How does it work?

Xalacom eye drops contain two active ingredients, latanoprostand timolol maleate. These are both medicines that decrease raised pressurewithin the eye. They work in different ways to produce a combined effectgreater than either medicine produces on its own.

The pressure within the eyeball is naturally maintained by acontinuous flow of liquid called aqueous humour through the eyeball. Aqueoushumour is produced by a part of the eye called the ciliary body. It drains outof the eyeball through channels called the trabecular meshwork. If the outflowof aqueous humour is blocked, the aqueous humour builds up inside the eye,increasing the pressure within the eyeball. This pressure needs to be reduced,as otherwise it can damage the optic nerve and impair vision as aresult.

Latanoprost is a type of medicine called a prostaglandinanalogue. It reduces the pressure in the eye by mimicking the action of anaturally-occuring prostaglandin. Prostaglandins are a group of natural bodychemicals found in many places in the body. In the eye, they increase thedrainage of the aqueous humour out of the eyeball. Latanoprost is a syntheticprostaglandin that acts on the same receptors in the eye as the naturalprostaglandins. It therefore causes an increase in the drainage of aqueoushumour out of the eyeball. This decreases the pressure within theeye.

Timolol is a type of medicine called a beta-blocker. Thesemedicines block beta-receptors in various parts of the body. Blocking the betareceptors in the eye reduces the amount of aqueous humour that is produced.Timolol therefore reduces the inflow of aqueous humour into the eyeball and sodecreases the pressure within the eye in a different way.

The combination of these two medicines is used to lower thepressure in the eye when a beta-blocker or a prostaglandin analogue eye dropdoes not lower the pressure enough on its own.

The eye drops should be put into the affected eye(s) once a day.The medicine is most effective if the drops are applied in the evening. Youshould not exceed the recommended dose, as using the drops more frequently thanthis can actually decrease their effect.

What is it used for?

• Open angle glaucoma.
• Raised pressure in the eye (ocular hypertension).

Warning!

• This medicine is not to be taken by mouth.
• When using these eye drops you should take care to not touch the dropper tip to any surface, or to your eye, in order to avoid contaminating the eye drops.
• Xalacom eye drops contain the preservative benzalkonium chloride, which can be absorbed by contact lenses and cause eye irritation. If you wear contact lenses, you should remove them before putting in these eye drops. You should wait at least 15 minutes after using the drops before putting your contact lenses back in.
• It is recommended that immediately after administering the eye drops, you press on the tear duct (at the corner of the eye closest to your nose) for about one minute. This is to minimise the amount of medicine that may be absorbed into the bloodstream and increase the local effect in the eye.
• These eye drops may cause your vision to blur temporarily after you have put them in your eye. Do not drive or operate machinery until this has worn off. You should also take into account that this medicine can sometimes cause other visual disturbances, eg double vision, and dizziness or fatigue, all of which may affect your ability to drive or operate machinary.
• Xalacom eye drops should be stored in a refrigerator at 2-8°C before opening. After opening the eye drops may kept outside of the fridge, but do not store them above 25°C. Keep the container in the outer carton in order to protect from light.
• Xalacom eye drops are sterile until opened. The bottles contain a preservative that helps keep the eye drops sterile once they are in use. However, any medicine remaining in the bottle after it has been open for four weeks or more is likely to be contaminated with germs and should no longer be used. Dispose of carefully, preferably by returning to your pharmacy. You may find it helpful to write the date of first opening on the packet.
• Latanoprost can cause your eye colour to gradually change, by increasing the amount of brown pigment in your iris. This is not associated with any symptoms and is not harmful. It predominately happens in people with green-brown, yellow-brown or blue/grey-brown eyes. If these eye drops are only used in one eye, this may cause your eyes to permanently become different colours. Ask your doctor, eye specialist or pharmacist for more information.
• While using this medicine you should have regular eye examinations.
• Beta-blockers such as timolol can be absorbed into the bloodstream after being applied into the eye. They may mask the symptoms of low blood sugar (hypoglycaemia) such as increased heart rate, tremor and nausea. For this reason, people with diabetes should carefully monitor their blood sugar while using these eye drops.
• Beta-blockers such as timolol can increase sensitivity to substances which cause allergy and the seriousness of severe allergic reactions (anaphylaxis). People who experience an anaphylactic reaction while using this medicine may need larger than normal doses of adrenaline to treat the reaction. Seek further medical advice from your doctor if you have a history of allergies.

