Package Insert: Information for the User

Cosduo 20 mg/ml + 5 mg/ml Eye Drops in Solution

dorzolamide/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 or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 package insert. See section 4.

6. Contents of the Container and Additional Information

Cosduo 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.

Cosduo is prescribed to reduce eye pressure in the treatment of glaucoma when the use of a beta-blocker eye drop as monotherapy is not suitable.

Cosduo eye drop solution is a sterile solution that does not contain preservatives.

No use Cosduo

• If you are allergic to dorzolamide, timolol, or any of the other components of this medication (listed in section 6);
• If you have or have had respiratory problems, such as asthma or chronic obstructive pulmonary disease (COPD);
• If you have a slow heart rate, heart failure, or irregular heart rhythms;
• If you have severe kidney disease or a history of kidney stones;
• If you have excessive blood acidity caused by a buildup of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether to use this medication, consult your doctor or pharmacist.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Cosduo.

Inform your doctor of any current or past medical or ocular problems, including:

• Coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or a feeling of choking), heart failure, low blood pressure;
• Irregular heart rhythms, such as decreased heart rate;
• Respiratory problems, asthma, or chronic obstructive pulmonary disease;
• Poor circulation of the blood (such as Raynaud's disease or Raynaud's syndrome);
• Diabetes, as timolol may mask signs and symptoms of low blood sugar;
• Hypersensitivity of the thyroid gland, as timolol may mask signs and symptoms.

If you have a history of contact hypersensitivity to silver, do not use this medication, as the drops dispensed may contain traces of silver from the packaging.

Inform your doctor before undergoing surgery that you are using dorzolamide/timolol, as timolol may affect the effects of some anesthetics.

Also inform your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.

Inform your doctor if you experience muscle weakness or have been diagnosed with myasthenia gravis.

If you develop any other eye irritation or new eye problems, such as eye redness or swelling of the eyelids, consult your doctor immediately.

If you suspect that Cosduo is causing an allergic reaction or hypersensitivity (such as skin rash, severe skin reaction, or eye redness and itching), stop using this medication and consult your doctor immediately.

Inform your doctor if you experience an eye infection, eye injury, undergo eye surgery, or develop a reaction that includes new symptoms or worsening of existing ones.

Cosduo may affect the entire body when instilled in the eye.

Cosduo has not been studied in patients with contact lenses. If you wear soft contact lenses, consult your doctor before using this medication.

Children and Adolescents

There is limited experience with the use of dorzolamide/timolol (preservative-containing formulation) in infants and children.

Use in Patients with Liver Impairment

Inform your doctor if you have or have had liver problems.

Other Medications and Cosduo

Cosduo may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medications to lower blood pressure, heart medications, or diabetes medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, particularly:

• Medications to lower blood pressure or treat heart disease (such as calcium channel blockers, beta blockers, or digoxin);
• Medications to treat irregular heart rhythms, such as calcium channel blockers, beta blockers, or digoxin;
• Other eye drops containing beta blockers;
• Other carbonic anhydrase inhibitors, such as acetazolamide;
• Monamine oxidase inhibitors (MAOIs);
• A medication that mimics the parasympathetic nervous system, which may have been prescribed to help eliminate urine. Parasympathomimetics are also a type of medication that may be used to help restore normal bowel movements;
• Narcotics, such as morphine used to treat moderate to severe pain;
• Medications to treat diabetes;
• Antidepressants, such as fluoxetine and paroxetine;
• Sulfonamide medications, such as sulfamethoxazole (used to prevent bacterial growth);
• Quinidine (used to treat heart rhythm disorders and some types of malaria).

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

Pregnancy and Lactation

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

Pregnancy

You should not use dorzolamide/timolol if you are pregnant unless your doctor considers it necessary.

Lactation

You should not use dorzolamide/timolol if you are breastfeeding. Timolol may pass into breast milk.

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 dorzolamide/timolol, such as blurred vision, which 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.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The appropriate dose and treatment duration will be established by your doctor.

The recommended doseis one drop in the affected eye or eyes in the morning and at night.

If you are using Cosduo with another eye drop, the drops should be applied at least 10 minutes apart.

Do not change the medication dose without consulting your doctor.

If you have difficulty administering the drops, seek help from a family member or caregiver.

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

Usage Instructions

Before dispensing the drops:

• Wash your hands before opening the bottle.
• Do not use this medication if you detect that the safety seal on the neck of the bottle is broken before the first opening.
• When using for the first time, before dispensing a drop in the eye, you must practice using the dropper by slowly dispensing a drop outside the eye.
• When you are sure you can dispense one drop at a time, you should position yourself in the most comfortable position to dispense the drops (you can sit, lie down, or stand in front of a mirror).

Dispensing:

1. Hold the bottle directly under the cap and unscrew the cap to open the bottle, do not touch anything with the tip of the bottle to avoid contaminating the solution.

1. Tilt your head back and hold the bottle above your eye.
2. Separate your lower eyelid and look up. Press the bottle gently in the middle and you should dispense one drop in the eye. Note that it may take a few seconds for the drop to come out. The bottle should not be pressed too hard.

If you are unsure how to use this medication, consult your doctor, pharmacist, or nurse.

1. Blink a few times to allow the drop to spread over the eye.

1. After using Cosduo, close your eye and press the inner corner of your eye with your finger for about two minutes. This helps to prevent the medication from reaching the rest of your body.

