Taptiqom Multi

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

TAPTIQOM Multi, 15 micrograms/ml + 5 mg/ml,

eye drops, solution
Tafluprost + Timolol

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What TAPTIQOM Multi is and what it is used for
• 2. Important information before using TAPTIQOM Multi
• 3. How to use TAPTIQOM Multi
• 4. Possible side effects
• 5. How to store TAPTIQOM Multi
• 6. Contents of the pack and other information

1. What TAPTIQOM Multi is and what it is used for

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

TAPTIQOM Multi eye drops contain tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-adrenergic blockers.
Tafluprost and timolol work together to lower the pressure in the eye. TAPTIQOM Multi is used when the pressure in the eye is too high.

What is this medicine used for?

TAPTIQOM Multi is used to treat a type of glaucoma called open-angle glaucoma and a condition called ocular hypertension in adults. Both of these conditions are associated with increased pressure inside the eye and can lead to vision disturbances.

2. Important information before using TAPTIQOM Multi

When not to use TAPTIQOM Multi:

• if the patient is allergic to tafluprost, timolol, beta-adrenergic blockers, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a respiratory disease, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing);
• if the patient has slow heart rate, heart failure, or irregular heart rhythm.

Warnings and precautions

Before starting to use TAPTIQOM Multi, the patient should discuss it with their doctor, pharmacist, or nurse.

Before using this medicine, the patient should inform their doctor if they currently have or have had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, low blood pressure;
• irregular heart rhythm, such as slow heart rate;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (e.g., Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the symptoms of low blood sugar;
• hyperthyroidism, as timolol may mask the symptoms of thyroid disease;
• any allergy or anaphylactic reaction;
• myasthenia (a rare disease that causes muscle weakness);
• other eye diseases, such as corneal disease (disease of the clear tissue covering the front of the eye) or eye disease requiring surgical treatment.

The patient should inform their doctor if they have:

• kidney problems,
• liver problems.

It should be consideredthat TAPTIQOM Multi may cause the following effects, some of which may be permanent:
TAPTIQOM Multi may

• increase the length, thickness, color intensity, and/or number of eyelashes and may cause abnormal hair growth on the eyelids.
• cause darkening of the skin color around the eyes. The patient should wipe off any excess solution from the skin around the eye. This will reduce the risk of skin darkening.
• change the color of the iris (the colored part of the eye). If TAPTIQOM Multi is used in only one eye, the color of the treated eye may change permanently and differ from the other eye.
• cause hair growth in areas where the solution comes into repeated contact with the skin.

Before surgery, the patient should tell their doctor that they are using TAPTIQOM Multi, as timolol may affect the action of certain medicines used during anesthesia.

Children and adolescents

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

TAPTIQOM Multi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Other medicines may affect the action of TAPTIQOM Multi, and TAPTIQOM Multi may affect the action of other medicines.
In particular, the patient should tell their doctor if they are taking or plan to take any of the following medicines:

• other eye drops for glaucoma,
• medicines to lower blood pressure,
• heart medicines,
• medicines for diabetes,
• quinidine (a medicine used to treat heart disease and some types of malaria),
• antidepressants, such as fluoxetine and paroxetine.

If the patient is also using other eye medicines, they should leave a gap of at least 5 minutes between administering TAPTIQOM Multi and the other medicine.

Contact lenses

The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back in.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.
If the patient may become pregnant, they must use an effective method of birth control during treatment with TAPTIQOM Multi. TAPTIQOM Multi should not be used during pregnancy unless the doctor recommends it. TAPTIQOM Multi should not be used during breastfeeding.

Driving and using machines

Certain side effects associated with the use of TAPTIQOM Multi, such as blurred vision, may affect the ability to drive or operate machinery. The patient should not drive or operate machinery until they feel well and their vision is clear.

TAPTIQOM Multi contains phosphates

This medicine contains 1.3 mg of phosphates per 1 ml. In patients with severe damage to the clear, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use TAPTIQOM Multi

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
The recommended dose is one drop of TAPTIQOM Multi in the eye(s) once a day. The patient should not use more drops or use the medicine more often than the doctor has told them. This may reduce the effect of TAPTIQOM Multi.
The patient should use TAPTIQOM Multi in both eyes only if their doctor has told them to.
For use as eye drops only. Do not swallow.
The patient should not let the tip of the multi-dose container touch the eye or the area around the eye. This could cause injury to the eye. It could also lead to contamination of the eye with bacteria and subsequent infection of the eye, leading to serious damage, including loss of vision. To avoid possible contamination of the single-dose container, the patient should not let the tip of the container touch any surface.

