Vardamir

Italy
Brand name Vardamir
Form solution, eye
Active substance / Dosage
DESAMETHASONE
TOBRAMYCIN
Prescription type Prescription only
ATC code
S01CA01
Registration number 042537
Manufacturer OMIKRON ITALIA S.R.L.

VARDAMIR 0.3% + 0.1% EYE DROPS, SOLUTION
Tobramycin and Dexamethasone
Equivalent medicinal product
PHARMACOTHERAPEUTIC CATEGORY
Corticosteroids and antimicrobials in combination.
INDICATIONS
VARDAMIR is indicated for the treatment of ocular inflammations when a corticosteroid is required and when there is an existing ocular infection or risk of ocular infections in adults and 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 to any of the other components of this medicine (listed in section “Composition”).
b) Acute epithelial keratitis due to Herpes Simplex (dendritic keratitis)
c) Vaccinia, varicella or other viral infections of the cornea and conjunctiva (except keratitis due to Herpes Zoster)
d) Fungal infections of the eye
e) Ocular infections caused by mycobacteria (ocular tuberculosis)
f) Endocular hypertension
g) Acute purulent ophthalmia, 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.

  • Hypersensitivity to topically administered aminoglycoside antibiotics may occur in some patients. If hypersensitivity develops during treatment, therapy should be discontinued.
  • Cross-sensitivity to other aminoglycosides may occur; therefore, consider the possibility that patients sensitized to topical tobramycin may also be sensitive to other aminoglycosides administered topically and/or systemically.
  • In patients receiving systemic aminoglycoside therapy, serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred. Although such effects have not been reported following topical ophthalmic use of tobramycin, caution is advised when administered concomitantly with systemic aminoglycoside therapy.
  • Prolonged use of corticosteroids may lead to ocular hypertension and/or glaucoma with optic nerve damage, reduced visual acuity and visual field defects, and formation of posterior subcapsular cataract. In patients undergoing long-term ophthalmic corticosteroid therapy, 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 higher in children under six years of age and may manifest earlier than in adults. The frequency and duration of treatment must 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 appears earlier in pediatric patients.
  • Prolonged use of corticosteroids may also reduce resistance to ocular infections and promote their development, and may mask clinical signs of infection, thereby preventing recognition of antibiotic inefficacy. In patients with persistent corneal ulceration, fungal infection should be suspected. If a fungal infection occurs, corticosteroid therapy must be discontinued.
  • As with other antibiotics, prolonged or repeated topical ocular use of tobramycin may lead to overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
  • In diseases causing 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 treatment of ocular inflammation or infection.
  • Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses before applying VARDAMIR and to wait at least 15 minutes after instillation before reinserting them.

