PATIENT INFORMATION LEAFLET

Dorzolamide/Timolol Eye Drops 20 mg/ml + 5 mg/ml

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Dorzolamida/Timolol Vir is a combination of 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".

These medications lower eye pressure in different ways.

Dorzolamida/Timolol Vir is prescribed to reduce 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 Vir

• If you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other components of this medication (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or prolonged 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 blood acidity caused by a buildup of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether to use this medication, consult your doctor or pharmacist.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Dorzolamida/Timolol Vir.

Inform your doctor of any current or past health problems, such as:

• Coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or a feeling of suffocation) heart failure, low blood pressure.
• Irregular heart rhythms, such as a decrease in heart rate.
• Respiratory problems, asthma, or chronic obstructive pulmonary 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.
• Hypothyroidism, as timolol may mask signs and symptoms.

Inform your doctor before undergoing surgery that you are using dorzolamide/timolol, as timolol may affect the effects of some anesthetics.

Also inform your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.

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

If you develop any other eye irritation or new eye problems, such as eye redness or swelling of the eyelids, consult your doctor immediately.

If you suspect that dorzolamide/timolol is causing an allergic reaction or hypersensitivity (such as skin rash, severe skin reaction, or eye redness and itching), stop using this medication and consult your doctor immediately.

Inform your doctor if you develop an eye infection, if you have an eye injury, if you undergo eye surgery, or if you develop a reaction that includes new symptoms or worsening of existing ones.

Dorzolamide/timolol may affect the entire body when instilled in the eye.

Children

There is limited experience withDorzolamida/Timolol Virin infants and children.

Use in elderly patients

In studies with Dorzolamida/Timolol, the effects were similar in both elderly patients and younger patients.

Use in patients with liver impairment

Inform your doctor if you have or have had liver problems.

Other medications and Dorzolamida/Timolol Vir

Dorzolamide/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, medications for the heart, or medications to treat diabetes.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is particularly important if you are:

• Taking medications to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta blockers, or digoxin).
• Using another eye drop that contains beta blockers.
• Taking another carbonic anhydrase inhibitor, such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs).
• Taking a parasymptomatic mimetic that may have been prescribed to help you urinate. Parasymptomatic mimetics are also a type of medication that may be used to help restore normal movements through the intestine.
• Taking narcotics, such as morphine, used to treat moderate to severe pain.
• Taking medications to treat diabetes.
• Taking antidepressants known as fluoxetine and paroxetine.
• Taking a sulfonamide.
• Taking quinidine (used to treat heart rhythm disorders and some types of malaria).

Pregnancy, breastfeeding, and fertility

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

Do not use Dorzolamida/Timolol during pregnancy unless your doctor considers it necessary.

Do not use Dorzolamida/Timolol if you are breastfeeding your child. Timolol may pass into breast milk.

Ask your doctor for advice before taking any medication during 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 dorzolamide/timolol, such as blurred vision, which may affect your ability to drive or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

Dorzolamida/Timolol Vir contains benzalkonium chloride

This medication contains approximately 0.002 mg of benzalkonium chloride in each drop, equivalent to 0.075 mg/ml.

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. Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will establish the appropriate dosage and treatment duration.

The recommended dose is one drop in the affected eye or eyes in the morning and at night.

If you use this medication at the same time as another eye drop, the drops should be applied at least 10 minutes apart.

Do not change the medication dose without consulting your doctor. .

Do not let the tip of the container touch your eyes or the surrounding areas. It may be contaminated with bacteria capable of causing eye infections that can cause severe eye damage and 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 think your medication may be contaminated, or if you develop an eye infection, consult your doctor immediately to find out if you can continue using this container.

Usage Instructions:

Do not use the container if the plastic safety strip around the neck of the container is not there or if it is broken. When opening the container for the first time, remove the plastic safety strip.

1 2

Each time you use Dorzolamida/Timolo Vir

1. Wash your hands.
2. Open the container. Be careful to avoid letting the tip of the dropper touch your eye, the skin around your eye, or your fingers.
3. Tilt your head back and hold the container upside down over your eye.
4. Pull your lower eyelid down and look up. Hold and squeeze the container gently by the flat sides and let one drop fall into the space between your lower eyelid and your eye.
5. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the medication from entering your body.
6. Repeat steps 3 to 5 in the other eye, if your doctor has instructed you to do so.
7. Replace the cap and close the container tightly.

