Tidimaz 20 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tidimaz 20 mg/ml + 5 mg/ml eye drops solution

Dorzolamide/Timolol

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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tidimaz is and what it is used for

Tidimaz is a sterile, preservative-free solution containing 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 intraocular pressure in different ways.

Tidimaz is prescribed to lower elevated intraocular pressure in the treatment of glaucoma when the use of a single beta-blocker eye drop is not appropriate.

2. What you need to know before using Tidimaz

Do not use Tidimaz

• 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 breathing problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• if you have severe kidney disease or a history of kidney stones.
• if you have excess acidity in the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis).

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

Warnings and precautions

Consult your doctor before starting to use Tidimaz.

Inform your doctor about any current or past medical or eye conditions you have, especially if you have:

• breathing or lung problems, asthma, or chronic obstructive pulmonary disease.
• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation), heart failure, low blood pressure.
• heart rhythm disorders such as a slow heartbeat.
• circulation problems (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• thyroid problems, i.e., overactivity of the thyroid gland, as timolol may mask signs and symptoms.
• liver problems.
• any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which 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 using the eye drops and contact your doctor immediately:

• any eye irritation or any new eye problems, 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” (e.g., 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 undergoing eye surgery, as timolol may alter the effects of certain medications used during anesthesia.

When Tidimaz is instilled into the eye, it may affect the entire body.

Tidimaz has not been studied in patients who wear contact lenses. If you wear soft contact lenses, you should consult your doctor before using Tidimaz. Before instilling this medicine, remove your contact lenses and wait at least 15 minutes after instillation before reinserting them.

Children

Limited experience is available with dorzolamide hydrochloride and timolol in infants and children.

Elderly patients

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

Other medicines and Tidimaz

Tidimaz may affect or be affected by other medicines you are taking.

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

• medicines to lower blood pressure or treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin).
• medicines to treat irregular or abnormal heartbeats, such as calcium channel blockers, beta-blockers, or digoxin.
• monoamine oxidase inhibitors (MAOIs), used to treat depression.
• a parasympathomimetic medicine that may have been prescribed to help you urinate. Parasympathomimetics are also a specific group of medicines sometimes used to help restore normal intestinal movements.
• opioids such as morphine used to treat moderate to severe pain.
• medicines to treat diabetes.
• antidepressants known as fluoxetine and paroxetine.
• medicines containing sulfonamides.
• quinidine (used to treat heart conditions and some types of malaria).
• other eye drops containing a beta-blocker or other carbonic anhydrase inhibitors such as acetazolamide.

Use in athletes:

This medicine contains timolol, which may result in a positive test in doping controls.

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.

Pregnancy

Do not use Tidimaz if you are pregnant. Inform your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

Timolol may pass into breast milk. If treatment with Tidimaz is required, breastfeeding is not recommended. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

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

3. How to use Tidimaz

Follow exactly the instructions for administering 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.

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

If you are using Tidimaz at the same time as another eye drop, the drops should be administered at least 10 minutes apart. Ophthalmic ointments should be used last.

Do not change the dose of this medicine without consulting your doctor.

Tidimaz is a sterile solution that contains no preservatives. See also Section 6 – Appearance of the product and contents of the container.

Before instilling the eye drops:

• When used for the first time, before administering a drop into the eye, you should first practice using the dropper bottle by slowly squeezing it to release one drop into the air, away from the eye.
• Once you are confident that you can administer a drop correctly, choose the position that is most comfortable for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).

Instructions for use:

1. Wash your hands thoroughly before using this medicine.
2. Do not use the medicine if the package or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap only after ensuring that the tamper-evident seal ring on the cap has not been broken. You should feel slight resistance until this tamper-evident ring breaks (see Image 1).
4. If the tamper-evident ring is loose, it must be discarded, as it could fall into the eye and cause injury.
5. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eye and the eyelid (see Image 2). Avoid contact between the tip of the bottle and the eyes, eyelids, or fingers to prevent contamination of the solution.
6. Instill one drop into the pouch by slowly pressing the bottle. Gently squeeze the middle of the bottle to release one drop into the eye. There may be a delay of a few seconds between squeezing and the drop coming out (see Image 3). Do not squeeze too hard. If you are unsure how to administer this medicine, ask your doctor, pharmacist, or nurse.
7. Close the eye and press with your finger on the inner corner of the eye for approximately two minutes. This helps prevent the drop from draining into the rest of the body.
8. Repeat steps 5, 6, and 7 in the other eye if instructed by your doctor.
9. After use and before recapping, shake the bottle once downward without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure proper administration of subsequent drops. Screw the cap back onto the bottle after use (see Image 4).

