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Eldepryl® 5 mg Tablets    10.04.15[2]

(selegiline hydrochloride)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is available using the above name but will be referred to as Eldepryl throughout the following leaflet.

Also available as Eldepryl 10 mg Tablet and as Eldepryl 10 mg/5 ml Syrup.

In this leaflet:

1.    What Eldepryl is and what it is used for

2.    Before you take Eldepryl

3.    How to take Eldepryl

4.    Possible side effects

5.    How to store Eldepryl

6.    Further information

1.    WHAT ELDEPRYL IS AND WHAT IT IS USED FOR

Eldepryl is a monoamine oxidase-B inhibitor, and is used in the treatment of Parkinson's disease. Eldepryl may be taken alone in the early stages of your condition, delaying the need for the addition of other medicines.

Eldepryl however can also be used in conjunction with other treatments such as Levodopa to reduce the on-off symptoms or uncontrolled movements you may experience. This happens especially when the effects of the other treatments are wearing-off.

Your doctor will explain why this medicine has been chosen for you.

2.    BEFORE YOU TAKE ELDEPRYL Do not take Eldepryl

-    if you are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Eldepryl (see Section 6: Further Information)

-    if you are taking any antidepressants (see Taking other medicines). Antidepressants should be stopped a number of weeks before taking Eldepryl, speak to your doctor for further advice

-    if you are taking pethidine or any other opioid painkillers such as codeine or tramadol

-    if you are taking any monoamine oxidase (MAO) inhibitors e.g. the antibiotic linezolid

-    if you are taking any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan

-    if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion

-    if you suffer from stomach or duodenal ulcers

-    if you suffer from a movement or muscle disorder not connected to Parkinson's disease.

Taking Eldepryl with Levodopa

Do not take Eldepryl together with Levodopa if you suffer from any of the following conditions:

-    major heart or blood vessel problems (cardiovascular disease)

-    chest pain (angina)

-    high blood pressure (arterial hypertension)

-    an erratic or fast heartbeat (e.g. tachycardia or arrhythmias)

-    an overactive thyroid gland (hyperthyroid disease)

-    an eye condition called narrow angle glaucoma

-    a tumour of your adrenal gland (phaeochromocytoma) or prostate (prostatic adenoma)

-    major mental health problems (e.g. schizophrenia or advanced dementia).

Take special care with Eldepryl

Talk to your doctor or pharmacist if any of the following applies to you:

-    if you have uncontrolled high blood pressure, chest pain (angina), the sensation of feeling your heartbeat (palpitations) or an abnormal or erratic heartbeat (arrhythmia)

-    if you have kidney or liver problems

-    if you are being treated for any mental illness, anxiety or sleep problems

-    if you have a history of stomach ulcers

-    if you are already taking a medicine called Levodopa as it can cause agitation and uncontrollable movements. Your doctor may need to monitor you closely and alter your dose

-    if you are going to have surgery as Eldepryl may interfere with some of the medicines used as part of a general anaesthetic

-    if you have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour). See section 4.

-    if you are taking Eldepryl Syrup and you have been told by your doctor that you have an intolerance to certain kinds of sugar.

Taking other medicines

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 it is important that you tell your doctor if you are taking any of the following:

-    amantadine, dopamine or levodopa (used to treat Parkinson's disease)

-    any type of antidepressant e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline and protriptyline cannot be taken with Eldepryl

-    pethidine or any other opioid painkillers such as codeine or tramadol cannot be taken with Eldepryl

-    the antibiotic linezolid cannot be taken with Eldepryl

-    if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion - these medicines cannot be taken with Eldepryl

-    any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan cannot be taken with Eldepryl

-    medicines for high or low blood pressure

-    medicines for mood or mental illness

-    medicines to treat anxiety, sleep problems or to relax the gut muscles (medicines that act on the central nervous system)

-    medicines used as part of an anaesthetic

-    medicines to treat heart problems (e.g. digitalis) as you may need more frequent check-ups with your doctor

-    medicines to thin the blood (anticoagulants) as you may need more frequent check-ups with your doctor

-    HRT (hormone replacement therapy)

-    altretamine (used to treat ovarian cancer)

-    oral contraceptives (The ‘pill', other forms of contraception should be discussed with your doctor).

Eldepryl needs a period of time to be completely removed from the body before starting certain other medicines. Please talk to your doctor for advice if you are thinking about starting other medication.

