CATIOLANZE 50 ?g/ml Emulsja krople do oczu

Treść ulotki

1. Catiolanze 50 micrograms/mL eye drops, emulsion
   1. What is Catiolanze and what is it used for
   2. What you need to know before using Catiolanze
   3. How to use Catiolanze
   4. Possible side effects
   5. How to store Catiolanze
   6. Package contents and other information

the user

Catiolanze 50 micrograms/mL eye drops, emulsion

latanoprost

Read this leaflet carefully before you start using this medicine as it contains important
information for you. Even if you have used Catiolanze or a similar medicine before, it is recommended to
read this leaflet carefully. The information may have been changed.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Never give it to anyone else, as it may be dangerous for others, even if they have the same symptoms as you.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or the doctor treating your child, or your pharmacist. See section
• 4.

Contents of this leaflet:

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

1. What is Catiolanze and what is it used for

Catiolanze contains the active ingredient latanoprost, which belongs to the category of medicines known
as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside
the eye into the bloodstream.
This medicine is used in the treatment of conditions known as open-angle glaucoma
(damage to the optic nerve caused by high pressure in the eye) or ocular hypertension (increased
pressure inside the eye) in adults. Both of these conditions are linked to an increase
in intraocular pressure caused by obstruction of the fluid drainage channels, which can ultimately
alter vision.
Catiolanze is also used in the treatment of elevated intraocular pressure and glaucoma
in children from 4 years of age and in adolescents.

2. What you need to know before using Catiolanze

Do not use Catiolanze

• If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine listed in section 6. If you are pregnant or planning a pregnancy.
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor or the doctor caring for your child, or your pharmacist before using
Catiolanze or before giving this medicine to your child if you think that any of the following
conditions apply to you or your child:

• If you or your child are about to have or have had eye surgery (including cataract surgery)
• If you or your child has eye problems (such as eye pain, irritation or inflammation, blurred vision)
• If you or your child has severe asthma or if asthma is not well controlled
• If you or your child uses contact lenses. You can still use Catiolanze following the instructions for contact lens wearers in section 3
• If you have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Catiolanze
Catiolanze can interact with other medicines. Tell your doctor or the doctor caring for your
child, or your pharmacist if you or your child are taking or have recently taken any other
medicines, including over-the-counter medicines (or eye drops).
In particular, tell your doctor or pharmacist if you know that you or your child are using
prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy and breastfeeding
Do not use this medicine during pregnancy or breastfeeding.
Tell your doctor immediately if you are pregnant, if you think you may be pregnant, or if you are planning a
pregnancy.

Driving and using machines
This medicine can cause transient blurred vision. If this happens, you should not drive or
use equipment or machinery until your vision is clear again.

Catiolanze contains cetalkonium chloride
Cetalkonium chloride may cause eye irritation.

3. How to use Catiolanze

Use Catiolanze exactly as your doctor or the doctor caring for your child has told you. If you have any doubts, consult your doctor or the doctor caring for your child or your pharmacist.
The recommended dose in adults and children is one drop once a day in the eye(s) to be treated. The optimal time for administration is in the evening.
Do not use Catiolanze more than once a day, as the effectiveness of the treatment may be reduced if the medicine is administered more frequently.
Use Catiolanze as your doctor or the doctor caring for your child has told you, until the doctor tells you to stop the treatment.

Contact lens wearers
If you or your child wear contact lenses, you must remove them before applying Catiolanze.
After applying this medicine, you must wait 15 minutes before re-applying the contact lenses.

Instructions for use

• For single use only.
• Use the liquid from a single dose container immediately after opening and administer one drop into the affected eye(s). Any remaining contents must be discarded immediately after use.
• After using Catiolanze, gently press a finger on the inner corner of the treated eye, near the nose. Maintain pressure for one minute, keeping the eye closed: see point 11 and figure 3.
• Avoid contact between the tip of the applicator and the eye/eyelids.

Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.

123

• 1.Wash your hands and sit or stand in a comfortable position.
• 2.Open the aluminum pouch with the 5 single-dose containers.
• 3.Take 1 single-dose container from the aluminum pouch, leaving the remaining containers.
• 4.Gently shake the single-dose container.
• 5.Turn the cap to break it off (figure 1).
• 6.Use a finger to gently lower the lower eyelid of the eye to be treated (figure 2).
• 7.Tilt your head back looking at the ceiling.
• 8.Position the tip of the single-dose container near the eye, without touching it.
• 9.Gently press to drop one drop of the medicine into the eye, then release the lower eyelid.
• 10.Blink a few times so that the medicine spreads throughout the eye.
• 11.After using Catiolanze, gently press a finger on the inner corner of the treated eye, near the nose. Maintain pressure for one minute, keeping the eye closed (figure 3).This is where a small tear duct drainage channel from the eye to the nose is located. Pressing in this point closes the opening of this drainage channel. This helps prevent Catiolanze from spreading throughout the body.
• 12.Repeat steps 6 to 11 for the other eye, if the doctor has told you to use the eye drops in both eyes.
• 13.After use, dispose of the single-dose container. Do not save it for reuse.

If you use Catiolanze with another eye drop
Use Catiolanze at least 5 minutes after using another eye drop.

If you use more Catiolanze than you should
Putting too many drops in your eyes can lead to mild irritation, tearing and redness of the eyes. These effects should be transient, but if you are concerned, contact your doctor or the doctor caring for your child for advice.
Contact your doctor as soon as possible if you or your child accidentally ingest Catiolanze.

