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LATANOPROST 50 MICROGRAMS/ML + TIMOLOL 5 MG/ML EYE DROPS

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TBC

LATANOPROST 50 MICROGRAMS/ml + TIMOLOL 5 mg/ml
EYE DROPS
(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 of the side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet, please tell you doctor or pharmacist.
Was is in this leaflet:
1. What Latanoprost/Timolol is and what it is used for.
2. What you need to know before you use Latanoprost/Timolol.
3. How to use Latanoprost/Timolol.
4. Possible side effects.
5. How to store Latanoprost/Timolol.
6. Contents of the pack and other information.
1. WHAT LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
Latanoprost/Timolol is a medicine for the treatment of increased intraocular pressure (pressure
inside the eye).
Latanoprost/Timolol is a drug combination containing two active substances: latanoprost (a
prostaglandin derivative) and timolol maleate (a beta‑blocker).
Fluid known as aqueous humour is produced inside the eye. This fluid is then drained back into
the bloodstream, thereby maintaining the required pressure within the eye. If this outflow is
obstructed, pressure within the eye increases.
Among other things, beta‑blockers reduce pressure inside the eye, by reducing the production of
aqueous humour. Prostaglandins promote the outflow of aqueous humour.
Latanoprost/Timolol is used:
• to reduce inner eye pressure in patients with open‑angle glaucoma (damage to the optic nerve,
caused by excessive pressure within the eye)
• to reduce inner eye pressure in patients for whom the effect of beta‑blockers or prostaglandin
derivatives alone is not sufficient.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
Do not use Latanoprost/Timolol:
• if you are allergic (hypersensitive) 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 a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).
Warning 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
• 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
• any kind of eye surgery (including cataract surgery)
• eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• dry eyes
• wear contact lenses. You can still use Latanoprost/Timolol but follow the instructions for
contact lens wearers in section 'Important information about some of the ingredients of
Latanoprost/Timolol'
• angina (particularly a type known as Prinzmetal angina)
• 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 as timolol
may change effects of some medicines used during anaesthesia.
Other medicines and Latanoprost/Timolol
Latanoprost/Timolol 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, have recently taken or might take any other
medicines (including eye drops). This also includes medicines obtained without a prescription.
Medicines can affect each other and interactions may occur. You must bear this in mind if you are
taking or using any of the following types of medicine:
• Calcium antagonists (e.g. in coronary heart disease or for high blood pressure)
Guanethidine (for high blood pressure)
Beta‑blockers (for high blood pressure)
Antiarrhythmics (medications that normalise the heart rhythm)
Digitalis glycosides (for heart failure)
Parasympathomimetic agents (e.g. for the treatment of glaucoma)
Taking/using Latanoprost/Timolol together with the above medicines can cause low blood
pressure and/or slow down the heart rate.
• Medicines that act in a similar way to Latanoprost/Timolol
If used at the same time as Latanoprost/Timolol, the effect of other medicines with a similar
action to Latanoprost/Timolol may be increased. For this reason, ophthalmic use (i.e. in the
eye) of two beta‑blockers or two prostaglandins, prostaglandin analogues or prostaglandin
derivatives is not recommended.
• Clonidine
If you are using the active substance clonidine to reduce inner eye pressure together with
Latanoprost/Timolol and you suddenly stop using clonidine, your blood pressure may rise. If you
are also using beta‑blockers at the same time to lower your blood pressure, your blood pressure
may ‑ due to this reverse effect ‑ rise even further.
• Quinidine (used to treat heart conditions and some types of malaria).
• Antidepressants known as fluoxetine and paroxetine.
• Epinephrine (adrenaline).
Children and adolescents
Latanoprost/Timolol is not recommended for children or adolescents.
Elderly patients
Latanoprost/Timolol is also suitable for the treatment of elderly patients.
Pregnancy and breast‑feeding Pregnancy
Do not use Latanoprost/Timolol if you are pregnant unless you doctor considers it necessary.
Breast‑feeding
Do not use Latanoprost/Timolol if you are breast‑feeding. Latanoprost/Timolol may get into
your milk.
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 taking this medicine.
Driving and using machines
After putting in Latanoprost/Timolol eye drops, your vision may become temporarily impaired.
If you should experience blurred vision – particularly after just putting in Latanoprost/Timolol
eye drops – you should:
• not drive any vehicles
• not use any tools or machines.
Latanoprost/Timolol contains benzalkonium chloride
This medicinal product contains a preservative called benzalkonium chloride which may cause eye
irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and
it is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at least 15 minutes before putting them
back in.
3. HOW TO USE LATANOPROST/TIMOLOL
Always use this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:
Adults, including elderly patients: insert one drop once a day into each affected eye.
Do not use Latanoprost/Timolol more than once a day, because the effectiveness of the treatment
can be reduced if you administer it more often.
Your doctor may want you to have extra checks on your heart and circulation if you use
Latanoprost/Timolol.
If you are using other eye drops in addition to Latanoprost/Timolol, these should be used at least
5 minutes apart.
Instructions for use:
1. Wash your hands and sit or stand in a comfortable position.
2. Remove the outer protective cap from the bottle.
3. Use your fingertip to gently pull down the lower lid of the affected eye.
4. Place the tip of the bottle close to, but not touching the eye. Carefully squeeze the bottle until
one drop falls into your eye. Please make sure that you do not squeeze the bottle too hard, so
that no more than one drop falls into the affected eye.
5. Let go of your eyelid.
6. After using Latanoprost/Timolol press a finger into the corner of your eye, by the nose for
2 minutes.
This helps to stop latanoprost/timolol getting into the rest of the body.

