Dorzolamida/timolol viatris 20 mg/ml + 5 mg/ml colirio

Label: information for the patient

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

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist,even if the adverse effects do not appear in this label.See section 4.

1.What isDorzolamida/Timolol Viatrisand for what it is used

2.What you need to know before starting to useDorzolamida/Timolol Viatris

3.How to useDorzolamida/Timolol Viatris

4.Possible adverse effects

5.Storage ofDorzolamida/Timolol Viatris

6.Contents of the package and additional information

Dorzolamida/Timolol Viatris contains two medications: dorzolamida and timolol.

•Dorzolamida belongs to a group of medications called "carbonic anhydrase inhibitors".

•Timolol belongs to a group of medications called "beta blockers".

This medication reduces eye pressure in several ways.

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

No use Dorzolamida/Timolol Viatris:

• If you are allergic to dorzolamida, timolol or any of the other components of this medication (including those listed in section 6).
• If you currently have or have had respiratory problems, such as asthma or chronic obstructive pulmonary disease (COPD) severe (serious lung disease that can cause wheezing, difficulty breathing and/or long-term coughing).
• If you have a slow heart rate, heart failure or irregular heart rhythms.
• If you have severe kidney disease or a history of kidney stones.
• If you have excessive acidity in the blood as a result of a buildup of chloride in the blood (hyperchloremic acidosis).

If you are unsure about using this medication, consult your doctor or pharmacist.

Warnings and Precautions

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

• Coronary heart disease (symptoms may include chest tightness or pain, shortness of breath or asphyxia), heart failure or low blood pressure.
• Irregular heart rhythms, such as a slow heart rate.
• Respiratory problems, asthma or chronic obstructive pulmonary disease.
• Circulatory disorders, such as Raynaud's disease or syndrome.
• Diabetes or hypoglycemia (low blood sugar levels), as timolol may mask the signs and symptoms of hypoglycemia.
• Hyperthyroidism, as timolol may mask the signs and symptoms.

Before undergoing surgery, inform your doctor that you are using dorzolamida/timolol, as timolol may affect the effects of some medications used during anesthesia. Also, inform your doctor of any allergies or allergic reactions, including urticaria, facial swelling, lip, tongue and/or throat swelling; as they may cause difficulty breathing or swallowing.

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

Inform your doctor immediately if you experience eye irritation or any new reaction in the eye, such as redness or inflammation of the eyelid.

If you suspect that dorzolamida/timolol is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction or redness and itching in the eye), discontinue use of this medication 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 worsening of symptoms.

Instilling dorzolamida/timolol in the eye may affect the body as a whole.

Children

There is limited experience with the use of dorzolamida/timolol in infants, children and adolescents.

Older patients

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

Patients with liver insufficiency

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

Athletes

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

Other medications and Dorzolamida/Timolol Viatris

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Do not use dorzolamida/timolol if you are breastfeeding your child. Timolol may reach the breast milk. Consult your doctor before taking any medication if you are breastfeeding.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive or operate machinery. There are adverse effects associated with dorzolamida/timolol, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate tools or machinery until you feel well or your vision is correct.

Dorzolamida/Timolol Viatris contains benzalkonium chloride

This medication contains 0.15 mg of benzalkonium chloride in each milliliter of eye drop solution.

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

If you use this medication with another eye drop, leave at least 10 minutes between the application of dorzolamida/timolol and the other medication.

Do not change the dose of this medication without consulting your doctor. If you must interrupt treatment, contact your doctor immediately.

Do not let the tip of the container touch the eye or the surrounding area. You may contaminate it with bacteria capable of causing eye infections that can cause serious eye damage, even vision loss. To avoid possible contamination of the container, wash your hands before using this medication and avoid letting the tip of the container come into contact with any surface. If you believe your medication may have been contaminated, or if you develop an eye infection, consult your doctor immediately to find out if you should continue using this container.

To ensure a correct dose - do not enlarge the hole in the tip of the dispenser.

Usage Instructions:

Do not use this eye drop if the plastic safety strip is not in place or is broken. To open the container for the first time, tear off the plastic safety strip.

Each time you use this medication:

1.Wash your hands.

2.Open the bottle. Be careful not to let the tip of the bottle touch the eye, the surrounding skin, or your fingers.

3.Tilt your head back and hold the bottle upside down over the eye.

4.Slowly pull the lower eyelid down and look up. Hold and gently squeeze the container on the sides, allowing one drop to fall into the space between the lower eyelid and the eye.

5.Close your eye and press the inner corner of the eye with your finger for two minutes. This helps the medication not to spread to the rest of the body.

6.Repeat steps 3-5 in the other eye if your doctor has instructed you to do so.

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 essential to maintain the dose prescribed by your doctor. If too many drops are applied to the eye or if you swallow something from the container, you may feel unwell, for example, you may experience a headache, feel tired or dizzy, feel disoriented, have difficulty breathing, experience dyspnea, or notice that your heart beats slower. If you experience any of these effects, you should seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Dorzolamida/Timolol Viatris

It is essential to administer this medication as instructed by your doctor.

