Fixapost

Leaflet accompanying the packaging: patient information

Fixapost, 50 micrograms/ml + 5 mg/ml, eye drops, solution

Latanoprost+ Timolol

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

• Keep this 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 tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fixapost and what is it used for

Fixapost contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines called beta-adrenergic blockers.
Latanoprost works by increasing the natural outflow of aqueous fluid from the eye into the bloodstream.
Timolol reduces the production of aqueous fluid in the eye.
Fixapost is used to reduce pressure in the eye, if you have glaucoma with open angle or increased intraocular pressure. Both of these conditions (states) are associated with increased pressure inside the eyeball and can affect vision. Your doctor will prescribe Fixapost to you if other medicines are not effective enough.
Fixapost is an eye drop solution without preservatives.

2. Important information before using Fixapost

Fixapost can be used by adults and the elderly, but it is not recommended for people under 18 years of age.

When not to use Fixapost:

Warnings and precautions

Before starting to use Fixapost, discuss with your doctor, pharmacist or nurse if any of the following apply to you now or in the past:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, choking), heart failure, low blood pressure,
• irregular heart rhythms, such as slow heartbeat,
• breathing problems, asthma, chronic obstructive pulmonary disease,
• diabetes, as timolol may mask the subjective and objective symptoms associated with low blood sugar levels,
• hyperthyroidism, as timolol may mask the subjective and objective symptoms of this condition,

Before surgery, tell your doctor that you are using Fixapost, as timolol may affect the action of certain medicines used during anesthesia.

Fixapost with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take, including eye drops and medicines available without a prescription.
Some medicines may affect the action of Fixapost, and Fixapost may affect the action of other medicines, including other eye drops used to treat glaucoma. Tell your doctor about using or planning to use medicines that lower blood pressure, heart medicines or anti-diabetic medicines.
In particular, discuss with your doctor or pharmacist if you are taking any of the following medicines:

• prostaglandins, analogues or derivatives of prostaglandins,
• beta-adrenergic blockers,
• adrenaline,
• medicines used to lower blood pressure, such as oral calcium channel blockers, guanethidine, anti-arrhythmic medicines, digitalis glycosides or parasympathomimetics,
• quinidine (a medicine used to treat heart conditions and some types of malaria),
• antidepressant medicines known as fluoxetine and paroxetine.

Fixapost with food and drink

Eating and drinking do not affect the time and method of using Fixapost.

Pregnancy, breastfeeding and fertility

Do not use Fixapost duringpregnancy or breastfeeding.
Fixapost may pass into breast milk.
In animal studies, it has been found that latanoprost and timolol do not affect fertility in women or men.
If you are pregnant, think you may be pregnant or plan to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

Using Fixapost may cause temporary vision disturbances. In this case, do not drive, use tools or operate machinery until the disturbances have resolved.
Fixapost contains macrogolglycerol hydroxystearate(derived from castor oil) which may cause skin reactions.

3. How to use Fixapost

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults (including the elderly) is one drop into the affected eye(s) once daily.
Do not use Fixapost more than once daily, as more frequent use may reduce the effectiveness of treatment.
Use Fixapost as instructed by your doctor for as long as your doctor tells you to.
Your doctor may recommend more frequent checks of your heart and circulatory system while using Fixapost.
This medicine is a preservative-free eye drop solution. Do not touch the tip of the bottle to the eye or its surroundings. This may lead to contamination with bacteria, which can cause eye infection leading to serious damage to the eye, even loss of vision.
To avoid possible contamination of the bottle, keep the tip away from contact with any surface.

Users of contact lenses

Remove contact lenses before using Fixapost. Wait 15 minutes after using the medicine before putting the lenses back in.

Method of administration

This medicine is for use in the eye only.
It is important to follow the instructions below when administering the medicine:

Before using the medicine for the first time: Check that the protective cap is intact. Then, screw off the protective cap to open the bottle. Wash your hands thoroughly and remove the cap from the tip of the bottle. Press the bottle with the dropper down several times to activate the pumping mechanism until the first drop appears. This procedure only applies to the first use of the medicine and is not necessary for subsequent administrations.

