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Timoptol 0.5% Unit Dose Ophthalmic Solution

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Timoptol® 0.5% Unit Dose Ophthalmic Solution

(timolol maleate)

Read all of this leaflet carefully before you start using this medicine.

-    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. It may harm them, even if their symptoms are the same as yours.

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

The name of your medicine is called Timoptol 0.5% Unit Dose Ophthalmic Solution, but will be referred to as Timoptol throughout this leaflet. Please note that this leaflet also contains information about the other strength: Timoptol 0.25% Unit Dose Ophthalmic Solution.

In this leaflet:

1.    What Timoptol is and what it is used for

2.    Before you use Timoptol

3.    How to use Timoptol

4.    Possible side effects

5.    How to store Timoptol

6.    Further information

1. WHAT TIMOPTOL IS AND WHAT IT IS USED FOR

Timoptol contains a substance called timolol which belongs to a group of medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when the pressure in the eye is raised.

2. BEFORE YOU USE TIMOPTOL

Do not use Timoptol if:

•    you are allergic (hypersensitive) to timolol, beta-blockers or any of the other ingredients of Timoptol (see section 6 for Further Information.

•    you have now or have had in the 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).

•    you have heart problems

•    slow heart beat

•    disorders of heart rhythm (irregular heart beats)

•    heart failure

- “cardiogenic shock” - a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of consciousness

If you are not sure whether you should use Timoptol talk to your doctor or pharmacist.

Take special care with Timoptol

•    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 the 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

•    allergies to any medicines

•    you wear soft contact lenses.

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

If your eye becomes irritated or any new eye problems come on, talk to your doctor straight away. Eye problems could include redness of the eye or swelling of the eyelids (see Section 4: Possible Side Effects).

If you suspect that Timoptol Unit Dose is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness and itching of the eye), stop using Timoptol Unit Dose and contact your doctor immediately.

Tell you doctor if:

•    you get an eye infection

•    you injure your eye or have an operation on it

•    your eye problems get worse or you get any new symptoms.

Use in children and adolescents

Timolol, the active ingredient in Timoptol eye drops, has been studied in infants and children aged 12 days to 5 years, who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.

Timoptol should generally be used with caution in young patients. In newborns, infants and younger children Timoptol should be used with extreme caution. If coughing, wheezing, abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication should be stopped immediately. Contact your doctor as soon as possible. A portable apnoea monitor may also be helpful.

Using other medicines

Timoptol 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 or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription.

It is important to tell your doctor before using Timoptol if you are taking one or more of the following medicines:

•    a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud's syndrome

•    digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat

•    medicines known as catecholamine-depleting agents, such as rauwolfia alkaloids/reserpine used for high blood pressure

•    medicines called pressor amines, such as adrenaline used to treat severe allergic reaction

•    quinidine (used to treat heart conditions and some types of malaria),

•    antidepressants known as fluoxetine and paroxetine.

•    clonidine, a medicine used to treat high blood pressure

•    other beta-blockers taken by mouth or used as eye drops, because they belong to the same group of medicines as Timoptol and could have an additive effect.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

Use in pregnancy

Do not use Timoptol if you are pregnant unless your doctor considers it necessary.

Use in breast-feeding

Do not use Timoptol if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice or pharmacist if you are not sure.

Driving and using machines

There are possible side effects associated with Timoptol, such as dizziness ; tiredness and changes in your eyesight, such as blurred vision, dropping of the upper eyelid (making the eye stay half closed), double vision which may affect your ability to drive and/or operate machinery. Do not drive and/or operate machinery until you feel well and your vision is clear.

3. HOW TO USE TIMOPTOL

Always use Timoptol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The doctor will decide how many drops you should use each day and how long you should use them.

The usual dose is one drop in the affected eye(s) twice each day:

•    one in the morning

•    one in the evening.

Do not change the dose of this medicine without talking to your doctor.

Do not allow the tip of the single dose container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infection leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the single dose container, keep the tip of the single dose container away from contact with any surface.

Instructions for use.

Open the drops container just before you want to use it. After using the drops, throw away what is left. This is because the drops cannot be kept free of bacteria after being opened.

1.    Open the foil sachet containing the individual single dose containers. There are three strips of 5 single dose containers in each sachet.

2.    First wash your hands and then break off a single dose container from the strip. Then twist open the top of the single dose container as shown.

