PACKAGE LEAFLET: INFORMATION FOR THE USER

LATANOPROST 50 MICROGRAMS/ml + TIMOLOL 5 mg/ml

EYE DROPS

(latanoprost / timolol)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet, please tell you doctor or pharmacist._

Was is in this leaflet:

1.    What Latanoprost/Timolol is and what it is used for.

2.    What you need to know before you use Latanoprost/Timolol.

3.    How to use Latanoprost/Timolol.

4.    Possible side effects.

5.    How to store Latanoprost/Timolol.

6.    Contents of the pack and other information.

1.    WHAT LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR

Latanoprost/Timolol is a medicine for the treatment of increased intraocular pressure (pressure inside the eye).

Latanoprost/Timolol is a drug combination containing two active substances: latanoprost (a prostaglandin derivative) and timolol maleate (a beta-blocker).

Fluid known as aqueous humour is produced inside the eye. This fluid is then drained back into the bloodstream, thereby maintaining the required pressure within the eye. If this outflow is obstructed, pressure within the eye increases.

Among other things, beta-blockers reduce pressure inside the eye, by reducing the production of aqueous humour. Prostaglandins promote the outflow of aqueous humour.

Latanoprost/Timolol is used:

•    to reduce inner eye pressure in patients with open-angle glaucoma (damage to the optic nerve, caused by excessive pressure within the eye)

•    to reduce inner eye pressure in patients for whom the effect of beta-blockers or prostaglandin derivatives alone is not sufficient.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL Do not use Latanoprost/Timolol:

•    if you are allergic (hypersensitive) to latanoprost or timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6)

•    if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease 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 heart beats). Warning and Precautions

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

•    disturbances of heart rate such as slow heart beat

•    breathing problems, asthma or chronic obstructive pulmonary disease

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

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

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

•    any kind of eye surgery (including cataract surgery)

•    eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)

•    dry eyes

•    wear contact lenses. You can still use Latanoprost/Timolol but follow the instructions for contact lens wearers in section 'Important information about some of the ingredients of Latanoprost/Timolol'

•    angina (particularly a type known as Prinzmetal angina)

•    severe allergic reactions that would usually require hospital treatment

•    you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).

Tell your doctor before you have an operation that you are using Latanoprost/Timolol as timolol may change effects of some medicines used during anaesthesia.

Other medicines and Latanoprost/Timolol

Latanoprost/Timolol 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, have recently taken or might take any other medicines (including eye drops). This also includes medicines obtained without a prescription.

Medicines can affect each other and interactions may occur. You must bear this in mind if you are taking or using any of the following types of medicine:

•    Calcium antagonists (e.g. in coronary heart disease or for high blood pressure)

Guanethidine (for high blood pressure)

Beta-blockers (for high blood pressure)

Antiarrhythmics (medications that normalise the heart rhythm)

Digitalis glycosides (for heart failure)

Parasympathomimetic agents (e.g. for the treatment of glaucoma)

Taking/using Latanoprost/Timolol together with the above medicines can cause low blood pressure and/or slow down the heart rate.

•    Medicines that act in a similar way to Latanoprost/Timolol

If used at the same time as Latanoprost/Timolol, the effect of other medicines with a similar action to Latanoprost/Timolol may be increased. For this reason, ophthalmic use (i.e. in the eye) of two beta-blockers or two prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended.

•    Clonidine

If you are using the active substance clonidine to reduce inner eye pressure together with Latanoprost/Timolol and you suddenly stop using clonidine, your blood pressure may rise. If you are also using beta-blockers at the same time to lower your blood pressure, your blood pressure may - due to this reverse effect - rise even further.

•    Quinidine (used to treat heart conditions and some types of malaria).

•    Antidepressants known as fluoxetine and paroxetine.

•    Epinephrine (adrenaline).

Children and adolescents

Latanoprost/Timolol is not recommended for children or adolescents.

