Cosduo 20 mg/ml + 5 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cosduo 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. 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. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Cosduo is and what it is used for
- What you need to know before using Cosduo
- How to use Cosduo
- Possible side effects
- How to store Cosduo
- Contents of the pack and other information
1. What Cosduo is and what it is used for
Cosduo contains 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 eye pressure in different ways.
Cosduo is prescribed to reduce intraocular pressure in the treatment of glaucoma when the use of a beta-blocker eye drop as monotherapy is not suitable.
Cosduo eye drops solution is a sterile solution without preservatives.
2. What you need to know before using Cosduo
Do not use Cosduo
- if you are allergic to dorzolamide, timolol, 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 prolonged 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 blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).
If you are unsure whether you should use this medicine, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Cosduo.
Inform your doctor about any current or past medical or eye conditions, such as:
- coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure;
- heart rhythm disorders such as slow heartbeat;
- breathing problems, asthma, or chronic obstructive pulmonary disease;
- circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
- diabetes, as timolol may mask signs and symptoms of low blood sugar;
- overactivity of the thyroid gland, as timolol may mask signs and symptoms.
If you have a history of contact hypersensitivity to silver, you should not use this medicine, as dispensed drops may contain traces of silver from the container.
Inform your doctor, prior to undergoing surgery, that you are using dorzolamide/timolol, as timolol may alter the effects of certain medications used during anesthesia.
Also inform your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if you experience muscle weakness or if you have been diagnosed with myasthenia gravis.
If you develop any other eye irritation or new eye problems, such as eye redness or eyelid swelling, consult your doctor immediately.
If you suspect that Cosduo is causing you an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or red, itchy eyes), stop using this medicine and consult your doctor immediately.
Inform your doctor if an eye infection occurs, if you suffer an eye injury, if you undergo eye surgery, or if you develop a reaction involving new symptoms or worsening of existing ones.
When Cosduo is instilled into the eye, it may affect the entire body.
Cosduo has not been studied in patients who wear contact lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine.
Children and adolescents
There is limited experience with the use of dorzolamide/timolol (preservative-containing formulation) in infants and children.
Use in patients with hepatic impairment
Inform your doctor if you have or have had liver problems.
Other medicines and Cosduo
Cosduo may interact with or be affected by other medicines you are taking, including other eye drops used to treat glaucoma. Inform your doctor if you are taking or plan to take medications to lower blood pressure, heart medications, or medications to treat diabetes. Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, particularly:
- medications to lower blood pressure or treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin);
- medications to treat irregular or abnormal heartbeats such as calcium channel blockers, beta-blockers, or digoxine;
- another eye drop containing beta-blockers;
- another carbonic anhydrase inhibitor such as acetazolamide;
- monoamine oxidase inhibitors (MAOIs);
- a parasympathomimetic drug that may have been prescribed to help eliminate urine. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal intestinal movements;
- narcotics such as morphine used to treat moderate to severe pain;
- medications to treat diabetes;
- antidepressants known as fluoxetine and paroxetine;
- a sulfonamide drug such as sulfamethoxazole (used to prevent bacterial growth);
- quinidine (used to treat heart disorders and certain types of malaria).
Use in athletes: This medicine contains timolol, which may produce a positive result in doping control tests.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not use dorzolamide/timolol during pregnancy unless your doctor considers it necessary.
Breastfeeding
You should not use dorzolamide/timolol while breastfeeding. Timolol may pass into breast milk.
Driving and use of machines
No studies have been conducted on the effects on the ability to drive or operate machinery. Adverse effects associated with dorzolamide/timolol, 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 Cosduo
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop into the affected eye(s) in the morning and at night.
If you are using Cosduo with another eye drop, the drops should be administered at least 10 minutes apart.
Do not change the dose of this medicine without consulting your doctor.
If you have difficulty administering the drops, seek help from a family member or caregiver.
Do not allow the tip of the multidose container to touch the eyes or surrounding areas. This may cause damage to your eyes. The solution in the eye drops may become contaminated with bacteria capable of causing eye infections that could lead to serious eye damage, and even loss of vision. To avoid possible contamination of the container, avoid contact between the tip of the container and any surface.
Instructions for use
Before dispensing the drops:
- Wash your hands before opening the bottle.
- Do not use this medicine if you notice that the safety seal on the neck of the bottle is broken before first opening.
- When used for the first time, before dispensing a drop into the eye, you should practice using the dropper by slowly squeezing it to dispense one drop outside the eye.
- Once you are confident that you can dispense one drop at a time, position yourself in the most comfortable way to administer the drops (you may sit, lie down, or stand in front of a mirror).
Dispensing:
- Hold the bottle directly below 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.
- Tilt your head backward and hold the bottle above your eye.
- Pull down the lower eyelid and look upward. Gently squeeze the bottle in the middle to dispense one drop into the eye. Note that it may take a few seconds from the moment you squeeze until the drop comes out. Do not squeeze the bottle too hard.
If you are unsure how to use this medicine, consult your doctor, pharmacist, or nurse.
- Blink several times so that the drop spreads over the eye.
- After using Cosduo, close your eye and press your finger against the inner corner of the eye for approximately two minutes. This helps prevent the medicine from reaching the rest of the body.
