Dorzolamide Mylan Generics

Package Leaflet: Information for the User

Dorzolamide Mylan Generics 20 mg/ml eye drops, solution

dorzolamide
Generic 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 they have the same symptoms as you, because it may 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 Dorzolamide Mylan Generics is and what it is used for
2. What you need to know before using Dorzolamide Mylan Generics
3. How to use Dorzolamide Mylan Generics
4. Possible side effects
5. How to store Dorzolamide Mylan Generics
6. Contents of the pack and other information

1. What Dorzolamide Mylan Generics is and what it is used for

Dorzolamide Mylan Generics is supplied as a sterile eye drop solution. Dorzolamide Mylan Generics contains as its active substance dorzolamide, a compound related to sulfonamides.
Dorzolamide belongs to a group of medicines called topical carbonic anhydrase inhibitors, which reduce elevated pressure within the eye.
Dorzolamide is used to lower increased intraocular pressure and to treat glaucoma (open-angle glaucoma, pseudo-exfoliative glaucoma). Dorzolamide Mylan Generics may be used alone or in combination with other medicines to reduce eye pressure (called beta-blockers).

2. What you need to know before using Dorzolamide Mylan Generics

Do not use Dorzolamide Mylan Generics:

• if you are allergic to dorzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems
• if you have a pH imbalance in your blood (acid-base disturbance)

Warnings and precautions
Talk to your doctor or pharmacist before using Dorzolamide Mylan Generics:

• if you have or have previously had liver problems
• if you have been told you have a corneal defect
• if you have had an allergic reaction to any medicine similar to sulfonamides, for example co-trimoxazole
• if you have undergone or are about to undergo eye surgery
• if you have experienced eye problems or very low intraocular pressure (hypotony)
• if you have a history of kidney stones
• if you are taking another carbonic anhydrase inhibitor by mouth, for example acetazolamide
• if you wear contact lenses (see section “Dorzolamide Mylan Generics contains benzalkonium chloride as a preservative”).

Attention for those engaged in sports: This product contains substances prohibited in doping.
Administration differing from that indicated for therapeutic purposes, dosage regimen, or route of administration is prohibited.
During treatment
Contact your doctor immediately if you develop eye irritation or any new eye problems such as eye redness or swelling of the surface layer of the eye or of the eyelid.
Stop using Dorzolamide Mylan Generics and contact your doctor immediately if you suspect that Dorzolamide Mylan Generics is causing you an allergic reaction (for example, skin rash, itching, or eye inflammation).
Children and adolescents
Dorzolamide Mylan Generics should be used in children and adolescents only if the benefits outweigh the risks. Your doctor will advise you accordingly.
Other medicines and Dorzolamide Mylan Generics
Tell your doctor or pharmacist if you are taking, using, or have recently taken or used, or might take or use any other medicines, including those obtained without a prescription.
In particular, inform your doctor if you are taking another carbonic anhydrase inhibitor by mouth, such as acetazolamide.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Pregnancy
You must not use this medicine during pregnancy. Inform your doctor if you are pregnant or if you are planning a pregnancy.
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
Dorzolamide Mylan Generics may cause dizziness and visual disturbances in some patients. Do not drive or operate machinery until symptoms have resolved.
Dorzolamide Mylan Generics contains benzalkonium chloride as a preservative
This medicine contains 0.075 mg of benzalkonium chloride per millilitre.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and reinsert them after 15 minutes.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain, after using this medicine, speak with your doctor.

3. How to use Dorzolamide Mylan Generics

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be determined by your doctor.
When Dorzolamide Mylan Generics is used alone, the recommended 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 Mylan Generics together with a beta-blocking eye drop (other
medicines that lower eye pressure), the recommended dose is one drop of Dorzolamide Mylan Generics
in the affected eye(s) twice daily, for example in the morning and evening.
If you are using Dorzolamide Mylan Generics with another eye drop, wait at least 10 minutes between
the administration of Dorzolamide Mylan Generics and the other medicine.
If you are starting Dorzolamide Mylan Generics to replace another eye drop used to lower eye pressure,
stop using the other medicine after taking the appropriate dose for that day, and start Dorzolamide Mylan Generics the following day.
Do not change the dose of this medicine without discussing it with your doctor. If you need to stop treatment, contact
your doctor immediately.
The dropper tip must not come into contact with the eye or surrounding areas. It may become contaminated with bacteria,
which could cause eye infections leading to serious eye damage or even loss of vision.
To avoid possible contamination of the dropper, keep the tip away from contact with any surface.

Instructions for use
It is recommended to always wash your hands before applying the eye drops.
It may be easier to apply the eye drops in front of a mirror.

1. Before first use, ensure that the security seal on the neck of the bottle is intact. A gap between the bottle and the cap is normal for an unopened bottle. Then break the seal.
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. Invert the bottle and squeeze until one single drop is instilled into the eye as prescribed by your doctor. DO NOT TOUCH THE DROPPER TIP TO 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 in an upright position after use.