Taking Eldepryl with food and drink

You may take Eldepryl with food and drink.

Alcohol should be avoided whilst you are taking Eldepryl.

Your doctor may recommend that you avoid certain foods containing tyramine such as mature cheese, broad beans, Bovril, yeast extracts or fermented soya bean products.

Pregnancy and breast-feeding

-    You should not take Eldepryl if you are pregnant, planning to become pregnant or if you think you may be pregnant.

-    You should not take Eldepryl if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Eldepryl may make you feel dizzy, drowsy or slow your reactions, therefore your ability to drive or operate machinery may be affected. If you experience these side effects then do not drive, use tools or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

-    Do not drive while taking this medicine until you know how it affects you.

-    It is an offence to drive if this medicine affects your ability to drive.

-    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Children

Eldepryl should not be given to children.

3. HOW TO TAKE ELDEPRYL

Always take Eldepryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will normally start you on a dose of 10 mg Eldepryl each day.

This may be taken either as one 10 mg or two 5 mg tablets, or one 5 ml spoonful of syrup.

-    Eldepryl can be taken as a single daily dose in the morning, or the prescribed daily dose taken in two parts, half dose in the morning and half dose at lunchtime. If you take your tablets in the evening or before going to bed they may keep you awake at night.

POM


PL 20636/2659


-    Eldepryl syrup should be shaken well before use. Always replace the cap after use.

-    Your doctor will tell you how long you should continue to take this medicine.

Make sure you ask your pharmacist if the label on your medicine does not tell you how to take Eldepryl.

If you take more Eldepryl than you should

Your doctor has carefully chosen the correct dosage for you so do not take more than the prescribed dose. However, if you accidentally take too much Eldepryl immediately contact your doctor or contact your nearest hospital casualty department.

Symptoms of an overdose include agitation, feeling irritable, restless or tired, severe headache, shaking, high or low blood pressure, difficulty breathing, shortness of breath, experiencing situations, visions or sounds which are not real (hallucinations), dizziness, fast irregular heartbeat, chest pain, severe muscle spasms, fever, excessive sweating, loss of consciousness and fits.

If you forget to take Eldepryl

If you forget to take a dose, take a dose as soon as you remember, but do not take more than the recommended dose every 24 hours.

If you stop taking Eldepryl

Do not stop taking Eldepryl unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If someone else takes your medicine

If someone else has swallowed any of your medicine, contact your nearest hospital casualty department or tell a doctor immediately.

4. POSSIBLE SIDE EFFECTS

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

Very Common (affecting more than 1 person in 10)

-    Sore mouth and swollen gums (stomatitis).

Common (affecting more than 1 person in 100, but less than 1 in 10)

-    Difficulty controlling your movements or loss of balance (dyskinesias, akinesia, bradykinesia), fall

-    slow heart beat (bradycardia)

-    dizziness, feeling faint, headache, shaking

-    sleep disorders, confusion, experiencing situations, visions or sounds which are not real (hallucinations)

-    feeling down (depressed)

-    high or low blood pressure

-    abnormal liver tests due to increase in liver enzymes

-    feeling sick, constipation, diarrhoea, mouth ulcers

-    blocked nose, sore throat

-    back pain, joint pain (arthralgia), muscle cramps

-    tiredness

-    ear disorders giving the sensation of dizziness (vertigo)

-    excessive sweating.

Uncommon (affecting more than 1 person in 1,000 but less than 1 person in 100)

-    Chest pain (angina pectoris), irritability, swelling of the ankles

-    irregular, erratic or fast heart beat, the sensation of feeling your heart beat (palpitations)

-    problems sleeping, strange dreams, feeling anxious or agitated, changes in mood, altered mental state / loss of contact with reality (psychoses)

-    shortness of breath (dyspnoea)

-    blurred vision

-    low blood pressure leading to a feeling of light-headedness particularly when standing up (orthostatic hypotension)

-    problems starting, passing and stopping urination or altered frequency of urination (micturition disorders)

-    abnormal liver tests due to increase in liver enzymes (transient rise of serum alanine aminotransferase (ALAT))

-    muscle weakness (myopathy)

-    low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections

-    loss of appetite

-    sore throat (pharyngitis), dry mouth

-    hair loss, blisters or spots on skin.

Rare (affecting more than 1 person in 10,000 but less than 1 in 1,000)

-    Low blood pressure leading to a feeling of light-headedness, dizziness or fainting, particularly when standing up (postural hypotension)

-    skin reactions.

