LUXAZONE 2 mg /G Maść Oftalmiczna
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Treść ulotki
Luxazone 2 mg/ml eye drops, suspension
Luxazone 2 mg/g ophthalmic ointment
Desamethasone
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What LUXAZONE is and what it is used for
- 2. What you need to know before you use LUXAZONE
- 3. How to use LUXAZONE
- 4. Possible side effects
- 5. How to store LUXAZONE
- 6. Contents of the pack and other information
1. What LUXAZONE is and what it is used for
LUXAZONE contains the active ingredient desamethasone, which belongs to a group of
medicines called corticosteroids that inhibit inflammatory symptoms.
LUXAZONE is used to treat conditions of allergic, inflammatory and congestive
nature of the anterior part of the eye and in particular in cases of inflammation of the posterior
area of the eye (choroid), of part or all of the tunic of the eye (acute and
subacute iridocyclitis, anterior uveitis), increased aqueous content within the cornea (corneal
edema) swelling of the clear layer of the eye, inflammation of the conjunctiva of allergic
origin (allergic conjunctivitis).
See your doctor if you do not feel better or if you feel worse.
2. What you need to know before using LUXAZONE
Do not use LUXAZONE
- if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from high pressure inside the eye (Ocular hypertension);
- if you have had a viral infection of the eye (acute herpes simplex infections) and most viral diseases of the front of the eye (cornea) except if you are being treated with specific drugs (chemotherapeutic agents), inflammation with superficial damage to the cornea even in the early stages (conjunctivitis with ulcerative keratitis) (positive fluorescein test);
- if you suffer from tuberculosis of the eye;
- if you have a fungal infection in the eye (eye mycosis);
- if you have an eye inflammation with pus production (acute purulent ophthalmias, purulent and herpetic conjunctivitis), which may be masked or aggravated by corticosteroids
- if you have a stye).
Warnings and precautions
Consult your doctor or pharmacist before using LUXAZONE.
Prolonged use of eye products containing corticosteroids can lead to adverse events (see section “UNDESIRABLE EFFECTS”): continuous application for more than 1 month is not recommended.
Consult your doctor if you feel swelling and weight gain around the trunk and face as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Luxazone. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.
Before using LUXAZONE, talk to your doctor if:
- you suffer from a disease called glaucoma, as prolonged use of Luxazone can increase pressure in the eye. Your doctor will subject you to frequent checks of your eye pressure;
- you have any untreated eye infection with other medicines, as Luxazone may mask or worsen it;
- you have any eye infection (including herpes simplex), as Luxazone may prolong the course and may worsen the severity of the infection;
- you have viral herpetic keratitis (inflammation of the cornea), in this case the doctor will prescribe Luxazone only if strictly necessary and under regular control;
- you are to undergo or have undergone any eye surgery (such as cataract surgery) as Luxazone may delay healing and increase the formation of blisters.
- you suffer from diseases that cause thinning of the ocular surface, the use of corticosteroids could cause perforation of the cornea or the “white of the eye” (sclera);
If you use LUXAZONE for a long time:
- your doctor will subject you to frequent checks
- the pressure in your eye may increase and damage the optic nerve causing vision problems.
- you may develop cataracts;
- your body, as a result of a lowering of the immune defenses, may not effectively counteract other types of infection in your eye, in particular infections from viruses or fungi;
To prevent eye injury or contamination, you should avoid touching the bottle or tube cap to your eye or any other surface. Using the bottle or tube by more than one person can spread infection.
Other medicines and LUXAZONE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe the product only if necessary and under his direct control.
Breastfeeding
If you are breastfeeding, the use of Luxazone is not recommended.
Driving and operating machinery
Luxazone does not alter or negligibly alters the ability to drive vehicles or operate machinery.
As with any eye medicine, if you experience transient blurred vision during use, wait for your vision to return to clarity before driving or operating machinery.
Luxazone eye drops, suspension contains:
- anhydrous sodium sulfite:rarely can cause severe hypersensitivity reactions and bronchospasm.
- benzalkonium chloride: this medicine contains 2.5 µg of benzalkonium chloride per drop, equivalent to 0.05 mg/ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.
- phosphate buffer:this medicine contains 0.15 mg of phosphate buffer per drop, equivalent to 3 mg/ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in very rare cases cause opaque spots on the cornea due to calcium accumulation during treatment.
