Package leaflet: Information for the user

Dorzolamide and Timolol Zentiva 20 mg/ml + 5 mg/ml eye drops, solution

Read all of this leaflet carefully before you start 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 pass it on to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dorzolamide and Timolol Zentiva is and what it is used for

Dorzolamide and Timolol Zentiva contains 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.
Dorzolamide and Timolol Zentiva is prescribed to lower high pressure inside the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not sufficient.

2. What you need to know before using Dorzolamide and Timololo Zentiva

Do not use Dorzolamide and Timololo Zentiva

if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
if you currently have or have previously had a respiratory disease such as asthma, or severe chronic obstructive pulmonary disease (a serious lung condition that may cause breathlessness, difficulty breathing, and/or persistent cough);
if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats);
if you have severe kidney disease or kidney problems, or have previously had kidney stones;
if you have excess acidity in the blood due to increased chloride levels in the blood (hyperchloremic acidosis).

If you are unsure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before using Dorzolamide and Timololo Zentiva.
Inform your doctor about any current or past health 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.
overactive thyroid gland, as timolol may mask its signs and symptoms.

Inform your doctor before undergoing surgery that you are using Dorzolamide and Timololo Zentiva,
as timolol may affect the effects of certain medicines used during anesthesia. Also, inform
your doctor of any allergies or allergic reactions, including hives, swelling of the face, lips,
tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if you experience muscle weakness or if you have been diagnosed with myasthenia gravis.
Contact your doctor immediately if you develop any eye irritation or any new eye problems,
such as redness of the eye or swelling of the eyelids.
If you suspect that Dorzolamide and Timololo Zentiva is causing an allergic reaction or hypersensitivity
(for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine and contact your doctor immediately.
Inform your doctor if you develop an eye infection, suffer an eye injury, need eye surgery, or develop a reaction involving new symptoms or worsening of existing symptoms.
When Dorzolamide and Timololo Zentiva is instilled into the eye, it may have effects throughout the body.
If you wear soft contact lenses, you must consult your doctor before using this medicine.
Children
There is limited experience with Dorzolamide and Timololo Zentiva in newborns and children.
Elderly
In clinical studies with dorzolamide hydrochloride + timolol maleate ophthalmic solution, the effects of
this medicine were similar in elderly patients and younger patients.
Hepatic impairment
Inform your doctor of any current or past liver problems you may have.
For athletes: the use of this medicine constitutes doping and may result in a positive anti-doping test.
Other medicines and Dorzolamide and Timololo Zentiva
Dorzolamide and Timololo Zentiva may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma.
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 using, have recently used, or might use any other medicine. This is particularly important if:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use during pregnancy
Do not use Dorzolamide and Timololo Zentiva if you are pregnant unless your doctor considers it necessary.
Use during breastfeeding
Do not use Dorzolamide and Timololo Zentiva if you are breastfeeding. Timolol may pass into breast milk. Ask
your doctor for advice before using any medicine during breastfeeding.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
There are adverse effects associated with the combination of dorzolamide hydrochloride + timolol maleate ophthalmic solution, such as blurred vision, which may affect the ability to drive and/or use machines. Do not drive or
use machines until you feel well or your vision is clear.
Dorzolamide and Timololo Zentiva contains benzalkonium chloride.
This medicine contains 0.075 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. Remove your contact lenses before application and wait at least 15 minutes before reinserting them.
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 your eyes, stinging, or eye pain after using this medicine, inform your doctor.

3. How to use Dorzolamide and Timolol Zentiva

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The appropriate dosage and duration of treatment will be determined by your doctor.
The recommended dose is one drop into the affected eye(s) twice daily, for example 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.
Do not allow the tip of the bottle to touch the eye or areas around the eye. It could become contaminated by bacteria that may cause eye infections, leading to serious eye damage and even loss of vision. To avoid possible contamination of the bottle, wash your hands before using this medicine and keep the dropper tip away from contact with any surface. If you think the medicine may have become contaminated, or if you develop an eye infection, contact your doctor immediately regarding continued use of this bottle.
To ensure correct dosing, the dropper tip must not be widened.

Instructions for use
It is recommended to wash your hands before instilling the eye drops.
It may be easier to apply the 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 a bottle that has not yet been opened.
Remove the bottle cap.
Tilt your head backwards and gently pull down the lower eyelid to form a small pocket between the eyelid and the eye.
Invert the bottle and press 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 Dorzolamide and Timolol Zentiva, close the eye and press with a finger on the inner corner of the eye for about 2 minutes. This helps prevent the medicine from passing into the rest of the body.