Not Known (frequency cannot be estimated from the available data) However these events can be considered to be very rare

-    Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)

-    unusual urges and/or behaviours (such as excessive gambling or other behaviours)

-    inability or difficulty passing urine.

Side effects when Eldepryl is used with Levodopa

When Eldepryl is taken with levodopa this may increase the side effects of levodopa such as:

-    excessive, uncontrollable movements after taking your medicine

-    confusion, hallucinations, problems sleeping, agitation, feeling restless

-    feeling your heartbeat (palpitations), irregular, erratic heart beat, chest pain, swollen ankles and shortness of breath

-    a feeling of sickness, dizziness, feeling faint, dry mouth, loss of appetite and problems passing urine

-    low blood pressure leading to a feeling of light-headedness, particularly when standing up

-    hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)

-    low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections and temporary liver problems

-    headache, skin reaction and loss of hair.

These side effects will usually stop when the amount of levodopa you are taking is reduced.

Talk to your doctor about reducing the dose if you experience any of these effects.

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 ELDEPRYL

Keep out of the sight and reach of children.

Do not store above 25°C. Keep container tightly closed.

Do not use Eldepryl after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required.

These measures will help to protect the environment

6.    FURTHER INFORMATION What Eldepryl contains

The active substance is selegiline hydrochloride.

Each tablet contains 5 mg selegiline hydrochloride.

The other ingredients are as follows: mannitol, maize starch, microcrystalline cellulose, povidone and magnesium stearate.

What Eldepryl looks like and contents of the pack.

Eldepryl tablets are round and white in colour.

Eldepryl are available in a bottle of 100 tablets.

Product Licence Holder and Manufacturer

Manufactured by Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland and Procured from within the EU by Product Licence Holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 10.04.15[2] Eldepryl is a trademark of Orion Corporation.

2659

Selegiline Hydrochloride 5 mg 1004 15121 Tablets

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is available using the above name but will be referred to as Selegiline Hydrochloride throughout the following leaflet.

Selegiline Hydrochloride is also available as a 10 mg Tablet and as Eldepryl 10 mg/5 ml Syrup.

In this leaflet:

1.    What Selegiline Hydrochloride is and what it is used for

2.    Before you take Selegiline Hydrochloride

3.    How to take Selegiline Hydrochloride

4.    Possible side effects

5.    How to store Selegiline Hydrochloride

6.    Further information

1.    WHAT SELEGILINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Selegiline Hydrochloride is a monoamine oxidase-B inhibitor, and is used in the treatment of

Parkinson's disease. Selegiline Hydrochloride may be taken alone in the early stages of your condition, delaying the need for the addition of other medicines. Selegiline Hydrochloride however can also be used in conjunction with other treatments such as Levodopa to reduce the on-off symptoms or uncontrolled movements you may experience. This happens especially when the effects of the other treatments are wearing-off.

Your doctor will explain why this medicine has been chosen for you.

2.    BEFORE YOU TAKE SELEGILINE HYDROCHLORIDE Do not take Selegiline Hydrochloride

-    if you are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Selegiline Hydrochloride (see Section 6: Further Information)

-    if you are taking any antidepressants (see Taking other medicines). Antidepressants should be stopped a number of weeks before taking Selegiline Hydrochloride, speak to your doctor for further advice

-    if you are taking pethidine or any other opioid painkillers such as codeine or tramadol

-    if you are taking any monoamine oxidase (MAO) inhibitors e.g. the antibiotic linezolid

-    if you are taking any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan

-    if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion

-    if you suffer from stomach or duodenal ulcers

-    if you suffer from a movement or muscle disorder not connected to Parkinson's disease.

Taking Selegiline Hydrochloride with Levodopa

Do not take Selegiline Hydrochloride together with Levodopa if you suffer from any of the following conditions:

-    major heart or blood vessel problems (cardiovascular disease)

-    chest pain (angina)

-    high blood pressure (arterial hypertension)

-    an erratic or fast heartbeat (e.g. tachycardia or arrhythmias)

-    an overactive thyroid gland (hyperthyroid disease)

-    an eye condition called narrow angle glaucoma

-    a tumour of your adrenal gland (phaeochromocytoma) or prostate (prostatic adenoma)

-    major mental health problems (e.g. schizophrenia or advanced dementia).