Close the eye and press with your finger on the inner corner of the eye for about two minutes. This helps
prevent the medicine from passing into the rest of the body.

If you use more Dorzolamide Mylan Generics than you should
If you instill too many drops into the eye or if the contents of the bottle are swallowed, contact your doctor immediately.

If you forget to use Dorzolamide Mylan Generics
It is important to use Dorzolamide Mylan Generics as prescribed by your doctor.
If you miss a dose, apply the missed dose as soon as you remember. However, if you do not remember the missed dose until shortly before the next scheduled dose, skip the missed dose and continue with the next dose at the usual time.
Do not use a double dose to make up for a forgotten dose.

If you stop using Dorzolamide Mylan Generics
Dorzolamide Mylan Generics must be used every day to work properly. If you need to stop treatment, contact your doctor immediately.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Dorzolamide Mylan Generics and go immediately to the nearest hospital Emergency Department
or seek medical advice from your doctor if you experience any of the following side effects:
Common (may affect up to 1 in 10 people)

• Damage to the front part of the eye, which may cause eye pain, eye redness, blurred vision, and possible sensitivity to light or sensation of a foreign body in the eye (superficial punctate keratitis)

Uncommon (may affect up to 1 in 100 people)

• Swelling of the iris (the coloured part of the eye) which may cause blurred vision, seeing dark floating spots that appear to move across the eye, or possible flashes of light (iridocyclitis)

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

• Allergic reactions which may present as sudden or intensely itchy skin rash, sudden swelling of the eye, eyelids, lips, tongue, face, hands or throat, which may cause difficulty breathing and breathlessness
• Severe painful skin redness, formation of large blisters, skin peeling, bleeding of lips, eyes, genitals or mouth, accompanied by fever (these symptoms may indicate Stevens-Johnson Syndrome or toxic epidermal necrolysis)
• Sudden loss of vision, accompanied by pain and sometimes nausea and vomiting, which may occur after eye surgery (choroidal detachment)
• Marked decrease in eye pressure, which may lead to eye problems such as loss of vision or distorted vision.

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

• Sensation of burning and stinging in the eyes.

Common (may affect up to 1 in 10 people)

• Headache
• Increased tear production
• Inflammation or infection of the eye
• Inflammation or crusting of the eyelids
• Itching of the eye
• Eyelid irritation
• Blurred vision (without other side effects)
• Nausea
• Bitter taste sensation
• Weakness or feeling of fatigue.

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

• Dizziness
• Tingling sensation in hands and/or feet
• Eye irritation which may cause redness and eye pain
• Difficulty focusing on distant objects (myopia), which normally resolves upon discontinuation of treatment
• Swelling of the front surface of the eye which may lead to blurred vision and possible halos around objects (corneal edema)
• Nosebleeds
• Throat irritation
• Dry mouth
• Itchy and scaly skin, sometimes with burning and stinging sensation, which may also appear on the skin around the eye and may be a sign of an allergic reaction of the eye
• Kidney stones.

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)
• Abnormal sensitivity of the eyes to light
• Strong heartbeat which may be rapid or irregular (palpitations)
• Increased heart rate
• Increased blood pressure.

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 https://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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and on the outer packaging after "Exp.". The expiry date refers to the last day of that month.
Keep the bottle in the outer carton to protect the medicine from light. Store below 30°C.
Once opened, Dorzolamide Mylan Generics can be stored for a maximum of 28 days. Therefore, you must discard the bottle 4 weeks after first opening, even if some solution remains.
To help you remember, write the date of opening on the packaging.
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 Dorzolamide Mylan Generics contains

• The active substance is dorzolamide. 1 ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
• The other components are: benzalkonium chloride (as preservative) (see section 2), mannitol, hydroxyethylcellulose, sodium citrate, sodium hydroxide to adjust pH, water for injections.

Description of the appearance of Dorzolamide Mylan Generics and contents of the pack
Dorzolamide Mylan Generics is a sterile, pH-buffered, colourless, slightly viscous solution contained in a white plastic bottle with a tamper-evident seal and a two-part tamper-proof cap.
Each bottle contains 5 ml of eye drops solution.
Dorzolamide Mylan Generics is available in packs containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturers:
Pharmathen S.A., Dervenakion 6, Pallini 15331, Attiki, Greece
Mc Dermott Laboratories Limited t/a Gerard Laboratories – 35 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Famar SA – 63 Agiou Dimitriou Street, Alimos, Athens, 174-56 Greece

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
France “Dorzolamide Viatris 2%, collyre en solution”
Italy “DORZOLAMIDE MYLAN GENERICS”
Portugal “Dorzolamida Mylan, 20 mg/ml, colírio, solução”
Netherlands “Dorzolamide Viatris 20 mg/ml, oogdruppels oplossing”
United Kingdom (Northern Ireland) “Dorzolamide 20 mg/ml eye drops solution”