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MIKELAN 1% EYE DROPS

Active substance(s): CARTEOLOL HYDROCHLORIDE

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Teoptic® 1% Eye Drops/Carteolol hydrochloride 1% Eye Drops/Mikelan® 1% Eye Drops
Teoptic® 2% Eye Drops/Carteolol hydrochloride 2% Eye Drops/Mikelan® 2% Eye Drops
(Carteolol Hydrochloride)
Your medicine is known by either of the above names, but will be referred to
as Teoptic Eye Drops throughout this:
Patient Information 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.
In this leaflet:
1) What Teoptic Eye Drops is and what it is used for
2) What you need to know before you use Teoptic Eye Drops
3) How to use Teoptic Eye Drops
4) Possible side effects
5) How to store Teoptic Eye Drops
6) Further information

1) What Teoptic Eye Drops is and what it is used for
Teoptic Eye Drops are 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 beta-blockers which
can help to reduce pressure in the eye. Teoptic Eye Drops is used to treat
conditions such as glaucoma (increased pressure in the eye).

2) What you need to know before you use Teoptic Eye Drops
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 heartbeats).
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
• overactivity of the thyroid gland as carteolol hydrochloride may mask signs
and symptoms
Tell your doctor before you have an operation that you are using Teoptic eye
drops as carteolol hydrochloride may change effects of some medicines used
during anaesthesia.
Other medicines and Teoptic eye drops
Teoptic eye drops 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 Eye Drops if you are breast-feeding. Carteolol
hydrochloride may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
Some people may have problems with their eyes such as blurred vision,
while they are using Teoptic Eye Drops. If you are affected, you should not
drive or use machinery.
Teoptic Eye Drops contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact with soft
lenses. Take out lenses before you use Teoptic eye drops and do not put
them back for at least 15 minutes. Benzalkonium chloride is known to
discolour soft contact lenses.

3) How to use Teoptic Eye Drops
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.
The recommended dose is one drop into the affected eye twice daily.
After using Teoptic eye drops, 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 Eye Drops
• 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

If you forget to use Teoptic Eye Drops
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.
If you use more Teoptic Eye Drops than you should
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.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4) Possible side effects

6) Further information

Like all medicines Teoptic Eye Drops can cause side effects although not
everybody gets them.

What Teoptic Eye Drops contains:
Each eye drop contains either 1% or 2% w/v Carteolol Hydrochloride as the
active ingredient.

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 Teoptic Eye
Drops without speaking to your doctor.
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:
• 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 preexisting 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).
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 Teoptic Eye Drops
• These drops are sterile until the seal is broken. Do not accept for initial use
if the seal is broken.
• Do not use after the expiry date shown on the label.
• Do not store above 25°C.
• Discard the contents 28 days after first opening the bottle.
• Keep all medicines out of the sight and reach of children
• Any left-over or out of date drops should be returned to your pharmacist
who will dispose of them safely for you.
• If the eye drops become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist.
• If your doctor tells you to stop using Teoptic Eye Drops, please take any left
back to your pharmacist to be destroyed. Only keep the drops if the doctor
tells you to. Do not throw them away with your normal household water or
waste. This will help to protect the environment.

It also contains the following ingredients; sodium phosphate, sodium acid
phosphate, sodium chloride, benzalkonium chloride and sterile purified water.
What Teoptic Eye Drops looks like and contents of the pack
The eye drops is a clear, colourless, odourless, sterile eye drop.
Teoptic Eye Drops are available in dropper bottles of 5ml.
PL 10383/1005
PL 10383/1006

Teoptic 1% Eye drops/Carteolol hydrochloride 1% Eye
Drops/Mikelan 1% Eye drops
POM
Teoptic 2% Eye drops/Carteolol hydrochloride 2% Eye
Drops/Mikelan 2% Eye drops
POM

Who makes and repackages your medicine?
Your medicine is manufactured by Otsuka Pharmaceuticals S.A., Avda.
Diagonal, 609-615, 08028 Barcelona, Spain. Procured from within the EU and
repackaged by Product Licence Holder Primecrown Ltd., 4/5 Northolt Trading
Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 06.03.2013
®

Teoptic is a registered trademark of Otsuka Pharmaceuticals Co. Ltd.,
Tokyo, Japan.

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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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