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ZELAPAR 1.25MG ORAL LYOPHILISATE

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Mock up

Assessed against UK PIL dated June 2010

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZELAPAR 1.25mg oral lyophilisate
(selegiline hydrochloride)
Your medicine is available as the above name but will be referred
to as Zelapar throughout this 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 get serious, or you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist
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

By whitneya
Taking Zelapar with other medicines at 1:30 pm, Feb 01, 2011
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including those obtained without a
prescription. This is especially important if you are taking any of the
following medicines for:
High or low blood pressure.
Anxiety, depression or sleep problems.
Heart problems.
Asthma e.g. Ventolin inhalers.
or any of the following:
Medicines to relieve congestion e.g. ephedrine.
Medicines to relax the gut muscles.
Medicines having antidepressant or mood elevating properties.
Oral contraceptives (the pill).
HRT (hormone replacement therapy).
Amantadine (used to treat Parkinson s).
Altretamine (used to treat ovarian cancer).









Taking Zelapar with food and drink
Do not drink alcohol when you are taking Zelapar.
Do not eat, drink or rinse your mouth for 5 minutes after taking Zelapar.
Pregnancy and breast-feeding
Do not take Zelapar if you are pregnant, breast-feeding or planning to
become pregnant.

The name of this medicine is Zelapar 1.25mg oral lyophilisate (tablet).
The active ingredient in this medicine is selegiline hydrochloride which
belongs to a group of medicines called monoamine oxidase B
inhibitors.

Driving and operating machinery
Zelapar may make you feel slow or drowsy, if this happens to you do
not drive or operate machinery.

Zelapar is used to treat Parkinson s disease and can be used on its
own or in combination with other medicines.

Important information about one of the ingredients of Zelapar
Zelapar contains a source of phenylalanine. May be harmful for
people with phenylketonuria.

2.

Before you take Zelapar
3.

Do not take Zelapar if you:
Are allergic (hypersensitive) to selegiline hydrochloride or any of
the other ingredients of Zelapar.
Have a stomach ulcer.
Have a condition called phenylketonuria.
Are taking pethidine or any other opioid painkiller.
Are taking any medicine for depression.
Are taking any monoamine oxidase inhibitors e.g. the antibiotic
linezolid.
Are taking any medicines for migraine e.g. rizatriptan.
If you are already taking a medicine called Levodopa for your
Parkinson s disease and suffer from any of the following conditions you
should not take Zelapar as well:
Major heart problems.
Chest pain (angina).
High blood pressure.
An erratic or fast heartbeat.
An overactive thyroid gland (hyperthyroid disease).
An eye condition called narrow angle glaucoma.
A tumour of your prostate gland.
Major mental health problems e.g. schizophrenia.
Take special care with Zelapar
If you already take Levodopa. It can cause agitation and you
should tell your doctor if this happens.
If you have:
Liver disease.
High or low blood pressure.
Erratic heartbeat.
Chest pain (Angina).
Severe dementia.
Mental health problems.
A history of stomach ulcers.
If any of the above apply to you, you should speak to your doctor
before taking this medicine.

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.
The usual dose is 1.25mg once a day.
Do not push the tablet through the foil blister. Peel back the foil and
carefully remove the tablet.
Place it on your tongue in the morning and allow it to dissolve.
The tablet will dissolve rapidly.
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 too much Zelapar you should contact your doctor or go to
the nearest hospital emergency department immediately. 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 to take your dose of Zelapar in the morning, ensure you
take it as soon as you remember before your next dose is due. Do not
take a double dose to make up for a forgotten dose.

4.

Possible side effects

Like all medicines, Zelapar can cause side effects, although not
everybody gets them.
Stop taking this medicine and tell your doctor immediately if you
have difficulty breathing or your mouth or throat begins to swell or if
you start suffering from a severe rash, itching or other skin reactions,
as these may be signs of a serious allergic reaction.
The following side effects have been reported:
Back pain, dizziness, shakes and sore throat.



Less commonly:
Sore mouth, mouth ulcers, blocked nose.
Falls, loss of balance, dizziness, problems sleeping, strange
dreams, hallucinations, confusion.
Muscle cramps and joint pains.
Constipation or diarrhoea, feeling sick.




In addition, the following side effects have also been reported:
Chest pain, headache, low blood pressure.
Muscle aches.
Depression, tiredness.
Dry mouth.
Abnormal liver tests.







