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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire 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, and you must not give it to others, 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.

Contents of the leaflet

1. What Dorzolamide/Timolol Stada is and what it is used for

2. What you need to know before using Dorzolamide/Timolol Stada

3. How to use Dorzolamide/Timolol Stada

4. Possible adverse effects

5. How to store Dorzolamide/Timolol Stada

6. Contents of the pack and other information

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

Dorzolamida/Timolol Stada is a combination of two medicines: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines known as "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines known as "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 appropriate.

2. What you need to know before using Dorzolamide/Timolol Stada

DO NOT use Dorzolamide/Timolol Stada

• If you are allergic to dorzolamide or timolol, beta-blockers, or any of the other components of this medicine (listed in section 6).
• If you currently have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).
• If you have severe kidney disease or a history of kidney stones.
• If you have disturbances in blood pH (acid/base balance).
• If you have certain heart conditions, including certain heart rhythm disorders that may cause an abnormally slow pulse or acute heart failure.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dorzolamide/Timolol Stada, especially if you currently have or have previously had:

• Coronary heart disease (symptoms may include chest pain [even at rest] or tightness, shortness of breath, or suffocation), heart failure, low blood pressure.
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask the signs and symptoms of hypoglycemia.
• Overactive thyroid gland, as timolol may mask the signs and symptoms.
• Any allergy to a medicine you have taken.

Inform your doctor before undergoing surgery that you are using Dorzolamide/Timolol Stada, as dorzolamide/timolol may alter the effects of certain medications used during anesthesia. A sudden drop in blood pressure may occur with the use of anesthetics.

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

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

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

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

If you wear soft contact lenses, it is important to remove them before applying the drops, and wait at least 15 minutes before reinserting them, as the preservative benzalkonium chloride may change the color of your soft contact lenses.

Children

Experience with the use of Dorzolamide/Timolol Stada in infants and children is limited.

Elderly

In clinical studies with dorzolamide/timolol ophthalmic solution, the effects of dorzolamide/timolol ophthalmic solution were similar in elderly and younger patients.

Use in athletes

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

Other medicines and Dorzolamide/Timolol Stada

Dorzolamide/Timolol Stada 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 using or plan to use medicines to lower heart pressure, heart medications, or medicines to treat diabetes.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is particularly important if you are:

Taking antihypertensive medicines to lower blood pressure or medicines for heart conditions, such as calcium channel blockers, beta-blockers, or digoxin.

• Taking medicines for irregular or abnormal heartbeat such as quinidine (also used to treat certain types of malaria) or digoxin.

• Using another eye drop containing beta-blockers.

• Using another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine orally, as eye drops, or by another route.

• Taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine and paroxetine) used to treat depression or other conditions.

• Taking a parasympathomimetic drug that may have been prescribed to help with urination. 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, or if you are taking high doses of acetylsalicylic acid. Although there is no evidence that dorzolamide hydrochloride interacts with acetylsalicylic acid, some other medicines related to dorzolamide hydrochloride, when administered orally, do interact with acetylsalicylic acid.

• Taking medicines to treat diabetes or if you have high blood sugar levels.

• Taking epinephrine (adrenaline).

Pregnancy and breastfeeding

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 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 Dorzolamide/Timolol Stada if you are breastfeeding. Timolol may pass into breast milk.

Inform your doctor if you are breastfeeding or intend to breastfeed.

Driving and use of machines

Dorzolamide/Timolol Stada may cause adverse effects such as blurred vision in some patients. Do not drive or operate machinery until this effect has subsided.

Dorzolamide/Timolol Stada contains benzalkonium chloride

This medicine contains 0.075 mg of benzalkonium chloride per 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 eye irritation, especially if you have dry eye or other corneal conditions (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 Stada

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Adults

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

If you are using Dorzolamida/Timolol Stada together with another eye drop, the drops should be administered at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor. If you need to stop treatment, consult your doctor immediately.

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, avoid contact between the tip of the container and any surface.

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

Instructions for use:

It is recommended that you wash your hands before administering the eye drops. Administration may be easier if done in front of a mirror.

