PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost + Timolol Bausch & Lomb 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. 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.

What is in this leaflet:

1.    What Latanoprost + Timolol Bausch & Lomb is and what it is used for

2.    What you need to know before you use Latanoprost + Timolol Bausch & Lomb

3.    How to use Latanoprost + Timolol Bausch & Lomb

4.    Possible side effects

5.    How to store Latanoprost + Timolol Bausch & Lomb

6.    Contents of the pack and other information

1. What Latanoprost + Timolol Bausch & Lomb is and what it is used for

Latanoprost + Timolol Bausch & Lomb contains two medicines: latanoprost and timolol.

•    Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. It belongs to a group of medicines known as prostaglandin analogues.

•    Timolol works by slowing the formation of fluid in the eye. It belongs to a group of medicines known as beta-blockers.

Latanoprost + Timolol Bausch & Lomb is used to reduce the pressure in your eye if you have open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, which eventually affects your eyesight. Your doctor will usually prescribe you Latanoprost + Timolol Bausch & Lomb when other medicines have not worked adequately.

2. What you need to know before you use Latanoprost + Timolol Bausch & Lomb

Latanoprost + Timolol Bausch & Lomb can be used in adult men and women, including the elderly. It is not recommended for use if you are less than 18 years of age.

Do not use Latanoprost + Timolol Bausch & Lomb eye drops solution

•    if you are allergic to latanoprost, 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 or 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

If any of these apply to you, do not use Latanoprost + Timolol Bausch & Lomb.

Warnings and precautions

Before you use this medicine, tell your doctor:

•    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 (hypotension)

•    if you have now or have had in the past disturbances of heart rate such as slow heart beat (bradycardia)

• if you suffer from angina, particularly a type known as Prinzmetal angina

•    if you suffer from circulatory problems or have low blood pressure

•    if you have now or have had in the past breathing problems, asthma or chronic obstructive pulmonary disease (lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough

•    if you have lung disease or problems with your lungs that cause difficulty breathing

•    if you have now or have had in the past poor blood circulation disease (peripheral arterial disease such as Raynaud’s disease or Raynaud’s syndrome)

•    if you have now or have had in the past diabetes as latanoprost/timolol may mask signs and symptoms of low blood sugar

•    if you have now or have had in the past overactivity of the thyroid gland as latanoprost/timolol may mask signs and symptoms

•    if you suffer from severe allergic reactions that usually require hospital treatment

•    if you are about to have eye surgery (including cataract surgery) or have had any eye surgery in the past

•    if you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV)

•    if you suffer from eye problems such as eye pain, eye irritation, eye inflammation, blurred vision, or dry eyes

•    if you wear contact lenses. You can still use Latanoprost + Timolol Bausch & Lomb but follow the instructions for contact lens wearers in Section 3

Your doctor may want you to have extra checks on your heart and circulation if you use Latanoprost + Timolol Bausch & Lomb.

Tell your doctor before you have an operation that you are using Latanoprost + Timolol Bausch & Lomb as latanoprost/timolol may change effects of some medicines used during anaesthesia.

Other medicines and Latanoprost + Timolol Bausch & Lomb

Latanoprost + Timolol Bausch & Lomb may interact with other medicines.-Please tell your doctor or pharmacist if you are taking or have recently taken eye drops or any other medicines, including medicines obtained without a prescription.

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

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

If you use Latanoprost + Timolol Bausch & Lomb with other eye drops

Wait at least 5 minutes between using Latanoprost + Timolol Bausch & Lomb and using the other eye drops.

Latanoprost + Timolol Bausch & Lomb 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. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Latanoprost + Timolol Bausch & Lomb 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.

Do not use Latanoprost + Timolol Bausch & Lomb if you are breast-feeding. Latanoprost/timolol may get into your milk.

Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines

When you use Latanoprost + Timolol Bausch & Lomb 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 Bausch & Lomb contains 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.