3. Tilt your head back and pull your lower eyelid now slightly

4. Put one drop in the affected eye(s) as directed by your doctor. Each single dose container contains enough solution for both eyes.

5.    After using Timoptol, press a finger into the corner of your eye, by the nose (Picture A) for 2 minutes. This helps to stop timolol getting into the rest of the body.

6.    After putting the drop into the eye(s), throw away the used container, even if there is solution remaining, to avoid contamination.

7.    Store the remaining containers in the foil sachet. The containers must be used within 15 days after opening the sachet. If any containers are left 15 days after opening the sachet, throw them away and open a new one.

Children and adolescents

Before you or your child starts to take Timoptol, your doctor or your child's doctor will have carried out a detailed medical examination and decided whether or not this medicine is suitable. You or your child, especially a newborn, should be closely monitored for one to two hours after the first dose and carefully monitored for any signs of side effects until surgery is carried out.

Method of administration:

One drop only of Timoptol should be instilled into the affected eye(s) each time. Follow the “Instructions for Use” above when administering the eye drops. After instillation keep the eyes closed for as long as possible (e.g. 3 - 5 minutes) and apply pressure to the corner of the eye closest to the nose to prevent the eye drops spreading throughout the body.

Duration of treatment:

Your doctor or your child's doctor will decide for how long the eye drops will be needed.

If you use more Timoptol than you should

If you put too many drops in your eye or swallow any of the drops, you may:

•    have a headache

•    feeling dizzy or light-headed

•    have difficulty breathing

•    chest pain

•    feel that your heart rate has slowed down.

If this happens, contact your doctor immediately.

If you forget to use Timoptol

It is important to use Timoptol as prescribed by your doctor.

•    If you miss a dose, use the drops as soon as possible.

•    If it is almost time for the next dose, skip the missed dose and use the next dose at the usual time.

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

If you stop using Timoptol

If you want to stop using this medicine talk to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Timoptol 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 Timoptol without speaking to your doctor.

Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with intravenous and/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.

If you develop 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, itchness, severe sudden life-threatening allergic reaction, stop taking your eye drops and seek medical attention immediately.

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 tingling or 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, 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, sensitivity to light, discharge from the eye, pain in the eye.

Ringing sound in the ears.

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, fainting, interference with the blood supply to the brain which may lead to a stroke, Raynaud's phenomenon, cold hands and feet, limping because there is a reduced blood supply to your legs. Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing,shortness of breath, wheezing, cough.

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

Sexual dysfunction, decreased sex drive, decreased libido. In men a condition which effects your penis called Peyronie's disease. The signs may be abnormal curve, pain or hardening of the tissue of your penis.

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

Muscle weakness/tiredness, muscle pain not caused by exercise.

A condition called lupus (systemic lupus erythematosus).

Ask your doctor or pharmacist for more information about the side effects. Both have a more complete list of side effects.

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

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 this 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 TIMOPTOL

Keep your eye drops out of the sight and reach of children.

Do not store above 25°C and keep in outer carton.

If you have any unit dose containers left when your doctor tells you to stop using them, return them to your pharmacist.

WARNING: If the solution become discoloured or show any signs of deterioration seek the advice of your pharmacist.

Do not use them if they are past the expiry date which is clearly marked on the box.

Remember, this medicine is for you. Do not share it with anyone else. It may not suit them.

6. FURTHER INFORMATION

What Timoptol contains

Timoptol 0.5% Unit Dose Ophthalmic Solution is available as 0.5% w/v solution of timolol maleate.

Other Ingredients:

Sodium phosphate monobasic, sodium phosphate dibasic, sodium hydroxide and water for injections.

What Timoptol looks like and contents of the pack

Timoptol 0.5% Unit Dose Ophthalmic solution is a clear, colourless to light yellow, sterile eye drops solution.

Timoptol 0.5% Unit Dose Ophthalmic Solution is available in cartons containing 30 unit doses.

Each Timoptol 0.5% Unit Dose Ophthalmic Solution dispenser contains 0.20 ml.

Manufactured by: Laboratories Merck Sharp & Dohme - Chibret, Mirabel Plant, Route de Marsat,

63203 Riom Cedex, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,

Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Timoptol 0.5% Unit Dose Ophthalmic Solution - PL No: 18799/1437

Leaflet date: 15.09.2014

Timoptol is registered trademark of Merck & Co.

