ASCOTODIN 10 ML Krople do oczu, roztwór
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Treść ulotki
ASCOTODIN 3 mg/ml + 1mg/ml eye drops, solution
N-methylbenzoquinoline methyl sulfate and tonzilamine hydrochloride
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 want more information or advice, ask your pharmacist.
- If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 7 days.
Contents of this leaflet:
- 1. What ASCOTODIN is and what it is used for
- 2. What you need to know before using ASCOTODIN
- 3. How to use ASCOTODIN
- 4. Possible side effects
- 5. How to store ASCOTODIN
- 6. Contents of the pack and other information
1. What ASCOTODIN is and what it is used for
ASCOTODIN is a combination of two active ingredients: N-methylbenzochinoline methyl sulfate and tonsilamine
hydrochloride. N-methylbenzochinoline methyl sulfate helps to protect the eye from damage caused by
ultraviolet rays, due to the sun or other sources. Tonsilamine hydrochloride belongs to a group of medicines
called antihistamines which are used for the treatment of allergies and in particular, to control itching.
This medicine is indicated:
- to prevent irritation and lesions caused by exposure to light for a long period of time (occupational and occasional photoophthalmic lesions);
- to relieve irritation from light diffraction in the eye in people who use contact lenses;
- for the treatment of eye diseases that have as a common symptom sensitivity to light (photophobia) (actinic and electric ophthalmias - unpleasant or painful sensations from too much light, keratitis - inflammation of the cornea and iritis - inflammation of the iris).
See your doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before using ASCOTODIN
Do not use ASCOTODIN
- if you are allergic to N-methylbenzochinoline methyl sulfate, tonzylamine hydrochloride or any of the other ingredients of this medicine (listed in section 6) or to other substances closely related from a chemical point of view;
- if you suffer from or have suffered from serious eye diseases such as narrow-angle glaucoma, characterized by an increase in pressure inside the eye.
- If you are taking antidepressant medications (medicines used to treat depression)
- The eye drops should not be used in children under three years of age.
Warnings and precautions
Consult your doctor or pharmacist before using ASCOTODIN.
Do not use this medicine for more than 7 consecutive days, as undesirable effects, even
serious ones, may occur (See section “Possible side effects”).
Before using this medicine, consult your doctor if you notice symptoms of an infection, the presence of pus or a
foreign body in the eye or if you have suffered mechanical, chemical or thermal damage.
Use this medicine with caution and inform your doctor in the following cases:
- if you suffer from high blood pressure (hypertension);
- if you suffer from a thyroid disease (hyperthyroidism);
- if you have heart problems (cardiac disorders);
- if you suffer from diabetes (hyperglycemia);
- if you are taking medications for the treatment of depression (antidepressants). Do not use this medicine at doses higher than those recommended. This medicine if ingested or used for long periods, can cause toxic effects. Ingestion, especially in children, can cause severe drowsiness (deep sedation) (See section “If you use more ASCOTODIN than you should”).
Children
The use of this medicine is contraindicated in children under 3 years of age.
Other medicines and ASCOTODIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other eye (ophthalmic) medicines are known.
Do not use ASCOTODIN if you are undergoing therapy with antidepressant medications.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, you can use this medicine. However, ask your
doctor or pharmacist for advice before using ASCOTODIN if you are pregnant, suspect or are planning
a pregnancy or if you are breastfeeding.
Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.
ASCOTODIN contains para-oxybenzoate esters
This medicine contains para-oxybenzoate esters which may cause allergic reactions (even delayed).
3. How to use ASCOTODIN
Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 drops, to be instilled into the eye at intervals of 5 minutes, before
exposure to very intense lights (strong sun, ultraviolet rays or artificial lights). If you are exposed to light for
a long time, you can repeat the administration after approximately 3 hours.
If you wear contact lenses, the recommended dose is 1 drop, 3 times a day.
If you suffer from excessive sensitivity to light (photophobia), you can use the medicine every 2 hours.
Do not exceed the recommended doses and not for more than 7 consecutive days.
If you use more ASCOTODIN than you should
Cases of overdose are not known.
In case of ingestion/taking an excessive amount of this medicine, seek immediate medical attention or go to the
nearest hospital (See section “Warnings and precautions”).
If you forget to use ASCOTODIN
Do not use a double dose to make up for a missed dose.
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 occur:
Frequency not known(the frequency cannot be estimated from available data)
- increased pupil size;
- increased blood pressure (hypertension);
- heart diseases;
- increased blood sugar levels (hyperglycemia);
- increased pressure inside the eyes;
- nausea;
- headache;
- allergic reactions (sensitization phenomena). If any of these side effects occur or if you experience any other effect not listed, stop treatment and consult your doctor who will establish appropriate therapy.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store ASCOTODIN
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 pack after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store the medicine at a temperature not exceeding 30°C, protected from light.
Once opened, the eye drops must be used within 30 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
WhatASCOTODINcontains
- The active ingredients are N-methylbenzoquinoline methyl sulfate and tonsilamine hydrochloride. 100 ml of solution contain 0.300 g of N-methylbenzoquinoline methyl sulfate and 0.100 g of tonsilamine hydrochloride.
- The other ingredients are: sodium chloride, sodium borate, carboxymethylcellulose, p-hydroxybenzoate esters, purified water.
Description of the appearance of ASCOTODIN eye drops and contents of the pack
10 ml bottle with dropper.
Marketing Authorisation Holder and Manufacturer
Bruschettini S.r.l. - Via Isonzo, 6 – 16147 Genova – Italy
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 10 ML
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ASKOTODINPostać farmaceutyczna: Eye drops, solution, 5%Substancja czynna: acetylcysteineProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 10MG/MLSubstancja czynna: artificial tears and other indifferent preparationsProducent: ABBVIE S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution in single-dose container, 0.9 MG/MLSubstancja czynna: ciclosporinProducent: SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.Bez recepty
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ASKOTODIN jest produkowany przez BRUSCHETTINI 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 ASKOTODIN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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