Fixaprost 50 microgramos/ml + 5 mg/ml colirio en solucion en envases unidosis

Prospecto:Information for the Patient

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

latanoprost / timolol

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist, or nurse.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.
• If you experience adverse effects,consult your doctor, pharmacist, or nurse,evenifthey are not listed in this prospect.See section 4.

1.What is Fixaprost and how is it used

2.What you need to knowbeforestarting touse Fixaprost

3.How to use Fixaprost

4.Possible adverse effects

5Storage of Fixaprost

6.Contents of the container and additional information

Fixaprost contains two active ingredients: 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 acts by increasing the natural drainage of fluid from the interior of the eye into the bloodstream. Timolol acts by reducing the formation of fluid in the eye.

Fixaprost is used to reduce eye pressure in cases of open-angle glaucoma or ocular hypertension. Both conditions are related to an increase in pressure within the eye, which can affect vision. Your doctor will typically prescribe Fixaprost when other medications have not worked adequately.

Fixaprost can be used in adults (including elderly patients) but it is not recommended for use in patients under 18 years of age.

Do not use Fixaprost:

• If you are allergic (hypersensitive) to latanoprost, timolol, beta-blockers or to any of the other components of this medication (listed in section 6).
• If you have or have had in the past 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 rhythm disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fixaprost, if you have or have had in the past:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or asphyxia), heart failure, low blood pressure.
• Alterations in heart rate such as slow heart rate.
• Respiratory 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.
• Hyperthyroidism, as timolol may mask signs and symptoms.
• If you are to undergo eye surgery (including cataract surgery) or have had any type of eye surgery.
• If you have eye problems (such as eye pain, irritation or inflammation in the eye or blurred vision).
• If you have dry eye.
• If you wear contact lenses. You may continue to use Fixaprost, but you must follow the instructions included in section 3 for contact lens users.
• If you have angina (particularly a type known as Prinzmetal's angina).
• If you have severe allergic reactions that usually require hospital treatment.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Inform your doctor that you are using Fixaprost before undergoing surgery, as timolol may modify the effects of some medications used during anesthesia.

Use of Fixaprost with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including eye drops and over-the-counter medications.

Fixaprost may affect or be affected by other medications you are using, including other eye drops for the treatment of glaucoma. Inform your doctor if you are using or intend to use medications to lower blood pressure, medications for the heart 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, guanetidine, antiarrhythmics, digitalis glycosides or cholinomimetics.
• Quinidine (used to treat heart diseases and certain types of malaria).
• Antidepressants such as fluoxetine and paroxetine.

Use of Fixaprost with food and beverages

Ordinary meals, foods and beverages have no effect on when or how to use Fixaprost.

Pregnancy,breastfeedingand fertility

Do not use Fixaprostif you are pregnant or breastfeeding.

Fixaprost may pass into breast milk.

In animal studies, latanoprost and timolol were found to have no effect on male or female fertility.

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

Driving and operating machinery

When using Fixaprost, blurred vision may occur for a short period of time. If this happens, do not drive or use tools or machines until your vision returns to normal again.

Fixaprost contains hydroxyestearate of macrogolglycerol(derived from ricin oil) that may cause skin reactions.

Use in athletes

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

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

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

Users of contact lenses

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

Instructions for use

This medication must be administered in the eye.

Follow these instructions to use the eye drops:

1. Wash your hands and sit or stand comfortably
2. Open the package containing 5 single-use vials. Note the date of first opening on the package.
3. Separate a single-use vial from the strip.

1. Turn the tip of the single-use vial as shown. Do not touch the tip after opening the vial.

1. Use your finger to gently separate the lower eyelid from the affected eye.
2. Place the tip of the single-use vial near the eye, but without touching it.
3. Press gently on the single-use vial so that one drop falls into the eye and thenremove your finger from the lower eyelid.

1. Press with your finger the affected eye's outer corner, near the nose. Apply pressure for 2 minutes, keeping your eye closed.

1. Repeat the procedure in the other eye, if your doctor has instructed you to do so. Each single-use vial contains enough for both eyes.

1. Dispose of the single-use vial after use. Do not save it for later use. As the sterility of the single-use vial cannot be guaranteed after opening, a new vial must be opened before each use.

1. Place the single-use vials without opening inside the package. Place the opened package inside the box. Single-use vials without opening can be used within 1 month after opening the package.

Using Fixaprost with other eye drops

Wait at least 5 minutes between applying Fixaprost and administering other eye drops..

Using more Fixaprost than you should

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

Swallowing Fixaprost

In case of accidental ingestion of Fixaprost, contact your doctor. If you ingest 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

Missing a dose of Fixaprost

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

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

You can continue using 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 to occur with the use of Fixaprost. The most important side effect is the possibility of a gradual and permanent change in the color of the eye. It is also possible that Fixaprost may cause severe changes in how the heart works. If you notice any change in heart rhythm or cardiac function, you must 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):

• A gradual change in the color of the eyes 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-colored eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to 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 only in 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 discontinued.

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

• Irritation of the eye (sensation of burning, sensation of sand in the eye, itching, stinging, and sensation 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, inflammation of the eyelids, irritation or erosion of the surface of the eye.
• Itching or prickling sensation on the skin (pruritus).
• Nausea, vomiting.

Otherside 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 one of the components of Fixaprost (latanoprost and timolol) and may therefore occur with the use of Fixaprost. The side effects listed 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 that include swelling under the skin that may occur in areas such as the face and extremities and may obstruct the airway causing difficulty swallowing or breathing, urticaria or itchy rash, localized or generalized rash, itching, sudden, severe, and potentially fatal 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 symptoms (muscular disorder), unusual sensation like pins and needles, and headache.

• Swelling at the back of the eye (macular edema), cyst filled with fluid in the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (greater depth of the eyelid fold)

• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision, and detachment of the layer under the retina and containing blood vessels after surgery that may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the anterior 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 (increase in number, length, thickness, and darkness), changes in the direction of growth of the eyelashes, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scars on the surface of the eye.

• Tinnitus (ringing in the ears).

• 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 speed, 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 circulation of blood that makes the hands and feet numb and pale, cold hands and feet.

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

• Alteration of 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.

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

• Sexual dysfunction, decreased libido.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box, top, and unit dose packaging.The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for its conservation.

After the first opening of the pouch:use unit dose packaging within 1 month.

Write the date of the first opening of the pouch.

After the first opening of the unit dose packaging:use immediately and discard the unit dose packaging after use.

Store unused unit dose packaging inside the opened pouch to protect them from light.

Medications should not be thrown away through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fixaprost

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

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

Appearance of the product and contents of the package

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 free of particles, presented in the interior of a package 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 sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

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

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

LABORATORIOS THEA, S.A.

C/ Enric Granados nº 86-88, 2nd floor

08008 Barcelona

Spain

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

Austria, Slovakia, France, Italy, Ireland, Poland, United Kingdom, Czech RepublicFixapost

Germany, Belgium, Bulgaria, Cyprus, Spain, Greece, Netherlands, Luxembourg, PortugalFixaprost

Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, SwedenFixopost

Croatia, SloveniaFixalpost

RomaniaFixanpost

PortugalMonoprost Duo

Last review date of thisleaflet: March 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.