Oculatax

Patient Information Leaflet: Information for the user

OCULATAX

50 micrograms/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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OCULATAX is and what it is used for

OCULATAX contains the active substance Latanoprost, which belongs to a class of medicines known as prostaglandin analogues. Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
OCULATAX is used to reduce the pressure inside the eye when you have a disease known as open-angle glaucoma (damage to the optic nerve caused by increased pressure inside the eye) or when you have elevated intraocular pressure (ocular hypertension).

2. What you should know before using OCULATAX

Do not use OCULATAX

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, planning to become pregnant, or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using OCULATAX.
OCULATAX can be used in adult women and men (including elderly patients). Use of OCULATAX is not recommended in patients under 18 years of age.
Use OCULATAX with caution:

• if you have undergone or are scheduled to undergo eye surgery (including cataract surgery, a condition caused by progressive loss of transparency of the lens inside the eye, the crystalline lens);
• if you have eye pain, irritation or inflammation, blurred vision;
• if you suffer from dry eye;
• if you suffer from severe or poorly controlled asthma;
• if you wear contact lenses. In this case, you may continue using OCULATAX, following the instructions provided in section “How to use OCULATAX”.
• if you have had or currently have a viral eye infection caused by herpes simplex virus (HSV).
• if you have risk factors for eye inflammation such as iritis and uveitis, or for a condition called cystoid macular edema.

OCULATAX may cause a gradual change in eye colour, which may be permanent, due to increased amounts of brown pigment in the coloured part of the eye called the iris (see “Possible side effects”).
A gradual change in the eyelashes of the treated eye and changes in the eyelid hair around the treated eye have been observed with OCULATAX (see “Possible side effects”).

Children and adolescents
OCULATAX is not recommended for children and adolescents under 18 years of age.

Other medicines and OCULATAX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines (or eye drops).
The use of OCULATAX together with other eye drops containing active substances similar to latanoprost (prostaglandins, prostaglandin analogues or prostaglandin derivatives) is not recommended.
If you use OCULATAX together with eye drops containing the active substance thiomersal, the two eye drops should be administered at least 5 minutes apart.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not use OCULATAX during pregnancy.

Breastfeeding
Do not use OCULATAX during breastfeeding.

Driving and using machines
When using OCULATAX, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.

OCULATAX contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact of the medicine with soft contact lenses. Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.
Benzalkonium chloride is known to have a decolouring effect on soft contact lenses.

3. How to use OCULATAX

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose in adults (including elderly patients)
The recommended dose is one drop of OCULATAX in the affected eye(s) once daily.
The optimal effect is achieved when OCULATAX is administered in the evening.
Do not instill OCULATAX more than once a day, as more frequent administration has been shown to reduce the pressure-lowering effect in the eye (intraocular pressure-lowering effect).

As with other eye drops, instill one drop into the eye and press gently with a finger on the inner corner of the treated eye. Keep your eyes closed for one minute, continuing to apply gentle pressure with your finger. This should be done immediately after instillation of each single drop.

Contact lens wearers
If you wear contact lenses, you must remove them before instilling the eye drops and may reinsert them after 15 minutes.

If you are using more than one topical ophthalmic medicine, administer them at least five minutes apart.

If you use more OCULATAX than you should
In case of accidental ingestion or overdose of OCULATAX, contact your doctor immediately or go to the nearest hospital.
If you instill too many drops into your eyes, you may experience mild irritation, tearing, and eye redness. These effects are transient, but you should still contact your doctor for advice.

If you forget to use OCULATAX
Do not use a double dose to make up for the missed dose.
If you forget to use OCULATAX, simply resume your regular dosing schedule at the usual time.

If you stop using OCULATAX
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very common side effects (may affect more than 1 in 10 people):

• gradual change in eye colour due to increased brown pigment in the coloured part of the eye (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 even after several years, although it generally appears within the first 8 months of treatment. The colour change may be permanent and may be more noticeable if OCULATAX is used in only one eye. No problems associated with eye colour changes have been observed. After discontinuation of OCULATAX treatment, no further change in eye colour has been observed;

• red eyes;

• eye irritation (burning sensation, feeling of sand in the eyes, itching, prickling sensation or foreign body sensation in the eyes);

• gradual changes in eyelashes of the treated eye and changes in the fine hair around the treated eye, observed mostly in people of Japanese origin. These changes include:

  increased length, thickness, darkening and increased number of eyelashes or fine hairs, and abnormal growth direction of eyelashes. Changes in eyelashes are reversible upon discontinuation of treatment.
  Common side effects (may affect up to 1 in 10 people):

• eye irritation or abrasion of the eye surface;

• inflammation of the eyelid margin (blepharitis);

• eye pain;

• light sensitivity (photophobia).

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

• eyelid swelling;
• dry eye;
• inflammation or irritation of the eye surface (keratitis);
• blurred vision;
• conjunctivitis;
• skin rash;
• nausea;
• vomiting.

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

• eye inflammation (iritis/uveitis);
• swelling of the retina (macular edema);
• symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital edema), altered eyelash orientation or abnormal eyelash growth;
• skin reactions on the eyelids;
• darkening of the skin of the eyelids;
• asthma, worsening of asthma, and shortness of breath (dyspnea).

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

• worsening of angina (chest pain due to lack of oxygen to the heart) if you suffer from heart disease;
• chest pain;
• sunken appearance of the eye (hollowing of the eye socket).

Also reported are:

• fluid-filled area in the coloured part of the eye (iris cyst);
• headache and dizziness;
• increased awareness of heartbeats (palpitations);
• myalgia (muscle pain) and arthralgia (joint pain);
• development of a viral eye infection caused by the herpes simplex virus (HSV).

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 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 http://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 OCULATAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the vial, store at a temperature not exceeding 25°C and the medicine must be used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the designated space provided on the pack.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What OCULATAX contains

• The active substance is latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
• The other components are: Benzalkonium chloride, Sodium chloride, Monosodium dihydrogen phosphate monohydrate, Disodium hydrogen phosphate anhydrous, Water for injections.

Description of the appearance of OCULATAX and pack contents
Carton pack containing 1 bottle of 2.5 ml - Eye drops, solution.
Marketing Authorization Holder
Bionativa S.p.A.
Via Raffaello 15
Loc. Sambuca V.P. - 50028 Florence
Italy
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)
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