If a drop misses the eye, try again.

Image 1 Image 2 Image 3 Image 4

If you use more Tidimaz than you should

If you instill too many drops into the eye or accidentally swallow part of the solution, you may experience effects such as dizziness, difficulty breathing, or a slower heartbeat. Contact 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, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to use Tidimaz

It is important to use Tidimaz exactly as prescribed by your doctor.

If you forget to instill a dose, apply it as soon as possible. However, if it is almost time for your next dose, do not apply 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 Tidimaz

If you wish to stop using this medicine, consult your doctor first.

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 experiences them.

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

The following adverse effects have been reported with dorzolamide hydrochloride and timolol maleate preservative-free or one of its components during clinical trials or post-marketing experience:

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

• Burning and stinging in the eyes, taste disturbance.

Common (may affect up to 1 in 10 people)

• Redness of and around the eyes, tearing or itching of the eyes, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of and around the eyes, sensation of a foreign body in the eye, decreased corneal sensitivity (failure to notice when something enters the eye and inability to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), feeling sick (nausea), weakness/tiredness, fatigue.

Uncommon (may affect up to 1 in 100 people)

• Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to discontinuation of miotic therapy in some cases), difficulty breathing (dyspnea), slow heart rate, fainting, indigestion, kidney stones (often marked by sudden onset of severe pain and cramps in the lower back and/or side, 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 hands or feet, difficulty sleeping (insomnia), nightmares, memory loss, muscle weakness (worsening of signs and symptoms of myasthenia gravis – a muscle disorder), decreased sexual desire, stroke, temporary myopia which may resolve when treatment is discontinued, retinal pigment epithelial detachment (a layer beneath the retina containing blood vessels) after filtration surgery which may cause visual disturbances, drooping eyelids (causing the eye to remain partially closed), double vision, crusting of the eyelids, corneal swelling (with symptoms of visual disturbances), low eye pressure, tinnitus (ringing in the ears), low blood pressure, irregular heartbeat (changes in the rhythm or rate of the heartbeat), congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), palpitations (faster and/or irregular heartbeats), cerebral ischemia (reduced 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 leg pain when walking (claudication), difficulty breathing, shortness of breath, nasal discharge or nasal congestion, nosebleeds, difficulty breathing (respiratory failure), narrowing of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis (skin rash with silvery-white appearance), Peyronie's disease (which may cause curvature of the penis), allergic-type reactions such as skin rash, urticaria, 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 (frequency cannot be estimated from available data)

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

Like other medicines applied to the eyes, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when medicines are taken orally or injected. Additional side effects listed include reactions observed within the beta-blocker class when used to treat ocular conditions:

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

Low blood glucose levels, heart failure, a type of cardiac arrhythmia, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tidimaz

This medicine does not require special storage conditions.

After opening, do not store above 25 °C.

5 ml vial:

Discard 60 days after first opening of the vial.

10 ml vial:

Discard 90 days after first opening of the vial.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tidimaz

• 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).

Each drop (approximately 35 microlitres (µl)) contains 0.70 mg of dorzolamide and 0.18 mg of timolol.

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

Appearance of the product and contents of the pack

Tidimaz is a sterile, colourless, transparent, viscous liquid.

It is supplied in white LDPE bottles (5 ml, 11 ml) with a multidose HDPE dropper dispenser that prevents contamination of the contents through a silicone valve system and filtered air return into the bottle, and with a tamper-evident HDPE screw cap, and cardboard carton.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

FRINO Pharm e.K.

Keplerweg 3

82538 Geretsried

Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Czech Republic – Dorzolamide/Timolol Farmaprojects

Germany – Tidimaz 20 mg/ml Augentropfen, Lösung

Spain – Tidimaz 20 mg/ml colirio en solución

Date of the most recent review of this leaflet: June 2024

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