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ZELAPAR1.25MG ORAL LYOPHILISATE

Active substance(s): SELEGILINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zelapar® 1.25 mg Oral Lyophilisate
(selegiline hydrochloride)
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 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
In this leaflet:
1) What Zelapar is and what it is used for
2) Before you take Zelapar
3) How to take Zelapar
4) Possible side effects
5) How to store Zelapar
6) Further information
1) WHAT ZELAPAR IS AND WHAT IT IS USED FOR
The full name of this medicine is Zelapar 1.25 mg oral lyophilisate. In this
leaflet the shorter name Zelapar will be used.
Zelapar contains a medicine called selegiline hydrochloride.
This belongs to a group of medicines called “monoamine oxidase B
inhibitors”. An oral lyophilisate looks like a tablet.
Zelapar is used to treat Parkinson’s disease. It can be used with another
medicine called Levodopa or on its own.
2) BEFORE YOU TAKE ZELAPAR
Do not take Zelapar if:
• You are allergic (hypersensitive) to selegiline hydrochloride or any of
the other ingredients of Zelapar (listed in Section 6)
• You have a stomach ulcer or ulcer in your gut
• You have a problem called “phenylketonuria”
• You have a movement or muscle problem (“extrapyramidal”) which is
not caused by a lack of dopamine.
Do not take Zelapar if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Zelapar.
Also, you must look in the “Taking other medicines” section below as
Zelapar cannot be taken with some medicines.
Take special care with Zelapar
Check with your doctor or pharmacist before taking your medicine if:
• You have a liver or kidney problem
• You have sudden and repeated increases in blood pressure
• You have chest pain (angina) or an uneven heart beat
• You have severe dementia
• You have any mental health problem
• You have ever had a stomach ulcer or ulcer in your gut
• You are taking any other medicines. Make sure you look in the
“Taking other medicines” section below.
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Zelapar.
The use of Zelapar may produce positive results in anti-doping tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. This is because Zelapar can
affect the way some other medicines work. Also some other medicines
can affect the way Zelapar works.
Do not take this medicine and talk to your doctor or pharmacist if you
are taking any of the following:
• pethidine or any other morphine-like painkiller
• medicines for depression, including tricyclic antidepressants, ‘selective
serotonin reuptake inhibitors’ (SSRIs), such as fluoxetine, and
venlafaxine.
Do not start Zelapar until at least 5 weeks after stopping fluoxetine.
Do not start Zelapar until at least 2 weeks after stopping sertraline.
If you have taken any other SSRI, wait at least 1 week after stopping
this SSRI before starting Zelapar.

