Catiolanze

Package leaflet: Information for the

user
Catiolanze 50 micrograms/mL eye drops, emulsion
latanoprost
Please read this leaflet carefully before using this medicine because it contains important
information for you. Even if you have previously used Catiolanze or a similar medicine, it is advisable to
read this leaflet carefully. The information may have been updated.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Never give it to others: this medicine could be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, 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 using 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 Catiolanze is and what it is used for

Catiolanze contains the active substance latanoprost, which belongs to a group 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 to treat conditions known as open-angle glaucoma (damage to the optic nerve caused by increased pressure in the eye) or ocular hypertension (increased pressure within the eye) in adults. Both of these conditions are related to elevated intraocular pressure due to blocked drainage channels for fluid, which may eventually impair vision.
Catiolanze is also used to treat elevated intraocular pressure and glaucoma in children from the age of 4 years and in adolescents.

2. What you need to know before using Catiolanze

Do not use Catiolanze

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

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

• If you or your child is about to undergo or has recently undergone 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 suffers from severe asthma or if asthma is not well controlled
• If you or your child wears contact lenses. You may still use Catiolanze by following the instructions for contact lens wearers provided in section 3
• If you or your child has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Other medicines and Catiolanze
Catiolanze may interact with other medicines. Inform your doctor, the doctor treating your
child, or pharmacist if you or your child are using or have recently used any other
medicines, including medicines (or eye drops) without a prescription.
In particular, inform your doctor or pharmacist if you know that you or your child is using
prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
Pregnancy and breastfeeding
Do not use this medicine during pregnancy or while breastfeeding.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a
pregnancy.
Driving and using machines
This medicine may cause temporary blurred vision. If this occurs, do not drive or
operate 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 prescribed by your doctor or the doctor treating your child. If you have any doubts, consult your doctor, the doctor treating your child, or pharmacist.
The recommended dose for adults and children is one drop once daily in the affected eye(s). The optimal time for administration is in the evening.
Do not use Catiolanze more than once a day, as treatment efficacy may be reduced if the medicine is administered more frequently.
Use Catiolanze as directed by your doctor or the doctor treating your child until the doctor instructs you to stop treatment.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying Catiolanze. After applying this medicine, wait 15 minutes before reinserting contact lenses.

Instructions for use

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

Follow these instructions carefully and ask your doctor or pharmacist if anything is unclear.

1 2 3

1. Wash your hands and sit or stand in a comfortable position.
2. Open the aluminum pouch containing the 5 single-dose containers.
3. Remove one single-dose container from the aluminum pouch, leaving the remaining containers inside.
4. Gently shake the single-dose container.
5. Twist the cap to break it open (figure 1).
6. Use a finger to gently pull down the lower eyelid of the eye to be treated (figure 2).
7. Tilt the head backward and look at the ceiling.
8. Position the tip of the single-dose container close to the eye, without touching it.
9. Gently squeeze to release one drop of the medicine into the eye, then release the lower eyelid.
10. Blink the eye several times so that the medicine spreads evenly over the eye.
11. After using Catiolanze, gently press a finger against the inner corner of the treated eye, near the nose. Maintain pressure for one minute with the eye closed (figure 3). This area contains a small tear drainage channel from the eye to the nose. By pressing here, you close the opening of this drainage channel, helping to prevent Catiolanze from spreading into the rest of the body.
12. Repeat steps 6 to 11 for the other eye if your doctor has instructed you to use the eye drops in both eyes.
13. After use, dispose of the single-dose container. Do not store 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
Applying too many drops into the eyes may cause mild irritation, tearing, and eye redness. These effects should be temporary, but if you are concerned, contact your doctor or the doctor treating your child for advice.
Contact your doctor as soon as possible if you or your child has accidentally swallowed Catiolanze.

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

If you stop using Catiolanze
You must inform your doctor or the doctor treating your child if you or your child intend to stop treatment with this medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

Common (may affect up to 1 in 10 people):

• Red eyes (conjunctival hyperaemia).
• Eye irritation [burning sensation, gritty feeling, itching, stinging pain (pinprick sensation) or foreign body sensation in the eyes, abnormal sensation in the eyes]. If you experience irritation severe enough to cause excessive tearing or that leads you to discontinue the medicine, contact your doctor, pharmacist or nurse immediately. Your therapy may need to be reviewed to ensure adequate treatment of your condition.
• Eye surface irritation or abrasion, eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):

• Swelling of the eyelids, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular oedema), inflammation of the eyelids (blepharitis).
• Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, observed mostly in people of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage of the ocular surface, swelling around the eyes (periorbital oedema), altered eyelash orientation or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the coloured part of the eye (iris cysts).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense skin itching.
• 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 affected by heart disease, sunken appearance of the eye (enophthalmos).

Side effects observed more frequently in children than in adults were:
runny and itchy nose, fever.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the outer carton, on the aluminium pouch,
and on the single-dose container after “EXP” or “SCAD”. The expiry date refers to the last day
of that month.
Store below 30 °C.
After opening the aluminium pouch, store the single-dose containers inside it to protect them from light and prevent evaporation.
Immediately discard each single-dose container after use.
Do not dispose of any medicine via waste water. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What Catiolanze contains

• The active substance 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 ingredients are: medium-chain triglycerides, cetalkonium chloride, polysorbate 80, glycerol and water for injections.

Description of the appearance of Catiolanze and pack contents
Catiolanze 50 micrograms/mL eye drops, emulsion, is a white liquid.
One pouch contains 5 single-dose containers. It is available in packs of 30, 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Santen Oy Santen Oy
Tél/Tel: +32 (0) 24019172 Tel: +370 37 366628

България Luxembourg/Luxemburg
Santen Oy Santen Oy
Teл.: +359 (0) 888 755 393 Tél/Tel: +352 (0) 27862006

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

Danmark Malta
Santen Oy Santen Oy
Tlf: +45 898 713 35 Tel: +358 (0) 3 284 8111

Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206

Eesti Norge
Santen Oy Santen Oy
Tel: +372 5067559 Tlf: +47 21939612

Ελλάδα Österreich
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +43 (0) 720116199

España Polska
Santen Pharmaceutical Spain S.L. Santen Oy
Tel: +34 914 142 485 Tel.: +48(0) 221042096

France Portugal
Santen Santen Oy
Tél: +33 (0) 1 70 75 26 84 Tel: +351 308 805 912

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

Ireland Slovenija
Santen Oy Santen Oy
Tel: +353 (0) 16950008 Tel: +358 (0) 3 284 8111

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

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

Κύπρος Sverige
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 85098833

Latvija United Kingdom (Northern Ireland)
Santen Oy Santen Oy
Tel: +371 677 917 80 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.