Taking Zelapar with Levodopa
If you take Zelapar with Levodopa you may also notice:
Difficulty controlling your movements or loss of balance.
Agitation, problems sleeping, confusion, serious mental health
problems, hallucinations or abnormal thoughts, anxiety, irritability,
depression and tiredness.
Dizziness or feeling faint, dry mouth, feeling sick, loss of appetite.
High or low blood pressure, chest pains, erratic or fast heartbeat.
Headache, blurred vision and excessive sweating.
Shortness of breath, swollen ankles and problems passing urine.
Skin rashes or spots.
Low levels of white blood cells (leucocytopenia) and platelets
(thrombocytopenia) in the blood which may make you more
vulnerable to infections or bruising.
Temporary liver problems.
Hair loss
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.
5.

How to store Zelapar

Keep out of the reach and sight of children.
Do not store above 25 C.
Do not use after the expiry date printed on the carton and sachet
labels.
If your medicine becomes 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 your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6.

Further information

What Zelapar contains
The active ingredient is selegiline hydrochloride. Each oral
lyophilisates contains 1.25mg selegiline hydrochloride (equivalent to
1.05mg free base).
Zelapar also contains gelatine, mannitol, aspartame, grapefruit flavour,
glycine, anhydrous citric acid and Opatint AD 22901 yellow (containing
yellow iron oxide (E172), hypromellose (E464) and ethanol).
Discard any unused medicine within 3 months of opening the sachet.

What Zelapar looks like and the contents of the pack
The tablets are yellow, round, and embossed with an A on one side
and plain on the resverse.
They come in blister packs sealed in a paper/aluminium foil sachet.
Zelapar comes in packs of 30 tablets (3 foil sachets of 10 tablets).
Manufacturer and Product Licence holder
Zelapar is manufactured by Catalent U.K. Swindon Zydis Limited,
Frankland Road, Blagrove, Swindon, Wiltshire SN5 8RU, United
Kingdom. Procured from within the EU and repackaged by the Product
Licence holder: G-Pharma Ltd., Dakota Avenue, Salford
M50 2PU.
PL 16369/1448

POM
th

Date of revision of this leaflet: 17 January 2011
Zelapar is a registered trademark of Cephalon Limited

Mock up

Assessed against UK PIL dated June 2010

PACKAGE LEAFLET: INFORMATION FOR THE USER
SELEGILINE HYDROCHLORIDE 1.25mg oral lyophilisate
Your medicine is available as the above name but will be referred to as
Selegiline oral lyophilisate throughout this 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 get serious, or you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist
In this leaflet:
1. What Selegiline oral lyophilisate is and what it is used for
2. Before you take Selegiline oral lyophilisate
3. How to take Selegiline oral lyophilisate
4. Possible side effects
5. How to store Selegiline oral lyophilisate
6. Further information
1.

or any of the following:
Medicines to relieve congestion e.g. ephedrine.
Medicines to relax the gut muscles.
Medicines having antidepressant or mood elevating properties.
Oral contraceptives (the pill).
HRT (hormone replacement therapy).
Amantadine (used to treat Parkinson s).
Altretamine (used to treat ovarian cancer).









Taking Selegiline oral lyophilisate with food and drink
Do not drink alcohol when you are taking Selegiline oral lyophilisate.
Do not eat, drink or rinse your mouth for 5 minutes after taking
Selegiline oral lyophilisate.

What Selegiline oral lyophilsate is and what it is used for

The name of this medicine is Selegiline oral lyophilisate (tablet).
The active ingredient in this medicine is selegiline hydrochloride which
belongs to a group of medicines called monoamine oxidase B
inhibitors.
Selegiline oral lyophilisate is used to treat Parkinson s disease and can
be used on its own or in combination with other medicines.
2.

By whitneya at medicines
Taking Selegiline oral lyophilisate with other 1:30 pm, Feb 01, 2011
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including those obtained without a
prescription. This is especially important if you are taking any of the
following medicines for:
High or low blood pressure.
Anxiety, depression or sleep problems.
Heart problems.
Asthma e.g. Ventolin inhalers.

Before you take Selegiline oral lyophilisate

Do not take Selegiline oral lyophilisate if you:
Are allergic (hypersensitive) to selegiline hydrochloride or any of
the other ingredients of Selegiline oral lyophilisate.
Have a stomach ulcer.
Have a condition called phenylketonuria.
Are taking pethidine or any other opioid painkiller.
Are taking any medicine for depression.
Are taking any monoamine oxidase inhibitors e.g. the antibiotic
linezolid.
Are taking any medicines for migraine e.g. rizatriptan.
If you are already taking a medicine called Levodopa for your
Parkinson s disease and suffer from any of the following conditions you
should not take Selegiline oral lyophilisate as well:
Major heart problems.
Chest pain (angina).
High blood pressure.
An erratic or fast heartbeat.
An overactive thyroid gland (hyperthyroid disease).
An eye condition called narrow angle glaucoma.
A tumour of your prostate gland.
Major mental health problems e.g. schizophrenia.
Take special care with Selegiline oral lyophilisate
If you already take Levodopa. It can cause agitation and you should
tell your doctor if this happens.
If you have:
Liver disease.
High or low blood pressure.
Erratic heartbeat.
Chest pain (Angina).
Severe dementia.
Mental health problems.
A history of stomach ulcers.
If any of the above apply to you, you should speak to your doctor
before taking this medicine.

