Label: Information for the User

Dorzolamida/Timolol Stada 20 mg/ml + 5 mg/ml Eye Drops Solution

Read this label carefully before starting to use this medication, as 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 to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. How to use Dorzolamida/Timolol Stada
2. Possible adverse effects

1. Storage of Dorzolamida/Timolol Stada
2. Contents of the package and additional information

Dorzolamida/Timolol Stada 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".

Dorzolamida/Timolol Stada 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 suitable.

Do not use Dorzolamida/Timolol Stada

• If you are allergic to dorzolamida or timolol, beta-blockers 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 bronchitis (serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough).
• If you have a severe kidney disease, or a history of kidney stones.
• If you have alterations in blood pH (acid-base balance).
• If you have certain heart diseases, including certain heart rhythm disorders that can cause an abnormally slow or acute heart failure.

If you think you have any of these conditions, do not use Dorzolamida/Timolol Stada until you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dorzolamida/Timolol Stada, especially if you have now or have had in the past:

• Coronary heart disease (symptoms may include chest pain [even at rest] or feeling of oppression, shortness of breath or asphyxia), heart failure, low blood pressure.
• Respiratory problems, asthma or chronic obstructive pulmonary disease.
• Circulatory blood insufficiency disease (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes as timolol may mask the signs and symptoms of hypoglycemia.
• Hyperactivity of the thyroid gland as timolol may mask the signs and symptoms.
• Any allergy to a medication you have taken.

Inform your doctor before undergoing surgery that you are using Dorzolamida/Timolol Stada as dorzolamida/timolol may change the effects of some medications used during anesthesia. There may be a sudden drop in blood pressure associated with the use of anesthetic.

Inform your doctor if you have or have had liver abnormalities, if you have muscle weakness or have been diagnosed with myasthenia gravis.

If you develop conjunctivitis (irritation or redness of the eyes), swelling in the eyes or eyelids, skin rash or itching around the eye, consult your doctor immediately. These symptoms may be due to an allergic reaction or be an adverse effect of Dorzolamida/Timolol Stada (see section 4 "Possible adverse effects").

If you suspect that this medication is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction or redness and itching in the eye), stop using this medication and contact your doctor immediately.

Inform your doctor if you develop an eye infection, if you suffer an eye injury, if you undergo eye surgery or if you develop other reactions that include new symptoms or worsening of symptoms.

If you use soft contact lenses, it is essential to remove them before application, and wait at least 15 minutes before reinserting them, as the preservative benzalkonium chloride may alter the color of your soft contact lenses.

Children

The experience on the use of Dorzolamida/Timolol Stada in infants and children is limited.

Advanced age

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

Use in athletes

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

Other medications and Dorzolamida/Timolol Stada

Dorzolamida/Timolol Stada may affect or be affected by other medications you are using, including other eye drops for the treatment of glaucoma. Inform your doctor if you are using or think you may use medications to reduce heart pressure, heart medications or diabetes medications.

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

Taking anti-hypertensive medications to reduce blood pressure or medications to treat heart diseases, such as calcium channel blockers, beta-blockers or digoxin.

• Taking medications to treat irregular heart rhythm such as quinidine (also used to treat certain types of malaria) or digoxin.
• Using another eye drop that contains beta-blockers.
• Using another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medication orally, as eye drops or any other method.
• Taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine and paroxetine) used to treat depression or other diseases.
• Taking a parasymptomatic mimetic that may have been prescribed to help eliminate urine. Parasymptomatic mimetics are also a type of medication that in some cases is used to help restore normal movements through the intestine.
• Taking narcotics, such as morphine used to treat moderate to severe pain or if you are taking high doses of aspirin. Although there is no evidence that hydrochloride of dorzolamida interacts with aspirin, some other medications related to hydrochloride of dorzolamida, administered orally, interact with aspirin.

• Taking medications to treat diabetes or have high blood sugar levels.
• Taking epinephrine (adrenaline).

Pregnancy and breastfeeding

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

Do not use Dorzolamida/Timolol Stada if you are pregnant, unless your doctor considers it necessary.

Inform your doctor if you are pregnant or intend to become pregnant.

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

Inform your doctor if you are breastfeeding your child or intend to do so.

Driving and operating machines

Dorzolamida/Timolol Stada may cause adverse effects, such as blurred vision, in some patients. Do not drive or operate machines until this effect has disappeared.

Dorzolamida/Timolol Stada contains benzalkonium chloride

This medication contains 0.075 mg of benzalkonium chloride in each ml.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). 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.

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

Adults

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

If you use Dorzolamida/Timolol Stada at the same time as another eye drop, the drops must be applied at least 10 minutes apart.

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

Do not let the tip of the container touch your eyes or surrounding areas. It may be contaminated with bacteria capable of causing eye infections that can cause serious eye damage, including loss of vision. To avoid possible contamination of the container, avoid letting the tip of the container come into contact with any surface.

To ensure correct dosing, the tip of the dropper should not be widened.

Usage Instructions:

It is recommended that you wash your hands before administering the eye drop solution. It may be easier to administer it in front of a mirror.

1. Before using the medication for the first time, make sure the safety seal on the neck of the bottle is intact. When the bottle has not been opened yet, it is normal for there to be a space between the bottle and the cap.

1. Remove the cap from the bottle.

1. Incline your head back and separate the lower eyelid slightly, forming a small separation between the eyelid and the eye.

