LATANOPROST + TIMOLOL 50 MICROGRAMS / ML + 5 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Latanoprost / Timolol Eye Drops is and what it is used for

• 2. What you need to know before you use Latanoprost / Timolol Eye Drops

• 3. How to use Latanoprost / Timolol Eye Drops

• 4. Possible side effects

• 5. How to store Latanoprost / Timolol Eye Drops

• 6. Contents of the pack and other information

1. what latanoprost / timolol eye drops is and what it is used for

Latanoprost / Timolol 50 micrograms / ml + 5 mg / ml Eye Drops, Solution contains two medicines: latanoprost and timolol.

Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.

Latanoprost / Timolol Eye Drops is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you Latanoprost / Timolol Eye Drops when other medicines have not worked adequately.

2. what you need to know before you use latanoprost / timolol eye drops

Latanoprost / Timolol Eye Drops can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age.

Do not use Latanoprost / Timolol Eye Drops:

• if you are allergic to latanoprost or timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6).
• if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).

if you have serious heart problems or heart rhythm disorders.

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

if you are breast feeding.

Warnings and precautions

Talk to your doctor or pharmacist before using Latanoprost / Timolol Eye Drops if you have now or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure.
• disturbances of heart rate such as slow heart beat.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syn­drome).
• diabetes as timolol may mask signs and symptoms of low blood sugar.
• overactivity of the thyroid gland as timolol may mask signs and symptoms.
• you are about to have any kind of eye surgery (including cataract surgery) or have had any kind of eye surgery in the past.
• you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision).
• you know that you suffer from dry eyes.
• you wear contact lenses. You can still use Latanoprost / Timolol Eye Drops but follow the instructions for contact lens wearers in section 3.
• you know that you suffer from angina (particularly a type known as Prinzmetal angina).
• you know that you suffer from severe allergic reactions that would usually require hospital treatment.
• you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
• Tell your doctor before you have an operation that you are using Latanoprost / Timolol Eye Drops as timolol may change effects of some medicines used during anaesthesia.

Other medicines and Latanoprost / Timolol Eye Drops

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including using eye drops).

Latanoprost / Timolol Eye Drops can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes.

In particular, speak to your doctor or pharmacist if you know that you are taking any of the following types of medicine:

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

Latanoprost / Timolol Eye Drops with food and drink

Normal meals, food or drink have no effect on when or how you should use Latanoprost / Timolol Eye Drops.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not use Latanoprost / Timolol Eye Drops if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.

Breast-feeding

Do not use Latanoprost / Timolol Eye Drops if you are breast-feeding. Latanoprost / Timolol Eye Drops may get into your milk. Ask your doctor for advice before taking any medicine during breastfeeding.

Fertility

Latanoprost and timolol have been found to have no effect on male or female fertility in animal studies.

Driving and using machines

When you use Latanoprost / Timolol Eye Drops your vision may become blurred for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.

Latanoprost / Timolol Eye Drops contains benzalkonium chloride and phosphate buffers

This medicine contains 0.2 mg of benzalkonium chloride in each millilitre.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

This medicine contains 6.345 mg phosphates in each millilitre.

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

3. how to use latanoprost / timolol eye drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Do not use Latanoprost / Timolol Eye Drops more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use Latanoprost / Timolol Eye Drops as instructed by your doctor until your doctor tells you to stop.

Your doctor may want you to have extra checks on your heart and circulation if you use Latanoprost / Timolol Eye Drops.

Contact lens wearers

If you wear contact lenses, you should remove them before using Latanoprost / Timolol Eye Drops. After using Latanoprost / Timolol Eye Drops you should wait 15 minutes before putting your contact lenses back in.

Instructions for use

• 1. Wash your hands and sit or stand comfortably.

• 2. The tamper-proof seal on the bottle neck must be unbroken before the product is being used for the first time. A gap between the bottle and the cap is normal for an unopened bottle.

• 3. Take off the cap of the bottle.

• 4. Tilt back your head and pull lower eyelid gently down to form a small pocket between the eyelid and the eye.

• 5. Place the tip of the bottle close to, but not touching the eye. Squeeze gently until a single drop is dispensed into the eye.

• 6. After using Latanoprost/Timolol Eye Drops, press a finger into the corner of your eye, by the nose for 2 minutes. This helps to stop latanoprost and timolol from getting into the rest of the body.

• 7. Repeat steps 4, 5 & 6 with the other eye if your doctor has told you so.

• 8. Put the cap back on and close the bottle straight after it has been used.

If you use Latanoprost / Timolol Eye Drops with other eye drops

Wait at least 5 minutes between using Latanoprost / Timolol Eye Drops and using the other eye drops.

