Package leaflet: Information for the user

ASCOTODIN 3 mg/ml + 1 mg/ml eye drops, solution

N-methylbenzochinoline methylsulfate and tonzilamine hydrochloride
Read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What ASCOTODIN is and what it is used for
What you need to know before using ASCOTODIN
How to use ASCOTODIN
Possible side effects
How to store ASCOTODIN
Contents of the pack and other information

1. What ASCOTODIN is and what it is used for

ASCOTODIN is a combination of two active substances: methylbenzochinoline methylsulfate and tonzylamine hydrochloride.
Methylbenzochinoline methylsulfate helps protect the eye from damage caused by ultraviolet rays from sunlight or other sources.
Tonzylamine hydrochloride belongs to a group of medicines called antihistamines, which are used to treat allergies and, in particular, to control itching.
This medicine is indicated:

to prevent irritations and injuries caused by prolonged exposure to light (professional and occasional photophthalmic injuries);
to relieve light diffraction-related irritations of the eye in people who wear contact lenses;
for the treatment of eye diseases having light sensitivity (photophobia) as a common symptom (actinic and electric ophthalmias – unpleasant or painful sensations due to excessive light, keratitis – inflammation of the cornea, and iritis – inflammation of the iris).

Consult 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-methylbenzochinolinium methylsulfate, to tonzilamine hydrochloride, or to any of the other ingredients of this medicine (listed in section 6), or to other substances chemically closely related;
if you currently have or have previously had severe eye diseases such as narrow-angle glaucoma, characterized by increased pressure inside the eye;
if you are taking antidepressant medicines (medicines used to treat depression);
The eye drops must not be used in children under three years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using ASCOTODIN.
Do not use this medicine for more than 7 consecutive days, as adverse 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, 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 if:

you have high blood pressure (hypertension);
you have a thyroid disease (hyperthyroidism);
you have heart problems (cardiac disorders);
you have diabetes (hyperglycaemia);
you are taking medicines for the treatment of depression (antidepressants).
Do not use this medicine at doses higher than those recommended. If ingested or used for prolonged periods, this medicine may cause toxic effects. Ingestion, especially in children, may cause severe drowsiness (profound 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
Inform 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 treatment with antidepressant medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, you may use this medicine. However, please consult your doctor or pharmacist before using ASCOTODIN if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
ASCOTODIN contains parahydroxybenzoate esters
This medicine contains parahydroxybenzoate esters which may cause allergic reactions (including delayed reactions).

3. How to use ASCOTODIN

Use this medicine exactly as stated 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 2 drops, administered into the eye 5 minutes apart, before exposure to excessively bright light (strong sunlight, ultraviolet rays, or artificial lights). If exposed to light for a prolonged period, you may repeat the administration after approximately 3 hours.
If you wear contact lenses, the recommended dose is 1 drop, 3 times daily.
If you suffer from excessive sensitivity to light (photophobia), you may use the medicine every 2 hours.
Do not exceed the recommended doses or use for more than 7 consecutive days.
If you use more ASCOTODIN than you should
Cases of overdose are unknown.
If you ingest/accidentally swallow an excessive amount of this medicine, contact your doctor or the nearest hospital immediately (See section “Warnings and precautions”).
If you forget to use ASCOTODIN
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

enlargement of the pupil;
increased blood pressure (hypertension);
heart disorders;
increased blood sugar levels (hyperglycaemia);
increased pressure inside the eyes;
nausea;
headache (cephalalgia);
allergic reactions (sensitisation phenomena). If any of the above side effects occur, or if you experience any side effect not listed, stop treatment and consult your doctor, who will determine appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 stated on the pack after “Exp.”.
The expiry date refers to the last day of that month and to the product in its original, unopened packaging,
properly stored.
Store the medicine at a temperature not exceeding 30°C, protected from light.
Once the container is opened, the eye drops must be used within 30 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ASCOTODIN contains

The active substances are N-methylbenzochinolinium methylsulfate and tonsilamine hydrochloride. 100 ml of solution contain 0.300 g of N-methylbenzochinolinium methylsulfate and 0.100 g of tonsilamine hydrochloride.
The other components are: sodium chloride, sodium borate, carboxymethylcellulose, p-hydroxybenzoic acid esters, purified water.

Description of the appearance of ASCOTODIN eye drops and package contents
10 ml bottle with dropper.
Marketing Authorization Holder and Manufacturer
Bruschettini S.r.l. - Via Isonzo, 6 – 16147 Genoa – Italy