Prospect: Patient Information

Taptiqom 15 micrograms/mL + 5 mg/mL eye drops in solution

tafluprost/timolol

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to 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 prospect. See section 4.

1.What Taptiqom is and for what it is used

2.What you need to know before starting to use Taptiqom

3.How to use Taptiqom

4.Possible adverse effects

5.Storage of Taptiqom

6.Contents of the package and additional information

What type of medication is it and how does it work?

Taptiqom eye drops in solution contain tafluprost and timolol. Tafluprost is a medication in the group called prostaglandin analogs and timolol belongs to the group of medications called beta-blockers. Tafluprost and timolol act together and reduce eye pressure. Taptiqom is used when eye pressure is too high.

What is the purpose of your medication?

Taptiqom is used to treat a type of glaucoma called open-angle glaucoma, a condition also known as ocular hypertension in adults. Both situations are related to an increase in eye pressure and may occasionally affect your vision.

No use Taptiqom:Taptiqom:

• If you are allergic to tafluprost, timolol, beta blockers, or any of the other ingredients in this medication (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, or prolonged coughing).
• If you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Taptiqom.

Before using this medication, inform your doctor if you have or have had:

• Heart disease (symptoms may include chest pain or pressure, shortness of breath, or asphyxiation), heart failure, or low blood pressure.
• Heart rhythm disorders, such as slow heartbeats.
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask the signs and symptoms of hypoglycemia.
• Hyperthyroidism, as timolol may mask the signs and symptoms of thyroid diseases.
• Any allergy or anaphylactic reaction.
• Myasthenia gravis (a serious disease that causes muscle weakness).
• Other eye diseases, such as corneal disease (the transparent layer covering the front of the eye) or a disease requiring eye surgery.

Inform your doctor if you have:

• Kidney problems.
• Liver problems.

Be aware that Taptiqom may cause the following effects, and some may be permanent:

Taptiqom may

• Lengthen, thicken, darken, or increase the density of your eyelashes and cause unusual hair growth on your eyelids.
• Darken the skin around your eyes. Wipe off any excess solution from the skin. This will reduce the risk of skin darkening.
• Change the color of your iris (the colored part of your eye). If you use Taptiqom in one eye, the treated eye may permanently have a different color from the other eye.
• Cause hair growth in areas where the solution comes into contact with the skin surface repeatedly.

If you are to undergo surgery, inform your doctor that you are using Taptiqom, as timolol may change the effects of some medications used during anesthesia.

Children and Adolescents

Taptiqom is not recommended for children and adolescents under 18 years of age due to a lack of data on safety and efficacy in this age group.

Taking Taptiqom with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or think you may need to take any other medication.

Taptiqom may affect, or be affected by, other medications you are taking.

Particularly, inform your doctor if you use/take or plan to use/take:

• Other eye drops for glaucoma treatment.
• Medications to lower blood pressure.
• Heart medications.
• Diabetes medications.
• Quinidine (used to treat heart problems and some types of malaria).
• Antidepressants known as fluoxetine or paroxetine.

If you use other eye medicationsin the eye, leave at least 5 minutes between instilling Taptiqom and the other medication.

Contact Lenses

Remove your contact lenses before administering the drops and wait at least 15 minutes before reinserting them.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. If you are a woman who may become pregnant, you must use an effective contraceptive method during Taptiqom treatment. Do not use Taptiqom if you are pregnant, except if your doctor has instructed you to. Do not use Taptiqom if you are breastfeeding. Consult your doctor.

Driving and Operating Machines

Some side effects associated with Taptiqom, such as blurred vision, may affect your ability to drive vehicles or operate machines. Do not drive or operate machines until you feel well and your vision is clear.

Taptiqom contains phosphates

This medication contains 1.3 mg of phosphates in each ml.

If you have severe damage to the cornea (the transparent layer covering the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one drop of Taptiqom per day in the affected eye or eyes. Do not instill more drops or do it more often than indicated by your doctor. If you do, Taptiqom may lose its effectiveness. Use Taptiqom in both eyes only if your doctor has instructed you to do so.

For use as eye drops only. Do not ingest.

Do not let the multidose container touch the eye or the surrounding area. It could damage the eye. It could also become contaminated with bacteria that could cause eye infections that could in turn cause eye damage, including loss of vision. To avoid possible contamination of the multidose container, avoid letting the tip of the container touch any surface.

Usage Instructions:

When using it for the first time, before applying a drop to the eye, you must first practice using the bottle, slowly pressing it to let a drop fall outside the eye.

When you are sure you can apply one drop at a time, choose the most comfortable position for drop instillation (you can sit, lie on your back, or stand in front of a mirror).

When starting a new bottle:

Do not use the bottle if the plastic ring around the neck of the bottle is not there or is broken. Write the date you opened the bottle in the space reserved for the date, on the outer box.

Each time you use Taptiqom:

You will be left with a residual volume of approximately 1 ml that cannot be administered. Do not attempt to empty the bottle.

If the drop falls outside the eye,try again.

If your doctor has told you to apply drops in both eyes,repeat steps 7 to 9 in the other eye.

If you use other eye medications,leave at least 5 minutes between applying Taptiqom and the other medication.

If you use more Taptiqom than you should,you may feel dizzy or have headaches, heart discomfort, or respiratory problems. If necessary, consult a doctor.

