Latanoprost Mylan Generics Italia

Package Leaflet: Information for the Patient

Latanoprost Mylan Generics Italia

50 micrograms/ml eye drops, solution
latanoprost
Generic medicine
Please read this entire leaflet carefully before you or your child starts 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, consult your doctor, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms appear to be the same as yours, as it may be harmful.
• If you notice any side effect, including those not listed in this leaflet, contact your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this package leaflet:

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

1. What Latanoprost Mylan Generics Italia is and what it is used for

The active ingredient of Latanoprost Mylan Generics Italia is latanoprost, which belongs to a group of
medicines known as prostaglandins. Latanoprost Mylan Generics Italia is a medicine that lowers the
pressure inside the eye by increasing the natural outflow of fluid from within the eye into the bloodstream.
Latanoprost Mylan Generics Italia is an eye drop used in patients with a condition known as open-angle
glaucoma, which causes increased pressure in the eye.
Latanoprost Mylan Generics Italia is also used to treat elevated intraocular pressure and glaucoma in children and adolescents of all ages.

2. What you should know before using Latanoprost Mylan Generics Italia

Latanoprost Mylan Generics Italia can be used in adult men and women, and in children from birth to 18 years of age. Latanoprost Mylan Generics Italia has not been studied in preterm infants (less than 36 weeks of gestation).
Do not use Latanoprost Mylan Generics Italia:

• if you are allergic to latanoprost, benzalkonium chloride, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, the doctor treating your child, or your pharmacist before using Latanoprost Mylan Generics Italia 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 have severe asthma or if asthma is not well controlled,
• if you or your child have a type of glaucoma known as "chronic angle-closure glaucoma",
• if you or your child have glaucoma despite being aphakic or having an artificial lens, if your eyes are aphakic (the lens is missing from your eye) or pseudophakic with posterior lens capsule rupture or with lenses in the anterior chamber,
• if you or your child have glaucoma caused by pigment dispersion within the angle of the eye chamber,
• if you or your child have glaucoma caused by eye inflammation or by formation of new blood vessels inside the eye,
• if you or your child have congenital glaucoma,
• if you have known risk factors for swelling at the back of the eye (macular edema) or for inflammation of the iris (iritis/uveitis), such as having an eye vascular disorder or retinal abnormalities due to diabetes,
• if you have a disorder affecting the front part of the eye (cornea),
• if you or your child are undergoing or have undergone eye surgery (including cataract surgery),
• if you or your child have had or currently have a viral eye infection caused by the Herpes simplex virus, especially if this was triggered by using similar prostaglandin-like products,
• if you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision),
• if you or your child have dry eyes; your doctor will carefully monitor this condition,
• if you or your child wear contact lenses. You may still use Latanoprost Mylan Generics Italia, but you must follow the instructions for contact lens wearers provided in section 3.

There is no experience with the use of latanoprost in treating acute angle-closure glaucoma attacks.
Other medicines and Latanoprost Mylan Generics Italia
Inform your doctor, the doctor treating your child, or your pharmacist if you or your child are taking, have recently taken, or might take or use any other medicines, including medicines (or eye drops) without a prescription. Latanoprost Mylan Generics Italia may interact with these medicines.
The effect of prostaglandins or prostaglandin derivatives (used for elevated intraocular pressure) may be influenced by Latanoprost Mylan Generics Italia. Their combination with Latanoprost Mylan Generics Italia is not recommended, as intraocular pressure may increase.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The fetus could be affected. Latanoprost Mylan Generics Italia must not be used during pregnancy.
Breastfeeding
If you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Latanoprost may pass into breast milk and therefore the infant could be affected.
Latanoprost Mylan Generics Italia must not be used during breastfeeding.
Driving and using machines
As with other eye drops, if your vision becomes blurred after instilling the drops, wait until the blurring clears before driving or using machinery.
Latanoprost Mylan Generics Italia contains phosphate buffer and benzalkonium chloride
This medicine contains 6.34 mg of phosphate buffer and 0.2 mg of benzalkonium chloride per 1 ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause corneal opacities due to calcium deposits during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the eye's most superficial transparent layer). If you experience unusual eye sensations, burning, or pain after using this medicine, speak with your doctor.

3. How to use Latanoprost Mylan Generics Italia

Always use this medicine exactly as prescribed by your doctor, the doctor treating your child, or your pharmacist. If you have any doubts, consult your doctor, the doctor treating your child, or your pharmacist.

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye, once daily. The best time to administer the dose is in the evening. If you are using other eye drops, you must wait at least 5 minutes before applying them.

Use caution when pressing the bottle to ensure only one drop is instilled into the affected eye. Do not use Latanoprost Mylan Generics Italia more than once a day, as the effectiveness of treatment may decrease if administered more frequently.

Follow the instructions below to help you use Latanoprost Mylan Generics Italia correctly:

1. Wash your hands and sit or position yourself comfortably,
2. Remove the cap from the bottle,
3. Gently pull down the lower eyelid of the affected eye with one finger,
4. Hold the tip of the bottle close to the eye without touching it,
5. Gently press the bottle so that a single drop falls into the eye, then release the lower eyelid,
6. Press with one finger on the inner corner of the affected eye (near the nose). Keep the eye closed for one minute,
7. Repeat the procedure in the other eye if your doctor has instructed you to do so,
8. Replace the cap on the bottle.

