DORZOLAMIDE/TIMOLOL STADA 20 mg/ml + 5 mg/ml eye drops solution

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

Do not use Dorzolamida/Timolol Stada

• If you are allergic to dorzolamida or timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6).
• If you currently have or have a history of 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 severe kidney disease or a history of kidney stones.
• If you have acid-base disturbances in the blood.
• If you have certain heart diseases, including certain irregular heartbeats that may cause an abnormally slow pulse or acute heart failure.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dorzolamida/Timolol Stada, especially if you currently have 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 suffocation), heart failure, low blood pressure.
• Respiratory problems, asthma or chronic obstructive pulmonary disease.
• Insufficient circulatory blood disease (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes as timolol may mask the signs and symptoms of hypoglycemia.
• Hyperthyroidism as timolol may mask the signs and symptoms.
• Any allergy to a medicine you have taken.

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

Tell your doctor if you have or have had liver problems, if you suffer from 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 a side effect of Dorzolamida/Timolol Stada (see section 4 "Possible side effects").

If you suspect that 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.

Tell your doctor if you get 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 important to remove them before application, and wait at least 15 minutes before putting them back, as the preservative benzalkonium chloride may alter the color of your soft contact lenses.

Children

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

Elderly

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

Use in athletes

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

Other medicines and Dorzolamida/Timolol Stada

Dorzolamida/Timolol Stada 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 reduce heart 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 especially important if you are:

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

• Taking medicines for irregular heartbeat or arrhythmia such as quinidine (also used for the treatment of 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 medicine orally, as eye drops or by any other method.
• Taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine and paroxetine) used for the treatment of depression or other diseases.
• Taking a parasympathomimetic drug that may have been prescribed to help eliminate urine. Parasympathomimetics are also a particular 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 or if you are taking high doses of acetylsalicylic acid. Although there is no evidence that dorzolamida hydrochloride interacts with acetylsalicylic acid, some other medicines related to dorzolamida hydrochloride, given orally, interact with acetylsalicylic acid.

• Taking medicines for diabetes or have high blood sugar levels.
• Taking epinephrine (adrenaline).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Stada if you are pregnant, unless your doctor considers it necessary.

Tell your doctor if you are pregnant or plan to become pregnant.

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

Tell your doctor if you are breast-feeding or plan to breast-feed.

Driving and using machines

Dorzolamida/Timolol Stada may cause side effects such as blurred vision, in some patients. Do not drive or use machines until this effect has worn off.

Dorzolamida/Timolol Stada contains benzalkonium chloride

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

Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other diseases of the cornea (the transparent layer on 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 Stada

Follow exactly the instructions of administration of this medicine given by your doctor. If you are not sure, ask 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(s) twice daily. For example, in the morning and at night.

If you use Dorzolamida/Timolol Stada 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. If you must interrupt treatment, consult your doctor immediately.

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 cause serious damage to the eyes, and even loss of vision. To avoid possible contamination of the container, avoid letting the tip of the container come into contact with any surface.

In order to ensure correct dosing, the dropper tip should not be enlarged.

Instructions for use:

It is recommended that you wash your hands before administering the eye drops solution. You can facilitate administration by doing it in front of a mirror.

1. Before using the medicine for the first time, make sure the security strip 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. Tilt your head back and gently pull the lower eyelid down to form 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.

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 medicine from entering the rest of the body.

1. Repeat steps 3 and 4 in the other eye if your doctor has told 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 important to maintain the dose that your doctor has prescribed. If you apply too many drops in the eye or swallow some of the contents of the bottle, you may feel unwell, for example dizziness, have difficulty breathing or notice that your heart beats more slowly. If you notice any of these effects, go to a doctor immediately.

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

If you forget to use Dorzolamida/Timolol Stada

It is important to administer Dorzolamida/Timolol Stada 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 scheduled dosing program as usual.

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

If you stop using Dorzolamida/Timolol Stada

If you must interrupt treatment, consult your doctor immediately.

If you have any further questions on 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 all people suffer from them.

Severe 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):

• Hives, swelling of the face, lips, tongue, and/or throat that can 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 can affect the mouth, eyes, and genitals.

Other Adverse Effects

You can continue using the drops, unless the 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 itching of the eyes, 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 having something 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, and fatigue.

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

Dizziness, depression, inflammation of the iris, blurred vision (in some cases due to the suspension of medication for the 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 (an immune disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, muscle weakness, decreased sexual desire, stroke, transient myopia that resolves when therapy is stopped, development of fluid under the retina (choroidal detachment after filtration surgery), drooping eyelid, double vision, crusts on the eyelid, swelling of the cornea (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, irregular heartbeats, chest pain, strong heartbeats that can 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 the arms or legs, decreased blood circulation that causes numbness of the fingers and toes and color change (Raynaud's phenomenon), leg cramps and/or leg pain when walking (claudication), shortness of breath, lack of breathing, runny or congested nose, nosebleeds, 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 of the skin in areas such as the face (swelling of the lips, eyes, and mouth) and extremities, and which can obstruct the airways causing difficulty swallowing or breathing, hives. Urticaria or rash with itching, localized and generalized rash, itching, severe allergic reaction that can be life-threatening.

Like other eye medications, timolol is absorbed into the bloodstream. This can cause adverse reactions similar to those observed with intravenous and/or oral beta-blockers. The incidence of adverse reactions after topical ophthalmic administration is lower than when medications are, for example, taken orally or injected. The list of adverse reactions includes reactions observed within the class of beta-blockers when used for the treatment of 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 (feeling that there is something in the eye)

Hallucinations

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dorzolamida/Timolol Stada

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage temperature.

Dorzolamida/Timolol Stada should be used within 28 days of first opening. Therefore, you should discard the bottle 4 weeks after its first opening, even if some solution remains. To help you remember the date, indicate the opening date on the carton space.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dorzolamida/Timolol Stada

• The active ingredients 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 injectable preparations.

Appearance of the Product and Package Contents

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

Dorzolamida/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, and containing 5 ml of ophthalmic solution.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory 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 Vienna

Austria

or

Eurogenerics N.V.

Heizel Esplanade B22,

1020 Brussels

Belgium

Date of the Last Revision of this Prospectus:February 2023

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