Tirocular

Package leaflet: Information for the patient

TIROCULAR 4% eye drops, solution

Acetylcysteine
Please 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 has instructed you to.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of time.

Contents of this leaflet:

1. What TIROCULAR 4% eye drops is and what it is used for
2. What you need to know before using TIROCULAR 4% eye drops
3. How to use TIROCULAR 4% eye drops
4. Possible side effects
5. How to store TIROCULAR 4% eye drops
6. Contents of the pack and other information

1. What TIROCULAR 4% eye drops is and what it is used for

TIROCULAR is indicated for the treatment of eye disorders caused by decreased tear secretion, with or without alteration of the eye's mucous membranes, such as: dry keratoconjunctivitis, corneal conditions due to reduced lacrimation, keratopathies of various etiologies, and corneal ulcers.

2. What you should know before using TIROCULAR 4% eye drops

Do not use TIROCULAR 4% eye drops

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using TIROCULAR 4% eye drops.
It is recommended not to wear soft contact lenses during treatment with TIROCULAR, as they may absorb the preservative contained in the solution.
Other medicines and TIROCULAR 4% eye drops
No interactions with other medicines are known when applied directly to the eye.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TIROCULAR 4% eye drops with food, drinks and alcohol
Not applicable.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine. There is no evidence advising against the use of TIROCULAR during pregnancy and breastfeeding.
Driving and using machines
TIROCULAR does not impair the ability to drive or operate machinery. However, avoid using TIROCULAR while driving a vehicle or operating machinery.
TIROCULAR 4% eye drops, solution contains benzalkonium chloride
This medicine contains 1.42 micrograms of benzalkonium chloride per drop, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any abnormal sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use TIROCULAR 4% eye drops

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: 1-2 drops inside the eye, gently pulling the eyelids apart, 3-4 times a day, according to medical prescription.
To administer:
a) remove the full tear-off seal
b) remove the rubber stopper
c) take the dedicated dropper from the packaging and fit it onto the neck of the bottle (Fig. 1)
d) remove the cap from the dropper and administer the drops (Fig. 2).
Use in children
There is no indication for a specific use of TIROCULAR 4% in the paediatric population.
If you use more TIROCULAR 4% eye drops than you should
Clinically significant consequences are not expected.
If you forget to use TIROCULAR 4% eye drops
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Localized transient irritations are possible, and in highly reactive subjects, sensitization phenomena may occur, requiring discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 further information on the safety of this medicine.

5. How to store TIROCULAR 4% eye drops

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. After opening, the eye drops can be used for a period not exceeding three weeks. It is recommended to close the bottle immediately after each single use.
Do not use this medicine after the expiry date stated on the carton and bottle after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 TIROCULAR 4% eye drops contains
The active substance is acetylcysteine. 4 g are dissolved in 100 ml of solution.
The other components are polyvinyl alcohol, edetate disodium, sodium chloride, potassium chloride, benzalkonium chloride, sodium hydroxide, water for injections.

Description of the appearance of TIROCULAR 4% eye drops and contents of the pack
Amber glass bottle containing 10 ml of 4% solution and dropper.

Marketing Authorisation Holder and Manufacturer
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan
Manufacturer
TUBILUX PHARMA S.p.A.
Via Costarica, 20/22
00071 Pomezia (ROME)