Prospect: information for the user

Latanoprost/Timolol STADA 50 micrograms/ml + 5 mg/ml eye drops in solution

Latanoprost/Timolol

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What you need to know before starting to use Latanoprost/Timolol Stada

1. How to use Latanoprost/Timolol Stada
2. Possible adverse effects

5.Storage of Latanoprost/Timolol Stada

1. Contents of the package and additional information

Latanoprost/Timolol Stada is a medication for the treatment ofincreased intraocular pressure(pressure inside the eye).

Latanoprost/timolol is a combination of two active principles: latanoprost (a prostaglandin derivative) and timolol maleate (a beta-blocker).

Inside the eye, a fluid called aqueous humor is produced. This liquid is drained back into the bloodstream, which maintains the necessary pressure inside the eye. If this outflow is blocked, the pressure inside the eye increases.

Among other things, beta-blockers reduce eye pressure by reducing the production of aqueous humor. Prostaglandins promote the drainage of aqueous humor.

Latanoprost/timolol Stada is used:

-For reducing internal eye pressure in patients with open-angle glaucoma (damage to the optic nerve, caused by excessive pressure inside the eye).

-For reducing internal eye pressure in patients in whom the effect of beta-blockers or prostaglandin derivatives alone is not sufficient.

Nouse Latanoprost/Timolol Stada colirio en solución

• if you areallergicto latanoprost or timolol, beta-blockers or to any of the other components of latanoprost/timolol (described in section 6).
• if you have or have had in the past respiratory problems such as asthma, chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing and/or long-term coughing).

• if you have severe heart problems or heart rhythm disturbances.

• if you are pregnant (or trying to become pregnant)
• if you are breastfeeding.

Advertencias and precautions

Before using this medication, inform your doctor if youhave or have had in the past

• coronary heart disease (symptoms may include chest pain or a feeling of pressure, shortness of breath or choking), heart failure, low blood pressure

• heart rhythm disturbances, such as slow heart rate

• respiratory problems, asthma or chronic obstructive pulmonary disease

• circulatory insufficiency (such as Raynaud's disease or Raynaud's syndrome)
• diabetes as timolol may mask the signs and symptoms of hypoglycemia

• hyperthyroidism as timolol may mask the signs and symptoms

• any type of eye surgery (including cataract surgery)

• eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)

• dry eye (dry eye)

• angina (particularly a type known as Prinzmetal's angina)

• severe adverse 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)

Use of contact lenses: You can continue to use latanoprost/timolol but following the instructions for contact lens users in the section “Latanoprost/Timolol Stada contains benzalkonium chloride”.

Before undergoing surgery, inform your doctor that you are using latanoprost/timolol as latanoprost/timolol may modify the effects of some medications during anesthesia.

Use in athletes

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

Use of Latanoprost/Timolol Stada with other medications

Latanoprost/timolol may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medications to reduce blood pressure, medications for the heart or to treat diabetes.

Inform your doctor or pharmacist if you are taking, have taken recently or may need to use any other medication (including the use of eye drops).

Medications can influence each other and may occurinteractions. You should be aware of this if you are taking or using any of the following types of medications:

• Calcium channel blockers(for example in coronary disease or high blood pressure)Guanetidina(for high blood pressure)

Beta-blockers(for high blood pressure)

Antiarrhythmics(medications to normalize heart rhythm)

Digitalis glycosides(for heart failure)

Cholinergic agonists(for example, for glaucoma treatment)

The use of latanoprost/timolol together with the above medications may cause low blood pressure and/or decrease heart rate.

• Medications that act similarly to latanoprost/timolol

If used at the same time as latanoprost/timolol, the effect of other medications with a similar action to latanoprost/timolol may be increased. For this reason, the use of two beta-blockers or two prostaglandin derivatives is not recommended.

• Clonidina

If you are using the active substance clonidina to reduce intraocular pressure together with latanoprost/timolol and suddenly stop using clonidina, your blood pressure may increase. If at the same time you are also using beta-blockers to reduce blood pressure, your blood pressure may - due to this adverse effect - increase even more.

• Quinidina(used to treat heart disease and some types of malaria)
• Antidepressantsknown as fluoxetine and paroxetine

Children and adolescents

Latanoprost/timolol is not recommended for children or adolescents.

Older patients

Latanoprost/timolol is also suitable for the treatment of older patients.

Pregnancy and lactation

Pregnancy

Do not use latanoprost/timolol if you are pregnant unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, if you think you may be pregnant or if you are planning to become pregnant.

Lactation

Do not use latanoprost/timolol if you are breastfeeding. Timolol and latanoprost may pass into breast milk. Ask your doctor for advice before taking any medication during breastfeeding.

Driving and operating machinery

After administering the latanoprost/timolol eye drop, your vision may be temporarily altered.

If you experience blurred vision - mainly after applying latanoprost/timolol eye drops - you should not:

• drive any vehicle

• use tools or machinery

Latanoprost/Timolol Stada contains benzalkonium chloride and phosphates

This medication contains 0.2 mg of benzalkonium chloride in each ml. Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove the contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front part of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

This medication contains 6.31 mg of phosphates in each ml. If you suffer from severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in rare cases, may cause cloudy patches in the cornea due to calcium.

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

Unless your doctor prescribes another dose, theusual doseis:

Adults, including elderly patients:insert one drop into each affected eye, once a day.

If, in addition to latanoprost/timolol, you are using other eye drops, these should be administered with an interval of at least five minutes.

Usage Instructions

1. Wash your hands and sit or stand comfortably.

1. Remove the outer protective cap from the bottle.
2. Use the tip of your finger to gently pull the lower eyelid of the affected eye downwards.

4.Place the tip of the bottle close, but do not touch the eye. Press the bottle carefully until a drop falls into the eye. Please make sure not to squeeze the bottle too hard, so that no more than one drop falls into the affected eye.

1. Release the eyelid.

1. After using latanoprost/timolol, press a finger against the eye, from the end of the nose, for 2 minutes.

This will help prevent latanoprost/timolol from passing into the rest of the body

Repeat the procedure in the other eye, if your doctor has instructed you to do so. If the drop falls outside the eye, apply another drop.

7.Close the bottle.

If you use more Latanoprost/Timolol Stada than you should

If too many drops have entered the eye, it may causeirritation and redness.

Inform yourdoctor immediatelyif you or anyone else hasaccidentally ingestedthe drops, or if you have been using the drops more frequently than prescribed.

Have the packaging of this medication handy, so that your doctor can have more information about the medication. He/she will decide what to do.

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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Latanoprost/Timolol Stada

If you have forgotten to use the eye drop, continue treatment by administering the next dose in the usual manner. The dose should not exceed one drop per day in the affected eye.

Do not take adouble doseto compensate for missed doses.

If you interrupt treatment with Latanoprost/Timolol Stada

Do not interrupt or stop treatment with latanoprost/timolol without first consulting your doctor.

If you do not use latanoprost/timolol regularly or if you frequently forget to administer it, thesuccess of your treatment may be at risk.

The increase in intraocular pressure (pressure inside the eye) can damage the optic nerve and worsen your vision. Blindness may occur. Normally, the increase in intraocular pressure is barely perceptible. The disorder can only be diagnosed through an examination performed by an ophthalmologist. If you have high intraocular pressure, regular eye exams, along with measurements of the internal pressure of the eye, are necessary. The pressure inside the eye should be measured at least every 3 months. Once a year, visual field measurements and optic nerve examinations should be performed.

If you have any other doubts about the use of this medication, ask 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 latanoprost/timolol without consulting your doctor.

The following describes the side effects of using an eye drop that contains the active substances latanoprost and timolol. The most important side effect is the possibility of a gradual, permanent change in the color of the eyes. It is also possible that eye drops containing latanoprost and timolol as active ingredients may cause significant changes in the functioning of your heart. If you notice changes in heart rhythm or cardiac function, you should talk to a doctor and tell them that you have been using latanoprost/timolol.

The frequency of the possible side effects described below is defined using the following convention

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

•A gradual change in eye color by increasing the amount of brown pigment in the colored part of the eye called the iris. If your eye color is a mixture of colors (blue-brown, gray-brown, yellow-brown, or green-brown), the change may be more noticeable than if you have eyes of a single color (blue, gray, green, or brown). Any change in eye color may take years to develop. The color change may be permanent and may be more noticeable if you use latanoprost/timolol in one eye only. It does not appear to be related to any problems with the change in eye color. The change in eye color does not continue after stopping treatment with latanoprost/timolol.

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

•Irritation of the eye (sensation of burning, grittiness, itching, stinging, or feeling of a foreign body 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, inflammation of the eyelids, irritation or alterations of the surface of the eye.
• Rash or itching on the skin (pruritus).

Other side effects

The following side effects have been observed with latanoprost:

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

Immune system disorders:

•Symptoms of an allergic reaction (swelling and redness of the skin and rash).

Nervous system disorders:

•Dizziness

Eye disorders:

•Changes in eyelashes and fine hair around the eye (increase in number, length, thickness, and darkness), changes in the direction of growth of eyelashes, inflammation around the eye, swelling of the colored part of the eye (iritis/uveitis), swelling in the back of the eye (macular edema), inflammation or irritation of the surface of the eye (keratitis), dry eyes, cyst filled with fluid within the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (greater depth of the eyelid fold), eye disorder affecting the cornea characterized by lesions on the corneal epithelium with a punctate pattern (punctate epithelial erosion), corneal edema (swelling and fluid retention in the cornea) and corneal erosion (damage to the anterior layer of the globe).

Heart disorders (cardiac):

•Angina, worsening of angina in patients with existing heart disease, awareness of heart rhythm (palpitations)

Respiratory disorders:

•Asthma, worsening of asthma, difficulty breathing.

Gastrointestinal disorders:

•Nausea, vomiting (uncommon).

Skin disorders:

•Darkening of the skin around the eyes

Musculoskeletal disorders:

•Joint pain, muscle pain.

General disorders:

•Chest pain.

Like other eye medications, latanoprost/timolol is absorbed into the bloodstream. The timolol portion of this combination may cause side effects similar to those that occur with intravenous and/or oral beta-blockers. The incidence of side effects after topical administration is lower than when the medications are taken, for example, orally or injected. The described side effects include reactions observed when beta-blockers are used to treat eye diseases:

• Generalized allergic reactions including swelling under the skin that may occur in areas such as the face and extremities, and may obstruct the airways causing difficulty swallowing or breathing. Urticaria or skin rash with itching, localized and generalized skin rash, itching, severe and sudden severe allergic reaction.

• Low blood sugar levels.

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

• Fainting, stroke, reduced blood flow to the brain, increased signs and symptoms of myasthenia gravis (muscular disease), dizziness, unusual sensations such as tingling, and headache.

• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and retinal detachment after surgery that may cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the anterior layer of the globe), eyelid drooping (making the eye half-closed), double vision.

• Tinnitus (ringing in the ears)

• Slow heart rate, chest pain, palpitations, edema (fluid accumulation), changes in heart rhythm or speed, congestive heart failure (heart disease, with difficulty breathing and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.

• Low blood pressure, Raynaud's phenomenon, cold hands and feet.

• Constriction of the airways in the lungs (predominantly in patients with pre-existing diseases), difficulty breathing, cough.

• Changes in 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, not caused by exercise.

• Sexual dysfunction, decreased libido.

• Muscle weakness / fatigue.

In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits produced during treatment.

Reporting of 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 the Spanish System for the Vigilance 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.

Keep out of thesight and reach of children.

Do not use this medication after theexpiration datethat appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Please note the following conservation instructions:

Unopened bottles: Store in refrigerator at 2°C - 8°C.

After the first opening of the bottle: Do not store at a temperature above 25ºC.

Once opened, discard the bottle - with the remaining contents - after 4 weeks.

Otherwise, there is a risk of ocular infection.

Medicines should not be disposed of throughdrainsor in thetrash. Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Latanoprost/Timolol Stada Composition

• Theactive ingredientsare: latanoprost and timolol maleate

1 ml of eye drops contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate, equivalent to 5.0 mg of timolol.

• Theother componentsare:

Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, dodecahydrate of disodium hydrogen phosphate, purified water, sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment.

Appearance of the product and contents of the package

Latanoprost/Timolol Stada is aclear and colorless liquid, free of visible particles,packaged in a transparent dropper bottle with a screw cap.

Latanoprost/Timolol Stada is available in the following package sizes:

1 bottle containing 2.5 ml of eye drops in solution,

3 bottles each containing 2.5 ml of eye drops in solution,

6 bottles each containing 2.5 ml of eye drops in solution.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

ROMPHARM COMPANY S.R.L.

Eroilor Street, no. 1A

Otopeni 075100, Ilfov district

Romania

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

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

Last review of this leaflet was in:June 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/