Latanoprost/timolol Stada 50 microgramos/ml / 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Latanoprost/Timolol STADA 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 as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Latanoprost/Timolol STADA is and what it is used for

2. What you need to know before using Latanoprost/Timolol STADA

3. How to use Latanoprost/Timolol STADA

4. Possible side effects

5. How to store Latanoprost/Timolol STADA

6. Contents of the pack and other information

1. What Latanoprost/Timolol Stada is and what it is used for

Latanoprost/Timolol Stada is a medicine used to treat elevated intraocular pressure (pressure inside the eye).

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

Inside the eye, a fluid called aqueous humour is continuously produced and then drained back into the bloodstream, maintaining the necessary pressure within the eye. If this outflow is blocked, pressure inside the eye increases.

Beta-blockers, among other effects, reduce intraocular pressure by decreasing the production of aqueous humour. Prostaglandins enhance the outflow of aqueous humour.

Latanoprost/timolol Stada is used:

• To reduce intraocular pressure in patients with open-angle glaucoma (damage to the optic nerve caused by excessive pressure inside the eye).
• To reduce intraocular pressure in patients in whom treatment with beta-blockers or prostaglandin analogues alone has not been sufficiently effective.

2. What you need to know before using Latanoprost/Timolol Stada

Do not use Latanoprost/Timolol Stada eye drops solution

• if you are allergic to latanoprost or timolol, beta-blockers, or to any of the other ingredients of latanoprost/timolol (listed in section 6).

• if you currently have or have previously had respiratory problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).

• if you have serious heart problems or heart rhythm disorders.

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

• if you are breastfeeding.

Warnings and precautions

Before using this medicine, inform your doctor if you currently have or have previously had:

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

• heart rhythm disorders, such as slow heartbeat

• respiratory problems, asthma, or chronic obstructive pulmonary disease

• circulatory insufficiency disorders (such as Raynaud's disease or Raynaud's syndrome)

• diabetes, as timolol may mask the signs and symptoms of hypoglycemia

• overactive thyroid gland, 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 syndrome)

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

• severe adverse reactions that usually require hospital treatment

• if you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV)

Use of contact lenses: You may continue using latanoprost/timolol, but follow the instructions for contact lens wearers 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 alter the effects of certain anesthetic medications.

Use in athletes

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

Using Latanoprost/Timolol Stada with other medicines

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

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

Medicines can interact with each other and interactions may occur. You should be aware of this if you are taking or using any of the following types of medicines:

• Calcium channel blockers (e.g., for coronary heart disease or high blood pressure)
  Guanethidine (for high blood pressure)

  Beta-blockers (for high blood pressure)

  Antiarrhythmics (medicines to normalize heart rhythm)

  Cardiac glycosides (for heart failure)

  Parasympathomimetic agents (e.g., for the treatment of glaucoma)

  Taking/using latanoprost/timolol together with the above medicines may cause low blood pressure and/or a decreased heart rate.

• Medicines that act similarly to latanoprost/timolol

  If used simultaneously with latanoprost/timolol, the effect of other medicines with a similar action to latanoprost/timolol may be increased. For this reason, the ophthalmic use (i.e., in the eye) of two beta-blockers or two prostaglandin analogues is not recommended.

• Clonidine

  If you are using the active substance clonidine to reduce intraocular pressure together with latanoprost/timolol and suddenly stop using clonidine, your blood pressure may increase. If you are also using beta-blockers to lower blood pressure, your blood pressure may rise even further due to this adverse effect.

• Quinidine (used to treat heart conditions and some types of malaria)

• Antidepressants known as fluoxetine and paroxetine

Children and adolescents

Latanoprost/timolol is not recommended for use in children or adolescents.

Elderly patients

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

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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

Driving and use of machines

After administration of latanoprost/timolol eye drops, your vision may be temporarily blurred.

If you experience blurred vision—mainly after instilling latanoprost/timolol eye drops—you should not:

• drive any vehicle

• operate tools or machinery

Latanoprost/Timolol Stada contains benzalkonium chloride and phosphates

This medicine contains 0.2 mg of benzalkonium chloride per ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

This medicine contains 6.31 mg of phosphates per ml. If you have severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates may, in very rare cases, lead to cloudy corneal deposits due to calcium.

3. How to use Latanoprost/Timolol Stada

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults, including elderly patients: one drop in each affected eye once daily.

If you are also using other eye drops, these should be administered at least five minutes apart.

Instructions for use

1. Wash your hands and sit or stand comfortably.

2. Remove the outer protective cap from the bottle.

3. Use your fingertip to gently pull down the lower eyelid of the affected eye.

4. Place the tip of the bottle close to, but without touching, the eye. Gently press the bottle until one drop falls into the eye. Please make sure not to squeeze the bottle too hard, so that no more than one drop enters the affected eye.

