LATANOPROST/TIMOLOL FARMALIDER 50 micrograms/mL + 5 mg/mL Eye Drops Solution

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

This eye drop may be used in adult men and women (including the elderly) but is not recommended for use in children under 18 years.

Do not use Latanoprost / Timolol Farmalider:

• If you are allergic (hypersensitive) to latanoprost or 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 or severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing and/or prolonged coughing).
• If you have or have had severe heart problems or heart rhythm disorders.
• If you are pregnant or plan to become pregnant.
• If you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Latanoprost / Timolol Farmalider if you:

• Have coronary heart disease (symptoms can include chest pain or feeling of tightness, shortness of breath or difficulty breathing), heart failure, low blood pressure.
• Have heart rhythm disturbances, such as slow heart beats.
• Have respiratory problems, asthma or chronic obstructive pulmonary disease.
• Have poor circulation (such as Raynaud's disease or Raynaud's syndrome).
• Have diabetes, as timolol may mask the signs and symptoms of low blood sugar.
• Have overactive thyroid, as timolol may mask the signs and symptoms.
• Have had any type of eye surgery (including cataract surgery) or have had any type of eye injury in the past.
• Suffer from eye problems (such as eye pain, irritation or inflammation of the eye or blurred vision).
• Suffer from dry eyes.
• Use contact lenses. You can continue to use this eye drop, but follow the instructions for contact lens wearers in Section 3.
• Know that you suffer from angina (in particular a type known as Prinzmetal's angina).
• Know that you suffer from severe allergic reactions that usually require hospital treatment.
• Have suffered or currently suffer from a viral infection of the eye caused by the herpes simplex virus (HSV).

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

Other medicines and Latanoprost/Timolol Farmalider

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including eye drops or medicines without a prescription.

Latanoprost/Timolol Farmalider may be affected by other medicines you are using, including eye drops for the treatment of glaucoma. Tell your doctor if you are taking or plan to take medicines for lowering blood pressure, heart medicines or medicines for treating diabetes.

In particular, tell your doctor or pharmacist if you know you are taking any of the following medicines:

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

Using Latanoprost/Timolol with food and drink

Normal meals, food or drink do not affect when or how you should use these eye drops.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

In animal studies, latanoprost/timolol has not been shown to have any effect on male or female fertility.

Driving and using machines

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

Latanoprost/Timolol Farmalider contains benzalkonium chloride

This eye drop contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption of the eye surface. It may be absorbed by soft contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. See the instructions for contact lens wearers in Section 3.

3. How to use Latanoprost/Timolol Farmalider

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.

The recommended dose for adults (including the elderly) is one drop once daily in each affected eye.

Do not use these eye drops more than once daily, as the efficacy of the treatment may be reduced if administered more frequently.

The use of Latanoprost/Timolol Farmalider is not recommended in children under 18 years.

Use this medicine as instructed by your doctor until your doctor tells you to stop.

Your doctor may require additional checks on your heart and circulation if you use Latanoprost/Timolol Farmalider.

Contact lens wearers

If you wear contact lenses, do not use these eye drops while your contact lenses are in your eyes. Remove your contact lenses before using these eye drops. Wait at least 15 minutes after using these eye drops before putting your contact lenses back in.

Instructions for use

• First, wash your hands and sit or stand in a comfortable position.
• Remove your contact lenses.
• If you are using the bottle for the first time, remove the protective cap, twisting it to break the security seal.
• Remove the inner cap.
• Tilt your head back and look upwards.
• Gently pull down the lower eyelid.
• Hold the bottle upside down over the eye and press it gently to release one drop into the eye.

Figure 1

• Keep the affected eye closed and press the inner corner of the eye with your finger for 2 minutes. This is important to reduce the amount of medicine that passes to the rest of the body.

Figure 2

• Repeat in the other eye, if your doctor has told you to do so.
• Replace the cap on the bottle after use and tighten it.

If you use this eye drop with other eye drops

Wait at least 5 minutes between using Latanoprost/Timolol Farmalider and the application (or use) of other eye drops.

If you use more Latanoprost/Timolol Farmalider than you should

If you have applied more drops in the eye than you should, you may feel a mild irritation in the eye and your eyes may become red and watery; this should disappear, but if you are concerned, talk to your doctor.

If you swallow a large amount of this eye drop, you may feel unwell, have stomach pain, tiredness, dizziness and flushing, and start to sweat. If you have taken too much or if someone else has taken your medicine, talk to your doctor or pharmacist or go to the nearest hospital casualty department immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist or the Poisons Information Centre (telephone: 91 562 04 20), indicating the medicine and the amount taken.

If you forget to use Latanoprost/Timolol Farmalider

Continue with the next dose at the usual time. Do not use a double dose to make up for a forgotten dose. If you are unsure, talk to your doctor or pharmacist.

If you stop using Latanoprost/Timolol Farmalider

If you want to stop using this medicine, talk to your doctor first. If you have any other questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Latanoprost/Timolol Farmalider can cause side effects, although not everybody gets them.

Normally, you can continue to use the drops, unless the effects are severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using this medicine without talking to your doctor.

The most common side effect is the possibility of a gradual or permanent change in the colour of your eyes. There is a possibility that these eye drops may cause significant changes in the way your heart works. If you notice changes in your heart rhythm or heart function, you should talk to a doctor and tell them that you have been using this eye drop.

