Leganto 3 mg/24 h transdermal patch

Leganto belongs to a group of medicines called dopamine agonists which stimulate a certain type of cells that bind with dopamine receptors in the brain.

Leganto is used to treat:

• the signs and symptoms of Restless Legs Syndrome (RLS), a condition that is characterized by an irresistible urge to move the legs..

Do not use Leganto

• if you are allergic (hypersensitive) to rotigotine or any of the other ingredients of Leganto (see Section 6, ?Further information?).
• if you need to have magnetic resonance imaging (method to visualise internal organs and tissues of the body) or cardioversion (treatment of abnormal heart rhythm). You must take your Leganto patch off before such procedures. You can put a new patch on after the procedure.

Take special care with Leganto

• This medicine may affect your blood pressure, so it should be measured regularly, especially at the beginning of your treatment.
• Eye examinations are recommended at regular intervals while using Leganto. However, if you notice any problems with your sight in-between examinations, you should contact your doctor immediately.
• If you have serious liver problems, your doctor may need to adjust the dose. If during treatment your liver problems get worse, you should contact your doctor as soon as possible.

• If you feel very drowsy or find that you fall asleep suddenly, please contact your doctor (see also below in this section, under ?Driving and using machines?).
• As with other medicines in this class, Leganto may cause excessive gambling and increased sex drive. If you notice such effects, please contact your doctor.
• Leganto may cause hallucinations (seeing or hearing things that are not real). If you notice such effects, please contact your doctor.
• You may experience that symptoms of Restless Legs Syndrome start earlier than usual, be more intense and involve other limbs.
• As with every patch or bandage, Leganto can cause skin reactions, such as reddening and itching. They are usually mild or moderate, and only affect the area of skin the patch has been on. The reactions normally disappear after a few hours when you remove the patch. If you have a skin reaction which lasts for more than a few days, is severe, or spreads outside the area of skin that was covered by the patch, please contact your doctor. Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by Leganto. To help avoid the skin reactions, you should put the patch on a different area ofskin every day, and only use the same area again after 14 days.
• Leganto should not be used by children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not take the following medicines while using Leganto, because they may decrease its effect: anti-psychotics (used to treat certain mental conditions) or metoclopramide (used to treat nausea and vomiting).

If you are treated with Leganto and levodopa at the same time, some side effects may get more serious, such as seeing or hearing things that are not real (hallucinations), involuntary movements related to Parkinson?s disease (dyskinesia), and swelling of legs and feet.

Please ask your doctor whether it is safe for you to:

• drink alcohol or
• take sedating medicines (for example benzodiazepines, medicines used to treat mental conditions or depression) while you are using Leganto.

Using Leganto with food and drink

Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine works. You should discuss with your doctor if it is safe for you to drink alcohol while using Leganto.

Pregnancy and breast-feeding

You should not use Leganto if you are pregnant, as the effects of rotigotine on pregnancy and the unborn baby are not known. Tell your doctor if you are pregnant or planning to become pregnant.

Breast-feeding is not recommended during treatment with Leganto. Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Leganto may make you feel very drowsy, and you may fall asleep very suddenly. If this affects you, you should not drive or take part in activities where not being alert may put you or others at risk of serious injury, for example, using machines.
In isolated cases people have fallen asleep while driving and this has caused accidents.

Important information about some of the ingredients of Leganto

Leganto contains sodium metabisulphite (E223), a substance that may rarely cause severe hypersensitivity reactions and bronchospasm.

Dose

Always use Leganto exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Leganto is generally used as a long term treatment. Normally, you will start your treatment with a low dose and, if necessary, increase it week by week, as told by your doctor, until reaching the right dose for you. You will then continue treatment with this dose, also called the maintenance dose.

You should change your Leganto patch once a day. For reaching the needed doses, different patches of Leganto are available, each releasing a different amount of the active substance per day: 1 mg/24 h, 2 mg/24h and 3 mg/24 h.