If you forget to use Catiolanze
Continue to take the usual dose at the usual time. Do not use a double dose to make up for a missed dose. If you have any doubts, ask your doctor or pharmacist.

If you stop the treatment with Catiolanze
You must inform your doctor or the doctor caring for your child if you or your child intends to stop the treatment with this medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following are known adverse events with the use of Catiolanze:

Very common(may affect more than 1 in 10 people):

• Gradual alteration of the eye color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change is more likely if your eyes are of mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) rather than a uniform color (blue, gray, green, or brown). Any change in eye color may occur after years, although it generally appears within the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use this medicine in only one eye. There seem to be no problems associated with the change in eye color. After stopping treatment with Catiolanze, no further change in eye color has been observed.

Common(may affect up to 1 in 10 people)

• Red eyes (conjunctival hyperemia).
• Eye irritation [burning sensation, gritty sensation, itching, stinging pain (pinprick sensation) or foreign body sensation in the eyes, abnormal sensation in the eyes]. If you experience irritation severe enough to produce excessive tearing in your eyes, or to induce discontinuation of the medicine, immediately consult your doctor, pharmacist or nurse. An update of the therapy may be necessary to ensure adequate treatment for your condition.
• Irritation or abrasion of the eye surface, eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon(may affect up to 1 in 100 people)

• Swelling of the eyelids, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema), inflammation of the eyelids (blepharitis).
• Gradual alteration of the eyelashes of the treated eye and alteration of the fluff around the treated eye, observed mostly in people of Japanese origin. These changes include an increase in darkening, lengthening, thickening, and densification of the eyelashes.
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare(may affect up to 1 in 1000 people):

• Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling of the area around the eyes (periorbital edema), altered orientation of the eyelashes or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe itching of the skin.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare(may affect up to 1 in 10,000 people):

• Worsening of angina in patients already suffering from heart disease, sunken eye appearance (hollowing of the eye socket).

The side effects observed more frequently in childrencompared to adults have been:
runny and itchy nose, fever.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Catiolanze

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 outer packaging, on the sachet
and on the single-dose container after “SCAD” or “EXP”. The expiry date refers to the last day
of that month.
Store at a temperature below 30 °C.
After opening the aluminium sachet, store the single-dose containers inside it to
protect them from light and prevent evaporation. Dispose of each
opened single-dose container immediately after use.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Catiolanze contains

• The active ingredient is latanoprost. One millilitre of emulsion contains 50 micrograms of latanoprost. One drop contains approximately 1.65 micrograms of latanoprost. Each single-dose container of 0.3 mL of Catiolanze eye drops, emulsion contains 15 micrograms of latanoprost.
• The other excipients are: medium-chain triglycerides, cetalkonium chloride, polysorbate 80, glycerol and water for injections.

Description of Catiolanze and package contents
Catiolanze 50 micrograms/mL eye drops, emulsion, is a white liquid.
One bag contains 5 single-dose containers. It is available in packs of 30 and 60, 90 or 120
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
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Santen Oy

Lietuva
Santen Oy
Tel/Tel: +32 (0) 24019172 Tel: +370 37 366628

България
Santen Oy
Тел.: +359 (0) 888 755 393

Luxembourg/Luxemburg
Santen Oy
Tél/Tel: +352 (0) 27862006

Česká republika
Santen Oy
Tel: +358 (0) 3 284 8111

Magyarország
Santen Oy
Tel: +358 (0) 3 284 8111

Danmark
Santen Oy
Tlf: +45 898 713 35

Malta
Santen Oy
Tel: +358 (0) 3 284 8111

Deutschland
Santen GmbH
Tel: +49 (0) 3030809610

Nederland
Santen Oy
Tel: +31 (0) 207139206

Eesti
Santen Oy
Tel: +372 5067559

Norge
Santen Oy
Tlf: +47 21939612

Ελλάδα
Santen Oy
Τηλ: +358 (0) 3 284 8111

Österreich
Santen Oy
Tel: +43 (0) 720116199

España
Santen Pharmaceutical Spain S.L.
Tel: +34 914 142 485

Polska
Santen Oy
Tel.: +48(0) 221042096

France
Santen
Tél: +33 (0) 1 70 75 26 84

Portugal
Santen Oy
Tel: +351 308 805 912

Hrvatska
Santen Oy
Tel: +358 (0) 3 284 8111

România
Santen Oy
Tel: +358 (0) 3 284 8111

Ireland
Santen Oy
Tel: +353 (0) 16950008

Slovenija
Santen Oy
Tel: +358 (0) 3 284 8111

Ísland
Santen Oy
Sími: +358 (0) 3 284 8111

Slovenská republika
Santen Oy
Tel: +358 (0) 3 284 8111

Italia Suomi/Finland
Santen Italy S.r.l.
Tel: +39 0236009983
Santen Oy
Puh/Tel: +358 (0) 974790211

Κύπρος
Santen Oy
Τηλ: +358 (0) 3 284 8111

Sverige
Santen Oy
Tel: +46 (0) 850598833

Latvija
Santen Oy
Tel: +371 677 917 80

United Kingdom (Northern Ireland)
Santen Oy
Tel: +353 (0) 16950008
(UK Tel: +44 (0) 345 075 4863)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency