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CARTEOL 1% EYE DROPS

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Carteol 1% Eye Drops/ Carteol 2% Eye Drops
Carteolol Hydrochloride 1% Eye Drops/
Carteolol Hydrochloride 2% Eye Drops
(carteolol hydrochloride)
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 onto 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.
The eye drops will usually be referred to as Carteol in this leaflet.
What is in this leaflet:
1. What Carteol is and what it is used for
2. What you need to know before you use Carteol
3. How to use Carteol
4. Possible side effects
5. How to store Carteol
6. Contents of the pack and other information
1. What Carteol is and what it is used for
Carteol 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 beta-blockers which
can help to reduce pressure in the eye. Carteol is used to treat conditions such
as glaucoma (increased pressure in the eye).
2. What you need to know before you use Carteol
Do not use Carteol 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).
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 Carteol as
carteolol hydrochloride may change effects of some medicines used during
anaesthesia.
Other medicines and Carteol
Carteol 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 Carteol if you are pregnant or trying to get pregnant unless your
doctor considers it necessary.
Do not use Carteol 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 Carteol. If you are affected, you should not drive or use
machinery.
Carteol contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact with soft lenses.
Take out lenses before you use Carteol and do not put them back for at least 15
minutes. Benzalkonium chloride is known to discolour soft contact lenses.
3. How to use Carteol
Always use Carteol 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 Carteol, 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.



PLPI: 17211/0188 & PLPI
17211/0187
Dimensions: 100mm x 400mm
Colours: Black

Use in children and adolescents
Carteol Eye Drops are not recommended for children.
How to use Carteol

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

Product: Carteol 1% Eye Drops/
Carteol 2% Eye Drops/
Carteolol Hydrochloride 1% Eye
Drops/ Carteolol Hydrochloride
2% Eye Drops

Item Code: CAR2003I/G
Proof: 32

1

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

2
CAR2003I/G



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

3


Replace the cap and wash your hands.

If you forget to use Carteol
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 Carteol 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 effects4.4
Like all medicines, Carteol 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
are worried, talk to a doctor or pharmacist. Do not stop using Carteol 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 ‘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:

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 swallowing or breathing, hives or itchy rash,
localised and generalised 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 Carteol
Keep out of the sight and reach of children.
The drops are sterile until the seal on the bottle is broken.
Protect from heat. Store below 250C. Do not accept for initial use if the seal is
broken.
Discard 28 days after opening.
Do not use after the expiry date shown on the label.
If the solution becomes discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
Carteol Eye Drops contain 1% and 2% w/v of the active ingredient, carteolol
hydrochloride. They also contain the inactive ingredients benzalkonium chloride,
sodium chloride, dibasic sodium phosphate and sterile distilled water for
injection.
Carteol is available in a polyethylene dropper bottle with a white cap, containing
5ml of clear, colourless, sterile solution. Pack size 1 x 5ml.
Manufacturer:
Societa Industria Farmaceutica italiana, SPA (SIFI), Officina Di Monterosso
Etneo, ACIS. Antonio, Catania, Italy. Procured from within the EU by the
Product Licence Holder Polyfarma Ltd and repackaged by Kent
Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.
POM

Carteol 1% Eye Drops
Carteol 2% Eye Drops

PL No: 17211/0188
PL No: 17211/0187

Product: Carteol 1% Eye Drops/
Carteol 2% Eye Drops/
Carteolol Hydrochloride 1% Eye
Drops/ Carteolol Hydrochloride
2% Eye Drops

Leaflet revision and issue date: 2316.11.2012
CAR2003I/G

PLPI: 17211/0188 & PLPI
17211/0187
Dimensions: 100mm x 400mm
Colours: Black
Item Code: CAR2003I/G
Proof: 32

Carteol 1% Eye Drops/ Carteol 2% Eye Drops
Carteolol Hydrochloride 1% Eye Drops/
Carteolol Hydrochloride 2% Eye Drops
(carteolol hydrochloride)
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 onto 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.
The eye drops will usually be referred to as Carteol in this leaflet.
What is in this leaflet:
1. What Carteol is and what it is used for
2. What you need to know before you use Carteol
3. How to use Carteol
4. Possible side effects
5. How to store Carteol
6. Contents of the pack and other information
1. What Carteol is and what it is used for
Carteol 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 beta-blockers which
can help to reduce pressure in the eye. Carteol is used to treat conditions such
as glaucoma (increased pressure in the eye).
2. What you need to know before you use Carteol
Do not use Carteol 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).
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 Carteol as
carteolol hydrochloride may change effects of some medicines used during
anaesthesia.
Other medicines and Carteol
Carteol 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 Carteol if you are pregnant or trying to get pregnant unless your
doctor considers it necessary.
Do not use Carteol 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 Carteol. If you are affected, you should not drive or use
machinery.
Carteol contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact with soft lenses.
Take out lenses before you use Carteol and do not put them back for at least 15
minutes. Benzalkonium chloride is known to discolour soft contact lenses.
3. How to use Carteol
Always use Carteol 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 Carteol, 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.



PLPI: 17211/0188 & PLPI
17211/0187
Dimensions: 100mm x 400mm
Colours: Black

Use in children and adolescents
Carteol Eye Drops are not recommended for children.
How to use Carteol

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

Product: Carteol 1% Eye Drops/
Carteol 2% Eye Drops/
Carteolol Hydrochloride 1% Eye
Drops/ Carteolol Hydrochloride
2% Eye Drops

Item Code: CAR2003I/G
Proof: 2

1

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

2
CAR2003I/G



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

3


Replace the cap and wash your hands.

If you forget to use Carteol
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 Carteol 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 effects4.4
Like all medicines, Carteol 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
are worried, talk to a doctor or pharmacist. Do not stop using Carteol 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 ‘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:

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 swallowing or breathing, hives or itchy rash,
localised and generalised 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 Carteol
Keep out of the sight and reach of children.
The drops are sterile until the seal on the bottle is broken.
Protect from heat. Store below 250C. Do not accept for initial use if the seal is
broken.
Discard 28 days after opening.
Do not use after the expiry date shown on the label.
If the solution becomes discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
Carteol Eye Drops contain 1% and 2% w/v of the active ingredient, carteolol
hydrochloride. They also contain the inactive ingredients benzalkonium chloride,
sodium chloride, dibasic sodium phosphate and sterile distilled water for
injection.
Carteol is available in a polyethylene dropper bottle with a white cap, containing
5ml of clear, colourless, sterile solution. Pack size 1 x 5ml.
Manufacturer:
Societa Industria Farmaceutica italiana, SPA (SIFI), Officina Di Monterosso
Etneo, ACIS. Antonio, Catania, Italy. Procured from within the EU by the
Product Licence Holder Polyfarma Ltd and repackaged by Kent
Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.
POM

Carteol 1% Eye Drops
Carteol 2% Eye Drops

PL No: 17211/0188
PL No: 17211/0187

Product: Carteol 1% Eye Drops/
Carteol 2% Eye Drops/
Carteolol Hydrochloride 1% Eye
Drops/ Carteolol Hydrochloride
2% Eye Drops

Leaflet revision and issue date: 23.11.2012
CAR2003I/G

PLPI: 17211/0188 & PLPI
17211/0187
Dimensions: 100mm x 400mm
Colours: Black
Item Code: CAR2003I/G
Proof: 3

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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