1. Repeat steps 2-5 to dispense drops in the other eye if your doctor has instructed you to do so. In some cases, only one eye may need treatment and your doctor will inform you if this applies to you and which eye needs treatment.

1. After each use and before closing it, you must shake the bottle once downwards, without touching the dropper tip, to eliminate any residual liquid in the tip. This is necessary to ensure the dispensing of the next drops.

1. At the end of the 28-day validity period for using this medication, there will be remaining Cosduo in the bottle. Do not use the excess medication that remains in the bottle once you have completed treatment. Do not use the eye drops after 28 days of opening the bottle for the first time.

If you use more Cosduo than you should

If you apply too many drops in the eye or swallow something from the bottle, 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 ingested.

If you forget to use Cosduo

It is essential to administer this medication as your doctor has instructed.

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 take a double dose to compensate for the missed doses.

If you interrupt treatment with Cosduo

If you want to interrupt treatment with this medication, consult your doctor first.

If you have any other doubts about using 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 experience any of the following side effects, stop using this medication and seek immediate medical help, as they may be signs of a medication reaction.

You may experience generalized allergic reactions that include swelling under the skin in areas such as the face and extremities, and may obstruct the airways, causing difficulty swallowing or breathing, hives or rash with itching, generalized and localized rash, itching, sudden severe allergic reaction that may be fatal.

Generally, you can continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Cosduo without talking to your doctor.

The following adverse reactions have been reported with dorzolamide/timolol 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 eye(s)
• Excessive tearing or itching in the eye(s)
• Keratitis (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye(s)
• Sensation of having something in the eye
• Decreased sensitivity of the cornea (does not feel like there is something in the eye and does not feel pain)
• Pain in the eye
• Dry eyes
• Blurred vision
• Headache
• Sinusitis (sensation of tension or congestion in the nose)
• Nausea
• Weakness/fatigue and tiredness

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Depression
• Iritis (inflammation of the iris)
• Alterations in vision, including changes in refraction (in some cases due to suppression of miotic therapy)
• Decreased heart rate
• Weakness
• Difficulty breathing
• Indigestion
• Renal stones

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

• SLE (systemic lupus erythematosus, an autoimmune disease that can cause inflammation of internal organs)
• Pruritus or paresthesia of the hands or feet
• Insomnia
• Nightmares
• Memory loss
• Increased signs and symptoms of myasthenia gravis (muscular disorder)
• Decreased libido
• Cerebrovascular accident
• Transient myopia that resolves upon cessation of therapy
• Retinal detachment that can cause visual disturbances after glaucoma filtration surgery
• Ptosis (eyelid drooping, causing the eye to remain half-closed)
• Diplopia (double vision)
• Crusts on the eyelid
• Corneal edema (with visual disturbances)
• Low intraocular pressure
• Tinnitus (ringing in the ear)
• Low blood pressure
• Changes in heart rhythm or rate
• Heart failure with respiratory distress and edema of the feet and legs due to fluid accumulation
• Edema (fluid accumulation)
• Cerebral ischemia (reduced blood flow to the brain)
• Chest pain
• Palpitations (strong, rapid, or irregular heartbeats)
• Myocardial infarction
• Raynaud's phenomenon, swollen or cold hands and feet, and decreased circulation in the arms and legs
• Leg cramps and/or pain when walking (claudication)
• Dyspnea (difficulty breathing)
• Respiratory insufficiency
• Rhinitis
• Nasal bleeding
• Pulmonary bronchospasm
• Cough
• Pharyngitis
• Xerostomia (dry mouth)
• Diarrhea
• Contact dermatitis
• Hair loss
• Psoriasiform eruption with a silvery white appearance
• Peyronie's disease (which can cause penile curvature)
• Allergic reactions such as skin rash, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the bloodstream. This can cause side effects similar to those seen with oral beta-blockers. The incidence of adverse reactions after topical ocular administration is lower than when, for example, medications are administered orally or injected. The following adverse reactions were observed with beta-blockers for the treatment of eye disorders:

Unknown(the frequency cannot be estimated from the available data)

• Low blood sugar levels
• Heart failure
• A type of arrhythmia
• Abdominal pain
• Vomiting
• Muscle pain not caused by exercise
• Sexual dysfunction
• Hallucinations
• Sensation of a foreign body in the eye (sensation of having something in the eye)
• Increased heart rate
• Increased blood pressure

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, 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 store at a temperature above 86°F (30°C).

After the first opening, the product must be stored for a maximum of 28 days. No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box and the bottle after “CAD”. The expiration date is the last day of the month indicated. Keep the container perfectly closed.

Do not use this medication if you observe that the closure is broken the first time you use the container.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Cosduo

• The active principles are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate).
• The other components are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection preparations.

Appearance of the product and contents of the packaging

Cosduo eye drops in solution are presented as a viscous, clear, almost colorless solution, in a 11 ml white opaque LDPE bottle and with a Novelia white (HDPE and silicone) nozzle and a white HDPE cap.

Packaging sizes: 1, 2, 3, 4, or 6 bottles per box.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible for manufacturing

Pharmathen S.A.

6, Dervenakion Str.

15351 Pallini Attikis

Greece

Excelvision

27 st. La Lombardière, ZI La Lombardière

07100 – Annonay

France

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Further information about this medicine can be obtained by contacting the local representative of the holder of the marketing authorization:

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7º

28045 Madrid, Spain

Last review date of this leaflet: January 2023.

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/