patient information leaflet betoptic suspension single dose

Patient Information Leaflet

BETOPTIC® SUSPENSION

Single Dose 0.25% w/v

Eye Drops

Betaxolol (as hydrochloride)

Read all of this leaflet carefully before you start using this medicine.

This medicine has been prescribed for you personally. You should not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
Keep this leaflet. You may need to read it again. If you still have questions after reading it, please ask your doctor or your pharmacist.

The active substance is betaxolol hydrochloride 2.8 mg/ml (equivalent to 2.5 mg/ml betaxolol).

Other ingredients: Amberlite [poly(styrene-divinyl benzene) sulphonic acid], carbomer, mannitol (E421) and purified water. Very small amounts of hydrochloric acid and/or sodium hydroxide may have been added to regulate the acidity/alkalinity of the product to ensure comfort in the eye.

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

If your doctor has prescribed this medicine for you to use then you will be suffering from glaucoma or high fluid pressure in your eye(s).

BETOPTIC Suspension Single Dose contains a substance called betaxolol which is a beta-adrenergic blocking agent (beta blocker for short) that is effective in reducing the fluid pressure in your eye(s). You may be using Betoptic Suspension Single Dose on its own or your doctor may have prescribed other medicines as well to treat the high fluid pressure in your eye(s). It is important that you continue to use all the medicines prescribed by your doctor unless otherwise instructed by your doctor.

Betoptic Suspension Single Dose has been designed especially for maximum comfort of the medicine in your eyes. It also does not contain any preservatives making it suitable for people who are sensitive or allergic to preservatives. The eye drops are supplied in single dose units which each contain 0.25ml of the suspension. Five units are packaged in a foil pouch.

2. WHAT YOU SHOULD KNOW BEFORE USING BETOPTIC SUSPENSION SINGLE DOSE

In some circumstances this medicine may not be suitable for you and your doctor may wish to give you a different medicine, so:

If you have a history of heart disease e.g. heart failure, bradycardia (slow heart beat), or heart block. Caution should be used as ocular beta blockers may decrease heart activity.
If you are diabetic or suffer from low blood sugar. You should be extremely alert with regard to the sugar level in your blood. Beta blockers may hide the signs and symptoms of a sudden decrease in blood sugar such as a fast heartbeat or trembling (hypoglycaemia).
If you have an overactive thyroid gland. Beta blockers may hide certain signs or symptoms of an overactive thyroid gland. Suddenly stopping the use of a beta blocker may cause a sudden and dangerous increase in thyroid symptoms.
If you have any form of lung disease or any condition that causes breathing difficulties e.g. asthma, emphysema or chronic bronchitis. The possibility of adverse respiratory effects cannot be ruled out if you are sensitive to beta blockers.
If you are taking psychotropic medicines (medications for mental, emotional or behavioural disorders).
If you have a neuromuscular disease like myasthenia gravis. Beta blockers may unmask or worsen symptoms of muscle weakness.
If you are about to have an operation which requires a general anaesthetic
If you have angle closure glaucoma
If you suffer from tear film abnormalities such as Sicca Syndrome (i.e. dry eyes)
If you are pregnant or intending to become pregnant
If you are breast feeding a baby
If you have ever had to stop taking a medicine because you were allergic to it

INFORM YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE

Pregnancy

During pregnancy use only when strictly needed. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

In case of breast-feeding use only when strictly needed. Ask your doctor or pharmacist for advice before taking any medicine.

Ability to drive and use machines

If your vision is blurred for a time just after you use BETOPTIC SUSPENSION SINGLE DOSE, do not drive or use machines until this effect has worn off.

Using BETOPTIC SUSPENSION SINGLE DOSE with other medicines

BETOPTIC SUSPENSION SINGLE DOSE contains a beta-blocking agent. Each interaction that is associated with systemically applied beta blockers can in principle appear with the use of beta blocker eye drops.

Betoptic Suspension Single Dose may have effects on other medicines that you are also taking e.g. other beta-blockers taken orally for heart disease or high blood pressure or other medicines taken to reduce high blood pressure e.g. reserpine. Make sure your doctor knows what other medicines you are taking.

