TIMOLOL 0.5 % W/V EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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S923-4 LEAFLET Timoptol 20130805

PACKAGE LEAFLET: INFORMATION FOR THE USER

TIMOPTOL 0.25% w/v EYE DROPS SOLUTION
TIMOPTOL 0.5% w/v EYE DROPS SOLUTION
timolol (as maleate)
Your medicine is known by the above names but will be referred to
as Timoptol throughout the following patient information leaflet
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.

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

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.

5. How to store Timoptol
6. Further information

Pregnancy and breast-feeding

1. WHAT TIMOPTOL IS AND WHAT IT IS USED FOR

Ask your doctor for advice before taking any medicine.

Timoptol contains a substance called Timolol 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.

Use in pregnancy

2. BEFORE YOU USE TIMOPTOL

Do not use Timoptol if you are breast-feeding. Timolol maleate may
get into your milk. Ask your doctor for advice or pharmacist if you
are not sure.

Do not use Timoptol if:


you are allergic (hypersensitive) to Timolol maleate, betablockers 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 condition 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

Do not use Timoptol if you are pregnant unless your doctor
considers it necessary.
Use in breast-feeding

Driving and using machines
There are possible side effects associated with Timoptol, such as
dizziness and changes in your eyesight, 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 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 use 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.

Before you use this medicine, tell your doctor if you have now or
have had in the past

Instructions for use.



coronary heart disease (symptoms can include chest pain or
tightness, breathlessness or choking), heart failure

It is recommended that you wash your hands before putting in your
eye drops.



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 Timoptol may mask signs and symptoms of low
blood sugar



overactivity of the thyroid gland as Timolol may mask signs and
symptoms



allergies to any medicines



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.

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
Timoptol as Timoptol 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.

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.

Tell you 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 in
infants and children. For example, in one small clinical study,
timolol, 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.

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

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.
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.

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

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.
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.

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 the 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.

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 pre-existing disease), difficulty breathing, shortness of breath,
wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth,
abdominal pain, vomiting.
Sexual dysfunction, decreased sex drive, decreased libido. In men
a condition which effects 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.
Muscle weakness/tiredness, muscle pain not caused by exercise. A
condition called lupus (systemic lupus erythematosus).
Ask your doctor or pharmacist for more information about the side
effects. Both have a more complete list of side effects.
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.

10. The dispenser tip is designed to provide a single drop; therefore
do NOT enlarge the hole of the dispenser tip.

5. HOW TO STORE TIMOPTOL


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



Do not use the bottle after it has been open for 28 days. Do not
use after the expiry date printed on the carton or bottle label.



Do not store above 25°C. Store the bottle in the outer carton as
this product is sensitive to light.

Use in children and adolescents



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

6. FURTHER INFORMATION
What Timoptol contains


Timoptol 0.25% w/v Eye Drops Solution contains timolol
maleate equivalent to 2.5 mg/ml timolol.



Timoptol 0.5% w/v Eye Drops Solution contains timolol maleate
equivalent to 5 mg/ml timolol.



Timoptol Eye Drops Solution also contains the following inactive
ingredients: sodium hydroxide, water for injection, disodium
phosphate dodecahydrate(E339) sodium dihydrogen phosphate
dihydrate(E339) and preservative benzalkonium chloride
solution.

What Timoptol looks like and contents of the pack
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:

Timoptol is a clear, colourless to light yellow, sterile eye drops
solution.
Timoptol Solution is available in bottles containing 5ml.
Product Licence holder



have a headache



feel dizzy or light-headed



have difficulty breathing

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



feel that your heart rate has slowed down.

Manufacturer

If this happens, contact your doctor immediately.
If you forget to use Timoptol
It is important to take Timoptol as prescribed by your doctor.

This product is manufactured by Merck Sharp & Dohme B.V., P.B.
581 – Waarderweg 39, NL-2003 PC Haarlem, The Netherlands.
POM

PL No. 19488/0923 Timoptol 0.25% Eye Drops Solution
PL No. 19488/0924 Timoptol 0.5% Eye Drops Solution



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.

Leaflet revision date: 05 August 2013
Timoptol is a registered trade mark of Merck & Co Inc, USA.



Do not take a double dose to make up for the forgotten dose.

Further information about glaucoma is available from:
International Glaucoma Association (IGA)

If you stop using Timoptol

15A Highpoint Business Village

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.

Henwood, Ashford

4. POSSIBLE SIDE EFFECTS

E-mail: info@iga.org.uk

Like all medicines Timoptol can cause side effects, although not
everybody gets them.

Registered Charity number 274681.

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.
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 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.
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,
itchness, severe sudden life-threatening allergic reaction. If they do
occur, you may need medical attention.
Low blood glucose levels.

Kent, TN24 8DH
Tel: +44 (0) 1233 648170

(The IGA is an independent charity organisation which helps
glaucoma patients and their relatives, and is not associated with
Merck Sharp & Dohme Limited.)
Alternatively, if you or someone you know has problems with their
vision, and you require further advice or information, please contact:
For the UK: the Royal National Institute for the Blind (RNIB)
Helpline on 0303 123 9999, Monday to Friday 8.45am to 6pm and
Saturday 9am to 4pm.
(The RNIB is an independent UK charity and is not associated with
Merck Sharp & Dohme Limited).
For Ireland: National Council for the Blind of Ireland, Whitworth
Road, Drumcondra, Dublin 9. Tel: 01 8307033 or Fax: 01 8307787
charity registration number: CHY 4626
(The National Council for the Blind of Ireland is an independent Irish
charity and is not associated with Merck Sharp & Dohme Limited).
S923-4 LEAFLET Timoptol 20130805

S923-4 LEAFLET Timolol 20130805

PACKAGE LEAFLET: INFORMATION FOR THE USER

TIMOLOL 0.25% w/v EYE DROPS SOLUTION
TIMOLOL 0.5% w/v EYE DROPS SOLUTION
timolol (as maleate)
Your medicine is known by the above names but will be referred to
as Timolol throughout the following patient information leaflet
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.