If you use more Latanoprost / Timolol Eye Drops than you should

If you put too many drops in your eye you may experience some minor irritation in your eye and your eyes may water and turn red. This should pass but if you are worried contact your doctor for advice.

If you swallow Latanoprost / Timolol Eye Drops

If you swallow Latanoprost / Timolol Eye Drops accidentally you should contact your doctor for advice. If you swallow a lot of Latanoprost / Timolol Eye Drops you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.

If you forget to use Latanoprost / Timolol Eye Drops

Carry on with the usual dosage at the usual time. Do not use a double dose to make up to the dose you have forgotten. If you are unsure about anything talk to your doctor or pharmacist.

If you stop using Latanoprost / Timolol Eye Drops

If you want to stop using this medicine talk to your doctor first.

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

4. possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. You can usually carry on using the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist.

Do not stop using Latanoprost / Timolol Eye Drops without speaking to your doctor.

Listed below are the known side effects of using Latanoprost / Timolol Eye Drops. The most important side-effect is the possibility of a gradual, permanent change in your eye colour. It is also possible that Latanoprost / Timolol Eye Drops might cause serious changes in the way your heart works. If you notice changes in your heart rate or heart function you should speak to a doctor and tell them you have been using Latanoprost / Timolol Eye Drops.

The following are known side effects of using Latanoprost / Timolol Eye Drops:

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

• A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellowbrown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may take years to develop. The colour change may be permanent and may be more noticeable if you use Latanoprost / Timolol Eye Drops in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Latanoprost / Timolol Eye Drops treatment is stopped.

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

• Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation 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, watery eyes, inflammation of the eyelids, irritation or disruption of the surface of the eye.
• Skin rashes or itching (pruritus).

Other side effects

Like other medicines used in the eyes, Latanoprost / Timolol Eye Drops (latanoprost and timolol) is absorbed into the blood. The incidence of side effects after using eye drops is lower than when medicines are, for example, taken by mouth or injected.

Although not seen with Latanoprost / Timolol Eye Drops, the following additional side effects have been seen with the medicines in Latanoprost / Timolol Eye Drops (latanoprost and timolol) and therefore might occur when you use Latanoprost / Timolol Eye Drops:

The listed side effects include reactions seen within the class of beta-blockers (e.g. timolol) when used for treating eye conditions:

• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
• Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden lifethreatening allergic reaction.
• Low blood glucose levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of

myasthenia gravis (muscle disorder), unusual sensations like pins and needles, and headache.

• Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured part of the

eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).

• 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 below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.

• Darkening of the skin around the eyes, changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes to the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), scarring of the surface of the eye.
• Whistling/ringing in the ears (tinnitus).
• Angina, worsening of angina in patients who already have heart disease.
• Slow heart rate, chest pain, palpitations (awareness of heart rhythm), oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation which makes the fingers and toes numb and pale, cold hands and feet.
• Shortness of breath, constriction of the airways in the lungs (predominantly in patients with preexisting disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of

psoriasis, skin rash.

• Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness.
• Sexual dysfunction, decreased libido.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store latanoprost / timolol eye drops

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle label. The expiry date refers to the last day of that month.

Store the unopened bottle of Latanoprost / Timolol Eye Drops in a refrigerator (between 2 °C to 8 °C). After opening the bottle it is not necessary to store it in a refrigerator but do not store it above 25 °C. After opening do not use this bottle for more than 28 days. When you are not using Latanoprost / Timolol Eye Drops, keep the bottle in the outer carton, in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.

The other ingredients are: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, hydrochloric acid solution (for adjustment to pH 6.0), sodium hydroxide solution (for adjustment to pH 6.0), water for injections.

What Latanoprost / Timolol Eye Drops looks like and contents of the pack

Each ml contains approximately 34 drops of Latanoprost / Timolol 50 micrograms / ml + 5mg / ml Eye Drops, Solution. 1 ml eye drops solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate (equivalent to 5 mg timolol).

This pack contains one bottle containing 2.5 ml of Latanoprost / Timolol Eye Drops, Solution.

Latanoprost / Timolol Eye Drops is a clear, colorless liquid.

Latanoprost / Timolol Eye Drops is available in pack sizes:

1 × 2.5 ml (single 5 ml bottle)

3 × 2.5 ml (three 5 ml bottles)

6 × 2.5 ml (six 5 ml bottles)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Crescent Pharma Limited,

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton,

Hampshire RG25 3ED

United Kingdom

Manufacturer:

IMUNA PHARM, a.s.

Jarkova 269/17

Sarisske Michal'any 082 22

Slovak Republic

This leaflet was last revised in March 2020