If you use more Dorzolamida/Timolol Vir than you should

If too many drops are applied to the eye or if you swallow some of the contents of the container, among other effects, you may feel drowsy, have difficulty breathing, or notice that your heart is beating more slowly.

If you experience any of these symptoms, consult your doctor 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 forget to use Dorzolamida/Timolol Vir

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

If you forget to apply 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 Vir

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

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

Generalized reactions including swelling under the skin that may occur in areas such as the face and limbs, and may obstruct the airways, causing difficulty swallowing, shortness of breath, hives or rash, generalized and localized eruption, itching, severe allergic reaction that suddenly puts life at risk.

You can usually continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using this medicine without talking to your doctor.

The following adverse reactions have been reported with this medicine or one of its components during clinical trials or after marketing:

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

Burning and stinging of the eyes, alteration of taste

Common (may affect up to 1 in 10 people):

Redness in and around the eye or eyes, tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye or eyes, sensation of having something in the eye, decreased sensitivity of the cornea (does not appreciate having something in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (sensation of tension or congestion in the nose), nausea, weakness/fatigue and tiredness.

Rare (may affect up to 1 in 100 people)

Dizziness, depression, iris inflammation, vision changes, including refractive changes (in some cases due to suspension of miotic therapy), decreased heart rate, fainting, shortness of breath, indigestion and kidney stones.

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

Systemic lupus erythematosus (a disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscular disorder), decreased libido, stroke, transient myopia that resolves upon cessation of therapy, retinal detachment that contains blood vessels after surgery that can cause visual disturbances, drooping eyelid (causing the eye to remain half-closed), double vision, crusts on the eyelid, corneal edema (with visual disturbance symptoms), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or speed, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, palpitations, heart attack, Raynaud's phenomenon, swollen or cold hands and feet and decreased circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, pulmonary function deterioration, nasal congestion or discharge, nasal bleeding, bronchial constriction in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasiform eruption with a silver-white appearance, Peyronie's disease (which can cause penile curvature), allergic reactions such as skin rash, hives, itching, 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 blood. 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 medications, for example, are taken orally or injected. Additional listed side effects 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 alteration, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucinations, and sensation of a foreign body in the eye (sensation of having something in the eye), palpitations, increased heart rate, and 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions

Once the bottle is opened, use Dorzolamida/Timolol Vir within the 28 days that follow. Therefore, you must discard the bottle 4 weeks after opening it, even if there is still some solution left. To help you remember, note the date you opened the bottle in the space on the packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dorzolamida/Timolol Vir

• The active principles are dorzolamida and timolol. Each ml contains 22.26 mg of dorzolamida hydrochloride corresponding to 20 mg of dorzolamida and 6.83 mg of timolol maleate corresponding to 5 mg of timolol.
• The other components are mannitol (E421), hydroxyethyl cellulose, benzalkonium chloride (as a preservative), sodium citrate (E331), sodium hydroxide (E524) to adjust the pH, and water for injections.

Appearance of the product and contents of the packaging

Your medicine is a sterile, transparent, slightly viscous, aqueous, and colorless eye drop solution.

Dorzolamida/Timolol Vir is presented in a white opaque polyethylene medium-density bottle with a low-density polyethylene dropper and a polyethylene high-density safety cap, containing 5 ml of eye drop solution.

Packaging size: 1 bottle of 5 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Industria Quimica Y Farmaceutica Vir, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid)

Spain

Responsible for manufacturing:

FAMAR S.A.

Plant A, 63 Agiou Dimitriou Street,

17456 Alimos, Athens

Greece

or

PHARMATHEN S.A.

Dervenakion 6,

15351 Pallini, Attiki

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Timolol + Dorzolamida Germed

Spain: Dorzolamida/Timolol Vir 20mg/ml + 5mg/ml eye drops in solution

Last review date of this leaflet: January 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es