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Repeat steps 2–5 to dispense drops into the other eye if instructed by your doctor. In some cases, treatment may only be required in one eye, and your doctor will inform you if this applies to you and which eye requires treatment.
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After each use and before replacing the cap, shake the bottle once downward without touching the dropper tip, in order to remove any residual liquid from the tip. This is necessary to ensure proper dispensing of subsequent drops.
- After the 28-day period of in-use shelf life of this medicine, there will still be some Cosduo remaining in the bottle. Do not use any leftover medicine remaining in the bottle once you have completed your treatment. Do not use the eye drops after 28 days from the first opening of the bottle.
If you use more Cosduo than you should
If you apply too many drops into the eye or swallow some of the contents of the bottle, 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, indicating the medicine and the amount ingested.
If you forget to use Cosduo
It is important to administer this medicine as directed by your doctor.
If you forget to take a dose, take 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 take a double dose to make up for missed doses.
If you stop using Cosduo
If you wish to stop treatment with 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 will experience them.
Serious adverse effects:
If you experience any of the following adverse effects, stop using this medicine and seek immediate medical help, as these may be signs of a drug reaction.
Severe generalized allergic reactions may occur, including swelling under the skin in areas such as the face and limbs, which may block the airways and cause difficulty swallowing or breathing, hives or itchy rash, widespread or localized rash, itching, or sudden severe allergic reaction that may be life-threatening.
Generally, you may continue using the drops unless the effects are serious. If you are concerned, consult your doctor or pharmacist. Do not stop using Cosduo without first talking to your doctor.
The following adverse reactions have been reported with dorzolamide/timolol or with 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
- Altered taste
Common (may affect up to 1 in 10 people)
- Redness in and around the eye(s)
- Tearing or itching of the eye(s)
- Corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye(s)
- Sensation of a foreign body in the eye
- Decreased corneal sensitivity (inability to perceive that something is in the eye and absence of pain)
- Eye pain
- Dry eyes
- Blurred vision
- Headache
- Sinusitis (feeling of pressure or congestion in the nose)
- Nausea
- Weakness/tiredness and fatigue
Uncommon (may affect up to 1 in 100 people)
- Dizziness
- Depression
- Inflammation of the iris
- Visual disturbances, including changes in refraction (in some cases due to withdrawal of miotic therapy)
- Decreased heart rate
- Fainting
- Difficulty breathing
- Indigestion
- Kidney stones
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
- Increase in signs and symptoms of myasthenia gravis (a muscle disorder)
- Decreased sexual desire
- Stroke
- Transient myopia that resolves upon discontinuation of therapy
- Detachment of the layer beneath the retina containing blood vessels after filtration surgery, which may cause visual disturbances
- Drooping eyelid (causing the eye to remain partially closed)
- Double vision
- Crusting of the eyelid
- Swelling of the cornea (with symptoms of visual disturbances)
- Low eye pressure
- Ringing in the ears
- Low blood pressure
- Changes in the rhythm or rate of heartbeat
- Congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation)
- Edema (fluid accumulation)
- Cerebral ischemia (reduced blood flow to the brain)
- Chest pain
- Strong heartbeats that may be rapid or irregular (palpitations)
- Heart attack
- Raynaud's phenomenon, swollen or cold hands and feet, and reduced circulation in arms and legs
- Leg cramps and/or leg pain when walking (claudication)
- Difficulty breathing
- Respiratory failure
- Rhinitis
- Nosebleeds
- Constriction of the airways in the lungs
- Cough
- Throat irritation
- Dry mouth
- Diarrhea
- Contact dermatitis
- Hair loss
- Skin rash with a silvery-white appearance (psoriasiform rash)
- Peyronie's disease (which may cause penile curvature)
- Allergic-type reactions such as skin rash, hives, itching, and 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 medicines, timolol may be absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. The incidence of adverse effects after topical ophthalmic administration is lower than when medicines are administered orally or by injection. The following adverse effects have been observed with beta-blocker medicines used to treat eye disorders:
Frequency not known (cannot be estimated from available data)
- Low blood glucose levels
- Heart failure
- A type of heart rhythm disorder
- Abdominal pain
- Vomiting
- Muscle pain not caused by exercise
- Sexual dysfunction
- Hallucinations
- Foreign body sensation in the eye (feeling that something is in the eye)
- Increased heart rate
- Increased blood pressure
- Abnormal sensitivity of the eyes to light
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cosduo
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
After first opening, the product should be stored for a maximum of 28 days. No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and on the bottle after “EXP”. The expiry date refers to the last day of the month indicated. Keep the container tightly closed.
Do not use this medicine if you notice that the closure is broken the first time you use the container.
Medicines should 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 in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cosduo
- The active substances 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 injections.
Appearance of the medicinal product and contents of the pack
Cosduo ophthalmic solution is presented as a viscous, clear, almost colorless solution in a 5 ml volume, contained in an opaque white LDPE bottle of 11 ml capacity with a white Novelia (HDPE and silicone) nozzle and a white HDPE cap.
Pack sizes: 1, 2, 3, 4 or 6 bottles per carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturers
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Santen Pharmaceutical Spain S.L.
Acanto, 22, 7º
28045 Madrid, Spain
Date of the most recent revision of this leaflet: January 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/