Akistan duo

Patient Information Leaflet

Akistan DUO, 50 micrograms/ml + 5 mg/ml, eye drops, solution
Latanoprost + Timolol
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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

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

1. What Akistan DUO is and what it is used for

Akistan DUO contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines called prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers. Latanoprost increases the outflow of fluid from the eyeball into the bloodstream. Timolol reduces the amount of fluid produced in the eye.

Akistan DUO is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Both conditions are associated with elevated intraocular pressure and may affect vision. Your doctor will usually recommend Akistan DUO if other treatments have not been sufficiently effective.

2. Important information before using Akistan DUO

Akistan DUO can be used in adult men and women (including elderly patients), but
is not recommended for use in individuals under 18 years of age.
When not to use Akistan DUO

• if the patient is allergic (hypersensitive) to the active substances in Akistan DUO (latanoprost or timolol), beta-adrenergic blocking agents, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had breathing problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing and/or long-term cough),
• if the patient has severe heart disease or heart rhythm disorders.

Warnings and precautions
Before starting treatment with Akistan DUO, inform your doctor or pharmacist if
the patient has or has had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure,
• disturbances in heart rate, such as slow heartbeat,
• difficulty breathing, asthma or chronic obstructive pulmonary disease,
• conditions related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, because timolol may mask symptoms of low blood sugar,
• hyperthyroidism, because timolol may mask signs and symptoms,
• planned eye surgery (including cataract surgery), or if such surgery has previously occurred,
• if the patient has eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision),
• if the patient has dry eyes,
• if the patient wears contact lenses. Akistan DUO may still be used, but the instructions regarding contact lens use described in section 3 must be followed,
• if the patient has angina (especially the type known as Prinzmetal's angina),
• if the patient has severe allergic reactions that usually require hospital treatment,
• if the patient has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Before surgery, inform the doctor about the use of Akistan DUO, as timolol may
affect the action of certain drugs used during anaesthesia.
Akistan DUO and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including eye drops and medicines available without a prescription.
Akistan DUO may interact with or be affected by other medicines, including eye drops used in the treatment of glaucoma. Inform the doctor about the use of, or intention to use, medicines that lower blood pressure, heart medications, and medicines used in the treatment of
diabetes.
In particular, inform the doctor or pharmacist if the patient is using a medicine belonging
to any of the following groups:

• prostaglandins, analogues or derivatives of prostaglandins,
• beta-adrenergic blocking agents,
• epinephrine,
• blood pressure-lowering medicines such as oral calcium channel blockers, guanethidine, antiarrhythmics, cardiac glycosides or parasympathomimetics,
• quinidine (used in the treatment of heart disorders and certain types of malaria),
• antidepressants such as fluoxetine, paroxetine.

Using Akistan DUO with food and drink
Eating regular meals, food or drinks does not affect when or how Akistan DUO should be used.
Pregnancy, breastfeeding and fertility
Pregnancy
Akistan DUO should not be used during pregnancy 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 child, she should consult a doctor before using this medicine.
Breastfeeding
Akistan DUO should not be used during breastfeeding. Akistan DUO may pass into human milk. Before using any medicine during breastfeeding, consult a doctor.
Fertility
Animal studies have shown no effect of latanoprost and timolol on fertility in males or females.
Driving and operating machinery
Blurred vision may occur temporarily after using Akistan DUO. If the patient experiences such symptoms, driving and operating machinery should be avoided until they resolve.
Akistan DUO contains benzalkonium chloride and phosphate buffer
The medicine contains 0.2 mg of benzalkonium chloride per millilitre, equivalent to 0.006 mg per drop.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter the colour of contact lenses. Contact lenses should be removed before using this medicine and reinserted after 15 minutes. Benzalkonium chloride may also cause eye irritation, particularly if the patient suffers from dry eyes or corneal disorders (the transparent front layer of the eye). If abnormal eye sensations, stinging or eye pain occur after using this medicine, consult a doctor.
Instructions regarding contact lens use are provided in section 3.
This medicine contains 6.33 mg of phosphates per millilitre, equivalent to 0.2 mg per drop. In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use Akistan DUO

