Iopize

PACKAGE LEAFLET: INFORMATION FOR THE USER

IOPIZE 50 mcg/ml eye drops, solution

Latanoprost
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, the doctor treating your child, or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you or your child experience any side effects, including those not listed in this leaflet, consult your doctor, the doctor treating your child, or pharmacist. See section 4.
  Contents of this leaflet:

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

1. WHAT IOPIZE IS AND WHAT IT IS USED FOR

IOPIZE is a solution intended for ophthalmic use only. It contains the active substance
latanoprost, which belongs to a group of medicines called prostaglandins.
IOPIZE is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension.
Both of these conditions are associated with elevated intraocular pressure, which may eventually impair vision.
IOPIZE is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in infants.

2. WHAT YOU SHOULD KNOW BEFORE USING IOPIZE

IOPIZE can be used in adult women and men (including the elderly) and in children from birth up to 18 years of age. The use of IOPIZE in premature infants (with gestational age less than 36 weeks) has not been studied.
Do not use IOPIZE:

• 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 a pregnancy.
• If you are breastfeeding.

Warnings and precautions
Talk to the doctor treating you or your child or to the pharmacist before using IOPIZE 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 has recently undergone, or is scheduled to undergo, 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 dry eye.
• If you or your child has severe asthma or if asthma is not well controlled.
• If you or your child wears contact lenses. You may still use IOPIZE, but follow 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 the Herpes Simplex virus (HSV).

Other medicines and IOPIZE
IOPIZE may interact with other medicines. Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are taking or have recently taken any other medicines, including medicines (or eye drops) without a prescription.
Pregnancy and breastfeeding
Pregnancy
Do not use IOPIZE during pregnancy. Inform your doctor immediately if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use IOPIZE during breastfeeding.
Driving and use of machinery
When using IOPIZE, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.
Important information about some excipients in IOPIZE
IOPIZE contains a preservative called benzalkonium chloride. This preservative may cause ocular irritation or changes to the ocular surface. Benzalkonium chloride may be absorbed by contact lenses and is known to cause a change in the colour of soft contact lenses. Therefore, contact with soft contact lenses should be avoided.
If you or your child wears contact lenses, they must be removed before applying IOPIZE. After applying IOPIZE, wait 15 minutes before reinserting the contact lenses. For instructions for contact lens wearers, refer to section 3.

3. HOW TO USE IOPIZE

Use IOPIZE exactly as directed by the doctor treating you or your child. If you have any doubts, consult the doctor treating you or your child, or speak to your pharmacist.

The usual dose in adults (including elderly patients) and children is 1 drop once daily in the affected eye(s). The best time for administration is in the evening.

Do not use IOPIZE more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.

Use IOPIZE as directed by your doctor, or the doctor treating your child, until the doctor tells you to stop treatment.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying IOPIZE. After applying IOPIZE, wait at least 15 minutes before reinserting contact lenses.

Instructions for use

1. Wash your hands before using the eye drops.
2. Rotate the outer protective cap with the “wings”.

3. Rotate the inner protective cap.

4. Tilt the head backwards. Gently pull down the lower eyelid of the eye to be treated with the index finger.
5. Bring the tip of the bottle close to the eye without touching it, and apply slight pressure so that one drop falls into the eye to be treated.

6. Release the lower eyelid and apply gentle pressure to the inner corner of the treated eye for one minute after instillation of the drop.
7. Replace the protective cap after use.

If you use IOPIZE with another eye drop
Wait at least 5 minutes between the administration of IOPIZE and any other eye drop.

If you use more IOPIZE than you should
Putting too many drops into the eyes may cause mild irritation, tearing, and eye redness. These effects should be temporary. However, 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 IOPIZE.

If you forget to use IOPIZE
If a dose is missed, continue treatment as normal with the next dose. Do not administer a double dose to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using IOPIZE
Consult your doctor or the doctor treating your child if you intend to stop treatment with IOPIZE.

If you have any questions about the use of this product, consult your doctor, the doctor treating your child, or your pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, IOPIZE can cause side effects, although not everybody gets them.
The following side effects have been reported:

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

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye (iris). This change is more likely to occur in people with heterochromatic eyes (blue-brown, grey-brown, yellow-brown or green-brown) than in people with uniformly coloured eyes (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 change in eye colour may be permanent and may be more noticeable if IOPIZE is used in only one eye. There appear to be no problems associated with the change in eye colour. After stopping treatment with IOPIZE, no further change in eye colour has been observed.
• Red eyes.
• Eye irritation (burning sensation, sensation of sand in the eyes, itching, stinging pain or foreign body sensation in the eyes).
• Gradual changes in the eyelashes of the treated eye (darkening, thickening, lengthening, increased number) and changes in the fine hair around the treated eye (observed mainly in the Japanese population).

Common side effects (may affect more than 1 in 100 and less than 1 in 10 people):

• Irritation of the ocular surface.
• Inflammation of the eyelid (blepharitis).
• Eye pain and sensitivity to light (photophobia).

Uncommon side effects (may affect more than 1 in 1,000 and less than 1 in 100 people):

• Swelling of the eyelid (eyelid oedema).
• Dry eye.
• Inflammation or irritation of the surface of the eye (keratitis).
• Blurred vision.
• Conjunctivitis.
• Skin rash.

Rare side effects (may affect more than 1 in 10,000 and less than 1 in 1,000 people):

• Inflammation of the iris, the coloured part of the eye (iritis/uveitis).
• Swelling of the retina (macular oedema).
• Swelling and damage to the surface of the eye (corneal oedema or erosion).
• Swelling of the area around the eyes (periorbital oedema).
• Misdirected growth of eyelashes.
• Asthma, worsening of asthma symptoms, and shortness of breath (dyspnoea).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Abnormal growth of an additional row of eyelashes (distichiasis).

Very rare side effects (may affect less than 1 in 10,000 people):

• Chest pain.
• Worsening of angina in patients with heart disorders.
• Sunken eye appearance (enophthalmos).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Palpitations (irregular or rapid heartbeat).
• Headache.
• Dizziness.
• Iris cysts.
• Muscle and joint pain.
• Viral infection of the eye caused by the Herpes Simplex virus (HSV).

Side effects observed more frequently in children than in adults were: runny and itchy nose, fever.
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) developed cloudy spots on the cornea due to calcium deposits during treatment.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IOPIZE

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
After first opening: store below 25°C and use within 4 weeks.
Keep the bottle in the outer carton to protect it from light.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What IOPIZE contains
The active substance is latanoprost.
1 ml of eye drops contains 50 mcg of latanoprost.
A 2.5 ml bottle of eye drops contains 125 mcg of latanoprost.
The other components are benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water.

Description of the appearance of IOPIZE and packaging contents
IOPIZE 50 mcg/ml eye drops, solution is a colourless, clear liquid.
IOPIZE is available in packs containing 1, 3 or 6 cartons.
Not all pack sizes may be marketed.
Each carton contains one bottle of IOPIZE. Each bottle contains 2.5 ml of eye drops.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S.I.F.I. S.p.A. – Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Manufacturers:
S.I.F.I. S.p.A.
Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Italy
Catalent Pharma Solutions (formerly known as Cardinal Health Inc)
2200 Lake Shore Drive - Woodstock, IL 60098
USA