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TIMOLOL 0.25 % W/V EYE DROPS SOLUTION

Active substance(s): TIMOLOL MALEATE / TIMOLOL MALEATE / TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



®

Timoptol 0.25% w/v Eye Drops Solution
(timolol maleate)
Read all of this leaflet carefully before you start using this medicine.
 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
This product is also available in other strengths.
®
Your medicine is called as Timoptol 0.25% w/v Eye Drops Solution, but it will
be referred as Timoptol throughout this leaflet.
In this leaflet:
1. What Timoptol is and what it is used for
2. Before you use Timoptol
3. How to use Timoptol
4. Possible side effects
5. How to store Timoptol
6. Further information

1. WHAT TIMOPTOL IS AND WHAT IT IS USED FOR
Timoptol contains a substance called timolol maleate which belongs to a group
of medicines called beta-blockers.
Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when
the pressure in the eye is raised.

2. BEFORE YOU USE TIMOPTOL
Do not use Timoptol if:
 you are allergic (hypersensitive) to timolol maleate, beta-blockers or any of
the other ingredients of Timoptol (see section 6 for Further Information)
 you have now or have had in the 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)
 you have heart problems
 slow heart beat
 disorders of heart rhythm (irregular heart beats)
 heart failure
- “cardiogenic shock” – a serious heart condition caused by very low
blood pressure, which may result in the following symptoms: dizziness
and lightheadedness, fast pulse rate, white skin, sweating, restlessness,
loss of consciousness.
If you are not sure whether you should use Timoptol talk to your doctor or
pharmacist.
Take special care with Timoptol
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 maleate may mask signs and symptoms of low blood
sugar

overactivity of the thyroid gland as timolol maleate may mask signs and
symptoms

you wear soft contact lenses. Your eye drops contain a preservative
which can be deposited on soft contact lenses. It is important that your
lenses are removed before using your eye drops and not put back into
your eyes for 15 minutes.
Tell your doctor before you have an operation that you are using Timoptol as
timolol maleate may change effects of some medicines used during
anaesthesia.
If your eye becomes irritated or any new eye problems come on, talk to your
doctor straight away. Eye problems could include redness of the eye or
swelling of the eyelids (see Section 4: Possible Side Effects).
If you suspect that Timoptol is causing an allergic reaction or hypersensitivity
(for example, skin rash, or redness and itching of the eye), stop using Timoptol
and contact your doctor immediately.
Tell your doctor if:
 you get an eye infection
 you injure your eye or have an operation on it
 your eye problems get worse or you get any new symptoms.
Use in children and adolescents
There is only very limited data available on the use of timolol maleate in
infants and children. For example, in one small clinical study, timolol maleate,
the active ingredient in Timoptol eye drops, has been studied in infants and
children aged 12 days to 5 years, who have elevated pressure in the eye(s) or
have been diagnosed with glaucoma.
For more information, talk to your doctor.
Timoptol should generally be used with caution in young patients. In newborns,
infants and younger children Timoptol should be used with extreme caution. If
coughing, wheezing, abnormal breathing or abnormal pauses in breathing
(apnoea) occur, the use of the medication should be stopped immediately.
Contact your doctor as soon as possible. A portable apnoea monitor may also
be helpful.
Using other medicines
Timoptol 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 other eye drops
or medicines obtained without a prescription.
It is important to tell your doctor before using Timoptol if you are taking one or
more of the following medicines:
 a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used
to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s
syndrome
 digoxin, a medicine used to relieve heart failure or treat abnormal
heartbeat







medicines known as catecholamine-depleting agents, such as rauwolfia
alkaloids or reserpine, used for high blood pressure
medicines called pressor amines, such as adrenaline used to treat severe
allergic reaction
quinidine (used to treat heart conditions and some types of malaria)
antidepressants known as fluoxetine and paroxetine
clonidine, a medicine used to treat high blood pressure
other beta-blockers taken by mouth or used as eye drops, because they
belong to the same group of medicines as Timoptol and could have an
additive effect.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
Do not use Timoptol if you are pregnant unless your doctor considers it
necessary.
Use in breast-feeding
Do not use Timoptol if you are breast-feeding. Timolol maleate may get into
your milk. Ask your doctor for advice before taking any medicine during breastfeeding.
Driving and using machines
There are possible side effects associated with Timoptol, such as dizziness,
tiredness and changes in your eyesight, such as blurred vision, drooping of the
upper eyelid (making the eye stay half closed), double vision which may affect
your ability to drive and/or operate machinery. Do not drive and/or operate
machinery until you feel well and your vision is clear.