This medicine should always be used exactly as directed by the physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adult patients (including elderly individuals) is 1 drop into the affected eye
(eyes) once daily.
Akistan DUO should not be used more frequently than once daily, as this may reduce the effectiveness
of treatment.
Akistan DUO should be used according to the physician's instructions, who will decide when to discontinue
treatment.
If the patient is using Akistan DUO, the doctor may recommend additional examinations of the heart and
circulatory system.
Use of contact lenses
If the patient wears contact lenses, they should be removed before applying Akistan DUO. After
applying Akistan DUO, wait 15 minutes before reinserting contact lenses.
Instructions for use

1. Wash your hands and sit or stand comfortably. 2. Unscrew the cap. Keep the cap for later use.	Fig. 1
3. Gently pull down the lower eyelid of the affected eye with your finger. 4. Place the tip of the bottle close to the eye, but make sure it does not touch the eye. 5. Gently squeeze the bottle so that one drop falls into the eye, then release the lower eyelid.	Fig. 2
6. After applying Akistan DUO, press with your finger on the inner corner of the eye near the nose (Fig. 3) for two minutes. This helps prevent latanoprost and timolol from entering the bloodstream.	Fig. 3

7. If advised by the doctor, repeat the procedure in the other eye.
8. After use, close the cap tightly.

Using Akistan DUO with other eye drops
Wait at least 5 minutes between using Akistan DUO and any other eye drops.

Using more than the recommended dose of Akistan DUO
If more drops than recommended are used, eye irritation, tearing, and redness of the eye may occur. These symptoms should resolve on their own, but if the patient is concerned, they should contact their doctor for advice.

Accidental ingestion of Akistan DUO
In case of accidental ingestion of Akistan DUO, contact a doctor. If a large amount of Akistan DUO eye drops is swallowed, symptoms such as malaise, abdominal pain, feeling of fatigue, facial flushing, dizziness, and sweating may occur.

Missing a dose of Akistan DUO
If a dose is missed, take the next dose at the scheduled time. Do not use a double dose to make up for the missed dose. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Usually, eye drops can be used until adverse effects become serious. If in doubt, consult a doctor or pharmacist.
Do not stop treatment with Akistan DUO without consulting a doctor.
Below are the known adverse effects occurring after use of Akistan DUO.
The most important adverse effect is the possibility of a gradual, permanent change in eye colour. Akistan DUO may also cause serious disturbances in heart function. Inform the doctor if the patient observes any changes related to normal heart action or heart function, and inform them about the use of Akistan DUO.

Known adverse effects occurring after use of Akistan DUO:
Very common (may affect 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 called the iris. In patients whose iris colour is a mixture of colours (such as blue-brown, grey-brown, yellow-brown or green-brown), these changes are observed significantly more frequently than in people with uniformly coloured eyes (blue, grey, green or brown). Changes in eye colour may develop over several years. The change in eye colour may be permanent and significantly more noticeable if Akistan DUO is administered to only one eye. The change in eye colour appears to be harmless. After discontinuation of Akistan DUO, the change in eye colour does not progress.

Common (may affect up to 1 in 10 people):

• Eye irritation (including burning sensation, grittiness, itching, stinging or foreign body sensation in the eye) and eye pain.

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

• Headache
• Redness of the eye, eye infection (conjunctivitis), blurred vision, tearing, blepharitis, eye surface irritation or damage
• Skin rash or itching (pruritus)
• Nausea
• Vomiting

Frequency not known (frequency cannot be determined from available data):

• Hallucinations

Other adverse effects
Like other eye medicines, Akistan DUO (latanoprost and timolol) is absorbed into the bloodstream. The frequency of systemic adverse effects after administration of eye drops is lower than with orally or intravenously administered medicines.
Below are adverse effects which, although not observed during use of Akistan DUO, have occurred with the individual components of this medicine (latanoprost and timolol), and therefore may also occur after use of Akistan DUO. Among these adverse effects are also those observed during use of beta-blocking agents (e.g. timolol) in the treatment of eye diseases.