1. Invert the bottle, and press until one drop is dispensed into the eye according to your doctor's instructions. DO NOT TOUCH THE EYE OR EYELID WITH THE TIP OF THE DROPPER.

1. After using Dorzolamida/Timolol Stada, close your eye and press the inner corner of your eye with your finger for about 2 minutes. This helps prevent the medication from entering the rest of your body.

1. Repeat steps 3 and 4 in the other eye if your doctor has instructed you to do so.

1. Close the cap and close the bottle immediately after use.

If you use more Dorzolamida/Timolol Stada than you should

It is essential to maintain the dosage prescribed by your doctor. If too many drops are applied to the eye or if you swallow some of the contents of the bottle, you may feel unwell, for example, dizziness, difficulty breathing, or a slower heart rate. If you notice any of the mentioned effects, 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 forget to use Dorzolamida/Timolol Stada

It is essential to administer Dorzolamida/Timolol Stada as instructed by your doctor.

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 Stada

If you must interrupt treatment, consult your doctor immediately.

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

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

Severe side effects

If you develop any of the following side effects, stop using this medication and seek immediate medical advice, as these may be signs of an allergic reaction to the medication:

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

• Hives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, you should stop using Dorzolamida/Timolol Stada and inform your doctor immediately.
• Severe skin reactions with blisters on the skin that may affect the mouth, eyes, and genitals.

Other side effects

You may continue using the drops, unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Dorzolamida/Timolol Stada without consulting your doctor.

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 around the eye or eyes, tearing or eye itching, and effects on the surface of the eye or eyes, inflammation and/or irritation in and around the eye or eyes, sensation of having something in the eye (corneal erosion), decreased sensitivity of the cornea (does not appreciate that there is 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 and fatigue.

Uncommon (may affect up to 1 in 100 people):

Dizziness, depression, inflammation of the iris, blurred vision (in some cases due to suspension of the medication for treatment of excessive contraction of the pupil of the eye), decreased heart rate, fainting, indigestion and kidney stones (often characterized by a sudden onset of pain and cramps with pain in the lower and/or lateral back, groin or abdomen).

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, muscle weakness, decreased libido, stroke, transient myopia that resolves with cessation of therapy, development of fluid under the retina (choroidal detachment after surgery), drooping eyelid, double vision, crusts on the eyelid, corneal edema (with visual disturbance symptoms), low eye pressure, ringing in the ear, low blood pressure, irregular heartbeats, chest pain, palpitations, heart attack, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), reduced blood flow to the brain, hands and feet swollen or cold and decreased circulation in your arms or legs, decreased circulation that causes numbness of the fingers of the hands and feet and color change (Raynaud's phenomenon), leg cramps and/or pain when walking (claudication), shortness of breath, lack of breathing, nasal congestion or runny nose, nosebleed, difficulty breathing, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie's disease (which can cause curvature of the penis), weakness/ fatigue, generalized allergic reactions including swelling in the skin in areas such as the face (swelling of the lips, eyes, and mouth) and extremities, and that may obstruct the airways causing difficulty swallowing or breathing, wheezing. Urticaria or localized and generalized rash, itching, sudden severe allergic reaction that may put your life at risk.

Like other eye medications, timolol is absorbed into the blood. This can cause side effects similar to those seen with intravenous and/or oral beta-blockers. The incidence of side effects after topical ocular administration is lower than when the medications are, for example, taken orally or injected. The list of side effects includes reactions observed within the class of beta-blockers when used to treat eye diseases:

Unknown (frequency cannot be estimated from available data):

Low blood sugar levels.

Heart failure.

Increased heart rate.

Increased blood pressure.

Abdominal pain, vomiting.

Muscle pain not caused by exercise.

Sexual dysfunction.

Difficulty breathing

Sensation of a foreign body in the eye (sensation of something in the eye)

Hallucinations

Reporting 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 medication.

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 temperature.

Dorzolamida/Timolol Stada must be used within 28 days after the first opening. Therefore, discard the bottle 4 weeks after its first opening, even if there is still some solution left. To help remember the date, indicate the opening date in the case's space.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Dorzolamida/Timolol Stada

• The active principles are dorzolamida and timolol. Each ml contains 20 mg of dorzolamida (as 22.26 mg of dorzolamida hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).

• The other components are mannitol (E421), hydroxyethylcellulose, benzalkonium chloride (as a preservative), sodium citrate (E331), sodium hydroxide (E524) for pH adjustment, and water for injection preparations.

Appearance of the product and contents of the packaging

Dorzolamida/Timolol Stada is a sterile, clear, slightly viscous, and colorless aqueous eye drop solution.

Dorzolamida/Timolol Stada is presented in an eye drop dispenser bottle, white, opaque, made of medium-density polyethylene, with a low-density polyethylene dropper, sealed with a high-density polyethylene screw cap, and containing 5 ml of eye drop solution.

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible manufacturer

Pharmathen S.A.

6 Dervenakion str.,

15351 Pallini, Athens

Greece

or

Famar S.A.,

Plant A

63 Agiou Dimitriou Street,

174 56 Alimos

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GMBH

Muthgasse 36,

1190 Vienna

Austria

or

Eurogenerics N.V.

Heizel Esplanade B22,

1020 Brussels

Belgium

Last review date of this leaflet:February 2023

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