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PATIENT INFORMATION LEAFLET

Selegiline Hydrochloride Tablets 5mg and 10mg

What this medicine is and what it is used for

Selegiline Hydrochloride belongs to a group of medicines known as monoamine oxidase-B (MAO-B) inhibitors.

It is used to treat Parkinson's disease or the symptoms of the disease (Parkinsonism), which can cause tremor, stiffness and shuffling.

Selegiline Hydrochloride Tablets are used in conjunction with existing treatment for Parkinson's disease, namely levodopa or levodopa and peripheral decarboxylase inhibitors (e,g. madopa and carbidopa)

Selegiline may also be used, in conjunction with levodopa, to reduce on-off symptoms or uncontrolled movements.

Before you take

Do not take if:

■    you are allergic (hypersensitive, including severe dizziness or low blood pressure) to selegiline or any of the other ingredients of this medicine (see Section 6)

■    you are taking any antidepressants (see Section 2, Taking other medicines), including venlafaxine and selective serotonin reuptake inhibitors (SSRIs) e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline.

Antidepressants should be stopped a number of weeks before taking Selegiline, speak to your doctor for further advice.

■    you are taking any monoamine oxidase inhibitors (MAOIs) e.g. antibiotic linezolid

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

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

■    you are taking any sympathomimetic medicines e.g. medicines to treat asthma or 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 with Levodopa

Do not take Selegiline together with levodopa if you suffer

from any of the following conditions:

■    severe heart problems

■    severe 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 and talk to your doctor before taking

■    if you have or have a history of stomach or duodenal ulcers

■    if you have uncontrolled high blood pressure

■    if you have an irregular heart beat

■    if you have severe chest pain (angina)

■    if you have any mental illness

■    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 may interfere with some of the medicines used as part of a general anaesthetic

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.

Selegiline must not be taken with the following medicines:

■    Any type of antidepressant e.g. venlafaxine, tricyclic antidepressants e.g. amitriptyline, protriptyline and SSRIs e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline.

SSRIs should be stopped a number of weeks before taking Selegiline e.g.

-    Fluoxetine : stopped at least 5 weeks before

-    Sertraline : stopped 2 weeks before

-    Other SSRIs : stopped 1 week before

■    Non-specific MAOIs e.g. linezolid (antibiotic)

MAOIs should not be started for at least 5 weeks after stopping Selegiline

■    Pethidine or any other opioid painkillers such as codeine or tramadol

■    Sympathomimetic medicines e.g. medicines to treat asthma or relieve nasal congestion

■    Medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan

Other medicines may interact with Selegiline, in particular the following:

■    Dopamine or amantadine, used to treat Parkinson's disease

■    Medicines for high or low blood pressure

■    Medicines for mood or mental illness

■    Medicines to treat anxiety or sleep problems

■    Oral contraceptives (the 'pill')

■    HRT (hormone replacement therapy)

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

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

■    Altretamine (used to treat ovarian cancer)

■    Other MAOIs e.g. moclobemide

Any medicine known to interact with Selegiline should not be started for at least 14 days after you have stopped taking Selegiline. Please ask your doctor for advice.

Taking Selegiline with food and alcohol

You should avoid drinking alcohol whilst taking this medicine.

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant, planning to become pregnant or think you may be pregnant you should not take Selegiline.

If you are breast-feeding you should not take Selegiline.

Driving or operating machinery

This 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:

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

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

o 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.

Important information about some of the ingredients of this medicine

continued....

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to take

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

■    Swallow the tablets whole with a glass of water.

■    The score line is not intended for breaking the tablet.

Usual dosage

The usual dose is 5mg taken in the morning. Your doctor may increase the dose to 10mg (two 5mg tablets or one 10mg tablet) taken in the morning.

The maximum dose is 10mg a day.

You must carry on taking your other medicines for Parkinson's disease while you are taking these tablets.

If you forget to take your Selegiline tablets

If you forget to take a dose at the right time, take it as soon as you remember.

Do not take a double dose to make up for a forgotten dose. If it is almost time to take the next dose, wait until then and then carry on as before.

