Taflotan eye drops 3 ml.

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. Used when the intraocular pressure is too high.
What is your medicine intended for?
Taflotan is used to treat a type of glaucoma called open-angle glaucoma and also a condition known as ocular hypertension in adults. Both conditions are associated with increased intraocular pressure and can eventually affect your vision.

2. What you need to know before you use Taflotan
Do not use Taflotan

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 may have the following effects and some of which may be permanent:

Taflotan may increase the length, thickness, color and / or number of your lashes and may cause abnormal hair growth on your eyelids.
Taflotan may cause darkening of the skin around the eyes. Wipe off excess solution from the skin. This will reduce the risk of darkening of the skin.
Taflotan can change the color of your iris (the colored part of your eye). If Taflotan is used for only one eye, the color of the treated eye may become different from the color of the other forever.
Taflotan may cause hair growth in the areas where the solution comes into repeated contact with the skin surface.
Tell your doctor

if you have kidney disease
if you have liver disease
if you have asthma
if you have other ophthalmic diseases
Children and adolescents
Taflotan is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.

Other medicines and Taflotan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are using other medicines in the eyes, wait at least 5 minutes before or after taking Taflotan and the other medicine.

Pregnancy, lactation and fertility
If you are likely to become pregnant, you must use an effective method of contraception during Taflotan therapy. Do not use Taflotan if you are pregnant. You should not use Taflotan if you are breast-feeding. Talk to your doctor.

Driving and using machines
Taflotan does not affect the ability to drive and use machines. Immediately after placing Taflotan in the eye, it is possible to detect blurred vision. Do not drive or use any tools or machines until your vision is clear.

3. How to use Taftotan
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
The recommended dose is 1 drop of Taflotan in the eye or eyes, once a day in the evening. Do not drip more drops and do not use more often than directed by your doctor. This may make Taflotan less effective.

Use Taflotan in both eyes only if your doctor tells you to. Use only as eye drops.

Do not swallow. Instructions for use:
When using the bottle for the first time, before you put a drop in the eye, you should first practice squeezing it slowly until a drop falls out of the eye.
When you are sure that you can place a drop, choose a position in which you feel most comfortable to place the drops (you can sit, lie on your back or face a mirror).

When you open a new bottle:
Do not use the bottle if the bag is torn or if the plastic ring around the neck of the bottle is missing or broken. Open the envelope along the broken line. Write the date on which you opened the bottle in the place of the package, intended for the date of the cardboard box.

Each time you use Taflotan:
1. Wash your hands.
2. When using the bottle for the first time, remove the protective ring from the cap by pulling on the beginning of the bottle.
3. Open the bottle by pulling out the cap.
4. When using the bottle for the first time, drip one drop out.
5. Hold the bottle between your thumb and
6. Tilt your head back or lie down. Put your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the top of your nose.
Pay special attention that the tip of the bottle should not touch your eye, the skin around the eye or your fingers to protect the solution from potential contamination.
7. Pull the lower eyelid with the other hand and look up. Gently squeeze the bottle so that a drop falls in the space between the lower eyelid and the eye. Note that there may be a slight delay between squeezing and dropping. Do not squeeze too hard.
Close your eye and press inwards
Common side effects
The following side effects may affect up to 1 in 10 people:

Nervous system effects:
headache
Effects on the eye:
itching in the eye
eye irritation
eye pain
redness of the eye
change in the length, thickness and number of lashes
dry eye
sensation of a foreign body in the eye
eyelash discoloration
redness of the eyelids
small punctate areas of inflammation on the surface of the eye
hypersensitivity to light
tearing
blurred vision
reducing the eye's ability to see details
change in the color of the iris (may be permanent).
Rare side effects
The following side effects may affect up to 1 in 100 people:

Effects on the eye:
discoloration of the skin around the eyes
swollen eyelids
eye fatigue
swelling of the surface membranes of the eye
ocular secretion
inflammation of the eyelids
signs of inflammation in the eye
eye discomfort
pigmentation of the surface membranes of the eye
follicles on the surface membranes of the eye
allergic inflammation
strange feeling in the eye
Effects on skin and subcutaneous tissue:
unusual hair growth on the eyelids.
Not known: frequency cannot be determined from the available data

Effects on the eye:
inflammation of the iris / uvea (middle layer of the eye)
sunken eyes
macular edema / cystoid macular edema (swelling of the retina of the eye leading to impaired vision).
Respiratory effects:
worsening of asthma, difficulty breathing.
In very rare cases, in some patients with severe damage to the transparent layer in the front of the eye (cornea), cloudy spots have formed on the cornea due to the accumulation of calcium during treatment.

How to store Taflotan

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.

Store in the original carton in order to protect from light.

You must discard the bottle 28 days after first opening to avoid infections and use a new bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Taflotan contains
The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains about 0.45 micrograms of tafluprost.
The other ingredients are glycerin, sodium dihydrogen phosphate dihydrate, disodium sodium, polysorbate 80 and water for injections. Hydrochloric acid and / or sodium hydroxide are added to adjust the pH.

What Taflotan looks like and contents of the pack
Taflotan is a clear, colorless liquid (solution), practically free of visible particles. It is available in a pack containing 1 or 3 clear plastic bottles with 3 ml of solution in each. The plastic bottles are closed with a cap. Each bottle is packed in an envelope. Not all pack sizes may be marketed.

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