3. HOW TO USE TIMOPTOL
Always use Timoptol eye drops solution exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure. The
doctor will decide how many drops you should take each day and how long
you should use them.
The usual dose is one drop in the affected eye(s) twice each day:
 one in the morning
 one in the evening.
Do not change your usual dose without talking to your doctor.
Do not allow the tip of the container to touch the eye or areas around the eye.
It may become contaminated with bacteria that can cause eye infection
leading to serious damage of the eye, even loss of vision. To avoid possible
contamination of the container, keep the tip of the container away from contact
with any surface.
Instructions for use.
It is recommended that you wash your hands before putting in your eye drops.
1. Before using the medication for the first time, be sure the Safety Strip on
the front of the bottle is unbroken. A gap between the bottle and the cap is
normal for an unopened bottle.

2. Tear off the safety strip to break the seal.

3. To open the bottle, unscrew the cap by turning as indicated by the arrows
on top of the cap. Do not pull the cap directly up and away from the bottle.
Pulling the cap directly up will prevent your dispenser from operating
properly.

4. Tilt your head back and pull your lower eyelid down slightly to form a
pocket between your eyelid and your eye.

Like other medicines applied into eyes, timolol is absorbed into the blood. This
may cause similar side effects as seen with intravenous and/or oral betablocking 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 betablockers when used for treating eye conditions.
If you develop 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, itchness, severe sudden life-threatening allergic reaction,
stop taking your eyes drops and seek medical attention immediately.
Low blood glucose levels.

5. Invert the bottle, and press lightly with your thumb or first finger over the
‘Finger-Push Area’ as shown until a single drop is dispensed into your eye,
as directed by your doctor.

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 tingling or 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, 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, sensitivity to light, discharge from the eye, pain in the eye.
Ringing sound in the ears.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

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, fainting, interference with the blood supply to the brain
which may lead to a stroke, Raynaud’s phenomenon, cold hands and feet,
limping because there is a reduced blood supply to your legs.
Constriction of the airways in the lungs (predominantly in patients with preexisting disease), difficulty breathing, shortness of breath, wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting.

6. After using Timoptol, press a finger into the corner of your eye, by the nose
for 2 minutes. This helps to stop timolol maleate getting into the rest of
your body.
Ophthalmic medications, if handled improperly, can become contaminated
by common bacteria known to cause infections. Serious damage to the
eye and subsequent loss of vision may result from using contaminated
ophthalmic medications. If you think your medication may be contaminated,
or if you develop an eye infection, contact your doctor immediately
concerning continued use of this bottle.
7. If drop dispensing is difficult after opening for the first time, replace the cap
on the bottle and tighten (do not overtighten) and then remove by turning
the cap in the opposite direction as indicated by the arrows on top of the
cap.
8. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
9. Replace the cap by turning until it is firmly touching the bottle. The arrow
on the left side of the cap must be aligned with the arrow on the left side of
the bottle label for proper closure. Do not overtighten or you may damage
the bottle and cap.
10. The dispenser tip is designed to provide a single drop; therefore do NOT
enlarge the hole of the dispenser tip.
11. After you have used all doses there will be some Timoptol left in the bottle.
You should not be concerned since an extra amount of Timoptol has been
added and you will get the full amount of Timoptol that your doctor has
prescribed. Do not attempt to remove the excess medicine from the bottle.
Use in children and adolescents
Before you or your child starts to take Timoptol, your doctor or your child’s
doctor will have carried out a detailed medical examination and decided
whether or not this medicine is suitable. You or your child, especially a
newborn, should be closely monitored for one to two hours after the first dose
and carefully monitored for any signs of side effects until surgery is carried out.
Method of administration:
One drop only of Timoptol should be instilled into the affected eye(s) each time.
Follow the “Instructions for Use” above when administering the eye drops.
After instillation keep the eyes closed for as long as possible (e.g. 3-5 minutes)
and apply pressure to the corner of the eye closest to the nose to prevent the
eye drops spreading throughout the body.
Duration of treatment:
Your doctor or your child’s doctor will decide for how long the eye drops will be
needed.
If you use more Timoptol than you should
If you put too many drops in your eye or swallow any of the drops, you may:
 have a headache
 feel dizzy or light-headed
 have difficulty breathing
 chest pain
 feel that your heart rate has slowed down.
If this happens, contact your doctor immediately.
If you forget to use Timoptol
It is important to take Timoptol as prescribed by your doctor.
 If you miss a dose, use the drops as soon as possible.
 If it is almost time for the next dose, skip the missed dose and take the
next dose at the usual time.
 Do not take a double dose to make up for the forgotten dose.
If you stop using Timoptol
If you want to stop using this medicine talk to your doctor first. If you have any
further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Timoptol 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 Timoptol
without speaking to your doctor.

