Dorzolamide/timolol Vir 20 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamide/Timolol Vir 20 mg/ml + 5 mg/ml eye drops solution

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Dorzolamida/Timolol Vir is a combination of 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 eye pressure in different ways.

Dorzolamida/Timolol Vir is prescribed to reduce 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 Vir

Do not use Dorzolamide/Timolol Vir

• 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 respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged 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 blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis)

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Dorzolamide/Timolol Vir.

Inform your doctor about any current or past medical conditions, such as:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation), heart failure, low blood pressure
• heart rhythm disorders such as reduced heart rate
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• circulatory disorders (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

Inform your doctor before undergoing surgery that you are using dorzolamide/timolol, as timolol may alter the effects of certain medications used during anesthesia.

Also inform your doctor about 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 have been diagnosed with myasthenia gravis.

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 dorzolamide/timolol is causing you an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eyes), stop using this medicine and consult your doctor immediately.

Inform your doctor if an eye infection occurs, if you suffer an eye injury, if you undergo eye surgery, or if you develop a reaction involving new symptoms or worsening of existing ones.

When dorzolamide/timolol is instilled into the eye, it may affect the entire body.

Children

Limited experience is available with Dorzolamide/Timolol Vir in infants and children.

Use in elderly patients

In studies with Dorzolamide/Timolol, effects were similar in elderly and younger patients.

Use in patients with hepatic impairment

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

Other medicines and Dorzolamide/Timolol Vir

Dorzolamide/Timolol may affect or be affected by other medicines you are taking, including other eye drops for the treatment of 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 need to 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)
• using another eye drop containing 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 specific type of medicine sometimes used to help restore normal intestinal movements
• 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Seek advice from your doctor before taking any medicine while breastfeeding.

Driving and use of 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 or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

Dorzolamide/Timolol Vir contains benzalkonium chloride

This medicine contains approximately 0.002 mg of benzalkonium chloride per 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 reinserting them.

Benzalkonium chloride may cause ocular 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 Vir

Follow exactly the instructions for using this medicine as given by your doctor. If in 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 are using this medicine at the same time as 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 let the tip of the container touch the eyes or surrounding areas. It may become contaminated with bacteria that can cause eye infections leading 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 be contaminated, or if you develop an eye infection, consult your doctor immediately to determine whether you should 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 opening the container for the first time, remove the plastic security strip.

1 2

Each time you use Dorzolamida/Timolol Vir

1. Wash your hands.
2. Open the container. Take special care to avoid letting the tip of the dropper touch your eye, the skin around the eye, or your fingers.
3. Tilt your head backward and hold the container upside down over the eye.
4. Pull the lower eyelid down and look upward. Hold and gently squeeze the container at the flattened sides and instill one drop into the space between the lower eyelid and the eye.
5. Close your eye and press gently on the inner corner of the eye with your finger for about two minutes. This helps prevent the medicine from draining into the rest of the body.
6. Repeat steps 3 to 5 in the other eye, if instructed by your doctor.
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 into the eye or if some of the contents are swallowed, you may experience, among other effects, dizziness, difficulty breathing, or a slower heartbeat.

If you experience any of these symptoms, consult your doctor 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 Vir

It is important to use this medicine as directed 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, do not take the missed dose and continue with your regular dosing schedule.

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

If you stop using Dorzolamida/Timolol Vir

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

If you have any further questions about the use of this product, 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 consult your doctor immediately, as they may be signs of a reaction to the medicine.

Generalized reactions including swelling under the skin that may occur in areas such as the face and limbs, and may obstruct the airways, possibly causing difficulty swallowing, shortness of breath, hives or itchy rash, generalized and localized rash, itching, or a severe allergic reaction that suddenly becomes life-threatening.

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 this medicine without speaking 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, altered taste

Common (may affect up to 1 in 10 people):
Redness of and around the eye(s), tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation of and around the eye(s), sensation of a foreign body in the eye, decreased corneal sensitivity (inability to perceive that something is in the eye and absence of pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), nausea, weakness/tiredness and fatigue.

Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, iris inflammation, visual disturbances, including changes in refraction (in some cases due to discontinuation 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 may cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, stroke, transient myopia that resolves upon discontinuation of therapy, detachment of the blood vessel-containing layer of the retina after filtration surgery which may cause visual disturbances, drooping eyelid (causing the eye to remain partially closed), double vision, eyelid crusting, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in the rhythm or rate of heartbeat, 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, strong heartbeats that may be rapid or irregular (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), difficulty breathing, worsening of lung function, runny or stuffy nose, nosebleeds, narrowing of the airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with a silvery 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 medicines are taken orally or injected. The additional adverse effects listed include reactions known to occur 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 exercise, sexual dysfunction, hallucinations, and sensation of a foreign body in the eye (feeling of something in the eye), strong heartbeats that may be rapid or irregular (palpitations), increased heart rate and blood pressure.

Reporting of adverse effects:

If you experience any adverse effect, consult 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 Vir

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After opening the bottle, use Dorzolamide/Timolol Vir within 28 days. Therefore, the bottle must be discarded 4 weeks after opening, even if some solution remains. To help you remember, write down the date you opened the bottle in the space provided on the packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dorzolamida/Timolol Vir

• The active substances are dorzolamide and timolol. Each ml contains 22.26 mg of dorzolamide hydrochloride, equivalent to 20 mg of dorzolamide, and 6.83 mg of timolol maleate, equivalent 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 pH, and water for injections.

Appearance of the medicine and contents of the pack

Your medicine is a sterile, transparent, slightly viscous, aqueous, and colourless ophthalmic drop solution.

Dorzolamida/Timolol Vir is supplied in a white opaque high-density polyethylene bottle with a low-density polyethylene dropper tip and a high-density polyethylene safety seal cap, containing 5 ml of ophthalmic solution.

Pack 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 medicine 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 drops solution

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

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