Zamidine

Package leaflet: Information for the patient

Zamidine 1 mg/ml eye drops, solution

Esamidine disulfate
Please read carefully this leaflet before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zamidine is and what it is used for

Zamidine contains an antibacterial antiseptic for ophthalmic use and is used as a local antiseptic for the treatment of certain eye infections and surrounding structures, for example:

• inflammation of the outer membrane of the eye (conjunctivitis),
• inflammation of certain parts of the eye: the conjunctiva and cornea (keratoconjunctivitis),
• localized inflammation of the eyelid margins, often at the base of the eyelashes (blepharitis),
• chronic inflammation of the tear sacs (dacryocystitis).

This medicine is also used for disinfection of the conjunctival sacs (the space between the eyelids and the eye) prior to surgical procedures.

Zamidine is a preservative-free eye drop solution.

2. What you need to know before using Zamidine

Do not use Zamidine

• if you are allergic to exadimine 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 this medicine.
Stop treatment and consult your doctor if:

• your condition does not improve after using this medicine as prescribed by your doctor,
• new symptoms appear (redness, eye pain or blurred vision). In case of ocular infection, contact lenses are contraindicated for the entire duration of treatment.

Other medicines and Zamidine
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
Pregnancy and breastfeeding
Zamidine may be used during pregnancy and breastfeeding.
Driving and using machines
Zamidine does not affect visual acuity but may cause temporary blurred vision or other visual disturbances, which could potentially affect your ability to drive or operate machinery.
If you experience blurred vision, do not drive or operate machinery until your normal vision is restored.

3. How to use Zamidine

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended treatment is one drop into the conjunctival sac (the space between the lower eyelid and
the eye) of the affected eye(s), 4 to 6 times a day.
Avoid prolonged or frequently repeated treatments due to the risk of development of resistant strains.
For this reason, do not exceed the treatment duration prescribed by your doctor.
Use in children
In children, the safety and efficacy of the eye drops have not been established. No data available.
Method and route of administration
This medicine is for ophthalmic use.
If you are using more than one ophthalmic medicine, the medicines should be administered at least 15 minutes apart.
This medicine is an eye drop solution without preservatives. Do not allow the tip of the multidose container to touch the eye or areas around the eye. The tip could become contaminated and may cause a risk of eye infections. To avoid possible contamination of the multidose container, keep the tip of the multidose container away from contact with any surface.
For the 0.6 ml multidose container:
Instructions for using Zamidine:

1. Wash your hands and sit or stand in a comfortable position.
2. Open the pouch containing 5 multidose containers. Mark the date of first opening on the pouch.
3. Detach one multidose container from the strip.

4. Open by twisting off the top end of the multidose container, as illustrated. After opening the container, do not touch the tip with your fingers.

5. Gently pull down the lower eyelid of the affected eye with your fingers.
6. Bring the tip of the multidose container close to the eye, near the eyelashes, other surfaces, or fingers, but without touching them with the dropper tip.
7. Gently press the multidose container so that a single drop falls into the eye, then release the lower eyelid.

8. If necessary, repeat the procedure in the other eye.
9. After use, immediately close the multidose container: if the entire content has not been used, press the cap back onto the container. The resealable multidose container can be reused within 24 hours.

10. Discard the multidose container after 24 hours or when empty.

For the 10 ml multidose container:

Instructions for use of Zamidine:

1. Wash your hands and sit or stand in a comfortable position.
2. Unscrew the cap to open the multidose container. Do not touch the tip with fingers after opening.

3. Tilt your head backwards and use your finger to gently pull down the lower eyelid of the affected eye.
4. Position the tip of the multidose container close to, but not touching, the eye, eyelashes, other surfaces or fingers with the dropper.
5. Gently squeeze the multidose container so that only one drop enters the eye, then release the lower eyelid.

6. Repeat the procedure in the other eye, if affected.
7. After use, close the multidose container by screwing the cap back on.

8. Discard the multidose container after 30 days.

If you use more Zamidine than you should
If you use more Zamidine than you should, rinse the eye with physiological saline solution.
If you forget to use Zamidine
Do not use a double dose to make up for the forgotten dose.
If you stop using Zamidine
Use this medicine exactly as described in this leaflet. Consult your doctor if you do not feel
better or if you feel worse.
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: cannot be estimated from the available data

• Local allergic reaction (eye redness, swelling and redness of the eyelids, itching).

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 via the national reporting system at 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 Zamidine

Keep this medicine out of the sight and reach of children.
For the 0.6 ml multidose container:
Do not use this medicine after the expiry date stated on the carton, the sachet, and the multidose container. The expiry date refers to the last day of that month.
For the 10 ml multidose container:
Do not use this medicine after the expiry date stated on the carton and the multidose container. The expiry date refers to the last day of that month.
Do not store above 25 °C.
For the 0.6 ml multidose container:
After first opening of the sachet: use the multidose containers within 30 days. Record the date of first opening on the sachet.
After first opening of the multidose container: use the resealable multidose container within 24 hours of first opening the multidose container.
For the 10 ml multidose container:
After first opening of the multidose container: use the multidose container within 30 days of first opening the multidose container.
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 Zamidine contains

• The active substance is hexamidine diisethionate. 1 ml contains 1 mg of hexamidine diisethionate.
• The other components are: boric acid, borax, sodium chloride and water for injections.

Description of the appearance of Zamidine and contents of the pack
For the 0.6 ml multidose container:
This medicinal product is an eye drop solution. A clear, colourless solution contained in multidose containers packed in a pouch of 5 units; each multidose container holds 0.6 ml of product.
Each 0.6 ml multidose container contains at least 12 drops without preservatives.
For the 10 ml multidose container:
This medicinal product is an eye drop solution. The clear, colourless solution is contained in a 10 ml multidose container.
Each 10 ml multidose container contains approximately 250 preservative-free drops.
A pack contains either 5 or 10 (2x5) 0.6 ml multidose containers or one 10 ml multidose container.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer
For the 0.6 ml multidose container:
LABORATOIRE UNITHER
1 rue de l’Arquerie
50200 Coutances
France
or
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

For the 10 ml multidose container:
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Marketing Authorisation Holder in Italy
THEA FARMA S.p.A.
Via Tiziano, 32
20145 MILANO
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium, Luxembourg ………………………………………………………………………….... Zasetic
Bulgaria, Germany, Italy, Poland, Romania……………………………………………………… Zamidine
Czech Republic, Denmark, Finland, Iceland, Norway, Portugal, Slovakia, Sweden
……………………………………………………………………………………………………… Zamisept
Greece, France…………………………………………………………………………………… Zameline

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA).

Health education advice for eye infections
Consult your doctor if you do not feel better or if you feel worse.
Your eye infection is contagious: therefore, take the simple measures listed below to avoid spreading it to your other eye or to members of your family:
Wash your hands regularly with warm water and soap
Do not rub your eyes
Wash pillows and towels with warm water and soap
Use individual towels and pillows