Take special care with Selegiline Hydrochloride

Talk to your doctor or pharmacist if any of the following applies to you:

-    if you have uncontrolled high blood pressure, chest pain (angina), the sensation of feeling your heartbeat (palpitations) or an abnormal or erratic heartbeat (arrhythmia)

-    if you have kidney or liver problems

-    if you are being treated for any mental illness, anxiety or sleep problems

-    if you have a history of stomach ulcers

-    if you are already taking a medicine called Levodopa as it can cause agitation and uncontrollable movements. Your doctor may need to monitor you closely and alter your dose

-    if you are going to have surgery as Selegiline Hydrochloride may interfere with some of the medicines used as part of a general anaesthetic

-    if you have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour). See section 4.

-    if you are taking Eldepryl Syrup and you have been told by your doctor that you have an intolerance to certain kinds of sugar.

Taking other medicines

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 it is important that you tell your doctor if you are taking any of the following:

-    amantadine, dopamine or levodopa (used to treat Parkinson's disease)

-    any type of antidepressant e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline and protriptyline cannot be taken with Selegiline Hydrochloride

-    pethidine or any other opioid painkillers such as codeine or tramadol cannot be taken with Selegiline Hydrochloride

-    the antibiotic linezolid cannot be taken with Selegiline Hydrochloride

-    if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion - these medicines cannot be taken with Selegiline Hydrochloride

-    any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan cannot be taken with Selegiline Hydrochloride

-    medicines for high or low blood pressure

-    medicines for mood or mental illness

-    medicines to treat anxiety, sleep problems or to relax the gut muscles (medicines that act on the central nervous system)

-    medicines used as part of an anaesthetic

-    medicines to treat heart problems (e.g. digitalis) as you may need more frequent check-ups with your doctor

-    medicines to thin the blood (anticoagulants) as you may need more frequent check-ups with your doctor

-    HRT (hormone replacement therapy)

-    altretamine (used to treat ovarian cancer)

-    oral contraceptives (The ‘pill', other forms of contraception should be discussed with your doctor).

Selegiline Hydrochloride needs a period of time to be completely removed from the body before starting certain other medicines. Please talk to your doctor for advice if you are thinking about starting other medication.

Taking Selegiline Hydrochloride with food and drink

You may take Selegiline Hydrochloride with food and drink.

Alcohol should be avoided whilst you are taking Selegiline Hydrochloride. Your doctor may recommend that you avoid certain foods containing tyramine such as mature cheese, broad beans, Bovril, yeast extracts or fermented soya bean products.

Pregnancy and breast-feeding

-    You should not take Selegiline Hydrochloride if you are pregnant, planning to become pregnant or if you think you may be pregnant.

-    You should not take Selegiline Hydrochloride if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Selegiline Hydrochloride may make you feel dizzy, drowsy or slow your reactions, therefore your ability to drive or operate machinery may be affected. If you experience these side effects then do not drive, use tools or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

-    Do not drive while taking this medicine until you know how it affects you.

-    It is an offence to drive if this medicine affects your ability to drive.

-    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Children

Selegiline Hydrochloride should not be given to children.

3. HOW TO TAKE SELEGILINE HYDROCHLORIDE

Always take Selegiline Hydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will normally start you on a dose of 10 mg Selegiline Hydrochloride each day.

POM


PL 20636/2659


This may be taken either as one 10 mg or two 5 mg tablets, or one 5 ml spoonful of syrup.

-    Selegiline Hydrochloride can be taken as a single daily dose in the morning, or the prescribed daily dose taken in two parts, half dose in the morning and half dose at lunchtime. If you take your tablets in the evening or before going to bed they may keep you awake at night.

-    Eldepryl syrup should be shaken well before use. Always replace the cap after use.

-    Your doctor will tell you how long you should continue to take this medicine.

Make sure you ask your pharmacist if the label on your medicine does not tell you how to take Selegiline Hydrochloride.

If you take more Selegiline Hydrochloride than you should

Your doctor has carefully chosen the correct dosage for you so do not take more than the prescribed dose. However, if you accidentally take too much Selegiline Hydrochloride immediately contact your doctor or contact your nearest hospital casualty department.

Symptoms of an overdose include agitation, feeling irritable, restless or tired, severe headache, shaking, high or low blood pressure, difficulty breathing, shortness of breath, experiencing situations, visions or sounds which are not real (hallucinations), dizziness, fast irregular heartbeat, chest pain, severe muscle spasms, fever, excessive sweating, loss of consciousness and fits.

