Jak stosować NOVESINA
Treść ulotki
Novesina 4 mg/ml eye drops, solution
oxybuprocaine hydrochloride
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 Novesina is and what it is used for
- 2. What you need to know before you use Novesina
- 3. How to use Novesina
- 4. Possible side effects
- 5. How to store Novesina
- 6. Contents of the pack and other information
1. What is Novesina and what is it used for
Novesina contains the active ingredient oxybuprocaine hydrochloride, a local anesthetic, particularly suitable
for performing a surface anesthesia at the level of the mucous membranes.
Novesina is used in cases of:
- measurement of intraocular pressure (Schlötz applanation tonometry), contact lens examinations
- removal of foreign bodies from the cornea
- preparation for injections into the eye (subconjunctival and retrobulbar)
- puncture of the anterior chamber for diagnostic purposes
- minor surgical procedures, such as pterygia (abnormal growth of the conjunctiva), chalazia (swelling and inflammation of the eyelid due to inflammation of lacrimal glands), excision of small tumors.
2. What you need to know before using Novesina
Do not use Novesina
- if you are allergic to oxibuprocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- in children under 2 years of age (see Novesina contains boric acid).
Warnings and precautions
Talk to your doctor before using Novesina, especially if you have problems:
- with the liver
- with the heart
- with blood vessels. Novesina will only be administered by your doctor when necessary. Do not use Novesina repeatedly as it may cause damage to the cornea.
In the anesthesia of the cornea and conjunctiva of the eye, Novesina 4 mg/ml eye drops do not cause
a burning sensation and therefore avoid contraction of the muscles of the eyelids (blepharospasm).
Novesina is tolerated by the corneal epithelium and does not cause
- pupil dilation (mydriasis)
- redness (hyperemia) of the conjunctiva
- allergic reactions
- epithelial lesions.
Other medicines and Novesina
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Novesina is not compatible with
- silver nitrate (bactericide)
- mercury salts (disinfectants)
- alkaline substances (e.g. detergents).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor for advice before using this medicine.
The use of oxibuprocaine hydrochloride during pregnancy and breastfeeding has not been adequately studied.
The doctor will assess whether the benefits for you clearly outweigh the risks to the fetus/child before
administering Novesina.
Driving and operating machinery
Wait until the anesthetic effect of Novesina has worn off before driving vehicles or operating machinery.
Novesina contains boric acid
This medicine should not be given to children under 2 years of age as it contains boron
and may damage fertility in the future.
3. How to use Novesina
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
Novesina 4 mg/ml eye drops, solution will be administered by letting the drops fall into the conjunctival sac, i.e. inside the lower part of the eye.
- Measurement of intraocular pressure (tonometry) with the Schiötz device, examinationson contact lensesThe recommended dose is one or two drops, one minute before applying the tonometer.
- Removal of foreign bodies from the cornea, preparation for injections into the eye (subconjunctivaland retrobulbar)The recommended dose is one drop for 2-3 times over 3 minutes.
- Puncture of the anterior chamber for diagnostic purposes, minor surgical procedures (pterygia, chalazia,excision of small tumors)The recommended dose is one drop every 30 seconds repeated for 5 - 10 times with the addition of 1 - 2 drops of 1% adrenaline.
In case of applications on extended surfaces and in case of instillation, the maximum dose is 1.5 mg per kg of body
weight, i.e. for an adult of 70 kg it is 100 mg of oxibuprocaine hydrochloride which corresponds to 25 ml
of the NOVESINA 4 mg/ml solution.
Use in children
Novesina is contraindicated in children under 2 years of age (see section Do not use Novesina).
If you use more Novesina than you should
In case of accidental ingestion of an excessive dose of Novesina or prolonged use of the medicine, contact
your doctor immediately or go to the nearest hospital, as toxic phenomena may occur.
The symptoms may be:
- difficulty breathing
- convulsions.
If you have any doubts about 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.
With the use of Novesina, you may experience one or more of the following side effects:
- mild burning sensation immediately after instillation, which usually resolves quickly
- temporary (hyperemia) redness of the conjunctivae
- allergic reactions of the conjunctivae
- allergic reactions of the eyelids and skin around the eyes
- corneal lesions: superficial lesions, erosions, inflammation inside the cornea (stromal infiltrates)
- cataract
- allergic phenomena after a second application.
Following absorption through the mucous membranes or damaged skin, effects involving the whole body may also occur:
- excitation of the central nervous system
- nausea
- vomiting
- depression of the cardiovascular system with pallor, sweating, hypotension
- heart rhythm disturbances (arrhythmias)
- abnormal accumulation of hemoglobin in the blood (methemoglobinemia).
Reporting of side effects
If you get any side effect, including any 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 Novesina
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 packaging after Expires. The expiry date refers to the last day of that month.
The single-dose containers, once removed from the protective sachet, should be stored for up to 3 months.
After first opening the single-dose container, the remaining product should not be reused.
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 Novesina contains
- The active ingredient is oxibuprocaine hydrochloride. One ml of solution contains 4 mg of oxibuprocaine hydrochloride.
- The other ingredients are boric acid, water for injections.
Description of the appearance of Novesina and contents of the pack
Each pack contains 30 polyethylene single-dose containers containing 0.5 ml of solution.
Marketing Authorisation Holder
Laboratoires Théa - 12 rue Louis Blériot - 63017 Clermont-Ferrand (F)
Marketing Authorisation Holder
THEA FARMA S.p.A. Via Tiziano,32 – 20145 MILANO
Manufacturer
C.O.C. FARMACEUTICI S.r.l.
Via Modena, 15 - Sant’Agata Bolognese (BO)
- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.4%
- Kod ATCS01HA02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki NOVESINAPostać farmaceutyczna: Eye drops, solution, 4 MG/MLSubstancja czynna: oxybuprocaineWymaga receptyPostać farmaceutyczna: Eye drops, solution, 40 MG/MLSubstancja czynna: lidocaineWymaga receptyPostać farmaceutyczna: Ophthalmic ointment, 20 MG/GSubstancja czynna: lidocaineProducent: LDD PHARMAWymaga recepty
Odpowiedniki NOVESINA w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik NOVESINA w Hiszpania
Odpowiednik NOVESINA w Polska
Odpowiednik NOVESINA w Ukraina
Lekarze online w sprawie NOVESINA
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NOVESINA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w NOVESINA jest oxybuprocaine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
NOVESINA jest produkowany przez LABORATOIRES THEA. 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 NOVESINA 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 NOVESINA 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 (oxybuprocaine) to m.in. BENOXINATO KLORIDRATO INTES, LIDOKAINA KLORIDRATO INTES, OPTESIK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