3. How to use Latanoprost + Timolol Bausch & Lomb

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

After using Latanoprost + Timolol Bausch & Lomb, press a finger into the corner of your eye, by the nose (see the picture below) by 2 minutes. This helps to stop latanoprost/timolol getting into the rest of the body.

Dosage

The usual dose for adults (including the elderly) is 1 drop once a day in the affected eye(s).

Do not use Latanoprost + Timolol Bausch & Lomb more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use in children and adolescents

Latanoprost + Timolol Bausch & Lomb is not recommended for use in children or adolescents (aged from birth to 18 years of age).

Contact lens wearers

If you wear contact lenses, you should remove them before using Latanoprost + Timolol Bausch & Lomb.

After using Latanoprost + Timolol Bausch & Lomb 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.    Twist off the cap.

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

4.    Place the tip of the bottle close to, but not touching your eye.

5.    Squeeze the bottle gently so that only 1 drop goes into your eye, then release the lower eyelid.

6.    Close the eye and press a finger against the corner of the affected eye by the nose.

Hold for 1 minute.

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

8.    Put the cap back on the bottle.

If you use Latanoprost + Timolol Bausch & Lomb with other eye drops

Wait at least 5 minutes between using Latanoprost + Timolol Bausch & Lomb and using the other eye drops.

Duration of use

Use Latanoprost + Timolol Bausch & Lomb as instructed by your doctor until your doctor tells you to stop.

If you use more Latanoprost + Timolol Bausch & Lomb 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 Bausch & Lomb

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

If you forget to use Latanoprost + Timolol Bausch & Lomb

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

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

Like all medicines Latanoprost + Timolol Bausch & Lomb eye drops solution can cause side effects, although not everybody gets them.

You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not stop using Latanoprost + Timolol Bausch & Lomb without speaking to your doctor.

The frequency of possible side effects listed below is defined using the following convention Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people)

Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people

Not known: frequency cannot be estimated from the available data

Most important side-effects to note are:

•    the possibility of a gradual, permanent change in your eye colour

•    serious changes to the way your heart works. If you notice changes in your heart rate or heart function you should speak to a doctor.

The following are known side effects of using Latanoprost + Timolol Bausch & Lomb:

Very common effects:

Latanoprost + Timolol Bausch & Lomb may change your eye colour, with a gradual increase in the amount of brown pigment. There appears to be no problem associated with this and changes may take years to develop. However, if you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change.

The colour change may be permanent and may be more noticeable if you use Latanoprost + Timolol Bausch & Lomb in only one eye. The eye colour change does not continue after Latanoprost + Timolol Bausch & Lomb treatment is stopped.

Common effects:

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

Uncommon effects:

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)

Like other medicines applied into the eyes (topically applied ophthalmic drugs), latanoprost/timolol is absorbed into the blood. This may cause similar side effects as seen with systemic beta-blocking agents. Side effects after topical application into the eyes are lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of ophthalmic beta-blockers when used for treating eye conditions:

Systemic allergic reactions including sudden swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema), hives (urticaria), localized and generalized rash, itchiness (pruritus), sudden life-threatening allergic reaction (anaphylactic reaction).

Low sugar levels in the blood (hypoglycaemia).

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

Fainting (syncope), stroke (cerebrovascular accident), decreased blood flow to parts of the brain (cerebral ischemia), increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, tingling or numbness of hands and feet, pins and needles (paraesthesia), and headache.

Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), swollen eyelid (blepharitis), irritation or feeling of having something in the eye (keratitis), blurred vision and low eye pressure and visual disturbances after an

eye operation (choroidal detachment following filtration surgery), decreased corneal sensitivity, dry eyes, damage to the front layer of the eyeball (corneal erosion), drooping of the upper or lower eyelid (ptosis), double vision (diplopia).

