fertility
No data are available regarding the effect of this medicine on male or female fertility.

Driving and operating machinery
VARDAMIR does not alter or transiently alters the ability to drive vehicles or operate machinery.
However, transient blurring of vision or other visual disturbances may impair the
ability to drive or operate machinery. If blurring of vision occurs after
instillation, the patient should wait until vision returns to normal before driving or operating machinery.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Instill 1 or 2 drops 4-5 times a day as prescribed by your doctor.
Paediatric population
VARDAMIR can be used in children from two years of age at the same doses as for adults.
Safety and efficacy have not been established and no data are available
in children under two years of age.

OVERDOSE
Considering the route of administration, topical ocular, it is unlikely that cases of
overdose occur. However, if this should happen, wash the eye thoroughly with running water.
Do not use the medicine again until the time scheduled for the next administration.

WHAT TO DO IF YOU FORGET TO TAKE A DOSE
If you forget to use VARDAMIR, 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 FURTHER QUESTIONS ON THE USE OF THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, VARDAMIR can cause side effects, although not everybody
gets them.
The following side effects have been reported with tobramycin eye drops:
Common side effects (affect 1 to 10 users out of 1,000)
Eye effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort,
eye irritation.
Rare side effects (affect 1 to 10 users out of 10,000)
Eye effects: allergy, blurred vision, dry eye, abnormal eye sensitivity, eye inflammation,
redness.
General side effects: unpleasant taste.
Side effects of unknown frequency (frequency cannot be estimated from available data)
Eye effects: swelling of the eyelids, increased pupil size, increased
tear production.
General side effects: headache, nausea, abdominal discomfort, skin rash, skin inflammation,
redness or itching, facial swelling.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 does not contain preservatives: after administration the vial should be discarded even if only
partially used.
The product should not be used 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 ingredients: Tobramycin: 750 micrograms; Dexamethasone sodium phosphate: 329 micrograms (equivalent to
dexamethasone 250 micrograms)

Excipients: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster),
water for injections.

PHARMACEUTICAL FORM AND CONTENT
Eye drops, solution
20 single-dose containers of 0.25 ml

MARKETING AUTHORISATION HOLDER
OMIKRON ITALIA S.R.L.
VIALE BRUNO BUOZZI, 5

• 00197 - ROME (RM)

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