3. How to use LUXAZONE
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Luxazone eye drops, suspension:
The recommended doseis 3-4 drops every 2-3 hours, as prescribed by your doctor, to be applied to the eye. Shake the bottle before use.
Luxazone ophthalmic ointment:
The recommended dose isone application into the conjunctival sac every 2-3 hours, as prescribed by your doctor.
Apply directly into the conjunctival sac.
Do not interrupt the therapy before the prescribed time.
Prolonged use may cause inconveniences: therefore, it is not recommended to apply the product continuously for more than one month.
If the bottle or tube is used by more than one person, this may spread infection.
Keep the bottle or tube tightly closed when not in use
Use in children and adolescents
There are no adequate and well-controlled studies in pediatric patients.
If you use more LUXAZONE than you should
In case of overdose, temporarily and gradually discontinue the use of LUXAZONE to avoid irritation, lesions or a sudden increase in intraocular pressure (acute glaucoma). Contact your doctor or pharmacist immediately.
If you accidentally ingest the product, immediately inform your doctor or go to the nearest hospital,and drink liquids to dilute it.
If you forget to use LUXAZONE
Do not use a double dose to make up for a missed dose.
If you stop using LUXAZONE
Do not stop using LUXAZONE before the prescribed time. Always ask your doctor if you decide to discontinue treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of Luxazone:
Eye related
- Eye irritation
- Eye burning
Systemic effects
- Allergic reactions (hypersensitivity)
The following side effects have been reported with medicines belonging to the same group of
medicines as Luxazone:
Eye related
- lens opacity that alters vision (subcapsular cataract)
- eye infection (including bacterial, fungal and viral infections)
- eye irritation
- eye perforation (scleral or corneal perforation)
- increased pressure in the eye
- eye disease due to increased pressure inside the eye (glaucoma)
- eye burning sensation
- blurred vision (frequency not known)
- eyelid drooping
Hormonal problems:
increased hair growth on the body (especially in women), weakness and muscle atrophy,
stretch marks on the skin of the body, increased blood pressure, irregular or absent menstrual
cycle, changes in protein and calcium levels in the body, delayed growth
in children and adolescents, and swelling and weight gain of the body and face (called
“Cushing’s syndrome”) (see section 2, “Warnings and precautions”).
Other side effects reported with eye drops containing phosphates
Very rarely, cases of corneal calcification associated with the use of
eye drops containing phosphates in patients with significantly damaged corneas have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
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 Luxazone
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
‘Exp.’. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Dispose of the container 28 days after first opening, even if there is still some product remaining.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Luxazone eye drops, suspension contains
- the active ingredient is: dexamethasone 2 mg/ml
- the other ingredients are: sodium chloride, monosodium phosphate, anhydrous sodium sulfite, benzalkonium chloride, hydroxypropyl methylcellulose, polysorbate 80, purified water.
What Luxazone ophthalmic ointment contains
- the active ingredient is: dexamethasone 2mg/g
- the other ingredients are: liquid paraffin, anhydrous lanolin, chlorobutanol, white soft paraffin.
Description of the appearance of Luxazone and package contents
Luxazone eye drops, suspension is contained in a 3 ml plastic bottle.
Luxazone ophthalmic ointment is contained in a 3 g aluminium tube.
Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
Pomezia (Roma)
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- Kraj rejestracji
- Postać farmaceutycznaOphthalmic ointment, 2 MG/G
- Kod ATCS01BA01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LUXATSONEPostać farmaceutyczna: Eye drops, solution, 1,5 MG/MLSubstancja czynna: dexamethasoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 1MG/MLSubstancja czynna: dexamethasoneProducent: LABORATOIRES THEAWymaga receptyPostać farmaceutyczna: Eye drops, solution in single-dose container, 1 MG/MLSubstancja czynna: dexamethasoneProducent: I.B.N. SAVIO S.R.LWymaga recepty
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LUXATSONE wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LUXATSONE jest dexamethasone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LUXATSONE jest produkowany przez ABBVIE S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie LUXATSONE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić LUXATSONE w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (dexamethasone) to m.in. DESADOK, DEXAMONO, DEXAVISONE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
