Taflotan multi

Package leaflet: Information for the patient

Taflotan Multi, 15 micrograms/ml, eye drops, solution
Tafluprost
Please read the entire 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. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Taflotan Multi is and what it is used for

What type of medicine is this and how does it work?
Taflotan Multi eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. Taflotan Multi lowers intraocular pressure. This medicine is used when the pressure in the eye is too high.
What is this medicine used for?
Taflotan Multi is used to treat a type of glaucoma called open-angle glaucoma and a condition known as 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 Multi

When not to use Taflotan Multi

• 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 to use Taflotan Multi, please discuss this with your doctor, pharmacist, or
nurse.
Please consider that Taflotan Multi may cause the following effects, some of which
may be permanent:

• Taflotan Multi may increase the length, thickness, color intensity, and (or) number of eyelashes and may cause unusual hair growth on the eyelids.
• Taflotan Multi may cause darkening of the skin around the eyes. Any solution remaining on the skin after instillation should be wiped off to reduce the risk of skin pigmentation.
• Taflotan Multi may change the color of the iris (the colored part of the eye). If Taflotan Multi is used in only one eye, the treated eye may permanently change color and differ from the other eye.
• Taflotan Multi may cause increased hair growth in areas where the solution repeatedly comes into contact with the skin.

Please inform 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 Multi is not recommended for children and adolescents under 18 years of age due to lack of data on efficacy and safety of use.
Taflotan Multi and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently using, has recently used, or plans to use.
If the patient is also using other eye medicines, at least a 5-minute interval should be maintained between instillation of Taflotan Multi and the other medicine.
Pregnancy, breastfeeding and fertility
If the patient may become pregnant, effective contraceptive methods must be used during treatment with Taflotan Multi. Taflotan Multi must not be used in pregnant women or in women who are breastfeeding. Please consult your doctor.
Driving and operating machinery
Taflotan Multi has minor influence on the ability to drive and use machines.
Vision may be blurred for a short time after instillation of Taflotan Multi. Do not drive or operate any tools or machinery until vision clears.
Taflotan Multi contains phosphates
This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.2 mg/ml.
In patients with severe corneal damage (the transparent front part of the eye), phosphates may very rarely cause corneal clouding due to calcium accumulation during treatment.

3. How to use Taflotan 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 of Taflotan Multi is 1 drop into the affected eye or eyes once daily in the
evening. Do not use more drops or use them more frequently than prescribed by your doctor, as this
could reduce the effectiveness of Taflotan Multi.
Use Taflotan Multi in both eyes only if specifically instructed by your doctor.
Taflotan Multi is for ophthalmic use only. Do not swallow.

Instructions for use:
Before first use, and prior to instilling the medicine into the eye, the patient should practice using
the bottle away from the eye by gently squeezing it until one drop is released.
Once the patient is confident in delivering a single drop, they should choose the most comfortable
position for instillation (sitting, lying down, or standing in front of a mirror).

When opening a new bottle:
Do not use the bottle if the plastic ring around the neck is missing or damaged. Record the date of
first opening in the space provided on the outer carton.
Each time Taflotan Multi is administered:

1. Wash your hands.

When opening the bottle for the first time,
remove the safety seal from the cap by pulling
on the tab.

3. Open the bottle by pulling off the cap.
4. When opening the bottle for the first time, discard the first drop.

5. Hold the bottle between your thumb and middle finger.
6. Tilt your head backward or lie down. Place your hand on your forehead. Your index finger should rest along the eyebrow or at the base of the nose. Take special care to ensure that the tip of the dropper 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 down the lower eyelid and look upward. Gently squeeze the bottle 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.

Close your eye and press with your finger
against the inner corner of the eye for about
one minute. This helps prevent the drop from
draining through the tear duct.

9. Wipe away any excess solution from the skin around the eye 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, which cannot be used.
Do not attempt to empty the bottle completely.
If the drop misses the eye, repeat the instillation procedure.
If your doctor has prescribed drops for both eyes, repeat steps 6 to 9 for the second eye.
If you are using other eye medicines, wait at least 5 minutes between applying Taflotan Multi and the other medicine.
Overdose of Taflotan Multi is unlikely to cause serious adverse effects. The next dose should be taken at the usual time.
If the medicine is accidentally swallowed, contact your doctor.
If you forget to use Taflotan Multi,
instill one drop into the eye(s) as soon as you remember, 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 Multi without consulting your doctor. Stopping treatment with Taflotan Multi
may lead to a recurrence of increased intraocular pressure, which can cause permanent eye damage.
If you have any further questions about the use of this medicine, 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.
In most cases, adverse effects are not serious.
Common adverse effects
The following effects may affect fewer than 1 in 10 treated patients:
Effects on the nervous system:

• headache

Effects on the eye:

• eye itching
• 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 color
• eyelid redness
• punctate keratitis (inflammation of the cornea)
• light sensitivity
• excessive tearing
• blurred vision
• reduced ability to see details clearly
• change in iris color (may be permanent).

Uncommon adverse effects
The following effects may affect fewer than 1 in 100 treated patients:
Effects on the eye:

• skin color changes around the eyes
• eyelid swelling
• feeling of eye fatigue
• conjunctival swelling
• eye discharge
• eyelid inflammation
• signs of intraocular inflammation
• eye discomfort
• conjunctival pigmentation
• conjunctival nodules
• allergic inflammation
• altered sensation in the eye.

Effects on the skin and subcutaneous tissue:

• abnormal hair growth on the eyelids

Unknown frequency: cannot be estimated from available data
Effects on the eye:

• uveitis/chorioretinitis (inflammation of the middle layer of the eye)
• sensation of sunken eyes
• macular edema/cystoid macular edema (retinal swelling leading to vision deterioration).

Effects on the respiratory system:

• 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 of Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Taflotan Multi

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and outer carton after EXP. The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
After opening: store at a temperature below 25°C.
Keep in the original packaging to protect from light.
To prevent contamination of the drop solution, the bottle should be discarded 3 months after first opening and a new bottle used. The 3 ml bottle is intended for 1 month of use, the 5 ml bottle for 2 months, and the 7 ml bottle for 3 months.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Taflotan Multi contains

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains approximately 0.45 microgram of tafluprost.
• Other components are: glycerol, disodium dihydrogen diphosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH to the appropriate value.

What Taflotan Multi looks like and contents of the pack
Taflotan Multi is a clear, colourless liquid (solution), practically free from visible solid particles.
Taflotan Multi is available in a pack containing 1 transparent plastic bottle with 3 ml, 5 ml or 7 ml of solution, or 3 transparent plastic bottles each containing 3 ml of solution. The plastic bottles are closed with dropper caps.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Tubilux Pharma S.P.A.
Via Costarica 20/22
00071 Pomezia (RM)
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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