Akistan

Package Leaflet: Information for the User

Akistan, 50 micrograms/ml, eye drops, solution

Latanoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Akistan and what is it used for

Akistan contains the active substance latanoprost. Latanoprost belongs to a group of medicines known as prostaglandin analogues. The medicine works by increasing the natural outflow of fluid from the eye into the bloodstream.
Akistan is used to treat open-angle glaucoma and increased intraocular pressure.
Both conditions are associated with increased pressure in the eye and can affect vision.
Akistan is also used to treat increased intraocular pressure and glaucoma in children of all ages.

2. Important information before using Akistan

Akistan can be used in adults, including the elderly, and in children from birth to 18 years. The use of Akistan in premature infants (born before 36 weeks of gestation) has not been studied.

When not to use Akistan:

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

Warnings and precautions

Before starting treatment with Akistan, discuss with your doctor or pharmacist if you have:

• no lens, a broken posterior lens capsule during artificial lens implantation, an artificial lens implanted in the anterior chamber of the eye, or if you have risk factors (e.g., retinal damage or retinal vein occlusion) for the development of macular edema (fluid accumulation in the posterior part of the eye).
• if you are going to have or have had eye surgery.
• if you have severe asthma or unstable asthma.
• if you have dry eyes.
• if you have eye problems, such as eye pain, eye irritation, eye inflammation, blurred vision, or if you wear contact lenses (you can still use Akistan, following the instructions in section 3 of the leaflet, intended for contact lens wearers).
• if you have had or still have a viral eye infection caused by the herpes simplex virus (HSV). In this case, you can still use Akistan, following the instructions in section 3 of the leaflet, intended for contact lens wearers.

Akistan and other medicines

Akistan may interact with other medicines. Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

Akistan should not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor.
Akistan should not be used during breastfeeding.

Driving and using machines

After using Akistan, temporary blurred vision may occur. In this case, do not driveor operate tools or machines until your vision is clear.

Akistan contains benzalkonium chloride

Akistan contains a preservative - benzalkonium chloride. This substance may cause changes on the surface of the eye and eye irritation. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Therefore, avoid contact between the medicine and soft contact lenses.
Remove contact lenses before using Akistan and wait at least 15 minutes before putting them back. More information for contact lens wearers can be found in section 3.

3. How to use Akistan

Always use this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
The usual dose for adults (including the elderly) and children is one drop into the affected eye(s) once a day.
The best time to use the drops is in the evening.
Instructions for use
When using Akistan, follow the instructions. Before using the eye drops, wash your hands.
When using Akistan, follow these steps:

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Remove the cap.
• 3. Gently pull down the lower eyelid of the affected eye.
• 4. Hold the upper part of the dropper close to the eye, making sure it does not touch the eye.
• 5. Gently squeeze the dropper to release one drop of medicine into the eye. Then release the lower eyelid.
• 6. Press the inner corner of the eye towards the nose. Keep the eye closed for 1 minute.
• 7. To use the drops in the other eye, if prescribed by your doctor, repeat all the steps.

Close the bottle tightly after use. Do not overtighten, as this may damage the cap or bottle. The dropper tip is designed to measure the drops, so do not enlarge the hole at the tip. A small amount of Akistan has been added intentionally to ensure the use of the prescribed amount. Therefore, do not try to squeeze out excess medicine from the bottle.

For contact lens wearers

If you wear contact lenses, remove them before using Akistan. After using Akistan, wait at least 15 minutes before putting your contact lenses back in.

Using Akistan with other eye drops

Wait at least 5 minutes between using Akistan and other eye drops.

Using more Akistan than prescribed

Using more drops than prescribed may cause mild eye irritation, tearing, and redness. This should pass. If you have any doubts, consult your doctor.
If you accidentally swallow Akistan, contact your doctor as soon as possible.

Missing a dose of Akistan

Take the dose at the usual time. Do not take a double dose to make up for a missed dose. If you have any further doubts about using this medicine, ask your doctor or pharmacist.

Stopping treatment with Akistan

If you want to stop using Akistan, consult your doctor.

4. Possible side effects

Like all medicines, Akistan can cause side effects, although not everybody gets them.

The following have been reported during treatment with Akistan:

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

• gradual change in eye color due to increased brown pigment in the colored part of the eye called the iris. This effect is more frequently observed in patients with mixed-colored irises (blue-brown, grey-brown, yellow-brown, or green-brown) than in patients with uniform eye color (blue, grey, green, or brown). The change in eye color may take years to develop, but it usually occurs within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Akistan is used in one eye only. No accompanying symptoms have been observed with the change in iris color. These changes revert after stopping treatment.

in patients with mixed-colored irises (blue-brown, grey-brown, yellow-brown, or green-brown), than in patients with uniform eye color (blue, grey, green, or brown). The change in eye color may take years to develop, but it usually occurs within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Akistan is used in one eye only. No accompanying symptoms have been observed with the change in iris color. These changes revert after stopping treatment.

• eye redness,
• eye irritation (feeling of burning, grittiness, itching, stinging, and foreign body sensation in the eye),
• gradual changes in the appearance of eyelashes and vellus hairs of the treated eye, such as darkening, lengthening, thickening, and increased number.

Common (affects 1 to 10 people in 100):

• eye surface irritation and disruption, eyelid inflammation, and eye pain.

Uncommon (affects 1 to 10 people in 1,000):

• eyelid swelling, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, conjunctivitis,
• chest pain,
• skin rash.

Rare (affects 1 to 10 people in 10,000):

inflammation of the iris, the colored part of the eye, or inflammation of the uvea, macular edema, symptomatic macular edema, feeling of something in the eye or damage to the eye surface, periorbital edema, changes in the direction of eyelash growth, appearance of additional rows of eyelashes, skin reactions on the eyelids; darkening of the eyelid skin,
asthma, worsening of asthma, shortness of breath (dyspnea),
skin itching (pruritus).

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

unstable angina (sudden chest pain). Chest pain.

Frequency not known (cannot be estimated from the available data):

• herpes simplex keratitis (inflammation of the cornea caused by the herpes simplex virus),
• accumulation of fluid in the colored part of the eye (iris cyst),
• sunken appearance of the eye (deepening of the orbit),
• scarring of the eye surface,
• increased sensitivity to light,
• headache,
• dizziness,
• palpitations,
• muscle pain,
• joint pain.

In children, itching and nasal discharge, as well as fever, occur more frequently than in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides)
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
email: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akistan

Keep this medicine out of the sight and reach of children.
Do not use Akistan after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of that month.
Before first opening: store in a refrigerator (at a temperature between 2°C and 8°C).
Store the bottle in the outer carton to protect from light.
After first opening: do not store above 25°C. Do not use Akistan after 28 days of first opening. After this time, the medicine should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Akistan contains

• The active substance is latanoprost at a concentration of 50 micrograms/ml. 1 ml of solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms of latanoprost.
• The other excipients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium hydroxide, and/or phosphoric acid (for pH adjustment), purified water.

What Akistan looks like and contents of the pack

Akistan is a clear, colorless, aqueous solution for eye drops. The medicine is available in a sterile bottle with a dropper and a plastic cap. Each bottle contains 2.5 ml of eye drop solution.
Akistan is available in packs of 1 x 2.5 ml, 3 x 2.5 ml, and 6 x 2.5 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: