LATANOPROST 50 MICROGRAMS/ML AND TIMOLOL 5MG/ML EYE DROPS SOLUTION
Active substance(s): LATANOPROST / TIMOLOL MALEATE / LATANOPROST / TIMOLOL MALEATE / LATANOPROST / TIMOLOL MALEATE
Package leaflet: Information for the user
Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution
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 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
WHAT LATANOPROST/TIMOLOL EYE DROPS ARE AND WHAT THEY ARE
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.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
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
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
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 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.
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
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
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
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.
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.
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 corner of your eye, by the
nose (figure 2) for 2 minutes. This helps to stop latanoprost and timolol getting into the rest of
Repeat in your other eye if your doctor has told you to do this.
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.
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
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)
Uncommon (may affect up to 1 in 100 people):
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
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 lifethreatening 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,
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
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
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
By reporting side effects you can help provide more information on the safety of this medicine.
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
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.
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.
Hoechst-Biotika, spol. s. r. o.
Sklabinská 30, SK-036 80 Martin
This leaflet was last revised in December 2015
If you would like a leaflet with larger text, please contact 01271
Pil Spec no
Actavis, Barnstaple,EX32 8NS, UK
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.