Latanoprost horus pharma

Package leaflet: Information for the user

Latanoprost Horus Pharma, 50 micrograms/ml, eye drops, solution in
single-dose containers
Latanoprostum
Please read all of this leaflet carefully before using the medicine, because
it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, the doctor treating your child, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual or their child. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Latanoprost Horus Pharma is and what it is used for

Latanoprost Horus Pharma belongs to a group of medicines known as prostaglandin analogues.
Latanoprost Horus Pharma works by increasing the natural outflow of aqueous humour from the eye into the bloodstream.
Latanoprost Horus Pharma is used in the treatment of open-angle glaucoma and ocular hypertension. Both conditions are associated with elevated pressure inside the eye and may affect vision.
Latanoprost Horus Pharma may also be used in children of any age for the treatment of elevated intraocular pressure and glaucoma.

2. Important information before using Latanoprost Horus Pharma

Latanoprost Horus Pharma can be used in adult men and women (including elderly patients) and in children and adolescents from birth up to 18 years of age.
The use of Latanoprost Horus Pharma has not been studied in premature newborns (born before completion of week 36 of pregnancy).
When not to use Latanoprost Horus Pharma

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

Warnings and precautions
Before starting treatment with Latanoprost Horus Pharma, discuss this with the treating physician of the adult or child, pharmacist, or nurse:

• if the adult or child has undergone eye surgery (including cataract surgery), or if such surgery is planned,
• if the adult or child has eye problems (such as eye pain, irritation or eye inflammation, blurred vision),
• if the adult or child has dry eyes,
• if the adult or child has severe or uncontrolled asthma,
• if the adult or child wears contact lenses. Latanoprost Horus Pharma may still be used in such cases, but follow the instructions for contact lens wearers (see section 3),
• if the adult has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Latanoprost Horus Pharma and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used by the adult or child, as well as any medicines the patient plans to take. Latanoprost Horus Pharma may interact with other medicines; therefore, concomitant use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Latanoprost Horus Pharma should not be used during pregnancy or breastfeeding.
Driving and operating machinery
For a short time after using Latanoprost Horus Pharma, vision disturbances may occur. In such cases, do not drive or operate tools or machinery until vision returns to normal.

3. How to use Latanoprost Horus Pharma

This medicine should always be used exactly as prescribed by the doctor 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 into the affected eye(s) once daily, preferably in the evening.
The single-dose container should be used immediately after opening; any remaining product must be discarded.
Do not use Latanoprost Horus Pharma more often than once daily, as more frequent administration may reduce the effectiveness of treatment.
Latanoprost Horus Pharma should be used for as long as the treating doctor advises the adult or child to continue.

Contact lens wearers
If the adult or child wears contact lenses, they should be removed before applying Latanoprost Horus Pharma. Wait 15 minutes after using Latanoprost Horus Pharma before reinserting contact lenses.

Instructions for use:

1. Wash your hands and sit or stand in a comfortable position.
2. Unscrew the cap of the single-dose container.
3. Using a finger, gently pull down the lower eyelid of the affected eye.
4. Bring the tip of the container close to the eye, but do not touch the eye.
5. Gently squeeze the container so that one drop enters the eye, then release the lower eyelid.
6. Press on the inner corner of the affected eye near the nose. Hold for 1 minute, with the eye closed.
7. Repeat the procedure in the other eye, if instructed by the doctor.
8. Discard the single-dose container.

Use of Latanoprost Horus Pharma with other eye drops
Wait at least 5 minutes between applying Latanoprost Horus Pharma and any other eye drops.

Use of more than the recommended dose of Latanoprost Horus Pharma
If too many drops are used, mild eye irritation with tearing and redness may occur. These symptoms should resolve, but if the patient is concerned, they should contact the treating doctor for advice.
If Latanoprost Horus Pharma is accidentally swallowed by an adult or child, seek immediate medical advice from a doctor.

