BRIMOFREE 2 mg /Ml Krople Do Oczu, Roztwór W Jednorazowym Pojemniku
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Treść ulotki
Brimofree 2 mg/ml eye drops, solution in single-dose container
Brimonidine tartrate
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 their symptoms are the same as yours, 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 Brimofree is and what it is used for
- 2. What you need to know before you use Brimofree
- 3. How to use Brimofree
- 4. Possible side effects
- 5. How to store Brimofree
- 6. Contents of the pack and other information
1. What is Brimofree and what is it used for
Brimofree is used to reduce the pressure inside the eye.
It can be used alone, when beta-blocker eye drops are contraindicated, or with another eye drop,
when a single medication is not sufficient to reduce the increase in eye pressure in the
treatment of open-angle glaucoma or ocular hypertension.
The active substance present in Brimofree is brimonidine tartrate, which works by reducing the pressure
inside the eyeball.
2. What you need to know before using Brimofree
Do not use Brimofree:
- If you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
- If you are taking monoamine oxidase inhibitors (MAOIs) or certain antidepressants. Tell your doctor if you are taking any antidepressant medicine.
- If you are breastfeeding.
- In newborns/children (from birth to two years of age).
Warnings and precautions
Talk to your doctor before using Brimofree
- If you suffer from or have suffered from depression, reduced mental capacity, reduced blood flow to the brain, heart problems, reduced blood flow to the limbs or blood pressure disorders.
- If you have or have had kidney or liver problems in the past.
- If you are giving it to a child between 2 and 12 years of age as the use of Brimofree is not recommended in this age group.
Children and adolescents
Clinical studies have not been conducted in adolescents (aged 12 to 17 years).
Brimofree is not recommended for use in children under 12 years of age and should not be
used in newborns and infants (under two years of age).
Other medicines andBrimofree
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
Tell your doctor if you are taking any of the following medicines:
- painkillers, sedatives, opioids, barbiturates or are a regular consumer of alcohol.
- anaesthetics.
- to treat a heart condition or to lower blood pressure.
- that can affect metabolism such as chlorpromazine, methylphenidate and reserpine.
- that act on the same receptor as Brimofree, for example isoprenaline and prazosin.
- monoamine oxidase inhibitors (MAOIs) and other antidepressants.
- medicines for any other condition, even if it is not related to your eye condition.
- or if the dose of any of your current medicines has changed. These can affect treatment with Brimofree.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Brimofree should not be used if you are breastfeeding.
Driving and using machines
- Brimofree may cause blurred or abnormal vision. This effect may appear worse at night or in conditions of reduced lighting.
- Brimofree may also cause drowsiness or fatigue in some patients.
- If you experience any of these symptoms, do not drive vehicles or use machines until the symptoms have disappeared.
3. How to use Brimofree
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Use in adults
The recommended dose is one drop twice a day in the affected eye(s), approximately 12
hours apart.
Use in children under 12 years
Brimofree should not be used in infants under 2 years of age.
Brimofree is not recommended for use in children (from 2 up to 12 years of age)
Instructions for use
- 1. Wash your hands.
- 2. Open the aluminum sachet and remove the block of single-dose containers.
- 3. Remove one of the single-dose containers from the strip (Fig. 1).
- 4. Replace the remaining single-dose containers and close the bag by folding over the end. Place the bag in the box.
- 5. Open the single-dose container by unscrewing the cap. Do not touch the cap after opening the container (Fig. 2).
- 6. Tilt your head back (Fig. 3).
- 7. Lower the lower eyelid with your finger and hold the single-dose container in the other hand.
Squeeze the container to release one drop into the eye (Fig. 4).
- 8. Close your eyes and press a finger on the inner corner of the eye for about one minute. This will prevent the drop from flowing through the tear duct into the throat and most of the drop will remain in the eyes (Fig. 5). If necessary, repeat from step 6 to 8 with the other eye.
- 9. Dispose of the single-dose container after use.
Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5
If you are using Brimofree with another eye drop, wait 5 to 15 minutes before applying the second eye drop.
If you use more Brimofree than you should
Adults
In adults who have instilled more drops than prescribed, the reported adverse effects are
those already known with the use of brimonidine.
Adults who have accidentally ingested brimonidine drops have experienced a
decrease in blood pressure, which in some patients was followed by an increase in
blood pressure.
Children
Serious adverse effects have been reported in children who have accidentally ingested brimonidine drops. The symptoms included drowsiness, floppiness, low body temperature, paleness and
difficulty breathing. If this occurs, contact your doctor immediately.
Adults and children
If Brimofree has been accidentally ingested or if you have used more Brimofree than you should, contact
your doctor immediately.
If you forget to use Brimofree
If you forget to administer a dose, take it as soon as you remember. If it is already time
for your next dose, leave out the forgotten dose altogether and follow your normal dosing times.
Do not use a double dose to make up for a missed dose.
If you stop using Brimofree
For it to work properly, Brimofree must be taken every day. Do not stop using
Brimofree unless your doctor tells you to do so.
If you have any doubts about using 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 be observed with brimonidine eye drops with preservative in
multi-dose container and may also occur when using brimonidine eye drops without
preservative in single-dose containers:
Related to the eyes
Very common (may affect more than 1 in 10 people):
- Eye irritation (red eye, burning, stinging pain, feeling of a foreign body in the eye, itching, follicles or white spots on the clear layer covering the surface of the eye)
- Blurred vision
- An allergic reaction in the eye
Common (may affect up to 1 in 10 people):
- Local irritation (inflammation and swelling of the eyelid, swelling of the clear layer covering the surface of the eye, sticky eyes, pain and tearing)
- Sensitivity to light
- Erosion and spots on the surface of the eye
- Dry eye
- Whitening of the clear layer covering the surface of the eye
- Altered vision
- Inflammation of the clear layer covering the surface of the eye
Very rare (may affect more than 1 in 10,000 people):
- Inflammation inside the eye
- Reduction in pupil size
Side effects whose frequency is not known (frequency cannot be estimated from available data):
- itching of the eyelids
- inflammation of the iris, that is the colored part of the eye, and the ciliary body, that is the muscles and tissue involved in focusing the eye (iridocyclitis). This condition is also called “anterior uveitis”. Related to the body
Very common (may affect more than 1 in 10 people):
- Headache
- Dry mouth
- Fatigue/drowsiness
Common (may affect up to 1 in 10 people):
- Dizziness
- Flu-like symptoms
- Symptoms involving the stomach and digestion
- Taste alteration
- General weakness
Uncommon (may affect up to 1 in 100 people):
- Depression
- Palpitations or changes in heart rate
- Dry nose
- General allergic reactions
Rare (may affect up to 1 in 1,000):
- Shortness of breath Very rare (may affect up to 1 in 10,000):
- Insomnia
- Fainting
- High blood pressure
- Low blood pressure
Side effects whose frequency is not known (frequency cannot be estimated from available data):
- Skin reactions including redness, facial swelling, itching, rash and widening of blood vessels
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Brimofree
Keep this medicine out of the sight and reach of children.
Store the single-dose container in the aluminum pouch to protect the medicine from light.
Do not use for more than 3 months after opening the aluminum pouch.
Brimofree does not contain a preservative. Once opened, the contents of the single-dose container must
be used immediately. Discard any remaining solution in the single-dose container after
application.
Do not use this medicine after the expiry date which is stated on the pack, on the pouch and on the
single-dose container after Exp. The expiry date refers to the last day of that month.
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 Brimofree contains
- The active ingredient is brimonidine tartrate. One ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. One drop contains 0.06-0.07 mg of brimonidine tartrate.
- The other ingredients are polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections and hydrochloric acid or sodium hydroxide (to adjust the pH).
Description of the appearance of Brimofree and contents of the pack
Brimofree is a clear, slightly yellowish-green solution. Each single-dose container contains
0.35 ml of solution. Two strips of 5 single-dose containers each are packaged in a
laminated aluminum foil sachet.
Brimofree is available in packs containing 30, 60, or 120 single-dose containers with 0.35 ml of
solution each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Manufacturer:
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Austria Brimonidin sine OmniVision
France Brimonidine OmniVision
Spain BRIMVERA
United Kingdom Brimonidine OmniVision
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution in single-dose container, 2 MG/ML
- Kod ATCS01EA05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BRIMOFREEPostać farmaceutyczna: Eye drops, solution, 2,5 MLSubstancja czynna: brimonidineProducent: ABBVIE S.R.L.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 2 MG/MLSubstancja czynna: brimonidineProducent: BRUSCHETTINI S.R.L.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 2 MG/MLSubstancja czynna: brimonidineProducent: MYLAN S.P.A.Wymaga recepty
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BRIMOFREE wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w BRIMOFREE jest brimonidine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BRIMOFREE jest produkowany przez OMNIVISION ITALIA SRL. 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 BRIMOFREE 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 BRIMOFREE 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 (brimonidine) to m.in. ALPAGAN, BRIMOFTAL, BRIMONIDINA MYLAN JENERIKS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
