Taflotan

Package leaflet: Information for the patient

TAFLOTAN, 15 micrograms/ml, eye drops, solution in a single-dose container
Tafluprost
Please read the entire leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What TAFLOTAN is and what it is used for

What type of medicine is it and how does it work?
TAFLOTAN eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. TAFLOTAN lowers intraocular pressure. This medicine is used when the pressure in the eye is too high.
What is this medicine used 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 inside the eyeball and may lead to vision impairment.

2. Important information before using TAFLOTAN

When not to use TAFLOTAN

• if the patient is allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Before starting treatment with TAFLOTAN, discuss this with your doctor, pharmacist, or
nurse.
Please bear in mind that TAFLOTAN may cause the following effects, some of which
may be permanent:

• TAFLOTAN may increase the length, thickness, colour intensity, and (or) number of eyelashes and may cause unusual hair growth on the eyelids.
• TAFLOTAN may cause darkening of the skin around the eyes. After instillation, wipe off any residual solution from the skin to reduce the risk of skin darkening.
• TAFLOTAN may change the colour of the iris (the coloured part of the eye). If TAFLOTAN is used in only one eye, the treated eye may permanently change colour and differ from the other eye.
• TAFLOTAN may cause increased hair growth in areas where the solution repeatedly comes into contact with the skin.

Tell your doctor

• if the patient has kidney disease;
• if the patient has liver disease;
• if the patient suffers from asthma;
• if the patient has other eye diseases.

Children and adolescents
TAFLOTAN is not recommended for children and adolescents under 18 years of age due to lack of data on efficacy and safety of use.
TAFLOTAN and other medicines
Tell 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.
If the patient is also using other eye medicines, wait at least 5 minutes between instilling TAFLOTAN and the other medicine.
Pregnancy, breastfeeding, and fertility
If the patient could become pregnant, she must use effective contraception during treatment with TAFLOTAN. TAFLOTAN must not be used in pregnant women or in women who are breastfeeding. Consult your doctor.
Driving and operating machinery
TAFLOTAN has no effect on the ability to drive or operate machinery. However, vision may be blurred for a short time after instillation of TAFLOTAN. Do not drive or operate any tools or machinery until vision returns to normal.
TAFLOTAN contains a phosphate buffer
This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.2 mg/ml.
In patients with severe damage to the cornea (the transparent front part of the eye), phosphates may, very rarely, cause corneal opacities during treatment due to calcium accumulation.

3. How to use TAFLOTAN

This medicine should always be used exactly as your doctor or pharmacist has told you. If in doubt,
please consult your doctor or pharmacist.
The recommended dose of TAFLOTAN is 1 drop into the eye or eyes once daily in the evening. Do not
use more drops or use them more often than prescribed by your doctor, as this could reduce the effectiveness of TAFLOTAN.
TAFLOTAN should be used in both eyes only if specifically instructed by your doctor.
TAFLOTAN is for ophthalmic use only. Do not swallow.

Instructions for use:
When opening a new sachet:
Do not use the single-dose containers if the sachet is damaged. Tear the sachet along the dotted line.
Write down the date of opening the sachet in the space provided on the sachet.
Each time TAFLOTAN is used:

1. Wash your hands.
2. Remove the connected containers from the sachet.
3. Separate one single-dose container.
4. Return the remaining containers to the sachet and fold the edge to close the sachet.
5. Make sure the solution is in the

lower part of the single-dose container.

6. Open the container by twisting and removing the tab at the

top of the container.

7. Tilt your head backwards.

8. Bring the tip of the container close to the eye.

9. Pull the lower eyelid downwards while looking upwards.

10. Gently squeeze the container to release one drop into the space between the lower eyelid and the eye.

11. Close the eye briefly and press with a finger on the

inner corner of the eye for about one minute. This helps prevent the drop from draining into the tear duct.

