FIXAPROST 50 micrograms/ml + 5 mg/ml EYE DROPS SOLUTION

Introduction

PACKAGE LEAFLET

Package Leaflet:information for the patient

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

latanoprost / timolol

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fixaprost and what is it used for
2. What you need to know before you use Fixaprost
3. How to use Fixaprost
4. Possible side effects

5 Storage of Fixaprost

1. Contents of the pack and other information

1. What is Fixaprost and what is it used for

Fixaprost 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-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by reducing the production of fluid in the eye.

Fixaprost is used to reduce eye pressure in patients with diseases such as open-angle glaucoma or ocular hypertension. Both of these diseases are related to an increase in pressure within the eye, which can affect vision. Your doctor will usually prescribe Fixaprost when other medicines have not worked adequately.

Fixaprost is a preservative-free eye drop solution.

2. What you need to know before you use Fixaprost

Fixaprost can be used in adult men and women, but it is not recommended for use in children under 18 years of age.

Do not use Fixaprost:

• If you are allergic (hypersensitive) to latanoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or long-term coughing).
• If you have severe heart problems or heart rate disorders.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Fixaprost if you have or have had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or wheezing), heart failure, low blood pressure.
• Heart rate disorders such as slow heart rate.
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Diseases characterized by poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask signs and symptoms of low blood sugar levels.
• Overactive thyroid gland, as timolol may mask signs and symptoms.
• If you are going to have eye surgery (including cataract surgery) or have had any type of eye surgery.
• If you have eye problems (such as pain, irritation, or inflammation in the eye or blurred vision).
• If you have dry eye.
• If you use contact lenses. You can continue to use Fixaprost, but you must follow the instructions for contact lens users included in section 3.
• If you have angina (in particular, a type known as Prinzmetal's angina).
• If you have severe allergic reactions that usually require hospital treatment.
• If you have had or are having a viral infection in the eye caused by the herpes simplex virus (HSV).

Tell your doctor that you are using Fixaprost before undergoing surgery, as timolol may affect the effects of some medicines used during anesthesia.

Using Fixaprost with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including eye drops and medicines obtained without a prescription.

Fixaprost may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, or diabetes medicines.

In particular, talk to your doctor or pharmacist if you are taking any of the following types of medicines:

• Prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
• Beta-blockers.
• Epinephrine.
• Medicines used to treat high blood pressure, such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics.
• Quinidine (used to treat heart diseases and certain types of malaria).
• Antidepressants such as fluoxetine and paroxetine.

Using Fixaprost with food and drink

Normal meals, food, and drinks do not affect when or how you should use Fixaprost.

Pregnancy, breast-feeding, and fertility

Do not use Fixaprostif you are pregnant or breast-feeding.

Fixaprost may pass into breast milk.

In animal studies, neither latanoprost nor timolol has been found to affect male or female fertility.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

When using Fixaprost, you may experience blurred vision for a short period. If this happens, do not drive or use tools or machines until your vision is clear again.

Use in athletes

This medicine contains timolol, which may produce a positive result in doping tests.

Fixaprost contains macrogolglyceride hydroxystearate(derived from castor oil) which may cause skin reactions.

3. How to use Fixaprost

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose for adults (including elderly patients) is one drop in the affected eye(s) once a day.

Do not use Fixaprost more than once a day, as the effectiveness of the treatment may decrease if it is administered more frequently.

Use Fixaprost as your doctor has told you until they tell you to stop.

Your doctor may want to perform additional heart and circulatory tests if you are using Fixaprost.

This medicine is a preservative-free eye drop solution. Do not let the tip of the bottle touch the eyes or the surrounding areas. It may become contaminated with bacteria that can cause eye infections and lead to serious damage to the eyes, including vision loss. To avoid contaminating the bottle, avoid letting the tip of the bottle come into contact with any surface.

Users of contact lenses

If you use contact lenses, you should remove them before using Fixaprost. After applying Fixaprost, wait 15 minutes before putting your contact lenses back in.

Instructions for use

This medicine is intended for administration in the eye.

It is important to follow the following instructions when using this product:

If you use Fixaprost with other eye drops

Wait at least 5 minutes between the application of Fixaprost and the administration of other eye drops.

If you use more Fixaprost than you should

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye, and your eyes may also become red and tearful. This situation should disappear, but if you are concerned, contact your doctor.

If you swallow Fixaprost

In case of accidental ingestion of Fixaprost, contact your doctor. If you swallow a large amount of Fixaprost, you may feel unwell, have stomach pain, feel tired, hot, dizzy, and start sweating.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Fixaprost

Continue with the administration of the next dose as usual. Do not use a double dose to make up for the forgotten dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Fixaprost

Use Fixaprost following the instructions of your doctor until your doctor tells you to stop. If you want to stop using Fixaprost, you must consult your doctor.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

You can continue to use the eye drops as usual, unless the side effects are serious. If you are concerned, talk to your doctor or pharmacist. Do not stop using Fixaprost without consulting your doctor.