Elderly patients

Latanoprost/Timolol is also suitable for the treatment of elderly patients.

Pregnancy and breast-feeding Pregnancy

Do not use Latanoprost/Timolol if you are pregnant unless you doctor considers it necessary. Breast-feeding

Do not use Latanoprost/Timolol if you are breast-feeding. Latanoprost/Timolol may get into your milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

After putting in Latanoprost/Timolol eye drops, your vision may become temporarily impaired.

If you should experience blurred vision - particularly after just putting in Latanoprost/Timolol eye drops - you should:

•    not drive any vehicles

•    not use any tools or machines.

Latanoprost/Timolol contains benzalkonium chloride

This medicinal product contains a preservative called benzalkonium chloride which may cause eye irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and it is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before putting them back in.

3. HOW TO USE LATANOPROST/TIMOLOL

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the usual dose is:

Adults, including elderly patients: insert one drop once a day into each affected eye.

Do not use Latanoprost/Timolol more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Your doctor may want you to have extra checks on your heart and circulation if you use Latanoprost/Timolol.

If you are using other eye drops in addition to Latanoprost/Timolol, these should be used at least 5 minutes apart.

Instructions for use:

1.    Wash your hands and sit or stand in a comfortable position.

2.    Remove the outer protective cap from the bottle.

3.    Use your fingertip to gently pull down the lower lid of the affected eye.

4.    Place the tip of the bottle close to, but not touching the eye. Carefully squeeze the bottle until one drop falls into your eye. Please make sure that you do not squeeze the bottle too hard, so that no more than one drop falls into the affected eye.

5.    Let go of your eyelid.

6.    After using Latanoprost/Timolol press a finger into the corner of your eye, by the nose for 2 minutes.

This helps to stop latanoprost/timolol getting into the rest of the body.

If prescribed by your doctor, repeat the procedure in your other eye. If the drop should miss your eye, apply another drop.

7. Close the bottle.

If you use more Latanoprost/Timolol than you should

If too many drops have gone into your eye, irritation and redness may occur. This should pass but if you are worried contact your doctor for advice.

Tell a doctor immediately if you or anyone else has swallowed the eye drops by mistake, or if you have been using the drops more often than prescribed. If you swallow a lot of Latanoprost/ Timolol, you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.

Keep the pack of this medicine ready, so that the doctor can find out more about the medication. He/she will then decide what to do next.

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If you forget to use Latanoprost/Timolol

If you have forgotten to use your eye drops, continue your treatment as normal at the next dose. The daily dose of one drop into the affected eye should not be exceeded.

Do not use a double dose to make up for a forgotten dose.

If you stop using Latanoprost/Timolol

Do not interrupt or stop your treatment with Latanoprost/Timolol without talking to your doctor first.

If you do not use Latanoprost/Timolol regularly or if you frequently forget to use it, the success of your treatment may be at risk.

Increased intraocular pressure (pressure within the eye) can damage the optic nerve and worsen your eyesight. Blindness may occur. Normally, you can barely feel increased intraocular pressure. The disorder can only be diagnosed via an examination by an eye specialist. If you suffer from increased intraocular pressure, regular eye tests are necessary, together with measurements of inner eye pressure. Pressure within the eye should be measured at least every 3 months.

Visual field measurements and optic nerve examinations should be performed at least once a year.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Listed below are the known side effects of using eye drops containing the active substances latanoprost and timolol. The most important side effect is the possibility of a gradual, permanent change in your eye colour. It is also possible that eye drops containing the active substances latanoprost and timolol might cause serious changes in the way your heart works. If you notice changes in your heart rate or heart function you should speak to a doctor and tell them you have been using Latanoprost/Timolol.

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 Latanoprost/Timolol without speaking to your doctor.

The following are known side effects of Latanoprost/Timolol.

Very common (may affect more than 1 in 10 people):

•    A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may take years

to develop. The colour change may be permanent and may be more noticeable if you use Latanoprost/Timolol in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Latanoprost/Timolol treatment is stopped.