If prescribed by your doctor, repeat the procedure in your other eye. If the drop should miss
your eye, apply another drop.
7. Close the bottle.
If you use more Latanoprost/Timolol than you should
If too many drops have gone into your eye, irritation and redness may occur. This should pass but
if you are worried contact your doctor for advice.

TBC

Tell a doctor immediately if you or anyone else has swallowed the eye drops by mistake, or if
you have been using the drops more often than prescribed. If you swallow a lot of Latanoprost/
Timolol, you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.
Keep the pack of this medicine ready, so that the doctor can find out more about the medication.
He/she will then decide what to do next.

Description Latanoprost Timolol Maleate 5 mg / ml 2.5 ml

Date: 28 Oct 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 744742

SAP No. N/A

Colours

Superceded Affiliate Item Code 10005100
TrackWise PR No. 744742
MA No. 04569/1301
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 266125
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

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Time: 09:08
Page Count

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Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 150 x 640mm

Min Text Size used 7 pt

Sign-offs

v1/May 2015

TBC

If you forget to use Latanoprost/Timolol
If you have forgotten to use your eye drops, continue your treatment as normal at the next dose.
The daily dose of one drop into the affected eye should not be exceeded.
Do not use a double dose to make up for a forgotten dose.
If you stop using Latanoprost/Timolol
Do not interrupt or stop your treatment with Latanoprost/Timolol without talking to your
doctor first.
If you do not use Latanoprost/Timolol regularly or if you frequently forget to use it, the success of
your treatment may be at risk.
Increased intraocular pressure (pressure within the eye) can damage the optic nerve and worsen
your eyesight. Blindness may occur. Normally, you can barely feel increased intraocular pressure.
The disorder can only be diagnosed via an examination by an eye specialist. If you suffer from
increased intraocular pressure, regular eye tests are necessary, together with measurements
of inner eye pressure. Pressure within the eye should be measured at least every 3 months.
Visual field measurements and optic nerve examinations should be performed at least once
a year.
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.
Listed below are the known side effects of using eye drops containing the active substances
latanoprost and timolol. The most important side effect is the possibility of a gradual, permanent
change in your eye colour. It is also possible that eye drops containing the active substances
latanoprost and timolol 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.
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 without speaking to your doctor.
The following are known side effects of Latanoprost/Timolol.
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 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
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
Although not seen with Latanoprost/Timolol, the following additional side effects have been
seen with the medicines in Latanoprost/Timolol and therefore might occur when you use
Latanoprost/Timolol:
The following side effects have been seen with latanoprost: Infections and Infestations:
• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Nervous System Disorders:
• Dizziness.
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), dry eyes, damage or disruption to the
surface of the eye or cornea, swelling (oedema) of the cornea, fluid filled cyst within the coloured
part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of
the eye sulcus).
Heart (Cardiac) Disorders:
• Worsening of angina, awareness of heart rhythm (palpitations).
Breathing (Respiratory) Disorders:
• Asthma, worsening of asthma, shortness of breath.
Skin Disorders:
• Darkening of the skin around the eyes.
Muscle and Skeletal Disorders:
• Joint pain, muscle pain.
General Disorders:
• Chest pain.
Like other medicines applied into eyes, Latanoprost/Timolol is absorbed into the blood.
The timolol portion of this combination may cause similar side effects as seen with 'intravenous'
or 'oral' beta‑blocking agents. Incidence of side effects after topical ophthalmic administration
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 generalized 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,
and headache
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness),
inflammation of the eyelid, inflammation in the cornea, inflammation/irritation of the surface
of the eye (keratitis), visual changes/disturbances, 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
• Whistling/ringing in the ears (tinnitus)
• Slow heart rate, chest pain, palpitations, 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, discolouration/coldness of the fingers and toes (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.
If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via 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
Keep this medicine out of the sight and reach of children.
Do not use this medicineafter the expiry date which is stated on the bottle label and carton after
'EXP'. The expiry date refers to the last day of that month.
Please note the following storage instructions:
Unopened bottles: Store in a refrigerator at 2°C ‑ 8°C.
After the first opening of the bottle: Do not store above 25°C.
Once opened, you must discard the bottle ‑ with any remaining contents ‑ after 4 weeks.
Otherwise, there is a risk of eye infection.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect
the environment.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Latanoprost/Timolol contains
The active substances are: latanoprost and timolol maleate
1 ml eye drops contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate, equivalent
to 5.0 mg timolol.
The other ingredients are:
Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium
hydrogen phosphate dodecahydrate, purified water, sodium hydroxide for pH adjustment and
hydrochloric acid for pH adjustment.
What Latanoprost/Timolol looks like and contents of the pack
Latanoprost/Timolol is a clear, colourless liquid packed in a transparent dropper bottle with a
screw cap.
Latanoprost/Timolol is available in the following pack sizes:
1 dropper bottle containing 2.5 ml eye drops,
3 dropper bottles, each containing 2.5 ml eye drops,
6 dropper bottles, each containing 2.5 ml eye drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

744742

This leaflet was last revised in 10/2015

Description Latanoprost Timolol Maleate 5 mg / ml 2.5 ml

Date: 28 Oct 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 744742

SAP No. N/A

Colours

Superceded Affiliate Item Code 10005100
TrackWise PR No. 744742
MA No. 04569/1301
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 266125
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

TBC

Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100, Ilfov district, Romania.

1

Time: 09:08
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 150 x 640mm

Min Text Size used 7 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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