TAFLOTAN 15 micrograms/ml eye drops solution

Introduction

Package Leaflet: Information for the Patient

Taflotan 15 micrograms/ml eye drops, solution

Tafluprost

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Taflotan and what is it used for
2. What you need to know before you use Taflotan
3. How to use Taflotan
4. Possible side effects
5. Storage of Taflotan
6. Contents of the pack and other information

1. What is Taflotan and what is it used for

What kind 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 reduces eye pressure. It is used when the pressure inside 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 also a condition known as ocular hypertension in adults. Both conditions are linked to an increase in the pressure inside the eye and, in the long term, can affect 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 you start using Taflotan.

Please note thatTaflotan may have the following effects, and some of them may be permanent:

• Taflotan may increase the length, thickness, color, and/or amount of eyelashes, and may cause abnormal hair growth on the eyelids.
• Taflotan may cause darkening of the skin color around the eyes. Wipe off any excess solution from the skin. This will reduce the risk of skin darkening.
• Taflotan may change the color of the iris (the colored part of the eye). If Taflotan is used in only one eye, it may become a different color from the untreated eye, permanently.
• Taflotan may cause hair growth in areas where the solution comes into repeated contact with the skin surface.

Tell your doctor:

Children and adolescents

Taflotan is not recommended for use in children and adolescents under 18 years of age, due to a lack of data on safety and efficacy.

Other medicines and Taflotan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you use other medicines in the eye, wait at least 5 minutes after applying Taflotan before using the other medicine.

Pregnancy, breastfeeding, and fertility

If you can become pregnant, you must use an effective method of birth control during treatment with Taflotan. Do not use Taflotan if you are pregnant. You should not use Taflotan if you are breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Taflotan has little influence on the ability to drive and use machines. After applying Taflotan, you may notice blurred vision for a while. Do not drive or use any tools or machines until your vision is clear.

Taflotan contains phosphates

This medicine contains approximately 0.04 mg of phosphates per drop, equivalent to 1.2 mg/ml. If you have severe corneal damage (the transparent layer on the front of the eye), treatment with phosphates, in very rare cases, can cause blurred vision due to calcium accumulation.

3. How to use Taflotan

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

The recommended dose is1 drop of Taflotan in one or both eyes, once a day, at night. Do not instill more drops or use it more frequently than prescribed by your doctor.

This may make Taflotan less effective.

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

For use only as eye drops. Do not swallow.

Instructions for use:

When you first use it, before applying a drop to the eye, you should first practice using the bottle by squeezing it slowly to drop a drop outside the eye.

When you are sure you can apply one drop at a time, choose the most comfortable position for instilling the drops (you can sit, 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 neck of the bottle is missing or broken. Write the date you opened the bottle in the space provided for the date on the outer carton.

Each time you use Taflotan:

There will be a residual volume of approximately 1 ml, which should not be administered. Do not attempt to empty the bottle.

If a drop does not fall into the eye, try again.

If your doctor has told you to use eye drops in both eyes, repeat steps 6 to 9 in the other eye.

If you use other medicines in the eye, wait at least 5 minutes after applying Taflotan before using the other medicine.

If you use more Taflotan than you should, it is unlikely to cause serious harm. Apply the next dose at the usual time.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Taflotan, apply one drop as soon as you remember, and then go back to your normal schedule. Do not use a double dose to make up for forgotten doses.

Do not stop using Taflotan without talking to your doctor. If you stop treatment with Taflotan, the pressure inside the eye will increase again. This can cause permanent damage to the eye.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are not serious.

Common side effects

The following effects may affect up to 1 in 10 people:

Effects on the nervous system:

• headache

Effects on the eye:

• itching in the eyes
• irritation of the eyes
• eye pain
• redness of the eye
• changes in the length, thickness, and amount of eyelashes
• dryness in the eye
• feeling of having a foreign body in the eye
• change in color of the eyelashes
• redness of the eyelids
• small areas of inflammation on the surface of the eye
• sensitivity to light
• watery eyes
• blurred vision
• decreased visual ability to see details
• change in color of the iris (may be permanent)

Uncommon side effects

The following effects may affect up to 1 in 100 people:

Effects on the eye:

• change in skin color around the eyes
• swelling of the eyelids
• tired eyes
• swelling of the superficial membranes of the eye
• watery eyes
• inflammation of the eyelids
• signs of inflammation inside the eye
• discomfort in the eye
• pigmentation of the superficial membranes of the eye
• follicles on the superficial membranes of the eye
• allergic inflammation
• abnormal sensation in the eye

Effects on the skin and subcutaneous tissue:

• unusual hair growth on the eyelids

Frequency not known: cannot be estimated from the available data

Effects on the eye:

• inflammation of the iris/uvea (central layer of the eye)
• sunken eyes
• macular edema/cystoid macular edema (inflammation of the retina inside the eye leading to vision impairment)

Effects on the respiratory system:

• worsening of asthma, difficult breathing

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Taflotan

Keep this medicine out of the sight and reach of children.

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

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

After opening the bottle, store below 25°C.

Store in the original package to protect from light.

You must discard the bottle 3 months after first opening, to avoid infections, and use a new bottle.The bottle with a fill volume of 3 ml is intended for a use period of 1 month, the bottle with a fill volume of 5 ml for 2 months, and the bottle with a fill volume of 7 ml for 3 months.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Taflotan

• The active substanceis tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. 1 drop contains approximately 0.45 micrograms of tafluprost.
• The other ingredientsare glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

Appearance and packaging of the product

Taflotan is a clear and colorless liquid (solution), practically free from visible particles. It is available in a carton containing 1 transparent plastic bottle with 3 ml, 5 ml, or 7 ml, or 3 transparent plastic bottles with 3 ml of solution in each bottle. The plastic bottles are closed with 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

Or

Tubilux Pharma, S.p.A.

Via Costarica 20/22

00071 Pomezia, Rome

Italy

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 Madrid

Phone: 91 414 24 85

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

Date of last revision of this package leaflet:June 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)