5. Release the eyelid.

6. After using Latanoprost/Timolol, press a finger against the eye at the corner near 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 misses 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, irritation and redness may occur.

Inform your doctor immediately if you or anyone else has accidentally swallowed the drops, or if the drops have been used more frequently than prescribed.

Keep the package of this medicine handy so the doctor can access further information about the product. He/she will decide on the appropriate course of action.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to use Latanoprost/Timolol Stada

If you have forgotten to use the eye drops, continue treatment by administering the next dose as usual. The dose must not exceed one drop once daily in the affected eye.

Do not use a double dose to make up for a missed dose.

If you stop using 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 frequently forget to administer it, the success of your treatment may be at risk.

Increased intraocular pressure (pressure inside the eye) can damage the optic nerve and worsen your vision. Blindness may result. Usually, increased intraocular pressure is barely noticeable. The condition can only be diagnosed through an examination performed by an ophthalmologist. If you have elevated intraocular pressure, regular eye examinations are necessary, along with measurements of internal eye pressure. Eye pressure should be measured at least every 3 months. Visual field testing and optic nerve examinations should be carried out once a year.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may 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 first consulting your doctor.

Below are described the side effects associated with the use of an eye drop containing the active substances latanoprost and timolol. The most important side effect is the possibility of a gradual, permanent change in eye color. Eye drops containing latanoprost and timolol as active ingredients may also cause significant changes in heart function. If you notice changes in your heart rhythm or cardiac function, you should speak to a doctor and inform them that you have been using latanoprost/timolol.

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

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

• Gradual change in eye color due to an increase in 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 evident if latanoprost/timolol is used in only one eye. There do not appear to be any health problems associated 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):

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

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

• Headache.
• Eye redness, eye infection (conjunctivitis), blurred vision, excessive tearing, eyelid swelling, eye surface irritation or abnormalities.
• Skin rash or itching (pruritus).

Other adverse effects

The following adverse effects have been observed with latanoprost:
Infections and infestations:

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

Immune system disorders:

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

Nervous system disorders:

• Dizziness

Eye disorders:

• Changes in eyelashes and fine hair around the eye (increased number, length, thickness, and darkness), changes in the direction of eyelash growth, swelling 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 eye surface (keratitis), dry eyes, fluid-filled cyst within the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (increased depth of the eyelid groove), eye disorder affecting the cornea characterized by lesions in the corneal epithelium with a punctate pattern (punctate epithelial erosion), swelling and fluid retention in the cornea (corneal edema), and corneal erosion (damage to the front layer of the eyeball).

Cardiac disorders:

• Angina, worsening of angina in patients who already have heart disease, awareness of heartbeat (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 component of this combination may cause side effects similar to those observed with intravenous and/or oral beta-blockers. The incidence of side effects after ophthalmic administration is lower than when medications are taken orally or injected. The side effects described include those observed when beta-blockers are used to treat eye diseases:

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

• Low blood sugar levels.

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

• Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disease), dizziness, unusual sensations such as tingling, and headache.

• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eyelid swelling, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels after filtration surgery, which may cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be partially closed), double vision.

• Ringing or buzzing in the ears (tinnitus)

• Slow heart rate, chest pain, palpitations, 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 buildup), 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 conditions), difficulty breathing, cough.

• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.

• Hair loss, skin rashes 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 clear front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits during treatment.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost/Timolol Stada

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Please observe the following storage instructions:

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

After first opening the bottle: Do not store above 25°C.

Once opened, the bottle - including any remaining contents - must be discarded after 4 weeks.

Otherwise, there is a risk of ocular infection.

Medicines must not be disposed of via drains or in the trash. Return unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Latanoprost/Timolol Stada

• The active substances are: 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.

• The other components are:

Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water, sodium hydroxide to adjust pH, hydrochloric acid to adjust pH.

Appearance of the product and contents of the container

Latanoprost/Timolol Stada is a clear, colourless liquid, free from visible particles, contained in a transparent dropper bottle with a screw cap.

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

1 bottle containing 2.5 ml of eye drop solution,

3 bottles each containing 2.5 ml of eye drop solution,

6 bottles each containing 2.5 ml of eye drop solution.

Only some of these pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

or

Nextpharma Oy

Niittyhaankatu 20

33720 Tampere

Finland

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

Denmark:	Latanostad Comp
Austria:	Latanoprost/Timolol Stada 50 microgram/ml + 5 mg/ml eye drops, solution
Spain:	Latanoprost/Timolol Stada 50 micrograms/ml + 5 mg/ml ophthalmic solution
Finland:	Oftastad comp 50 microg/ml + 5 mg/ml eye drops, solution
Iceland	Latanostad Comp

The last revision of this leaflet was in: December 2025

The detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/