	1. Before each use, wash your hands thoroughly and remove the cap from the tip of the bottle. Avoid touching the tip of the bottle with your fingers.
	2. Place your thumb on the tab on top of the bottle and your index finger on the base of the bottle. Then, place your middle finger on the second tab at the base of the bottle. Hold the bottle upright with the base facing down.
	3. To administer a drop, tilt your head slightly backwards and hold the bottle with the dropper pointing downwards vertically over the eye. With the index finger of the other hand, gently pull the lower eyelid down. The space created is called the lower conjunctival sac. Avoid touching the tip of the bottle with your fingers or eyes. To release a drop into the lower conjunctival sac of the affected eye(s), squeeze the bottle briefly and firmly. Due to the automatic dosing, the drop is released precisely with each pump.
If a drop does not fall, gently shake the bottle to remove the drop remaining on the tip. In this case, repeat step 3.
	4. Close your eyes and press the inner corner of your eye near your nose with your finger for 2 minutes. This helps prevent the medicine from entering the entire body.
	5. Immediately after use, put the cap back on the tip of the bottle.

Using Fixapost with other eye drops

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

Using a higher dose of Fixapost than recommended

Using too many drops in the eye may cause mild eye irritation, tearing, and redness. These symptoms should resolve, but if they bother you, ask your doctor for advice.

Swallowing Fixapost drops

In case of accidental ingestion of Fixapost, contact your doctor for advice. Ingestion of a large amount of Fixapost drops may cause nausea, stomach pain, feeling of tiredness, redness of the face, dizziness, and sweating.

Missing a dose of Fixapost

Continue using the established dose at the usual time. Do not use 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 use of Fixapost

If you want to stop using Fixapost, consult your doctor.
If you have any further doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Fixapost can cause side effects, although not everybody gets them.
Usually, you can continue using the drops, unless the side effects are severe. If you are in doubt, consult your doctor or pharmacist. Do not stop using Fixapost without consulting your doctor.
The following are known side effects associated with the use of Fixapost. The most important possible side effect is a gradual, permanent change in eye color. There is also a possibility of serious changes in heart function. If you experience changes in heart rhythm or heart function, you should consult your doctor and inform them that you are using Fixapost.
The following side effects have been observed during the use of Fixapost:

Very common (may affect more than 1 in 10 people):

• Gradual change in eye color due to an increase in the amount of 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, gray-brown, yellow-brown or green-brown) than in patients with uniform eye color (blue, gray, green or brown). The change in eye color may take years. This change may be permanent and may be more noticeable if Fixapost is administered to only one eye. No discomfort has been observed to accompany the change in eye color. These changes do not worsen after stopping Fixapost.

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 1 in 100 people):

• Headache,
• Eye redness, eye infection (conjunctivitis), blurred vision, eye tearing, eyelid inflammation, irritation or damage to the surface of the eye,
• Skin rash or itching,
• Nausea, vomiting.

Other side effects

Like other eye medicines, Fixapost (latanoprost and timolol) is absorbed into the bloodstream.
The frequency of side effects after using eye drops is lower than when taking medicines orally or by injection.
Although the following additional side effects have not been observed with Fixapost, they may occur during treatment, as they have been reported with the substances contained in Fixapost (latanoprost and timolol). The following side effects include reactions observed during the treatment of eye diseases with beta-adrenergic blockers (e.g., timolol):

• Development of viral eye infection caused by the herpes simplex virus (HSV).
• General allergic reactions, including angioedema, which can occur in the face and limbs and can limit airway patency, making swallowing and breathing difficult,

hives or itchy rash, localized and generalized rash, itching, severe, life-threatening allergic reaction.

• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, decreased blood flow to the brain, worsening of myasthenia symptoms (muscle disorder), unusual sensations, such as tingling and numbness, headache.
• Swelling in the back of the eye (macular edema), fluid-filled cyst in the colored part of the eye (iris cyst), sensitivity to light (photophobia), sunken appearance of the eyes (deepening of the eyelid sulcus).
• Symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer under the retina, which can cause vision problems, reduced corneal sensitivity, dry eye, erosion (ulceration) of the cornea (damage to the front layer of the eyeball), drooping of the upper eyelid (which causes the eye to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in the appearance of eyelashes and fine hairs around the eye (increased number, length, thickness, and darkening), changes in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (uveitis), scarring of the surface of the eye.
• Ringing or buzzing in the ears (tinnitus).
• Angina, worsening of angina pectoris in patients with heart disease.
• Slow heart rate, chest pain, palpitations (feeling of heartbeat), swelling (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of irregular heartbeat, heart attack, heart failure.
• Low blood pressure, poor circulation, which can cause numbness and paleness of the fingers and toes, cold hands and feet.
• Shallow breathing (shortness of breath), narrowing of the airways in the lungs (mainly in patients with pre-existing lung disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, stomach pain, vomiting.
• Hair loss, skin rash with a white-silvery appearance (psoriasis-like rash or worsening of psoriasis, skin rash).
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.
• Sexual function disorders, decreased libido.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 Fixapost

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Before first opening the bottle: no special precautions for storage are necessary.
After first opening the bottle: Fixapost can be used for 4 weeks in a 2.5 ml bottle and for 3 months in a 6 ml bottle, without special precautions for storage.
Write the date of first opening on the carton.
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 Fixapost contains

The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other ingredients are macrogolglycerol hydroxystearate, sorbitol, macrogol 4000, carbomer, disodium edetate, sodium hydroxide (to adjust pH), water.

What Fixapost looks like and contents of the pack

Fixapost is a light yellow, opalescent solution without preservatives, practically free from visible particles.
Fixapost is available in the following pack sizes:

• bottle of 2.5 ml (at least 80 drops without preservatives) with a dropper, for 4 weeks of treatment, in an Easygrip system, in a cardboard box.
• bottle of 6 ml (at least 190 drops without preservatives) with a dropper, for 3 months of treatment, in an Easygrip system, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
DELPHARM TOURS
Rue Paul Langevin
37170 Chambray-lès-Tours
France
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

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

Austria, Germany …………………….. Fixapost 50 Mikrogramm/ml + 5 mg/ml Augentropfen, Lösung
Belgium, France ……………………….. Fixaprost 50 microgrammes/ml + 5 mg/ml, collyre en solution
Bulgaria, Cyprus, Greece, Netherlands, Luxembourg …………………………………………. FIXAPROST
Croatia ……………………………… Fixalpost 50 mikrograma/ml + 5 mg/ml kapi za oko, otopina
Czech Republic …………………………………………………………………………………………. Fixapost
Denmark, Finland, Iceland, Norway, Sweden ……………………………………………….. Fixopost
Estonia ……………………………………………………………………………………... FIXOPOST
Spain …………………………... FIXAPROST 50 microgramos/ml + 5 mg/ml, colirio en solución
Lithuania …………………………………………... Fixopost 50 mikrogramų/5 mg/ml akių lašai (tirpalas)
Latvia …………………………………………. Fixopost 50 mikrogrami/5 mg/ml acu pilieni, šķīdums
Poland, Slovakia, Italy …………………………………………………………………. FIXAPOST
Portugal ……………………………………………………………………………… Monoprost Duo
Romania …………………………. Fixanpost 50 micrograme/ml + 5 mg/ml Picǎturi oftalmice, soluţie
Slovenia ……………………….. Fixalpost 50 mikrogramov/ml + 5 mg/ml, kapljice za oko, raztopina

Date of last revision of the leaflet: 18-03-2022

Detailed information on this medicine is available on the website www.urpl.gov.pl