Sexual dysfunction, decreased sex drive, decreased libido. In men a condition
which affects your penis called Peyronie’s disease. The signs may be
abnormal curve, pain or hardening of the tissue of your penis.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash)
or worsening of psoriasis, skin rash, itching.
Muscle weakness/tiredness, muscle pain not caused by exercise.
A condition called lupus (systemic lupus erythematosus).
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 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 TIMOPTOL
Keep your eye drops out of the sight and reach of children.
 Do not store your eye drops above 25℃.
 Store the bottle in the outer carton in order to protect from light.
 You can use Timoptol for 28 days after first opening the bottle.
Do not use Timoptol 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. Make
sure the container is properly closed.
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. FURTHER INFORMATION
What Timoptol contains
The active substance is timolol maleate.
Each ml contains timolol maleate equivalent to 5mg of timolol.
The other ingredients are:
 benzalkonium chloride as preservative,
 disodium phosphate dodecahydrate,
 sodium dihydrogen phosphate dihydrate,
 sodium hydroxide,
 water for injections.
What Timoptol looks like and contents of the pack
The OCUMETER Plus ophthalmic dispenser consists of a translucent highdensity polyethylene container with a sealed dropper tip. The OCUMETER
Plus ophthalmic dispenser contains 5 ml of solution. The solution is clear,
colorless to light yellow, sterile eye drops solution.
Manufactured by: Merck Sharp and Dohme B.V., P.B. 581- Waarderweg 39,
NL-2003 PC HAARLEM.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate,
Slough, SL1 4NL, UK

Timoptol® 0.25% w/v Eye Drops Solution,
PL 39352/0143

POM

Leaflet date: 05/01/2016
®

Timoptol is a registered trademark of Merck & Corp., a subsidiary of Merck &
Co., Inc., Whitehouse Station, New Jersey, U.S.A.

PACKAGE LEAFLET: INFORMATION FOR THE USER



Timolol 0.25% w/v Eye Drops Solution
(timolol maleate)



Read all of this leaflet carefully before you start using this medicine.
 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
This product is also available in other strengths.
Your medicine is called as Timolol 0.25% w/v Eye Drops Solution, but it will be
referred as Timolol throughout this leaflet.
In this leaflet:
1.
What Timolol is and what it is used for
2.
Before you use Timolol
3.
How to use Timolol
4.
Possible side effects
5.
How to store Timolol
6.
Further information

1. WHAT TIMOLOL IS AND WHAT IT IS USED FOR
Timolol contains a substance called Timolol maleate which belongs to a group
of medicines called beta-blockers.
Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when
the pressure in the eye is raised.

2. BEFORE YOU USE TIMOLOL
Do not use Timolol if:
 you are allergic (hypersensitive) to Timolol maleate, beta-blockers or any
of the other ingredients of Timolol (see section 6 for Further Information)
 you have now or have had in the 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)
 you have heart problems
 slow heart beat
 disorders of heart rhythm (irregular heart beats)
 heart failure
- “cardiogenic shock” – a serious heart condition caused by very low
blood pressure, which may result in the following symptoms: dizziness
and lightheadedness, fast pulse rate, white skin, sweating, restlessness,
loss of consciousness.
If you are not sure whether you should use Timolol talk to your doctor or
pharmacist.
Take special care with Timolol
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 maleate may mask signs and symptoms of low blood
sugar

overactivity of the thyroid gland as timolol maleate may mask signs and
symptoms

you wear soft contact lenses. Your eye drops contain a preservative
which can be deposited on soft contact lenses. It is important that your
lenses are removed before using your eye drops and not put back into
your eyes for 15 minutes.






medicines known as catecholamine-depleting agents, such as rauwolfia
alkaloids or reserpine, used for high blood pressure
medicines called pressor amines, such as adrenaline used to treat severe
allergic reaction
quinidine (used to treat heart conditions and some types of malaria)
antidepressants known as fluoxetine and paroxetine
clonidine, a medicine used to treat high blood pressure
other beta-blockers taken by mouth or used as eye drops, because they
belong to the same group of medicines as Timolol and could have an
additive effect