The following side effects are known with the use of Fixaprost. The most important side effect is the possibility of a gradual and permanent change in eye color. It is also possible that Fixaprost may cause serious changes in the way the heart works. If you notice any change in heart rhythm or heart function, you should consult a doctor and tell them that you have been using Fixaprost.

The following side effects may occur with Fixaprost:

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 known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown, or green-brown), it is more likely that you will experience this change than if your eyes are a single color (blue, gray, green, or brown). The change in eye color may take years to develop. The change in eye color may be permanent and may be more noticeable if you use Fixaprost in only one eye. The change in eye color does not seem to be associated with the development of any problems. The change in eye color does not progress once treatment with Fixaprost has been stopped.

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

• Eye irritation (feeling of stinging, feeling of grit in the eye, itching, pricking, and feeling of a foreign body in the eye) and eye pain.

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

• Headache.
• Redness of the eyes, eye infection (conjunctivitis), blurred vision, tearing, eyelid inflammation, irritation or erosion of the eye surface.
• Rash or itching of the skin (pruritus).
• Nausea, vomiting.

Otheradverse effects

Like other eye medications, Fixaprost (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse effects after using eye drops is lower than when medications are taken orally or injected.

Although not seen with Fixaprost, the following adverse effects have been observed with some of the components of Fixaprost (latanoprost and timolol) and therefore, could occur with the use of Fixaprost. The indicated adverse effects include reactions observed within the group of beta-blockers (e.g., timolol) when used to treat eye conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).

• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airway causing difficulty swallowing or breathing, hives or itchy rash, localized or generalized rash, itching, sudden and severe allergic reaction.

• Low blood sugar levels.

• Dizziness.

• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.

• Fainting, stroke, insufficient blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscular disorder), unusual sensation like muscle cramps and headache.

• Swelling of the back of the eye (macular edema), fluid-filled cyst in the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (increased depth of the eyelid sulcus)

• Signs and 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 after filtration surgery that can cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the outer layer of the eyeball), drooping of the upper eyelid (causing the eye to be half-closed), double vision.

• Darkening of the skin around the eyes, changes in the eyelashes and fine hair 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 (iritis/uveitis), scars on the eye surface.

• Ringing/buzzing in the ears (tinnitus).

• Angina, worsening of angina in patients who already had heart disease. Low heart rate, chest pain, palpitations (feeling the heartbeat), edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.

• Low blood pressure, poor blood circulation that causes fingers and toes to become numb and pale, cold hands and feet.

• Difficulty breathing, constriction of airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.

• Altered taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.

• Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.

• Sexual dysfunction, decreased libido.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Surveillance System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fixaprost

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and bottle. The expiration date is the last day of the month indicated.

Before the first opening of the bottle: this medication does not require special storage conditions.

After the first opening of the bottle: Fixaprost can be used for up to 4 weeks for the 2.5 ml bottle and up to 3 months for the 6 ml bottle, without special storage conditions.

Write the date of first opening on the box.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Fixaprost

The active ingredients are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.

The other components are: macrogolglyceride hydroxystearate, sorbitol, macrogol, carbomer, disodium edetate, sodium hydroxide (to adjust pH), water.

Appearance of the product and package contents

Fixaprost is a slightly yellow and opalescent solution, practically free of particles.

Fixaprost is available in the following package sizes:

• 2.5 ml multidose bottle (with a minimum of 80 drops without preservatives) for 4 weeks of treatment, which includes a pump equipped with an Easygrip device with ergonomic supports.
• 6 ml multidose bottle (with a minimum of 190 drops without preservatives) for 3 months of treatment, which includes a pump equipped with an Easygrip device with ergonomic supports.

Only some package sizes may be marketed.

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 Les Tours

France

or

Laboratoires THEA

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

LABORATORIOS THEA, S.A.

C/ Enric Granados nº 86-88, 2ª planta

08008 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany…………………………………Fixaprost 50 Mikrogramm/ml + 5 mg/ml eye drops, solution

Austria…………………………………... Fixapost 50 Mikrogramm/ml + 5 mg/ml eye drops, solution

Belgium…………………………………… Fixaprost 50 microgrammes/ml + 5 mg/ml eye drops, solution

Bulgaria, Cyprus, Greece, Netherlands, Luxembourg Fixaprost

Croatia………………………Fixalpost 50 mikrograma/ml + 5 mg/ml eye drops, solution

Slovenia………………………………Fixalpost 50 mikrogramov/ml + 5 mg/ml, eye drops, solution

Slovakia, Poland, Czech Republic Fixapost

Spain……………………………………. Fixaprost 50 microgramos/ml + 5 mg/ml eye drops, solution

Denmark, Estonia, Finland, Iceland, Norway, Sweden Fixopost

France………………………FIXAPOST 50 microgrammes/ml + 5 mg/ml, eye drops, solution

Latvia…………………………… Fixopost 50 mikrogrami/5 mg/ml eye drops, solution

Lithuania……………………… Fixopost 50 mikrogramu/5 mg/ml eye drops (solution).

Portugal………………………………………………………………………Monoprost Duo

Romania………………… Fixanpost 50 micrograme/ml + 5 mg/ml eye drops, solution

Date of the last revision of thisprospectus: March 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.