Latanoprost Aurobindo

Package leaflet: Information for the user

Latanoprost Aurobindo 50 micrograms/ml eye drops, solution

Generic medicine
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Latanoprost Aurobindo is and what it is used for

Latanoprost Aurobindo 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.
Latanoprost Aurobindo is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are associated with increased intraocular pressure, which may eventually impair vision.
Latanoprost Aurobindo is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using Latanoprost Aurobindo

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

• If you are allergic to latanoprost or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or planning to become pregnant.
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor, your child’s doctor, or pharmacist before using Latanoprost Aurobindo 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 are about to undergo, or have recently undergone, 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 suffer from dry eye.
• If you or your child suffer from severe asthma or if asthma is not well controlled.
• If you or your child wear contact lenses. You may still use Latanoprost Aurobindo, but you must follow the instructions for contact lens wearers provided in section 3.
• If you have had or currently have a viral eye infection caused by herpes simplex virus (HSV).

Other medicines and Latanoprost Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Latanoprost Aurobindo may interact with other medicines. Inform your doctor, your child’s doctor, or pharmacist if you or your child are using or have recently used any other medicines, including non-prescription medicines (or eye drops).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Latanoprost Aurobindo if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use Latanoprost Aurobindo during breastfeeding.
Driving and use of machines
When using Latanoprost Aurobindo, you may experience temporary blurred vision. If this occurs, you must not drive or operate machinery until your vision clears.
Latanoprost Aurobindo contains benzalkonium chloride and sodium
Latanoprost Aurobindo contains a preservative called benzalkonium chloride. This preservative may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
If you or your child wear contact lenses, you must remove them before applying Latanoprost Aurobindo. After applying Latanoprost Aurobindo, wait 15 minutes before reinserting the contact lenses. See the instructions for contact lens wearers in section 3.
This medicine contains less than 1 mmol (23 mg) of sodium per 2.5 ml bottle, i.e. it is essentially “sodium-free”.

3. How to use Latanoprost Aurobindo

Use this medicine exactly as directed 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) and children is one drop once daily in the affected eye(s). The optimal time for administration is in the evening.

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

Use Latanoprost Aurobindo as directed by your doctor or the doctor treating your child until you are told to stop treatment.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying Latanoprost Aurobindo. After applying Latanoprost Aurobindo, wait 15 minutes before reinserting the contact lenses.

Instructions for use

1. Wash your hands and sit or stand comfortably.
2. Remove the outer cap of the bottle (this can be discarded).

3. Unscrew the inner protective cap. The protective cap must be kept.

4. Use a finger to gently pull down the lower eyelid of the affected eye.
5. Hold the dropper tip close to the eye without touching it.

6. Gently squeeze the bottle so that a single drop falls into the eye, then release the lower eyelid.
7. Press with a finger on the inner corner of the affected eye (near the nose). Keep the eye closed for one minute.
8. Repeat the procedure in the other eye if your doctor has instructed you to do so.
9. Close the bottle with the inner protective cap.

If you use Latanoprost Aurobindo with another eye drop
Wait at least 5 minutes between administering Latanoprost Aurobindo and any other eye drop.

If you use more Latanoprost Aurobindo than you should
Putting too many drops into the eyes may cause mild eye 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.
Contact your doctor as soon as possible if you or your child has accidentally swallowed Latanoprost Aurobindo.

If you forget to use Latanoprost Aurobindo
Continue with your next dose at the usual time. Do not use a double dose of Latanoprost Aurobindo to make up for a forgotten dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Aurobindo
You must inform your doctor or the doctor treating your child if you intend to stop treatment with Latanoprost Aurobindo.

If you have any questions about how to use this medicine, consult 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 adverse events associated with the use of Latanoprost Aurobindo:

Very common (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 called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after years, although it generally appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable if you use Latanoprost Aurobindo in only one eye. There appear to be no associated problems with the change in eye colour. After stopping treatment with Latanoprost Aurobindo, no further change in eye colour has been observed.

• Red eyes.

• Eye irritation [burning sensation, sensation of sand in the eyes, itching, stinging pain (pinprick sensation) or foreign body sensation in the eyes]. If you experience irritation severe enough to cause excessive tearing of your eyes, or if it leads you to stop using the medicine, contact your doctor, pharmacist or nurse immediately (within one week). Your treatment may need to be reviewed to ensure your condition continues to be properly managed.

• Gradual changes in the eyelashes of the treated eye and changes in the surrounding eyelid hair, mostly observed in people of Japanese origin. These changes include increased darkening, lengthening, thickening and increased number of eyelashes.

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

• Irritation or abrasion of the eye surface, inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

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

• Swelling of the eyelids, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

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

• Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eye area (periorbital edema), altered direction of eyelashes or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the coloured part of the eye (iris cyst).

• Skin reactions on the eyelids, darkening of the eyelid skin.

• Worsening of asthma.

• Severe skin itching. Development of a viral eye infection caused by herpes simplex virus (HSV).

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

• Worsening of angina in patients already suffering from heart disease, sunken appearance of the eye (deepening of the eye socket).

Side effects observed more frequently in children than in adults include runny and itchy nose and fever.
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2° - 8°C).
Keep the container in the outer carton to protect the medicine from light.
After first opening of the container: do not store above 25°C. After four weeks from 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 Aurobindo contains

• The active substance is latanoprost.
• The other components are: benzalkonium chloride, monosodium phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, purified water.

Each bottle of Latanoprost Aurobindo contains 2.5 ml of eye drops solution, corresponding to
approximately 80 drops of solution.
Latanoprost Aurobindo 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.
One ml of eye drops contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.

Description of the appearance of Latanoprost Aurobindo and contents of the pack
Latanoprost Aurobindo is a clear, colourless eye drop solution in an LDPE dropper bottle with a screw cap made of HPDE.
Each bottle contains 2.5 ml of eye drops solution, corresponding to approximately 80 drops of solution.
Latanoprost Aurobindo is available in packs containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA), Italy

Manufacturers:
HBM Pharma s.r.o., Sklabinská 30, 03680 Martin, Slovak Republic
Pharma Stulln, Werkstr. 3, D-92551 Stulln, Germany
Jadran Galenski Laboratorij d.d., Pulac 4A, 51000 Rijeka, Croatia
Jadran Galenski Laboratorij d.d., Svilno 20, 51000 Rijeka, Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Latanoprost Aurobindo
Spain: Latanoprost Aurovitas 50 microgramos/ml colirio en solución
Netherlands: Latanoprost Actavis 50 micrograms/ml Oogdruppels, oplossing