If you use more Latanoprost Mylan Generics Italia than you should
Use caution when pressing the bottle to ensure only one drop is instilled into the affected eye. If you have instilled too many drops into the eye, this may cause mild irritation, tearing, and redness. These effects should be temporary, but if you are concerned, contact your doctor or the doctor treating your child for advice.
If you or your child has accidentally swallowed Latanoprost Mylan Generics Italia, contact a doctor as soon as possible. You may experience nausea, fatigue, stomach redness or pain, and sweating.

If you forget to use Latanoprost Mylan Generics Italia
Do not use a double dose of Latanoprost Mylan Generics Italia to make up for a missed dose. If you forget to use your eye drops at the usual time, wait until it is time for your next scheduled dose. Do not use a double dose to replace the missed one.

If you stop using Latanoprost Mylan Generics Italia
You should speak with your doctor or the doctor treating your child if you wish to stop using Latanoprost Mylan Generics Italia.

If you wear contact lenses:
If you or your child wears contact lenses, they must be removed before using Latanoprost Mylan Generics Italia. Do not reinsert contact lenses for at least 15 minutes after using Latanoprost Mylan Generics Italia. A preservative in Latanoprost Mylan Generics Italia called benzalkonium chloride may cause eye irritation and may discolor soft contact lenses.

If you have further questions about the use of this medicine, ask your doctor, the doctor treating your child, or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop using this medicine and contact your doctor or go to the nearest hospital emergency department as soon as possible.
Uncommon (may affect up to 1 in 100 people)

• Inflammation of the outer or middle layer of the eye, which may cause eye pain, blurred vision, sensitivity to light, excessive tearing, redness of the eye, and possibly seeing floaters
• Swelling at the back of the eye (macular edema) or fluid-filled cysts at the back of the eye
• Chest pain, which may spread to the arms, neck or jaw, chest pain with a feeling of tightness or pressure, shortness of breath or feeling unwell (nausea). These may be signs of angina, in which your heart is not receiving enough blood

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

• A viral eye infection caused by the herpes simplex virus, associated with inflammation/irritation of the eye surface (keratitis)

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

• Change in eye colour (eyes become browner and darker)
• Red eyes
• Eye irritation: a burning sensation, feeling like there is sand in the eyes (stinging), itching and pricking in the eyes, as if something is in the eye; If you experience eye irritation severe enough to cause excessive tearing or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse immediately (within one week). Your treatment may need to be reviewed to ensure you continue to receive appropriate therapy for your condition
• Increase in number, darkening, thickening or lengthening of eyelashes and eyelid hair

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

• Abrasion or damage to the surface of the eye (cornea) (punctate keratitis), which usually occurs without obvious symptoms. Your doctor or optometrist may notice this when examining the surface of your eye
• Inflammation of the eyelid margins, resulting in crusting and stickiness
• Eye irritation (eye pain)
• Increased sensitivity of the eyes to light
• Itchy, red and watery eyes with a sticky coating on the eyelid (conjunctivitis)

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

• Headache
• Dizziness
• Swelling of the eyelids
• Dry eyes
• Blurred vision
• Fast heartbeat noticeable in the chest (palpitations)
• Sudden onset of chest tightness caused by muscle spasms and swelling of the airway linings, often with cough and mucus production (asthma)
• Shortness of breath (dyspnoea)
• Skin rash
• Muscle and joint pain
• Chest pain
• Nausea
• Vomiting

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

• Swelling and damage to the cornea (corneal edema)
• Swelling around the eye area (periorbital edema)
• Eyelashes growing inward, which occasionally may cause eye irritation
• A new row of eyelashes grows beyond the existing ones
• A fluid-filled cyst within the coloured part of the eye (iris cyst)
• Worsening of asthma
• Skin rashes on the eyelids
• Darkening of the skin of the eyelids
• Itchy skin

Very rare (may affect up to 1 in 10,000 people):

• Changes in the skin and tissue around the eyes that may cause deep skin folds
• In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment

Additional side effects in children and adolescents
Side effects observed more frequently in children than in adults are: itchy, runny nose and fever.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Latanoprost Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer carton after the word “Expiry”. The expiry date refers to the last day of that month.
Store in a refrigerator (2° - 8°C).
Keep the bottle in the outer carton to protect the medicine from light.
After first opening the bottle: do not store above 25°C. Four weeks after first opening, the medicine must be discarded, even if not completely used.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Latanoprost Mylan Generics Italia contains
The active substance is latanoprost.
One ml of eye drop solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
The other components are: benzalkonium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate (see section 2 “Latanoprost Mylan Generics Italia contains phosphate buffer and benzalkonium chloride”), sodium chloride, purified water.

What Latanoprost Mylan Generics Italia looks like and contents of the pack
Latanoprost Mylan Generics Italia is an eye drop solution, a practically clear, colourless solution, contained in a clear LDPE bottle with a dropper and a white HPDE screw cap.
Each bottle of Latanoprost Mylan Generics Italia contains 2.5 ml of eye drop solution, equivalent to approximately 80 drops of solution. Latanoprost Mylan Generics Italia is available in pack sizes of 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturers
Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka 51000, Croatia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Latanoprost Mylan Generics Italia
Spain: Latanoprost Viatris 50 microgramos/ml colirio en solución
Netherlands: Latanoprost Mylan 0,05 mg/ml, oogdruppels, oplossing