Latanoprost/Timolol

0.005% w/v / 0.5% w/v eye drops, solution Latanoprost / Timolol

Read all of this leaflet carefully before you start using this r

-    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. Do not pass it on to others. are the same as yours.

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

In this leaflet:

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

2.    Before you use Latanoprost/Timolol SIFI

3.    How to use Latanoprost/Timolol SIFI

4.    Possible side effects

5.    How to store Latanoprost/Timolol SIFI

6.    Further information

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

Latanoprost/Timolol SIFI contains two active substances: latanoprost and timolol.

Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from the eye into the bloodstream.

Timolol belongs to a group of medicines known as beta-blockers. It works by slowing the formation of fluid in the eye.

Latanoprost/Timolol SIFI is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe Latanoprost/Timolol SIFI when other medicines have not worked adequately.

2. Before you use Latanoprost/Timolol SIFI

Latanoprost/Timolol SIFI can be used in adult men and women (including the elderly), but is not recommended if you are less than 18 years of age.

Do not use Latanoprost/Timolol SIFI

-    if you are allergic (hypersensitive) to latanoprost timolol, beta-blockers or any of the other ingredients.

-    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 suffer from certain heart disorders, e.g. slow heartbeat (sinus bradycardia, second or third-degree atrioventricular block), a weak heart (manifest cardiac insufficiency) or in acute or chronic heart failure (cardiogenic shock)if you are pregnant or trying to become pregnant.

-    if you are breast feeding.

Take special care with Latanoprost/Timolol SIFI

Before you use this medicine, tell your doctor if you have now or have had in the past:

-    about to have any kind of eye surgery (including cataract surgery) or have had any kind of eye surgery in the past.

-    eye problems such as eye pain, eye irritation, eye inflammation or blurred vision

-    dry eyes.

-    contact lenses. You can still use Latanoprost/Timolol SIFI but follow the instructions for contact lens wearers in Section 3.

-    breathing problems, asthma or chronic obstructive pulmonary disease

-    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

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

-    diabeties as Timolol may mask signs and symptoms of low blood sugar

-    over activity of the thyroid gland as Timolol may mask signs and symptoms.

-    angina (particularly a type known as Prinzmetal angina).

-    severe allergic reactions that may have required hospital treatment.

-    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 SIFI as Timolol may change effects of some medicines used during anesthesia.

Taking other medicines

Latanoprost/Timolol SIFI 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, quinidine (used to treat heart conditions and some types of malaria), antidepressants known as fluoxetine and paroxetine.

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, speak to your doctor or pharmacist if you are taking any of the following types of medicine:

-    Prostaglandins, prostaglandin analogues or prostaglandin derivatives (e.g. other medicines for the treatment of glaucoma).

-    Beta-blockers (e.g. for high blood pressure).

-    Epinephrine (adrenaline).

-    Medicines used to treat high blood pressure (e.g. oral calcium channel blockers, guanethidine, antiarrhyth-mics, digitalis glycosides or parasympathomimetics).

-    Clonidine; if you are using the active substance clonidine to reduce inner eye pressure together with Latanoprost/Timolol SIFI 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.

Taking Latanoprost/Timolol SIFI with food and drink

Food or drink has no effect on when or how you should use Latanoprost/Timolol SIFI.

Fertility, pregnancy and breast-feeding

Do not use Latanoprost/Timolol SIFI if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.

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

Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines

When you use Latanoprost/Timolol SIFI your vision may become blurred for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.

Important information about some of the ingredients of Latanoprost/Timolol SIFI

Latanoprost/T imolol SIFI 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 is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. See the instructions for contact lens wearers in Section 3.

3. How to use Latanoprost/Timolol SIFI

Always use Latanoprost/Timolol SIFI exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults (including the elderly)

The usual dose for adults is one drop once a day in the affected eye(s).

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

Use Latanoprost/Timolol SIFI as instructed by your doctor until your doctor tells you to stop.

Your doctor may want you to have extra checks on your heart and circulation if you use Latanoprost/Timolol SIFI. After using Latanoprost/Timolol SIFI , press a finger into the corner of your eye, by the nose for 2 minutes. This helps to stop Latanoprost or Timolol getting into the rest of the body.

Contact lens wearers

If you wear contact lenses, you should remove them before using Latanoprost/Timolol SIFI. After using Latanoprost/Timolol SIFI you should wait 15 minutes before putting your contact lenses back in.

Use in children: Latanoprost/Timolol SIFI is not recommended for children and adolescents.

1.    Wash your hands and sit or stand comfortably.

2.    Twist off the outer cap (which can be thrown away).

3.    Unscrew the protective inner cap. The protective cap should be retained.

4.    Use your finger to gently pull down the lower eyelid of your affected eye.

5.    Place the tip of the bottle close to, but not touching your eye.

6.    Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.

7.    Press a finger against the corner of the affected eye by the nose. Hold for 2 minute whilst keeping the eye closed.

