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TIMOPTOL UNIT DOSE 0.25% W/V EYE DROPS SOLUTION

Active substance(s): TIMOLOL / TIMOLOL MALEATE

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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 medicines2
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 Timopol 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.

Timoptol® Unit Dose 0.25% w/v
Eye Drops Solution
Timoptol® Unit Dose 0.5% w/v
Eye Drops Solution

timolol (as 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.
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

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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.
Tell your doctor before you have an operation that you
are using Timoptol 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
2 in infants and children. For example, in one small
timolol
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.
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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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.

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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.

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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, 2
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.
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.

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5. HOW TO STORE TIMOPTOL Unit Dose
Keep your eye drops out of the reach and sight of children.
Do not store your eye drops above 25°C and keep in outer
carton in order to protect from light.
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
The active substance is timolol maleate.
Timoptol Unit dose is available in two strengths:
• 0.25% w/v solution of timolol maleate
• 0.5% w/v solution of timolol maleate.
The other ingredients are:
• disodium phosphate dodecahydrate E339
• sodium dihydrogen phosphate dihydrate E339
• sodium hydroxide
• water for injections.
What Timoptol Unit Dose looks like and contents of the
pack
Timoptol Unit Dose is available in cartons containing
30 unit doses.
Each Timoptol Unit Dose dispenser contains 0.20 ml
without preservative.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder UK and Ireland
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Laboratories Merck Sharp & Dohme – Chibret (Mirabel)
Route de Marsat
RIOM 63963 Clermont –Ferrand
Cedex 9
France
This leaflet was last revised in June 2015.
This leaflet gives the most important patient information
about Timoptol Unit Dose. If you have any questions after
you have read it, ask your doctor or pharmacist who will
give you further information.
Further information about glaucoma is available from:
International Glaucoma Association (IGA)
15A Highpoint Business Village
Henwood, Ashford
Kent, TN24 8DH
Tel: 01233 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 Santen Oy.)
Alternatively, if you or someone you know has problems
with their vision, and you require further advice or
information, please phone the Royal National Institute for
the Blind (RNIB) Helpline on 0845 776 9999, Monday to
Friday 9am to 5 pm, calls charged at local rates.
(The RNIB is an independent UK charity and is not
associated with Santen Oy).

4. POSSIBLE SIDE EFFECTS

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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.
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.
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.
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.
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,2pain 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.

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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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