Taptiqom 15 micrograms/ml + 5 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Taptiqom 15 micrograms/ml + 5 mg/ml eye drops solution in single-dose container
Tafluprost / Timolol
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Taptiqom is and what it is used for
- What you need to know before using Taptiqom
- How to use Taptiqom
- Possible side effects
- How to store Taptiqom
- Contents of the pack and other information
1. What Taptiqom is and what it is used for
What type of medicine is it and how does it work?
Taptiqom eye drops solution contains tafluprost and timolol. Tafluprost is a medicine belonging to the group called prostaglandin analogues, and timolol belongs to a group of medicines called beta-blockers. Tafluprost and timolol work together to reduce intraocular pressure. Taptiqom is used when the pressure inside the eye is too high.
What is your medicine used for?
Taptiqom is used to treat a type of glaucoma called open-angle glaucoma, a condition also known as ocular hypertension in adults. Both conditions are associated with increased pressure in the eye and may occasionally affect your vision.
2. What you need to know before using Taptiqom
Do not use Taptiqom:
- if you are allergic to tafluprost, timolol, beta-blockers, or any of the other components of this medicine (listed in section 6).
- if you 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, or prolonged cough).
- 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 medicine, inform your doctor if you have or have had:
- heart disease (symptoms may include chest pain or tightness, breathing difficulties, or suffocation), heart failure, or low blood pressure
- heart rhythm disorders, such as slow heartbeat
- breathing 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)
- overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disorders
- any allergies or anaphylactic reactions
- myasthenia gravis (a serious condition causing muscle weakness)
- other eye conditions, such as corneal disease (the transparent tissue covering the front of the eye) or a condition requiring eye surgery.
Inform your doctor if you have:
- kidney problems
- liver problems
Please note that Taptiqom may cause the following effects, some of which may be permanent:
- Taptiqom may increase the length, thickness, color, or density of your eyelashes and may cause unusual hair growth on your eyelids.
- Taptiqom may cause darkening of the skin around the eyes. Wipe off any excess solution from the skin to reduce the risk of skin darkening.
- Taptiqom may change the color of your iris (the colored part of your eye). If Taptiqom is used in only one eye, the treated eye may permanently become a different color than the untreated eye.
- Taptiqom may cause hair growth in areas where the solution repeatedly comes into contact with the skin.
If you are undergoing surgery, inform your doctor that you are using Taptiqom, as timolol may alter the effects of certain medications used during anesthesia.
Children and adolescents
Taptiqom is not recommended for children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.
Taking Taptiqom with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taptiqom may affect, or be affected by, other medicines you are taking.
In particular, inform your doctor if you use/take or plan to use/take:
- other eye drops for the treatment of glaucoma
- medicines to lower blood pressure
- heart medications
- medicines for the treatment of diabetes
- quinidine (used to treat heart problems and certain types of malaria)
- antidepressants known as fluoxetine or paroxetine
If you use other medicines in the eye, wait at least five minutes between instilling Taptiqom and the other medicine.
Contact lenses
Remove your contact lenses before applying the drops and wait at least fifteen minutes before reinserting them.
Pregnancy, breastfeeding, and fertility
If you are a woman who could become pregnant, you must use an effective method of contraception during treatment with Taptiqom. Do not use Taptiqom if you are pregnant. Do not use Taptiqom if you are breastfeeding. Consult your doctor.
Driving and use of machines
Some adverse effects associated with Taptiqom, such as blurred vision, may affect your ability to drive or operate machinery. Do not drive or operate machinery until you feel well and your vision is clear.
Taptiqom contains phosphate buffer
This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.3 mg/ml. If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.
3. How to use Taptiqom
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one drop of Taptiqom daily in the affected eye or eyes. Do not instill more drops or use it more often than prescribed by your doctor. If you do, Taptiqom may lose effectiveness. Use Taptiqom in both eyes only if your doctor has specifically instructed you to do so. Discard the opened single-dose container and any remaining contents immediately after use.
For ophthalmic use only. Do not ingest.
Do not let the single-dose container touch the eye or surrounding area. This could damage the eye. It could also become contaminated with bacteria, which might cause eye infections leading to eye damage, including loss of vision. To avoid possible contamination of the single-dose container, avoid letting the tip touch any surface.
Instructions for use:
When opening a new pouch:
Do not use the single-dose container if the pouch is damaged. Open the pouch by tearing along the dotted line. Write the date you opened the pouch in the space provided on the pouch for this purpose.
Each time you use Taptiqom:
- Wash your hands.
- Remove the strip of containers from the pouch.
- Detach one single-dose container from the strip.
- Return the remaining strip to the pouch and fold the edge to close it.
- To open the container, break off the tab by twisting (Figure A).
- Hold the container between your thumb and index finger. Ensure the tip of the container does not extend more than 5 mm beyond the edge of your index finger (Figure B).
- Tilt your head backward or lie down. Place your hand on your forehead, with your index finger aligned with your eyebrow or resting on the bridge of your nose. Look upward. With the other hand, gently pull down the lower eyelid. Ensure no part of the container touches the eye or surrounding area. Gently squeeze the container to release one drop into the space between the eyelid and the eye (Figure C).
