Prospect: Patient Information

Taptiqom 15 micrograms/ml + 5 mg/ml eye drops in single-dose 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 medicationis 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.

Do not use Taptiqom:

• if you are allergic to tafluprost, timolol, beta-blockers, or any of the other ingredients of this medication (listed in section 6).
• if you have or have had severe respiratory problems such as asthma, chronic obstructive pulmonary disease (COPD) that may 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 asphyxia), 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 (low blood sugar).
• hyperthyroidism, as timolol may mask the signs and symptoms of thyroid diseases.
• any allergy or anaphylactic reaction.
• myasthenia gravis (a severe disease that causes muscle weakness).
• other eye diseases, such as corneal disease (the transparent layer at the front of the eye) or a disease that requires eye surgery.

Inform your doctor if you have:

• kidney problems.
• liver problems.

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

• Taptiqom may increase the length, thickness, color, or density of your eyelashes and cause unusual hair growth on your eyelids.
• Taptiqom may cause darkening of the skin around your eyes. Wipe off any excess solution from your skin. This will reduce the risk of skin darkening.
• Taptiqom may 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.
• Taptiqom may cause hair growth in areas where the solution comes into contact with the skin surface repeatedly.

If you are undergoing 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.
• blood pressure-lowering medications.
• heart medications.
• diabetes medications.
• quinidine (used to treat heart problems and some types of malaria).
• antidepressants such as fluoxetine or paroxetine.

If you use other eye medications, wait at least five 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 a woman who may become pregnant, use an effective contraceptive method during Taptiqom treatment. Do not use Taptiqom if you are pregnant. Do not use Taptiqom if you are breastfeeding. Consult your doctor.

Driving and operating machinery

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

Taptiqom contains phosphate buffer

This medication contains approximately 0.04 mg of phosphate in each drop, equivalent to 1.3 mg/ml. If you have severe damage to the cornea (the transparent layer at 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 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 use 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. Dispose of the opened package and remaining contents immediately after use.

For use only as eye drops. Do not ingest.

Do not let the single-use container touch the eye or 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 vision loss. To avoid possible contamination of the single-use container, avoid letting the tip of the container touch any surface.

Usage Instructions:

When opening a new package:

Do not use the single-use container if the pouch is torn. Open the pouch by tearing along the dotted line. Write, in the space reserved for this purpose on the pouch, the date you opened the pouch.

Each time you use Taptiqom:

1. Wash your hands.
2. Remove the strip of containers from the package.
3. Remove one single-use container from the strip.
4. Put the rest of the strip back in the package and fold the edge to close it.
5. To open the container, break the tab by rotating it (Figure A).
6. Hold the container with your thumb and index finger. Make sure the tip of the container does not protrude more than 5 mm from the edge of your index finger (Figure B).
7. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of your nose. Look up. Press down on the upper eyelid with your other hand. Do not let any part of the container touch the eye or surrounding area. Press the container gently so that one drop falls into the space between the eyelid and the eye (Figure C).
8. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the drop from draining through the tear duct (Figure D).
9. Wipe away any excess solution from the skin around your eye.

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. The contents of one single-use container are sufficient for both eyes. Dispose of the opened container and remaining contents immediately after use.

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

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

If you accidentally ingest the medication,consult a doctor.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to use Taptiqom,put 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 make up for the missed doses.

Do not stop using Taptiqom without consulting your doctor. If you interrupt treatment with Taptiqom, eye pressure will increase again. This could cause permanent damage to the eye. If you have any other questions about the use of 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 unless the side effects are severe. If you are unsure, consult a doctor or pharmacist.

The known side effects of Taptiqom use are:

Frequent side effects

The following effects can 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

The following effects can 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/macular cystoid edema (inflammation of the retina within the eye leading to worsening 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 (decreased blood sugar levels).

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). Ptosis. 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 difficulty breathing 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 pre-existing condition). Difficulty breathing. Cough.

Gastrointestinal disorders

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

Skin disorders

Hair loss. Skin rash with a silvery 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 single-dose container, the pouch, and the box after "CAD" and “EXP”. The expiration date is the last day of the month indicated.

Store the aluminum pouches unopened in a refrigerator (between 2 and 8 °C). Do not open the pouch until you are about to start using the eye drops, as unused containers from an opened pouch must be discarded 28 days after opening the pouch for the first time.

After opening the aluminum pouch:

• Store the single-dose containers in the original aluminum pouch to protect them from light.
• Store below 25 °C.
• Discard the single-dose containers 28 days after the first opening of the aluminum pouch.
• Discard the opened single-dose containers with the remaining solution immediately after using them.

Medications should not be thrown away through 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. By doing so, 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.
• The other components are glycerol, disodium dodecahydrate phosphate, disodium edetate, polisorbate 80, hydrochloric acid or sodium hydroxide (to adjust the pH) and water for injection preparations.

Appearance of the product and contents of the packaging

Taptiqom is a transparent and colorless liquid (solution) presented in single-dose plastic containers that contain 0.3 ml of solution each. The single-dose containers are contained, ten in ten, in a bag. Taptiqom is supplied in containers with 30 or 90 single-dose containers.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible manufacturer

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Further information about this medicine can be requested from the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7th floor

28045 – Madrid

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Taptiqom:Germany, Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Netherlands, Hungary, Ireland, Iceland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden

Loyada:Italy

Last review date of this leaflet:June 2022

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