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TIMOLOL UNIT DOSE 0.25% W/V/ EYE DROPS SOLUTION

Active substance(s): TIMOLOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Timoptol Unit Dose 0.25% w/v Eye Drops Solution
(timolol)
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.
®

The name of your medicine is Timoptol Unit Dose 0.25% w/v Eye
Drops Solution, but will be referred as Timoptol Unit Dose
throughout the leaflet.
Another strength of 0.5% w/v is also available.
In this leaflet:
1. What Timoptol Unit Dose is and what it is used for
2. Before you use Timoptol Unit Dose
3. How to use Timoptol Unit Dose
4. Possible side effects
5. How to store Timoptol Unit Dose
6. Further information
1. WHAT TIMOPTOL Unit Dose IS AND WHAT IT IS USED
FOR
Timoptol Unit Dose 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.
2. BEFORE YOU USE TIMOPTOL Unit Dose
Do not use Timoptol Unit Dose if:
 you are allergic (hypersensitive) to timolol, beta-blockers or
any of the other ingredients of Timoptol Unit Dose (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 Unit Dose talk
to your doctor or pharmacist.
Take special care with Timoptol Unit Dose
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 heartbeat
 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 maleate may mask
signs and symptoms
 you wear soft contact lenses

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 Unit Dose 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/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 Unit Dose 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 Unit Dose if you are pregnant unless your
doctor considers it necessary.
Use in breast-feeding
Do not use Timoptol Unit Dose if you are breast-feeding. Timolol
may get into your milk. Ask your doctor for advice before taking
any medicine during breast-feeding
Driving and using machines
There are possible side effects associated with Timoptol Unit Dose,
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 Unit Dose
Always use Timoptol Unit Dose 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 the dose of this medicine without talking to your
doctor.
Do not allow the tip of the single dose 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 single dose container, keep the tip of the single dose container
away from contact with any surface.
Instructions for use.
Open the drops container just before you want to use it. After
using the drops, throw away what is left. This is because the drops
cannot be kept free of bacteria after being opened.
1. Open the foil sachet containing the individual single dose
containers. There are three strips of 5 single dose containers
in each sachet.
2. First wash your hands and then break off a single dose
container from the strip. Then twist open the top of the single
dose container as shown.

Tell your doctor before you have an operation that you are using
Timoptol Unit Dose 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 Timoptol Unit Dose is causing an allergic
reaction or hypersensitivity (for example, skin rash, or redness and
itching of the eye), stop using Timoptol Unit Dose 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 in
infants and children. For example, in one small clinical study,
timolol, the active ingredient in Timoptol Unit Dose eye drops, has
been studied in infants and children aged 12 days to 5 years, who
have raised pressure in the eye(s) or have been diagnosed with
glaucoma. For more information, talk to your doctor.

3. Tilt your head back and pull your lower eyelid now slightly.

4. Put one drop in the affected eye(s) as directed by your doctor.
Each single dose container contains enough solution for both
eyes.

Timoptol Unit Dose should generally be used with caution in young
patients. In newborns, infants and younger children Timoptol Unit
Dose 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 Unit Dose 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

5. After using Timoptol Unit Dose, press a finger into the corner
of your eye, by the nose for 2 minutes. This helps to stop
timolol getting into the rest of your body.

6. After putting the drop into the eye(s), throw away the used
container, even if there is solution remaining, to avoid
contamination.
7. Store the remaining containers in the foil sachet. The
containers must be used within 15 days after opening the
sachet. If any containers are left 15 days after opening the
sachet, throw them away and open a new one.

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.

Children and Adolescents
Before you or your child starts to take Timoptol Unit Dose, 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.

5. HOW TO STORE TIMOPTOL Unit Dose

Method of administration:
One drop only of Timoptol Unit Dose 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 Unit Dose than you should
If you put too many drops in your eye or swallow any of the drops,
you may:
 have a headache
 feeling 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 Unit Dose
It is important to take Timoptol Unit Dose 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 Unit Dose
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 Unit Dose 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.
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,
itchiness, severe sudden life-threatening allergic reaction, stop
taking your eye drops and seek medical attention immediately.
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 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.
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 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).
Ask your doctor or pharmacist for more information about the side
effects. Both have a more complete list of side effects.

Keep your eye drops out of the sight and reach of children.
Do not store your eye drops above 25℃. Protect from Light.
Store in the original package.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
Do not use Timoptol Unit Dose after the expiry date which is
stated on the carton after EXP. The expiry date refers to the last
day of that month.
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’ Unit Dose contains
Each ml contains timolol maleate equivalent to 5.0 mg timolol.
Each unit dose contains 0.2 ml sterile preservative-free eye drops
solution.
The other ingredients are:
 disodium phosphate dodecahydrate
 sodium dihydrogen phosphate dihydrate
 sodium hydroxide
 water for injections.
What ‘Timoptol’ Unit Dose looks like and contents of the pack
Timoptol Unit Doses are Clear, colourless to light yellow, sterile
eye drops which are presented in Unit-dose Dispensers.
Timoptol Unit Dose is available in cartons containing 30 unit doses.
Each ‘Timoptol’ Unit Dose dispenser contains 0.20 ml without
preservative.
Manufactured by: Laboratories Merck Sharp and Dohme- Chibret
(Mirabel). Route de Marsat, RIOM 63963 Clermont-Ferrand,
Cedex 9, France.
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma (UK) Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, UK

