TIMOPTOL UNIT DOSE 0.25% EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet

Timoptol® Unit Dose 0.25% Eye Drops Solution
(timolol maleate)
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Timoptol Unit Dose 0.25% Eye Drops
Solution but will be referred to as Timoptol Unit Dose throughout the
remainder of the leaflet.
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 to (hypersensitive) timolol maleate, beta blockers or
any of the other ingredients of Timoptol Unit Dose (see section 6 for
Further information)
• If 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 longstanding 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 heart beat.
• Breathing problems, asthma or chronic obstructive pulmonary disease.
• Poor circulation disease (such as Raynaud’s disease or Raynaud’s
syndrome)
• Diabetes as timolol maleate may mask signs and symptoms of low
blood sugar.
• Overactivity of the thyroid gland as timolol maleate may mask signs
and symptoms.
• allergies to any medicines
• you wear soft contact lenses.
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.

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 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 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 or pharmacist if you are not
sure.
Driving and using machines
There are possible side effects associated with Timoptol Unit Dose, 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 Unit Dose
Always use Timoptol Unit Dose 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 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 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 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
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 Timoptal 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.

3. Tilt your head back and pull your lower eyelid down 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.

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.

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 maleate getting
into the rest of the 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 Adolscents
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-LA 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
• 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 Unit Dose may 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.
Generalised 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 in swallowing or breathing, hives or
itchy rash, localized and generalised rash, itchiness, severe sudden lifethreatening allergic reaction.
Low blood glucose levels
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
Fainting, stroke, reduced blood supply to the brain, increase 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, sensitivity to light,
discharge from the eye, pain in the eye.

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 get serious, or if you notice any side effects not
mentioned in this leaflet, please, tell your doctor or pharmacist.
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. 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. 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.
If your medicine show any signs of deterioration or discolouration, consult
your pharmacist for advice. If damaged please tell your doctor or
pharmacist.
6. Further Information
What ‘Timoptol’ Unit Dose contains
Each unit dose contains 0.2ml sterile preservative-free eye drops
solution.
Each ml contains timolol maleate equivalent to 2.5mg timolol.
Also contains, disodium phosphate dodecahydrate, sodium dihydrogen
phosphate dihydrate, sodium hydroxide and water for injections.
A clear, colourless to light yellow, sterile eye drops solution in a clear
plastic vial sealed in sterile pack.
Timoptol Unit Dose is available in a carton containing 30 unit doses.
Each ‘Timoptol’ Unit Dose dispenser contains 0.2 ml of ophthalmic
solution.
Timoptol Unit Dose 0.25% eye Drops Solution is manufactured by:
Laboratoires Merck Sharp & Dohme – Chibret, Mirabel Plant, Route de
Marsat, 63963 Riom Cedex France. Procured from within the EU.
Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Timoptol Unit Dose 0.25% Eye Drops Solution

PL 20774/1104

Timoptol is a registered trademark of Merck & Co. Inc
rd

Date of preparation 23 September 2013

POM

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.
International Glaucoma Association (IGA) 15A Highpoint Business
Village Henwood Ashford, Kent TN24 8DH
(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 phone the Royal
National Institute for Blind (RNIB).
Helpline on 0845 776 9999, Monday to Friday 9am to 5pm, calls change
at local rates.

PP3/1104/V3

Expand view ⇕

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.

Hide
(web5)