FIXAPROST 50 micrograms/ml + 5 mg/ml EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Leaflet:information for the patient

Fixaprost 50 micrograms/ml + 5 mg/ml eye drops solution in single-dose container

latanoprost / timolol

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

5 Storage of Fixaprost

1. Container contents and additional 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 medications known as prostaglandin analogs. Timolol belongs to a group of medications called beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the inside of the eye into the bloodstream. Timolol works by reducing the production of fluid in the eye.

Fixaprost is used to reduce eye pressure in cases where you suffer from diseases known as open-angle glaucoma or ocular hypertension. Both diseases are related to an increase in pressure inside the eye, which can affect vision. Your doctor will normally prescribe Fixaprost when other medications have not worked adequately.

2. What you need to know before starting to use Fixaprost

Fixaprost can be used in adults (including elderly patients) but 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 components of this medication (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions

Consult 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 suffocation), heart failure, low blood pressure.
• Abnormal heart rhythms 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.
• Overactivity of the thyroid gland, as timolol may mask signs and symptoms.
• If you are going to undergo 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 included in section 3 for contact lens users.
• 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 suffering from a viral eye infection 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 medications used during anesthesia.

Using Fixaprost with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including eye drops and medications obtained without a prescription.

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

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

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

Using Fixaprost with food and drinks

Usual meals, foods, and drinks do not affect when or how you should use Fixaprost.

Pregnancy, breastfeeding, and fertility

Do not use Fixaprostif you are pregnant or breastfeeding.

Fixaprost may pass into breast milk.

In animal studies, neither latanoprost nor timolol has been found to have any effect on male or female fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and using machines

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

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

Use in athletes

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

3. How to use Fixaprost

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, 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 indicated until they tell you to stop.

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

Contact lens users

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

Instructions for use

This medication must be administered in the eye.

Follow these instructions to use the eye drops:

1. Open the pouch containing 5 single-dose containers. Note the date of first opening on the pouch.
2. Separate a single-dose container from the strip.

1. Turn the tip of the single-dose container as shown. Do not touch the tip after opening the container.

1. Use your finger to gently separate the lower eyelid of the affected eye.
2. Place the tip of the single-dose container close to the eye, without touching it.
3. Gently press the single-dose container so that one drop falls into the eye, and then remove your finger from the lower eyelid.

1. Press the tip of the affected eye, near the nose, with your finger. Apply pressure for 2 minutes, keeping your eye closed.

1. Repeat the operation in the other eye, if your doctor has indicated it. Each single-dose container contains enough for both eyes.

1. Discard the single-dose container after use. Do not store it for later use. Since the sterility of the single-dose container cannot be guaranteed after opening, a new container must be opened before each use.

1. Place the unused single-dose containers inside the opened pouch. Place the opened pouch inside the box. Unused containers can be used for 1 month after opening the pouch.

If you use Fixaprost with other eye drops

Wait at least 5 minutes between applying Fixaprost and administering 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 mild 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 medication 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 doubts, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You can continue to use the eye drops as usual, unless the side effects are severe. If you are concerned, consult 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 how 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 appear 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, pinching, 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.

Other side effects

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

Although not seen with Fixaprost, the following side effects have been observed with some of the components of Fixaprost (latanoprost and timolol) and may therefore occur with the use of Fixaprost. The side effects listed include reactions observed in 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, urticaria or rash with itching, localized or generalized rash, itching, sudden, severe, and potentially life-threatening allergic reaction.

• Low blood sugar levels.

• Dizziness.

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

• Fainting, stroke, insufficient blood supply to the brain, worsening of myasthenia gravis (muscle disorder), unusual sensation like 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 (greater 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, which 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 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), scarring on the eye surface.

• Ringing/buzzing in the ears (tinnitus).

• Angina, worsening of angina in patients who already had heart disease.

• Slow 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.

• Pain in the joints, muscle pain not caused by exercise, muscle weakness, fatigue.

• Sexual dysfunction, decreased libido.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 shown on the box, pouch, and single-dose containers. The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for storage.

After first opening the pouch:use the single-dose containers within 1 month.

Write the date of first opening of the pouch.

After first opening the single-dose container:use immediately and discard the single-dose container after use.

Store unused single-dose containers inside the opened pouch to protect them from light.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Packaging Content 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 (for pH adjustment), water for injectable preparations.

Appearance of the Product and Packaging Content

This medication is presented as an eye drop solution in single-dose containers.

The solution is slightly yellow and is an opalescent solution without preservatives, practically particle-free, presented inside a packet with 5 units, each single-dose container contains 0.2 ml of eye drop solution.

The boxes contain 30 (6 x 5) or 90 (18 x 5) single-dose containers.

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

EXCELVISION

27, rue de la Lombardière

07100 Annonay

FRANCE

or

Laboratoires THEA

12, rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

FRANCE

Further information about this medication can be obtained 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 under the following names:

Austria, Slovakia, France, Italy, Ireland, Poland, United Kingdom, Czech Republic Fixapost

Germany, Belgium, Bulgaria, Cyprus, Spain, Greece, Netherlands, Luxembourg, Portugal Fixaprost

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

Croatia, Slovenia Fixalpost

Romania Fixanpost

Portugal Monoprost Duo

Date of the last revision of this leaflet: March 2023

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