Dorzolamide/timolol Viatris 20 mg/ml + 5 mg/ml eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dorzolamide/Timolol Viatris 20 mg/ml + 5 mg/ml eye drops

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dorzolamide/Timolol Viatris is and what it is used for

Dorzolamide/Timolol Viatris 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".

This medicine reduces pressure in the eye in several ways.

Dorzolamide/Timolol Viatris is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when the use of a beta-blocker eye drop as monotherapy is not appropriate.

2. What you need to know before using Dorzolamide/Timolol Viatris

Do not use Dorzolamide/Timolol Viatris:

• If you are allergic to dorzolamide, timolol, or any of the other ingredients of this medicine (listed in section 6).
• If you currently have or have previously had breathing problems, such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).
• If you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• If you suffer from severe kidney disease or have a history of kidney stones.
• If you have excess acidity in the blood due to an accumulation of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether you can use this medicine, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to use dorzolamide/timolol if you experience:

• Coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or suffocation), heart failure, or low blood pressure.
• Heart rate disorders such as slow heartbeat.
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Disease due to insufficient blood circulation, such as Raynaud's disease or syndrome.
• Diabetes or hypoglycemia (low blood sugar levels), as timolol may mask the signs and symptoms of hypoglycemia.
• Overactivity of the thyroid gland, as timolol may mask the signs and symptoms.

Before undergoing surgery, inform your doctor that you are using dorzolamide/timolol, as timolol may alter the effects of certain medications used during anesthesia. Also, inform your doctor of any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, as these could cause difficulty breathing or swallowing.

Inform your doctor if you have muscle weakness or have been diagnosed with myasthenia gravis (muscle weakness).

Inform your doctor immediately if eye irritation occurs or any new eye reaction develops, such as redness or eyelid inflammation.

If you suspect that dorzolamide/timolol is causing an allergic reaction or hypersensitivity (e.g., 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, undergo eye surgery, experience any other reaction, or if your symptoms worsen.

Instilling dorzolamide/timolol into the eye may affect the entire body.

Children

Limited experience is available with the use of dorzolamide/timolol in infants, children, and adolescents.

Elderly patients

In studies with dorzolamide/timolol, the effects of dorzolamide/timolol were similar in elderly patients and younger patients.

Patients with hepatic impairment

Inform your doctor about any liver problems you currently have or have had in the past.

Athletes

This medicine contains timolol, which may produce a positive result in doping control tests.

Other medicines and Dorzolamide/Timolol Viatris

Dorzolamide/timolol may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or medicines to treat diabetes. Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, even those obtained without a prescription. This is particularly important if you are:

• Taking medicines to lower blood pressure or treat heart disease (e.g., calcium channel blockers, beta-blockers, or digoxin).
• Taking medicines used to treat irregular or altered heartbeats, such as calcium channel blockers, beta-blockers, or digoxin.
• Using another eye drop containing beta-blockers.
• Taking another carbonic anhydrase inhibitor such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs), which are used to treat depression.
• Taking a parasympathomimetic medicine, which may have been prescribed to help eliminate urine. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal intestinal movements.
• Taking opioids, such as morphine, for the treatment of moderate to severe pain.
• Taking medicines to treat diabetes.
• Taking antidepressants known as fluoxetine or paroxetine.
• Taking a sulfa medicine.
• Taking quinine (used to treat heart conditions or certain types of malaria).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use dorzolamide/timolol if you are pregnant unless your doctor considers it necessary.

Do not use dorzolamide/timolol if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medicine if you are breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines. Adverse effects associated with dorzolamide/timolol, such as blurred vision, may affect your ability to drive and/or use machines. Do not drive or operate tools or machinery until you feel well or your vision is clear.

Dorzolamide/Timolol Viatris contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride in each milliliter of ophthalmic solution.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Dorzolamida/Timolol Viatris

Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The appropriate dosage and duration of treatment will be determined by your doctor.

The recommended dose is one drop into the affected eye or eyes twice daily, for example, in the morning and at night.

If you are using this medicine together with another eye drop, leave at least 10 minutes between the application of dorzolamide/timolol and the other medicine.