Use with caution in

• Closed angle glaucoma.
• Glaucoma caused by accumulation of pigment particles in the drainage channels of the eye (pigmentary glaucoma).
• Glaucoma caused by inflammation inside the eye (inflammatory glaucoma).
• Glaucoma caused by the growth of new blood vessels over the iris (neovascular glaucoma).
• Glaucoma present from birth (congenital glaucoma).
• Inflammatory conditions of the eye, eg conjunctivitis.
• People with an artificial lens in the eye (pseudophakia).
• People with no lens in the eye (aphakia).
• Closed or blocked retinal vein.
• Diabetes affecting the eyes (diabetic retinopathy).
• Diabetes.
• People who suffer from drops in blood sugar (hypoglycaemia).
• History of severe heart disease.
• Heart failure.
• A severe form of angina pectoris, not caused by exertion (Prinzmetal's angina).
• Severe disorders of blood circulation.
• Low blood pressure (hypotension).
• Overactive thyroid gland (hyperthyroidism).
• History of allergies.
• Psoriasis.
• Abnormal muscle weakness (myaesthenia gravis).

Not to be used in

• Asthma or history of asthma.
• Severe chronic obstructive pulmonary disease (COPD).
• Slow heart rate caused by the pacemaker of the heart (sinus bradycardia).
• Serious defect in the heart's electrical message pathways resulting in decreased function of the heart (2nd or 3rd degree heart block).
• Uncontrolled heart failure.
• Failure of the heart to maintain adequate circulation of blood (cardiogenic shock).
• Pregnancy.
• Breastfeeding.
• This medicine is not recommended for children and adolescents, as there is no information regarding its safety and efficacy in this age group.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine should not be used during pregnancy, as it may be absorbed into the bloodstream and could be harmful to the unborn baby. Women who could get pregnant should use an effective method of contraception to avoid getting pregnant while using these eye drops. Seek medical advice from your doctor.
• This medicine can pass into breast milk after being applied into the eye. The manufacturer states that it should not be used by women who are breastfeeding. Mothers who need to use this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

• Change in colour of the iris (the coloured part of the eye - see warning above).
• Darkening, thickening and lengthening of the eyelashes.
• Eye irritation including stinging, burning and itching.
• Red eye(s) due to increased blood supply (hyperaemia).
• Disorders of the front layer of the eye (cornea).
• Inflammation of the lining of the eye(s), causing pain and redness (conjunctivitis).
• Inflammation of the eyelid(s) (blepharitis).
• Eye pain.
• Headache.
• Skin rashes.
• Swelling of the area at the back of the eye responsible for seeing fine detail (macular oedema).
• Dry eye(s).
• Double vision.
• Drooping of the upper eyelid (ptosis).
• Chest pain.
• Slowed heart rate (bradycardia).
• Low blood pressure (hypotension).
• Dizziness.
• Shortness of breath.
• Difficulty sleeping (insomnia).

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

You should always tell your doctor or pharmacist what medicinesyou are already using, including those bought without a prescription and herbalmedicines, before you start treatment with this medicine. Similarly, check withyour doctor or pharmacist before using any new medicines while using this one,to ensure that thecombination is safe.

If you are using more than one type of eye drop you shouldadminister them at least five minutes apart, to prevent the second drop washingaway the first. Use eye gels or ointments last.

Eye drops can be absorbed into the bloodstream from the eye, andonce in the bloodstream they have the potential to interact with othermedicines. For this reason you should be aware of the following:

In people with diabetes, timolol can prolong the lowering ofblood sugar (hypoglycaemia) caused by insulin or other antidiabetic medicines.People with diabetes should monitor their blood sugar, as timolol can also maskthe signs of hypoglycaemia.

The timolol in these eye drops may enhance the effects of thefollowing medicines taken by mouth, which may result in low blood pressureand/or a slowed heart rate:

• beta-blockers, eg atenolol
• calcium channel blockers, eg nifedipine, verapamil, diltiazem
• digoxin
• medicines for abnormal heart rhythms (antiarrhythmics), eg amiodarone.

If the medicine clonidine is suddenly stopped it can cause anincrease in blood pressure. This increase in blood pressure may be worse inpeople taking beta-blockers, including eye drops such as this one.

Beta-blockers oppose the action of medicines for asthma thatopen the airways, which is why these eye drops should not be used by peoplewith asthma or other breathing difficulties.

Xalacom eye drops should not be used in combination with otherprostaglandin analogue eye drops, because the combination may actually increasethe pressure in the eye.

Other beta-blocker eye drops are not recommended for use incombination with Xalacom eye drops.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK thatcontain both latanoprost and timolol as the active ingredients.

Xalatan eye dropscontain just latanoprost.

Nyogel,Timoptol andTimoptol-LA eyedrops contain just timolol.