Betaxolol 5.0 mg/ml (asbetaxololhydrochloride 5.6 mg/ml)

Please read this leaflet carefully before you start to take your medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The medicine will be called Betaxolol in this leaflet.

In this leaflet:

1.    What Betaxolol is and what is it used for

2.    Before you use Betaxolol

3.    How to use Betaxolol

4.    Possible side effects

5.    How to store Betaxolol

6.    Further information

1.    WHAT BETAXOLOL IS AND WHAT IS IT USED FOR

The active ingredient betaxolol belongs to a group of medicines called beta-blockers. Betaxolol is used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions including glaucoma and ocular hypertension.

2.    BEFORE YOU USE BETAXOLOL Donotuseifyou:

•    are allergic (hypersensitive) to betaxolol hydrochloride or beta-blockers or to any other ingredient of this medicine (see section 6 for more details)

•    have now or have had in 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)

•    have a slow heartbeat, heart failure or disorders of heart rhythm (irregular heart beats). Take special care with Betaxolol

Before you use Betaxolol please 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

•    disturbances ofheart rate such as slow heart beat

•    are suffering from muscle weakness, condition called myasthenia gravis

•    diabetes as betaxolol may mask signs and symptoms of low blood sugar

•    overactivity of the thyroid gland as betaxolol may mask signs and symptoms

•    breathing problems, asthma or chronic obstructive pulmonary disease

•    poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)

Tell your doctor before you have an operation that you are using Betaxolol Eye Drops as betaxolol may change effects of some medicines used during anaesthesia.

Taking other medicines

•    Betaxolol 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 in particular:

•    a calcium antagonist (e.g. verapamil or diltiazem) often used to treat high blood pressure, angina, or an abnormal heartbeat

•    digoxin, often used to treat heart failure or an abnormal heartbeat

•    medicines known as a catecholamine-depleting agents (e.g. rauwolfia alkaloids/ reserpine) used to treat high blood pressure

•    a pressor amine (e.g. adrenaline) used to treat severe allergic reaction

•    clonidine to treat high blood pressure

•    quinidine, a medicine often used to treat abnormal heartbeat

•    other beta-blockers (e.g. other preparations of Betaxolol both oral and/or ocular), which belong to the same group of medicines

Pregnancy and breast-feeding

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

Driving and using machines

No effects on ability to drive and use machines have been reported. However do not drive or operate machines if you experience any visual disturbance or dizziness after using the product. Wait until this clears before driving or using machines.

Important information about some of the ingredients of Betaxolol Eye Drops:

The eye drops contain benzalkonium chloride as preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting. The preservative is known to discolour soft contact lenses.

3.    HOW TO USE BETAXOLOL

Always use Betaxolol exactly as your doctor has told you. You should check with your doctor orpharmacist if you are not sure.

The usual dose is one drop into each affected eye(s) twice daily, approximately 12 hours apart. If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop.

Use in children:

It is not recommended to use Betaxolol in children.

Instructions for use:

(please also refer to pictograms at the end of the leaflet)

•    First wash your hands

•    Avoid touching the eye (or any other surface) with the tip of the bottle

•    If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting

•    These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle

•    Tilt your head back and look at the ceiling

•    Pull the lower eyelid gently downwards

•    Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye

•    After using Betaxolol, press a finger into the comer of your eye, by the nose for 2 minutes. This helps to stop betaxolol getting into the rest of the body.

•    Repeat for the other eye if necessary

•    Replace and tighten the cap immediately after use.

Be careful not to touch the tip of the bottle on your eye or on any other surface.

Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately.

Keep using your medicine until your doctor tells you to stop.

If you use more Betaxolol than you should

If you accidentally use too much, contact your doctor or go to the nearest hospital casualty department immediately.

Overdose:

There is no experience of an overdosage with Betaxolol which is unlikely when given as eyedrops. The signs of overdosage include slow heart rate, drop of blood pressure, breathing difficulties, and heart attack.

If you forget to use Betaxolol

Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Betaxolol can cause side effects, although not everybody gets them.

If you experience a rare (these may affect between 1 in 1,000 and 1 in 10,000 patients) but serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips, tongue, or face or hives) to betaxolol, stop using the medication and contact your doctor immediately.

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 Betaxolol 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 intraveneous' and/or 'oral' as applicable betablocking 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:

The frequency ofpossible side effects listed below is defined using the following convention Very common (affects more than 1 user in 10)

Common (affects ItolOusersinlOO)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Not known (frequency cannot be estimated from the available data)

Common: eye discomfort

Rare: 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), sleep disorders, depression, any other psychiatric disturbances, confusion, nightmares, dizziness, unusual sensations (like pins and needles), and headache. Signs and symptoms of eye irritation (e.g. burning, stinging, itching, watering eyes, redness), inflammation of the eyelid, inflammation in the eye, blurred vision, sensitivity to light, unequal pupils, changes to the surface of the eye, pain, whitening of the membrane covering the inside of the eyelid / white of the eye. Slow heart rate, heart failure. Low blood pressure, Raynaud's phenomenon, cold hands and feet, worsening of leg pain when exercising. Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, worsening of asthma. Nausea, diarrhoea, vomiting. Hair loss, skin rash. Sexual dysfunction. Tiredness.

Frequency unknown: memory loss, fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder). Detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased comeal sensitivity, dry eyes, comeal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision. Congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, a type ofheart rhythm disorder, heart attack. Cough. Taste disturbances, indigestion, dry mouth, abdominal pain. Skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis. Muscle pain not caused by exercise, muscle weakness. Decreased libido.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE BETAXOLOL

Keep all medicines out of the sight and reach of children.

Do not store at a temperature above 30°C.

Discard the bottle 28 days after opening, even if there is solution remaining.

Do not use Betaxolol after the expiry date which is stated on the bottle and on the carton the bottle is packed in.

6.    FURTHER INFORMATION What Betaxolol contains

The active ingredient is betaxolol, where 5mg/ml betaxolol is equivalent to 5.6mg/ml of betaxolol hydrochloride. This product also contains disodium edetate, sodium chloride, benzalkonium chloride (as preservative) 0.01 % w/v and water for injection.

What Betaxolol look like and contents of the pack One bottle of Betaxolol contains 5 ml solution.

Your medicine is a clear colourless, sterile solution.

Marketing Authorisation Holder and Manufacturer

FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, P0157FE

PL number: 15872/0007

Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help.

This leaflet was last revised in: 06/2015

Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.