15 micrograms/ml + 5 mg/ml eye drops , solution
tafluprost/timolol
What Taptiqom sine is and what it is used for
What kind of medicine is it and how does it work?
Taptiqom eye drops contain tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogs and timolol belongs to a group of medicines called beta blockers. Tafluprost and timolol work together to lower the pressure in the eye. Taptiqom sine is used when the pressure in the eye is too high.
What is your medicine for?
Taptiqom sine is used to treat a type of glaucoma called open-angle glaucoma and also a condition called ocular hypertension in adults. Both of these conditions are associated with increased pressure in the eye and can ultimately affect your vision.
Tafluprost and timolol found in Taptiqom sine may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Taptiqom sine
Do not use Taptiqom sine
- if you are allergic to tafluprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
- if you have or have previously had problems with breathing such as asthma, severe chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing)
- if you have a slow heart rhythm, heart failure, or heart rhythm disturbances (irregular heart rhythm).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Taptiqom sine.
Talk to your doctor before using this medicine if you have or have ever had:
- coronary heart disease (symptoms may include chest pain, chest tightness, shortness of breath, or feeling of suffocation), heart failure, low blood pressure
- heart rhythm disturbances, such as slow heart rate
- breathing problems, asthma, or chronic obstructive pulmonary disease
- disease with poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
- diabetes, as timolol may mask signs and symptoms of low blood sugar
- an overactive thyroid, as timolol may mask signs and symptoms of thyroid disease
- allergy or anaphylactic reactions
- myasthenia gravis (a rare disease that causes muscle weakness)
- other eye diseases, such as diseases of the cornea (the transparent membrane that covers the front of the eye) or a disease that requires eye surgery.
Tell your doctor if you have
- kidney problems
- liver problems.
Please note that Taptiqom sine may have the following effects and some of them may be permanent:
Taptiqom sine can
- increase the length, thickness, color, and/or a number of eyelashes and may cause abnormal hair growth on your eyelids.
- darken the skin around the eyes. Wipe off any solution that may have ended up on the skin. This reduces the risk of skin darkening.
- change the color of the iris (the colored part of your eye). If Taptiqom sine is used in only one eye, the color of the treated eye may be permanently different from the color of the other eye.
- cause hair growth on areas where the solution repeatedly comes into contact with the skin surface.
Before having an operation, tell your doctor that you are using Taptiqom sine, as timolol can change the effects of some medicines used for anesthesia.
Children and young people
Taptiqom sine is not recommended for children or adolescents under 18 years of age as there is a lack of data on safety and efficacy in this age group.
Other medicines and Taptiqom sine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taptiqom sine can affect or be affected by other medicines you use.
In particular, tell your doctor if you are using or intend to use:
- other eye drops for the treatment of glaucoma
- drugs to lower blood pressure et
- heart medication
- drugs for the treatment of diabetes
- quinidine (used to treat heart disease and some types of malaria )
- antidepressants called fluoxetine and paroxetine.
If you are using other medicines in the eye, wait at least 5 minutes after you have put in Taptiqom sine before using the other drug.
Contact lenses
Remove the contact lenses before using the eye drops and wait at least 15 minutes before putting the contact lenses back in.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. If you can become pregnant, you must use effective contraception during treatment with Taptiqom sine. Do not use Taptiqom sine if you are pregnant, unless your doctor has told you to. You should not use Taptiqom sine if you are breastfeeding.
Driving ability and use of machinery
Taptiqom sine may cause side effects, such as blurred vision, which may affect your ability to drive and/or operate machinery. Wait to drive or use machines until you feel well and your vision is clear.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Taptiqom sine contains phosphate
This medicine contains 1.3 mg of phosphate per ml. If you have a severely damaged cornea, phosphate can in very rare cases cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How to use Taptiqom sine
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 drop of Taptiqom sine in the eye or eyes once daily. Do not drip in more drops and do not use more often than prescribed by your doctor. This may make Taptiqom sine less effective.
Only use Taptiqom sine in both eyes if your doctor has prescribed it.
To be used only as eye drops. Do not swallow.
Make sure that the tip of the multi-dose container does not touch the eye or the area around the eye. It can damage your eye. It can also lead to contamination with bacteria, which can cause eye infections. Such an infection can lead to serious eye damage, even loss of vision. To avoid contamination of the multi-dose container, the tip of the multi-dose container should not touch other surfaces.
Instructions for use:
When using the bottle for the first time and before putting a drop in the eye, you should practice using the bottle. Gently press the bottle so that a drop comes out. Point the bottle away from the eye.
When you are sure that you can drip one drop at a time, choose the position that feels most comfortable for you to drip the drops (you can sit, lie down 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 bottle neck is missing or broken. Write down the date you opened the bottle in the designated date space on the outer carton.
Every time you use Taptiqom sine:
About 1 ml will remain, which cannot be dosed. Do not attempt to empty the bottle.
If a drop ends up outside the eye, try again.
If your doctor prescribed you to use drops in both eyes, repeat steps 7 to 9 for the other eye.
If you are using other medicines in the eye, wait at least 5 minutes after you have put in Taptiqom sine before using the other drug.
