DORZOLAMIDE 20 mg /Ml Mouthwash

Зміст інструкції

1. Dorzolamide Mylan Generics 20 mg/ml eye drops, solution
   1. What is Dorzolamide Mylan Generics 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

Dorzolamide Mylan Generics 20 mg/ml eye drops, solution

Dorzolamide

Generic medicine
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Dorzolamide Mylan Generics and what it is used for

Dorzolamide Mylan Generics is supplied as a sterile solution eye drop. Dorzolamide Mylan
Generics contains dorzolamide as its active ingredient, a compound related to sulfonamides.
Dorzolamide belongs to a group of medicines called carbonic anhydrase inhibitors
ophthalmic which reduces high pressure in the eye.
Dorzolamide is used to lower increased intraocular pressure and to treat
glaucoma (open-angle glaucoma, pseudoexfoliative glaucoma). Dorzolamide Mylan
Generics can be used alone or in combination with other medicines to reduce the pressure
in the eye (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 any of the excipients of this medicine (listed in section 6).
• if you have severe kidney problems
• if you have an alteration of the pH in the blood (acid-base balance)

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

• if you suffer from or have suffered in the past from liver problems
• if you have been told you have a corneal defect
• if you have experienced an allergy to any medicine similar to sulfonamides, e.g. co-trimoxazole
• if you are undergoing or are about to undergo eye surgery.
• if you have suffered from eye problems or very low eye pressure (hypotonia).
• if you have a history of kidney stones
• if you are taking another carbonic anhydrase inhibitor orally, e.g. acetazolamide
• if you wear contact lenses (see section “Dorzolamide Mylan Generics contains benzalkonium chloride as a preservative”).

During treatment
You should immediately contact your doctor if you develop eye irritation or any new
eye problem such as eye redness or swelling of the superficial layer
of the eye or eyelid.
Stop taking Dorzolamide Mylan Generics and immediately contact your doctor if
you suspect that Dorzolamide Mylan Generics is causing you an allergic reaction (e.g. rash
or itching or inflammation of the eye).

Children and adolescents
Dorzolamide Mylan Generics should be used in children and adolescents only if the benefits
outweigh the risks. Your doctor will be able to advise you.

Other medicines and Dorzolamide Mylan Generics
Tell your doctor or pharmacist if you are taking or using or have recently taken or used or
may take or use any other medicine, even those available without a prescription.
In particular, you should tell your doctor if you are taking another carbonic anhydrase inhibitor
orally 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, ask your doctor or pharmacist for advice before using this
medicine.
Pregnancy
You should not use this medicine during pregnancy. Inform your doctor if you are pregnant or if you are
planning a pregnancy.
Breastfeeding
If treatment with this medicine is necessary, breastfeeding is not
recommended. Inform your doctor if you are breastfeeding or if you intend to breastfeed.

Driving and using machines
Dorzolamide Mylan Generics may cause dizziness and visual disturbances in some patients. Do not drive or
use machines until the symptoms have disappeared.

Dorzolamide Mylan Generics contains benzalkonium chloride as a preservative.
This medicine contains 0.075 mg of benzalkonium chloride in each millilitre.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changes in their colour. Remove your contact lenses before using this medicine and
reapply them after 15 minutes. Benzalkonium chloride can also cause eye irritation,
especially if you have dry eyes or corneal disorders (the most superficial transparent layer
of the eye). If you experience an abnormal feeling in the eye, burning or pain after using
this medicine, talk to your doctor.

3. How to use Dorzolamide Mylan Generics

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be established by your doctor.
When Dorzolamide Mylan Generics is used alone, the recommended dose is one drop
into the affected eye/s 3 times a day, for example in the morning, afternoon and evening.
If your doctor has prescribed you to use Dorzolamide Mylan Generics with a beta-blocking eye drop
(other medicines that lower eye pressure, the recommended dose is 1 drop of
Dorzolamide Mylan Generics into the affected eye/s 2 times a day, for example in the morning and
evening.
If you are using Dorzolamide Mylan Generics with another eye drop, wait at least 10 minutes between administering
Dorzolamide Mylan Generics and the other medicine.
If you are about to start using Dorzolamide Mylan Generics to replace another eye drop used to
lower eye pressure, you must stop using the other medicine after taking the
appropriate dose of that day and start Dorzolamide Mylan Generics the next day.
Do not change the dose of the medicine without talking to your doctor. If you need to stop
treatment, contact your doctor immediately.
The tip of the dropper must not come into contact with the eye or the areas surrounding the eye.
It may become contaminated with bacteria, which can cause eye infections that
can lead to serious eye damage or even vision loss.
To avoid possible contamination of the dropper, keep the tip of the dropper 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 using the medicine for the first time, make sure that the safety seal on the neck of the bottle is intact. A space between the bottle and the cap is normal for a bottle that has not yet been opened. Then break the seal.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and gently pull down your lower eyelid to form a pocket between the eyelid and the eye.
• 4. Turn the bottle upside down, and press until a single drop has been introduced into the eye as prescribed by your doctor. DO NOT LET THE TIP OF THE DROPPER COME INTO CONTACT WITH 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 using it.

