IMIDAZYL 1 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
Imidazyl 1 mg/ml eye drops, solution
nafazoline nitrate
Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 4 days of treatment.
Contents of this leaflet:
- 1. What Imidazyl is and what it is used for
- 2. What you need to know before using Imidazyl
- 3. How to use Imidazyl
- 4. Possible side effects
- 5. How to store Imidazyl
- 6. Contents of the pack and other information
1. What is Imidazyl and what is it used for
Imidazyl contains the active ingredient naphazoline nitrate which belongs to a group of
medicines called decongestants.
Imidazyl is used to treat allergies and inflammation of the eye (conjunctiva),
characterized by a burning sensation, also caused by external agents, associated with excessive
tearing, light sensitivity, and redness.
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.
2. What you need to know before using Imidazyl
Do not use Imidazyl
- if you are allergic to naphazoline nitrate or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other medicines belonging to the same class as Imidazyl; in particular xylometazoline, oxymetazoline, tetrizoline
- if you have a disease due to high pressure inside the eye (narrow-angle glaucoma) or if you have other serious eye diseases
- if you are taking certain medicines used to treat depression (monoamine oxidase inhibitors) at the same time (see section “Other medicines and Imidazyl”)
- in children under 12 years of age.
Warnings and precautions
Consult your doctor or pharmacist before using Imidazyl:
- if you suffer from high blood pressure (hypertension);
- if you have heart problems;
- if you suffer from excessive activity of a gland called the thyroid (hyperthyroidism);
- if you have high blood sugar levels (hyperglycemia, diabetes);
- if you have breathing difficulties (bronchial asthma).
Imidazyl is not suitable for the treatment of infections, mechanical (trauma), chemical or heat damage or for removing foreign bodies from the eye.
Caution for those who engage in sports: the product contains substances prohibited for doping.
Different administration, dosage regimen or route of administration than those reported are prohibited.
Children
Imidazyl is contraindicated in children under 12 years of age.
Imidazyl should be kept out of the reach of children as accidental ingestion can cause toxic effects (see section “If you use more Imidazyl than you should”).
Other medicines and Imidazyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not use Imidazyl if you are taking medicines for depression (belonging to the class of monoamine oxidase inhibitors) and for the two weeks following such use, as a significant increase in blood pressure (severe hypertensive crises) may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Imidazyl should be used during pregnancy and breastfeeding only after consulting your doctor and weighing the risks and benefits of treatment with him.
Driving and operating machinery
Imidazyl does not impair the ability to drive vehicles or operate machinery.
Imidazyl (10 ml bottle) contains benzalkonium chloride (preservative)
This medicine contains 0.10 mg of benzalkonium chloride per 1 ml of solution.
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 reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the most superficial 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.
If you are allergic to the preservative or wear soft contact lenses, you can use Imidazyl Collirio single-dose container which does not contain preservatives.
Imidazyl (0.5 ml single-dose container and 10 ml bottle) contains phosphate buffer
Imidazyl in 0.5 ml single-dose container contains 0.91 mg of phosphate in 0.5 ml of solution.
Imidazyl in 10 ml bottle contains 0.45 mg of phosphate in 1 ml of solution.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates can very rarely cause opaque spots on the cornea due to calcium accumulation during treatment.
3. How to use Imidazyl
Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops to be instilled drop by drop directly into the irritated eye.
Apply the medicine 1-2 times a day in the open eye.
Caution: do not exceed the indicated doses without your doctor's advice. A higher dose
even if applied locally and for a short period of time can lead to serious undesirable effects on the entire body.
Do not use Imidazyl for more than 4 consecutive days, unless otherwise prescribed by your doctor, as there is
a possibility that undesirable effects may occur.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.
Imidazyl 1 mg/ml eye drops, solution (10 ml bottle)
INSTRUCTIONS FOR OPENING THE BOTTLE
Safety cap
To prevent accidental opening by children
To open To close
- 1. press down 2. simultaneously unscrew 3. screw back on tightly
The closure is childproof if, when unscrewing the cap without pressing, you hear a click.
Imidazyl 1 mg/ml eye drops, solution (single-dose container)
INSTRUCTIONS FOR OPENING THE SINGLE-DOSE CONTAINER
- 1. Open the single-dose container by detaching the cap, which can be used, inverted, to temporarily reclose the container.
