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TIMOLOL UNIT DOSE 0.5% W/V EYE DROPS SOLUTION

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Previously assessed against UK PIL dated June
2008 with the addition of safety warnings for
Ophthalmic beta-blockers

By berrys at 1:56 pm, Mar 22, 2012
CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Timoptol 0.5% eye drops

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/2810E

DATE OF PROOF:

12/03/12

DATE:

MOCK UP
PROOF HISTORY:
v.3 - waymade - 12/03/12

DATE:

Leaflet Flat Size = 296 x 317

Add/ amend to include 'if you have a slow heart beat,
heart failure or disorders of heart rhythm (irregular heart
beats)' under Do not use

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL GRANTED JUNE 2008
INC ADDITIONAL SAFETY WARNING
FOR OPHTHALMIC BETA-BLOCKERS

Pg 4

Like other medicines applied into the eyes, timolol is absorbed into the blood. This may cause similar side
effects as seen with intravenous and/or oral as applicable 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, itchiness, severe sudden life-threatening allergic reaction.
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 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.
Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the
heart beat, 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, Raynaud's phenomenon, cold hands and feet.
Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty
breathing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis,
skin rash.
Muscle pain not caused by exercise.
Sexual dysfunction, decreased libido.
Muscle weakness/tiredness.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please
tell your doctor or pharmacist.

5. How to store Timoptol
Keep your eye drops out of the reach and sight of children.
Do not store your eye drops above 25 C and keep in the original package.
Do not use Timoptol after the expiry date which is stated on the carton after EXP. The expiry date refers to
the last day of that month.
If your doctor tells you to stop using the eye drops, please take them back to the pharmacist for safe
disposal. Only keep the eye drops if your doctor tells you to.
If the eye drops become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
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.
Your medicine is called Timoptol Unit Dose 0.5% w/v Eye Drops.
Each millilitre of clear, colourless solution contains 6.8mg of the active ingredient timolol maleate,
equivalent to 5mg of timolol.
Timoptol Unit Dose 0.5% w/v Eye Drops also contain the following ingredients:
sodium monobasic phosphate dehydrate, disodium phosphate dodecahydrate and water for injection.
What Timoptol looks like and contents of the pack
Timoptol Unit Dose 0.5% w/v Eye Drops are available in packs of 30 unit doses.
Each individual plastic container contains 0.2ml of ophthalmic solution without preservative.
Marketing Authorisation Holder and Manufacturer
POM

PL: 06464/2810

This product is manufactured by Laboratoires Merck Sharp and Dohme, Chibret Riom, France and
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 9.3.2012
Timoptol is a registered trademark of Merck & Co. Inc.
Further information about glaucoma is available from:
International Glaucoma Association (IGA),
15A Highpoint Business Village
Henwood, Ashford, Kent TN24 8DH
Tel: 01233 648170
Registered Charity number 274681
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 9 am to 5 pm, calls charged at local rates.
Both the IGA and RNIB are independent UK charities and are not associated with Waymade Plc.

Pg 1

TIMOPTOL UNIT DOSE 0.5% w/v EYE DROPS SOLUTION/
TIMOLOL UNIT DOSE 0.5% w/v EYE DROPS SOLUTION
(Timolol maleate)
Patient Information Leaflet

This product is known as either of the above names but will be referred to as Timoptol throughout this
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.
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 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 eye drops solution if

you are allergic to timolol, beta-blockers or any of the other ingredients

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 have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats)

you have heart problems
- 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 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.
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 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
Timoptol is not recommended for use in children and adolescents.
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 medicines obtained without a prescription:

quinidine (used to treat heart conditions and some typs of malaria)

antidepressants known as fluoxetine and paroxetine

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 called pressor amines, such as adrenaline used to treat severe allergic reaction

medicines known as catecholamine-depleting agents, such as rauwolfia alkaloids or reserpine,
used for high blood pressure

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.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Timoptol 0.5% eye drops

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

06464/2810E

DATE OF PROOF:

12/03/12

DATE:

PROOF HISTORY:
v.3 - waymade - 12/03/12

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL GRANTED JUNE 2008
INC ADDITIONAL SAFETY WARNING
FOR OPHTHALMIC BETA-BLOCKERS

Pg 2

Pregnancy and breast-feeding
Do not use Timoptol if you are pregnant unless your doctor considers it necessary.
Do not use Timoptol if you are breast feeding. Timolol may get in to your milk .
Ask your doctor or pharmacist for advice before taking any medicine during 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 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 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 container, keep the tip of the 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.

Dose
Tim

op
0.25% tol

timo
w/v
Eye Unit
for lol (as
Dro

ocular male
ps
64288/2 use ate)
0.2 mlSolution
60307

Tim

op
0.25% tol

timolol w/v Eye Un
for ocul (as male Drop it Do
ate) 0.2 s Solu se
tion
ml

6428 ar use
8/26
0307

Tim

op
0.25% tol

Un

timolol w/v Eye Un
for ocul (as male Drop it Do
ate) 0.2 s Solu se
tion
ml

6428 ar use
8/26
0307

Tim

op
0.25% tol

lol (as Eye
it
for ocul male Drop Do
s Solu se
6428 ar use ate)
8/26
0.2 ml tion
0307

6428 ar use
8/26
0307

Timop
0.25% tol
timo
w/v

timolol w/v Eye Un
for ocul (as male Drop it Do
ate) 0.2 s Solu se
tion
ml

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.

4. Possible side effects

Like all medicines, Timoptol eye drops solution 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.
The frequency of possible side effects listed below is defined using the following convention
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)
If they do occur, you may need medical attention. In some patients these may include:
Allergic reactions

allergic skin rash and hives

severe allergic reaction which causes difficulty in breathing or dizziness.
Eyes and ears

burning and stinging

dry eyes

irritation and redness of the eye or eyelid

sensitivity to light

discharge from the eye

visual changes such as double vision

decreased sensation of your eye surface

pain in your eye

drooping eyelid

ringing in your ears.
Heart and circulation

chest pain

heart attack

fainting

palpitations

an irregular heartbeat

a slowing of your heart rate

low blood pressure

interference with the blood supply to the brain which may lead to a stroke

too much fluid, mainly water, accumulating in the body

limping because there is a reduced blood supply to your legs

swelling or coldness of your hands, feet and extremities, caused by constriction of your blood
vessels.
Chest






3. Tilt your head back and pull your lower eyelid down slightly.
4. Put one drop into the affected eye(s) as directed by
your doctor. Each single dose container contains enough
solution for both eyes.

Pg 3

wheezing
shortness of breath
difficulty breathing
cough.

Stomach and gut

nausea

diarrhoea

indigestion

vomiting

dry mouth.
Sexual




5. After using Timoptol, 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
the body.
6. After putting the drops 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.

decreased sex drive
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.

Skin and hair

hair loss

a skin disease called psoriasis, where areas of skin such as knees and elbows are covered in
scales

worsening of psoriasis.

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

feel that your heart rate has slowed down.

Nervous system

dizziness

depression

unable to sleep

nightmares

memory loss

increase in signs and symptoms of myasthenia gravis

tingling sensation.

If this happens, CONTACT your doctor immediately.

General

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.






headache
tiredness
weakness
a condition called lupus (systemic lupus erythematosus).

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.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand Transcript

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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