Taptiqom multi

Package leaflet: Information for the patient

Taptiqom Multi, 15 micrograms/ml + 5 mg/ml,
eye drops, solution
Tafluprostum + Timololum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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-blockers. Tafluprost and timolol work together to reduce intraocular pressure. Taptiqom Multi is used when eye pressure 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 may lead to vision impairment.

2. Important information before using Taptiqom Multi

When not to use Taptiqom Multi:

• if the patient is allergic to tafluprost, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had a respiratory disorder, such as asthma, or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing and/or a long-lasting cough);
• if the patient has a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeat).

Warnings and precautions
Before starting treatment with Taptiqom Multi, discuss this with your doctor, pharmacist or nurse.
Before using this medicine, inform your doctor if the patient currently has or has previously had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or chest discomfort), heart failure, hypotension;
• heart rhythm disorders, such as slow heart rate;
• breathing disorders, asthma or chronic obstructive pulmonary disease;
• circulatory disorders (e.g. Raynaud's disease or Raynaud's phenomenon);
• diabetes, because timolol may mask the physical and subjective symptoms of low blood sugar;
• overactive thyroid, because timolol may mask the physical and subjective symptoms of thyroid disease;
• any allergy or anaphylactic reaction;
• myasthenia (a rare condition causing muscle weakness);
• other eye disorders, for example corneal disease (affecting the clear tissue covering the front part of the eye) or an eye condition requiring eye surgery.

Inform your doctor if the patient has:

• kidney problems,
• liver problems.

It should be considered that Taptiqom Multi may cause the following effects, some of which may be permanent:
Taptiqom Multi may

• increase the length, thickness, colour intensity and/or number of eyelashes, and may cause unusual hair growth on the eyelids.
• cause darkening of the skin around the eyes. Excess solution around the eye should be wiped off. This will help reduce the risk of skin pigmentation.
• change the colour of the iris (the coloured part of the eye). If Taptiqom Multi is used in only one eye, the treated eye may permanently change colour and differ from the other eye.
• cause increased hair growth in areas where the solution repeatedly comes into contact with the skin.

Before undergoing surgery, inform the doctor about the use of Taptiqom Multi, as timolol may affect the action of certain drugs used during anaesthesia.
Children and adolescents
Taptiqom Multi is not recommended for children and adolescents under 18 years of age due to lack of data on efficacy and safety in this age group.
Taptiqom Multi and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Other medicines may affect the action of Taptiqom Multi, and Taptiqom Multi may affect the action of other medicines.
In particular, inform your doctor if the patient is taking or plans to take any of the following medicines:

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

If the patient is also using other eye medicines, at least 5 minutes should be left between the administration of Taptiqom Multi and the other medicine.
Contact lenses
Contact lenses should be removed before instilling the drops and at least 15 minutes should be waited before reinserting them.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
If the patient could become pregnant, she must use an effective method of contraception during treatment with Taptiqom Multi. Do not use Taptiqom Multi during pregnancy unless advised by a doctor. Taptiqom Multi should not be used during breastfeeding.
Driving and operating machinery
Certain adverse effects associated with the use of Taptiqom Multi, such as blurred vision, may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until good well-being and clear vision return.
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 very rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use TAPTIQOM Multi

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 drop of TAPTIQOM Multi into the affected eye or eyes once daily. Do not use more drops or use the medicine more frequently than prescribed by your doctor, as this may reduce the effectiveness of TAPTIQOM Multi.
Use TAPTIQOM Multi in both eyes only if instructed to do so by your doctor.
For topical ophthalmic use only. Do not swallow.
Do not allow the multi-dose container to come into contact with the eye or surrounding area. This could cause eye injury and may also lead to bacterial contamination of the eye, resulting in eye infection and potentially serious damage or even loss of vision. To prevent possible contamination of the single-dose container, do not allow the tip of the container to touch any surface.

Instructions for use:
At first use, before administering drops into the eye, the patient should practice using the bottle by slowly squeezing it until one drop is dispensed, away from the eye.
Once the patient is confident that they can deliver one drop at a time, they should choose the most comfortable position for instillation (sitting, lying on the back, or standing in front of a mirror).

When using the bottle for the first time:
Do not use if the plastic tamper-evident ring around the neck of the bottle is damaged or missing. Record the date the bottle was opened in the space provided for the date on the outer carton.
Each time when using TAPTIQOM Multi:

1. Wash your hands.
2. When opening the bottle for the first time, remove the cap’s safety ring by pulling the tab.
3. Open the bottle by pulling the cap.

4. At first use of the bottle, discard one or more drops.
5. Hold the bottle between your thumb and middle finger.
6. Tilt your head backward or lie down. Rest your hand on your forehead. Your index finger should be along the eyebrow.

Take special care to ensure that the tip of the dropper bottle does not touch the eye, the skin around the eye, or your fingers to avoid potential contamination of the solution.

7. With the other hand, gently pull the lower eyelid downward and look upward. Gently squeeze the container to release a single drop into the space between the lower eyelid and the eye. Note that there may be a slight delay between squeezing the bottle and the drop appearing. Do not squeeze too hard.

