DORZOLAMIDE/TIMOLOL VIR 20 mg/mL + 5 mg/mL EYE DROPS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamida/Timolol Vir 20 mg/ml + 5 mg/ml eye drops, solution

Read 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Dorzolamida/Timolol Vir and what is it used for
2. What you need to know before you use Dorzolamida/Timolol Vir
3. How to use Dorzolamida/Timolol Vir
4. Possible side effects
5. Storage of Dorzolamida/Timolol Vir
6. Contents of the pack and other information

1. What is Dorzolamida/Timolol Vir and what is it used for

Dorzolamida/Timolol Vir is a combination of two medicines: dorzolamida and timolol.

• Dorzolamida belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers".

These medicines reduce 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 alone is not adequate.

2. What you need to know before you use Dorzolamida/Timolol Vir

Do not use Dorzolamida/Timolol Vir

• if you are allergic to dorzolamida hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
• if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that may cause wheezing, difficulty breathing and/or prolonged coughing)
• if you have a slow heart rate, heart failure or heart rhythm disturbances (irregular heartbeats);
• if you suffer from severe kidney disease or a history of kidney stones.

• if you have excess acidity of the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are not sure if you should use this medicine, consult your doctor or pharmacist

Warnings and precautions

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

Tell your doctor about any current or past health problems, such as:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or shortness of breath) heart failure, low blood pressure.
• heart rhythm disturbances such as decreased 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.
• overactivity of the thyroid gland, as timolol may mask signs and symptoms.

Tell your doctor before you have surgery that you are using dorzolamida/timolol, as timolol may affect the effects of some medicines used during anesthesia.

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

Tell your doctor if you have muscle weakness or if you have been diagnosed with severe myasthenia.

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

If you suspect that dorzolamida/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 consult your doctor immediately.

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

When dorzolamida/timolol is instilled in the eye, it can affect the whole body.

Children

There is limited experience with Dorzolamida/Timolol Vir in infants and children.

Use in elderly patients

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

Use in patients with liver impairment

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

Other medicines and Dorzolamida/Timolol Vir

Dorzolamida/Timolol may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines or medicines to treat diabetes.

Tell 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 diseases (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 parasympathomimetic drug that may have been prescribed to help you urinate. Parasympathomimetics are also a type of medicine that is sometimes used to help restore normal movement through the intestine.
• taking narcotics, such as morphine, used to treat moderate to severe pain taking medicines to treat diabetes.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfonamide.
• taking quinidine (used to treat heart disorders and some types of malaria).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

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

Ask your doctor for advice before taking 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 side effects associated with dorzolamida/trimolol such as blurred vision, which may affect your ability to drive or use machines. Do not drive or operate machinery until you feel well or your vision is clear.

Dorzolamida/Timolol Vir contains benzalkonium chloride

This medicine 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 medicine and wait 15 minutes before putting them back.

Benzalkonium chloride can cause eye irritation, especially if you have dry eyes or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

3. How to use Dorzolamida/Timolol Vir

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

The recommended dose is one drop in the affected eye(s) in the morning and at night.

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

Do not change the dose of the medicine without consulting your doctor.

Do not let the tip of the container touch the eyes or the areas surrounding them. It may be contaminated with bacteria that can cause eye infections that can lead to serious damage to the eyes and even loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and avoid touching the tip of the container to any surface. If you think your medicine may be contaminated, or if you develop an eye infection, consult your doctor immediately to find out if you can continue using this container.

Instructions for use:

Do not use the container if the plastic security strip around the neck of the container is missing or broken. When you open the container for the first time, remove the plastic security strip.

1 2

Every time you use Dorzolamida/Timolol Vir

1. Wash your hands.
2. Open the container. Be careful not to touch the tip of the dropper with 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 the lower eyelid down and look up. Hold the container by the flat sides and gently squeeze it to release one drop into the space between the lower eyelid and the eye.
5. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the medicine from reaching the rest of your body.
6. Repeat steps 3 to 5 in the other eye, if your doctor has told you to do so.
7. Put the cap back on and close the container tightly.

If you use more Dorzolamida/Timolol Vir than you should

If you apply too many drops in the eye or swallow some of the contents of the bottle, among other effects, you may feel dizzy, have difficulty breathing, or notice that your heart beats more slowly.

If you have any of these symptoms, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: (91) 562 04 20 indicating the medicine and the amount ingested.

If you forget to use Dorzolamida/Timolol Vir

It is important to administer this medicine as your doctor has indicated.

If you forget to apply a dose, you should 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 normal dosing schedule.

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

If you stop using Dorzolamida/Timolol Vir

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious 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 reaction to the medicine.

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

Usually, you can continue using the drops, unless the 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 with 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 itching of the eyes, erosion of the cornea (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 that something is in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or congestion in the nose), nausea, weakness/fatigue and tiredness.

Uncommon (may affect up to 1 in 100 people)

dizziness, depression, inflammation of the iris, vision changes, including changes in refraction (in some cases due to the 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 (an immune disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, transient myopia that resolves when therapy is stopped, detachment of the layer under the retina that contains blood vessels after filtration surgery that can cause vision changes, drooping eyelid (making the eye stay half-closed), double vision, crusts on the eyelid, swelling of the cornea (with symptoms of vision changes), low eye pressure, ringing in the ears, low blood pressure, changes in heart rate and blood pressure.

Frequency not known (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, hallucinations and sensation of a foreign body in the eye (sensation of having something in the eye), strong and rapid or irregular heartbeats (palpitations), increased heart rate and blood pressure.

Reporting of side effects:

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

5. Storage of Dorzolamida/Timolol Vir

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

Do not use this medicine after the expiry date that appears on the container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions

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

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dorzolamida/Timolol Vir

• The active ingredients 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 injectable preparations.

Appearance of the Product and Package Contents

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

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

Package size: 1 bottle of 5 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Quimica Y Farmaceutica Vir, S.A.

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

28923- Alcorcón (Madrid)

Spain

Manufacturer:

FAMAR S.A.

Plant A, 63 Agiou Dimitriou Street,

17456 Alimos, Athens

Greece

or

PHARMATHEN S.A.

Dervenakion 6,

15351 Pallini, Attiki

Greece

This medication is authorized in the member states of the European Economic Area under the following names:

Portugal: Timolol + Dorzolamida Germed

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

Date of the last revision of this prospectus: January 2023

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