Patient leaflet - NEUPRO 1 MG / 24 H TRANSDERMAL PATCH
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Neupro
1 mg/24 h
3 mg/24 h
Transdermal patch rotigotine
iEn| Package leaflet: Information for the user
Aes Ae^aQu a^a A A A 1 Aesica Queenborough Ltd. NOTE: Artwork studio checks pre-press suitability of this artwork only. T Q 1 North Road, Queenborough, Ensure the artwork has been thoroughly checked for textual accuracy Aesica Development 8. Manufacture API & Finished Dose Kent ME11 5EL UK and has been approved as such. | Font size body text: 8.5pt Pharma code: 1101 Colours: Tech Colours: Black DIE-CUT TECHNICAL (do not print) |
Product name: NEUPRO 1_3MG PAT IPK | |
Creation date: 07/02/2020 DCMF No: N/A | |
Operator: RM Commodity: UCB10674 | |
Ref no: CIB72208B Core spec size: TI013PIL-005–03 – 110×110 CMO Code: 6515627 | |
Revision: 2019_NOV_0087_1 | |
Pages: 28 | |
Amended by: RM Modification date: 19/02/2020 Proof no: 04 |
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Package leaflet: Information for the user
Neupro® 1 mg/24 h transdermal patch
Neupro® 3 mg/24 h transdermal patch
Rotigotine
Read all of this leaflet carefully before you start using 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, 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
1. what neupro is and what it is used for
What Neupro is
Neupro contains the active substance rotigotine.
It belongs to a group of medicines called ‘dopamine agonists’.
Dopamine is a messenger in the brain which is important for movement.
What Neupro is used for
Neupro is used in adults to treat the signs and symptoms of:
-
■ Restless Legs Syndrome (RLS) – this can be associated with discomfort in your legs or arms, urges to move around, sleep disturbance and feeling tired or sleepy during the day. These symptoms are either reduced or their duration is shortened with Neupro treatment.
2. what you need to know before you use neuprodo not use neupro if:■ you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
-
■ you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
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You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium. You can put a new patch on afterwards.
If any of the above apply to you, do not use Neupro. If you are not sure about this, talk to your doctor or pharmacist first.
Warnings and precautions
Talk to your doctor or pharmacist before using Neupro. This is because:
-
■ your blood pressure needs checking regularly while using Neupro, especially at the start of the treatment. Neupro may affect your blood pressure.
-
■ your eyes need checking regularly while using Neupro. If you notice any problems with your eyesight between checks, talk to your doctor straight away.
-
■ if you have serious liver problems , your doctor may need to change the dose. If your liver problems get worse during treatment, talk to your doctor straight away.
-
■ you may get skin problems caused by the patch – see ‘Skin problems caused by the patch’ in section 4.
-
■ you may feel very sleepy or fall asleep suddenly – see ‘Driving and using machines’ in section 2.
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your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and involve other limbs. If you experience such symptoms either before or after beginning treatment with Neupro, contact your doctor as your treatment may need to be adjusted.
Loss of consciousness can occur
Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking
Neupro can cause side effects that change your behaviour (how you act). You may find it helpful to tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information.
Children and adolescents
Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.
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Other medicines and Neupro
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines obtained without
a prescription and herbal medicines.
Do not take the following medicines while using Neupro – because they may decrease its effect:
-
■ ‘anti-psychotic’ medicines – used to treat certain mental illnesses
-
■ metoclopramide – used to treat nausea (feeling sick) and vomiting.
Talk to your doctor before using Neupro if you are taking:
-
■ sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
-
■ medicines that lower blood pressure. Neupro may decrease blood pressure when you stand up – this effect may be worsened by the medicines used to lower blood pressure.
Your doctor will let you know if it is safe to keep taking these medicines while using Neupro.
Neupro with food, drink and alcohol
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body.