12. Wipe away any excess solution from the skin around the eye.

If the drop misses the eye, repeat the instillation procedure.
If your doctor has prescribed drops for both eyes, repeat steps 7 to 12 for the second eye.
The contents of one single-dose container are sufficient for administration to both eyes.
Immediately after use, discard the single-dose container with any remaining solution.
If you are using other eye medicines, wait at least 5 minutes between applying TAFLOTAN and any other eye medication.
Accidental overdose of TAFLOTAN is unlikely to cause serious harmful effects. The next dose should be taken at the usual time.
If the medicine is accidentally swallowed, contact your doctor.
Missed dose of TAFLOTAN. As soon as you remember, apply one drop to the eye or eyes, then return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.
Do not stop using TAFLOTAN without first consulting your doctor. Stopping TAFLOTAN treatment may lead to a renewed increase in intraocular pressure, which can cause permanent eye damage.
If you have any further questions about the use of this medicine, please consult 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.

Common adverse effects
The following effects may affect fewer than 1 in 10 people treated:
Nervous system symptoms:

• headache

Eye-related symptoms:

• itchy eye
• eye irritation
• eye pain
• eye redness
• changes in length, thickness, and number of eyelashes
• dry eye
• sensation of a foreign body in the eye
• change in eyelash colour
• eyelid redness
• punctate keratitis (superficial inflammation of the cornea)
• light sensitivity
• excessive tearing
• blurred vision
• reduced ability to see fine details clearly
• change in iris colour (may be permanent)

Uncommon adverse effects
The following effects may affect fewer than 1 in 100 people treated:
Eye-related symptoms:

• skin discolouration around the eyes
• eyelid swelling
• feeling of eye fatigue
• conjunctival oedema (swelling of the conjunctiva)
• eye discharge
• eyelid inflammation
• signs of intraocular inflammation
• feeling of eye discomfort
• conjunctival pigmentation
• granules on the conjunctiva
• allergic inflammation
• altered sensation in the eye

Skin and subcutaneous tissue symptoms:

• abnormal hair growth on the eyelids

Unknown frequency: cannot be estimated from available data
Eye-related symptoms:

• iritis/uveitis (inflammation of the uvea, the middle layer of the eye)
• sunken appearance of the eyes
• macular oedema/cystoid macular oedema (retinal swelling leading to vision deterioration)

Respiratory system symptoms:

• worsening of asthma, shortness of breath

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 4921 301, Fax: +48 22 4921 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store TAFLOTAN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, pouch, and outer carton after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Unopened foil pouches should be stored in a refrigerator (2°C – 8°C). Open the pouch only immediately before using the eye drops, because any unused single-dose containers from an opened pouch must be discarded 28 days after the first opening of the pouch.
After opening the foil pouch:

• Store the single-dose containers in the original foil pouch;
• Store at a temperature below 25°C;
• Discard any unused single-dose containers 28 days after the first opening of the pouch;
• Immediately after use, dispose of the opened single-dose container together with any remaining solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Package contents and other information

What TAFLOTAN contains

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One single-dose container (0.3 ml) contains 4.5 micrograms of tafluprost. One drop (approximately 30 µl) contains about 0.45 micrograms of tafluprost.
• The other ingredients are: glycerol, disodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Very small amounts of hydrochloric acid or sodium hydroxide are added to maintain the appropriate pH.

What TAFLOTAN looks like and contents of the pack
TAFLOTAN is a clear, colourless liquid (solution) contained in plastic single-dose containers holding 0.3 ml of solution. One sachet contains ten single-dose containers. TAFLOTAN is available in packs containing 30 or 90 single-dose containers. 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 medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Bulgaria, Czech Republic, Denmark, Finland, Estonia, Hungary, Iceland, Lithuania, Latvia, Norway, Poland, Slovakia, Sweden: TAFLOTAN
Austria, Belgium, Cyprus, France, Greece, Spain, the Netherlands, Ireland, Luxembourg, Malta, Portugal, Romania, Slovenia, Italy, United Kingdom (Northern Ireland): SAFLUTAN
Germany: TAFLOTAN sine

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.