PACKAGE LEAFLET: INFORMATION FOR THE USER

DORZAMOX 20 mg/ml + 5 mg/ml eye drops, solution

Dorzolamide and timolol
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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DORZAMOX is and what it is used for
What you need to know before using DORZAMOX
How to use DORZAMOX
Possible side effects
How to store DORZAMOX
Contents of the pack and other information

1. What DORZAMOX is and what it is used for

DORZAMOX is a combination of two medicines: dorzolamide and timolol.
Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
Timolol belongs to a group of medicines called "beta-blockers".
These medicines reduce the pressure inside the eye in different ways.
DORZAMOX is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when beta-blocker eye drops used alone are not sufficient.

2. What you need to know before using DORZAMOX

Do not take DORZAMOX:

if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6)
if you have or have previously had a breathing problem such as asthma, or severe chronic obstructive pulmonary disease (severe lung condition that may cause wheezing, difficulty breathing, and/or persistent cough)
if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats)
if you have severe kidney problems or a history of kidney stones
if you have excess acidity in the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis)

If you are unsure whether you should take this medicine, contact your doctor or pharmacist.
Warnings and precautions:
Talk to your doctor or pharmacist before using DORZAMOX.
Inform your doctor about any current or past eye diseases or eye problems you have:

coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
heart rhythm disorders such as slow heartbeat
breathing problems, asthma, or chronic obstructive lung disease
poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
diabetes, as timolol may mask signs and symptoms of low blood sugar
overactivity of the thyroid gland, as timolol may mask signs and symptoms

Inform your doctor before undergoing surgery that you are using DORZAMOX, as
timolol may affect the effects of certain medicines used during anesthesia.
Also inform your doctor of any allergies or allergic reactions including hives, facial swelling,
swelling of the lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if you experience muscle weakness or have been diagnosed with myasthenia gravis.
Contact your doctor immediately if you develop any eye irritation or any new eye problems such as eye redness or eyelid swelling.
If you suspect that DORZAMOX is causing an allergic reaction or hypersensitivity (for
example, skin rash, severe skin reaction, or eye redness and itching), stop using this medicine and contact your doctor immediately.
Inform your doctor if you develop an eye infection, suffer an eye injury, require eye surgery, or develop a reaction involving new symptoms or worsening of symptoms.
When DORZAMOX is instilled into the eye, it may have systemic effects throughout the body.
If you wear soft contact lenses, you must consult your doctor before using this medicine.
Children
Experience with dorzolamide + timolol eye drops in neonates and children is limited.
Elderly
In studies with dorzolamide/timolol eye drops, the effects of this medicine were similar in elderly and younger patients.
Patients with hepatic impairment
Inform your doctor about any current or past liver problems you may have.
If you are engaged in sports: using this medicine without therapeutic need constitutes doping and
may result in a positive anti-doping test.
Other medicines and DORZAMOX
DORZAMOX may affect or be affected by other medicines you are taking, including
other eye drops for glaucoma treatment. Inform your doctor if you are taking or plan to
take medicines to lower blood pressure, heart medications, or medicines to treat diabetes.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any
other medicines. This is particularly important if you:

are taking medicines to lower high blood pressure or medicines to treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin)
are taking medicines to treat rapid or irregular heartbeat such as calcium channel blockers, beta-blockers, or digoxine
are using another eye drop containing a beta-blocker
are taking another carbonic anhydrase inhibitor such as acetazolamide
are taking monoamine oxidase inhibitors (MAOIs) used to treat depression
are taking a parasympathomimetic medicine that may be prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal intestinal movement
are taking narcotics such as morphine used to treat moderate or severe pain
are taking medicines to treat diabetes
are taking antidepressants known as fluoxetine and paroxetine
are taking a sulfonamide medicine
are taking quinidine (used to treat heart conditions and some types of malaria)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use DORZAMOX if you are pregnant unless your doctor considers it necessary.
Breastfeeding
Do not use DORZAMOX if you are breastfeeding. Timolol may be excreted in breast
milk.
Driving and use of machinery
No studies have been conducted on the effects on the ability to drive vehicles or use machinery.
There are adverse effects associated with the dorzolamide hydrochloride + timolol maleate eye drop combination, such as blurred vision, which may affect the ability to drive vehicles and/or use machinery. Do not drive or operate machinery until you feel well or your vision is clear.
DORZAMOX contains the preservative benzalkonium chloride.
This medicine contains 0.075 mg of benzalkonium chloride in 1 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.
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). Talk to your doctor if you experience an unusual sensation in the eye, stinging, or eye pain after using this medicine.

3. How to take DORZAMOX

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose and duration of treatment.
The recommended dose is one drop 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 change the dose of this medicine without consulting your doctor.
Make sure the dropper tip does not touch the eye or surrounding areas. It may become contaminated with bacteria that can cause eye infections, leading to serious eye damage, including loss of vision. To avoid possible contamination of the dropper, keep the tip away from any surface. If you think the medicine may have become contaminated, or if an eye infection develops, contact your doctor immediately regarding continued use of this bottle.
To ensure the correct dose, the dropper tip must not be widened.