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

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



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.

5. How to store Timolol
6. Further information

Pregnancy and breast-feeding

1. WHAT TIMOLOL IS AND WHAT IT IS USED FOR

Ask your doctor for advice before taking any medicine.

Timolol contains a substance called timolol 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.

Use in pregnancy

2. BEFORE YOU USE TIMOLOL

Do not use Timolol if you are breast-feeding. Timolol may get into
your milk. Ask your doctor for advice or pharmacist if you are not
sure.

Do not use Timolol if:


you are allergic (hypersensitive) to timolol maleate, betablockers 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 condition 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

Do not use Timoptol if you are pregnant unless your doctor
considers it necessary.
Use in breast-feeding

Driving and using machines
There are possible side effects associated with Timolol, such as
dizziness and changes in your eyesight, 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 exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. The doctor will decide
how many drops you should use 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.

Before you use this medicine, tell your doctor if you have now or
have had in the past

Instructions for use.



coronary heart disease (symptoms can include chest pain or
tightness, breathlessness or choking), heart failure

It is recommended that you wash your hands before putting in your
eye drops.



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



allergies to any medicines



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.

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 docotor before you have an operation that you are using
Timolol as timolol 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.

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.

Tell you 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 in
infants and children. For example, in one small clinical study,
timolol, 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.

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

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.
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.

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

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.

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 the 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.

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 pre-existing disease), difficulty breathing, shortness of breath,
wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth,
abdominal pain, vomiting.
Sexual dysfunction, decreased sex drive, decreased libido. In men
a condition which effects 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.
Muscle weakness/tiredness, muscle pain not caused by exercise. A
condition called lupus (systemic lupus erythematosus).
Ask your doctor or pharmacist for more information about the side
effects. Both have a more complete list of side effects.
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.
5. HOW TO STORE TIMOLOL


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use the bottle after it has been open for 28 days. Do not
use after the expiry date printed on the carton or bottle label.



Do not store above 25°C. Store the bottle in the outer carton as
this product is sensitive to light.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. FURTHER INFORMATION
What Timolol contains


Timolol 0.25% w/v Eye Drops Solution contains timolol maleate
equivalent to 2.5 mg/ml timolol.



Timolol 0.5% w/v Eye Drops Solution contains timolol maleate
equivalent to 5 mg/ml timolol.



Timolol Eye Drops Solution also contains the following inactive
ingredients: sodium hydroxide, water for injection, disodium
phosphate dodecahydrate(E339) sodium dihydrogen phosphate
dihydrate(E339) and preservative benzalkonium chloride
solution.

What Timolol looks like and contents of the pack
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:

Timolol is a clear, colourless to light yellow, sterile eye drops
solution.
Timolol Solution is available in bottles containing 5ml.



have a headache

Product Licence holder



feel dizzy or light-headed



have difficulty breathing

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



feel that your heart rate has slowed down.

Manufacturer

If this happens, contact your doctor immediately.
If you forget to use Timolol
It is important to take Timolol as prescribed by your doctor.

This product is manufactured by Merck Sharp & Dohme B.V., P.B.
581 – Waarderweg 39, NL-2003 PC Haarlem, The Netherlands.
POM

PL No. 19488/0923 Timolol 0.25% Eye Drops Solution
PL No. 19488/0924 Timolol 0.5% Eye Drops Solution



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.

Leaflet revision date: 05 August 2013



Do not take a double dose to make up for the forgotten dose.

International Glaucoma Association (IGA)

Further information about glaucoma is available from:
15A Highpoint Business Village

If you stop using Timolol

Henwood, Ashford

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.

Kent, TN24 8DH

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.
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 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.
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,
itchness, severe sudden life-threatening allergic reaction. If they do
occur, you may need medical attention.
Low blood glucose levels.

Tel: +44 (0) 1233 648170
E-mail: info@iga.org.uk
Registered Charity number 274681.
(The IGA is an independent charity organisation which helps
glaucoma patients and their relatives, and is not associated with
Merck Sharp & Dohme Limited.)
Alternatively, if you or someone you know has problems with their
vision, and you require further advice or information, please contact:
For the UK: the Royal National Institute for the Blind (RNIB)
Helpline on 0303 123 9999, Monday to Friday 8.45am to 6pm and
Saturday 9am to 4pm.
(The RNIB is an independent UK charity and is not associated with
Merck Sharp & Dohme Limited).
For Ireland: National Council for the Blind of Ireland, Whitworth
Road, Drumcondra, Dublin 9. Tel: 01 8307033 or Fax: 01 8307787
charity registration number: CHY 4626
(The National Council for the Blind of Ireland is an independent Irish
charity and is not associated with Merck Sharp & Dohme Limited).
S923-4 LEAFLET Timolol 20130805

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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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