If you accidentally ingest the medication,consult a doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Taptiqom,apply one drop as soon as you remember and return to your normal routine. However, if it is close to the time of the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

Do not stop using Taptiqom without consulting your doctor. If you interrupt treatment withTaptiqom, eye pressure will increase again. This could cause permanent damage to the eye.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are not serious.

You can usually continue using the drops except if the side effects are severe. In case of doubt, consult a doctor or pharmacist.

The known side effects of Taptiqom use are:

Frequent side effects(may affect up to 1 in 10 people):

Eye disorders

Eye itching. Eye irritation. Eye pain. Redness of the eyes. Changes in the length, thickness, and density of eyelashes. Sensation of foreign bodies in the eye. Discoloration of eyelashes. Light sensitivity. Blurred vision.

Rare side effects(may affect up to 1 in 100 people):

Nervous system disorders

Headache.

Eye disorders

Dry eye. Redness of the eyelids. Small areas of inflammation on the surface of the eye. Watery eyes. Swelling of the eyelids. Tired eyes. Inflammation of the eyelids. Inflammation within the eye. Eye discomfort. Allergic eye reaction. Inflammation of the eye. Abnormal sensation in the eye.

The following additional side effects have been observed in the medications that make up Taptiqom (tafluprost and timolol) and may therefore appear when using Taptiqom:

The following side effects have been observed with tafluprost:

Eye disorders

Reduced ability of the eye to see details. Change in the color of the iris (may be permanent). Change in the color of the skin around the eyes. Inflammation of the surface membranes of the eye. Eye discharge. Pigmentation of the surface membranes of the eye. Follicles on the surface membranes of the eye. Sunken eye. Iritis/uveitis (inflammation of the colored part of the eye). Macular edema/cystoid macular edema (inflammation of the retina within the eye leading to worsening of vision).

Skin disorders

Unusual hair growth on the eyelids.

Respiratory system effects

Worsening of asthma, respiratory insufficiency.

The following side effects have been observed with timolol:

Immune system disorders

Allergic reactions, including skin inflammation, urticaria, and rashes. Sudden and potentially fatal allergic reaction. Itching.

Metabolism and nutrition disorders

Hypoglycemia.

Psychiatric disorders

Depression. Sleep disorders. Nightmares. Memory loss. Nervousness. Hallucinations

Nervous system disorders

Dizziness. Weakness. Unusual sensations (such as tingling and pins and needles). Increased signs and symptoms of myasthenia gravis (muscular disorder). Stroke. Reduced cerebral blood flow.

Eye disorders

Corneal inflammation. Reduced corneal sensitivity. Visual disturbances, including refractive changes (sometimes due to discontinuation of miotic therapy). Drooping eyelid. Double vision. Blurred vision and detachment of the layer beneath the retina, which contains blood vessels, after surgery for filtration, which may cause visual disturbances. Corneal erosion.

Auditory disorders

Tinnitus (ringing in the ears).

Cardiac disorders

Slow heart rate. Chest pain. Palpitations. Edema (fluid accumulation). Changes in heart rhythm or rate. Congestive heart failure (heart disease with respiratory difficulty and swelling of feet and legs due to fluid accumulation). A type of arrhythmia. Myocardial infarction. Cardiac arrest.

Vascular disorders

Low blood pressure. Gait disturbance. Raynaud's phenomenon, cold hands and feet.

Respiratory disorders

Constriction of the airways in the lungs (especially in patients with a previous disease). Respiratory difficulty. Cough.

Gastrointestinal disorders

Nausea. Indigestion. Diarrhea. Dry mouth. Taste alterations. Abdominal pain. Vomiting.

Skin disorders

Hair loss. Skin rash with a silver-white appearance (psoriasis-like rash) or worsening of psoriasis. Skin rash.

Musculoskeletal and skeletal disorders

Unexplained muscle pain not caused by exercise. Joint pain.

Reproductive and breast system disorders

Peyronie's disease (which may cause curvature of the penis). Sexual dysfunction. Reduced libido.

General disorders

Muscle weakness/ fatigue. Thirst.

Reporting 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: https;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store unopened bottles in a refrigerator (between 2 and 8 °C). Do not freeze.

Store the bottle in the original packaging to protect it from light.

After opening the bottle:

• Do not store at a temperature above 25ºC. Do not freeze.
• Store the bottle in the original packaging to protect it from light.
• After the first opening, to avoid infections, the bottle should be discarded at a maximum of 3 months. The 3 ml filled bottle is intended for a period of use of 1 month, the 5 ml bottle for 2 months, and the 7 ml bottle for 3 months.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at 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 Taptiqom

• The active principles are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol (in the form of maleate).
• The other components are glycerol, disodium dodecahydrate phosphate, disodium edetate, polisorbate 80, hydrochloric acid and/or sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the packaging

T aptiqom is a transparent and colorless liquid (solution) that is practically free of visible particles. It is presented in a packaging that contains 1 transparent plastic vial that contains 3 ml, 5 ml, or 7 ml, or 3 transparent plastic vials with 3 ml of solution each. The plastic vials are closed with stoppers.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible for manufacturing

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7th floor

28045 – Madrid

Last review date of this leaflet: November 2021

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