Timoptol® Unit Dose 0.25% w/v Eye Drops Solution,
PL 39352/0056
®

Timoptol Unit Dose is a registered trademark of Merck & Corp., a
subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey,
U.S.A.
POM
Leaflet date: 01.12.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Timolol Unit Dose 0.25% w/v
Eye Drops Solution
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.
The name of your medicine is Timolol Unit Dose 0.25% w/v Eye
Drops Solution, but will be referred as Timolol Unit Dose
throughout the leaflet.
Another strength of 0.5% w/v is also available.
In this leaflet:
1. What Timolol Unit Dose is and what it is used for
2. Before you use Timolol Unit Dose
3. How to use Timolol Unit Dose
4. Possible side effects
5. How to store Timolol Unit Dose
6. Further information
1. WHAT TIMOLOL Unit Dose IS AND WHAT IT IS USED
FOR
Timolol Unit Dose 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.
2. BEFORE YOU USE TIMOLOL Unit Dose
Do not use Timolol Unit Dose if:
 you are allergic (hypersensitive) to timolol, beta-blockers or
any of the other ingredients of Timolol Unit Dose (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 Unit Dose talk
to your doctor or pharmacist.
Take special care with Timolol Unit Dose
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 heartbeat
 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 maleate may mask
signs and symptoms
 you wear soft contact lenses
Tell your doctor before you have an operation that you are using
Timolol Unit Dose as timolol may change effects of some
medicines used during anaesthesia.

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 Unit Dose 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/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 Unit Dose 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 Unit Dose if you are pregnant unless your
doctor considers it necessary.
Use in breast-feeding
Do not use Timolol Unit Dose if you are breast-feeding. Timolol
may get into your milk. Ask your doctor for advice before taking
any medicine during breast-feeding
Driving and using machines
There are possible side effects associated with Timolol Unit Dose,
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 Unit Dose
Always use Timolol Unit Dose 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 the dose of this medicine without talking to your
doctor.
Do not allow the tip of the single dose 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 single dose container, keep the tip of the single dose container
away from contact with any surface.
Instructions for use.
Open the drops container just before you want to use it. After
using the drops, throw away what is left. This is because the drops
cannot be kept free of bacteria after being opened.
1. Open the foil sachet containing the individual single dose
containers. There are three strips of 5 single dose containers
in each sachet.
2. First wash your hands and then break off a single dose
container from the strip. Then twist open the top of the single
dose container as shown.

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 Unit Dose is causing an allergic
reaction or hypersensitivity (for example, skin rash, or redness and
itching of the eye), stop using Timolol Unit Dose and contact your
doctor immediately.

3. Tilt your head back and pull your lower eyelid now slightly.

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 in
infants and children. For example, in one small clinical study,
timolol, the active ingredient in Timolol Unit Dose eye drops, has
been studied in infants and children aged 12 days to 5 years, who
have raised pressure in the eye(s) or have been diagnosed with
glaucoma. For more information, talk to your doctor.

4. Put one drop in the affected eye(s) as directed by your doctor.
Each single dose container contains enough solution for both
eyes.

Timolol Unit Dose should generally be used with caution in young
patients. In newborns, infants and younger children Timolol Unit
Dose 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 Unit Dose 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

5. After using Timolol Unit Dose, press a finger into the corner of
your eye, by the nose for 2 minutes. This helps to stop timolol
getting into the rest of your body.

6. After putting the drop into the eye(s), throw away the used
container, even if there is solution remaining, to avoid
contamination.
7. Store the remaining containers in the foil sachet. The
containers must be used within 15 days after opening the
sachet. If any containers are left 15 days after opening the
sachet, throw them away and open a new one.
Children and Adolescents
Before you or your child starts to take Timolol Unit Dose, 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 Unit Dose 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 Unit Dose than you should
If you put too many drops in your eye or swallow any of the drops,
you may:
 have a headache
 feeling 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 Unit Dose
It is important to take Timolol Unit Dose 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 Unit Dose
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 Unit Dose 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.
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,
itchiness, severe sudden life-threatening allergic reaction, stop
taking your eye drops and seek medical attention immediately.
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 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.
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 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).
Ask your doctor or pharmacist for more information about the side
effects. Both have a more complete list of side effects.

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 Unit Dose
Keep your eye drops out of the sight and reach of children.
Do not store your eye drops above 25℃. Protect from Light.
Store in the original package.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
Do not use Timolol Unit Dose after the expiry date which is stated
on the carton after EXP. The expiry date refers to the last day of
that month.
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’ Unit Dose contains
Each ml contains timolol maleate equivalent to 5.0 mg timolol.
Each unit dose contains 0.2 ml sterile preservative-free eye drops
solution.
The other ingredients are:
 disodium phosphate dodecahydrate
 sodium dihydrogen phosphate dihydrate
 sodium hydroxide
 water for injections.
What ‘Timolol’ Unit Dose looks like and contents of the pack
Timolol Unit Doses are Clear, colourless to light yellow, sterile eye
drops which are presented in Unit-dose Dispensers.
Timolol Unit Dose is available in cartons containing 30 unit doses.
Each ‘Timolol’ Unit Dose dispenser contains 0.20 ml without
preservative.
Manufactured by: Laboratories Merck Sharp and Dohme- Chibret
(Mirabel). Route de Marsat, RIOM 63963 Clermont-Ferrand,
Cedex 9, France.
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma (UK) Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, UK

Timolol Unit Dose 0.25% w/v Eye Drops Solution,
PL 39352/0056
POM
Leaflet date: 01.12.2015

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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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