If you are using more than one eye preparation, wait 15 minutes between each application.

3. HOW TO USE BETOPTIC SUSPENSION SINGLE DOSE

Eye drops containing beta blockers can be absorbed into the body. Consequently, the same undesirable effects can appear as with beta blockers taken by mouth. The following measures are, after application of the eye drops, useful to reduce side effects occurring in other parts of your body:

Keep the eyelid closed for 2 minutes.
Close the tear duct with the finger for 2 minutes.

DOSE

Adults
The normal dose is one drop in the affected eye(s) twice daily. However, it is possible that your doctor may change the dose to suit your particular condition. The dosage instructions will be specified on the label attached to the outer carton of your medicine. If they are not or you are not sure then ask your doctor or pharmacist. It is important that you use Betoptic Suspension Single Dose as instructed by your doctor.
Children
The safety and efficacy in children have not been established yet

Routine eye examinations are critical to ensure that the pressure in your eye(s) remains under control.

In some patients, the eye pressure lowering responses may require a few weeks to stabilise.

Your doctor will tell you how long you should use BETOPIC SUSPENSION SINGLE DOSE. Do not stop treatment before you are told by your doctor.

How to put the drops in your eye

By following the steps listed below you will ensure that BETOPTIC Suspension Single Dose is being used correctly and to the best effect.

	1. Wash your hands before using Betoptic Suspension Single Dose.
	2. Sit down in front of a mirror so that you can see what you are doing.
	3. Open the foil pouch, remove the plastic vial and shake it well.
	4. Twist off the cap of the plastic vial.
	5. Hold the vial upside down.
	6. Using the forefinger of your other hand, gently pull down the lower eyelid of the affected eye.
	7. Place the tip of the vial close to, but not touching, your eye and gently squeeze the vial so that one drop falls into the gap between the eye and lower lid.
	8. Now release the lower eyelid and keep closed for 2 minutes.
	9. Repeat steps 5-8 above for the other eye if necessary.
	10. If, for any reason, the drop of Betoptic Suspension does not remain in your eye(s) then repeat the dose by placing another drop in your eye(s)

What you should do if you miss a dose of BETOPTIC Suspension Single Dose

If you miss a dose, apply 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.

What you should do if you put too much BETOPTIC Suspension Single Dose in your eye

If you put too much of this medicine in your eye(s) it can be washed out with warm water. Placing too much of BETOPTIC SUSPENSION SINGLE DOSE in your eye is unlikely to occur and cause problems.
If you have accidentally swallowed BETOPTIC SUSPENSION SINGLE DOSE, immediately seek advice from your doctor, pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicine, BETOPTIC SUSPENSION SINGLE DOSE, can have undesirable effects.
- You may experience some or all of the following reactions in your eye(s):
  - Common: Stinging and burning, eye irritation, redness.
  - Uncommon: itching, a feeling of something in the eye, blurred vision, sensitivity to light, watery eyes.
  - Rare: inflammation of the cornea (clear surface of the eye), dry eyes, drooping of the eyelid, loss of eyelashes.
You may also experience reactions in other areas of your body including:
- Rare: slowing of the heart beat, short of breath, asthma, inability to sleep, headaches, depression, hair loss, muscular weakness, muscular pain, numb or tingling sensations (paraesthesia), cold extremities or leg pains (especially if history of poor circulation), low blood sugar (especially if history of poorly controlled diabetes), unmasking or worsening of symptoms of myasthenia gravis.
If you experience any of the reactions listed above or any others not listed, after using Betoptic Suspension Single Dose then tell your doctor and follow his/her advice.

5. STORING BETOPTIC SUSPENSION SINGLE DOSE

Keep BETOPTIC Suspension Single Dose in a safe place out of the reach and sight of children
Do not store above 25°C
Do not use this medicine after the expiry date shown as "EXP" on the container, foil pouch and carton
Each unit dose dispenser contains sufficient medicine for one administration (one or both eyes as directed by your doctor). Dispose of the container after use. Do not keep an opened container for re-use.

Medicine: betoptic suspension single dose