Latanoprost genoptim

Package leaflet: Information for the patient

Latanoprost Genoptim, 50 µg/ml, eye drops, solution
Latanoprostum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Latanoprost Genoptim 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 Genoptim is used to treat open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with elevated intraocular pressure, which may impair vision.
Latanoprost Genoptim is also used to treat elevated eye pressure and glaucoma in children and infants of any age.

2. Important information before using Latanoprost Genoptim

Latanoprost Genoptim may be used in adult men and women (including elderly patients) and in children from birth to 18 years of age. The use of Latanoprost Genoptim has not been studied in preterm infants (born before week 36 of pregnancy).

When not to use Latanoprost Genoptim:

• If the patient is allergic to latanoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If any of the following apply to the patient, speak to the doctor or the child's doctor before taking Latanoprost Genoptim or administering it to a child.

• If the patient has recently undergone or will undergo eye surgery (including cataract surgery).
• If the patient has eye symptoms (such as eye pain, irritation or inflammation, blurred vision).
• If the patient has dry eye syndrome.
• If the patient has severe asthma or poorly controlled asthma.
• If the patient wears contact lenses. Latanoprost Genoptim may still be used, but follow the instructions for contact lens wearers provided in section 3.
• If the patient has had or currently has a viral eye infection caused by the herpes simplex virus ( Herpes Simplex Virus - HSV).

Latanoprost Genoptim and other medicines

Latanoprost Genoptim may interact with other medicines. Inform the doctor, the child's doctor, or pharmacist about all medicines currently used or used recently, including eye drops and over-the-counter medicines. In particular, consult the doctor or pharmacist if the patient is using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

Latanoprost Genoptim should not be used during pregnancy or breastfeeding unless the doctor decides it is necessary. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Driving and operating machinery

While using Latanoprost Genoptim, blurred vision may occur temporarily. If this occurs, do not drive or use any tools or operate any machinery until vision clears.

Latanoprost Genoptim contains benzalkonium chloride

Latanoprost Genoptim contains 0.500 mg of benzalkonium chloride per bottle, equivalent to 0.200 mg/ml. Benzalkonium chloride may be absorbed by contact lenses and may cause discoloration of soft contact lenses.

Contact lenses must be removed before instilling the drops and at least 15 minutes should elapse before reinserting them. For instructions for contact lens wearers, see section 3.

Benzalkonium chloride may also cause eye irritation, particularly if the patient has dry eyes or corneal disorders (the transparent layer at the front of the eye). If abnormal eye sensation, stinging, or eye pain occurs after using this medicine, consult the doctor.

Latanoprost Genoptim eye drops contain phosphates.

This medicine contains 15.625 mg of phosphates per bottle, equivalent to 6.250 mg/ml.

In cases of severe damage to the transparent layer at the front of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium accumulation during treatment.

3. How to use Latanoprost Genoptim

Latanoprost Genoptim should always be used exactly as prescribed by the physician treating the adult or child. If in doubt, consult a doctor or pharmacist.

The recommended dose for adults (including elderly patients) and children is one drop once daily in the affected eye(s). It is best to administer the medication in the evening.

Do not use Latanoprost Genoptim more than once a day, as more frequent administration may reduce the effectiveness of treatment.

Latanoprost Genoptim should be used continuously as directed by the treating physician for the adult or child, or until the physician advises to discontinue treatment.

For contact lens wearers

If the adult patient or child wears contact lenses, they should be removed before instilling Latanoprost Genoptim. After instillation of Latanoprost Genoptim, wait at least 15 minutes before reinserting the contact lenses.

Instructions for use

Following the steps below in the correct order will help ensure proper use of Latanoprost Genoptim:

1. Wash your hands and assume a comfortable sitting or standing position.
2. Before first use, check that the bottle cap is intact.
3. Unscrew the cap by turning it to the left.
4. Tilt your head backward and gently pull down the lower eyelid with your finger to create a small pocket between the eye and the eyelid.
5. Turn the bottle upside down and gently squeeze the middle part with your thumb and index finger to instill one drop into the conjunctival sac (the space between the eyelid and eyeball) as directed by your physician. Avoid touching the eye or eyelid with the dropper tip. After instillation, press the lacrimal sac (the tear drainage pathway from the conjunctival sac to the nasal cavity) for approximately 1 minute (by pressing the inner corner of the eye near the nose with a finger) and keep the eye(s) closed during this time. This helps the drop to be absorbed into the eye and likely reduces the amount of medication draining through the tear duct into the nose.
6. To instill in the second eye, if prescribed by the physician, repeat steps 4 and 5.
7. Replace the cap on the bottle. Do not overtighten the cap.

