DORZOLAMIDE/TIMOLOL FARMALIDER 20 mg/ml + 5 mg/ml EYE DROPS SOLUTION

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

Do not use Dorzolamida/Timolol Farmalider

• if you are allergic to dorzolamida hydrochloride, timolol maleate, or any of the other ingredients of Dorzolamida/Timolol Farmalider (listed in section 6)
• if you have or have had in the past certain respiratory diseases such as asthma, or severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty in breathing and/or coughing)
• if you have a slow heart rate, heart failure or irregular heart rhythm (irregular heartbeat)
• if you have severe kidney disease or a history of kidney stones
• if you have excess acidity of the blood caused by an accumulation of chloride in the blood (hyperchloremic acidosis)

If you are not sure whether you can use Dorzolamida/Timolol Farmalider, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before you start using Dorzolamida/Timolol Farmalider.

Before using Dorzolamida/Timolol Farmalider, tell your doctor about any current or past medical or eye problems:

• coronary heart disease (symptoms can include chest pain, shortness of breath or feeling of suffocation), heart failure, low blood pressure
• changes in heart rate such as slow heart rate
• respiratory problems, asthma or chronic obstructive pulmonary disease
• disease due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar levels
• overactivity of the thyroid gland as timolol may mask signs and symptoms
• allergies or allergic reactions, including hives or inflammation of the face, lips, tongue and/or throat which could cause difficulty in breathing or swallowing

Tell your doctor if you have muscle weakness or if you have been diagnosed with myasthenia gravis (muscle weakness).

If you experience eye irritation or any new eye problems, such as redness of the eye or inflammation of the eyelids, contact your doctor immediately.

If you suspect that Dorzolamida/Timolol Farmalider is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction or redness and itching of the eye), stop using Dorzolamida/Timolol Farmalider and contact your doctor immediately.

Tell your doctor if you have an eye infection, suffer an eye injury, have eye surgery or develop a reaction, including new symptoms or worsening of previous ones.

Before undergoing surgery, tell your doctor that you are using Dorzolamida/Timolol Farmalider as timolol may affect the effects of certain medicines used during anesthesia.

Instilling Dorzolamida/Timolol Farmalider in the eye may affect the whole body.

If you wear soft contact lenses, you should consult your doctor before using Dorzolamida/Timolol Farmalider.

Children

Experience with Dorzolamida/Timolol Farmalider in infants and children is limited.

Elderly

In studies with Dorzolamida/Timolol Farmalider, its effects were similar in elderly and younger patients.

Patients with liver impairment

Tell your doctor about any current or past liver problems.

Dorzolamida/Timolol Farmalider with other medicines

Dorzolamida/Timolol Farmalider 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 lower blood 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 medicines. This is especially important if you:

• take medicines to lower blood pressure or treat heart disease (for example, calcium channel blockers, beta-blockers or digoxin)
• take medicines for irregular heartbeats, for example calcium channel blockers, beta-blockers or digoxin
• use another eye drop that contains a beta-blocker
• take another carbonic anhydrase inhibitor, such as acetazolamide
• take monoamine oxidase inhibitors (MAOIs) used to treat depression
• take a parasymphathomimetic drug, which may have been prescribed to help you urinate. Parasymphathomimetics are also a type of medicine sometimes used to restore normal bowel movements
• take opioids, for example morphine, for the treatment of moderate to severe pain
• take medicines for diabetes
• take quinidine (used to treat heart disease and some types of malaria)
• take antidepressants known as fluoxetine and paroxetine
• take a sulfonamide

Use in athletes

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Use during pregnancy

Do not use Dorzolamida/Timolol Farmalider if you are pregnant or planning to become pregnant unless your doctor considers it necessary.

Use during breastfeeding

Do not use Dorzolamida/Timolol Farmalider if you are breastfeeding. Timolol may pass into your breast milk.

Consult your doctor before taking any medicine during breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. There are some side effects associated with Dorzolamida/Timolol Farmalider, such as blurred vision, that may affect your ability to drive and/or operate machines. Do not drive or operate tools or machines until you feel well or your vision has cleared.

Dorzolamida/Timolol Farmalider contains benzalkonium chloride

Dorzolamida/Timolol Farmalider contains the preservative benzalkonium chloride, which may cause eye irritation. If you wear contact lenses, you should consult your doctor before using this medicine. You should avoid using it with soft contact lenses (the preservative benzalkonium chloride may alter the color of the lenses).

3. How to use Dorzolamida/Timolol Farmalider

Follow exactly the instructions of administration of Dorzolamida/Timolol Farmaliderindicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Your doctor will determine the appropriate dose and duration of treatment.

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

If you use Dorzolamida/Timolol Farmalider with another eye drop, the application of the drops should be spaced at least 10 minutes apart.

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

Do not let the tip of the dropper touch the eye or the surrounding areas. It could become contaminated with bacteria that can cause eye infections and serious damage to the eye, including loss of vision. To avoid possible contamination of the container, wash your hands before using the medicine and keep the tip of the container away from contact with any surface. If you think that your medicine may have become contaminated, or if you have an eye infection, consult your doctor immediately to determine whether you should continue using this bottle.

Instructions for use

• First, wash your hands.
• Avoid touching the eye (or any other surface) with the tip of the dropper.
• If you wear soft contact lenses, you should remove them before using the drops and wait at least 15 minutes before putting them back.
• Dorzolamida/Timolol Farmalider comes in a plastic bottle with a cap and a dust cap with a safety seal. When using the bottle for the first time, remove the dust cap by twisting it in a clockwise direction to break the safety seal.

