Latanoprost Pensapharma

Package leaflet: Information for the user

LATANOPROST PENSA PHARMA 50 micrograms/ml eye drops, solution

Latanoprost
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as yours, because it could 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 PENSA PHARMA is and what it is used for
2. What you need to know before you use LATANOPROST PENSA PHARMA
3. How to use LATANOPROST PENSA PHARMA
4. Possible side effects
5. How to store LATANOPROST PENSA PHARMA
6. Contents of the pack and other information

1. What LATANOPROST PENSA PHARMA is and what it is used for

LATANOPROST PENSA PHARMA 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.
LATANOPROST PENSA PHARMA is used to reduce the pressure inside the eye in patients with a disease known as open-angle glaucoma (damage to the optic nerve caused by increased intraocular pressure) or in patients with elevated intraocular pressure (ocular hypertension).

2. What you need to know before using LATANOPROST PENSA PHARMA

Do not use LATANOPROST PENSA PHARMA

• 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 LATANOPROST PENSA PHARMA.
LATANOPROST PENSA PHARMA can be used in adult women and men (including elderly patients). Use of LATANOPROST PENSA PHARMA is not recommended in patients under 18 years of age.
Use LATANOPROST PENSA PHARMA 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 experience eye pain, irritation, or inflammation, or blurred vision;
• if you suffer from dry eye;
• if you have severe or poorly controlled asthma;
• if you wear contact lenses. In this case, you may continue using LATANOPROST PENSA PHARMA, following the instructions provided in the section "How to use LATANOPROST PENSA PHARMA".
• if you have had or currently have a viral eye infection caused by the 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.

LATANOPROST PENSA PHARMA may cause a gradual change in eye colour, which may be permanent, due to increased brown pigment in the coloured part of the eye called the iris (see "Possible side effects").
Gradual changes in the eyelashes of the eye treated with LATANOPROST PENSA PHARMA and changes in the hair growth around the treated eye have been observed (see "Possible side effects").

Children and adolescents
LATANOPROST PENSA PHARMA is not recommended for children and adolescents under 18 years of age.

Other medicines and LATANOPROST PENSA PHARMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines (or eye drops).
The use of LATANOPROST PENSA PHARMA together with other eye drops containing active substances similar to latanoprost (prostaglandins, prostaglandin analogues, or prostaglandin derivatives) is not recommended.
If you use LATANOPROST PENSA PHARMA 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, 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 PENSA PHARMA during pregnancy.

Breastfeeding
Do not use LATANOPROST PENSA PHARMA while breastfeeding.

Driving and using machines
When using LATANOPROST PENSA PHARMA, you may experience temporary blurred vision (transient). If this occurs, do not drive or operate machinery until your vision is clear again.

LATANOPROST PENSA PHARMA contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your 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 transparent outermost layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use LATANOPROST PENSA PHARMA

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 LATANOPROST PENSA PHARMA once daily in the eye(s) to be treated.
The optimal effect is achieved when LATANOPROST PENSA PHARMA is administered in the evening.
Do not instill LATANOPROST PENSA PHARMA 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 with a finger on the inner corner of the affected eye. Wait one minute with your eyes closed, continuing to apply 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 15 minutes after instillation.
If you are using more than one locally acting eye medicine, administer them at least five minutes apart.

If you use more LATANOPROST PENSA PHARMA than you should
In case of accidental ingestion or overdose of LATANOPROST PENSA PHARMA, 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 temporary, but you should still contact your doctor for advice.

If you forget to use LATANOPROST PENSA PHARMA
Do not use a double dose to make up for the missed dose.
If you forget to use LATANOPROST PENSA PHARMA, continue using your usual dose at the regular time.

If you stop using LATANOPROST PENSA PHARMA
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 everyone experiences 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 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 even after years, although it usually appears within the first 8 months of treatment. The colour change may be permanent and may be more noticeable if you use LATANOPROST PENSA PHARMA in only one eye. No problems associated with eye colour changes have been reported. After stopping treatment with LATANOPROST PENSA PHARMA, no further change in eye colour has been observed;

• red eyes;

• eye irritation (burning sensation, gritty feeling, itching, stinging (pinprick sensation), or foreign body sensation in the eyes); if the irritation is severe enough to cause excessive tearing or leads you to discontinue the medicine, contact your doctor, pharmacist or nurse immediately (within one week). Therapy may need to be adjusted to ensure adequate treatment of your condition.

• gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, mostly observed in people of Japanese origin. These changes include increased length, thickness, darkening, and density of eyelashes or fine hair, and growth of eyelashes in an abnormal direction. Eyelash changes are reversible upon discontinuation of treatment.

Common side effects (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 side effects (may affect up to 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 edema);
• skin rash;
• chest pain (angina), increased awareness of heartbeat (palpitations);
• asthma, shortness of breath (dyspnea);
• chest pain;
• headache, dizziness;
• muscle pain (myalgia), joint pain (arthralgia);
• nausea;
• vomiting.

Rare side effects (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 eyes (periorbital edema), altered eyelash direction or abnormal eyelash growth, corneal surface scarring, fluid-filled area in the coloured part of the eye (iris cyst);
• skin reactions on the eyelids;
• darkening of the skin of the eyelids;
• worsening of asthma;
• intense skin itching;
• development of a viral eye infection caused by herpes simplex virus (HSV).

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;
• sunken appearance of the eye (enophthalmos).

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 effects, 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 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 PENSA PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 bottle, store at a temperature not exceeding 25°C and use the medicine 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 carton.
Do not dispose of medicines 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 LATANOPROST PENSA PHARMA 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 LATANOPROST PENSA PHARMA and contents of the pack
Carton pack containing 1 bottle of 2.5 ml - Eye drops, solution.
Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milan
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)
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