Package Insert: Information for the Patient

Tidimaz 20 mg/ml + 5 mg/ml Eye Drops Solution

Dorzolamida/Timolol

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Tidimazis a sterile solution without preservatives that contains two medications: dorzolamide and timolol.

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

These medications lower eye pressure in different ways.

Tidimazis prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when the use of a single beta-blocker eye drop is not suitable.

No useTidimaz

• If you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medication (listed in section 6).
• If you currently have or have had in the past respiratory problems, such as asthma or chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing for a long time).
• If you have a slow heart rate, heart failure, or irregular heart rhythm (irregular heartbeats).
• If you have severe kidney disease or a history of kidney stones.
• If you have excessive acidity in the blood caused by a buildup of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether to useTidimaz, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before starting to useTidimaz.

Inform your doctor about any medical or eye problems you have now or have had in the past, especially if you have:

• Respiratory or pulmonary problems, asthma, or chronic obstructive pulmonary disease.
• Coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or choking), heart failure, low blood pressure.
• Irregular heart rhythms, such as decreased heart rate.
• Circulatory problems (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask signs and symptoms of low blood sugar levels.
• Thyroid problems, such as hyperactive thyroid gland, as timolol may mask signs and symptoms.
• Liver problems.
• Any allergy or allergic reaction, including hives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.
• Muscle weakness or if you have been diagnosed with myasthenia gravis.

If you experience any of the following symptoms,stop usingthe eye drops and contact your doctor immediately:

• Any eye irritation or new eye problem, such as redness of the eyes or swelling of the eyelids, contact your doctor immediately.
• Symptoms of an allergic reaction. See section 4 “Possible side effects” (for example, skin rash or redness and itching of the eyes).

Inform your doctor that you are using Tidimaz if you have an eye injury or are about to undergo eye surgery, as timolol may change the effects of some medications used during anesthesia.

When instillingTidimazin the eye, it may affect the entire body.

Tidimazhas not been studied in patients using contact lenses. If you use soft contact lenses, consult your doctor before usingTidimaz. Before instilling this medication, remove your contact lenses and reapply them at least 15 minutes after instillation.

Children

There is limited experience withdorzolamide hydrochloride and timololin infants and children.

Older patients

In studies with dorzolamide hydrochloride and timolol with preservatives, the effects were similar in older patients and younger patients.

Other medications andTidimaz

Tidimazmay affect or be affected by other medications you are using.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including other eye drops or those obtained without a prescription. This is particularly important if you are taking:

• Medications to lower blood pressure or treat heart disease (such as calcium channel blockers, beta blockers, or digoxin).
• Medications to treat irregular or abnormal heart rhythms, such as calcium channel blockers, beta blockers, or digoxin.
• Monamine oxidase inhibitors (MAOIs), which are used to treat depression.
• Parasympathomimetic medication that may have been prescribed to help you urinate. Parasympathomimetics are also a group of medications that are sometimes used to help restore normal movements through the intestine.
• Opioids such as morphine used to treat moderate to severe pain.
• Medications to treat diabetes.
• Antidepressants known as fluoxetine and paroxetine.
• Medications containing sulfonamide.
• Quinidine (used to treat heart disease and some types of malaria).
• Other eye drops that also contain a beta blocker or other carbonic anhydrase inhibitors such as acetazolamide.

Use in athletes:

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

Pregnancy and breastfeeding

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

Pregnancy

Do not useTidimazif you are pregnant. Inform your doctor if you are pregnant or intend tobecome pregnant.

Lactation

Timolol may pass into breast milk. If you need treatment withTidimaz, breastfeeding is not recommended. Inform your doctor if you are breastfeeding or intend tobreastfeed.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive or operate machinery. There are adverse effects associated with Tidimaz, such as blurred vision, that may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well oryour vision is clear.

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.

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

If you are usingTidimazat the same time as another eye drop, the drops should be instilled at least 10minutes apart.The eye ointment should be administered last.

Do not change the medication dose without consulting your doctor.

Tidimaz is a sterile solution that does not contain preservatives. See also Section 6 - Appearance of the product and contents of the package.

Before instilling the eye drop:

-When using for the first time, before administering a drop in the eye, first practice using the dropper bottle by slowly squeezing it to administer a drop in the air, away from the eye.

-When confident that a drop can be administered, choose the position that feels most comfortable for drop instillation (you can sit, lie on your back, or stand in front of a mirror).

Instructions for use:

1.Wash your hands carefully before using this medication.

2.If the box or bottle is damaged, do not use the medication.

3.When using the medication for the first time, remove the cap after ensuring that the sealed ring on the cap has not been broken. You should feel a slight resistance until this tamper-evident ring breaks (see Image 1).

4.If the tamper-evident ring is loose, discard it because it may fall into the eye and cause injury.

5.Tilt your head back and gently lower your lower eyelid to form a pouch between the eye and the eyelid (see Image 2). You should avoid contact between the tip of the bottle and the eyes, eyelids, or fingers to prevent solution contamination.

