AMIRIOX 0.3 MG/ML Krople do oczu, roztwór
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Treść ulotki
Amiriox 0,3 mg/mL eye drops, solution
Bimatoprost
Generic medicine
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 could 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 Amiriox is and what it is used for
- 2. What you need to know before you use Amiriox
- 3. How to use Amiriox
- 4. Possible side effects
- 5. How to store Amiriox
- 6. Contents of the pack and other information
1. What is Amiriox and what is it used for
Amiriox contains the active substance bimatoprost which is a glaucoma medication. It belongs to a
category of drugs called prostamides.
Amiriox is used to reduce increased intraocular pressure in adults. This medicine can be
used alone or together with other eye drops called beta-blockers, which also serve to
reduce pressure in the eye.
This drug works by increasing the amount of fluid that is eliminated from the eye in order to
prevent its accumulation. In this way, it reduces the pressure inside the eye. Elevated intraocular
pressure, if not reduced, can cause a disease called glaucoma and can eventually cause
damage to vision.
This medicine does not contain any preservatives.
2. What you need to know before using Amiriox
Do not use this medicine
- if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Amiriox.
Consult your doctor or pharmacist if:
- you suffer from respiratory problems
- you have liver or kidney problems
- you have had cataract surgery in the past
- you suffer or have suffered from low blood pressure or slowed heartbeat
- you have had a viral infection or inflammation of the eyes Amiriox can cause darkening and lengthening of the eyelashes, and it can also darken the skin around the eyelids. Over time, the color of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated. If you have had a history of contact hypersensitivity to silver, do not use this medicine.
Children and adolescents
Amiriox has not been tested on patients under 18 years of age, therefore it should not be used on
patients under 18 years of age.
Other medicines and Amiriox
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
If you are using another medicine for the eyes, wait at least 5 minutes between applying Amiriox and
applying the other medicine. Eye ointments should be used last.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Amiriox can pass into breast milk, therefore it is advisable not to breastfeed during treatment with
this medicine.
Driving and operating machinery
After administering Amiriox, you may experience transient blurred vision. In this
case, do not drive or use machinery until your vision has returned to normal.
Amiriox contains phosphates
This medicine contains 0.9 mg of phosphates in each millilitre. 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 Amiriox
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Amiriox must be applied only to the eyes. The recommended dose is one drop of Amiriox once
a day, in the evening, in each eye to be treated.
Amiriox has not been studied in patients who wear contact lenses. Before instillation, it is necessary
to remove contact lenses, which can be reapplied 15 minutes after administration.
If you use Amiriox with another ophthalmic medicine, wait at least 5 minutes after using Amiriox before
applying the second ophthalmic medicine.
Do not use it more than once a day, as the effectiveness of the treatment may be reduced.
Amiriox is a sterile solution that does not contain any preservative. See paragraph 6. Description
of the appearance of Amiriox and contents of the pack.
Before administering the eye drops:
- If you are using the medicine for the first time, before instilling a drop into your eye, practice using the dropper bottle by gently squeezing it to release a drop, away from your eye.
- When you are sure you can deliver one drop at a time, choose the position you find most comfortable for administering the eye drops (sitting, lying down or standing in front of a mirror).
Instructions for use:
- 1. Wash your hands thoroughly before using this medicine.
- 2. If the packaging or the bottle shows signs of damage, do not use the medicine.
- 3. When using the medicine for the first time, unscrew the cap after making sure that the tamper-evident seal on the cap is not broken. You should feel slight resistance until this anti-tamper ring is broken ( seefigure 1).
- 4. If the tamper-evident ring is loose, remove it as it may fall into the eye and cause injury.
- 5. Tilt your head back and gently lower your lower eyelid to form a small pocket between your eye and your eyelid ( seefigure 2).Avoid contact between the tip of the bottle and your eye, eyelids or fingers.
- 6. Instill one drop of eye drops into the pocket between your eye and your eyelid (conjunctival sac) by gently squeezing the bottle ( see figure 3). Gently press the bottle in the middle to release one drop into the eye. There may be a delay of a few seconds between pressing the bottle and the drop coming out. Do not press too hard. If you have any doubts about how to administer the medicine, consult your doctor, pharmacist or nurse.
- 7. Keeping your eye closed, press a finger against the corner of your eye (the point where your eye meets your nose) and hold it for 2 minutes. This ensures that the drop is absorbed by your eye and helps to prevent the medicine from penetrating into the rest of your body.
- 8. Repeat operations 5, 6 and 7 in the other eye if your doctor has prescribed it.
- 9. After use and before closing, shake the bottle once downwards, without touching the tip of the dropper, to remove any residual liquid on the tip. This ensures the dispensing of subsequent drops. After instillation, screw the cap back onto the bottle ( seefigure 4).
