Package Insert: Information for the User

Catiolanze 50 micrograms/mL Eye Drop Solution

latanoprost

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, or the doctor treating your child, or your pharmacist.
• This medication has been prescribed only for you or your child and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, or the doctor treating your child, or your pharmacist, even if they are not listed in this package insert. See section 4.

Catiolanze contains the active ingredient latanoprost, which belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural drainage of fluid from inside the eye into the bloodstream.

This medicine is used to treat certain diseases known as open-angle glaucoma (damage to the optic nerve caused by high pressure inside the eye) and ocular hypertension (increased pressure inside the eye) in adults. Both diseases are related to an increase in pressure within the eye due to obstruction of the fluid drainage channels, which can affect vision.

Catiolanze is also used to treat increased pressure within the eye and glaucoma in children aged 4 years and older and adolescents.

Do not use Catiolanze

• If you are allergic (hypersensitive) to latanoprost or to any of the other components of this medication (listed in section 6).

Warnings and precautions

If you consider that any of the following situations affect you or your child, consult your doctor, or the doctor treating your child, or the pharmacist before using Catiolanze or before administering it to your child:

• If you or your child have undergone or are going to undergo eye surgery (including cataract surgery).
• If you or your child have eye problems (such as eye pain, irritation, or inflammation, blurry vision).

• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child use contact lenses. They may continue to use Catiolanze, but they must follow the instructions included in section 3 for contact lens users.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Other medications and Catiolanze

Catiolanze may interact with other medications. Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are using or have recently used other medications (or eye drops), including those purchased without a prescription.

Particularly, consult your doctor or pharmacist if you or your child are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use this medication if you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

This medication may cause blurry vision for a short period of time. If this happens, do not drive or use tools or machinery until your vision returns to normal.

Catiolanze contains cetalkonium chloride.

Cetalkonium chloride may cause eye irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor, or by the doctor treating your child. Consult your doctor, or the doctor treating your child, or the pharmacist if you have any doubts.

The recommended dose for adults and children is one drop in the eye or in the affected eyes once a day. It is preferable to administer it at night.

Do not use Catiolanze more than once a day; the effectiveness of the treatment may decrease if administered more frequently.

Use Catiolanze as your doctor or the doctor treating your child has instructed you to, until they tell you to stop.

Users of contact lenses

If you or your child use contact lenses, you must remove them before using Catiolanze. After applying this medication, wait 15 minutes before putting the contact lenses back on.

Usage instructions

• For single use.
• Use the liquid from a single-use vial immediately after opening and administer one drop in the affected eye or eyes. The remaining content should be discarded immediately after use.
• After using Catiolanze, gently press with your finger the affected eye's end, near the nose. Maintain the pressure for 1 minute with the eye closed. See step 11 and image 3.

• Prevent the tip of the dropper from coming into contact with the eye and eyelids.

Follow these instructions exactly and, in case of doubt, consult your doctor or pharmacist.

1. Wash your hands and stand or sit in a comfortable position.
2. Open the aluminum foil package containing 5 single-use vials.
3. Remove a single-use vial from the aluminum foil package and leave the others inside.
4. Gently shake the single-use vial.
5. Turn the cap (image 1).
6. Separate the lower eyelid of the affected eye with your finger (image 2).
7. Incline your head back and look up.
8. Place the tip of the single-use vial near the eye, but not touching it.
9. Press gently so that one drop of the medication falls into the eye, then remove your finger from the lower eyelid.
10. Blink a few times to allow the medication to spread across the eye.
11. After using Catiolanze, gently press with your finger the affected eye's end, near the nose. Maintain the pressure for 1 minute with the eye closed (image 3).

This is a small drainage canal that drains tears from the eye into the nose. By pressing on this point, the opening of this drainage canal is closed. In this way, Catiolanze is prevented from reaching the rest of the body.

1. Repeat steps 6 to 11 in the other eye, if the doctor has instructed you to apply the drops in both eyes.
2. Discard the single-use vial after use. Do not save it for later use.

Using Catiolanze with other eye drops

Use Catiolanze at least 5 minutes after using other eye drops.

Using more Catiolanze than you should

If more drops than necessary have been applied to the eye, you may feel a slight irritation in the eye and the eyes may become red and tearful; this situation should resolve, but if you are concerned, contact your doctor or the doctor treating your child.

In case of accidental ingestion by you or your child, consult your doctor or pharmacist as soon as possible.

Missing a dose of Catiolanze

Continue with the administration of the next dose as usual. Do not use a double dose to compensate for the missed dose. If you have any doubts, consult your doctor or pharmacist.

Stopping treatment with Catiolanze

If you or your child wish to stop using this medication, consult your doctor or the doctor treating your child.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following are known side effects when using Catiolanze:

Very common side effects(may affect more than 1 in 10 patients):

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-colored eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, gray, green, or brown). The change in eye color takes years to develop, although it can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if this medicine is used in only one eye. The change in eye color does not appear to be associated with any problems. The change in eye color does not progress once treatment with Catiolanze has been discontinued.

Common side effects(may affect up to 1 in 10 patients):

• Redness of the eye (conjunctival hyperemia).
• Ocular irritation (sensation of grit, sensation of foreign body in the eye, itching, pain, and abnormal sensation in the eye). If you experience severe ocular irritation that causes excessive tearing or makes you consider interrupting treatment, consult your doctor, pharmacist, or nurse as soon as possible. You may need to have your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
• Irritation or erosion of the eye surface, eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon side effects(may affect up to 1 in 100 patients):

• 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 change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in most patients of Japanese origin. These changes include an increase in color (darkening), lengthening, thickening, and an increase in the number of eyelashes.
• Skin rash.
• Chest pain (angina), feeling the heart rhythm (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare side effects(may affect up to 1 in 1,000 patients):

• Inflammation of the iris (iritis), symptoms of swelling or damage to the eye surface, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, scarring of the eye surface, accumulation of fluid in the colored part of the eye (iris cyst), light sensitivity (photophobia).
• Reactions on the skin of the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Intense itching of the skin.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare side effects(may affect up to 1 in 10,000 patients):

• Worsening of angina in patients with underlying heart problems, appearance of sunken eyes (greater depth of the eyelid sulcus).

The side effects observedin childrenat a frequency greater than in adults are runny nose, nasal itching, and fever.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not use this medication after the expiration date that appears on the box, the overwrap, and the unit dose container after “EXP”. The expiration date is the last day of the month indicated.

Store below 30 °C.

After opening the aluminum overwrap, the unit dose containers should be kept in the overwrap to protect them from light and prevent evaporation. Dispose of the opened unit dose containers immediately after use.

Medicines should not be thrown away through drains. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. This will help protect the environment.

Composition of Catiolanze

• The active ingredient is latanoprost. One milliliter of emulsion contains 50 micrograms of latanoprost. Each single-dose vial of 0.3 ml of emulsion contains 15 micrograms of latanoprost. One drop contains approximately 1.65 micrograms of latanoprost.
• The other components are: medium-chain triglycerides, cetalkonium chloride, polisorbate 80, glycerol, and water for injectable preparations.

Appearance of the product and contents of the package

Catiolanze 50 micrograms/ml eye drops in emulsion is a white liquid.

One pack contains 5 single-dose vials. Available in package sizes of 30, 60, 90, or 120 single-dose vials.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible for manufacturing:

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

Detailed information about this medication 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.