To be used under direct medical supervision.
For topical ophthalmic use only.
INTERACTIONS
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.
No interaction studies have been performed.
If more than one topical ophthalmic medicine is being used, at least 5 minutes should elapse between instillation of each medicine.
Incompatibility
The component tyloxapol, contained in the eye drops, is incompatible with tetracycline.
SPECIAL WARNINGS
Pregnancy, breastfeeding and fertility
Consult your doctor before taking any medicine.
If you are pregnant or may become pregnant, or if you are breastfeeding, consult your doctor before using this medicine.
Pregnancy
There are no adequate data on 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 administered topically to the eye are excreted in breast milk. Risk to the infant cannot be excluded. A decision should be made whether to discontinue breastfeeding or discontinue therapy with VARDAMIR, taking into account the benefit of breastfeeding for the infant 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 use of machinery
VARDAMIR does not affect or only transiently affects the ability to drive vehicles or operate machinery.
However, transient blurred vision or other visual disturbances may impair the ability to drive or use machinery. If blurred vision occurs after instillation, the patient should wait until vision clears before driving or operating machinery.
Important information about an excipient contained in VARDAMIR 0.3% + 0.1% eye drops, solution
VARDAMIR contains benzalkonium chloride, which may cause eye irritation and is known to decolorize 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 before reinserting them.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
Instill 1 or 2 drops 4–5 times daily as prescribed by the physician.
Pediatric population
VARDAMIR can be used in children from two years of age onwards at the same doses as in adults.
Safety and efficacy in children under two years of age have not been established and no data are available.
OVERDOSE
Given the route of administration (topical ocular), overdose is unlikely. However, if it occurs, thoroughly rinse the eye with running water.
Do not use the medicine again until the next scheduled dose.
WHAT TO DO IF YOU FORGET TO TAKE ONE OR MORE DOSES
If you forget to use VARDAMIR, continue treatment with the next dose as scheduled.
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 missed dose.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF THIS MEDICINE, CONSULT YOUR DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, VARDAMIR may cause undesirable effects, although not everyone experiences them.
The following undesirable effects have been reported with the use of tobramycin eye drops:
Uncommon undesirable effects (affect 1 to 10 users out of 1,000)
Eye disorders: increased pressure in the eye(s), eye pain, eye pruritus, eye discomfort, eye irritation.
Rare side effects (affect 1 to 10 users out of 10,000)
Eye disorders: allergy, blurred vision, dry eye, abnormal eye sensitivity, ocular inflammation, redness.
General undesirable effects: unpleasant taste.
Side effects of unknown frequency (frequency cannot be estimated from available data)
Eye disorders: eyelid swelling, increased pupil size, increased tear production.
General undesirable effects: headache, nausea, abdominal discomfort, skin rash, skin inflammation, redness or itching, facial swelling.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Undesirable effects can also be reported directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY AND STORAGE
Do not use after the expiry date stated on the outer packaging and on the bottle.
The expiry date refers to the last day of the month.
No special storage precautions required.
The expiry date applies to the product when unopened and properly stored.
The product must not be used more than 28 days after first opening of the container.
Keep the medicine out of the sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
COMPOSITION
1 ml of eye drops contains:
Active substances: tobramycin 3 mg, dexamethasone sodium phosphate 1.316 mg (equivalent to dexamethasone 1 mg).
Excipients: tyloxapol, benzalkonium chloride, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), 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 - ROMA (RM)
MANUFACTURER
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
VARDAMIR 0.3% + 0.1% EYE DROPS, SOLUTION
Tobramycin and Dexamethasone
Equivalent medicinal product
PHARMACOTHERAPEUTIC CATEGORY
Corticosteroids and antimicrobials in combination.
INDICATIONS
VARDAMIR is indicated for the treatment of ocular inflammations when a corticosteroid is required and when there is an existing ocular infection or risk of ocular infections in adults and 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 to any of the other components of this medicine (listed in section “Composition”).
j) Acute epithelial keratitis due to Herpes Simplex (dendritic keratitis)
k) Vaccinia, varicella or other viral infections of the cornea and conjunctiva (except keratitis due to Herpes Zoster)
l) Fungal infections of the eye
m) Ocular infections caused by mycobacteria (ocular tuberculosis)
n) Endocular hypertension
o) Acute purulent ophthalmia, purulent conjunctivitis and purulent and herpetic blepharitis which may be masked or aggravated by corticosteroids
p) Hordeolum (stye).
PRECAUTIONS FOR USE
Before using VARDAMIR, consult your doctor.

  • Hypersensitivity to topically administered aminoglycoside antibiotics may occur in some patients. If hypersensitivity develops during treatment, therapy should be suspended.
  • Cross-sensitivity to other aminoglycosides may occur; therefore, consider the possibility that patients sensitized to topical tobramycin may also be sensitive to other aminoglycosides administered topically and/or systemically.
  • In patients receiving systemic aminoglycoside therapy, serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred. Although such effects have not been reported following topical ophthalmic use of tobramycin, caution is advised when administered concomitantly with systemic aminoglycoside therapy.
  • Prolonged use of corticosteroids may lead to ocular hypertension and/or glaucoma with optic nerve damage, reduced visual acuity and visual field defects, and formation of posterior subcapsular cataract. In patients undergoing long-term ophthalmic corticosteroid therapy, 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 higher in children under six years of age and may manifest earlier than in adults. The frequency and duration of treatment must 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 appears earlier in pediatric patients.
  • Prolonged use of corticosteroids may also reduce resistance to ocular infections and promote their development, and may mask clinical signs of infection, thereby preventing recognition of antibiotic inefficacy. In patients with persistent corneal ulceration, fungal infection should be suspected. If a fungal infection occurs, corticosteroid therapy must be discontinued.
  • As with other antibiotics, prolonged or repeated topical ocular use of tobramycin may induce abnormal overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
  • In diseases causing 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 treatment of ocular inflammation or infection.