The following is a list of side effects of Latanoprost/Timolol Farmalider:

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

Gradual change in the colour of the eyes (due to an increase in the amount of brown pigment in the coloured part of the eye known as the iris). If you have mixed-colour eyes (e.g. blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are a single colour (e.g. blue, grey, green or brown). The change in eye colour may take years to develop and may be permanent. The change in eye colour may be more noticeable if this eye drop is used in one eye only. The change in eye colour does not appear to be associated with any problems. The change in eye colour does not progress once treatment with Latanoprost/Timolol Farmalider is stopped.

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

• Irritation of the eyes (a feeling of burning, stinging, itching, grittiness or foreign body sensation 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, watery eyes, swelling (inflammation) of the eyelids, irritation or disruption of the eye surface.
• Skin rash or itching (pruritus).
• Nausea, vomiting.

Other side effects

Although not seen with Latanoprost/Timolol Farmalider, the following additional side effects have been seen with latanoprost and timolol.

The following side effects have been seen with latanoprost:

Infections and infestations:

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

Immune system disorders:

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

Psychiatric disorders:

• Depression, memory loss, decreased sexual desire, sleeplessness, nightmares.

Nervous system disorders:

• Dizziness, tingling or numbness of the skin, changes in blood flow to the brain, worsening of symptoms of myasthenia gravis (if you already suffer from this condition), sudden fainting or feeling of possible fainting (syncope).

Eye disorders:

• Changes in the eyelashes and fine hairs around the eye (increased number, length, thickness and pigmentation), changes in the direction of growth of the eyelashes, swelling around the eyes, swelling of the coloured part of the eye (iritis or uveitis), swelling of the back of the eye (macular oedema), inflammation/irritation of the eye surface (keratitis), dry eyes, fluid-filled cyst within the coloured part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eye (deepening of the eye cup).

Hearing disorders:

• Ringing or buzzing in the ears (tinnitus).

Heart disorders:

• Worsening of angina, awareness of heart rhythm (palpitations).

Respiratory disorders:

• Asthma, worsening of asthma, difficulty breathing.

Skin disorders:

• Darkening of the skin around the eyes.

Musculoskeletal and connective tissue disorders:

• Joint pain, muscle pain.

General disorders:

• Chest pain.

As with other eye drops, this eye drop is absorbed into the bloodstream. The timolol portion of this combination may cause side effects similar to those seen with beta-blockers when used orally or intravenously. The incidence of side effects after topical ocular administration is lower than when medicines are given orally or by injection.

List of side effects including reactions that are seen with beta-blockers when used for the treatment of eye diseases:

• Allergic reactions including swelling under the skin which can occur in areas such as the face and limbs, and can obstruct the airways, potentially causing difficulty in swallowing or breathing, urticaria or skin rash with itching, localised or generalised skin rash, itching, life-threatening allergic reactions.

• Low blood sugar levels.
• Depression, memory loss, difficulty sleeping (insomnia), nightmares.
• Fainting, stroke, decreased blood flow to the brain, worsening of symptoms of myasthenia gravis (if you already suffer from this condition), dizziness, unusual sensations (such as pins and needles) and headache.
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eyelid inflammation, inflammation of the cornea, blurred vision and detachment of the layer beneath the retina that contains blood vessels after filtration surgery which can cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the outer layer of the eyeball), drooping of the upper eyelid (making the eye stay half-closed), double vision.
• Slow heart rate, chest pain, feeling of heart beats (palpitations), fluid accumulation (oedema) and changes in heart rhythm or rate, and congestive heart failure (heart disease with shortness of breath 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.
• Difficulty breathing, cough, constriction of the airways in the lungs (mainly in patients with pre-existing diseases).
• Feeling unwell (nausea), diarrhoea, dry mouth, changes in taste, indigestion, stomach pain, vomiting.
• Hair loss/baldness, skin rash, skin rash with a silvery-white appearance (psoriasiform skin rash) or worsening of psoriasis.
• Muscle pain not caused by exercise.
• Muscle weakness, tiredness.
• Sexual dysfunction, decreased libido.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost/Timolol Farmalider

Do not use this medication after the expiration date shown on the packaging and on the bottle after CAD.

The expiration date is the last day of the month indicated.

Keep out of sight and reach of children.

Store the unopened bottle in the refrigerator (between 2°C and 8°C) to protect it from light.

Once the bottle is opened, it is not necessary to store it in the refrigerator, but do not store it at a temperature above 25°C.

When not using this medication, store the bottle in the outer packaging to protect it from light.

It must be used within 4 weeks of opening.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Latanoprost/Timolol Farmalider

The active ingredients are latanoprost and timolol. Each ml contains 50 micrograms of latanoprost and 5 mg of timolol (as 6.8 mg of timolol maleate)

The other components (excipients) are: sodium chloride, benzalkonium chloride, dihydrogen phosphate, sodium monohydrate, anhydrous disodium phosphate, hydrochloric acid solution, and sodium hydroxide solution (for pH adjustment), and water for injectable preparations.

Appearance of the Product and Package Contents

Each package contains a bottle of Latanoprost/Timolol. Each bottle contains 2.5 ml of Latanoprost/Timolol eye drops.

Latanoprost/Timolol eye drop solution is a clear and colorless liquid. Latanoprost/Timolol is available in package sizes of 1, 3, and 6.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Farmalider, S.A.

C/ La granja, 1

28108 Alcobendas

Madrid, Spain

Manufacturer:

FDC International Ltd.,

Unit 6, Fulcrum 1, Solent Way,

Whiteley, Fareham,

Hampshire,

PO15 7FE,

United Kingdom

or

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas

Madrid, Spain

Date of the Last Revision of this Leaflet:March 2022

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