- 2. Gently press on the body of the single-dose container and let the eye drops drip into the eye, as described above.
Imidazyl 1 mg/ml eye drops, solution (single-dose container)does not contain preservatives; for
this reason, each single-dose container, once opened, must be discarded after
use, even if used only in part.
Use in children
Imidazyl is contraindicated in children under 12 years of age.
If you use more Imidazyl than you should
The medicine, if accidentally ingested or if used for a long period at excessive
doses, can determine toxic phenomena.
A significantly higher dose than the recommended dose of Imidazyl, for example in case of
accidental ingestion of Imidazyl, can cause serious adverse effects on the heart and
blood circulation. Symptoms may include: slowed heart rate
(bradycardia), severe headache, nausea, vomiting, breathing problems, increased heart rate (tachycardia) and chest pain.
Accidental ingestion of the medicine, especially in children, can cause depression
of the nervous system: severe drowsiness (marked sedation, hypotonia) and coma.
If you experience adverse effects or in case of accidental ingestion/intake of an
excessive dose of Imidazyl, immediately inform your doctor or go to the nearest
hospital.
If you forget to use Imidazyl
Do not use a double dose to make up for a missed dose.
If you stop using Imidazyl
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The use of the medicine may sometimes determine
- pupil dilation,
- increased internal eye pressure,
- nausea,
- headache,
- general effects on the body such as
- increased blood pressure,
- heart disorders,
- increased blood sugar (glucose) levels.
Rarely, allergic (hypersensitivity) reactions may occur; in this case, discontinue
treatment and consult your doctor.
undesirable effects.
These side effects are generally transient. If they occur, consult your doctor
or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
consult 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.
Reporting side effects can help provide more information on the
safety of this medicine.
5. How to store Imidazyl
Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Imidazyl 1 mg/ml eye drops, solution (10 ml bottle)
Shelf life after first opening of the bottle: 30 days.
Imidazyl 1 mg/ml eye drops, solution (single-dose container)
Each single-dose container, once opened, must be discarded after use, even if
only partially used.
Do not use this medicine after the expiry date which is stated on the pack after
“Expiry”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep
6. Contents of the pack and other information
What Imidazyl contains
10 ml bottle
- The active ingredient is naphazoline nitrate. 1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline).
- The other ingredients are benzalkonium chloride, sodium chloride, disodium edetate, sodium phosphate monobasic dihydrate, disodium phosphate dihydrate, water for injections, pH correctors (sodium hydroxide, hydrochloric acid to pH 5.5).
Single dose container
- The active ingredient is naphazoline nitrate. 1 ml of solution contains 1 mg of naphazoline nitrate (equivalent to 770 micrograms of naphazoline).
- The other ingredients are disodium phosphate dihydrate, sodium phosphate monobasic dihydrate, sodium chloride, water for injections.
Description of the appearance of Imidazyl and contents of the pack
Imidazyl is presented in the form of eye drops, solution for ophthalmic use (to be instilled drop by
drop directly into the open eye).
The contents of the pack are a 10 ml bottle or 10 single dose containers of 0.5 ml.
Marketing authorisation holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milano.
Manufacturer
10 ml bottle
Tubilux Pharma S.p.A. – via Costarica, 20/22 – Pomezia (Roma).
Single dose container
Farmigea S.p.A. – via G. Battista Oliva, 8 – Ospedaletto (Pisa).
COC Farmaceutici S.r.l. - Via Modena, 15 – 40019 Sant’Agata Bolognese (BO).
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 1 MG/ML
- Kod ATCS01GA01
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki IMIDATSYLPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: naphazolineProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.8 MG/MLSubstancja czynna: naphazolineProducent: DOMPE' FARMACEUTICI S.P.A.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.5 MG/MLSubstancja czynna: naphazolineProducent: MONTEFARMACO OTC S.P.A.Bez recepty
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IMIDATSYL nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w IMIDATSYL jest naphazoline. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
IMIDATSYL jest produkowany przez RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA 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 IMIDATSYL 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 IMIDATSYL 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 (naphazoline) to m.in. BRUNITSINA, KOLLIRIO ALFA DEKONJESTIONANTE, IRIDINA DUE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