6.Apply one drop to the pouch by slowly pressing the bottle. Squeeze the bottle gently in the middle and let a drop fall into the eye. There may be a delay of a few seconds between compression and drop release (see Image 3). Do not squeeze too hard. If unsure how to administer this medication, ask your doctor, pharmacist, or nurse.

7.Close your eye and press the inner corner of the eye with your finger for approximately two minutes. This helps prevent the drop from reaching the rest of the body.

8.Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.

9.After use and before re-capping, shake the bottle once downwards, without touching the tip of the dropper, to remove any residual liquid in the tip. This is necessary to ensure the administration of subsequent drops. Tighten the cap of the bottle after application (see Image 4).

If a drop does not reach the eye, try again.

Image 1Image 2Image 3Image 4

If you use more Tidimaz than you should

If you apply too many drops to the eye or swallow part of the bottle contents, among other effects, you may feel drowsy, have difficulty breathing, or notice that your heart beats slower. Contact your doctor 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 taken. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forget to useTidimaz

It is essential to useTidimazas prescribed 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 planned dose schedule normally.

Do not use a double dose to compensate for missed doses.

If you interrupt treatment withTidimaz

If you want to stop using this medication, consult your doctor first.

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

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

If you develop allergic reactions that include hives or itching, localized and generalized hives, itching, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing or chest pain, shortness of breath, sweating, sensation of anxiety, nausea (symptoms of heart attack), stop using Tidimaz andtalk to your doctor immediately.

The following side effects have been reported with dorzolamide hydrochloride and timolol maleate without preservatives or one of its components during clinical trials or during post-marketing experience:

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

• Burning and stinging in the eyes, alteration of taste.

Common (may affect up to 1 in 10 people)

• Redness in and around the eyes, tearing or itching in the eyes, erosion of the cornea (damage to the front layer of the eyeball), swelling and/or irritation in and around the eyes, sensation of having something in the eye, decreased sensitivity of the cornea (not feeling like something is in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (sensation of tension or congestion in the nose), feeling sick, also known as nausea, weakness/fatigue, fatigue.

Rare (may affect up to 1 in 100 people)

• Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to suspension of miotic therapy in some cases), difficulty breathing (dyspnea), slow heart rate, fainting, indigestion, kidney stones (often marked by a sudden onset of severe and cramping pain in the lower back and/or side, groin, or abdomen).

Very rare (may affect up to 1 in 1,000 people)

• SLE (systemic lupus erythematosus) (a disease that can cause inflammation of internal organs), tingling or numbness of hands or feet, difficulty sleeping (insomnia), nightmares, memory loss, muscle weakness (increase in signs and symptoms of myasthenia gravis - muscular disorder), decreased libido, stroke, temporary myopia that may resolve when treatment is stopped, retinal detachment that can cause visual disturbances after surgery, drooping eyelids (making the eye stay half-closed), double vision, crust formation on eyelids, corneal edema (with visual disturbances), low eye pressure, ringing in the ears, low blood pressure, irregular heartbeats (changes in heart rate or rhythm), congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), palpitations (irregular heartbeats), cerebral ischemia (decreased blood supply to the brain), chest pain, heart attack, Raynaud's phenomenon, swelling or coldness of hands and feet and reduced circulation in arms and legs, leg cramps and/or pain when walking (claudication), difficulty breathing, sensation of shortness of breath, nasal secretion or congestion, nasal bleeding, respiratory insufficiency, bronchial constriction in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis (skin eruption with a silver-white appearance), Peyronie's disease (which can cause curvature of the penis), allergic reactions such as skin rash, hives, itching, in rare cases possible swelling of lips, eyes, and mouth, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

Difficulty breathing, sensation of foreign body in the eye (sensation of something in the eye), hallucinations, strong heartbeats that may be rapid or irregular (palpitations),increased heart rate, increased blood pressure.

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

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

Low blood sugar, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

This medication does not require special storage conditions.

Once opened, do not store at a temperature above 25 °C.

5 ml bottle:

Discard 60 days after the first bottle opening.

10 ml bottle:

Discard 90 days after the first bottle opening.

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

Do not use this medication after the expiration date that appears on the box and on the bottle labelafter CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Tidimaz

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

Cada gota (aproximadamente 35 microlitros ( µl)) contiene 0.70 mg de dorzolamida y 0.18 mg de timolol.

• The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, water for injectable preparations.

Aspect of the product and contents of the packaging

Tidimaz is a sterile, colorless, transparent, and viscous liquid.

It is presented in white LDPE bottles (5 ml, 11 ml) with a multidose HDPE dropper applicator that prevents contamination of the contents thanks to a silicone valve system and filtered air return to the bottle and HDPE screw cap tamper-proof, and cardboard box.

Packaging sizes: 1 x 5 ml, 3 x 5 ml, 1 x 10 ml, 2 x 10 ml.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible manufacturer

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

FRINO Pharm e.K.

Keplerweg 3

82538 Geretsried

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of Czechia – Dorzolamide/Timolol Farmaprojects

Germany – Tidimaz 20 mg/ml Augentropfen, Lösung

Spain – Tidimaz 20 mg/ml colirio en solución

Last review date of this leaflet: June 2024

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