Leganto
rotigotine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist or nurse.
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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Leganto is and what it is used for
What you need to know before you use Leganto
How to use Leganto
Possible side effects
How to store Leganto
Contents of the pack and other information
Medicinal product no longer authorised
Leganto 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.
Leganto is used in adults to treat the signs and symptoms of:
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)
you need ‘cardioversion’ (specific treatment for abnormal heart beat). –
You must take your Leganto 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 Leganto. If you are not sure about this, talk to your doctor or pharmacist first or nurse.
Talk to your doctor or pharmacist or nurse before using Leganto. This is because:
your blood pressure needs checking regularly while using Leganto, especially at the start of the treatment. Leganto may affect your blood pressure.
your eyes need checking regularly while using Leganto. 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.
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 Leganto, contact your doctor as your treatment may need to be adjusted.
Medicines used to treat Restless Legs Syndrome should be reduced or stopped gradually. Tell your doctor if after stopping or reducing your Leganto treatment you experience symptoms such as depression, anxiety, fatigue, sweating or pain.
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy.
Medicinal product no longer authorised
Leganto 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. Tell your doctor if you or your family/carer notices you are using the drug excessively or developing craving for large doses of Leganto or other medicines used to treat Restless Legs Syndrome.
See ‘Changes to your behaviour and abnormal thinking’ in section 4 for more information.
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.
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 Leganto, – 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 Leganto if you are taking:
sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
medicines that lower blood pressure. Leganto 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 Leganto.
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 while using Leganto.
Do not use Leganto 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 Leganto. 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.
Leganto 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.
Medicinal product no longer authorised
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Leganto 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 Leg 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 Leganto’ in section 3.
Leganto 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.
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.
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.
Do not stick Leganto on the same area of skin twice
Do not stick the patch on broken or damaged skin – or on skin that is red or irritated.
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
Medicinal product no longer authorised
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.
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 Leganto 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.
Peel apart the foil.
Open the sachet.
Medicinal product no longer authorised
Take the patch out of the sachet.
The sticky side of the patch is covered by a transparent release liner.
Hold the patch in both hands with the release liner facing you.
Bend the patch in half. This makes the S-shaped break in the liner open up.
Peel off one side of the release liner.
Do not touch the sticky side of the patch with your fingers.
Hold the other half of the rigid release liner.
Then put the sticky half of the patch onto your skin.
Press the sticky side of the patch firmly into place.
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.
Medicinal product no longer authorised
Wash your hands with soap and water straight after handling the patch.
Slowly and carefully peel off the used patch.
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.
Using higher doses of Leganto 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 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. Do not use a double dose to make up for a forgotten dose.
Do not stop using Leganto 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 Leganto,the daily dose should be lowered gradually:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist or nurse if you notice any side effects.
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.
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.
Medicinal product no longer authorised
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.
Leganto can cause loss of consciousness. This can happen especially when you start using Leganto or when your dose is increased. Tell your doctor if you lose consciousness or feel dizzy.
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. Leganto 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).
Leganto 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
disorientation
aggressive behaviour
agitation
delirium.
Contact your doctor if you notice signs of an allergic reaction – these can include swelling of the face, tongue or lips.
Tell your doctor or pharmacist if you notice any of the following side effects:
headache
feeling sick (nausea)
feeling weak (fatigue)
skin irritations under the patch such as redness and itching
itching
feeling irritable
allergic reaction
Medicinal product no longer authorised
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)
feeling agitated
feeling dizzy when standing up because of a fall in blood pressure
being aggressive
disorientation
craving large doses of medicines like Leganto – more than needed for the illness. This is known as ‘dopamine dysregulation syndrome’ and can lead to use of too much Leganto
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
redness, increased sweating
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
Medicinal product no longer authorised
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.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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.
The active substance is rotigotine.
1 mg/24 h:
Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm2 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-α-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.
Leganto 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 Leganto 1 mg/24 h or 3 mg/24 h.
Leganto is available in the following pack-sizes:
Medicinal product no longer authorised
Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Not all pack sizes may be marketed.
UCB Pharma S.A.
Allée de la Recherche 60 B-1070 Bruxelles Belgium
UCB Manufacturing Ireland Ltd. Shannon, Industrial Estate,
Co. Clare, Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UCB Pharma Oy Finland
Tel: +358-92 514 4221 (Suomija)
Ю СИ БИ България ЕООД
Teл.: +359-(0)2 962 30 49
UCB s.r.o.
Tel: +420-221 773 411
UCB Magyarország Kft. Tel.: +36-(1) 391 0060
UCB Nordic A/S
Tlf: +45-32 46 24 00
Pharmasud Ltd.
Tel: +356-21 37 64 36
Bayer Vital GmbH
Tel: +49-(0)214-30 513 48
UCB Pharma B.V.
Tel.: +31-(0)76-573 11 40
UCB Pharma Oy Finland
Tel: +358-92 514 4221 (Soome)
UCB Nordic A/S
Tlf: +45-32 46 24 00
UCB Α.Ε.
Τηλ: +30-2109974000
UCB Pharma GmbH Tel: +43-(0)1 291 80 00
UCB Pharma S.A.
Tel: +34-91 570 34 44
UCB Pharma Sp. z o.o. Tel.: +48-22 696 99 20
UCB Pharma S.A.
Medicinal product no longer authorised
Tél: +33-(0)1 47 29 44 35
BIAL-Portela & Cª, S.A. Tel: +351-22 986 61 00
Medis Adria d.o.o.
Tel: +385-(0)1 230 34 46
UCB Pharma România S.R.L. Tel: +40-21 300 29 04
UCB (Pharma) Ireland Ltd. Tel: +353-(0)1 46 37 395
Medis, d.o.o.
Tel: +386-1 589 69 00
Vistor hf.
Sími: +354-535 7000
UCB s.r.o., organizačná zložka Tel: +421-(0)2 5920 2020
UCB Pharma S.p.A. Tel: +39-02 300 791
UCB Pharma Oy Finland Puh/Tel: +358-92 514 4221
Lifepharma (Z.A.M.) Ltd Τηλ: +357-22 05 63 00
UCB Nordic A/S
Tel: +46-(0)40 29 49 00
UCB Pharma Oy Finland
Tel: +358-92 514 4221 (Somija)
UCB Pharma Ltd.
Tel : +44-(0)1753 534 655
Medicinal product no longer authorised