Dorzonorm

PACKAGE LEAFLET: INFORMATION FOR THE USER

DORZONORM 20 mg/mL eye drops, solution

dorzolamide
Equivalent medicine
Please read this leaflet carefully 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DORZONORM is and what it is used for

DORZONORM is a sterile ophthalmic solution. DORZONORM contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to reduce elevated pressure inside the eye and for the treatment of glaucoma.
This medicine may be used alone or in combination with other medicines that reduce intraocular pressure (called beta-blockers).

2. What you need to know before using DORZONORM

Do not take DORZONORM:

• if you are allergic to dorzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe renal impairment or a history of kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before using DORZONORM:

• about any medical conditions you currently have or have had in the past, including eye problems and eye surgery, and for any allergies to any medicines.
• if you have had allergic reactions to any medicine.

Contact your doctor immediately if you develop eye irritation or any new eye problems, such as redness or swelling of the eyelids.
Stop using this medicine and contact your doctor immediately if you suspect that this medicine is causing an allergic reaction (for example, hives, severe skin reaction, or itching).

Children
Dorzolamide has been studied in infants and children under 6 years of age with increased pressure in the eye(s) or who have been diagnosed with glaucoma. Talk to your doctor for further information.

Elderly
In clinical studies with dorzolamide, the effects of this medicine were similar in elderly patients and younger patients.

Patients with hepatic impairment
Inform your doctor about any current or past liver problems.

Other medicines and DORZONORM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including eye drops).
This is particularly important if you are taking another carbonic anhydrase inhibitor such as acetazolamide or medicines containing sulfur.

Pregnancy and breastfeeding
Pregnancy
You must not use this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Breastfeeding
Breastfeeding is not recommended if treatment with this medicine is necessary. Inform your doctor if you are breastfeeding or intend to breastfeed.

Driving and using machines
No studies have been conducted on the ability to drive or use machinery. There are side effects, such as dizziness and blurred vision, which may interfere with your ability to drive and/or use machinery. Do not drive or operate machinery until you feel well or your vision is clear.

DORZONORM contains the preservative benzalkonium chloride
This medicine contains 0.075 mg of benzalkonium chloride per mL of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. You must remove your contact lenses before using this medicine and reinsert them 15 minutes after use.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer at the front of the eye). If you experience an unusual sensation in the eyes, burning, or eye pain after using this medicine, speak to your doctor.

3. How to take DORZONORM

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide the right dose and how long you should take the medicine.
When DORZONORM is used alone, the recommended dose is one drop into the affected eye or eyes in the morning, afternoon, and evening.
If your doctor has recommended that you use DORZONORM together with a beta-blocking eye drop to reduce eye pressure, the recommended dose is one drop of DORZONORM into the affected eye or eyes in the morning and evening.
If you are using this medicine together with another eye drop, the drops should be administered at least 10 minutes apart.
Do not touch the tip of the dropper to your eye or the area around your eye. It could become contaminated with bacteria that cause eye infections, which may lead to serious damage to the eye, including loss of vision. To avoid possible contamination, keep the dropper tip away from any surface. If you think your medicine may be contaminated or if you develop an eye infection, contact your doctor immediately regarding continued use of this bottle.

Instructions for use:
It is recommended to wash your hands before applying the eye drops.
It may be easier to apply the drops while looking into a mirror.

1. Before using the medicine for the first time, check that the security seal on the neck of the bottle is intact. A gap between the bottle and the cap is normal for a bottle that has not yet been opened.
2. Remove the cap from the bottle.
3. Tilt your head backwards and gently pull down the lower eyelid to form a small pocket between the eyelid and the eye.
4. Turn the bottle upside down and squeeze until a single drop is instilled into the eye as directed by your doctor. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP.
5. Repeat steps 2 and 3 for the other eye if your doctor has instructed you to do so.
6. Replace the cap and close the bottle tightly immediately after use.

If you use more DORZONORM than you should
If you have instilled too many drops into the eye or if the contents of the container are swallowed, contact your doctor immediately.

If you forget to use DORZONORM
It is important that you use this medicine exactly as your doctor has told you.
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the missed dose.

If you stop using DORZONORM
If you want to stop using this medicine, talk to your doctor first.
If you have any questions about how to use this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with this medicine and seek immediate medical advice if allergic reactions occur, including hives, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.

The following side effects have been reported with dorzolamide during clinical studies or post-marketing experience:

Very common (affects more than 1 in 10 people)

• burning and stinging pain

Common (affects from 1 to 10 in 100 people)

• corneal disorder with painful eye and blurred vision (superficial punctate keratitis), itchy eye discharges (conjunctivitis), eyelid irritation/inflammation, blurred vision
• nausea, bitter taste
• fatigue
• headache

Uncommon (affects from 1 to 10 in 1,000 people)

• inflammation of the iris

Rare (affects from 1 to 10 in 10,000 people)

• tingling or numbness in the hands or feet
• temporary myopia, which may resolve when treatment is discontinued
• development of fluid under the retina (choroidal detachment, after filtration surgery)
• eye pain
• crusting of the eyelid
• low eye pressure
• swelling of the cornea (with symptoms of visual disturbances)
• eye irritation including redness
• kidney stones
• dizziness
• nosebleed
• throat irritation
• dry mouth
• localized skin rash (contact dermatitis)
• severe skin reactions
• allergic-type reactions such as skin rash, hives, itching, and in rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and even more rarely wheezing

Not known (frequency cannot be estimated from the available data)

• shortness of breath
• sensation of a foreign body in the eye (feeling that something is in the eye)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website:
http://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 DORZONORM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and on the carton
after "Exp.". The expiry date refers to the last day of that month.
Keep the bottle in the cardboard carton to protect the medicine from light.
Store the medicine at a temperature below 30°C.
DORZONORM must be used within 28 days of first opening the bottle. Therefore,
discard the bottle 4 weeks after first opening, even if some solution remains. To help you remember,
write the date of first opening in the space provided on the carton and on the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DORZONORM contains

• The active substance is dorzolamide. Each mL contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
• The other components are: mannitol (E421), hydroxyethylcellulose, benzalkonium chloride 50% solution (as preservative), sodium citrate, sodium hydroxide to adjust pH, and water for injections.

Description of the appearance of DORZONORM and contents of the container
DORZONORM is a sterile, isotonic, buffered, clear, colourless, slightly viscous aqueous solution in a white opaque low-density polyethylene bottle with a dropper and a sealed two-part cap. Each bottle contains 5 mL of eye drops, solution.
DORZONORM is available in packs containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Responsible manufacturer for batch release
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini Attiki
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Greece: Rezlod
Italy: DORZONORM
Poland: Adolamid
Portugal: Dorzolamide Pharmathen
Spain: Dorzolamida Aristo
United Kingdom: Dorzolamide