• Unscrew the inner cap.
• Tilt your head back and look up.
• Gently pull down the lower eyelid to form a pouch between your eyelid and your eye.

• Hold the bottle upside down over the eye and gently squeeze to release one drop. DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE BOTTLE.
• Keep your eye closed and press the inner corner of your eye with your finger for two minutes. This will help prevent Dorzolamida/Timolol Farmalider from reaching the rest of your body.
• Repeat in the other eye, if your doctor has told you to do so.
• Replace the cap on the bottle after each use, and screw the cap back on the dropper.

If you use more Dorzolamida/Timolol Farmalider than you should

If you put too many drops or swallow some of the contents of the container, among other effects, you may feel dizzy, have difficulty breathing, or feel that your heart is beating more slowly. Consult 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 medicine and the amount ingested.

If you forget to use Dorzolamida/Timolol Farmalider

It is important to use Dorzolamida/Timolol Farmalider as indicated by your doctor.

If you have missed a dose, use it as soon as possible. However, if it is almost time for your next dose, do not use the missed dose and return to your regular dosing schedule.

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

If you stop using Dorzolamida/Timolol Farmalider

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dorzolamida/Timolol Farmalider can cause side effects, although not everybody gets them.

Normally, you can continue using the eye drops unless the effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Dorzolamida/Timolol Farmalider without talking to your doctor first.

If the effects are severe or if you experience allergic reactions, including hives or skin rash, itching, inflammation of the face, lips, tongue and/or throat which could cause difficulty in breathing or swallowing, severe allergic reaction that suddenly puts your life in danger, you should stop using Dorzolamida/Timolol Farmalider and consult your doctor immediately.

The frequency of the possible side effects listed below is defined as follows:

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

Common (may affect up to 1 in 10 users)

Uncommon (may affect up to 1 in 100 users)

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

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

Very common:

Burning and stinging in the eyes, alteration of taste

Common:

Headache, signs and symptoms of eye irritation (such as itching and tearing), blurred vision, decreased corneal sensitivity (not noticing the presence of something in the eye and not feeling pain), dry eyes, corneal erosion (damage to the front layer of the eyeball), sinusitis (a feeling of tension or fullness in the nose), nausea, weakness/fatigue and tiredness. Redness in and around the eye or eyes, inflammation and/or irritation in and around the eye or eyes, feeling of having something in the eye.

Uncommon:

Depression, dizziness, fainting, inflammation of the iris, changes in vision including changes in refraction (in certain cases due to the suspension of medication for excessive pupil constriction), slow heart rate, difficulty breathing (dyspnea), indigestion and kidney stones (often characterized by the sudden onset of severe, spasmodic pain in the lumbar and/or lateral, groin or abdominal area).

Rare:

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), difficulty sleeping (insomnia), nightmares, memory loss, stroke, cerebral ischemia (decreased blood flow to the brain), worsening of myasthenia gravis symptoms (muscle disorder), numbness of hands or feet, drooping eyelids (which makes the eye half-closed), transient myopia (which disappears when treatment is stopped), double vision, detachment of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances, eye pain, crust formation on the eyelids, inflammation of the cornea (with symptoms of visual disturbances), low eye pressure, ringing in the ears, chest pain, palpitations (faster and/or irregular heartbeat), edema (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), myocardial infarction, low blood pressure, Raynaud's phenomenon, swollen and cold hands and feet and decreased circulation in your arms and legs, claudication (leg cramps and/or leg pain when walking), difficulty breathing, shortness of breath, nasal discharge or stuffy nose, nosebleeds, constriction of airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, sore throat, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with a white, silvery appearance (psoriasiform rash) or worsening of psoriasis, systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs), Peyronie's disease (which can cause curvature of the penis), decreased libido.

As with other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when medicines, for example, are taken by mouth or injected. The additional side effects listed include reactions that occur within the class of beta-blockers when used to treat eye disorders.

Frequency not known:

Low blood sugar levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, unprovoked muscle pain, sexual dysfunction, hallucinations, feeling of a foreign body in the eye (feeling of having something in the eye), increased heart rate and increased blood pressure.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dorzolamida/Timolol Farmalider

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Keep the bottle in the outer packaging to protect it from light. Use the solution within 28 days of opening the bottle.

Do not use Dorzolamida/Timolol Farmalider after the expiration date shown on the bottle and carton. The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dorzolamida/Timolol Farmalider

• The active ingredients are dorzolamida and timolol.
• Each ml contains 22.26 mg of dorzolamida hydrochloride equivalent to 20 mg of dorzolamida, and 6.83 mg of timolol maleate, corresponding to 5 mg of timolol.
• The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injectable preparations.

Benzalkonium chloride is added as a preservative.

Appearance of Dorzolamida/Timolol Farmalider and Package Contents

Each bottle of Dorzolamida/Timolol Farmalider contains 5 ml of solution. It is a clear, colorless, and slightly viscous solution, packaged in a 5 ml low-density polyethylene (LDPE) bottle labeled with a dark blue screw cap on an LDPE applicator, with an LDPE dust cap and a security seal that seals the bottle cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La granja, 1

28108 Alcobendas (Madrid)

Spain

Manufacturer

FDC International Ltd

Unit 6, Fulcrum 1, Solent Way,

Whiteley, Fareham,

Hampshire,

PO15 7FE

United Kingdom

This leaflet was approved in January 2023

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

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