• medicines called “monoamine oxidase inhibitors” or MAOIs used to
treat depression and also the antibiotic linezolid
• medicines called sympathomimetics, such as medicines for nasal
congestion, ephedrine
• medicines for migraine such as rizatriptan
• Levodopa, a medicine used for your Parkinson’s disease and you have
any of the following:
− High blood pressure or a major heart problem, such as chest pain
(angina) or an uneven or fast heart beat
− A tumour of your prostate gland
− A tumour of your adrenal gland (phaeochromocytoma)
− An eye problem called ‘narrow angle glaucoma’
− An overactive thyroid gland (hyper-thyroid disease)
− Major mental health problems such as schizophrenia
− Severe dementia.
Do not take Zelapar and talk to your doctor or pharmacist if any of the
above apply to you.
Also tell your doctor or pharmacist if you are taking any of the
following:
• Levodopa (used for Parkinson’s disease). If you take the maximum
dose of Levodopa and Zelapar together you can feel agitated. Your
doctor may lower your Levodopa dose slightly when you start Zelapar
• Oral contraceptives (the pill)
• HRT (hormone replacement therapy)
• Altretamine (used for ovarian cancer)
• Amantadine (used for Parkinson’s disease)
• Dopamine or Digoxin (used for heart problems)
• Medicines for heart problems
• Medicines to relax the gut muscles
• Medicines for anxiety or sleep problems
• Medicines for high or low blood pressure
• Medicines for asthma such as a salbutamol inhaler
• Medicines for depression
• Medicines to thin your blood.
Please tell your doctor if you are due to have a general anaesthetic.
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Zelapar.
Also, talk to your doctor or pharmacist if you need to take any of the
medicines shortly after stopping Zelapar. Wait at least 14 days between
stopping Zelapar and starting to take any of the medicines listed in this
“Taking other medicines” section. Wait at least 24 hours between
stopping Zelapar and starting to take any serotonin agonists (such as
triptan medicines used to treat migraine).
Taking Zelapar with food and drink
• Do not eat, drink or rinse your mouth for 5 minutes after taking
Zelapar.
• Do not drink alcohol when you are taking Zelapar.
• If you are taking Zelapar with another ‘monoamine oxidase inhibitor’
(MAOI), your doctor may ask you to restrict your diet.
Pregnancy and breast-feeding
Do not take Zelapar if you are pregnant, breast-feeding or planning to
become pregnant.
Driving and using machines
You may feel slow, dizzy or sleepy or have blurred vision while taking
Zelapar. If this happens, do not drive or use any tools or machines.
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 some of the ingredients of Zelapar
Zelapar contains a source of phenylalanine. This may be harmful for
people with phenylketonuria.
3) HOW TO TAKE ZELAPAR
Always take Zelapar exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Your doctor will monitor you during your treatment to see how you
respond.
Taking this medicine
• The usual dose is 1.25 mg (1 tablet) once a day, before breakfast.
• Do not push the tablet through the foil blister.
• To get the tablet out of the packaging, peel back the foil and carefully
take out the tablet.
• Place it on your tongue and let it dissolve. The tablet will dissolve
quickly (in less than 10 seconds).
• Do not eat, drink or rinse your mouth out for 5 minutes after taking it.
If you take more Zelapar than you should
If you take more Zelapar than you should, talk to a doctor or go to a
hospital straight away.
Take the packet and this leaflet with you so that the doctor will know what
you have taken.
If you forget to take Zelapar
• If you forget a dose of Zelapar in the morning, take it as soon as you
remember later that day.
• Do not eat, drink or rinse your mouth out for 5 minutes after taking it.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Zelapar
You should continue taking Zelapar for as long as your doctor has
advised. Do not stop taking Zelapar without talking to your doctor. Do not
stop Zelapar suddenly. If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Zelapar can cause side effects, although not
everybody gets them.
Stop taking Zelapar and talk to a doctor straight away, if you notice
any of the following:
• Difficulty breathing or your mouth or throat begins to swell. Also if you
start to get a severe rash, itching or other skin reactions.
These may be signs of a serious allergic reaction. Stop taking Zelapar
and talk to a doctor straight away if any of the above apply to you.
Talk to a doctor straight away, if you notice any of the following:
• Seeing, feeling or hearing things that are not there (hallucinations) or
being confused - these are common and affect less than 1 in 10
patients treated
• Serious mental health problems - these are uncommon and affect less
than 1 in 100 patients treated
• Chest pains (angina) - these are uncommon and affect less than 1 in
100 patients treated.
Talk to a doctor straight away if any of the above apply to you.
Other side effects include:
Very common (affects more than 1 in 10 patients treated)
• Sore mouth
Common (affects less than 1 in 10 patients treated)
• Mouth ulcers
• Blocked nose, sore throat
• Sweating more than usual
• High or low blood pressure, low heart rate
• Joint pains, back pain and muscle cramps
• Problems sleeping, depression, feeling tired
• Feeling dizzy or like you are spinning (vertigo)
• Falls, loss of balance, tremor, feeling dizzy, headache
• Constipation or diarrhoea, feeling sick (nausea), dry mouth
• Abnormal liver tests (seen in a blood test)
• Strange movements including lack of movement and slow movement
Uncommon (affects less than 1 in 100 patients treated)
• Feeling faint
• Blurred vision
• Loss of appetite
• Muscle weakness









Pounding heart beat (palpitations), uneven or fast heartbeat
Hair loss, skin rashes or spots
Strange dreams, feeling agitated, anxious or irritable, mood changes
Swollen ankles
Throat infections
Problems passing urine
Low blood pressure when standing. This may make you feel dizzy or
faint
• Low levels of white blood cells (leukocytopenia) and platelets
(thrombocytopenia) in the blood. This may make you more likely to get
infections or bruising. Tell your doctor if you bruise or bleed easily, or
often get sore throats or fever.
Rare (affects less than 1 in 1000 patients treated)
• Skin reactions
The following side effects have also been reported with the use of
Zelapar but it is not known how often they may occur: being excessively
interested or involved in sexual activitiy and inability to pass urine.
Side effects if you take Zelapar with Levodopa
Zelapar increases the effect of Levodopa. This means the side effects
you get with Levodopa may also be increased. Your doctor may want to
reduce your dose of Levodopa while you are taking Zelapar. If you take
Zelapar with Levodopa you may also notice the following side effects:
• Difficulty controlling your movements. This is common and affects less
than 1 in 10 patients treated.
• Feeling restless
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 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 ZELAPAR






Keep out of the sight and reach of children
Do not store above 25oC.
Discard the contents of the sachets within 3 months of opening
Do not take this medicine after the expiry date shown on the pack
If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 Zelapar contains
Each oral lyophilisate contains 1.25mg selegiline hydrochloride
(equivalent to 1.05mg selegiline free base).
Also contains aspartame (E951).

The other ingredients:
Gelatin, mannitol (E421), grapefruit flavour, glycine, anhydrous citric acid
and yellow colouring (yellow iron oxide E172 and hypromellose)
What Zelapar looks like and the contents of the pack
Zelapar are pale yellow round tablets embossed with the letter A on one
side.
Zelapar come in blister packs sealed in a foil sachet.
Zelapar is available in packs of 30 tablets.
Manufactured by
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem,
The Netherlands.
Procured from within the EU by the Product Licence holder MPT Pharma
Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall
WS9 8ER, UK.
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx
Leaflet dated 29th September 2015
Leaflet coded xxxxxxxxx
PL: 33532/0291
Zelapar® is a registered trademark of Cephalon (UK) Ltd.

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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