Timolol 0.5% Unit Dose Ophthalmic Solution

(timolol maleate)

Read all of this leaflet carefully before you start using this medicine.

-    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. It may harm them, even if their symptoms are the same as yours.

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

The name of your medicine is called Timolol 0.5% Unit Dose Ophthalmic Solution, but will be referred to as Timolol throughout this leaflet. Please note that this leaflet also contains information about the other strength: Timoptol 0.25% Unit Dose Ophthalmic Solution.

In this leaflet:

1.    What Timolol is and what it is used for

2.    Before you use Timolol

3.    How to use Timolol

4.    Possible side effects

5.    How to store Timolol

6.    Further information

1. WHAT TIMOLOL IS AND WHAT IT IS USED FOR

Timolol contains a substance called timolol which belongs to a group of medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when the pressure in the eye is raised.

2. BEFORE YOU USE TIMOLOL

Do not use Timolol if:

•    you are allergic (hypersensitive) to timolol, beta-blockers or any of the other ingredients of Timolol (see section 6 for Further Information.

•    you have now or have had in the 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).

•    you have heart problems

•    slow heart beat

•    disorders of heart rhythm (irregular heart beats)

•    heart failure

- “cardiogenic shock” - a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of consciousness

If you are not sure whether you should use Timolol talk to your doctor or pharmacist.

Take special care with Timolol

•    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 the 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

•    allergies to any medicines

•    you wear soft contact lenses.

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

If your eye becomes irritated or any new eye problems come on, talk to your doctor straight away. Eye problems could include redness of the eye or swelling of the eyelids (see Section 4: Possible Side Effects).

If you suspect that Timolol Unit Dose is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness and itching of the eye), stop using Timolol Unit Dose and contact your doctor immediately. Tell you doctor if:

•    you get an eye infection

•    you injure your eye or have an operation on it

•    your eye problems get worse or you get any new symptoms.

Use in children and adolescents

Timolol, the active ingredient in Timolol eye drops, has been studied in infants and children aged 12 days to 5 years, who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.

Timolol should generally be used with caution in young patients. In newborns, infants and younger children Timolol should be used with extreme caution. If coughing, wheezing, abnormal breathing or abnormal pauses in breathing (apnoea) occur, the use of the medication should be stopped immediately. Contact your doctor as soon as possible. A portable apnoea monitor may also be helpful.

Using other medicines

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 or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription.

It is important to tell your doctor before using Timolol if you are taking one or more of the following medicines:

•    a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud's syndrome

•    digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat

•    medicines known as catecholamine-depleting agents, such as rauwolfia alkaloids/reserpine used for high blood pressure

•    medicines called pressor amines, such as adrenaline used to treat severe allergic reaction

•    quinidine (used to treat heart conditions and some types of malaria),

•    antidepressants known as fluoxetine and paroxetine.

•    clonidine, a medicine used to treat high blood pressure

•    other beta-blockers taken by mouth or used as eye drops, because they belong to the same group of medicines as Timolol and could have an additive effect.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

Use in pregnancy

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

Use in breast-feeding

Do not use Timolol if you are breast-feeding. Timolol may get into your milk. Ask your doctor for advice or pharmacist if you are not sure.

Driving and using machines

There are possible side effects associated with Timolol, such as dizziness: tiredness and changes in your eyesight, such as blurred vision, dropping of the upper eyelid (making the eye stay half closed), double vision which may affect your ability to drive and/or operate machinery. Do not drive and/or operate machinery until you feel well and your vision is clear.

3. HOW TO USE TIMOLOL

Always use Timolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The doctor will decide how many drops you should use each day and how long you should use them.

The usual dose is one drop in the affected eye(s) twice each day:

•    one in the morning

•    one in the evening.

Do not change the dose of this medicine without talking to your doctor.

Do not allow the tip of the single dose container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infection leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the single dose container, keep the tip of the single dose container away from contact with any surface.

Instructions for use.

Open the drops container just before you want to use it. After using the drops, throw away what is left. This is because the drops cannot be kept free of bacteria after being opened.

1.    Open the foil sachet containing the individual single dose containers. There are three strips of 5 single dose containers in each sachet.