If you use too much Taptiqom sine
you may feel dizzy or have a headache, heart symptoms, or breathing problems. If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Consult a doctor if the medicine is accidentally swallowed.
If you forget to use Taptiqom sine
drip in a single drop as soon as you remember, then return to your routine. However, if it is almost time for the next dose, you can skip the missed dose. Do not take a double dose to make up for a missed dose
Do not stop using Taptiqom sine without asking your doctor
If you stop using Taptiqom sine, the pressure in the eye will increase again. This can cause permanent damage to the eye.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are not serious.
You can usually continue to use the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist.
The following are known side effects when using Taptiqom sine:
Common side effects ( may affect up to 1 in 10 users):
Eyes
Itching in the eye. Eye irritation. Eye pain. Redness in the eye. Change in length, thickness, and number of eyelashes. The sensation of a foreign body in the eye. Discoloration of the eyelashes. Light sensitivity. Blurred vision.
Uncommon side effects ( may affect up to 1 in 100 users):
Central and peripheral nervous system
Headache.
Eyes
Dry eyes. Redness of the eyelids. Small spot-like inflamed areas on the surface of the eye. Watery eyes. Swollen eyelids. Tired eyes. Inflammation of the eyelids. Inflammation inside the eye. Eye discomfort. Eye allergy. Inflammation in the eye. Abnormal sensation in the eye.
The following side effects have been seen when using the medicines Taptiqom sine consists of (tafluprost and timolol ) and may therefore occur when you use Taptiqom sine:
The following side effects have been seen with tafluprost:
Eyes
Impairment in the eye’s ability to see details. Change in the color of the iris (may be permanent). Change in color of the skin around the eyes. Swelling of the surface membrane of the eye. Eye discharge. Pigmentation of the surface membrane of the eye. Follicles in the surface membrane of the eye. Sunken eyes. Iritis/uveitis ( inflammation of the colored part of the eye). Macular edema/cystic macular edema (swelling of the retina of the eye leading to impaired vision).
The skin
Abnormal hair growth on the eyelids.
Effects on the respiratory tract
Worsened asthma, shortness of breath.
The following side effects have been seen with timolol:
The immune system
Allergic reactions, including swelling under the skin, hives, and rash. Severe sudden life-threatening allergic reaction. Itching.
Metabolism and nutrition
Low blood sugar.
Mental disorders
Depression. Difficulty sleeping. Nightmares. Memory loss. Nervousness. Hallucination.
Central and peripheral nervous system
Dizziness. Fainting. Unusual sensations (such as tingling and numbness). Increases in signs and symptoms of myasthenia gravis (muscle disease). Stroke. Decreased blood supply to the brain.
Eyes
Inflammation of the cornea. Decreased sensation in the cornea. Visual disturbances include refractive changes (sometimes due to discontinuation of miotic therapy). Drooping upper eyelids. Double vision. Blurry vision and detachment of the blood vessel-containing membrane under the retina after filtration surgery, which can cause visual disturbances. Corneal damage.
Ears
Tinnitus (ringing in the ears).
The heart
Slow heartbeat. Chest pain. Palpitation. Edema (fluid accumulation). Changes in pulse or heart rhythm. Chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid retention). A type of heart rhythm disorder. Heart attack. Heart failure .
Blood vessels
Low blood pressure . Limping. Raynaud’s phenomenon, cold hands and feet.
Breath
Spasm in the airways (preferably in people with existing disease). Difficulty breathing. Cough.
Gastrointestinal tract
Nausea. Indigestion. Diarrhea. Dry mouth . Taste changes. Abdominal pains. Vomiting.
The skin
Hair loss. Skin rash with a white to silvery appearance (psoriasis-like rash) or worsening psoriasis . Rash.
Muscles and bones
Muscle pain not caused by exercise. Joint pain.
Reproductive organs and mammary gland
Peyronie’s disease (which can cause bending of the penis). Sexual Dysfunction . Decreased libido .
General symptoms
Muscle weakness/fatigue. Thirst.
How to store Taptiqom sine
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle label and the outer carton after “EXP”. The expiration date is the last day of the specified month.
Store unopened bottles in a refrigerator (2 °C–8 °C). Do not freeze.
Store the bottle in the original box. Light sensitive.
After opening the bottle:
- Store at a maximum of 25 °C. Do not freeze.
- Store the bottle in the original box. Light sensitive.
- To prevent infection , the bottle must be discarded no later than 3 months after it was opened for the first time. The 3 ml bottle is intended for 1 month of use, the 5 ml bottle is intended for 2 months and the 7 ml bottle is intended for 3 months.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are tafluprost and timolol . 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol .
- Other ingredients are glycerol , disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH ) and water for injections.
Appearance and package sizes of the medicine
Taptiqom sine is a clear, colorless liquid (solution), practically free of visible particles. It is supplied in packs containing either 1 clear plastic bottle of 3 ml, 5 ml or 7 ml, or 3 clear plastic bottles of 3 ml solution each. The plastic bottles are closed with a lid.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the names:
Tapticom:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland)
Taptiqom sine: Denmark, Estonia, Finland, Iceland, Norway, Sweden
Taptiqom Multi: Poland
Loyada: Italy