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

2. Remove the cap from the bottle.

3. Tilt your head backward and gently pull down the lower eyelid, creating a small pocket between the eyelid and the eye.

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

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

1. Repeat steps 3 and 4 in the other eye if instructed by your doctor.

2. Replace the cap and close the bottle immediately after use.

If you use more Dorzolamida/Timolol Stada than you should

It is important to maintain the dose prescribed by your doctor. If too many drops are applied to the eye or if some of the solution is swallowed, you may experience discomfort, such as dizziness, difficulty breathing, or a slower heartbeat. If you experience any of these symptoms, seek medical attention 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 Stada

It is important to use Dorzolamida/Timolol Stada as directed by your doctor.

If you forget to administer 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 missed doses.

If you stop using Dorzolamida/Timolol Stada

If you need to stop treatment, consult your doctor immediately.

If you have any further questions about the use of this medicine, 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 develop any of the following adverse effects, stop using this medicine and seek immediate medical advice, as these may be signs of allergic reactions to the medicine:

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

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

Other adverse effects

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

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

Burning and stinging of the eyes, taste disturbance.

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

Redness around the eye(s), tearing or eye itching, and effects on the surface of the eye(s), inflammation and/or irritation in and around the eye(s), sensation of having something in the eye (corneal erosion), decreased corneal sensitivity (not noticing when something is in the eye and no pain felt), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), nausea and fatigue.

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

Dizziness, depression, iris inflammation, blurred vision (in some cases due to discontinuation of medication used to treat excessive eye pupil constriction), decreased heart rate, fainting, indigestion and kidney stones (often characterized by sudden onset of pain and cramps with pain in the lower and/or side of the back, groin or abdomen).

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 in the hands or feet, insomnia, nightmares, memory loss, muscle weakness, decreased sexual desire, stroke, transient myopia that resolves upon discontinuation of therapy, development of fluid under the retina (choroidal detachment after filtration surgery), drooping eyelid, double vision, eyelid crusting, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, irregular heartbeat, chest pain, strong heartbeats that may be rapid or irregular (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, swollen or cold hands and feet and decreased circulation in arms or legs, reduced blood circulation causing numbness in fingers of hands and feet and color change (Raynaud's phenomenon), leg cramps and/or leg pain when walking (claudication), shortness of breath, difficulty breathing, nasal discharge or congestion, nosebleeds, difficulty breathing, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie's disease (which may cause penile curvature), weakness/tiredness, generalized allergic reactions including skin swelling in areas such as the face (swelling of lips, eyes and mouth) and limbs, which may obstruct airways causing difficulty swallowing or breathing, wheezing. Urticaria or itchy rash, localized and generalized rash, itching, sudden severe allergic reaction that may be life-threatening.

Like other eye medications, timolol is absorbed into the bloodstream. This may cause adverse reactions similar to those observed with intravenous and/or oral beta-blockers. The incidence of adverse reactions following topical ophthalmic administration is lower than when medicines are taken orally or injected. The list of adverse reactions includes those observed within the class of beta-blockers when used to treat eye diseases:

Frequency not known (frequency cannot be estimated from available data):

Low blood glucose levels.

Heart failure.

Increased heart rate.

Increased blood pressure.

Abdominal pain, vomiting.

Muscle pain not caused by exercise.

Sexual dysfunction.

Difficulty breathing.

Foreign body sensation in the eye (feeling that something is in the eye).

Hallucinations.

Abnormal sensitivity of the eyes to light.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Stada

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 is the last day of the month indicated.

This medicine does not require any special storage temperature.

Dorzolamide/Timolol Stada should be used within no more than 28 days after first opening. Therefore, the bottle must be discarded 4 weeks after first opening, even if some solution remains. To help you remember the date, write down the date of opening in the space provided on the carton.

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 dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Dorzolamide/Timolol Stada

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

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

Appearance of the product and contents of the container

Dorzolamide/Timolol Stada is a sterile, clear, slightly viscous, colourless aqueous eye drop solution.

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

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 Wien

Austria

or

Eurogenerics N.V.

Heizel Esplanade B22,

1020 Brussels

Belgium

Date of the most recent revision of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/