Taflotan 15 micrograms/ml eye drops, tafluprost solution
What Taflotan Is And What It Is Used For
What kind of medicine is it, and how does it work?
Taflotan eye drops contain tafluprost, a substance that belongs to a group of medicines called prostaglandin analogs. The tablet lowers the pressure in the eye. It is used when the pressure in the eye is too high.
What is your medicine for?
Taflotan 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 in the eye and can ultimately affect your vision.
Tafluprost contained in Taflotan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Using Taflotan
Do Not Use Taflotan Eye Drops
- If you are allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6).
Warnings And Precautions
Talk to your doctor, pharmacist, or nurse before using Taflotan.
Please note that Taflotan can have the following effects and that some of them can be permanent:
- Taflota can increase the length, thickness, and colour of the number of your eyelashes and can cause abnormal hair growth on your eyelids.
- Taflota can 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.
- The float can change the colour of the iris (the coloured part of your eye). If Taflotan is used in only one eye, the colour of the treated eye may be permanently different from the colour of the other eye.
- Taflotan can cause hair growth in areas where the solution repeatedly touches the skin’s surface.
Tell your doctor
- If you have kidney problems
- If you have liver problems
- If you have asthma
- If you have any other eye diseases
Children And Young People
Taflotan is not recommended for children or adolescents under 18 because there is a lack of data on safety and efficacy in this age group.
Other Medicines And Taflotan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you use other medicines in the eye, you must wait at least 5 minutes after instilling Taflotan before taking the other medicine.
Pregnancy, Breastfeeding, And Fertility
If you can become pregnant, you must use effective contraception during Taflotan treatment. Do not use Taflotan if you are pregnant. You should not use Taflotan if you are breastfeeding. Consult a doctor.
Driving Ability And Use Of Machinery
Taflotan has less effect on the ability to drive and use machines. You may experience that your vision becomes blurred for a while after you have dropped Taflotan in your eye. Do not drive or use any tools or machinery until you can see again.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
The Tablet Contains Excipients
Taflota contains phosphate
This medicine contains approximately 0.04 mg phosphate per drop, corresponding to 1.2 mg/ml. If you have a severely damaged cornea, phosphate can, in rare cases, cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How To Use Taflotan
Taflotan uses
- 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 Taflotan in the eye or eyes once daily in the evening. Do not drip in more drops, and do not use more often than your doctor prescribes. This can make Taflotan less effective.
- Only use Taflotan in both eyes if your doctor has prescribed it.
- To be used only as eye drops. Do not swallow.
- Instructions for use:
- When using the bottle for the first time, before a drop is instilled in the eye, practice using the bottle by gently pressing it and putting a drop somewhere other than the eye.
- When you are sure you can drip only one drop at a time, choose the position that feels most comfortable to drip the drops (you can sit down, lie 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 space on the outer carton.
- Every time you use Taflotan
- Wash your hands.
- When using the bottle for the first time, remove the sealing ring around the cap by pulling the tab.
- Open the bottle by pulling off the cap.
- When you use the bottle for the first time, squeeze out a drop and discard it.
- Hold the bottle between your thumb and forefinger.
- Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be in line with your eyebrow or resting on the bridge of your nose.
To avoid contamination of the solution, be especially careful not to touch the tip of the bottle to the eye, the skin around the eye, or the fingers. - Pull down the lower eyelid with the other hand and look up. Press the bottle and let a drop fall into the space between the lower eyelid and the eye.
Note that it may take a while before a drop comes out when you press the bottle. Do not press too hard. - Close the eye and press a finger on the inner corner of the eye for about a minute. This prevents the eye drop from flowing into the tear duct.
- Wipe off any solution that may have ended up on the skin around the eye. This reduces the risk of skin darkening.
- Shake the bottle with the tip down once to get rid of any remaining solution in the tip. Do not touch the tip or wipe it.
- Put the cap on and close the bottle tightly.
- 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 has prescribed you to use drops in both eyes, repeat steps 6-9 for the other eye. If you use other medicines in the eye, you must wait at least 5 minutes after instilling Taflotan before using the other medicine.
If you have used too much Taflotan, it is unlikely to cause serious harm. Drop in the next dose at the usual time.
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 Taflotan, drop in a single drop as soon as you remember, then return to your usual routine. Do not take a double dose to make up for a missed dose.
Do not stop using Taflotan without asking your doctor. If you stop using Taflotan, the pressure in the eye will increase again. This can cause permanent damage to the eye.
Ask your doctor, pharmacist, or nurse if you have any questions about this medicine.
Possible Taflotan Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Most side effects are not serious.
Common taflotan side effectss ( may affect up to 1 in 10 users):
Effects on the central nervous system:
- Headache.
- Effects on the eye:
- Itchy eyes
- Eye irritation
- Eye pain
- Redness of the eye
- Changed the length and thickness of and changed the number of eyelashes
- Dry eyes
- The feeling of debris in the eye
- Eyelash discoloration _
- Eyelid redness
- Small point-shaped inflammations on the surface of the eye
- Light sensitivity
- Watery eyes
- Blurred vision
- Reduced ability of the eye to perceive details
- Iris colour change (may be permanent).
Uncommon side effects ( may affect up to 1 in 100 users): Effects in the eye:
- Colour change in the skin around the eyes
- Swollen eyelids
- Tired eyes
- Swelling of the conjunctiva
- Eye secretions
- Eyelid inflammation
- Signs of inflammation inside the eye
- Discomfort in the eye
- Pigmentation of the conjunctiva
- Small blisters on the conjunctiva
- Allergic inflammation
- Abnormal sensation in the eye.
Effects on the skin and tissue under the skin:
- Abnormal hair growth on the eyelids.
Side effects with no known frequency (cannot be calculated from available data) Effects in the eye:
- Inflammation of the iris/uvea (middle layer of the eye)
- The eyes look sunken
- Macular edema/cystic macular edema (swelling of the eye’s retina leading to impaired vision).
Effects on the respiratory tract:
- Aggravated asthma
- Shortness of breath
Repo
How Taflotan Should Be Stored
- Keep this medicine out of sight and reach of children.
- Use before the expiry date, which is stated on the bottle label and outer carton after “EXP.” The expiration date is the last day of the specified month.
- Store in a refrigerator (2 °C–8 °C). Do not freeze.
- After opening, store at a maximum of 25 °C.
- Store in the original packaging. Light sensitive.
- To prevent infection, the bottle must be discarded 3 months after it was first opened and a new bottle put into use. 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 substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains approximately 0.45 micrograms of tafluprost.
- Other ingredients are glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid or sodium hydroxide has been added to adjust the pH.
Appearance And Package Sizes Of The Medicine
- Taflotan is a clear, colourless liquid (solution) largely free of visible particles.
- It is supplied in packs containing 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 Authorization Holder And Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Roma)
Italy
This medicine is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Germany | TAFLOTAN sine |
| Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Latvia, Lithuania, Norway, Portugal, Slovakia, Sweden, Spain | The board float |
| Poland | Taflotan Multi |
| Austria, Belgium, United Kingdom (Northern Ireland), Croatia, Ireland, Luxembourg, Netherlands, Romania, Slovenia, | The juice flute |
| Italy | Safluround |