SELEGILINE HYDROCHLORIDE TABLETS 10 MG - Patient leaflet, side effects, dosage

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Final Preparation Date For Submission: 10/05/2017 Packing Site Technical Approval:

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PATIENT INFORMATION LEAFLET

Selegiline Hydrochloride 5mg and 10mg Tablets

Read all of this leaflet carefully before you start taking 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, please 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:

D What this medicine is and what it is used for

2 What you need to know before you take Selegiline

• 3 How to take Selegiline

• 4 Possible side effects

• 5 How to store Selegiline

• 6 Contents of the pack and other information

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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 fluctuations in your condition, on-off symptoms or uncontrolled movements.

What you need to know before you take Selegiline

Do not take if:

• ■ You are allergic (hypersensitive, including severe dizziness or low blood pressure) to Selegiline, monoamine oxidase-B (MAO-B) inhibitors or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”)

• ■ You are taking antidepressants, including tricyclic antidepressants and Selective Serotonin Reuptake Inhibitors (SSRIs) e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline and Serotonin Noradrenaline Reuptake Inhibitors (SNRI) (venlafaxine). Antidepressants should be stopped a number of weeks before taking Selegiline, speak to your doctor for further advice. (See section 2 “Other medicines and Selegiline”)

• ■ You are taking monoamine oxidase inhibitors (MAOIs) e.g. antibiotic linezolid

• ■ You are taking pethidine or any other opioid pain relievers such as codeine or tramadol

• ■ You are taking medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan (serotonin-agonists)

• ■ You are taking 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

• ■ Do not take Selegiline together with levodopa if you suffer from any of the following conditions: o Severe heart problems

o Severe chest pain (angina)

o High blood pressure (arterial hypertension)

o An erratic or fast heartbeat (e.g. tachycardia or arrhythmias)

o An overactive thyroid gland (hyperthyroid disease)

o An eye condition called narrow angle glaucoma o A tumour of your adrenal gland

(phaeochromocytoma) or prostate (prostatic adenoma)

o Major mental health problems.e.g. schizophrenia or advanced dementia

Warnings and precautions

Talk to your doctor before taking Selegiline

• ■ If you have or have a history of stomach or duodenal ulcers

• ■ If you have uncontrolled high blood pressure

• ■ If you have an irregular heartbeat

• ■ If you have severe chest pain (angina)

• ■ If you suffer from any mental illness (psychosis)

• ■ 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

• ■ If you are being treated with dopamine agonists and other dopaminergic treatments

Other medicines and Selegiline

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

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 pain relievers 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 (serotonin agonists)

Other medicines which may interact with Selegiline:

• ■ 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant you should not take Selegiline.

Breast-feeding

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

Driving and using machines

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.

Selegiline contains lactose

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

continued…

How to take Selegiline

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 take more Selegiline than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of an overdose include: drowsiness, dizziness, feeling faint, irritability, restlessness, agitation, 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.

If you forget to take Selegiline

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Selegiline

It is important that you keep taking Selegiline for as long as your doctor has told you to.

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

Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

• ■ Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness

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

• ■ Sore mouth and swollen gums (stomatitis)

Common side effects (may affect up to 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 (nausea)

• ■ Constipation

• ■ Diarrhoea

• ■ Mouth ulcers

• ■ Temporary increase in serum alanine amiotransferase (ALAT) or mild increase in liver enzymes

• ■ Dizziness

• ■ Headache

• ■ Shaking (tremor)

• ■ Slower heartbeat (bradycardia)

• ■ Low or high blood pressure (hypotension, hypertension)

• ■ Blocked nose

• ■ Sore throat

• ■ Increased sweating

• ■ Joint pain (arthralgia), back pain, muscle cramps

• ■ Feeling tired (fatigue)

• ■ Falling over

Uncommon side effects (may affect up to 1 in 100 people)

• ■ Dry mouth

• ■ Sore throat (pharyngitis)

• ■ Mood changes

• ■ Mild sleep disorders (short-term)

• ■ Abnormal dreams

• ■ Feeling agitated or anxious

• ■ Faster heartbeat (tachycardia)

• ■ 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 (dyspnoea)

• ■ Hair loss

• ■ Blisters or spots on the skin

• ■ Muscle weakness (myopathy)

• ■ Difficulty passing urine

• ■ Chest pain

• ■ Irritability

• ■ Swelling of the ankles

• ■ Irregular heartbeat

• ■ Feeling your heartbeat (palpitations)

• ■ Chest pain (angina pectoris)

• ■ Mental illness (psychoses)

Rare side effects (may affect up to 1 in 1,000 people)

• ■ 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 (dyskinesia/hy­perkinesis)

• ■ Feeling agitated or restless

• ■ Overactive restlessness

• ■ Feeling confused

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

• ■ Feeling light-headed, especially on standing up (due to low blood pressure) [postural hypotension]

• ■ Irregular heartbeat

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Selegiline

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

• ■ Keep this medicine out of the sight and reach of children.

• ■ Store in a dry place, below 25°C. Store in the original package in order to protect from light.

• ■ Do not use this medicine after the expiry date which is stated on the carton/blister/con­tainer 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 you no longer use. These measures will help to protect the environment.

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Contents of the pack and other information

What Selegiline Hydrochloride Tablets contain:

• ■ Each 5mg tablet contains 5mg of selegiline hydrochloride

• ■ Each 10mg tablet contains 10mg of selegiline hydrochloride

The other ingredients are: lactose, maize starch, povidone K-30, citric acid monohydrate, purified water and magnesium stearate.

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

• ■ Selegiline 5mg are white, round shaped tablets, with an approximate diameter of 6mm, embossed „SEL5“ on one side and break line on the other side.

• ■ Selegiline 10mg are white, round shaped tablets, with an approximate diameter of 8mm, embossed „SEL10“ on one side and break line on the other side.