- Close the eye and press gently on the inner corner of the eye with your finger for about two minutes. This helps prevent the drop from draining through the tear duct (Figure D).
- Wipe away any excess solution from the skin around the eye.
If the drop misses the eye, try again.
If your doctor has instructed you to apply drops to both eyes, repeat steps 7 to 9 in the other eye. The contents of one single-dose container are sufficient for both eyes. Discard the opened single-dose container and any 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 experience headache, heart discomfort, or breathing difficulties. If necessary, consult a doctor.
If you accidentally swallow the medicine, consult a doctor.
You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to use Taptiqom, apply one drop as soon as you remember and then return to your normal routine. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed dose.
Do not stop using Taptiqom without consulting your doctor. If you interrupt treatment with Taptiqom, eye pressure will rise again. This could lead to permanent eye damage. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most adverse effects are not serious.
You can usually continue using the drops unless the effects are severe. If in doubt, consult a doctor or pharmacist.
Known adverse effects of using Taptiqom are:
Frequent adverse effects
The following effects may affect up to 1 in 10 people:
Eye disorders
Itching of the eyes. Eye irritation. Eye pain. Redness of the eyes. Changes in length, thickness, and density of eyelashes. Foreign body sensation in the eye. Discoloration of eyelashes. Light sensitivity. Blurred vision.
Uncommon adverse effects
The following effects may affect up to 1 in 100 people:
Nervous system disorders
Headache.
Eye disorders
Dry eyes. Redness of the eyelids. Small areas of inflammation at points on the surface of the eye. Watery eyes. Swelling of the eyelids. Tired eyes. Inflammation of the eyelids. Inflammation inside the eye. Eye discomfort. Ocular allergy. Inflammation of the eye. Abnormal sensation in the eye.
The following additional adverse effects have been observed with the medicines that make up Taptiqom (tafluprost and timolol) and therefore may occur when using Taptiqom:
The following side effects have been observed with tafluprost:
Eye disorders
Reduced ability of the eye to see detail. Change in iris color (may be permanent). Change in skin color around the eyes. Inflammation of the membranes on the surface of the eye. Eye discharge. Pigmentation of the membranes on the surface of the eye. Follicles on the membranes on the surface of the eye. Sunken eye. Iritis/uveitis (inflammation of the colored part of the eye). Macular edema/cystoid macular edema (inflammation of the retina inside the eye leading to worsening vision).
Skin disorders
Unusual growth of eyelashes.
Effects on the respiratory system
Worsening of asthma, respiratory failure.
The following side effects have been observed with timolol:
Immune system disorders
Allergic reactions, including inflammation under the skin, urticaria, and rashes. Sudden and potentially life-threatening 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 pricking). Worsening of signs and symptoms of myasthenia gravis (a muscle disorder). Stroke. Reduced blood flow to the brain.
Eye disorders
Corneal inflammation. Reduced corneal sensitivity. Visual disturbances, including refractive changes (sometimes due to discontinuation of miotic therapy). Drooping of the upper eyelid. Double vision. Blurred vision and detachment of the layer located beneath the retina, containing blood vessels, after filtration surgery, which may cause visual disturbances. Corneal erosion.
Ear disorders
Tinnitus (ringing in the ears).
Cardiac disorders
Slow heartbeat. Chest pain. Palpitations. Edema (fluid accumulation). Changes in heart rhythm or rate. Congestive heart failure (heart disease with breathing difficulty and swelling of feet and legs due to fluid accumulation). A type of heart rhythm disorder. Myocardial infarction. Heart failure.
Vascular disorders
Low blood pressure. Claudication. Raynaud's phenomenon, cold hands and feet.
Respiratory disorders
Constriction of airways in the lungs (especially in patients with pre-existing disease). Difficulty breathing. Cough.
Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Taste disturbances. Abdominal pain. Vomiting.
Skin disorders
Hair loss. Skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis. Skin rash.
Musculoskeletal disorders
Muscle pain not caused by exercise. Joint pain.
Reproductive and breast disorders
La Peyronie's disease (which may cause curvature of the penis). Sexual dysfunction. Decreased libido.
General disorders
Muscle weakness/fatigue. Thirst.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Taptiqom
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, the aluminum pouch, and the outer carton, following "CAD" and "EXP". The expiry date refers to the last day of the month indicated.
Store unopened aluminum pouches in a refrigerator (between 2 and 8 °C). Do not open the pouch until you are ready to start using the eye drops, as unused containers from an opened pouch must be discarded 28 days after the pouch is first opened.
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 aluminum pouch was first opened.
- Immediately discard any opened single-dose containers with remaining solution after use.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Taptiqom
- The active substances are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
- The other components are glycerol, disodium phosphate dodecahydrate, edetate disodium, polysorbate 80, hydrochloric acid or sodium hydroxide (to adjust pH), and water for injections.
Appearance of the product and contents of the container
Taptiqom is a clear, colourless liquid (solution) supplied in single-dose containers made of plastic, each containing 0.3 ml of solution. The single-dose containers are packed ten in a pouch. Taptiqom is supplied in packs containing 30 or 90 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
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
This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under 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
Date of the most recent review of this leaflet: June 2022
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/