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
Do not use Timolol if you are pregnant unless your doctor considers it
necessary.
Use in breast-feeding
Do not use Timolol if you are breast-feeding. Timolol maleate may get into
your milk. Ask your doctor for advice before taking any medicine during breastfeeding.
Driving and using machines
There are possible side effects associated with Timolol, such as dizziness,
tiredness and changes in your eyesight, such as blurred vision, drooping of the
upper eyelid (making the eye stay half closed), double vision which may affect
your ability to drive and/or operate machinery. Do not drive and/or operate
machinery until you feel well and your vision is clear.

3. HOW TO USE TIMOLOL
Always use Timolol eye drops solution exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure. The
doctor will decide how many drops you should take each day and how long
you should use them.
The usual dose is one drop in the affected eye(s) twice each day:
 one in the morning
 one in the evening.
Do not change your usual dose without talking to your doctor.
Do not allow the tip of the container to touch the eye or areas around the eye.
It may become contaminated with bacteria that can cause eye infection
leading to serious damage of the eye, even loss of vision. To avoid possible
contamination of the container, keep the tip of the container away from contact
with any surface.
Instructions for use.
It is recommended that you wash your hands before putting in your eye drops.
1. Before using the medication for the first time, be sure the Safety Strip on
the front of the bottle is unbroken. A gap between the bottle and the cap is
normal for an unopened bottle.

2. Tear off the safety strip to break the seal.

Tell your doctor before you have an operation that you are using Timolol as
timolol maleate may change effects of some medicines used during
anaesthesia.
If your eye becomes irritated or any new eye problems come on, talk to your
doctor straight away. Eye problems could include redness of the eye or
swelling of the eyelids (see Section 4: Possible Side Effects).
If you suspect that Timolol is causing an allergic reaction or hypersensitivity
(for example, skin rash, or redness and itching of the eye), stop using Timolol
and contact your doctor immediately.
Tell your doctor if:
 you get an eye infection
 you injure your eye or have an operation on it
 your eye problems get worse or you get any new symptoms.
Use in children and adolescents
There is only very limited data available on the use of timolol maleate in
infants and children. For example, in one small clinical study, timolol maleate,
the active ingredient in Timolol eye drops, has been studied in infants and
children aged 12 days to 5 years, who have elevated pressure in the eye(s) or
have been diagnosed with glaucoma. For more information, talk to your doctor.
Timolol should generally be used with caution in young patients. In newborns,
infants and younger children Timolol should be used with extreme caution. If
coughing, wheezing, abnormal breathing or abnormal pauses in breathing
(apnoea) occur, the use of the medication should be stopped immediately.
Contact your doctor as soon as possible. A portable apnoea monitor may also
be helpful.
Using other medicines
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 or have recently taken any other medicines, including other eye drops
or medicines obtained without a prescription.
It is important to tell your doctor before using Timolol if you are taking one or
more of the following medicines:
 a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used
to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s
syndrome
 digoxin, a medicine used to relieve heart failure or treat abnormal
heartbeat

3. To open the bottle, unscrew the cap by turning as indicated by the arrows
on top of the cap. Do not pull the cap directly up and away from the bottle.
Pulling the cap directly up will prevent your dispenser from operating
properly.

4. Tilt your head back and pull your lower eyelid down slightly to form a
pocket between your eyelid and your eye.

Like other medicines applied into eyes, timolol is absorbed into the blood. This
may cause similar side effects as seen with intravenous and/or oral betablocking 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 betablockers when used for treating eye conditions.
If you develop 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, itchness, severe sudden life-threatening allergic reaction,
stop taking your eyes drops and seek medical attention immediately.
Low blood glucose levels.
Difficulty sleeping (insomnia) depression, nightmares, memory loss.

5. Invert the bottle, and press lightly with your thumb or first finger over the
‘Finger-Push Area’ as shown until a single drop is dispensed into your eye,
as directed by your doctor.

Fainting, stroke, reduced blood supply to the brain, increases in signs and
symptoms of myasthenia gravis (muscle disorder), dizziness, unusual
sensations like tingling or 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, 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, sensitivity to light, discharge from the eye, pain in the eye.
Ringing sound in the ears.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

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, fainting, interference with the blood supply to the brain
which may lead to a stroke, Raynaud’s phenomenon, cold hands and feet,
limping because there is a reduced blood supply to your legs.
Constriction of the airways in the lungs (predominantly in patients with preexisting disease), difficulty breathing, shortness of breath, wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting.