Common (may affect up to 1 in 10 people):

•    Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye) and eye pain.

Uncommon (may affect up to 1 in 100 people):

•    Headache.

•    Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or disruption of the surface of the eye.

•    Skin rashes or itching (pruritus).

Other side effects

Although not seen with Latanoprost/Timolol, the following additional side effects have been seen with the medicines in Latanoprost/Timolol and therefore might occur when you use Latanoprost/Timolol:

The following side effects have been seen with latanoprost: Infections and Infestations:

•    Developing a viral infection of the eye caused by the herpes simplex virus (HSV).

Nervous System Disorders:

•    Dizziness.

Eye Disorders:

•    Changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes to the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitus), swelling at the back of the eye (macular oedema), inflammation/irritation of the surface of the eye (keratitis), dry eyes, damage or disruption to the surface of the eye or cornea, swelling (oedema) of the cornea, fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).

Heart (Cardiac) Disorders:

•    Worsening of angina, awareness of heart rhythm (palpitations).

Breathing (Respiratory) Disorders:

•    Asthma, worsening of asthma, shortness of breath.

Skin Disorders:

•    Darkening of the skin around the eyes.

Muscle and Skeletal Disorders:

•    Joint pain, muscle pain.

General Disorders:

•    Chest pain.

Like other medicines applied into eyes, Latanoprost/Timolol is absorbed into the blood.

The timolol portion of this combination may cause similar side effects as seen with 'intravenous' or 'oral' beta-blocking 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:

•    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, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction

•    Low blood glucose levels

•    Difficulty sleeping (insomnia), depression, nightmares, memory loss

•    fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache

•    Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, inflammation/irritation of the surface of the eye (keratitis), visual changes/disturbances, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision

•    Whistling/ringing in the ears (tinnitus)

•    Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, 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

•    Low blood pressure, discolouration/coldness of the fingers and toes (Raynaud's phenomenon), cold hands and feet

•    Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough

•    Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting

•    Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash

•    Muscle pain not caused by exercise

•    Sexual dysfunction, decreased libido

•    Muscle weakness/tiredness.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LATANOPROST/TIMOLOL

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the bottle label and carton after 'EXP'. The expiry date refers to the last day of that month.

Please note the following storage instructions:

Unopened bottles: Store in a refrigerator at 2°C - 8°C.

After the first opening of the bottle: Do not store above 25°C.

Once opened, you must discard the bottle - with any remaining contents - after 4 weeks. Otherwise, there is a risk of eye infection.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Latanoprost/Timolol contains

The active substances are: latanoprost and timolol maleate

1 ml eye drops contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate, equivalent to 5.0 mg timolol.

The other ingredients are:

Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water, sodium hydroxide for pH adjustment and hydrochloric acid for pH adjustment.

What Latanoprost/Timolol looks like and contents of the pack

Latanoprost/Timolol is a clear, colourless liquid packed in a transparent dropper bottle with a screw cap.

Latanoprost/Timolol is available in the following pack sizes:

1 dropper bottle containing 2.5 ml eye drops,

3 dropper bottles, each containing 2.5 ml eye drops,

6 dropper bottles, each containing 2.5 ml eye drops.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100, Ilfov district, Romania.

This leaflet was last revised in 10/2015

Component Type	Leaflet	Pharma Code	TBC	No. of colours	1	Page Count
Affiliate Item Code	744742	SAP No.	N/A	Colours	Black
Superceded Affiliate Item Code	10005100		266125
TrackWise PR No.	744742	Trackwise Proof No.	1	Non-Print Colours
MA No.	04569/1301	Glams Proof No.	N/A	Equate CMYK
Packing Site/Printer	N/A	Client Market	United Kingdom	with
Supplier Code	N/A	Keyline/DrawingNoj	N/A	Main Font	Myriad Pro		Body Text Size	9 pt
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v1/May 2015