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 ingested, you should 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 forget a dose, apply the forgotten dose as soon as possible. However, if you do not
remember the forgotten dose until just before the time scheduled for the next dose, skip the
forgotten dose and continue with the next dose at the scheduled time.
Do not use a double dose to make up for a missed 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 emergency room of the nearest hospital or seek medical advice from your doctor if any of the following side effects occur:
Common (may affect up to 1 in 10 people)

• Damage to the front part of the eye, which can cause eye pain, redness of the eye and blurred vision with possible sensitivity to light or a feeling of something in the eye (superficial punctate keratitis)

Uncommon (may affect up to 1 in 100 people)

• Swelling of the iris (the colored part of the eye) which can cause blurred vision, and seeing dark spots that seem to move in the eye, or possible flashes of light (iridocyclitis)

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

• Allergic reactions that can manifest with a sudden or very itchy rash, sudden swelling of the eye, eyelids, lips, tongue, face, hands or throat, which can cause difficulty breathing and shortness of breath
• Excessively painful skin redness, formation of large blisters, peeling of the skin, 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 that can occur after eye surgery (choroidal detachment)
• Notable decrease in eye pressure, which can lead to eye problems such as vision loss or distorted vision.

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

• Burning and stinging sensation in the eyes.

Common (may affect up to 1 in 10 people)

• Headache
• Increased tearing
• Eye inflammation or infection
• Inflammation or formation of crusts on the eyelids
• Itchy eyes
• Irritation of the eyelids
• Blurred vision (without other side effects)
• Nausea
• Bitter taste
• Weakness or feeling tired.

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

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

Not known (frequency cannot be estimated from available data)

• Shortness of breath
• Feeling of something in the eye (sensation that there is something in the eye)
• Strong heartbeat that may be fast or irregular (palpitations)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can 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 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 which is stated on the bottle and the packaging
after “Exp.”. The expiry date refers to the last day of that month.
Keep the bottle in the outer packaging to protect the medicine from light. Store at
a temperature below 30°C.
Once opened, Dorzolamide Mylan Generics can be stored for a maximum of 28 days.
Therefore, you must throw away the bottle after 4 weeks from the first opening, even if some of the solution remains.
To help you remember, write the date of opening the bottle on the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dorzolamide Mylan Generics contains

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

Description of the appearance of Dorzolamide Mylan Generics and contents of the pack
Dorzolamide Mylan Generics is a sterile, buffered solution, colorless to slightly viscous,
contained in a white plastic bottle with a safety strip and a tamper-evident cap consisting of two parts.
Each bottle contains 5 ml of eye drops solution.
Dorzolamide Mylan Generics is available in packs of 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
Generics (UK) – Station Close, Potters Bar, Hertfordshire, EN6 1AG, United Kingdom
Famar SA – 63 Agiou Dimitriou Street, Alimos, Athens, 174-56 Greece
This medicinal product is authorised in the Member States of the EEA with the following denominations:
Belgium “Dorzolamide Mylan 2% oogdruppels”
Denmark “Dorzolamid Mylan øyedråber, opløsning 20 mg / ml”
Finland “Dorzolamid Mylan 20 mg / ml silmätipat, liuos”
France “Dorzolamide Mylan 2%, collyre en solution”
Germany “Dorzolamid dura 20mg/ml Augentropfen“
Greece “DORZOLAMIDE / GENERICS”
Ireland “Dorzolamide Mylan 20 mg/ml eye drops solution”
Italy “DORZOLAMIDE MYLAN GENERICS”
Norway “Dorzolamid Mylan 20 mg/ml øyedråper, oppløsning”
Portugal“Dorzolamida Mylan, 20 mg/ml, colírio, solução”
Sweden “Dorzolamid Mylan 20 mg/ml ögondroppar”
Netherlands “Dorzolamide Mylan 20 mg/ml, oogdruppels oplossing”
United Kingdom “Dorzolamide 20 mg/ml eye drops solution”