Treatment of Restless Legs Syndrome
You will start by using one Leganto 1 mg/24 h patch daily. If necessary, this daily dose may be increased by 1 mg, on a weekly basis, until reaching the right (maintenance) dose for you. The maximum dose is 3 mg per day.

If you have to stop taking this medicine, see Section 3, ?If you stop using Leganto?.

FOLLOW THESE INSTRUCTIONS WHEN USING LEGANTO:

You should stick a new Leganto patch onto the skin once a day. Leave the patch on your skin for 24 hours, then remove it and apply a new one. Make sure that you take the old patch off before applying a new one; place the new patch on a different area of skin.
You should change your patch at around the same time every day.
Do not cut the Leganto 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 indicated by the grey areas in the picture shoulder upper arm belly thigh hip flank your side, between your ribs and your hip.

To help avoid skin irritation:

• Stick the patch onto a different area of skin each day, for example on the right side of your body one day, then on the left side the next day; on your upper body one day, then on your lower body.
• Do not stick Leganto 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. If you still get problems with your skin because of the patch, please see in Section 4 ?Possible side effects? the details about what you should do.

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 on the area of skin you will be sticking the patch 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 daysbefore sticking the patch there. If the patch falls off, a new patch should be applied for the rest of the day, then replace the patch at the same time as usual.

NOTE

• Bathing, showering and exercising should not affect how Leganto works. Nevertheless, check that the patch has not fallen off afterwards.
• You should avoid external heat (for example excessive sunlight, saunas, hot baths heating pads or hot-water bottles) on the area of the patch.
• If the patch has irritated your skin, you should keep that area protected from direct sunlight, as it may cause changes in the colour of the skin.

How to use the patch

Each patch is packed in a separate sachet. You should stick Leganto onto your skin as soon as you have opened the sachet and removed the protective liner.

1. To open the sachet, hold the two sides of the sachet. Peel apart the foil and open the sachet. 2. Take the patch out of the sachet. 3. The sticky side of the patch is covered by a transparent protective liner. Hold the patch in both hands with the protective liner facing you.

4. Bend the patch in half so that the S-shaped break in the liner opens. 5. Peel off one side of the protective liner. Dont touch the sticky side of the patch with your fingers. 6. Hold the other half of the rigid protective liner and put the sticky surface of the patch onto your skin. Press the sticky side of the patch firmly into place. 7. Fold back the other half of the patch and remove the other side of the protective liner. 8. Press the patch down firmly with the palm of your hand for about 20 to 30 seconds to make sure the patch is touching the skin and the edges stick well.

Wash your hands with soap and water immediately after handling the patch.

How to remove a used patch

Slowly and carefully peel off the used patch.

Gently washing the area with warm water and mild soap should remove any adhesive that stays on your skin after you remove the patch. You can also use a small amount of baby oil to remove any adhesive that won?t wash off.
Do not use alcohol or other dissolving liquids such as nail polish remover as these may irritate your skin.
Choose a new area of skin where you will apply a new patch, then follow the instructions above.

If you use more Leganto than you should

Using higher doses of Leganto than your doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion or extreme sleepiness.
If you have used more patches than your doctor told you to, remove the extra patches and contact yourdoctor or hospital for advice immediately.

If you have forgotten to change the patch at the usual time

If you have forgotten to change the patch at your usual time, change it as soon as you remember: remove 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, on the following day you should use a new patch at the usual time. Do not use a double dose to make up for a forgotten dose.

If you stop using Leganto

Do not stop using Leganto suddenly without talking to your doctor. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma).
Your daily dose of Leganto should be reduced gradually

• by 1 mg every other day - if you use Leganto for Restless Legs Syndrome

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Leganto can cause side effects, although not everybody gets them.

You may experience nausea (feeling sick) and vomitingat the beginning of treatment. These effects are usually mild or moderate and only last for a short time. You should contact your doctor if they last for a long time or if you worry about them.