You should discuss with your doctor if it is safe for you to drink alcohol
Pregnancy and breast-feeding
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Do not use Neupro if you are pregnant. This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Do not breast-feed during treatment with Neupro. This is because rotigotine may pass into your breast milk and affect your baby. It is also likely to lower the amount of milk you produce.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Neupro may make you feel very sleepy and you may fall asleep very suddenly. If this happens, do not drive. In isolated cases, people have fallen asleep while driving and this has caused accidents.
Also do not use tools or machines if you feel very sleepy – or do anything else which may put others or yourself at risk of serious injury.
Neupro contains sodium metabisulphite (E223)
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
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3. How to use Neupro
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Which strength patches to use
Neupro is available in different strength patches which release the medicine over 24 hours.
The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Legs Syndrome.
-
■ Your starting dose will be one, 1 mg/24 h patch each day.
-
■ From the second week, your daily dose may be increased by 1 mg each week until you get to the right maintenance dose for you. This is when you and your doctor agree that the symptoms are being controlled well enough and the side effects of the medicines are acceptable.
-
■ Please follow the instructions of the prescriber carefully.
-
■ The maximum dose is 3 mg per day.
If you have to stop taking this medicine, see ‘If you stop using Neupro’ in section 3.
How to use the Neupro patches
Neupro is a patch that is put on the skin.
-
■ Make sure that you take the old patch off before putting on a new one.
-
■ Stick the new patch on a different area of the skin each day.
-
■ Leave the patch on your skin for 24 hours, then take it off and put on a new one.
-
■ Change the patches at about the same time every day.
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■ Do not cut the Neupro patches into pieces.
Where to stick the patch
Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:
-
■ Shoulder or upper arm.
-
■ Belly.
-
■ Flank (your side, between the ribs and hips).
-
■ Thigh or hip.
To avoid skin irritation
■ Application sites
-
■ Stick the patch onto a different area of skin each day. For example, put it on the right side of your body one day, then on the left side of your body the next day. Or on your upper body one day, then on your lower body the day after that.
Front Side Back
■ Do not stick Neupro on the same area of skin twice within 14 days.
■ Do not stick the patch on broken or damaged skin – or on skin that is red or irritated.
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If you still get problems with your skin because of the patch, please see ‘Skin problems caused by the patch’ in section 4 for more information.
To prevent the patch becoming loose or falling off
-
■ Do not put the patch in an area where it can be rubbed by tight clothing.
-
■ Do not use creams, oils, lotions, powders or other skin products where you will put the patch. Also do not use them on or near a patch you are already wearing.
-
■ If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days before sticking the patch there.
-
■ If the edges of the patch lift, the patch may be taped down with adhesive medical tape.
If the patch falls off, put on a new patch for the rest of the day – then replace the patch at the usual time.
-
■ Do not let the area of the patch get hot – for example too much sunlight, saunas, hot baths, heating pads or hot-water bottles. This is because the medicine may be released faster. If you think that too much heat has been applied, contact your doctor or pharmacist.
-
■ Always check that the patch has not fallen off after activities such as bathing, showering or exercising.
If the patch has irritated your skin, keep that area protected from direct sunlight. This is because it may change the colour of the skin.
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How to use the patch
-
■ Each patch is packed in a separate sachet.
-
■ Before opening the sachet decide where you are going to stick this new patch and check you have removed any old patch.
-
■ Stick the Neupro patch onto your skin as soon as you have opened the sachet and removed the release liner.
To open the sachet, hold the sachet in both hands.
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The sticky side of the patch is covered ■ Bend the patch in half.
by a transparent release liner. This makes the S-shaped break
■ Hold the patch in both hands with in the liner open up.
the release liner facing you
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Fold back the other half of the patch and remove the other side of the release liner.
-
■ Press the patch down firmly with the palm of your hand.
-
■ Keep it pressed for about 30 seconds.
This makes sure the patch is touching the skin and the edges stick down well.
Wash your hands with soap and water straight after handling the patch.
How to take off a used patch
-
■ Slowly and carefully peel off the used patch.
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-
■ Gently wash the area with warm water and mild soap. This will remove any stickiness that stays on your skin. You can also use a little baby oil to remove any stickiness that will not wash off.
