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TEOPTIC EYE DROPS 2%

Active substance(s): CARTEOLOL HYDROCHLORIDE

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531 LEAFLET Teoptic 20150413

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEOPTIC EYE DROPS 1%
CARTEOLOL HYDROCHLORIDE EYE DROPS 1%
TEOPTIC EYE DROPS 2%
CARTEOLOL HYDROCHLORIDE EYE DROPS 2%
(carteolol hydrochloride)
Your medicine is known by either of the above names but will be
referred to as Teoptic throughout the following leaflet.
Read all of this leaflet carefully before you start to use this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have further questions, ask your doctor, pharmacist or
nurse.



This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.

What is in this leaflet:
1. What Teoptic is and what it is used for

Other medicines and Teoptic
Teoptic 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.
Pregnancy, breast-feeding and fertility
Do not use Teoptic if you are pregnant or trying to get pregnant
unless your doctor considers it necessary.
Do not use Teoptic if you are breast-feeding. Carteolol hydrochloride
may get into your milk.
Ask your doctor for advice before taking any medicine during breastfeeding.
Driving and using machines
Some people may have problems with their eyes such as blurred
vision, while they are using Teoptic. If you are affected, you should
not drive or use machinery.
Teoptic contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact with
soft lenses.
Take out lenses before you use Teoptic and do not put them back for
at least 15 minutes. Benzalkonium chloride is known to discolour soft
contact lenses.

2. What you need to know before you use Teoptic
3. How to use Teoptic

3. HOW TO USE TEOPTIC

4. Possible side effects

Always use Teoptic eye drops solution exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.

5. How to store Teoptic
6. Contents of the pack and other information
1. WHAT TEOPTIC IS AND WHAT IT IS USED FOR
Teoptic is available in two different strengths containing either 1% or
2% of the active ingredient, carteolol hydrochloride.
Carteolol hydrochloride is one of a group of drugs called betablockers which can help to reduce pressure in the eye. Teoptic is
used to treat conditions such as glaucoma (increased pressure in the
eye).

The recommended dose is one drop into the affected eye twice daily.
After using Teoptic, press a finger into the corner of your eye, by the
nose (picture 3) for 2 minutes. This helps to stop carteolol
hydrochloride getting into the rest of the body.
Use in children and adolescents
Teoptic Eye Drops are not recommended for children.
How to use Teoptic

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEOPTIC
Do not use Teoptic eye drops solution:


if you are allergic to carteolol hydrochloride, beta-blockers or to
any of the other ingredients of this medicine (listed in section 6.)



if you have now or have had in 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)



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



Wash your hands before using the drops



Remove the cap from the dropper bottle



Make sure that the tip of the bottle does not touch anything



Hold the bottle in one hand between the thumb and forefinger



Tilt your head back, and use your other
forefinger to pull down the lower eyelid



Place the dropper tip close to your eye,
but not touching the eye or lid, and
gently squeeze the bottle to release
one drop into your eye



Close your eyelid and gently press the
corner of your eye with your forefinger
for 2 minutes

Replace the cap and wash your hands.

Warnings and precautions
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



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 carteolol hydrochloride may mask signs and
symptoms of low blood sugar

If you forget to use Teoptic



overactivity of the thyroid gland as carteolol hydrochloride may
mask signs and symptoms

If you forget to use your eye drops, put them in as soon as possible.
Do not take a double dose to make up for a forgotten dose.

Tell your doctor before you have an operation that you are using
Teoptic as carteolol hydrochloride may change effects of some
medicines used during anaesthesia.

If you use more Teoptic than you should

5. HOW TO STORE TEOPTIC

If you use too much or if you accidentally swallow the eye drops, see
your doctor at once or go to your nearest hospital casualty
department. Take your medicine with you.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the eye drops above 25°C.

If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.



Do not break the bottle seal until you are going to use the drops.
They are sterile until the seal is broken. They must be used within
28 days of first breaking the seal.



Do not use the drops after the expiry date shown on the pack.



You can usually carry on taking the drops, unless the effects are
serious. If you are worried, talk to a doctor or pharmacist. Do not stop
using Teoptic without speaking to your doctor.

If your doctor tells you to stop using the drops, please take them
back to the pharmacist for safe disposal. Only keep them if your
doctor tells you to. If the drops become discoloured or show any
other signs of deterioration take them back to the pharmacist.



Like other medicines applied into eyes, carteolol hydrochloride is
absorbed into the blood. This may cause similar side effects as seen
with ‘intraveneous’ 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:

REMEMBER this medicine was prescribed for you. You should
not give it to anyone else even if you think their symptoms are
similar. It may harm them.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS
Like all medicines, Teoptic eye drops, solution can cause side effects,
although not everybody gets them



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, unusual sensitivity to light.



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, 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, feeling of discomfort, feeling of
tension or fullness in the nose, cheeks and behind your eyes,
sometimes with a throbbing ache, fever, stuffy nose and loss of
the sense of smell (sinusitis).

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.

What Teoptic contains


Teoptic Eye Drops 1% contain 1% w/v of the active ingredient
carteolol hydrochloride.



Teoptic Eye Drops 2% contain 2% w/v of the active ingredient
carteolol hydrochloride.



The other ingredients are: benzalkonium chloride (a preservative),
sodium chloride, sodium acid phosphate, sodium phosphate and
purified water.

What Teoptic looks like and contents of the pack
Teoptic is a clear sterile solution. The bottle is fitted with a dropper
device and a white plastic cover with tamper-evident seal.
Teoptic is available as bottle of 5 ml solution.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley,
Middlesex, HA0 1DX, UK.
Manufacturer
This product is manufactured by Otsuka Pharmaceutical s.a Avda.
Diagonal, 609-615 08028 Barcelona.
POM

PLPI 08747/0531
PLPI 08747/0532

Leaflet revision date: 13 April 2015
Teoptic is a registered trademark used by agreement with Otsuka,
Japan.
531 LEAFLET Teoptic 20150413

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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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