Skin problems caused by the patch

You may get skin reactions from the patch such as redness, itching. They are usually mild or moderate and only affect the area of skin the patch has been on. The reactions normally disappear after a few hours when you remove the patch.
If you have a skin reaction that lasts longer than a few days, is severe, or spreads outside the area of skin that was covered by the patch, you should contact your doctor.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)

If you are using Leganto for Restless Legs Syndrome the following side effects may occur:

Very common side effects

• feeling sick (nausea)
• skin irritations under the patch such as redness and itching
• weakness (fatigue)
• headache

Common side effects

• vomiting, heartburn
• irritability
• allergic reaction
• sleepiness, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams
• increased sex drive
• itching
• high blood pressure

Uncommon side effects

• inability to resist the impulse to perform an action that is harmful involving excessive gambling and repetitive meaningless actions
• feeling dizzy when standing up because of a fall in blood pressure
• unwanted and uncontrolled thoughts and behaviors

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use Leganto after the expiry date which is stated on the label and carton.
Store in a refrigerator (2°C ? 8°C).

What to do with the used and unused patches

Used patches still contain active substance, 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines not longer required. These measures will help to protect the environment.

What Leganto contains

• The active substance is rotigotine. Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm 2 contains 6.75 mg of rotigotine.
• The other ingredients are poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-?-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). Protective liner: Transparent fluoropolymer coated polyester film.

What Leganto looks like and contents of pack

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 3 mg/24 h.

Leganto is available in the following pack-sizes:
Cartons containing 7, 20, 28, 30, 56, 60, 84 (2x42), 90 or 100 (2x50) patches, which are individually sealed in sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

SCHWARZ PHARMA Ltd.
Shannon, Industrial Estate,
Co. Clare, Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien UCB Pharma SA NV TelTél 32 02 559 92 00 LuxembourgLuxemburg UCB Pharma SANV TélTel 32 02 559 92 00

Te. 359 0 2 962 30 49 Magyarország UCB Magyarország Kft. Tel. 36-1 391 0060

eská republika UCB s.r.o. Tel 420 221 773 411 Malta Pharmasud Ltd. Tel 356 21 37 64 36

Danmark UCB Nordic AS Tlf 45 32 46 24 00 Nederland UCB Pharma B.V. Tel. 31 076-573 11 40

Deutschland Bayer Vital GmbH Tel 49 0214-30 513 48 Norge UCB Nordic AS Tlf 45 32 46 24 00

Eesti UCB Pharma Oy Finland Tel 358 10 234 6800 Soome Österreich UCB Pharma GmbH Tel 43 1 291 80 00

UCB .. 30 2109974000 Polska UCB Pharma Sp. z o.o. Tel. 48 22 696 99 20

España UCB Pharma, S.A. Tel 34 91 570 34 44 Portugal UCB Pharma Produtos Farmacêuticos, Lda Tel 351 21 302 5300

France UCB Pharma S.A. Tél 33 01 47 29 44 35 România UCB Pharma România S.R.L. Tel 40 21 300 29 04

Ireland UCB Pharma Ireland Ltd. Tel 353 01-46 37 395 Slovenija Medis, d.o.o. Tel 386 1 589 69 00

Ísland Vistor hf. Tel 354 535 7000 Slovenská republika UCB s.r.o., organizaná zloka Tel 421 0 2 5920 2020

Italia UCB Pharma S.p.A. Tel 39 02 300 791 SuomiFinland UCB Pharma Oy Finland PuhTel 358 10 234 6800

Lifepharma Z.A.M. Ltd 357 22 34 74 40 Sverige UCB Nordic AS Tel 46 0 40 29 49 00

Latvija UCB Pharma Oy Finland Tel 358 10 234 6800 Somija United Kingdom UCB Pharma Ltd. Tel 44 01753 534 655

Lietuva
UCB Pharma Oy Finland
Tel: + 358 10 234 6800 (Suomija)

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