2.    First wash your hands and then break off a single dose container from the strip. Then twist open the top of the single dose container as shown.

3. Tilt your head back and pull your lower eyelid now slightly

4. Put one drop in the affected eye(s) as directed by your doctor. Each single dose container contains enough solution for both eyes.

5.    After using Timolol, press a finger into the corner of your eye, by the nose (Picture A) for 2 minutes. This helps to stop timolol getting into the rest of the body.

6.    After putting the drop into the eye(s), throw away the used container, even if there is solution remaining, to avoid contamination.

7.    Store the remaining containers in the foil sachet. The containers must be used within 15 days after opening the sachet. If any containers are left 15 days after opening the sachet, throw them away and open a new one.

Children and adolescents

Before you or your child starts to take Timolol, your doctor or your child's doctor will have carried out a detailed medical examination and decided whether or not this medicine is suitable. You or your child, especially a newborn, should be closely monitored for one to two hours after the first dose and carefully monitored for any signs of side effects until surgery is carried out.

Method of administration:

One drop only of Timolol should be instilled into the affected eye(s) each time. Follow the “Instructions for Use” above when administering the eye drops. After instillation keep the eyes closed for as long as possible (e.g. 3 - 5 minutes) and apply pressure to the corner of the eye closest to the nose to prevent the eye drops spreading throughout the body.

Duration of treatment:

Your doctor or your child's doctor will decide for how long the eye drops will be needed.

If you use more Timolol than you should

If you put too many drops in your eye or swallow any of the drops, you may:

•    have a headache

•    feeling dizzy or light-headed

•    have difficulty breathing

•    chest pain

•    feel that your heart rate has slowed down.

If this happens, contact your doctor immediately.

If you forget to use Timolol

It is important to use Timolol as prescribed by your doctor.

•    If you miss a dose, use the drops as soon as possible.

•    If it is almost time for the next dose, skip the missed dose and use the next dose at the usual time.

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

If you stop using Timolol

If you want to stop using this medicine talk to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Timolol 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 Timolol without speaking to your doctor.

Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with intravenous and/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.

If you develop 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, itchness, severe sudden life-threatening allergic reaction, stop taking your eye drops and seek medical attention immediately.

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 tingling or 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, 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, sensitivity to light, discharge from the eye, pain in the eye.

Ringing sound in the ears.

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, fainting, interference with the blood supply to the brain which may lead to a stroke, Raynaud's phenomenon, cold hands and feet, limping because there is a reduced blood supply to your legs. Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing,shortness of breath, wheezing, cough.

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

Sexual dysfunction, decreased sex drive, decreased libido. In men a condition which effects your penis called Peyronie's disease. The signs may be abnormal curve, pain or hardening of the tissue of your penis.

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

Muscle weakness/tiredness, muscle pain not caused by exercise.

A condition called lupus (systemic lupus erythematosus).

Ask your doctor or pharmacist for more information about the side effects. Both have a more complete list of side effects.

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

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 this 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 TIMOLOL

Keep your eye drops out of the sight and reach of children.

Do not store above 25°C and keep in outer carton.

If you have any unit dose containers left when your doctor tells you to stop using them, return them to your pharmacist.

WARNING: If the solution become discoloured or show any signs of deterioration seek the advice of your pharmacist.

Do not use them if they are past the expiry date which is clearly marked on the box.

Remember, this medicine is for you. Do not share it with anyone else. It may not suit them.

6. FURTHER INFORMATION

What Timolol contains

Timolol 0.5% Unit Dose Ophthalmic Solution is available as 0.5% w/v solution of timolol maleate.

Other Ingredients:

Sodium phosphate monobasic, sodium phosphate dibasic, sodium hydroxide and water for injections. What Timolol looks like and contents of the pack

Timolol 0.5% Unit Dose Ophthalmic solution is a clear, colourless to light yellow, sterile eye drops solution. Timolol 0.5% Unit Dose Ophthalmic Solution is available in cartons containing 30 unit doses.

Each Timolol 0.5% Unit Dose Ophthalmic Solution dispenser contains 0.20 ml.

Manufactured by: Laboratories Merck Sharp & Dohme - Chibret, Mirabel Plant, Route de Marsat,

63203 Riom Cedex, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,

Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Timolol 0.5% Unit Dose Ophthalmic Solution - PL No: 18799/1437

Leaflet date: 15.09.2014