CATIOLANZE 50 micrograms/ml EMULSION EYE DROPS

Introduction

Package Leaflet: Information for the User

Catiolanze 50 micrograms/ml eye drops, emulsion

latanoprost

Read all of this 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 further questions, ask your doctor, or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, or the doctor treating your child, or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Catiolanze and what is it 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 the eye into the bloodstream.

This medicine is used to treat conditions known as open-angle glaucoma (damage to the optic nerve caused by high pressure in the eye) and ocular hypertension (high pressure in the eye) in adults. Both conditions are related to high pressure in the eye due to blockage of the fluid drainage channels, which can lead to impaired vision.

Catiolanze is also used to treat increased pressure in the eye and glaucoma in children from 4 years of age and adolescents.

2. What you need to know before you use 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).

Warnings and precautions

If you think any of the following apply to you or your child, consult your doctor, or the doctor treating your child, or your pharmacist before using Catiolanze or before giving it to your child:

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

• If you or your child have severe asthma or uncontrolled asthma.
• If you or your child wear contact lenses. You can continue to use Catiolanze, but you must follow the instructions in section 3 for contact lens wearers.
• If you have had or are suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).

Other medicines and Catiolanze

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

In particular, consult your doctor or pharmacist if you or your child are taking prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

This medicine may cause blurred vision for a short time. If this happens, do not drive or use tools or machines until your vision is clear again.

Catiolanze contains cetalkonium chloride.

Cetalkonium chloride may cause eye irritation.

3. How to use Catiolanze

Follow the instructions for administration of this medicine exactly as told by your doctor, or the doctor treating your child. Ask your doctor, or the doctor treating your child, or your pharmacist if you are unsure.

The recommended dose for adults and children is one drop in the affected eye(s) once daily. It is best to administer it at night.

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

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

For contact lens wearers

If you or your child wear contact lenses, you must remove them before using Catiolanze. After applying this medicine, you must wait 15 minutes before putting your contact lenses back in.

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). The remaining contents must be discarded immediately after use.
• After using Catiolanze, gently press the tip of the affected eye, near the nose, with your finger. Apply pressure for 1 minute while keeping the eye closed. See step 11 and image 3.

• Avoid contact between the dropper tip and the eye and eyelids.

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

1. Wash your hands and stand or sit in a comfortable position.
2. Open the aluminum pouch containing 5 single-dose containers.
3. Remove one single-dose container from the aluminum pouch and leave the others inside the pouch.
4. Gently shake the single-dose container.
5. Twist the cap (image 1).
6. Gently separate the lower eyelid of the affected eye with your finger (image 2).
7. Tilt your head back and look up at the ceiling.
8. Place the tip of the single-dose container near the eye, without touching it.
9. Gently squeeze until a single drop of the medicine falls into the eye, and then remove your finger from the lower eyelid.
10. Blink a few times to spread the medicine throughout the eye.
11. After using Catiolanze, gently press the tip of the affected eye, near the nose, with your finger. Apply pressure for 1 minute while keeping the eye closed (image 3).

There is a small drainage channel that drains tears from the eye to the nose. By pressing on this point, the opening of this drainage channel is closed. This prevents Catiolanze from reaching the rest of the body.

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

If you use Catiolanze with other eye drops

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

If you use more Catiolanze than you should

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may become red and watery; this should disappear, but if it worries you, contact your doctor or the doctor treating your child.

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

If you forget to use Catiolanze

Continue with the next dose as usual. Do not use a double dose to make up for forgotten doses. If you are unsure, consult your doctor or pharmacist.

If you stop using Catiolanze

If you or your child want to stop using this medicine, consult your doctor or the doctor treating your child.

If you have any further questions 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 everybody gets them.

The following are known side effects of using Catiolanze:

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

• 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-color 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 seem to be associated with any problems. The change in eye color does not progress once treatment with Catiolanze has been stopped.

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

• Redness of the eye (conjunctival hyperemia).
• Eye irritation (feeling of burning, feeling of grit in the eye, itching, pain, and abnormal sensation in the eye). If you experience severe eye irritation that makes your eyes water excessively or makes you consider stopping 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 right treatment for your condition.
• Irritation or erosion of the eye surface, eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon side effects(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 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), length, thickness, and number of eyelashes.
• Skin rash.
• Chest pain (angina), feeling your heartbeat (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 people):

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or extra row of eyelashes, scarring of the eye surface, accumulation of fluid in the colored part of the eye (iris cyst), sensitivity to light (photophobia).
• Reactions on the skin of 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 side effects(may affect up to 1 in 10,000 people):

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

Side effects observed in childrenat a higher frequency than in adults are runny nose and itchy nose and fever.

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 leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton, the aluminum pouch, and the single-dose container after “EXP”. The expiry date is the last day of the month shown.

Store below 30°C.

After opening the aluminum pouch, the single-dose containers must be kept in the pouch to protect them from light and prevent evaporation. Discard the opened single-dose containers immediately after use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What is in Catiolanze

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

Appearance and packaging

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

An aluminum pouch contains 5 single-dose containers. Available in pack sizes 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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.