PATIENT INFORMATION LEAFLET

Xalacom™

Eye drops, solution

Latanoprost

Timolol maleate

Please read this leaflet carefully before you start using Xalacom. It provides some useful information on your medicine. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. For further information or advice ask your doctor or pharmacist.

What does Xalacom contain?

Each millilitre (1 ml) of Xalacom eye drops, solution contains:

Active substances: 50 micrograms latanoprost and timolol maleate corresponding to 5 mg timolol.

Other ingredients: benzalkonium chloride (preservative), sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections. To bring the solution to the correct pH level, very small amounts of hydrochloric acid or sodium hydroxide may be added to the solution during manufacture.

Each bottle of Xalacom contains 2.5 ml eye drops.

What is Xalacom?

Xalacom eye drops is a combination of two different medicines that both contribute to lowering the pressure in the eye, but in different ways. Timolol is one of a group of medicines known as “beta-blockers” and lowers the pressure in the eye by reducing the inflow of fluid inside the eye. Latanoprost lowers the pressure by increasing the natural outflow of fluid from the inside of the eye.

Information is supplied by

Product Authorisation Holder:

Manufacturer:

What is Xalacom used for?

Xalacom is used for lowering increased pressure within the eye (called ocular hypertension) and for the treatment of glaucoma.

When should Xalacom not be used?

Xalacom should not be used if you:

• have a respiratory disease such as asthma or a history of asthma, or have severe respiratory problems due to another cause;
• have heart problems, such as heart failure or heart rhythm disorders; and
• are allergic to any of the ingredients in Xalacom.

If you think any of these points apply to you, do not use Xalacom until you have talked to your doctor.

What else should you know about taking Xalacom?

You should tell your doctor if you have, or have had, asthma or other lung problems, heart problems, circulatory problems, low blood pressure, diabetes or low blood sugar (hypoglycaemia), or allergies to other medicines that you have used.

If you have any heart problems your doctor will want to make sure that the situation is under control before you take your eye drops. Your doctor may want you to have extra checks on your heart and circulation whilst you are using Xalacom.

If you have a coloured part of the eye (iris) that is a mixture of colours, i.e. blue/grey-brown, green-brown or yellow-brown, you may find that you slowly and gradually develop an increase in the brown colour of the iris. Changes in purely blue, grey, green or brown eyes are rare. The brown colour change occurs slowly and is noticed only after months to years. If you are being treated with Xalacom in one eye only, this can result in a difference in colour between eyes. The change in colour is harmless, but will probably be permanent.

If the coloured parts of your eyes are a mixture of colours or if you observe an increase in the brown colour of the iris, talk to your doctor.

Before surgery and anaesthesia, the doctor/dentist should know that you are being treated with Xalacom, since there is a risk that blood pressure can suddenly fall in association with anaesthesia.

A preservative in Xalacom called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses. If you wear contact lenses it is important that the lenses are taken out before applying Xalacom and not replaced until at least 15 minutes after application.

Xalacom is not recommended for children or adolescents.

How to use Xalacom

If this is the first time that you have used this bottle, write the date in the space provided on the carton so that you will know when they should no longer be used because they are out of date.

The usual dosage is: 1 drop into the affected eye (eyes) once daily.

If Xalacom is being used together with other eye drops, they should be put in at least 5 minutes apart.

If a dose is missed, you should wait until the next dose. Do not make up for a missed dose by putting an extra drop into the eye.

Instructions for Use

Wash your hands before using eyedrops.

• 1. Twist off the colourless protective cap with the “wings”

• 2. Unscrew the cap

• 3. Using your forefinger, gently pull down the lower eyelid of the eye that is to be treated.

• 4. Place the tip close to the eye and squeeze gently, so that one drop falls into the eye.
• 
  
• 5. Replace the cap after use.

If you should accidentally use more Xalacom then you should, always contact your doctor or hospital.

Possible side effects of Xalacom

Like all medicines, Xalacom can cause unwanted effects, known as side effects.

Effects on the eye:

A change in eye colour was seen in nearly a third of all patients which may be permanent.

Very common side effect which may affect more than 1 in 10 patients:

• Change in the coloured part of the eye (iris) which may be permanent. For more details refer to the earlier section of this leaflet under the heading “What else should you know about taking Xalacom?”.

The most common side-effects (i.e. those affecting between 1 in 10 and 1 in 100 patients) which have been reported with Xalacom are:

• Eye irritation (including stinging, burning and itching); and
• Eye pain.

Uncommon side-effects (i.e. those affecting between 1 in 100 and 1 in 1000 patients) are:

• Headache;
• Pink/Redness of the eye;
• Blurred vision;
• Watery eyes;
• Sore eyelids; and
• Skin rashes/itching.

Some side-effects have been seen with the two individual medicines (latanoprost and timolol maleate) within Xalacom. The following effects on the eye may occur with Xalacom:

• Darker, thicker, longer and more eyelashes and fine (vellus) hair;
• Eyelashes growing in the “wrong” direction sometimes resulting in eye irritation;
• Swelling around the eyes;
• Small marks on the eye surface (punctate keratitis), eye discomfort;
• Inflammation and swelling in and around the eye/eyelid;
• Eye becoming sensitive to light;
• Dry eyes;
• Visual disturbances (such as double vision); and
• Drooping eyelid.

When the Xalacom is instilled into the eye, a small amount of active medicines (latanoprost and timolol maleate) in Xalacom can be absorbed into the blood and may cause effects elsewhere in the body, not only in the eye.

The following effects have been reported on the body for the individual medicines (latanoprost and timolol maleate) within Xalacom. These side effects may occur with Xalacom:

• Asthma (acute and worsening of existing asthma), laboured breathing, shortness of breath, cough;
• Chest pain, fainting, a slowing of your heart rate;
• Worsening of angina in patients with pre-existing disease;
• Fatigue (tiredness), dizziness, abnormal sensations, light-headedness, ringing in the ears, depression, abnormal skin sensations;
• oint and muscle pain;
• Nausea, diarrhoea, indigestion, dry mouth;
• Low blood pressure, stroke, swelling or coldness of your hands, feet and extremities, caused by constriction of the blood vessels in response to stimuli, including the cold; and
• Depression, memory loss, nightmares, decreased sex drive, difficulty in sleeping.

Hypersensitivity reactions such as skin rash (localised or generalised), itching, hair loss, darkening of the skin of the eyelid, exacerbation of psoriasis and a worsening of myasthenia gravis (increased muscle weakness). A more severe allergic-type reactions may cause sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, fainting and rapid pulse.

If you experience any of these side effects and are concerned, please tell your doctor as soon as possible.

If you feel unwell in any other way not mentioned in this leaflet whilst taking Xalacom, please inform your doctor or pharmacist.

How to store Xalacom

Keep your bottle out of the reach and sight of children.

Before Xalacom is first opened, it should be stored at 2°C-8°C (in a refrigerator).

Once the bottle has been opened, Xalacom can be kept at room temperature (below 25°C) for up to 4 weeks. Xalacom should not be used after the expiry date on the bottle. Xalacom should not be used 4 weeks after opening the container for the first time.

Keep the container in the outer carton to protect the medicine from light.

Date leaflet revised November 2007

Pharmacia Limited

XM4_0