Missed dose of Latanoprost Horus Pharma
If a dose is missed, apply the next dose at the usual scheduled time. Do not use a double dose to make up for a missed dose. If in doubt, consult a doctor or pharmacist.

Stopping Latanoprost Horus Pharma
If the patient wishes to stop using this medicine, they should consult their doctor.
If there are any further questions about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

The following adverse reactions have been observed following the use of Latanoprost Horus Pharma:

Very common (may occur in 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 known as the iris. These changes may be more noticeable in patients with mixed-coloured eyes (blue-brown, grey-brown, yellow-brown or green-brown) than in patients with uniformly coloured eyes (blue, grey, green or brown). Any changes in eye colour may take several years to appear, although they are normally observed within 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if Latanoprost Horus Pharma is used in only one eye. The change in iris colour does not appear to be associated with any symptoms. After discontinuation of Latanoprost Horus Pharma, the change in eye colour does not progress.

• Redness of the eye.

• Eye irritation (sensation of burning, grittiness, itching, stinging or foreign body sensation in the eye). If eye irritation occurs and is so severe that it causes excessive tearing or a desire to discontinue treatment, medical advice should be sought immediately (within one week) from a doctor, pharmacist or nurse. Treatment may need to be reviewed to ensure appropriate management for the patient.

• Gradual changes in the appearance of eyelashes and vellus hair around the treated eye, particularly in individuals of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

Common (may occur in no more than 1 in 10 people):

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

Uncommon (may occur in no more 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 (may occur in no more than 1 in 1,000 people):

• Iritis, symptomatic swelling or scratches/damage to the eye surface, swelling around the eye (periorbital oedema), changes in the direction of eyelash growth or development of an additional row of eyelashes, scarring on the eye surface, formation of fluid-filled areas in the coloured part of the eye (iris cysts).
• Local skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Acute itching of the skin.
• Development of a viral eye infection caused by herpes simplex virus (HSV).

Very rare (may occur in no more than 1 in 10,000 people):

• Worsening of angina in patients with heart disease, chest pain, sensation of sunken eyes (deepening of the eyelid groove).

In very rare cases, some patients with significantly damaged transparent membrane covering the front part of the eyeball (cornea) have developed corneal clouding during treatment due to calcium deposits.

Adverse reactions occurring more frequently in children and adolescents than in adults include nasal inflammation (catarrh), nasal itching and fever.

Reporting of adverse reactions

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 492 1301
Fax: +48 22 492 1309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Latanoprost Horus Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after: EXP. The expiry date refers to the last day of the stated month.
• Store in a refrigerator (2°C - 8°C). After opening the sachet, store at a temperature not exceeding 25°C for no longer than 7 days.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Latanoprost Horus Pharma contains

• The active substance is latanoprost in a dose of 50 micrograms/mL.
• The other components of the medicine are: monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, water for injections.

What Latanoprost Horus Pharma looks like and contents of the pack
Latanoprost Horus Pharma is a clear, transparent, sterile eye drop solution in single-dose containers. Each single-dose container contains 0.2 mL of eye drops.
Pack sizes:
15, 30, 45, 60, 90, 120 single-dose containers of 0.2 mL.
A sachet contains 5 single-dose containers. The sachet is placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
HORUS PHARMA
22, Allée Camille Muffat
INEDI 5
06200 Nice
France

Manufacturer
GENETIC S.P.A
Contrada Canfora
84084 Fisciano (SA)
Italy

This medicinal product is authorised in the European Economic Area under the following names:
Netherlands Xalof 0.05 mg/mL eye drops, solution in single-dose container
Belgium Xalof 0.05 mg/mL eye drops, solution in single-dose container
France XIOP 50 micrograms/mL, eye drops, solution in single-dose container
Spain Xiop 50 micrograms/mL eye drops, solution in single-dose container
Luxembourg Xalof 0.05 mg/mL eye drops, solution in single-dose container
Poland Latanoprost Horus Pharma 50 micrograms/mL, eye drops, solution in single-dose containers