BETOPTIC SUSPENSION SINGLE DOSE 0.25% W/V EYE DROPS

Active substance: BETAXOLOL HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

1823
15.08.12[5]

Betoptic® Suspension Single Dose
0.25% w/v eye drops
(betaxolol hydrochloride)
The name of your medicine Betoptic Suspension Single Dose 0.25% w/v
Eye Drops but will be referred to as Betoptic Suspension Single Dose
throughout the following 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 question, ask your doctor or your 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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Betoptic Suspension Single Dose is and what it is used for
2. Before you use Betoptic Suspension Single Dose
3. How to use Betoptic Suspension Single Dose
4. Possible side effects
5. How to store Betoptic Suspension Single Dose
6. Further information
1. What Betoptic Suspension Single Dose is and what it is used for
Betoptic Suspension Single Dose belongs to a group of medicines
known as beta blockers.
It is used to treat glaucoma or ocular hypertension (high pressure in the
eye) by reducing the fluid pressure in your eye(s).
2. Before you use Betoptic Suspension Single Dose
Do not use Betoptic Suspension Single Dose...
• If you are allergic to betaxolol, beta-blockers or any of the other
ingredients 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 longstanding cough).
• if you have a slow heart beat, heart failure or disorders of heart rhythm
(irregular heartbeats).
Ask your doctor for advice.
Take special care...
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 (hypotension)
• disturbances of heart rate such as slow heart beat (bradycardia)
• breathing problems, asthma or chronic obstructive pulmonary
disease (lung disease which may cause wheeziness, difficulty in
breathing and/or long-standing cough).








poor blood circulation disease (such as Raynaud's disease or
Raynaud's syndrome)
diabetes, as betaxolol may mask the signs and symptoms of low blood
sugar
overactivlty of the thyroid gland as betaxolol may mask the signs
and symptoms
muscle weakening disease such as myasthenia gravis. Your
symptoms may get worse
angle-closure glaucoma
dry eyes (Sicca Syndrome)

Tell your doctor before you have an operation that you are using
Betoptic as betaxolol may change the effects of some medicines used
during anaesthesia.
If any of these apply you may still be able to use Betoptic Suspension
Single Dose, but discuss it with your doctor first.
Using other medicines
Betoptic Suspension Single 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, medicines to treat diabetes or
medicines to treat emotional, behavioural or mental disorders such as
anxiety or depression.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
If you are using more than one type of eye drop, wait 15 minutes
between using each one.

How to use

















Wash your hands before you start.
Open the foil pouch, remove the plastic vial
and shake well. (picture 1)
Twist off the cap of the plastic vial. (picture 2)
Hold the vial upside down.
Tilt your head back.
Pull down your lower eyelid with a finger,
until there is a ‘pocket’ between the eyelid
and your eye. The drop will go in here.
Bring the tip of the vial close to the eye. Do
this in front of a mirror if it helps.
Do not touch your eye or eyelid,
surrounding areas or other surfaces with the
tip of the vial. It could infect the drops.
Gently squeeze the vial so that one drop
falls into the gap between the eye and lower
lid (picture 3).
Release the lower eyelid. After using
Betoptic Suspension Single Dose, press a
finger into the corner of your eye by the
nose (picture 4) for 2 minutes. This helps to
stop betaxolol getting into the rest of the
body.
If you use drops in both eyes, repeat the
steps for your other eye.
Dispose of the vial after use. Do not keep to use again.
If a drop misses your eye, try again
If you miss a dose, just take it as soon as possible. However, if it is
almost time for your next dose, skip the missed dose and go back to
your regular dosing schedule. Do not use a double dose to make
up.
If you use more Betoptic Suspension Single Dose than you
should it can be washed out of your eye with warm water.

Pregnancy and breast-feeding
Do not use Betoptic Suspension Single Dose if you are pregnant unless
your doctor considers it necessary.
Do not use Betoptic Suspension Single Dose if you are breastfeeding.
Betaxolol may get into your milk.
Ask your doctor for advice before taking any medicine during breastfeeding.