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

Do not allow the tip of the container to touch the eye or surrounding area. It may become contaminated with bacteria capable of causing eye infections that could lead to serious eye damage, or even loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and avoid letting the tip of the container come into contact with any surface. If you think your medicine may have become contaminated, or if you develop an eye infection, consult your doctor immediately to determine whether you should continue using this container.

To ensure correct dosing—do not enlarge the hole at the tip of the dispenser.

Instructions for use:

Do not use this eye drop if the plastic security strip is missing or broken. To open the container for the first time, remove the plastic security strip.

Each time you use this medicine:

1. Wash your hands.
2. Open the bottle. Be careful that the tip of the bottle does not touch the eye, the surrounding skin, or your fingers.
3. Tilt your head backwards and hold the bottle upside down over the eye.
4. Gently pull down the lower eyelid and look upwards. Hold and gently squeeze the container from the sides, allowing one drop to fall into the space between the lower eyelid and the eye.
5. Close the eye and press gently on the inner corner of the eye with your finger for two minutes. This helps prevent the medicine from draining into the rest of the body.
6. Repeat steps 3–5 in the other eye if instructed by your doctor.
7. Replace the cap on the bottle and close the bottle tightly after use.

If you use more Dorzolamida/Timolol Viatris than you should

It is important to maintain the dose prescribed by your doctor. If too many drops are applied into the eye or if you accidentally swallow some of the solution, you may feel unwell; for example, you may experience headache, feel tired or dizzy, feel lightheaded, have difficulty breathing (dyspnea), or notice that your heart is beating more slowly. If you experience any of these effects, seek medical attention immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Dorzolamida/Timolol Viatris

It is important to administer this medicine as directed by your doctor.

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose and continue with your regular dosing schedule.

Do not use a double dose to make up for missed doses.

If you stop using Dorzolamida/Timolol Viatris

If you wish to discontinue treatment with this medicine, consult your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the following adverse effects, stop using this medicine and speak to your doctor immediately, as they could be signs of a reaction to the medicine.

General allergic reactions may occur, including swelling under the skin in areas such as the face and limbs, which may obstruct airways, leading to difficulty swallowing, shortness of breath, hives or skin rash, localized or generalized rash, itching, or sudden, severe, and potentially fatal reactions.

Generally, you may continue using the drops unless the effects are serious. If you are concerned, consult your doctor or pharmacist. Do not stop using dorzolamide/timolol without first talking to your doctor.

The following adverse effects have been reported with dorzolamide/timolol or one of its components in clinical trials or during post-marketing experience.

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

• Burning and stinging in the eyes, altered taste.

Common (may affect up to 1 in 10 people)

• Redness in and around the eye(s).
• Watery and itchy eye(s).
• Corneal erosion (damage to the front layer of the eyeball).
• Inflammation and/or irritation in and around the eye(s).
• Sensation of a foreign body in the eye.
• Decreased corneal sensitivity (failure to notice the presence of something in the eye and inability to feel pain).
• Eye pain.
• Dry eyes.
• Blurred vision.
• Headache.
• Sinusitis (a feeling of pressure or fullness in the nose).
• Feeling of discomfort (nausea).
• Weakness/tiredness (fatigue).

Uncommon (may affect up to 1 in 100 people)

• Dizziness.
• Depression.
• Inflammation of the iris.
• Vision disturbances, including changes in refraction (in some cases due to discontinuation of medication used to treat excessive pupil constriction).
• Slow heart rate.
• Fainting.
• Shortness of breath.
• Feeling short of breath.
• Indigestion.
• Kidney stones (often characterized by sudden onset of severe, spasmodic pain in the lower back and/or flank, groin, or abdomen).

