Selegiline Hydrochloride Tablets 10 Mg
PACKAGE LEAFLET
Selegiline Hydrochloride 5mg and 10mg Tablets
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.
In this leaflet
1. What Selegiline tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What Selegiline tablets are and what they are used for
Selegiline belongs to a group of medicines called monoamine-oxidase-B inhibitors and are used to treat Parkinson’s disease or symptoms of Parkinson’s disease. It can be used alone or with another medicine called Levodopa.
2. Before you take
Do not take selegiline tablets and tell your doctor if you:
• are allergic (hypersensitive) to selegiline or any of the other ingredients (see section 6).
• are taking antidrepressants called selective seretonin reuptake inhibitors (SSRIs), venlafaxine (a seretonin noradrenaline reuptake inhibitor), tricyclic antidepressants, or monoamine oxidase inhibitors (such as linezolide).
• are taking sympathomimetics such as salbutamol
• are taking a strong painkiller such as pethidine
• are taking a medicine called Levodopa,
• have an active intestinal or stomach ulcer.
Check with your doctor or pharmacist before taking selegiline tablets if you:
• have or have had a stomach ulcer or bleeding in the gut.
• have uncontrolled high blood pressure.
• suffer from irregular heart beats, angina or any heart problems.
• are being treated for a mental illness.
• suffer from severe liver or kidney problems
• are likely to have surgery which requires 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. Especially:
• Levodopa (used to treat Parkinson’s disease)
• sympathomimetics,
• pethidine,
• antidepressants such as selective seretonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) and tricyclic antidepressants..
• MAO inhibitors, such as moclobemide (used to treat depression)
• Oral contraceptives.
• medicines that thin the blood such as warfarin, or digitalis (such as digoxin) as these require careful monitoring
Taking with food and drink
Check with your doctor if you are taking selegiline as dietary restrictions may be necessary.
Alcohol should be avoided whilst taking selegiline
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, check with your doctor or pharmacist before taking this medicine.
Driving and using machines
Selegiline tablets may cause dizziness, therefore make sure you are not affected before driving or operating 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.
Important information about one of the ingredients in selegiline tablets
Mannitol may have a mild laxative effect.
3. How to take
Always take selegiline tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Doses:
Adults (including the elderly): 10mg daily, either alone or in combination with Levodopa.
Selegiline can be taken either as a single dose in the morning or in two divided doses taken at breakfast and lunchtime.
To be taken with water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without their advice.
If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an
overdose include; agitation, tremor, alternating low and high blood pressure, difficulty breathing, severe muscle spasms, a rise in body temperature, unconciousness and fits.
Take any remaining tablets and the container with you.
If you forget to take the tablets
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.
If you stop taking the tablets
Talk to your doctor before you stop taking the tablets and follow their advice.
4. Possible side effects
Like all medicines, selegiline tablets can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occurs in less than 1 in 10 users); dizziness, headache, slow heart beat, feeling sick, mild increased liver enzymes
Uncommon (occurs in less than 1 in 100 users): mood change.difficulty sleeping, abnormally fast heart beat, dry mouth,
Rare (occurs in less than 1 in 1,000 users): feeling faint when getting up due to low blood pressure, skin reactions,
Not known (cannot be established from the available data); increased sex drive, depression, confusion, psychosis, agitation tremor, low blood pressure, constipation, diarrhoea, being sick, stomatitis, back pain, muscle cramps, joint pain urinary retention, difficulty in passing water, sore throat,
The following side effects may be experience if selegiline is taken with Levodopa;
restlessness, hyperactivity, abnormal movements, agitation, confusion, hallucinations (seeing, hearing or feeling things that are not there), feeling faint when getting up due to low blood pressure, irregular heart beat.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
5. How to store
Keep out of the reach and sight of children.
Store below 25°C, in a dry place and protect from light. Store in the original packaging.
Do not use selegiline tablets after the expiry date stated on the label/carton/bottle. 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.
6. Further information
What Selegiline Tablets contain
• The active substance (the ingredient that makes the tablet work) is selegiline hydrochloride. Each tablet contains either 5mg or 10mg of the active ingredient Selegiline hydrochloride.
• The other ingredients are magnesium stearate, mannitol, Microcrystalline Cellulose (E460), Purified Talc (E553),
What selegiline tablets look like and contents of the pack
Selegiline tablets are white, uncoated tablets.
Pack sizes are 28s, 30s, 56s, 60s, 84s, 100s, 112s.
Not all pack sizes may be available
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of revision: February 2014