Slow heart beat (bradycardia), chest pain, palpitations, fluid build up (oedema), changes in the rhythm or speed of the heart beat (arrhythmia), heart disease with shortness of breath and swelling of the feet and legs due to fluid build up (congestive heart failure), heart condition (atrioventricular block), heart attack (cardiac arrest), heart (cardiac) failure.

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

Bronchospasm wheezing or difficulty breathing - usually in patients with pre-existing bronchospastic disease), shortness of breath (dyspnoea), cough.

Taste disturbances (dysgeusia), nausea, indigestion (dyspepsia), diarrhoea, dry mouth, abdominal pain, vomiting.

Hair loss (alopecia), skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

Muscle weakness or pain not caused by exercise (myalgia).

Sexual dysfunction, decreased libido.

Asthenia/fatigue.

Unusual muscle weakness or pain not caused by exercise (asthenia) or tiredness (fatigue).

Other side effects

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

Infections and Infestations:

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

Immune System Disorders:

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

Psychiatric Disorders:

Depression, memory loss, decreased sex drive, inability to sleep, nightmares.

Nervous System Disorders:

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).

Eye Disorders:

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), iris cyst, dry eyes, visual changes/disturbances, double vision, drooping of the upper eyelid and injury to the lining of the back of the eye (a condition known as retinal detachment, but only seen when used following some kinds of eye surgery).

Ear Disorders:

Whistling/ringing in the ears (tinnitus).

Heart (Cardiac) Disorders:

Worsening of angina, awareness of heart rhythm (palpitations), changes in heart rhythm, slowing of the heart, heart failure (cardiac arrest, heart block or congestive heart failure).

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 Bausch & Lomb.

Bloodflow (Vascular) Disorders:

Low blood pressure, discolouration/coldness of the fingers and toes (Raynaud’s phenomenon) and coldness of the hands and feet.

Breathing (Respiratory) Disorders:

Asthma, worsening of asthma, shortness of breath, sudden difficulty to breathe (bronchospasm), cough.

Digestive System (Gastrointestinal) Disorders:

Feeling sick (nausea), diarrhoea, dyspepsia, dry mouth.

Skin Disorders:

Darkening of the skin around the eyes, hair loss/baldness (alopecia), itchy rash or worsening of itchy skin conditions.

Muscle and Skeletal Disorders:

Joint pain, muscle pain

General Disorders:

Chest pain, fatigue, swelling (oedema)

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. How to store Latanoprost + Timolol Bausch & Lomb

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

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

Store the unopened bottle of Latanoprost + Timolol Bausch & Lomb 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 first opening do not use this bottle for more than 4 weeks.

When you are not using Latanoprost + Timolol Bausch & Lomb, keep the bottle in the outer carton, 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 to protect the environment.

6. Contents of the pack and other information

What Latanoprost + Timolol Bausch & Lomb contains

The 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

Water, highly purified

What Latanoprost + Timolol Bausch & Lomb looks like and contents of the pack

This pack contains one bottle containing 2.5 ml of Latanoprost + Timolol Bausch & Lomb Eye Drops, Solution.

Latanoprost + Timolol Bausch & Lomb is a clear, colourless liquid.

Latanoprost + Timolol Bausch & Lomb is available in the following pack sizes: one bottle of 2.5 ml, 3 bottles of 2.5 ml and 6 bottles of 2.5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

BAUSCH & LOMB U.K. LIMITED, 106 LONDON ROAD, KINGSTON UPON THAMES, SURREY, KT2 6TN, UNITED KINGDOM

Manufacturer

Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH Brunsbutteler Damm 165 - 173 13581 Berlin Germany

Phone: ++49 (0)30 33093 0 Fax: ++49 (0)30 33093 350 E-Mail: ophthalmika@bausch.com

This medicinal product is authorised in the Member States of the EEA under the following names

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in 02/2012.

Other sources of information

Detailed information on this medicine is available on the web site of {MA/Agency}

Page 8 of 8