If you take more Selegiline tablets than you should

It is important not to take too many tablets.

If you have swallowed too many tablets or if you think a child or someone else has swallowed any contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and any tablets with you to show the doctor.

Symptoms of an overdose include drowsiness, dizziness, feeling faint, irritable, restless, agitated, severe headache, seeing or hearing things that are not real (hallucinations), shaking, alternating high or low blood pressure, rapid and irregular pulse, chest pain, difficulty breathing, severe muscle spasm, fever, excessive sweating, coma and fits.

Possible side effects

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

Very common side effects (affects more than 1 in 10 people)

■    Sore mouth and swollen gums (stomatitis)

Common side effects (affects less than 1 in 10 people) Sleep disorders    ■ Feeling confused

Seeing or hearing things that are not real (hallucinations)

Depression

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

Feeling of dizziness or 'spinning' (vertigo)

Feeling sick    ■    Constipation

Diarrhoea    ■    Mouth ulcers

Temporary increase in serum alanine amiotransferase (ALAT) or mild increase in liver enzymes, which is detected by liver test Dizziness    ■    Headache

Shaking    ■    Slower heart beat

Low or high blood pressure Blocked nose    ■    Sore throat

Increased sweating Joint pain, back pain, muscle cramps Feeling tired    ■    Falling over

Uncommon side effects (affects less than 1 in 100 people)

■    Dry mouth    ■    Sore throat

■    Mood changes

■    Mild sleep disorders (transient)

■    Abnormal dreams

■    Feeling agitated or anxious

■    Faster heart beat

■    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    ■ Blurred vision

■    Low blood pressure leading to a feeling of lightheadedness particularly when standing up (orthostatic hypotension)

■ Breathlessness    ■ Hair loss

■    Blisters or spots on the skin

■    Muscle weakness

■    Difficulty passing urine

■    Chest pain, irritability, swelling of the ankles

Rare side effects (affects less than 1 in 1,000 people)

■    Irregular heart beat

■    Feeling your heart beat (palpitations)

■    Chest pain (angina pectoris)

■    Skin reactions

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

Other side effects (frequency not known)

■    Excessive interest in sexual activity or involvement

■    Difficulty emptying the bladder

Side effects when Selegiline is used with Levodopa

When Selegiline is taken with levodopa, it may increase the side effects of levodopa.

The side effects are often due to the dose of levodopa being too high and usually disappear when the dose is reduced. Talk to your doctor about reducing the dose if you experience any of the effects below.

■    Abnormal movements (dyskinesias)

■    Feeling sick

■    Feeling agitated or restless

■    Overactive restlessness

■    Feeling confused

■    Seeing or hearing things that are not real (hallucinations)

■    Headache

■    Feeling light-headed, especially on standing up (due to low blood pressure)

■    Irregular heart beat

■    Feeling of dizziness or 'spinning' (vertigo)

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.

How to store

Keep your tablets in a safe place, out of sight and reach of children.

Store your tablets in a dry place, below 25°C and away from light.

Keep them in the pack they came in. Do not put them into another container.

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

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.

Further information

What Selegiline Hydrochloride Tablets contain:

■    Active ingredient: selegiline hydrochloride 5mg or 10mg

■    Other ingredients: lactose, maize starch, povidone, citric acid monohydrate and magnesium stearate (inactive ingredients)

What Selegiline Hydrochloride Tablets look like and the contents of the pack

Selegiline Hydrochloride 5mg Tablets are white, round shaped tablets, embossed "SEL5" on one side and break line on the other side.

Selegiline Hydrochloride 10mg Tablets are white, round shaped tablets, embossed "SEL10" on one side and break line on the other side.

This medicine is available in blisters or containers containing 7, 14, 21,28, 30, 50, 56, 60, 84, 90, 100, 112 or 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon, St. Neots,

Cambridgeshire, PE19 8ET United Kingdom

Product Licence Numbers

Selegiline 5mg: PL 11311/0381

Selegiline 10mg: PL 11311/0382 Date of last revision: February 2014

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.8s