Skip to Content

LATANOPROST/TIMOLOL 50 MICROGRAMS/ML AND 5 MG/ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST / TIMOLOL MALEATE

View full screen / Print PDF » Download PDF ⇩
Transcript
RPXP260BNA

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST/TIMOLOL 50 micrograms/ml and 5mg/ml eye
drops, solution
latanoprost/timolol
because it contains important information for you.
- 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.
-

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
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).
then drained back into the bloodstream, thereby maintaining the required
increases.
Among other things, beta-blockers reduce pressure inside the eye, by
reducing the production of aqueous humour. Prostaglandins promote the
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).
beta-blockers or prostaglandin derivaties alone is not sufficient

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
LATANOPROST/TIMOLOL
Do not use Latanoprost/Timolol eye drops, solution
- if you are allergic to latanoprost or timolol, beta-blockers or any of the
other ingredients of Latanoprost/Timolol (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
- if you have serious heart problems or heart rhythm disorders
- if you are pregnant (or trying to become pregnant)
- if you are breast-feeding.
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
- 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)
vision)
- dry eyes
- wear contact lenses. You can still use Latanoprost/Timolol but follow the
instructions for contact lens wearers in section “Latanoprost/Timolol
contains”
- angina (particularly a type known as Prinzmetal angina)
- severe allergic reactions that would usually require hospital treatment
eye caused by the herpes simplex virus (HSV)
Tell your doctor before you have an operation that you are using
medicines used during anaesthesia.
Other medicines and Latanoprost/Timolol
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines (including eye drops).
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
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
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
Quinidine (used to treat heart conditions and some types of malaria)
Antidepressants
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 and fertility
Pregnancy
Do not use Latanoprost/Timolol if you are pregnant unless your doctor
considers it necessary.
Breast-feeding
Do not use Latanoprost/Timolol if you are breast-feeding. Latanoprost/
Timolol may get into your milk.
Ask your doctor or pharmacist for advice before taking any medicine during
pregnancy or breast-feeding.
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
This medicinal product contains benzalkonium chloride which may cause
eye irritation. Avoid contact with soft contact lenses. Remove contact lenses
prior to application and wait at least 15 minutes before putting them back
in. Benzalkonium chloride is known to discolour soft contact lenses.

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
.
If you are using other eye drops in addition to Latanoprost/Timolol, these
should be used at least 5 minutes apart.
Directions for use
1. Wash your hands and sit or stand in a comfortable position.
2. Remove the outer protective cap from the bottle.
3.
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
5. Let go of your eyelid.
6.
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. 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.
about the medication. He/she will then decide what to do next.
If you forget to use Latanoprost/Timolol
If you have forgotten to use your eye drops, continue your treatment as
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
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
increased intraocular pressure, regular eye tests are necessary, together
with measurements of inner eye pressure. Pressure within the eye should
nerve examinations should be performed at least once a year.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
everybody gets them.
serious. If you are worried, talk to a doctor or pharmacist. Do not stop using
Latanoprost/Timolol without speaking to your doctor.
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.
following convention:
Very common
• 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
• Eye irritation (a feeling of burning, grittiness, itching, stinging or the
sensation of a foreign body in the eye) and eye pain.
Uncommon
• Headache.
• Redness of the eye, eye infection (conjunctivitis), blurred vision, watery
the eye
• Skin rashes or itching (pruritus)

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:
from this condition), sudden fainting or feeling you may faint (syncope).
Eye Disorders:
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),
(photophobia), sunken eye appearance (deepening of the eye sulcus).
Ear Disorders:
• Whistling/ringing in the ears (tinnitus).
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
lower than when medicines are, for example, taken by mouth or injected.
when used for treating eye conditions:
• Generalized 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.
• 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,
cornea, blurred vision and detachment of the layer below the retina that
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.
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
• Low blood pressure, Raynaud’s phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with
• 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, nurse or pharmacist. 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
Keep out of the sight and reach of children.
Do not use this medicine after 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.
Once opened, you must discard the bottle - with any remaining contents after 4 weeks. Otherwise, there is a risk of eye infection.
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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER 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
Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK.
Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100,
IIfov., Romania
This leaflet was last revised 07/2015.
RPXP260BNA

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.

Hide