-
■ Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate your skin.
If you use more Neupro than you should
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.
In such cases, contact your doctor or hospital straight away. They will tell you what to do.
If you forget to change the patch at your usual time
-
■ If you have forgotten to change the patch at your usual time, change it as soon as you remember. Take off the old patch and use a new one.
-
■ If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
In both cases, use a new patch at the usual time on the following day.
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If you stop using Neupro
Do not stop using Neupro without talking to your doctor. A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).
If your doctor says you should stop Neupro, the daily dose should be lowered gradually :
-
■ Restless Legs Syndrome – lowered by 1 mg every other day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any side effects.
Side effects more likely at the start of treatment
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are worried about them.
en 15
Skin problems caused by the patch
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■ You may get redness and itching on the skin where the patch has been
– these reactions are usually mild or moderate.
-
■ The reactions normally go away after a few hours – once you remove the patch.
-
■ Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. Also do this if it spreads outside the area of skin that was covered by the patch.
-
■ Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.
-
■ To help avoid the skin reactions, you should put the patch on a different area of skin every day, and only use the same area again after 14 days.
Loss of consciousness can occur
Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. They will discuss ways of managing or reducing symptoms.
INSIDE PAGE -
(all inside pages are unvarnished)
You may find it helpful to also tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour. Neupro can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.
These may include:
-
■ strong impulse to gamble too much – even if this seriously affects you or your family
-
■ altered or increased sexual interest and behaviour which causes significant concern to you or others – for example, an increased sex drive
-
■ uncontrolled shopping or spending too much
-
■ binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Neupro may cause other behaviours and abnormal thinking.
These may include:
■ abnormal thoughts about reality
■ delusions and hallucinations (seeing or hearing things that are not real) confusion
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-
■ aggressive behaviour
-
■ agitation
-
■ delirium.
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. They will discuss ways of managing or reducing symptoms.
Allergic reactions
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, tongue or lips.
Side effects when using Neupro for Restless Legs Syndrome
Tell your doctor or pharmacist if you get any of the following side effects:
Very common: may affect more than 1 in 10 people
-
■ headache
-
■ feeling sick (nausea)
-
■ feeling weak (fatigue)
-
■ skin irritations under the patch such as redness and itching.
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Common: may affect up to 1 in 10 people
-
■ itching
-
■ feeling irritable
-
■ allergic reaction
-
■ increased sex drive
-
■ high blood pressure
-
■ vomiting, heartburn
-
■ swelling of legs and feet
-
■ feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams
-
■ unable to resist the impulse to perform an action that is harmful involving excessive gambling, repetitive meaningless actions, uncontrolled shopping or spending too much
-
■ binge eating (eating large amount of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).
Uncommon: may affect up to 1 in 100 people
-
■ feeling agitated
-
■ feeling dizzy when standing up because of a fall in blood pressure.
Rare: may affect up to 1 in 1,000 people ■ being aggressive
Not known: it is not known how often these happen
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-
■ craving large doses of medicines like Neupro – more than needed for the illness. This is known as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro
-
■ seeing or hearing things that are not real (hallucinations)
-
■ nightmares
-
■ paranoia
-
■ confusion
-
■ psychotic disorders
-
■ delusion
-
■ delirium
-
■ feeling dizzy
-
■ loss of consciousness, involuntary movements (dyskinesia)
-
■ involuntary muscle spasms (convulsion)
-
■ blurry vision
-
■ visual disturbances such as seeing colours or lights
-
■ vertigo (sensation of whirling motion)
-
■ feeling of heartbeat (palpitation)
-
■ abnormal heart rhythm
-
■ low blood pressure
-
■ hiccups
-
■ constipation, dry mouth
-
■ stomach discomfort and pain
-
■ diarrhoea
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-
■ generalised itching, skin irritation
-
■ generalised rash
-
■ unable to achieve or maintain an erection
-
■ weight loss, weight increase
-
■ increased or abnormal liver function test results
-
■ increased heart rate
-
■ increased levels of creatine phosphokinase (CPK)
(CPK is an enzyme found mainly in skeletal muscles)
-
■ falling
-
■ rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems)
Talk to your doctor or pharmacist if you notice any of the side effects
listed above.