Pregnancy and breast-feeding
Do not take Selegiline oral lyophilisate if you are pregnant, breastfeeding or planning to become pregnant.
Driving and operating machinery
Selegiline oral lyophilisate may make you feel slow or drowsy, if this
happens to you do not drive or operate machinery.
Important information about one of the ingredients of Selegiline
oral lyophilisate
Selegiline oral lyophilisate contains a source of phenylalanine.
May be harmful for people with phenylketonuria.
3.

How to take Selegiline oral lyophilisate

Always take Selegiline oral lyophilisate exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.
The usual dose is 1.25mg once a day.
Do not push the tablet through the foil blister. Peel back the foil and
carefully remove the tablet.
Place it on your tongue in the morning and allow it to dissolve.
The tablet will dissolve rapidly.
Do not eat, drink or rinse your mouth out for 5 minutes after taking it.
If you take more Selegiline oral lyophilisate than you should
If you take too much Selegiline oral lyophilisate you should contact
your doctor or go to the nearest hospital emergency department
immediately. Take the packet and this leaflet with you so that the
doctor will know what you have taken.
If you forget to take Selegiline oral lyophilisate
If you forget to take your dose of Selegiline oral lyophilisate in the
morning, ensure you take it as soon as you remember before your next
dose is due. Do not take a double dose to make up for a forgotten
dose.

4.

Possible side effects

Like all medicines, Selegiline oral lyophilisate can cause side effects,
although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you
have difficulty breathing or your mouth or throat begins to swell or if
you start suffering from a severe rash, itching or other skin reactions,
as these may be signs of a serious allergic reaction.
The following side effects have been reported:
Back pain, dizziness, shakes and sore throat.



Less commonly:
Sore mouth, mouth ulcers, blocked nose.
Falls, loss of balance, dizziness, problems sleeping, strange
dreams, hallucinations, confusion.
Muscle cramps and joint pains.
Constipation or diarrhoea, feeling sick.




In addition, the following side effects have also been reported:
Chest pain, headache, low blood pressure.
Muscle aches.
Depression, tiredness.
Dry mouth.
Abnormal liver tests.







Taking Selegiline oral lyophilisate with Levodopa
If you take Selegiline oral lyophilisate with Levodopa you may also
notice:
Difficulty controlling your movements or loss of balance.
Agitation, problems sleeping, confusion, serious mental health
problems, hallucinations or abnormal thoughts, anxiety, irritability,
depression and tiredness.
Dizziness or feeling faint, dry mouth, feeling sick, loss of appetite.
High or low blood pressure, chest pains, erratic or fast heartbeat.
Headache, blurred vision and excessive sweating.
Shortness of breath, swollen ankles and problems passing urine.
Skin rashes or spots.
Low levels of white blood cells (leucocytopenia) and platelets
(thrombocytopenia) in the blood which may make you more
vulnerable to infections or bruising.
Temporary liver problems.
Hair loss
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.
5.

How to store Selegiline oral lyophilisate

Keep out of the reach and sight of children.
Do not store above 25 C.
Do not use after the expiry date printed on the carton and sachet
labels.
If your medicine becomes 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 your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6.

Further information

What Selegiline oral lyophilisate contains
The active ingredient is selegiline hydrochloride. Each oral
lyophilisates contains 1.25mg selegiline hydrochloride (equivalent to
1.05mg free base).
Selegiline oral lyophilisate also contains gelatine, mannitol, aspartame,
grapefruit flavour, glycine, anhydrous citric acid and Opatint AD 22901
yellow (containing yellow iron oxide (E172), hypromellose (E464) and
ethanol).

Discard any unused medicine within 3 months of opening the sachet.
What Selegiline oral lyophilisate looks like and the contents of the
pack
The tablets are yellow, round, and embossed with an A on one side
and plain on the resverse.
They come in blister packs sealed in a paper/aluminium foil sachet.
Selegiline oral lyophilisate comes in packs of 30 tablets (3 foil sachets
of 10 tablets).
Manufacturer and Product Licence holder
Selegiline oral lyophilisate is manufactured by Catalent U.K. Swindon
Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire SN5
8RU, United Kingdom. Procured from within the EU and repackaged
by the Product Licence holder: G-Pharma Ltd., Dakota Avenue, Salford
M50 2PU.
PL 16369/1448

POM
th

Date of revision of this leaflet: 17 January 2011

Expand Transcript

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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