LATANOPROST + TIMOLOL BAUSCH & LOMB 50 MICROGRAMS/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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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
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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
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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.
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After using Latanoprost + Timolol Bausch & Lomb you should wait 15 minutes before putting
your contact lenses back in.
Instructions for use
1.
2.
3.
4.
5.
6.

Wash your hands and sit or stand comfortably.
Twist off the cap.
Use your finger to gently pull down the lower eyelid of your affected eye.
Place the tip of the bottle close to, but not touching your eye.
Squeeze the bottle gently so that only 1 drop goes into your eye, then release the lower eyelid.
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.

4. Possible side effects
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.
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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, yellowbrown 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.
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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).

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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.
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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
Brunsbütteler 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}
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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