8.    Repeat in your other eye if your doctor has told you to do this.

9.    Put the protective inner cap back on the bottle.

If you use Latanoprost/Timolol SIFI with other eye drops

After using Latanoprost/Timolol SIFI, wait at least 5 minutes before using the other eye drops.

If you use more Latanoprost/Timolol SIFI than you should

If you put too many drops in your eye you may experience some minor irritation in your eye and your eyes may water and turn red. This should pass but if you are worried contact your doctor for advice.

If you swallow Latanoprost/Timolol SIFI

If you swallow Latanoprost/Timolol SIFI accidentally you should contact your doctor for advice. If you swallow a lot of Latanoprost/Timolol SIFI you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.

If you forget to use Latanoprost/Timolol SIFI

Carry on with the usual dosage at the usual time. Do not take a double dose to make up for the dose you have forgotten.

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

4. Possible side effects

Like all medicines, Latanoprost/Timolol SIFI eye drops can cause side effects, although not everybody gets them. 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 SIFI without speaking to your doctor.

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

Common (affects 1 to 10 users in 100)

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).

The most important side-effect is the possibility of a gradual, permanent change in your eye colour. It is also possible that Latanoprost/Timolol SIFI 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 SIFI.

The following side effects have been reported:

Very common effects (affects more than 1 in 10 patients):

-    A gradual change in your eye colour due to an increasing 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 SIFI 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 SIFI treatment is stopped.

Common effects (affects less than 1 in 10 patients):

-    Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye)

-    Eye pain.

Uncommon effects (affects less than 1 in 100 patients):

-    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:

Like other medicines applied into eyes, Timolol is absorbed into the blood. This 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:

Infections:

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

Effects on your immune system:

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, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.

Effects on your metabolism and nutrition:

Low blood glucose levels Psychiatric Disorders:

Depression, memory loss, , difficulty sleeping (insomnia), nightmares.

Effect on your nervous system:

Dizziness, tingling or numbness in the skin, reduced blood supply to the brain, worsening of symptoms of myasthenia gravis (muscle disorder)- (if you already suffer from this condition), sudden fainting or feeling you may faint (syncope), stroke, unusual sensations like pins and needles, and headache.

Effect on your eye:

Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), 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, visual changes/dis-turbances, double vision, inflammation of the eyelid, drooping of the upper eyelid (making the eye stay half closed) and injury to the lining of the back of the eye (a condition known as retinal detachment, but only seen when used following some kinds of eye surgery), fluid filled cyst within the coloured part of the eye (iris cyst).

Effect on your ear:

Whistling/ringing in the ears (tinnitus).

Effect on your heart:

Worsening of angina, slow heart rate, chest pain, oedema (fluid buildup), awareness of heart rhythm (palpitations), changes in heart rhythm, or speed of the heart beat, heart failure (cardiac arrest, heart block), 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.

Effect on your blood flow:

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

Effect on your respiratory system:

Asthma, worsening of asthma, constriction of the airways in the lungs (predominantly in patients with pre-existing disease), shortness of breath, difficulty breathing (bronchospasm), cough.

Effect on your digestion:

Feeling sick (nausea), diarrhoea, dyspepsia, dry mouth,taste disturbances, indigestion, abdominal pain, vomiting (being sick).

Effect on your skin:

Darkening of the skin around the eyes, hair loss/baldness (alopecia), itchy rash or worsening of itchy skin conditions, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

Effect on your reproductive system and breast:

Sexual dysfunction, decreased libido (decreased sex drive).

Effect on your muscles and joints:

Joint pain, muscle pain not caused by exercise, muscle weakness/tiredness Genreral effect:

Fatigue

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

5.    How to store Latanoprost/Timolol SIFI

Keep out of the reach and sight of children.

Do not use Latanoprost/Timolol SIFI after the expiry date which is stated on the carton and bottle label after EXP The expiry date refers to the last day of that month.

Store the unopened bottle of Latanoprost/Timolol SIFI in a refrigerator (between 2 °C to 8 °C). After opening do not store above 25 °C and do not use this bottle for more than 28 days. Keep the bottle in the outer carton, in order to protect from light.

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.    Further information

What Latanoprost/Timolol SIFI contain

The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.

The other ingredients are benzalkonium chloride, sodium chloride, sodium dihydrogen, phosphate dihydrate, disodium phosphate dodecahydrate, purified water.

What Latanoprost/Timolol SIFI looks like and contents of the pack

Eye drops, solution.

A clear colourless solution.

Pack sizes::! bottle x 2.5 ml eye drops, 3 bottles x 2.5 ml eye drops, 6 bottles x 2.5 ml eye drops.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

SIFI SpA, Via Ercole Patti 36, 95025 Lavinaio, Aci S. Antonio (CT), Italy Manufacturer:

SIFI SpA, Via Ercole Patti 36, 95025 Lavinaio, Aci S. Antonio (CT), Italy This leaflet was last revised on {05/2012}.