Dorzolamide Aurobindo

Package leaflet: Information for the user

Dorzolamide Aurobindo 20mg/ml eye drops, solution

Read this entire 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 effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dorzolamide Aurobindo is and what it is used for

Dorzolamide Aurobindo is a sterile ophthalmic solution. Dorzolamide Aurobindo contains dorzolamide, a sulfonamide-type substance, as the active ingredient.
Dorzolamide Aurobindo is an ophthalmic carbonic anhydrase inhibitor that reduces ocular hypertension.
It is indicated for the treatment of elevated intraocular pressure in conditions such as ocular hypertension and glaucoma (open-angle glaucoma, pseudoexfoliative glaucoma). Dorzolamide Aurobindo may be used as monotherapy or in combination with other medications that reduce intraocular pressure (known as beta-blockers).

2. What you need to know before using Dorzolamide Aurobindo

Do not use Dorzolamide Aurobindo

• if you are allergic to dorzolamide or to any of the other ingredients of this medicine.
• if you have severe kidney problems.

Warnings and precautions
Talk to your doctor before using Dorzolamide Aurobindo

• if you have or have previously had liver problems
• if you have been diagnosed with a corneal defect
• if you have allergies to any medicine
• if you have undergone, or are about to undergo, eye surgery
• if you have suffered eye injuries or have an eye infection
• if you have previously had kidney stones
• if you are taking orally another carbonic anhydrase inhibitor
• if you wear contact lenses (see section 'Dorzolamide Aurobindo contains the preservative benzalkonium chloride').

Contact your doctor immediately if you experience irritation or any new eye problems,
such as redness or swelling on the surface of the eye or on the eyelid.
Stop using Dorzolamide Aurobindo and contact your doctor immediately if you think
Dorzolamide Aurobindo is causing you an allergic reaction (for example, skin rash, serious adverse
reactions with skin blisters that may affect the mouth, eyes and genitals, itching,
inflammation of the eye).
Children
Dorzolamide Aurobindo has been studied in infants and children under 6 years of age who have elevated intraocular pressure or have been diagnosed with glaucoma. For further information, consult your doctor.
Dorzolamide Aurobindo and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking another carbonic anhydrase inhibitor such as
acetazolamide. This medicine may be taken orally, as eye drops, or by any other method.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Dorzolamide Aurobindo must not be used during pregnancy unless clearly indicated by your doctor.
Dorzolamide Aurobindo must not be used during breastfeeding.
Driving and using machines
Dorzolamide Aurobindo may cause dizziness and visual disturbances in some patients. Do not drive or operate machinery until these symptoms have resolved.
Dorzolamide Aurobindo contains the preservative benzalkonium chloride
Benzalkonium chloride may cause eye irritation.
Benzalkonium chloride is known to discolor soft contact lenses.
Avoid contact with soft contact lenses.
Remove contact lenses before instillation and wait at least 15 minutes before reinserting them.

3. How to use Dorzolamide Aurobindo

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose and duration of treatment.

When Dorzolamide Aurobindo is administered alone, the usual dose is one drop in the affected eye(s) three times daily, for example in the morning, afternoon, and evening.

If your doctor has prescribed Dorzolamide Aurobindo in combination with a beta-blocking eye drop (medicines that reduce eye pressure), the usual dose is one drop of Dorzolamide Aurobindo in the affected eye(s) twice daily, for example in the morning and evening.

If Dorzolamide Aurobindo is used together with another eye drop, wait at least 10 minutes between instilling Dorzolamide Aurobindo and the other medicine. Alternatively, if you are switching from another eye drop used to lower eye pressure to Dorzolamide Aurobindo, discontinue the other medicine after taking the appropriate dose for that day, and start treatment with Dorzolamide Aurobindo the following day.

Do not change the dose of this medicine without first consulting your doctor. If you need to stop treatment, contact your doctor immediately.

Avoid letting the dropper tip touch the eye or surrounding areas. It could become contaminated with bacteria that may cause infections leading to serious eye damage, including loss of vision. To avoid possible bacterial contamination, avoid contact of the dropper tip with any surface.

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

1. Before first use, ensure that the security seal on the front of the bottle is intact. A gap between the bottle and the cap is normal for an unopened bottle.
2. Remove the cap from the bottle.
3. Tilt your head backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye.
4. Invert the bottle and gently squeeze until one single drop is instilled into the eye, as prescribed by your doctor. DO NOT LET THE DROPPER TIP TOUCH THE EYE OR EYELID.
5. Repeat steps 3 and 4 for the other eye, if your doctor has prescribed treatment for both eyes.
6. Replace the cap and close the bottle immediately after use.