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

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 an unopened bottle.
Remove the cap from the bottle.
Tilt your head backwards and gently pull down the lower eyelid to form a pouch between the eyelid and the eye.
Invert the bottle 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.
After using DORZAMOX, press your finger against the corner of the eye near the nose or close your eyelids for two minutes. This helps prevent the medicine from passing into the rest of the body.
Repeat steps 3 and 5 for the other eye, if your doctor has instructed you to do so.
Replace the cap and close the bottle tightly immediately after use.
Close the eye and press with your finger at the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.

Black line drawing on white background showing a stylized face with a finger touching the eyelid

If you use more DORZAMOX than you should
If you have instilled too many drops into an eye or accidentally swallowed some of the contents of the bottle, you may experience, among other effects, a feeling of dizziness, difficulty breathing, or a slow heartbeat. Contact your doctor immediately.

If you forget to use DORZAMOX
It is important that you use this medicine as directed by your doctor.
If you miss a dose, use 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 forgotten dose.

If you stop using DORZAMOX
If you wish to stop using this medicine, speak to your doctor first.
If you have any questions 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 everyone gets them.
In general, you may continue using the eye drops unless the side effects are severe. If you have any doubts, consult your doctor or pharmacist. Do not stop using DORZAMOX without first consulting your doctor.

If you experience generalized allergic reactions including swelling under the skin (which may occur in areas such as the face and limbs and may block the airways, causing difficulty swallowing or breathing), hives or itchy rash, localized or widespread skin rash, itching, or a severe and sudden life-threatening allergic reaction, you must stop treatment with DORZAMOX and contact your doctor immediately.

The following side effects have been reported with dorzolamide+timolol, eye drops solution, or one of its components during clinical studies or post-marketing experience.

Very common (affects more than 1 in 10 people):
Eye burning and irritation, taste disturbances

Common (affects up to 1 in 10 people):
Redness in and around the eye(s), tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eye(s), sensation of a foreign body in the eye (corneal erosion), decreased corneal sensitivity (inability to notice a foreign body in the eye and absence of pain), eye pain, dry eye, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), feeling unwell also known as nausea, weakness/tiredness and fatigue

Uncommon (affects up to 1 in 100 people):
Dizziness, depression, inflammation of the iris, visual disturbances including changes in refraction (in some cases due to discontinuation of medicines used to treat excessive pupil constriction), slowed heart rate, weakness, difficulty breathing (dyspnea), indigestion, and kidney stones (often presenting as sudden, sharp, and spasmodic pain in the lower back and/or side, groin, or abdomen)

Rare (affects up to 1 in 1,000 people):
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, difficulty falling asleep (insomnia), nightmares, memory loss, increased signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual drive, stroke, temporary myopia which may resolve when treatment is discontinued, detachment of the retinal layer containing blood vessels following filtering surgery, which may cause visual disturbances, drooping of the eyelids (causing the eye to be half-closed), double vision, formation of crusts on the eyelids, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rate or rhythm, congestive heart failure (a heart condition causing shortness of breath and swelling of legs and feet due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), palpitations (faster and/or irregular heartbeat), heart attack, Raynaud's phenomenon, swelling or coldness of hands and feet, reduced circulation in arms and legs, cramps and/or leg pain while walking (claudication), shortness of breath, feeling of breathlessness, runny or blocked nose, nosebleeds, narrowing of the lung airways causing breathing difficulties, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, rash appearing as silvery-white patches (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic reactions such as skin rash, urticaria, itching, and in rare cases possible swelling of lips, eyes and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

As with other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when medicines are taken orally or injected. Additional side effects listed include reactions observed within the class of beta-blockers when used to treat ocular conditions.

Not known (frequency cannot be estimated from the available data):
Low blood sugar levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucination, labored breathing, sensation of a foreign body in the eye (feeling that something is in the eye), strong heartbeat which may be rapid or irregular (palpitations), increased heart rate, increased blood pressure, abnormal sensitivity of the eyes to light.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website:
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 DORZAMOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the box after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
DORZAMOX 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 down the date of first opening in the space provided on the box 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 DORZAMOX contains

The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate).
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 DORZAMOX and contents of the pack
DORZAMOX is a sterile, clear, slightly viscous, colourless, aqueous solution.
DORZAMOX is supplied in a white opaque MDPE bottle with a dropper tip sealed in LDPE and
a closure cap made of HDPE with a tamper-evident screw cap, containing 5 ml of eye drops.
Pack sizes: 1 bottle of 5 ml, 3 bottles of 5 ml, or 6 bottles of 5 ml.
It is possible that not all pack sizes are marketed.

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

Responsible manufacturer for batch release
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini Attiki
Greece
FAMAR S.A.
Plant A
63 Agiou Dimitriou Street
174 56 Alimos
Athens
Greece

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