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BETOPTIC SUSPENSION SINGLE DOSE 0.25% W/V EYE DROPS

Active substance(s): BETAXOLOL HYDROCHLORIDE

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BETOPTIC®

2. BEFORE YOU USE BETOPTIC SUSPENSION
SINGLE DOSE
Do not use BETOPTIC Suspension Single Dose eye drops, suspension...





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 the past, respiratory problems such as
severe asthma, severe chronic obstructive bronchitis (severe lung
condition 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).

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
• overactivity 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.
BETOPTIC Suspension Single Dose may reduce the effectiveness of
adrenaline, which can be used to treat serious allergic reactions

3. HOW TO USE BETOPTIC SUSPENSION
SINGLE DOSE
BETOPTIC Suspension Single Dose should only be used in the eye(s).
The usual dose is...
The usual dose is 1 drop in the affected eye(s) twice daily.
Not recommended for use in CHILDREN.

Wash your hands before you start.
Open the foil pouch, remove the
plastic vial and shake well (picture 1)

The undersigned :
name

vorname



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.

2

confirms that this proof contains an
accurate translation of the English
Corporate Standard text, and is in
compliance with the registered
information and the legal rules.
Please also carefully check :
- local barcodes if any
- formula
- components if mentionned
- shelflife if mentionned
- storage conditions
- trademarks

This proof is approved :



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 the lower lid (picture 3).

[]as is
[]conditionally

Customer request :
[]new proof

Signature and date :

3

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 for a missed dose.
If you use more BETOPTIC Suspension Single Dose than you
should it can be washed out of your eye with warm water.



4. POSSIBLE SIDE EFFECTS
Like all medicines, BETOPTIC Suspension Single Dose 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
BETOPTIC Suspension Single Dose without speaking to your doctor.
Like other medicines applied into eyes, betaxolol is absorbed into the
blood. This may cause similar side effects as seen with beta-blockers given
by injection or taken by mouth. Incidence of side effects after beta-blockers
are used in the treatment of eye conditions is lower than when medicines
are, for example, taken by mouth or injected. Listed side effects include
reactions seen following treatment with Betaxolol eye drops and within the
class of other beta-blockers used for treating eye conditions.

Very common: may affect more than 1 in 10 users
• Eye discomfort (includes a feeling of something in the eye)

RA APPROVAL

1

Dispose of the vial after use. Do not keep
to use again.




Common (affects 1 to 10 users in 100):
• Blurred vision, watery eyes
• Headache

How to use


If you use drops in both eyes, repeat the
steps for your other eye.



Side effects experienced by patients during clinical trials with
BETOPTIC Suspension Single Dose are:

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.




Date
Name
Date

Contrôlé et approuvé par

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.

Name

[]FILM

l’épreuve V.......... du.............................

/ []BAT

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.

Plan Alcon : 110905 v2
Type machine MONO7/MANUEL

It is used to treat glaucoma or ocular hypertension (high pressure in the
eye) by reducing the fluid pressure in your eye(s).

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 breast milk.
Ask your doctor for advice before taking any medicine during breast- feeding.

QQ DIELINE

BETOPTIC Suspension Single Dose belongs to a group of medicines
known as beta blockers.

If you are using more than one type of eye drop, wait 5 minutes
between using each one. Eye ointments should be administered last.

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 have any further questions on the use of BETOPTIC Suspension
Single Dose, ask your doctor or pharmacist.

„„ 1/1 NOIR

1. WHAT BETOPTIC SUSPENSION SINGLE DOSE
IS AND WHAT IT IS USED FOR

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

Insert R°/V° 178 x 274 mm

What BETOPTIC Suspension Single Dose is and what it is used for
Before you use BETOPTIC Suspension Single Dose
How to use BETOPTIC Suspension Single Dose
Possible side effects
How to store BETOPTIC Suspension Single Dose
Further information

NOTICE BETOPTIC
UK-IRL (GBI)

1.
2.
3.
4.
5.
6.



4

1° proof + 11/12/2015

1933

1933

(anaphylaxis). Tell your doctor if you have a history of anaphylaxis or
allergic reactions.

429736

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 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.

BLEU BANQUISE

Betaxolol (as hydrochloride)

CS

Suspension Single Dose 0.25% w/v eye drops

IN THIS LEAFLET

Contrôlé par rapport à

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Uncommon (affects 1 to 10 users in 1000):
• Inflammation of the eye surface, conjunctivitis or symptoms of
conjunctivitis, visual impairment, sensitivity to light, painful, dry or tired
eyes, excessive blinking, irritated, red or swollen eyes, a feeling of
something in the eye, eye itchiness eye discharge, weeping eyelids,
bloodshot eyes
• Slow heart beat or unusually rapid heart beat
• Asthma, difficulty breathing, blocked nose
• Nausea





Low blood glucose levels.
Nightmares, memory loss, hallucinations, delusions and confusion.
Stroke, reduced blood supply to the brain, increases in signs and
symptoms of myasthenia gravis (muscle disorder), unusual sensations
(like pins and needles).
• 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), 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.
• 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).
• Indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Skin rash with white silvery coloured appearance (psoriasiform rash) or
worsening of psoriasis.
• Muscle pain not caused by exercise.
• Sexual dysfunction, impotence.
• Tiredness.
An increased in Anti Nuclear Antibodies has also been seen in patients
taking ophthalmic beta blockers.
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 national reporting system listed below. By
reporting side effects, you can help provide more information on the safety
of this medicine.
United Kingdom - Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland - HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971
Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5. HOW TO STORE BETOPTIC SUSPENSION
SINGLE DOSE










Keep out of the reach and sight of children.
Do not store above 25°C.
Do not freeze.
Store in the original package in order to protect from light.
Do not use the drops after the expiry date (marked 'Exp') 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 after use. Do not keep an open vial to use again.
Medicines should not be disposed of via waste water 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.

Rare (affects 1 to 10 users in 10,000):
• Cataract formation, decreased sensitivity of the eye, inflammation of
the eyelid
• Anxiety, difficulty sleeping (insomnia), depression
• Fainting
• Low blood pressure
• Cough, runny nose
• Taste disturbances
• Inflamed, itchy skin or rash, hair loss
• Libido decreased

6. FURTHER INFORMATION

The following side effects have also been reported by people using
BETOPTIC Suspension Single Dose. The frequency cannot be
estimated from the available data:
• Hypersensitivity reaction
• Dizziness
• Changes in the rhythm or speed of the heartbeat
• Loss or lack of strength

What BETOPTIC Suspension Single Dose looks like and contents of
the pack
BETOPTIC Suspension Single Dose is a white to off-white liquid
supplied in a plastic single-dose dispenser containing 0.25 ml. Five
dispensers are enclosed in a foil overwrap. Each pack contains
50 single dose dispensers.

Additional side effects have been seen with other ophthalmic
beta-blockers and could potentially occur with BETOPTIC Suspension
Single Dose. The frequency is 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.

Marketing authorisation holder:
Alcon Laboratories (UK) Ltd
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR
United Kingdom.

What BETOPTIC Suspension Single Dose contains
• The active substance is betaxolol 0.25% w/v (2.5 mg/ml) (as the
hydrochloride). Each single dose dispenser contains 625 micrograms of
betaxolol (as the hydrochloride).
• The other ingredients are amberlite (Poly (styrene divinyl benzene)
sulphonic acid), carbomer, mannitol, hydrochloric acid and/or sodium
hydroxide (to adjust pH) and purified water.

Suitable for people who are sensitive to preservatives.
Manufacturer:
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in November 2015.

© 2013, 2015 Novartis
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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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