8. Close the eye and press with one finger on the inner corner of the eye (near the nose) for about 2 minutes. This helps prevent the drop from draining through the tear duct.
9. Wipe away any excess solution from the skin around the eyes to reduce the risk of skin darkening of the eyelids.
10. Shake the bottle once downward to remove any residual solution from the dropper tip. Do not touch or wipe the dropper tip.
11. Replace the cap and close the bottle tightly.

Approximately 1 ml of solution will remain in the bottle after use is completed, which cannot be used. Do not attempt to completely empty the bottle.
If the drop misses the eye, repeat the procedure.
If your doctor has prescribed drops in both eyes, repeat steps 7 to 9 for the second eye.
If the patient is also using other eye medicines, wait at least 5 minutes between administering TAPTIQOM Multi and any other eye medication.
In case of overdose, the patient may experience dizziness, headache, heart-related symptoms, or breathing difficulties. Seek medical advice if necessary.
If TAPTIQOM Multi is accidentally swallowed, contact a doctor immediately.
If a dose of TAPTIQOM Multi is missed, administer one drop as soon as the missed dose is remembered, then continue using the medicine as scheduled. However, if it is almost time for the next dose, do not take the missed dose. Do not use a double dose to make up for a missed dose.
Do not stop using TAPTIQOM Multi without consulting your doctor. Stopping treatment with TAPTIQOM Multi may lead to a renewed increase in intraocular pressure, which could cause permanent eye damage.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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 eye drops if the side effects are not serious. If you have any concerns, speak to your doctor or pharmacist.
The following are known side effects of TAPTIQOM Multi:
Common side effects (may affect less than 1 in 10 people treated)
Eye disorders
itching of the eye, eye irritation, eye pain, redness of the eye, changes in length, thickness and number of eyelashes, sensation of a foreign body in the eye, change in eyelash colour, light sensitivity, blurred vision.
Uncommon side effects (may affect less than 1 in 100 people treated)
Nervous system disorders
headache
Eye disorders
dry eye, redness of the eyelids, small punctate areas of inflammation on the eye surface, watery eyes, swelling of the eyelids, eye fatigue, eyelid inflammation, inflammation inside the eye, feeling of eye discomfort, eye allergy, eye inflammation, abnormal sensations in the eye.
The following side effects have been observed with the active substances in TAPTIQOM Multi (tafluprost and timolol) and therefore may also occur with the use of TAPTIQOM Multi:
The following side effects have been observed with tafluprost:
Eye disorders
reduced ability to see fine details, change in iris colour (may be permanent), change in skin colour around the eyes, conjunctival oedema, eye discharge, conjunctival pigmentation, nodules on the conjunctiva, enophthalmos (sunken eye), iritis (inflammation of the coloured part of the eye) and/or uveitis (inflammation of the vascular layer of the eye), macular oedema and/or cystoid macular oedema (retinal swelling leading to vision deterioration).
Skin disorders
unusual hair growth on the eyelids.
Respiratory system disorders
worsening of asthma, shortness of breath.
The following side effects have been observed with timolol:
Immune system disorders
allergic reactions, including angioedema, rash and urticaria, severe sudden allergic reaction threatening life, itching.
Metabolism and nutrition disorders
low blood sugar levels
Psychiatric disorders
depression, difficulty sleeping, nightmares, memory loss, nervousness, hallucinations.
Nervous system disorders
dizziness, fainting, unusual sensations (e.g. tingling and numbness), worsening of objective and subjective symptoms of myasthenia (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 drugs), drooping of the upper eyelid, double vision, blurred vision and detachment of the vascular layer behind the retina after filtering eye surgery, which may lead to visual disturbances, corneal erosion.
Ear disorders
tinnitus (ringing in the ears).
Cardiac disorders
slow heart rate, chest pain, palpitations (awareness of heart beating), oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease causing breathlessness and swelling of feet and legs due to fluid accumulation), certain types of heart rhythm disorders, heart attack, heart failure.
Vascular disorders
low blood pressure, claudication, Raynaud's phenomenon, cold hands and feet.
Respiratory system disorders
narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease), breathing difficulties, cough.
Gastrointestinal disorders
nausea, indigestion, diarrhoea, dry mouth, taste disturbances, abdominal pain, vomiting.
Skin disorders
hair loss, skin rash with silvery scaling (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 may cause penile curvature), sexual dysfunction, decreased libido.
General disorders
muscle weakness and fatigue, thirst.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Taptiqom Multi

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

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

6. Contents of the package and other information

What TAPTIQOM Multi contains

• The active substances are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
• Other components are: glycerol, disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, hydrochloric acid, concentrated and (or) sodium hydroxide (for pH adjustment), and water for injections.

What TAPTIQOM Multi looks like and contents of the pack
TAPTIQOM Multi is a clear, colourless liquid (solution), practically free from visible solid particles. TAPTIQOM Multi is available in LDPE bottles with an OSD (Ophthalmic Squeeze Dispenser) dispenser made of PE, PP, cyclic olefin copolymer, and an LDPE cap with a tamper-evident ring, packed in a cardboard box. The pack contains 1 transparent plastic bottle of 3 ml, 5 ml or 7 ml of solution or 3 transparent plastic bottles of 3 ml of solution each.

Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicinal product is authorised in the European Economic Area and 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