Taflotan 15 micrograms/ml solution for ophthalmic use

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Taflotan 15 micrograms/ml eye drops, solution

Tafluprost

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

What this leaflet contains

1. What Taflotan is and what it is used for
2. What you need to know 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 reduces intraocular pressure. It is used when the pressure inside the eye is too high.

What is this medicine 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 disorders are associated with increased pressure inside the eye and, over time, may affect vision.

2. What you need to know before using Taflotan

Do not use Taflotan

• If you are allergic to tafluprost or to 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 cause the following effects, some of which may be permanent:

• Taflotan may increase the length, thickness, color, and/or number of eyelashes and may cause abnormal hair growth on the eyelids.
• Taflotan may darken 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, that eye may permanently become a different color than the untreated eye.
• Taflotan may cause hair growth in areas where the solution repeatedly comes into contact with the skin.

Tell your doctor if:

• you have any kidney problems.
• you have any liver problems.
• you have asthma.
• you have other eye diseases.

Children and adolescents

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

Other medicines and Taflotan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy, breastfeeding, and fertility

If you are able to become pregnant, you should use an effective method of contraception during treatment with Taflotan. Do not use Taflotan if you are pregnant. You should not use Taflotan while breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Taflotan has minor influence on the ability to drive and use machines. After applying Taflotan, you may experience blurred vision for a period of time. Do not drive or operate tools or machinery 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 phosphate-containing medicines may, in very rare cases, lead to blurred vision due to calcium accumulation.

3. How to use Taflotan

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 drop of Taflotan in one or both eyes, once daily, at night. Do not instill more drops or use it more frequently than instructed by your doctor.

Doing so may make Taflotan less effective.

Use Taflotan in both eyes only if directed by your doctor.

For ophthalmic use only. Do not swallow.

Instructions for use:

When using it for the first time, before applying a drop to the eye, first practice using the bottle by slowly squeezing it to release a drop outside the eye.

Once you are confident that you can apply a single drop each time, choose the most comfortable position for instilling the drops (you may 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:

A residual volume of approximately 1 ml will remain, which must not be administered. Do not attempt to empty the vial.

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 are using other eye medications, wait at least five minutes after applying Taflotan before using the other medication.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Taflotan, apply one single drop as soon as you remember, and then return to your regular schedule. Do not use a double dose to make up for missed doses.

Do not stop using Taflotan without consulting your doctor. If you interrupt treatment with Taflotan, the pressure inside the eye will rise again. This may cause permanent eye damage.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Most adverse effects are not serious.

Frequent adverse effects

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

Effects on the nervous system:

• headache

Effects on the eye:

• eye itching
• eye irritation
• eye pain
• eye redness
• changes in length, thickness, and amount of eyelashes
• dry eye
• sensation of having a foreign body in the eye
• change in eyelash colour
• eyelid redness
• small inflamed areas at points on the surface of the eye
• light sensitivity
• watery eyes
• blurred vision
• reduced visual ability to see details
• change in iris colour (may be permanent)

Uncommon adverse effects

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

Effects on the eye:

• change in skin colour around the eyes
• eyelid swelling
• tired eyes
• swelling of the superficial membranes of the eye
• watery eyes
• eyelid inflammation
• signs of inflammation inside the eye
• eye discomfort
• 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 tissues beneath the skin:

• abnormal growth of eyelid hair

Frequency not known: cannot be estimated from available data

Effects on the eye:

• inflammation of the iris/uvea (the middle layer of the eye)
• sunken eyes
• macular edema/cystoid macular edema (swelling of the retina within the eye leading to worsening vision)

Effects on the respiratory system:

• worsening of asthma, difficulty breathing

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the label of the bottle and on the carton, following “EXP”. The expiry date refers to the last day of the month indicated.

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

After opening the bottle, store below 25°C.

Keep in the original packaging to protect from light.

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 1-month period of use, the bottle with a fill volume of 5 ml for a 2-month period, and the bottle with a fill volume of 7 ml for a 3-month period.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Taflotan

• The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. 1 drop contains approximately 0.45 micrograms of tafluprost.
• The other components are 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.

Nature of the product and contents of the container

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

Only certain 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, Roma
Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Santen Pharmaceutical Spain, S.L.
Acanto, 22, 7th floor
28045 Madrid
Tel.: 91 414 24 85

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:

Date of the last review of this leaflet: June 2023

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