If you are using the eye drops in both eyes, repeat the instructions for the other eye.
Replace the cap and close the bottle immediately after use.

If you use more Dorzolamide and Timololo Zentiva than you should
If you have instilled too many drops into an eye or swallowed part of the bottle's contents, you may experience, among other effects, a sensation of emptiness in the head, breathing difficulties, or a slow heartbeat.
Contact your doctor immediately.

If you forget to use Dorzolamide and Timololo Zentiva
It is important to use this medicine as prescribed by your doctor.
If you forget to apply a dose, apply it as soon as possible. However, if it is almost time for the 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 Dorzolamide and Timololo Zentiva
If you wish to stop using this medicine, consult your doctor first.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Usually, you can continue using the eye drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Dorzolamide and Timololo Zentiva without first talking to your doctor.

The following adverse reactions have been reported with the combination of dorzolamide hydrochloride + timolol maleate ophthalmic solution or one of its components, both during clinical trials and post-marketing experience.

If you experience any of the following side effects, inform your doctor immediately or contact the nearest hospital emergency department:

Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): Generalized allergic reactions including swelling under the skin that may occur in areas such as the face and limbs, and may block the airways causing difficulty in swallowing or breathing. Hives or skin rash with itching, localized and generalized skin rash, itching, and sudden severe life-threatening allergic reaction may also occur.
Severe skin conditions (rare frequency: may affect up to 1 in 1,000 people): Skin blistering, mouth, eyes, and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other serious conditions (rare frequency: may affect up to 1 in 1,000 people): Heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation (congestive heart failure); chest pain; signs such as feeling of weakness or numbness on one side of the body, difficulty speaking and understanding speech (stroke).

Other side effects include:
Very common (may affect more than 1 in 10 people):
Burning and stinging sensation, altered taste sensation.
Common (may affect up to 1 in 10 people):
Redness inside and around the eye(s), tearing or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation inside and around the eye(s), sensation of having something in the eye, decreased corneal sensitivity (not realizing there is something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness / fatigue and tiredness.
Uncommon (may affect 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 miotic therapy), slow heartbeat, fainting, difficulty breathing (dyspnea), indigestion, and kidney stones.
Rare (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs), tingling or numbness in hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (muscle disease), decreased sexual desire, temporary myopia that may resolve when treatment is discontinued, detachment of the layer beneath the retina containing blood vessels as a consequence of filtering surgery, which may cause visual disturbances, drooping of the eyelids (causing the eye to be half-closed), double vision, crusting on the eyelid, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or heart rate, edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), heartbeat that may be strong and irregular (palpitations), heart attack, Raynaud's phenomenon, swelling or coldness of hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, impaired lung function, runny or blocked nose, nosebleeds, narrowing of the lung airways, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, rash appearing silvery-white (psoriasiform rash), Peyronie's disease (which may cause penile curvature).

As with other eye medications, timolol may be 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. The additional side effects listed include reactions observed within the class of beta-blockers when used to treat ocular conditions.
Frequency not known (frequency cannot be estimated from available data):
Low blood glucose levels, hallucination, sensation of foreign body in the eye (feeling something is in the eye), abnormal sensitivity of the eyes to light, heart failure, a type of heart rhythm disorder, increased heart rate, increased blood pressure, shortness of breath, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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 and Timolol Zentiva

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 carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Dorzolamide and Timolol Zentiva must be used within 28 days after 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 space provided on the carton.
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 and Timololo Zentiva contains

The active substances are dorzolamide and timololo. Each ml contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timololo (as 6.83 mg timololo maleate).
The other components are mannitol (E421), hydroxyethylcellulose, benzalkonium chloride (as preservative), sodium citrate (E331), sodium hydroxide (E524) to adjust pH, and water for injections.

Description of the appearance of Dorzolamide and Timololo Zentiva and the contents of the pack
The medicine is in the form of eye drops, a sterile, clear, slightly viscous, colourless aqueous ophthalmic solution.
Dorzolamide and Timololo Zentiva is supplied in a white opaque medium-density polyethylene bottle – with a dropper tip sealed in low-density polyethylene and a high-density polyethylene cap with a tamper-evident seal – containing 5 ml of ophthalmic solution.
Pack sizes: 1, 3 or 6 bottles of 5 ml each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milano, Italy

Manufacturers:
Pharmathen S.A
6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Famar S.A.
Plant A
63 Agiou Dimitriou Street, 174 56 Alimos, Greece

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
United Kingdom: Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops solution
France: Dorzolamide/Timololo Zentiva 20mg/5mg/ml, collyre en solution
Italy: Dorzolamide e Timololo Zentiva 20 mg/ml + 5 mg/ml collirio, soluzione