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

• Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), with symptoms such as joint pain (similar to rheumatoid arthritis), fever, changes in blood counts, and skin rashes.
• Tingling or numbness in the hands or feet.
• Difficulty sleeping.
• Nightmares.
• Memory loss.
• Worsening of signs and symptoms of myasthenia gravis (a muscle disorder).
• Decreased sex drive.
• Stroke.
• Myopia, which may resolve upon discontinuation of treatment.
• Detachment of the layer beneath the retina containing blood vessels after filtration surgery, which may lead to visual disturbances.
• Drooping of the eyelids (causing eyes to be partially closed).
• Double vision.
• Crusting of the eyelids.
• Inflammation of the cornea (with symptoms of visual disturbances).
• Low eye pressure.
• Ringing in the ears.
• Low blood pressure.
• Changes in heart rhythm or heartbeat rate.
• Congestive heart failure (heart disease causing difficulty breathing and swelling of feet and legs due to fluid accumulation).
• Edema (fluid accumulation).
• Cerebral ischemia (reduced blood flow to the brain).
• Chest pain.
• Faster and/or irregular heartbeat (palpitations).
• Heart attack.
• Raynaud's phenomenon, swollen or cold hands and feet, and reduced circulation in arms and legs.
• Leg cramps and/or leg pain when walking (claudication).
• Nasal discharge or nasal congestion.
• Nosebleeds.
• Constriction of airways in the lungs.
• Cough.
• Throat irritation.
• Dry mouth.
• Diarrhea.
• Contact dermatitis.
• Hair loss.
• Skin rash with a silvery-white appearance (psoriasiform rash).
• Peyronie's disease (which may cause penile curvature).
• Allergic-type reactions such as skin rash, hives, itching, and in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the bloodstream. This may cause adverse effects similar to those seen with oral beta-blockers. The incidence of adverse effects after topical ophthalmic administration is lower than when medications are taken orally or injected.

The additional adverse effects listed include reactions occurring within the beta-blocker class when used to treat ocular disorders.

Frequency not known (cannot be estimated from available data)

• Low blood glucose levels.
• Heart failure.
• A type of heart rhythm disturbance.
• Abdominal pain.
• Vomiting.
• Muscle pain not caused by physical exercise.
• Sexual dysfunction.
• Hallucinations.
• Foreign body sensation in the eye (sensation of having something in the eye).
• Increased heart rate.
• Increased blood pressure.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dorzolamide/Timolol Viatris

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 CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions. Store in the original container to protect it from light and moisture.

Dorzolamide/Timolol Viatris must be used within 28 days of first opening the bottle. Therefore, it should be discarded four weeks after first opening the bottle, even if there is still solution remaining. To help you remember, write down the date you opened it in the space provided on the container.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their containers to a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dorzolamide/Timolol Viatris

• 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), hydroxyethyl cellulose, benzalkonium chloride (as preservative; see section 2 “Dorzolamide/Timolol Viatris contains the preservative benzalkonium chloride”), sodium citrate (E331), sodium hydroxide (E524), and water for injections.

Nature of the product and contents of the container

The medicine is a sterile, clear, slightly viscous, aqueous, colourless eye drop solution.

Dorzolamide/Timolol Viatris is supplied in a white opaque high-density polyethylene bottle with a low-density polyethylene dropper tip and a high-density polyethylene cap with a tamper-evident band, containing 5 ml of ophthalmic solution.

Pack sizes: 1, 3 or 6 bottles of 5 ml each.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Pharmathen S.A.
6 Dervenakion str., 15351 Pallini, Attiki
Greece

or

Famar S.A.
Plant A
63 Agiou Dimitriou Street, 174 56 Alimos
Greece

or

Viatris Sante
1 Rue de Turin
69007 Lyon
France

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Dorzolamid + Timolol Viatris 20 mg/ml + 5 mg/ml - Augentropfen
Belgium: TensocViatris 20 mg/ml + 5 mg/ml oogdruppels, oplossing
Denmark: Tirzopt
Spain: Dorzolamida/Timolol Viatris 20 mg/ml + 5 mg/ml colirio en solución
France: Dorzolamide/Timolol Viatris 20 mg/ml + 5 mg/ml, collyre en solution
Italy: Dorzolamide e timololo Mylan Generics
Netherlands: Dorzolamide/Timolol Viatris 20/5 mg/ml, oogdruppels, oplossing
Portugal: Timolol + Dorzolamida Mylan
United Kingdom: Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops, solution
(Northern Ireland)
Czech Republic: Dorzogen Combi

Date of the most recent review of this leaflet: January 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/