If you forget to take Selegiline Hydrochloride

If you forget to take a dose, take a dose as soon as you remember, but do not take more than the recommended dose every 24 hours.

If you stop taking Selegiline Hydrochloride

Do not stop taking Selegiline Hydrochloride unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If someone else takes your medicine

If someone else has swallowed any of your medicine, contact your nearest hospital casualty department or tell a doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Selegiline Hydrochloride can cause side effects, although not everybody gets them.

Very Common (affecting more than 1 person in 10)

-    Sore mouth and swollen gums (stomatitis).

Common (affecting more than 1 person in 100, but less than 1 in 10)

-    Difficulty controlling your movements or loss of balance (dyskinesias, akinesia, bradykinesia), fall

-    slow heart beat (bradycardia)

-    dizziness, feeling faint, headache, shaking

-    sleep disorders, confusion, experiencing situations, visions or sounds which are not real (hallucinations)

-    feeling down (depressed)

-    high or low blood pressure

-    abnormal liver tests due to increase in liver enzymes

-    feeling sick, constipation, diarrhoea, mouth ulcers

-    blocked nose, sore throat

-    back pain, joint pain (arthralgia), muscle cramps

-    tiredness

-    ear disorders giving the sensation of dizziness (vertigo)

-    excessive sweating.

Uncommon (affecting more than 1 person in 1,000 but less than 1 person in 100)

-    Chest pain (angina pectoris), irritability, swelling of the ankles

-    irregular, erratic or fast heart beat, the sensation of feeling your heart beat (palpitations)

-    problems sleeping, strange dreams, feeling anxious or agitated, changes in mood, altered mental state / loss of contact with reality (psychoses)

-    shortness of breath (dyspnoea)

-    blurred vision

-    low blood pressure leading to a feeling of light-headedness particularly when standing up (orthostatic hypotension)

-    problems starting, passing and stopping urination or altered frequency of urination (micturition disorders)

-    abnormal liver tests due to increase in liver enzymes (transient rise of serum alanine aminotransferase (ALAT))

-    muscle weakness (myopathy)

-    low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections

-    loss of appetite

-    sore throat (pharyngitis), dry mouth

-    hair loss, blisters or spots on skin.

Rare (affecting more than 1 person in 10,000 but less than 1 in 1,000)

-    Low blood pressure leading to a feeling of light-headedness, dizziness or fainting, particularly when standing up (postural hypotension)

-    skin reactions.

Not Known (frequency cannot be estimated from the available data)

However these events can be considered to be very rare

-    Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)

-    unusual urges and/or behaviours (such as excessive gambling or other behaviours)

-    inability or difficulty passing urine.

Side effects when Selegiline Hydrochloride is used with Levodopa

When Selegiline Hydrochloride is taken with levodopa this may increase the side effects of levodopa such as:

-    excessive, uncontrollable movements after taking your medicine

-    confusion, hallucinations, problems sleeping, agitation, feeling restless

-    feeling your heartbeat (palpitations), irregular, erratic heart beat, chest pain, swollen ankles and shortness of breath

-    a feeling of sickness, dizziness, feeling faint, dry mouth, loss of appetite and problems passing urine

-    low blood pressure leading to a feeling of light-headedness, particularly when standing up

-    hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)

-    low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections and temporary liver problems

-    headache, skin reaction and loss of hair.

These side effects will usually stop when the amount of levodopa you are taking is reduced.

Talk to your doctor about reducing the dose if you experience any of these effects.

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 SELEGILINE HYDROCHLORIDE

Keep out of the sight and reach of children.

Do not store above 25°C. Keep container tightly closed.

Do not use Selegiline Hydrochloride after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required.

These measures will help to protect the environment

6.    FURTHER INFORMATION

What Selegiline Hydrochloride contains

The active substance is selegiline hydrochloride.

Each tablet contains 5 mg selegiline hydrochloride

The other ingredients are as follows: mannitol, maize starch,

microcrystalline cellulose, povidone and magnesium stearate.

What Selegiline Hydrochloride looks like and contents of the pack.

Selegiline Hydrochloride tablets are round and white in colour.

Selegiline Hydrochloride are available in a bottle of 100 tablets.

Product Licence Holder and Manufacturer

Manufactured by Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland and Procured from within the EU by Product Licence Holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 10.04.15[2]