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:
United Kingdom
Yellow Card Scheme – Website: or search for
MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website:
By reporting side effects you can help provide more information on the
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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and box.
Do not store above 30°C.
What to do with the used and unused patches
-
■ Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then throw it away safely, out of the reach of children.
-
■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat neupro containsthe active substance is rotigotine.
-
■ 1 mg/24 h:
Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm contains 2.25 mg of rotigotine.
-
■ 3 mg/24 h:
Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm2 contains 6.75 mg of rotigotine.
The other ingredients are:
-
■ Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-a-tocopherol (E307).
-
■ Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
-
■ Release liner: Transparent fluoropolymer coated polyester film.
What Neupro looks like and contents of the pack
Neupro is a transdermal patch. It is thin and has three layers. It is square-shaped with rounded edges. The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h or 3 mg/24 h.
Neupro is available in the following pack-sizes:
Boxes containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Not all pack sizes may be marketed.
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The sticky side of the patch is covered ■ Bend the patch in half.
by a transparent release liner. This makes the S-shaped break
■ Hold the patch in both hands with in the liner open up.
the release liner facing you
INSIDE PAGE -
(all inside pages are unvarnished)
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(all inside pages are unvarnished)
Fold back the other half of the patch and remove the other side of the release liner.
-
■ Press the patch down firmly with the palm of your hand.
-
■ Keep it pressed for about 30 seconds.
This makes sure the patch is touching the skin and the edges stick down well.
Wash your hands with soap and water straight after handling the patch.
How to take off a used patch
-
■ Slowly and carefully peel off the used patch.
INSIDE PAGE -
(all inside pages are unvarnished)
-
■ Gently wash the area with warm water and mild soap. This will remove any stickiness that stays on your skin. You can also use a little baby oil to remove any stickiness that will not wash off.
-
■ Do not use alcohol or other dissolving liquids – such as nail polish remover. These may irritate your skin.
If you use more Neupro than you should
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.
In such cases, contact your doctor or hospital straight away. They will tell you what to do.
If you forget to change the patch at your usual time
-
■ If you have forgotten to change the patch at your usual time, change it as soon as you remember. Take off the old patch and use a new one.
-
■ If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
In both cases, use a new patch at the usual time on the following day.
INSIDE PAGE -
(all inside pages are unvarnished)
If you stop using Neupro
Do not stop using Neupro without talking to your doctor. A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome’ which could be life-threatening. The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).
If your doctor says you should stop Neupro, the daily dose should be lowered gradually :
-
■ Restless Legs Syndrome – lowered by 1 mg every other day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any side effects.
Side effects more likely at the start of treatment
You may feel sick (nausea) and vomit at the start of treatment. These effects are usually mild or moderate and only last for a short time. Talk to your doctor if they last for a long time or if you are worried about them.
en 15
Skin problems caused by the patch
INSIDE PAGE -
(all inside pages are unvarnished)
■ You may get redness and itching on the skin where the patch has been
– these reactions are usually mild or moderate.
-
■ The reactions normally go away after a few hours – once you remove the patch.
-
■ Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe. Also do this if it spreads outside the area of skin that was covered by the patch.
-
■ Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.
-
■ To help avoid the skin reactions, you should put the patch on a different area of skin every day, and only use the same area again after 14 days.
Loss of consciousness can occur
Neupro can cause loss of consciousness. This can happen especially when you start using Neupro or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy.
Changes in behaviour and abnormal thinking
Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below. They will discuss ways of managing or reducing symptoms.
INSIDE PAGE -
(all inside pages are unvarnished)
You may find it helpful to also tell a member of your family or carer that you are using this medicine and ask them to read this leaflet. This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour. Neupro can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.