To be used under direct medical supervision.
For topical ophthalmic use only.
INTERACTIONS
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.
No interaction studies have been performed.
If more than one topical ophthalmic medicine is being used, at least 5 minutes should elapse between instillation of each medicine.
Incompatibility
The component tyloxapol, contained in the eye drops, is incompatible with tetracycline.
SPECIAL WARNINGS
Pregnancy, breastfeeding and fertility
Consult your doctor before taking any medicine.
If you are pregnant or may become pregnant, or if you are breastfeeding, consult your doctor before using this medicine.
Pregnancy
There are no adequate data on 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 administered topically to the eye are excreted in breast milk. Risk to the infant cannot be excluded. A decision should be made whether to discontinue breastfeeding or discontinue therapy with VARDAMIR, taking into account the benefit of breastfeeding for the infant 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 use of machinery
VARDAMIR does not affect or only transiently affects the ability to drive vehicles or operate machinery.
However, transient blurred vision or other visual disturbances may impair the ability to drive or use machinery. If blurred vision occurs after instillation, the patient should wait until vision clears before driving or operating machinery.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
Instill 1 or 2 drops 4–5 times daily as prescribed by the physician.
Pediatric population
VARDAMIR can be used in children from two years of age onwards at the same doses as in adults.
Safety and efficacy in children under two years of age have not been established and no data are available.
OVERDOSE
Given the route of administration (topical ocular), overdose is unlikely. However, if it occurs, thoroughly rinse the eye with running water.
Do not use the medicine again until the next scheduled dose.
WHAT TO DO IF YOU FORGET TO TAKE ONE OR MORE DOSES
If you forget to use VARDAMIR, continue treatment with the next dose as scheduled.
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 missed dose.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF THIS MEDICINE, CONSULT YOUR DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, VARDAMIR may cause undesirable effects, although not everyone experiences them.
The following undesirable effects have been reported with the use of tobramycin eye drops:
Uncommon undesirable effects (affect 1 to 10 users out of 1,000)
Eye disorders: increased pressure in the eye(s), eye pain, eye pruritus, eye discomfort, eye irritation.
Rare side effects (affect 1 to 10 users out of 10,000)
Eye disorders: allergy, blurred vision, dry eye, abnormal eye sensitivity, ocular inflammation, redness.
General undesirable effects: unpleasant taste.
Side effects of unknown frequency (frequency cannot be estimated from available data)
Eye disorders: eyelid swelling, increased pupil size, increased tear production.
General undesirable effects: headache, nausea, abdominal discomfort, skin rash, skin inflammation, redness or itching, facial swelling.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Undesirable effects can also be reported directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY AND STORAGE
Do not use after the expiry date stated on the outer packaging and on the bottle.
The expiry date refers to the last day of the month.
No special storage precautions required.
The expiry date applies to the product when unopened and properly stored.
The product does not contain preservatives: after administration, the single-dose container must be discarded even if partially used.
The product must not be used more than 28 days after opening the sachet containing the single-dose containers.
Keep the medicine out of the sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
COMPOSITION
One single-dose container contains:
Active substances: Tobramycin: 750 micrograms; Dexamethasone sodium phosphate: 329 micrograms (equivalent to dexamethasone 250 micrograms)
Excipients: tyloxapol, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.
PHARMACEUTICAL FORM AND CONTENT
Eye drops, solution
20 single-dose containers of 0.25 ml each
MARKETING AUTHORISATION HOLDER
OMIKRON ITALIA S.R.L.
VIALE BRUNO BUOZZI, 5
00197 - ROMA (RM)
MANUFACTURER
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)