Zelapar 1.25mg Oral Lyophilisate
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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Zelapar 1.25 mg Oral Lyophilisate will be referred to as Zelapar throughout this leaflet.
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 ZELPAR 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 one 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.
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, pharmacist or nurse. 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 25°C.
• 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 (tablet) 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, 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.
Manufacturer
Manufactured by: Catalent U.K. Swindon Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8RU, UK.
Procured from within the EU and repackaged by the Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL,
UK.
Zelapar® 1.25mg Oral Lyophilisate,
PL 39352/0241 _
Zelapar® is a registered trademark of Cephalon (UK) Ltd.
Leaflet date: 23.01.2015
Xilopar® 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Xilopar 1.25 mg Oral Lyophilisate will be referred to as Xilopar throughout this leaflet.
In this leaflet:
1) What Xilopar is and what it is used for.
2) Before you take Xilopar.
3) How to take Xilopar.
4) Possible side effects.
5) How to store Xilopar.
6) Further information.
1. WH AT XILOPAR IS AND WHAT IT IS USED FOR
The full name of this medicine is Xilopar 1.25 mg oral lyophilisate. In this leaflet the shorter name Xilopar will be used.
Xilopar 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.
Xilopar is used to treat Parkinson's disease. It can be used with another medicine called Levodopa or on its own.
2. BEFORE YOU TAKE XILOPAR Do not take Xilopar if:
• You are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Xilopar (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 Xilopar if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Xilopar. Also, you must look in the “Taking other medicines” section below as Xilopar cannot be taken with some medicines Take special care with Xilopar 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 Xilopar.
The use of Xilopar 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 Xilopar can affect the way some other medicines work.
Also some other medicines can affect the way Xilopar 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 Xilopar until at least 5 weeks after stopping fluoxetine. Do not start Xilopar 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 Xilopar.
• 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 Xilopar 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 Xilopar together you can feel agitated. Your doctor may lower your Levodopa dose slightly when you start Xilopar
• 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 Xilopar.
Also, talk to your doctor or pharmacist if you need to take any of the medicines shortly after stopping Xilopar. Wait at least 14 days between stopping Xilopar and starting to take any of the medicines listed in this “Taking other medicines” section. Wait at least 24 hours between stopping Xilopar and starting to take any serotonin agonists (such as triptan medicines used to treat migraine).
Taking Xilopar with food and drink
• Do not eat, drink or rinse your mouth for 5 minutes after taking Xilopar.
• Do not drink alcohol when you are taking Xilopar.
• If you are taking Xilopar with another ‘monoamine oxidase inhibitor' (MAOI), your doctor may ask you to restrict your diet.
Pregnancy and breast-feeding
Do not take Xilopar 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 Xilopar. 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 one of the ingredients of Xilopar
Xilopar contains a source of phenylalanine. This may be harmful for people with phenylketonuria.
3. HOW TO TAKE XILOPAR
Always take Xilopar 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 Xilopar than you should
If you take more Xilopar 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 Xilopar
• If you forget a dose of Xilopar 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.
You should continue taking Xilopar for as long as your doctor has advised. Do not stop taking Xilopar without talking to your doctor. Do not stop Xilopar 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, Xilopar can cause side effects, although not everybody gets them.
Stop taking Xilopar 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 Xilopar 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 Xilopar 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 Xilopar with Levodopa
Xilopar 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 Xilopar.
If you take Xilopar 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, pharmacist or nurse. 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 XILOPAR
• Keep out of the sight and reach of children
• Do not store above 25°C.
• 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 Xilopar contains
Each oral lyophilisate (tablet) 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, hypromellose)
What Xilopar looks like and the contents of the pack
Xilopar are pale yellow round tablets embossed with the letter A on one side.
Xilopar come in blister packs sealed in a foil sachet.
Xilopar is available in packs of 30 tablets.
Manufacturer
Manufactured by: Catalent U.K. Swindon Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8RU, UK.
Procured from within the EU and repackaged by the Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL,
UK.
Xilopar® 1.25mg Oral Lyophilisate,
PL 39352/0241 ' _
Xilopar® is a registered trademark of Cephalon (UK) Ltd.
Leaflet date: 23.01.2015
Selegiline Hydrochloride 1.25 mg Oral Lyophilisate
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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Selegiline Hydrochloride 1.25 mg Oral Lyophilisate will be referred to as Selegiline Hydrochloride Lyophilisate throughout this leaflet.
In this leaflet:
1) What Selegiline Hydrochloride Lyophilisate is and what it is used for.
2) Before you take Selegiline Hydrochloride Lyophilisate.