If you have any further question on the use of Betoptic Suspension
Single Dose, ask your doctor or pharmacist.

Driving and using machines
If your sight is affected in any way following the use of Betoptic
Suspension Single Dose, you should not drive or operate machinery.

4. Possible side effects
Like all medicines, Betoptic Suspension Single Dose can cause side
effects, although not everybody gets them.

Important information if you wear Contact Lenses
Do not use the drops while wearing contact lenses. Wait at least 15
minutes after use before putting your lenses back in.

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
Betoptic Suspension Single Dose without speaking to your doctor.

3. How to use Betoptic Suspension Single Dose
The usual dose is...
The usual dose is 1 drop in the affected eye(s) twice daily.

Like other medicines applied into eyes, betaxolol is absorbed into the
blood. This may cause similar side effects as seen with intraveneous
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.

Not recommended for use in CHILDREN.
Always use Betoptic Suspension Single Dose exactly as your doctor has
told you. You should check with your doctor or pharmacist if you are not
sure



The frequency of possible side effects listed below is defined using the
following convention:

If any of the side effects get serious, or you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data)

5. How to store Betoptic Suspension Single Dose
Keep out of the sight and reach of children
o
Do not store above 25 C. Do not store in refrigerator or freeze.
Store in the original package in order to protect from light.
Do not use the drops after the expiry date marked on the sachet and the
carton. The expiry date refers to the last day of that month.
Once opened use immediately.
Dispose of the vial alter use. Do not keep an open vial to use again.
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
Do not pass this medicine on to others. It may harm them even if their
symptoms are the same as yours.

Common:
• Eye discomfort, stinging, or burning.
Uncommon:
Watery eyes.



Rare:
Blurred vision, corneal disease such as discolouration of the eye,
inflammation of the eye or decreased sensitivity of the eye, allergic
reactions, dry eye(s), a feeling of something in the eye, itching,
intolerance to light.
• Difficulty sleeping (insomnia), depression, headache, slow heart beat,
shortness of breath, wheezing, hair loss.



Frequency unknown:
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.
• Nightmares, memory loss, hallucinations, delusions and confusion.
• 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).
• Signs and symptoms of eye irritation (e.g. redness), inflammation of the
eyelid, and detachment of the layer below the retina that contains blood
vessels following filtration surgery which may cause visual
disturbances, corneal erosion (damage to the front layer of the eyeball),
drooping of the upper eyelid (making the eye stay half closed), double
vision.
• 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 with
a blue colour, leg pains (especially if you have a history of poor
circulation).
• 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.
• 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, impotence.
• Muscle weakness/tiredness.



6. Further information
What Betoptic Suspension Single Dose contains.
Each single dose contains betaxolol 0.25% w/v (2.5 mg/ml) (as betaxolol
hydrochloride). Each single dose dispenser contains 625 micrograms of
betaxolol (as the hydrochloride).
Also contains poly (styrene divinylbenzene) sulphonic acid, carbomer 974
P, mannitol, purified water, hydrochloric acid and/or sodium hydroxide.
What Betoptic Suspension Single Dose looks like and contents of
the pack
Betoptic Suspension Single Dose is white to off-white eye drop
suspension supplied in a plastic single dose dispensers containing
0.25 ml.
5 dispensers are enclosed in a foil overwrap
Each pack contains 50 or 60 plastic single dose dispenser containing
0.25 ml.
Suitable for people who are sensitive to preservatives.
Please note: The single dose containers contained within the
sachets are labelled as Betoptic S. This is another name for Betoptic
Suspension Single Dose 0.25% w/v Eye Drops.
Manufacturer and Product Licence Holder
Manufactured by Laboratoires Alcon SA, 23 Rue Avenue Georges
Ferrenbach, F-68240, Kaysersberg, France. Procured from within the EU
by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/1823

Leaflet revision and issue date (ref) 15.08.12[4]
Betoptic is a trademark of Novartis AG.

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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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