• Reactivation of viral eye infection caused by herpes simplex virus (HSV).
• General allergic reactions including subcutaneous swelling which may occur in the face and limbs and may obstruct airflow through the airways, causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, pruritus, severe acute life-threatening allergic reactions.
• Low blood sugar levels.
• Dizziness.
• Difficulty falling asleep (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood flow to the brain, worsening of symptoms of myasthenia (muscle weakness and pain in patients with this disease), tingling or numbness sensation, and headache.
• Swelling of the back of the eye (macular oedema), formation of fluid-filled cysts in the iris (iris cysts), light sensitivity (photophobia), changes in the eye socket and eyelids leading to deepening of the eyelid sulcus.
• Eye irritation symptoms (burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision, and retinal pigment epithelial detachment following filtration surgery, which may lead to visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the outer surface of the eyeball), drooping of the upper eyelid (causing eyes to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the coloured part of the eye (iritis/uveitis), scarring of the eye surface.
• Ringing or buzzing in the ears (tinnitus).
• Angina pectoris, worsening of angina pectoris in people with pre-existing heart disease.
• Slowing of heart rate, palpitations (awareness of heartbeat), oedema (fluid accumulation), disturbances in heart rhythm and rate, congestive heart failure (a condition characterised by shortness of breath and swelling of feet and legs due to fluid accumulation), arrhythmias, cardiac arrest, heart failure.
• Low blood pressure, poor circulation causing numbness and pallor of fingers and toes, cold hands and feet.
• Shallow breathing, narrowing of airways in the lungs (mainly in patients with pre-existing respiratory disease), breathing difficulties, cough, asthma, exacerbation of asthma.
• Taste disturbances, nausea, dyspepsia, diarrhoea, dry mouth sensation, abdominal pain, vomiting.
• Hair loss, rash with white-silvery lesions (psoriasiform) or worsening of psoriasis symptoms, skin rash.
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

Very rarely, in some patients with significantly damaged transparent front part of the eye (cornea), calcium deposits have led to the development of corneal opacities.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a 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.: + 48 22 49 21 301
Fax: + 48 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 Akistan DUO

Keep this medicine out of the sight and reach of children.
Do not use Akistan DUO after the expiry date stated on the outer packaging and on the bottle after EXP. The expiry date refers to the last day of the stated month.
Unopened bottles of Akistan DUO should be stored in a refrigerator (from 2°C to 8°C). Do not freeze.
After opening the bottle, it is not necessary to store the medicine in the refrigerator, but it should not be stored at temperatures above 25°C. After first opening, the medicine may be used for up to 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Akistan DUO contains
The active substances in this medicine are latanoprost at a concentration of 50 micrograms/ml and timolol (as timolol maleate) at a concentration of 5 mg/ml.
The other components are: sodium chloride, benzalkonium chloride 10% (w/w), disodium dihydrogen phosphate dihydrate, dodecahydrate disodium hydrogen phosphate, phosphoric acid 10% (w/v) and/or sodium hydroxide 10% (w/v) (to adjust pH to 5.5–6.5), purified water.

What Akistan DUO looks like and contents of the pack
Akistan DUO is a sterile, transparent, colourless solution.
Akistan DUO is available in packs containing 1, 3 or 6 bottles. Each bottle contains 2.5 ml of Akistan DUO solution. The approximate number of drops per bottle is 80 drops.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharmaselect International Beteiligungs GmbH
Ernst-Melchior-Gasse 20
1020 Vienna
Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Bulgaria, Czech Republic, Poland, Slovakia, Hungary: Akistan DUO
Belgium, Slovenia: AKISTANCOMB
Netherlands: BEKISTAN