These may include:
-
■ strong impulse to gamble too much – even if this seriously affects you or your family
-
■ altered or increased sexual interest and behaviour which causes significant concern to you or others – for example, an increased sex drive
-
■ uncontrolled shopping or spending too much
-
■ binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Neupro may cause other behaviours and abnormal thinking.
These may include:
■ abnormal thoughts about reality
■ delusions and hallucinations (seeing or hearing things that are not real) confusion
INSIDE PAGE -
(all inside pages are unvarnished)
-
■ aggressive behaviour
-
■ agitation
-
■ delirium.
Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above. They will discuss ways of managing or reducing symptoms.
Allergic reactions
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, tongue or lips.
Side effects when using Neupro for Restless Legs Syndrome
Tell your doctor or pharmacist if you get any of the following side effects:
Very common: may affect more than 1 in 10 people
-
■ headache
-
■ feeling sick (nausea)
-
■ feeling weak (fatigue)
-
■ skin irritations under the patch such as redness and itching.
INSIDE PAGE –
(all inside pages are unvarnished)
Common: may affect up to 1 in 10 people
-
■ itching
-
■ feeling irritable
-
■ allergic reaction
-
■ increased sex drive
-
■ high blood pressure
-
■ vomiting, heartburn
-
■ swelling of legs and feet
-
■ feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams
-
■ unable to resist the impulse to perform an action that is harmful involving excessive gambling, repetitive meaningless actions, uncontrolled shopping or spending too much
-
■ binge eating (eating large amount of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).
Uncommon: may affect up to 1 in 100 people
-
■ feeling agitated
-
■ feeling dizzy when standing up because of a fall in blood pressure.
Rare: may affect up to 1 in 1,000 people ■ being aggressive
Not known: it is not known how often these happen
INSIDE PAGE -
(all inside pages are unvarnished)
-
■ craving large doses of medicines like Neupro – more than needed for the illness. This is known as ‘dopamine dysregulation syndrome’ and can lead to use of too much Neupro
-
■ seeing or hearing things that are not real (hallucinations)
-
■ nightmares
-
■ paranoia
-
■ confusion
-
■ psychotic disorders
-
■ delusion
-
■ delirium
-
■ feeling dizzy
-
■ loss of consciousness, involuntary movements (dyskinesia)
-
■ involuntary muscle spasms (convulsion)
-
■ blurry vision
-
■ visual disturbances such as seeing colours or lights
-
■ vertigo (sensation of whirling motion)
-
■ feeling of heartbeat (palpitation)
-
■ abnormal heart rhythm
-
■ low blood pressure
-
■ hiccups
-
■ constipation, dry mouth
-
■ stomach discomfort and pain
-
■ diarrhoea
INSIDE PAGE -
(all inside pages are unvarnished)
-
■ generalised itching, skin irritation
-
■ generalised rash
-
■ unable to achieve or maintain an erection
-
■ weight loss, weight increase
-
■ increased or abnormal liver function test results
-
■ increased heart rate
-
■ increased levels of creatine phosphokinase (CPK)
(CPK is an enzyme found mainly in skeletal muscles)
-
■ falling
-
■ rhabdomyolysis (a rare severe muscle disorder which causes pain, tenderness and weakness of the muscles and may lead to kidney problems)
Talk to your doctor or pharmacist if you notice any of the side effects
listed above.
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:
United Kingdom
Yellow Card Scheme – Website: or search for
MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website:
By reporting side effects you can help provide more information on the
INSIDE PAGE -
(all inside pages are unvarnished)
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and box.
Do not store above 30°C.
What to do with the used and unused patches
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■ Used patches still contain the active substance ‘rotigotine’, which may be harmful to others. Fold the used patch with the sticky side inwards. Put the patch in the original sachet and then throw it away safely, out of the reach of children.
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■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat neupro containsthe active substance is rotigotine.
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■ 1 mg/24 h:
Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm contains 2.25 mg of rotigotine.
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■ 3 mg/24 h:
Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm2 contains 6.75 mg of rotigotine.
The other ingredients are:
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■ Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-a-tocopherol (E307).
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■ Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
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■ Release liner: Transparent fluoropolymer coated polyester film.