3) How to take Selegiline Hydrochloride Lyophilisate.
4) Possible side effects.
5) How to store Selegiline Hydrochloride Lyophilisate.
6) Further information.
1. WH AT SELEGILINE HYDROCHOLRIDE LYOPHILISATE IS AND WHAT IT IS USED FOR
The full name of this medicine is Selegiline Hydrochloride 1.25 mg oral lyophilisate. In this leaflet the shorter name Selegiline Hydrochloride Lyophilisate will be used.
Selegiline Hydrochloride Lyophilisate 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.
Selegiline Hydrochloride Lyophilisate is used to treat Parkinson's disease. It can be used with another medicine called Levodopa or on its own.
2. BEFORE YOU TAKE SELEGILINE HYDROCHLORIDE LYOPHILISATE
Do not take Selegiline Hydrochloride Lyophilisate if:
• You are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Selegiline Hydrochloride Lyophilisate (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 Selegiline Hydrochloride Lyophilisate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Selegiline Hydrochloride Lyophilisate. Also, you must look in the “Taking other medicines” section below as Selegiline Hydrochloride Lyophilisate cannot be taken with some medicines
Take special care with Selegiline Hydrochloride Lyophilisate
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 Selegiline Hydrochloride Lyophilisate.
The use of Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate can affect the way some other medicines work.
Also some other medicines can affect the way Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate until at least 5 weeks after stopping fluoxetine. Do not start Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate.
• 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 Selegiline Hydrochloride 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 Selegiline Hydrochloride Lyophilisate together you can feel agitated. Your doctor may lower your Levodopa dose slightly when you start Selegiline Hydrochloride Lyophilisate.
• 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 Selegiline Hydrochloride Lyophilisate.
Also, talk to your doctor or pharmacist if you need to take any of the medicines shortly after stopping Selegiline Hydrochloride Lyophilisate. Wait at least 14 days between stopping Selegiline Hydrochloride Lyophilisate and starting to take any of the medicines listed in this “Taking other medicines” section. Wait at least 24 hours between stopping Selegiline Hydrochloride Lyophilisate and starting to take any serotonin agonists (such as triptan medicines used to treat migraine).
Taking Selegiline Hydrochloride Lyophilisate with food and drink
• Do not eat, drink or rinse your mouth for 5 minutes after taking Selegiline Hydrochloride Lyophilisate.
• Do not drink alcohol when you are taking Selegiline Hydrochloride Lyophilisate.
• If you are taking Selegiline Hydrochloride Lyophilisate with another ‘monoamine oxidase inhibitor' (MAOI), your doctor may ask you to restrict your diet.
Pregnancy and breast-feeding
Do not take Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate. 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 one of the ingredients of Selegiline Hydrochloride Lyophilisate
Selegiline Hydrochloride Lyophilisate contains a source of phenylalanine. This may be harmful for people with phenylketonuria.
POM
3. HOW TO TAKE SELEGILINE HYDROCHLORIDE LYOPHILISATE
Always take Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate than you should
If you take more Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate
• If you forget a dose of Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate
You should continue taking Selegiline Hydrochloride Lyophilisate for as long as your doctor has advised. Do not stop taking Selegiline Hydrochloride Lyophilisate without talking to your doctor. Do not stop Selegiline Hydrochloride Lyophilisate 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, Selegiline Hydrochloride Lyophilisate can cause side effects, although not everybody gets them.
Stop taking Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate with Levodopa
Selegiline Hydrochloride Lyophilisate 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 Selegiline Hydrochloride Lyophilisate.
If you take Selegiline Hydrochloride Lyophilisate 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, pharmacist or nurse. 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 SELEGILINE HYDROCHLORIDE LYOPHILISATE
• Keep out of the sight and reach of children
• Do not store above 25°C.
• 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 Selegiline Hydrochloride Lyophilisate contains
Each oral lyophilisate (tablet) 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, hypromellose)
What Selegiline Hydrochloride Lyophilisate looks like and the contents of the pack
Selegiline Hydrochloride Lyophilisate are pale yellow round tablets embossed with the letter A on one side.
Selegiline Hydrochloride Lyophilisate come in blister packs sealed in a foil sachet.
Selegiline Hydrochloride Lyophilisate is available in packs of 30 tablets.
Manufacturer
Manufactured by: Catalent U.K. Swindon Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8RU, UK.
Procured from within the EU and repackaged by the Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL,
UK.
Selegiline Hydrochloride 1.25mg Oral Lyophilisate,
PL 39352/0241
Leaflet date: 23.01.2015