Catiolanze 50 micrograms/ml eye drops in emulsion

Package leaflet: Information for the user

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, as 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 and must not be given to other people, 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 effects not listed in this leaflet. 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 elevated pressure inside the eye) and ocular hypertension (increased pressure inside the eye) in adults. Both conditions are associated with increased pressure within the eye due to blockage of the fluid drainage channels, which may eventually affect vision.

Catiolanze is also used to treat elevated intraocular pressure and glaucoma in children from 4 years of age and adolescents.

2. What you need to know before starting to use Catiolanze

Do not use Catiolanze

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

Warnings and precautions

If you consider that any of the following situations apply to you or your child, consult your doctor, 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 about to undergo 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 asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Catiolanze, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or are currently experiencing 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 the pharmacist if you or your child are using or have recently used any 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 become pregnant, consult your doctor before using this medicine.

Driving and using machines

This medicine may cause blurred vision for a short period of time. If this occurs, do not drive or operate tools or machinery until your vision returns to normal.

Catiolanze contains cetylpyridinium chloride.

Cetylpyridinium chloride may cause eye irritation.

3. How to use Catiolanze

Follow exactly the administration instructions for this medicine as given by your doctor, or by the doctor treating your child. Consult your doctor, the doctor treating your child, or your pharmacist if you have any doubts.

The recommended dose for adults and children is one drop into the affected eye or eyes once daily. It is preferable to administer it in the evening.

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

Use Catiolanze exactly as directed by your doctor or the doctor treating your child until they tell you to stop.

Contact lens users

If you or your child wear contact lenses, remove them before using Catiolanze. After applying this medicine, wait 15 minutes before reinserting 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 or eyes. Any remaining contents must be discarded immediately after use.

• After using Catiolanze, gently press with your finger on the inner corner of the affected eye, near the nose. Maintain this pressure for 1 minute while keeping the eye closed. See step 11 and image 3.

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

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

1. Wash your hands and remain standing or sitting in a comfortable position.
2. Open the aluminum foil 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 off the cap (image 1).
6. Gently pull down the lower eyelid of the affected eye with your finger (image 2).
7. Tilt your head backward and look at the ceiling.
8. Place the tip of the single-dose container close to the eye, but without touching it.
9. Gently squeeze so that a single drop of the medicine falls into the eye, then release the lower eyelid.
10. Blink several times to spread the medicine across the eye.
11. After using Catiolanze, gently press with your finger on the inner corner of the affected eye, near the nose. Maintain this pressure for 1 minute while keeping the eye closed (image 3).

This is where a small duct drains tears from the eye into the nose. Pressing at this point closes the opening of the drainage duct, thereby preventing Catiolanze from reaching the rest of the body.

1. Repeat steps 6 to 11 in the other eye if your doctor has instructed you to apply the drops to 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 into the eye than intended, you may experience mild eye irritation, redness, and tearing; this should resolve on its own. However, if you are concerned, contact your doctor or the doctor treating your child.

In case of accidental ingestion of Catiolanze by you or your child, 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 missed doses. If you have any doubts, consult your doctor or pharmacist.

If you stop using Catiolanze

If you or your child wish 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following are known adverse effects when using Catiolanze:

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

• Gradual change in eye color due to an increase in 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 of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is usually noticeable around 8 months after starting treatment. The color change may be permanent and may be more pronounced if this medicine is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The eye color change does not progress once treatment with Catiolanze is discontinued.

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

• Eye redness (conjunctival hyperemia).
• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation, abnormal sensation in the eye). If you experience severe eye irritation causing excessive tearing or making you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible. You may need your treatment reviewed to ensure you are receiving the appropriate therapy for your condition.
• Irritation or erosion on the eye surface, eye pain, light sensitivity (photophobia), conjunctivitis.

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

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), retinal swelling (macular edema), eyelid inflammation (blepharitis).
• Gradual changes in eyelashes and fine hair around the treated eye, observed in most Japanese-origin patients. These changes include increased pigmentation (darkening), lengthening, thickening, and increased number of eyelashes.
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, breathing difficulty (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

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

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

• Worsening of angina in patients with existing heart problems, appearance of sunken eyes (increased depth of the eyelid crease).

Adverse effects observed in children at a higher frequency than in adults include runny nose, nasal itching, and fever.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Catiolanze

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

Do not use this medicine after the expiry date stated on the carton, the aluminium pouch, and the single-dose container after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30 °C.

After opening the aluminium pouch, the single-dose containers should be kept within the pouch to protect them from light and prevent evaporation. Immediately discard individual single-dose containers after use.

Medicines should not be disposed of via wastewater drains. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Catiolanze

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

Nature of the product and contents of the pack

Catiolanze 50 micrograms/ml ophthalmic emulsion is a white liquid.

A sachet contains 5 single-dose containers. Available pack sizes of 30, 60, 90 or 120 single-dose containers.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer:

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

Further information on this medicinal product is available from the Marketing Authorization Holder's local representative:

Date of the most recent review of this summary:

Other sources of information

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

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