Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution

What is in this leaflet

1.    What Latanoprost/Timolol eye drops are and what they are 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 ARE AND WHAT THEY ARE USED FOR

Latanoprost/Timolol eye drops contain 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 either of the medicines in Latanoprost/Timolol eye drops (latanoprost or timolol), beta-blockers, or any of the other ingredients of this medicine (listed in section 6).

-    have now or have had in past respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).

-    have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).

Warnings and precautions

Talk to your doctor before using this medicine 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 eye drops and medicines obtained without a prescription.

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 if you know that you are using any of the following types of medicines:

-    medicines that contain prostaglandins or prostaglandin-like substances;

-    calcium channel blockers (e.g. nifedipine, verapamil or diltiazem) often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s syndrome;

-    digitalis glycosides (medicines used to relieve heart failure or treat abnormal heartbeat, e.g. digoxin);

-    medicines used to treat abnormal heartbeat, such as amiodarone;

-    clonidine and guanethidine, medicines used to treat high blood pressure;

-    other beta-blockers (e.g. other preparations of timolol both oral and/or ocular), which belong to the same group of medicines as timolol and could have an additive effect;

-    medicine to treat diabetes;

-    medicines to enable you to urinate more easily or in order to restore normal bowel movements (parasympathomimetics);

-    medicines that contain adrenaline (epinephrine);

-    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 and breast-feeding and fertility

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

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 have a baby.

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 breast-feeding.

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 contain benzalkonium chloride

Latanoprost/Timolol eye drops contain a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the surface of the eye. It can be absorbed by 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 EYE DROPS

Always use Latanoprost/Timolol eye drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

General instructions

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

The following steps will help you to use Latanoprost/Timolol eye drops

Wash your hands before using eye drops.

Twist off the colourless protective cap with the “wings”.

Unscrew the cap.

Using your forefinger, gently pull down the lower eyelid of the eye that is to be treated (figure 1).

Place the tip close to the eye but not touching your eye (figure 1). Squeeze gently, so that one drop falls into the eye (figure 1).

Release the lower eyelid.

After using Latanoprost/Timolol eye drops press a finger into the comer of your eye, by the nose (figure 2) for 2 minutes. This helps to stop latanoprost and timolol getting into the rest of the body.

9.    Repeat in your other eye if your doctor has told you to do this.

10.    Replace the cap after use.

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 dose at the usual time. Do not use a double dose to make up for a forgotten dose. If you are unsure about anything, talk to 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, yellow-brown 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)

-    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

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 following side effects have been seen with latanoprost:

-    Developing a viral infection of the eye caused by the herpes simplex virus (HSV)

-    Symptoms of allergic reaction (swelling and redness of the skin and rash)

-    Dizziness, tingling or numbness in 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 you may faint (syncope).

-    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/uveitus), swelling at the back of the eye (macular oedema), inflammation/irritation of the surface of the eye (keratitis), dry eyes, fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).

-    Whistling/ringing in the ears (tinnitus).

-    Worsening of angina, awareness of heart rhythm (palpitations)

-    Asthma, worsening of asthma, shortness of breath

-    Darkening of the skin around the eyes

-    Joint pain, muscle pain

-    Chest pain.

Like other medicines applied into eyes, Latanoprost/Timolol eye drops is absorbed into the blood. The timolol portion of this combination may cause similar side effects as seen with intravenous and/or oral beta-blocking agents. Incidence of side effects after topical ophthalmic application is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:

-    Generalised 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 generalised rash, itchiness, severe sudden life-threatening allergic reaction

-    Low blood glucose levels

-    Difficulty sleeping (insomnia),    depression,    nightmares, memory loss

-    Fainting, stroke, reduced blood    supply to the brain,    increases    in    signs and symptoms of

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

-    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, damage to the front layer of the eyeball (corneal erosion), drooping of the upper eyelid (making the eye stay half closed), double vision

-    Slow heart rate, chest pain, awareness of heart rhythm (palpitations), fluid build up (oedema), changes in the rhythm or speed of the heartbeat, heart disease with shortness of breath and swelling of the feet and legs due to fluid build up (congestive heart failure), a type of heart rhythm disorder, heart attack, heart failure

-    Low blood pressure, poor blood circulation which makes the toes and fingers numb and change colour (Raynaud's phenomenon), cold hands and feet

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

-    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

-    Muscle pain not caused by exercise

-    Sexual dysfunction, decreased libido

-    Muscle weakness/tiredness.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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.

Before Latanoprost/Timolol eye drops is first opened, it should be stored at 2°C - 8°C (in a refrigerator).

Once the bottle has been opened, Latanoprost/Timolol eye drops can be kept at room temperature (below 25°C) for up to 4 weeks.

Latanoprost/Timolol eye drops should not be used 4 weeks after opening the bottle for the first time. You can write the date you first opened the bottle on the bottle itself after “Opening:”.

Keep the container in the outer carton in order to protect from light.

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

Do not throw away 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 INFORMATION

What Latanoprost/Timolol eye drops contain

Each millilitre (1 ml) of Latanoprost/Timolol eye drops contain:

Active substances: 50 micrograms latanoprost and timolol maleate corresponding to 5mg timolol. Other ingredients: sodium dihydrogen phosphate monohydrate, sodium chloride, disodium phosphate anhydrous, benzalkonium chloride (preservative) and water for injections.

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

What Latanoprost/Timolol eye drops looks like and contents of the pack Latanoprost/Timolol eye drops is supplied in a dropper containing 2.5ml eye drops solution.

The droppers are singly packed.

The pack sizes are: 1 bottle x 2.5ml

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Hoechst-Biotika, spol. s. r. o.

Sklabinska 30, SK-036 80 Martin Slovakia

This leaflet was last revised in December 2015

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