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Latanoprost 50micrograms/Ml And Timolol 5mg/Ml Eye Drops Solution

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Latanoprost 50 micrograms/ml and Timolol 5mg/ml Eye Drops Solution

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What 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 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 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 when other medicines have not worked adequately.

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

Latanoprost/Timolol 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 if you

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

•    have or have had breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)

•    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)

•    are pregnant or trying to become pregnant, or are breast feeding.

Warnings and precautions

Talk to your doctor before using Latanoprost/Timolol

In particular, 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 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).

Surgery

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

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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, antiarrhythmics, digitalis glycosides or parasympathomimetics).

•    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.

Latanoprost/Timolol with food and drink

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

Pregnancy, breast-feeding and fertility

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 using this medicine.

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

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

Driving and using machines

When you use Latanoprost/Timolol 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.

Latanoprost/Timolol contains benzalkonium chloride

Latanoprost/Timolol 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

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

Adults (including the elderly)

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

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. Use Latanoprost/Timolol 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.

After using Latanoprost/Timolol, 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. After using Latanoprost/Timolol you should wait 15 minutes before putting your contact lenses back in.

Use in children and adolescents

Latanoprost/Timolol is not recommended for children and adolescents.

Instructions for use

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 comer 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 with other eye drops

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

If you use more Latanoprost/Timolol 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

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

If you forget to use Latanoprost/Timolol

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

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.

Stop using Latanoprost/Timolol and contact your doctor at once if you experience the following:

•    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.

Contact your doctor at once if you experience the following:

•    Serious changes in the way your heart works, you may notice changes in your heart rate or heart function

Tell your doctor if you notice any of the following side effects or notice any other effects not listed: 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 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 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 injectable or oral beta-blocking agents. Incidence of side effects after administration

of an eyedrop 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 metabolism and nutrition:

•    Low blood glucose levels.

Psychiatric Disorders:

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

Effect on your nervous system:

•    Dizziness, reduced blood supply to the brain, worsening of symptoms of myasthenia gravis (muscle disorder),sudden fainting or feeling you may faint (syncope), stroke, unusual sensations like pins and needles.

Effect on your eye:

•    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/disturbances, double vision, 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 or being sick, diarrhoea, dyspepsia, dry mouth,taste disturbances, indigestion, abdominal pain.

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 sex drive.

Effect on your muscles and joints:

•    Joint pain, muscle pain not caused by exercise, muscle weakness/tiredness.

General effect:

•    Fatigue.

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.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 out of the sight and reach of children.

Do not use Latanoprost/Timolol 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 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 contains

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 looks like and contents of the pack

Eye drops, solution.

A clear colourless solution.

Pack sizes: 1 bottle x 2.5ml eye drops

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Manufacturer:

SIFI SpA, Via Ercole Patti 36, 95020 Lavinaio, Aci S. Antonio (CT), Italy This leaflet was last revised in October 2014.

If you would like a leaflet with larger text, please contact 01271 385257.

Procedure numbers : UK/H/ 4884/01/DC 7