If a drop fails to enter the eye, try again.
To avoid infection and injury to the eye, the tip of the bottle must not touch the eye or come into
contact with other surfaces. After using the bottle, replace the cap and close the bottle.
Figure 1.Figure 2.Figure 3.Figure 4.
If you use more Amiriox than you should
If you use this medicine more than you should, it is unlikely to cause serious consequences.
Administer the next dose at the usual time. If this causes you concern, consult your doctor or
pharmacist.
If you forget to use Amiriox
If you forget to use this medicine, as soon as you remember, put one drop and then return
to your normal times of administration. Do not take a double dose to make up for the missed dose.
If you stop using Amiriox
For it to work correctly, Amiriox must be used every day. If you stop using Amiriox, the
eye pressure may increase, so you should talk to your doctor before stopping this
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.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
Very common: may affect more than 1 in 10 people
Related to the eye
Mild redness (up to 24% of people)
Common: may affect up to 1 in 10 people
Related to the eye
- Small ulcers on the surface of the eye, with or without inflammation
- Irritation
- Eye itching
- Pain
- Dryness
- Foreign body sensation in the eye
- Longer eyelashes
- Darkening of the skin around the eye
- Reddened eyelids
Uncommon: may affect up to 1 in 100 people
Related to the eye
- Tired eyes
- Sensitivity to light
- Darkening of the iris color
- Itchy and swollen eyelids
- Tearing
- Swelling of the transparent layer covering the surface of the eye
- Blurred vision
Related to the body
- Headache
- Growth of hair around the eye
Frequency not known: the frequency cannot be estimated from the available data
Related to the eye
- Sticky eyes
- Eye discomfort
Related to the body
- Asthma
- Worsening of asthma
- Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
- Shortness of breath
- Symptoms of an allergic reaction (swelling, redness of the eye and skin rash)
- Dizziness
- Increased blood pressure values
- Change in skin color (around the eye)
In addition to the side effects of bimatoprost 0.3 mg/mL single-dose preservative-free, the following side effects have been
observed with the multi-dose formulation of bimatoprost 0.3 mg/mL
containing the preservative and may occur in patients taking bimatoprost 0.3 mg/mL
multi-dose preservative-free:
- Burning sensation inside the eye
- Allergic reaction in the eye
- Inflamed eyelids
- Difficulty seeing clear images
- Worsening of vision
- Darkening of eyelashes
- Retinal bleeding
- Inflammation inside the eye
- Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
- Inflammation of the iris
- Eyelid spasms
- Narrowing of the eyelid, which moves away from the surface of the eye
- Sunken eyes
- Nausea
- Redness of the skin around the eyes
- Weakness
- Increased blood test values related to liver function
Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front of
the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during
treatment.
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 Amiriox
This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
box. The expiry date refers to the last day of that month.
After the first opening of the bottle: store for 90 days at a temperature below 25°C.
Dispose of the bottle 90 days after the first opening.
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. Contents of the pack and other information
What Amiriox contains
- The active ingredient is bimatoprost. One mL of solution contains 0.3 mg of bimatoprost.
- The other ingredients are disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid, diluted (for pH adjustment), purified water.
Description of the appearance of Amiriox and contents of the pack
Amiriox is a clear, colorless solution.
This medicine is available in white LDPE bottles of 5 mL, each containing 3 mL of
solution, with a multi-dose HDPE dropper and a tamper-evident HDPE screw cap.
The dropper has a silicone valve system that prevents contaminated liquid from flowing back into the
bottle and allows filtered air to enter.
Pack size:
Carton packs of 1 or 3 bottles, each containing 3 mL of solution.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
SIFI S.p.A.
Via Ercole Patti 36
95025 Aci Sant'Antonio (CT)
Italy
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A. (Warsaw Pharmaceutical Works Polfa S.A.)
22/24 Ul. Karolkowa
01-207 Warsaw
Poland
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.3 MG/ML
- Kod ATCS01EE03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki AMIRIOXPostać farmaceutyczna: Eye drops, solution, 0.1 MG/MLSubstancja czynna: bimatoprostProducent: GENETIC S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.1 MG/MLSubstancja czynna: bimatoprostProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.1 MG/MLSubstancja czynna: bimatoprostProducent: FB VISION SPAWymaga recepty
Odpowiedniki AMIRIOX w innych krajach
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AMIRIOX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w AMIRIOX jest bimatoprost. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
AMIRIOX jest produkowany przez SIFI S.P.A.. 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 AMIRIOX 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 AMIRIOX 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 (bimatoprost) to m.in. BIALVITS, BIMADOK, BIMANEXT. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