Instructions for use:

When using the bottle for the first time, before administering the drops to the eye, the patient should test the bottle by squeezing it slowly until one drop is released from the bottle, away from the eye.
Once the patient is sure they can deliver one drop at a time, they should choose the most comfortable position for administration (they can sit, lie on their back, or stand in front of a mirror).
When using the bottle for the first time:
The patient should not use the bottle if the plastic protective ring around the neck of the bottle is damaged or missing. The patient should write the date of opening on the space provided on the outer carton.
Every time the patient uses TAPTIQOM Multi:

• 1. Wash hands.
• 2. When opening the bottle for the first time, the patient should remove the protective ring from the nozzle by pulling the protection.
• 3. Open the bottle by pulling the nozzle.

• 4. When using the bottle for the first time, the patient should discard one or more drops.
• 5. Hold the bottle between the thumb and middle finger.
• 6. Tilt the head back or lie down. Rest the hand on the forehead. The index finger should be along the eyebrow. The patient should be careful not to let the tip of the bottle with the dropper touch the eye, the skin around the eye, or the fingers, to avoid potential contamination of the solution
• 7. With the other hand, pull the lower eyelid down and look up. Gently squeeze the container to release a single drop into the space between the lower eyelid and the eye. The patient should note that there may be a slight delay between squeezing the bottle and the drop appearing. The patient should not squeeze too hard.

• 8. Close the eye and press the inner corner of the eye with the finger for about 2 minutes. This will prevent the drop from flowing through the tear duct.
• 9. Wipe off any excess solution from the skin around the eyes to reduce the risk of skin darkening.

• 10. Shake the bottle once downwards to remove any remaining solution from the tip of the dispenser. The patient should not touch or wipe the dispenser.
• 11. Put the nozzle back and close the bottle tightly.

After using the medicine, about 1 ml of solution remains in the bottle, which cannot be used.
The patient should not try to empty the bottle completely.
If a drop misses the eye, the patient should try again.
If the doctor has told the patient to use drops in both eyes, the patient should repeat steps 7 to 9 for the second eye.
If the patient is using other eye medicines, they should leave a gap of at least 5 minutes between administering TAPTIQOM Multi and the other medicine.
If the patient uses more TAPTIQOM Multi than they should, they may feel dizzy, have a headache, heart problems, or breathing difficulties. If necessary, the patient should consult their doctor.
If the medicine is accidentally swallowed, the patient should contact their doctor.
If the patient misses a dose of TAPTIQOM Multi, they should use one drop as soon as they remember, and then continue with the medicine as planned.
However, if it is almost time for the next dose, the patient should not use the missed dose.
The patient should not use a double dose to make up for a missed dose.
The patient should not stop using TAPTIQOM Multi without consulting their doctor.If the patient stops using TAPTIQOM Multi, the pressure in the eye will increase again. This may cause permanent damage to the eye.
If the patient has any further questions about the use of this medicine, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, TAPTIQOM Multi can cause side effects, although not everybody gets them. Most side effects are not serious.
Usually, the patient can continue to use the eye drops if the side effects are not serious. If the patient is concerned, they should talk to their doctor or pharmacist.

The following are known side effects of TAPTIQOM Multi:

Common side effects(may affect less than 1 in 10 people treated)
Eyelid disorders
itching of the eye, irritation of the eye, eye pain, redness of the eye, changes in the length, thickness, and number of eyelashes, feeling of a foreign body in the eye, change in eyelash color, sensitivity to light, blurred vision.
Uncommon side effects(may affect less than 1 in 100 people treated)
Nervous system disorders
headache
Eyelid disorders
dry eye, redness of the eyelids, small punctate spots of inflammation on the surface of the eye, tearing, swelling of the eyelids, eye fatigue, eyelid inflammation, inflammation of the inside of the eye, feeling of discomfort in the eye, eye allergy, eye inflammation, abnormal sensations in the eye.