Using Latanoprost Genoptim with other eye drops

Wait at least 5 minutes between instilling Latanoprost Genoptim and any other eye drops.

If more than the recommended dose of Latanoprost Genoptim is used

If too many drops are instilled into the eye, mild irritation, tearing, and redness may occur. These symptoms should resolve on their own, but if they persist or are bothersome, contact your doctor. Seek immediate medical attention if Latanoprost Genoptim is accidentally swallowed.

If a dose of Latanoprost Genoptim is missed

If a dose is missed, instill the next dose at the usual time. Do not use a double dose to make up for a missed dose. If in doubt, consult your doctor or pharmacist.

Stopping Latanoprost Genoptim

If it becomes necessary to discontinue use of Latanoprost Genoptim, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Known adverse effects occurring after administration of Latanoprost Genoptim:

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

• gradual change in the colour of the treated eye due to increased amount of brown pigment in the iris (the part of the eye responsible for eye colour). Patients with mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) have a higher probability of this change than patients with uniformly coloured eyes (blue, grey, green or brown). The change in eye colour may not appear until after several years, although it is usually observed within the first 8 months of treatment. The change in eye colour may be permanent and more noticeable if Latanoprost Genoptim is used in only one eye. No health problems have been associated with the change in eye colour. The change in eye colour stops after discontinuation of Latanoprost Genoptim;
• redness of the eye;
• eye irritation (a burning, gritty, itching, stinging sensation or a feeling of a foreign body in the eye). If eye irritation is so severe that it causes excessive tearing or a desire to discontinue the medicine, consult a doctor, pharmacist or nurse without delay (within one week). A change of medicine may be necessary to ensure proper treatment;
• gradual changes in the eyelashes of the treated eye and in the fine hairs around the treated eye, which occur most frequently in people of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

Common (in less than 1 in 10 people):

• eye surface irritation or damage, eyelid inflammation and eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (in less than 1 in 100 people):

• eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular oedema);
• skin rash;
• chest pain (angina), palpitations;
• asthma, shortness of breath (dyspnoea);
• chest pain;
• headache, dizziness;
• muscle pain, joint pain;
• nausea;
• vomiting.

Rare (in less than 1 in 1,000 people):

• inflammation of the iris (iritis); symptoms of swelling, scratching or damage to the eye surface, swelling around the eye (periorbital oedema), altered direction of eyelash growth or an additional row of eyelashes, scarring on the eye surface, formation of fluid-filled cysts in the coloured part of the eye (iris cysts);
• skin reactions on the eyelids, darkening of the eyelid skin;
• worsening of asthma;
• acute skin itching;
• viral eye infections caused by herpes simplex virus (HSV).

Very rare (in less than 1 in 10,000 people):

• worsening of angina symptoms in patients with heart disease, sensation of sunken eyes. Cold and fever are adverse effects occurring more frequently in children and adolescents than in adults.
• in very rare cases, some patients with significantly damaged transparent membrane covering the front of the eyeball (cornea) developed corneal clouding during treatment due to calcium deposits.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Latanoprost Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the bottle in the outer packaging to protect from light.
After first opening the bottle: do not store above 25°C.
Discard the product four weeks after first opening, even if some solution remains.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Latanoprost Genoptim contains
One bottle of Latanoprost Genoptim contains 2.5 ml of eye drop solution, corresponding to approximately 80 drops of solution.
The active substance is latanoprost.
1 ml of eye drop solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
Other ingredients are: benzalkonium chloride, monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), water for injections.

What Latanoprost Genoptim looks like and contents of the pack
Latanoprost Genoptim is a clear, colourless eye drop solution.
One bottle contains 2.5 ml of eye drop solution, corresponding to approximately 80 drops of solution.
Latanoprost Genoptim is available in the following pack sizes:
1 bottle with dropper containing 2.5 ml of eye drop solution,
3 bottles with dropper, each containing 2.5 ml of eye drop solution,
6 bottles with dropper, each containing 2.5 ml of eye drop solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel.: 22 321 62 40

Manufacturer:
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka
P.O. Box 37
19002 Paiania Attika, Athens
Greece

This medicinal product has been authorised in EEA Member States under the following trade names:
ES: Latanoprost Combix 50 microgramos/ml colirio en solución
PL: Latanoprost Genoptim