6. After using Timolol, press a finger into the corner of your eye, by the nose
for 2 minutes. This helps to stop timolol maleate getting into the rest of
your body.
Ophthalmic medications, if handled improperly, can become contaminated
by common bacteria known to cause infections. Serious damage to the
eye and subsequent loss of vision may result from using contaminated
ophthalmic medications. If you think your medication may be contaminated,
or if you develop an eye infection, contact your doctor immediately
concerning continued use of this bottle.
7. If drop dispensing is difficult after opening for the first time, replace the cap
on the bottle and tighten (do not overtighten) and then remove by turning
the cap in the opposite direction as indicated by the arrows on top of the
cap.
8. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
9. Replace the cap by turning until it is firmly touching the bottle. The arrow
on the left side of the cap must be aligned with the arrow on the left side of
the bottle label for proper closure. Do not overtighten or you may damage
the bottle and cap.
10. The dispenser tip is designed to provide a single drop; therefore do NOT
enlarge the hole of the dispenser tip.
11. After you have used all doses there will be some Timolol left in the bottle.
You should not be concerned since an extra amount of Timolol has been
added and you will get the full amount of Timolol that your doctor has
prescribed. Do not attempt to remove the excess medicine from the bottle.
Use in children and adolescents
Before you or your child starts to take Timolol, your doctor or your child’s
doctor will have carried out a detailed medical examination and decided
whether or not this medicine is suitable. You or your child, especially a
newborn, should be closely monitored for one to two hours after the first dose
and carefully monitored for any signs of side effects until surgery is carried out.
Method of administration:
One drop only of Timolol should be instilled into the affected eye(s) each time.
Follow the “Instructions for Use” above when administering the eye drops.
After instillation keep the eyes closed for as long as possible (e.g. 3-5 minutes)
and apply pressure to the corner of the eye closest to the nose to prevent the
eye drops spreading throughout the body.
Duration of treatment:
Your doctor or your child’s doctor will decide for how long the eye drops will be
needed.
If you use more Timolol than you should
If you put too many drops in your eye or swallow any of the drops, you may:
 have a headache
 feel dizzy or light-headed
 have difficulty breathing
 chest pain
 feel that your heart rate has slowed down.
If this happens, contact your doctor immediately.
If you forget to use Timolol
It is important to take Timolol as prescribed by your doctor.
 If you miss a dose, use the drops as soon as possible.
 If it is almost time for the next dose, skip the missed dose and take the
next dose at the usual time.
 Do not take a double dose to make up for the forgotten dose.
If you stop using Timolol
If you want to stop using this medicine talk to your doctor first. If you have any
further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Timolol 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 Timolol
without speaking to your doctor.

Sexual dysfunction, decreased sex drive, decreased libido. In men a condition
which affects your penis called Peyronie’s disease. The signs may be
abnormal curve, pain or hardening of the tissue of your penis.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash)
or worsening of psoriasis, skin rash, itching.
Muscle weakness/tiredness, muscle pain not caused by exercise.
A condition called lupus (systemic lupus erythematosus).
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 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 TIMOLOL
Keep your eye drops out of the sight and reach of children.
 Do not store your eye drops above 25℃.
 Store the bottle in the outer carton in order to protect from light.
 You can use Timolol for 28 days after first opening the bottle.
Do not use Timolol 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. Make
sure the container is properly closed.
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. FURTHER INFORMATION
What Timolol contains
The active substance is Timolol maleate.
Each ml contains timolol maleate equivalent to 5mg of timolol.
The other ingredients are:
 benzalkonium chloride as preservative
 disodium phosphate dodecahydrate
 sodium dihydrogen phosphate dihydrate
 sodium hydroxide
 water for injections
What Timolol looks like and contents of the pack
The OCUMETER Plus ophthalmic dispenser consists of a translucent highdensity polyethylene container with a sealed dropper tip. The OCUMETER
Plus ophthalmic dispenser contains 5 ml of solution. The solution is clear,
colorless to light yellow, sterile eye drops solution.
Manufactured by: Merck Sharp and Dohme B.V., P.B. 581- Waarderweg 39,
NL-2003 PC HAARLEM.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate,
Slough, SL1 4NL, UK

Timolol 0.25% w/v Eye Drops Solution,
PL 39352/0143
Leaflet date: 05/01/2016

POM

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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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