DROPLATAN 50 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

1. Droplatan 50 micrograms/ml eye drops, solution
   1. What is Droplatan and what is it used for
   2. What you need to know before using Droplatan
   3. How to use Droplatan
   4. Possible side effects
   5. How to store Droplatan
   6. Contents of the pack and other information

Droplatan 50 micrograms/ml eye drops, solution

Latanoprost
Generic medicine

Read this leaflet carefully before you start using this medicine as 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 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, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Droplatan and what is it used for

Droplatan reduces intraocular pressure by increasing the natural flow of fluid from inside the eye into the
blood. It belongs to a group of medicines called prostaglandin analogues.
Droplatan is used in the treatment of open-angle glaucoma and intraocular hypertension in adults.
These conditions are caused by increased intraocular pressure. If not treated adequately,
they can affect vision.
Droplatan is also used in the treatment of elevated intraocular pressure and glaucoma in
children of all ages and infants.

2. What you need to know before using Droplatan

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

Do not use Droplatan

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

Warnings and precautions
Consult your doctor or the doctor caring for your child before using Droplatan or before giving this medicine to your child if you think that any of the following conditions apply to you or your child:
If you or your child suffer from severe asthma, or poorly controlled asthma.
If you or your child have undergone eye surgery, such as cataract surgery, or are about to undergo eye surgery.
If you or your child present lesions in the area surrounding the eye lens.
If you or your child present any clinical condition that may affect vision (such as diabetes).
If you or your child present swelling of the posterior portion of the eye (a condition of the eye known as macular edema) or any other eye inflammation.
If you or your child suffer from dry eyes.
If you or your child use contact lenses. You can still use Droplatan following the instructions for contact lens wearers in section 3.
If you have suffered or are currently suffering from an eye viral infection caused by the herpes simplex virus (HSV).
Droplatan is used in open-angle glaucoma and ocular hypertension. Tell your doctorif you have another type of glaucoma. Droplatan can permanently alter the color of the eye, which may also affect the eyelashes and skin around the eyes (see section 4).
Consult your doctor or pharmacist before using Droplatan.

Other medicines and Droplatan
Tell your doctor or the doctor caring for your child or your pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Droplatan may interact with other medicines taken at the same time.
Do not use Droplatan with any other medicine containing prostaglandins, because intraocular pressure may increase.

Pregnancy, breastfeeding and fertility
Droplatan must not be usedduring pregnancy.
Droplatan can pass into breast milk and must not be used during breastfeeding.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
As with other eye drops, if your vision is blurred after the first instillation of the drops, wait for the symptoms to disappear before driving or operating machinery.

Droplatancontainsbenzalkonium chloride
This medicine contains 5.26 micrograms of benzalkonium chloride per drop equivalent to 0.2 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

Droplatancontains phosphate
This medicine contains 0.167 mg of phosphate per drop equivalent to 6.34 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use Droplatan

Use this medicine following the instructions of your doctor or the doctor caring for your child exactly. If you have any doubts, consult your doctor or the doctor caring for your child or your pharmacist.
The recommended dose for adults, including elderly patients, is one drop of Droplatan in the affected eye(s) once a day. The best time to use it is in the evening.
Do not use Droplatan more than once a day, as the effectiveness of the treatment may be reduced if the medicine is administered more frequently.
Use Droplatan as directed by your doctor, or the doctor caring for your child, until the doctor tells you to stop the treatment.

Contact lens wearers
If you or your child wear contact lenses, you must remove them before applying Droplatan. After applying Droplatan, you must wait 15 minutes before reinserting the contact lenses.

Use with other eye drops:
If you need to use other eye drops, you must wait at least five minutes before using them.

How to use Droplatan
Follow the procedure described below to facilitate the correct use of Droplatan:

• 1. Wash your hands and sit or stand comfortably.
• 2. Unscrew the outer protective cap.
• 3. With your fingers, gently lower the lower eyelid of the affected eye.
• 4. Position the bottle nozzle close to the eye but without touching it.
• 5. Apply slight pressure to the bottle so that only one dropreaches the eye and then release the lower eyelid.
• 6. Press with a finger on the corner of the affected eye, near the nose. Wait for 1 minute, keeping your eyes closed.
• 7. If your doctor has told you to do so, repeat the same procedure for the other eye.
• 8. Close the bottle tightly.

If you use more Droplatan than you should
If you have instilled too many drops into the eye, you may experience mild eye irritation or redness may occur in the eye area. If this condition persists, or if you accidentally ingest Droplatan

consult your doctor or the doctor caring for your child as soon as possible.
If you forget to useDroplatan
If you forget to apply the drops at the usual time, do not instill a double dose to compensate for the missed dose. Instead, wait until the next instillation, and then take the normal dose.

If you stop using Droplatan
You must use Droplatan eye drops until your doctor or the doctor caring for your child tells you to stop. If you stop using this medicine, intraocular pressure may rise.
If you have any doubts 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 adverse events with the use of Droplatan:

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

• Gradual alteration of the eye color due to the increase in the amount of brown pigment in the colored part of the eye called the iris. This change will be more likely if your eyes are of a mixed color (blue-brown, gray-brown, yellow-brown or green-brown)

rather than a uniform color (blue, gray, green or brown). Any alteration of the eye color may occur after years, although it generally occurs within the first 8 months of
treatment. The color change may be permanent and may be more evident if you use
Droplatan in only one eye. There appear to be no problems associated with the change in eye color.
After stopping treatment with Droplatan, no further alteration of the eye color has been observed.

• Reddened eyes.
• Eye irritation [burning sensation, gritty sensation, itching, stinging sensation (feeling of pinpricks) or foreign body sensation in the eyes]. If you experience irritation severe enough to produce excessive tearing in your eyes, or to induce discontinuation of the medicine, immediately consult (within one week) your doctor, pharmacist or nurse. A therapy update may be necessary to ensure adequate treatment for your condition.
• Gradual alteration of the eyelashes of the treated eye and alteration of the fluff around the treated eye, observed mostly in people of Japanese origin. These changes include an increase in darkening, lengthening, thickening, and densification of the eyelashes. Common:(may affect less than 1 in 10 people):
• Irritation or abrasion of the ocular surface, inflammation of the eyelid margin (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon:(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).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Headache, dizziness.
• Muscle pain, joint pain
• Nausea
• Vomiting.

Rare:(may affect up to 1 in 1000 people) :

• Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage to the ocular surface, swelling around the eyes (periorbital edema), altered orientation of the eyelashes or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the colored part of the eye (iris cyst).
• Skin reactions on 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:(may affect up to 1 in 10,000 people)

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

The side effects observed more frequently in children compared to adults were: runny
nose and itching, fever.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause in
very rare cases opaque spots on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Droplatan

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 package and vial after “Exp.”.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package to protect the medicine from light.
After the first opening of the vial: do not store at a temperature above 25°C and use within
four weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Droplatan contains
The active ingredient is latanoprost 50 micrograms in one ml.
The other ingredients are: sodium chloride, benzalkonium chloride, sodium phosphate monobasic monohydrate, disodium phosphate anhydrous, water for injections.

Description of the appearance of Droplatan and contents of the pack
5 ml polyethylene dropper bottle with a transparent polyethylene screw cap.
Each bottle contains 2.5 ml of eye drops solution corresponding to approximately 80 drops of solution.
Pack sizes: 1 x 2.5 ml
3 x 2.5 ml
6 x 2.5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano

Manufacturer
Tubilux Pharma Spa
Via Costarica 20/22
00071 Pomezia (Roma) Italia