The following side effects have been observed with the use of the active substances of TAPTIQOM Multi (tafluprost and timolol), and may also occur with the use of TAPTIQOM Multi:

The following side effects have been observed with the use of tafluprost:

Eyelid disorders
reduced ability to see details, change in iris color (may be permanent), change in skin color around the eyes, swelling of the conjunctiva, discharge from the eye, discoloration of the conjunctiva, nodules on the conjunctiva, sunken eye, inflammation of the iris and/or uvea, swelling of the macula and/or cystoid macular edema (swelling of the retina that can lead to vision impairment).
Skin disorders
abnormal hair growth on the eyelids.
Respiratory disorders
worsening of asthma, shortness of breath.

The following side effects have been observed with the use of timolol:

Immune system disorders
allergic reactions, including angioedema, rash, and urticaria, severe life-threatening allergic reaction, itching.
Metabolic and nutritional disorders
low blood sugar
Psychiatric disorders
depression, difficulty sleeping, nightmares, memory loss, nervousness, hallucinations.
Nervous system disorders
dizziness, fainting, unusual sensations (e.g., tingling and numbness), worsening of myasthenic symptoms, stroke, reduced blood flow to the brain.
Eyelid disorders
inflammation of the cornea, reduced corneal sensitivity, visual disturbances, including changes in refraction (sometimes caused by discontinuation of miotic drugs), drooping of the upper eyelid, double vision, blurred vision, and detachment of the layer behind the retina with blood vessels after filtration surgery, which can cause vision disturbances, corneal ulcers.
Ear disorders
ringing in the ears.
Heart disorders
slow heart rate, chest pain, palpitations, swelling (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease that causes shortness of breath and swelling of the feet and legs due to fluid accumulation), a certain type of heart rhythm disorder, heart attack, heart failure.
Vascular disorders
low blood pressure, intermittent claudication, Raynaud's phenomenon, cold hands and feet.
Respiratory disorders
constriction of airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough.
Gastrointestinal disorders
nausea, indigestion, diarrhea, dry mouth, taste disturbances, stomach pain, vomiting.
Skin disorders
hair loss, skin rash with a white-silver appearance (psoriasiform rash) or exacerbation of psoriasis, skin rash.
Musculoskeletal disorders
muscle pain not caused by physical exertion, joint pain.
Reproductive system and breast disorders
Peyronie's disease (which can cause curvature of the penis), sexual dysfunction, decreased libido.
General disorders
muscle weakness and fatigue, thirst.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store TAPTIQOM Multi

The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
Unopened bottles should be stored in the refrigerator (2°C – 8°C). Do not freeze.
Store the bottle in the original packaging to protect from light.
After opening the bottle:

• Do not store above 25°C. Do not freeze.
• Store the bottle in the original outer packaging to protect from light.
• After opening, to prevent infections, the bottle should be discarded after 3 months at the latest. The 3 ml solution bottle is intended for 1 month of use, the 5 ml solution bottle for 2 months, and the 7 ml solution bottle for 3 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TAPTIQOM Multi contains

• The active substances of TAPTIQOM Multi are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
• The other ingredients are: glycerol, disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, hydrochloric acid, and/or sodium hydroxide (to adjust pH) and water for injections.

What TAPTIQOM Multi looks like and contents of the pack

TAPTIQOM Multi is a clear, colorless solution (solution), practically free from visible particles. TAPTIQOM Multi is available in LDPE bottles with an OSD (Ophthalmic Squeeze Dispenser) dropper made of PE, PP, cyclic olefin copolymer, and an LDPE nozzle with a protective ring, in a cardboard box. The pack contains 1 transparent plastic bottle of 3 ml, 5 ml, or 7 ml solution or 3 transparent plastic bottles of 3 ml solution each.

Marketing authorization holder

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

TAPTIQOM: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, France, Greece, Spain, Netherlands, Ireland, Latvia, Lithuania, Luxembourg, Germany, Portugal, Slovakia, Slovenia, Hungary, United Kingdom (Northern Ireland).
TAPTIQOM sine:Denmark, Estonia, Finland, Iceland, Norway, Sweden
TAPTIQOM Multi:Poland
Loyada:Italy

Date of last revision of the leaflet: 12/2021