If you use more Dorzolamide Aurobindo than you should
If you put too many eye drops in your eye or accidentally swallow some, contact your doctor immediately.

If you forget to use Dorzolamide Aurobindo
It is important to use Dorzolamide Aurobindo as prescribed by your doctor.
If you miss a dose, instill 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 a missed dose.

If you stop using Dorzolamide Aurobindo
Dorzolamide Aurobindo must be used every day to work properly. If you need to stop treatment, contact your doctor immediately.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using this medicine and seek immediate medical advice if you develop allergic reactions. Symptoms of allergic reactions include:

• swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
• severe skin reactions with blistering of the skin which may affect the mouth, eyes and genitals
• hives

The following side effects may occur with Dorzolamide Aurobindo:

Very common side effects (may affect more than 1 in 10 people)

• burning and stinging sensation in the eye

Common side effects (may affect up to 1 in 10 people)

• corneal disease with eye redness and blurred vision (superficial punctate keratitis), inflammation or swelling of the outer surface of the eye(s), possible inflammation of the eyelid(s) and/or skin around the eye(s), tearing or itching of the eye(s), blurred vision, effects on the outer surface of the eye
• nausea, bitter taste sensation
• asthenia/fatigue
• headache

Uncommon side effects (may affect up to 1 in 100 people)

• inflammation of the middle layer of the eye

Rare side effects (may affect up to 1 in 1,000 people)

• swelling of the ocular surface layer, choroidal detachment which may be accompanied by disturbances/changes in vision (following eye surgery), ocular hypotony, eye redness, eye pain, eyelid crusting, transient myopia (which resolves upon discontinuation of the medicine)
• throat irritation, dry mouth
• Hypersensitivity: signs and symptoms of localized reactions (reactions on the eyelids) and systemic allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause breathing or swallowing difficulties, hives and itching, shortness of breath and, more rarely, bronchospasm (contraction of bronchial smooth muscle)
• dizziness, numbness/tingling sensation
• formation of calculi in the urinary tract
• nosebleeds
• severe skin reaction, skin inflammation

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

• Shortness of breath
• Foreign body sensation in the eye (feeling that something is in the eye)

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 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 Dorzolamide Aurobindo

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.
Store the bottle in the outer carton to protect the medicine from light. Store below 30°C.
Dorzolamide Aurobindo must be used within 28 days of first opening the bottle. Therefore, the bottle must be discarded 4 weeks after first opening, even if some solution remains. To help you remember, write down the date of opening in the designated space on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Dorzolamide Aurobindo contains

• The active substance is dorzolamide. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
• The other components are mannitol, hydroxyethylcellulose, benzalkonium chloride (as preservative), sodium citrate, sodium hydroxide for pH adjustment, and water for injections.

Description of the appearance of Dorzolamide Aurobindo and package contents
Dorzolamide Aurobindo is a sterile, isotonic, colourless, clear, slightly viscous buffered solution contained in an opaque medium-density polyethylene bottle with a sealed dropper and a two-part assembled cap. Each bottle contains 5 ml of eye drops.
Dorzolamide Aurobindo is available in pack sizes of 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer responsible for batch release
Pharmathen S.A. – 6 Dervenakion str. – 15351 Pallini, Attika (Greece)
Famar S.A., Plant A – 63 Agiou Dimitriou Street – 17456 Alimos (Greece)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Dorzolamid Actavis 20 mg/ml Augentropfen
Cyprus Domide
Denmark Arzolamid
Estonia Dorzolamide Actavis
Finland Dorzolamid Actavis 20mg/ml silmätipat, liuos
Germany Dorzolamid-Actavis 20mg/ml Augentropfen
Ireland Dorzolamide 20mg/ml Eyedrops
Italy Dorzolamide Aurobindo
Lithuania Dorzolamide Actavis 20 mg/ml akių lašai, tirpalas
Latvia Dorzolamide Actavis
Malta Domide
Netherlands Dorzolamide Actavis 20 mg/ml, oogdruppels, oplossing
Portugal Dorzolamida Aurovitas
United Kingdom Dorzolamide 20mg/ml Eye Drops Solution
Spain Dorzolamida Actavis 20 mg/ml colirio en solución

This summary of product characteristics was last approved in