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

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Dorzolamida/Timolol Viatris

If you want to interrupt treatment with this medication, consult your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Severe side effects

If you experience any of the following side effects, stop using this medication and speak immediately with your doctor, as they may be signs of a medication reaction.

You may experience general allergic reactions, including skin inflammation in areas such as the face and extremities, and that may obstruct airways, causing difficulty swallowing, shortness of breath, urticaria or skin rash, localized or generalized rash, itching, severe, sudden, and fatal reactions.

Generally, you can continue using the drops unless the side effects are severe. If you are concerned, consult with your doctor or pharmacist. Do not stop using dorzolamide/timolol without speaking with your doctor first.

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

Very common(may affect more than1 in 10 people)

Common(may affect up to1 in 10 people)

Uncommon(may affect up to1 in 100 people)

• Dizziness.
• Depression.
• Iritis inflammation.
• Visual disturbances, including refractive changes (in some cases due to suspension of medication to treat excessive pupil constriction).
• Slow heart rate.
• Fainting.
• Shortness of breath.
• Feeling of shortness of breath.
• Indigestion.
• Kidney stones (often characterized by the sudden onset of a severe, spasmodic, and intense pain in the lumbar, lateral, inguinal, or abdominal area).

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

• SLE (systemic lupus erythematosus) (a type of autoimmune disease that can cause inflammation of internal organs) with symptoms such as joint pain (similar to rheumatoid arthritis), fever, changes in blood counts, and skin rashes.
• Tickling or numbness in the hands or feet.
• Difficulty sleeping.
• Nightmares.
• Memory loss.
• Increased signs and symptoms of myasthenia gravis (muscular disorder).
• Decreased libido.
• Stroke.
• Myopia that may resolve after stopping treatment.
• Retinal detachment that may occur after surgery, causing visual disturbances.
• Eye drooping (causing the eyes to be half-closed).
• Diplopia.
• Crust formation on the eyelids.
• Keratitis inflammation (with visual disturbances).
• Low intraocular pressure.
• Tinnitus.
• Low blood pressure.
• Changes in heart rhythm or rate.
• Heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation).
• Edema (fluid accumulation).
• Cerebral ischemia (reduced blood flow to the brain).
• Chest pain.
• Palpitations.
• Myocardial infarction.
• Raynaud's phenomenon,swollen or cold hands and feet, and decreased circulation in the arms and legs.
• Leg cramps and/or pain when walking (claudication).
• Nasal secretion or nasal congestion.
• Nasal bleeding.
• Pulmonary bronchospasm.
• Cough.
• Throat irritation.
• Dry mouth.
• Diarrhea.
• Contact dermatitis.
• Hair loss.
• Psoriasiform rash with a silvery appearance.
• Peyronie's disease (which may cause penile curvature).
• Allergic reactions such as skin rash, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, shortness of breath, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the bloodstream. This can cause side effects similar to those that appear with oral beta-blockers. The incidence of side effects after topical ocular administration is lower than when the medications, for example, are taken orally or injected.

The additional side effects listed include reactions that appear within the class of beta-blockers when used to treat eye disorders.

Unknown frequency(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label of the bottle and on the boxafter CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not requireany special storage temperature. Store in the original packaging to protect it from light and humidity.

Dorzolamida/Timolol Viatris must be used within 28 days after the first opening of the bottle. Therefore, it must be discarded at four weeks after the first opening of the bottle, even if there is still solution left. To help you remember, note the date when you opened it in the space on the packaging.

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications that you do not need in the SIGRE pointof the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help to protect the environment.

Composition of Dorzolamide/Timolol Viatris

• The active ingredients 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 a preservative; see section 2 “Dorzolamide/Timolol Viatris contains the preservative benzalkonium chloride”), sodium citrate (E331), sodium hydroxide (E524), and water for injection.

Appearance of the product and contents of the package

The medicine is a sterile, transparent, slightly viscous, colorless aqueous solution.

Dorzolamide/Timolol Viatris is presented in a medium-density polyethylene bottle with a low-density tip-closed dropper and a high-density polyethylene cap with a safety strip, containing 5 ml of eye drops.

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization 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 Santé

1 Rue de Turin

69007 Lyon

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:Dorzolamide + Timolol Viatris 20 mg/ml + 5 mg/ml - Eye drops

Belgium:TensocViatris 20 mg/ml + 5 mg/ml eye drops, solution

Denmark:Tirzopt

Spain:Dorzolamide/Timolol Viatris 20 mg/ml + 5 mg/ml eye drops in solution

France:Dorzolamide/Timolol Viatris 20 mg/ml + 5 mg/ml, eye drops in solution

Italy:Dorzolamide and timolol Mylan Generics

Netherlands:Dorzolamide/Timolol Viatris 20/5 mg/ml, eye drops, solution

Portugal:Timolol + Dorzolamide Mylan

United Kingdom:Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops, solution

(Northern Ireland)

Czech Republic:Dorzogen Combi

Last review date of this leaflet:January 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/