Neupro 3 mg/24 h transdermal patch Rotigotine - United Kingdom[英国药品]

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Neupro 3 mg/24 h transdermal patch Rotigotine

2014-08-01 20:37:40 来源: 作者: 【大中小】浏览:306次评论:0条

For doctors

What is it and how is it used?

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

Neupro is used to treat:

What do you have to consider before using it?

Do not use Neupro

Take special care with Neupro

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 Neupro, 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 Neupro 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:

Using Neupro 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 Neupro.

Pregnancy and breast-feeding

You should not use Neupro 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 Neupro. 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

Neupro 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 Neupro

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

How is it used?

Dose

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

Neupro 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 Neupro patch once a day. For reaching the needed doses, different patches of Neupro 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 Neupro 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 Neupro‘.

FOLLOW THESE INSTRUCTIONS WHEN USING NEUPRO:

You should stick a new Neupro 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 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 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:

To prevent the patch becoming loose or falling off

NOTE

How to use the patch

Each patch is packed in a separate sachet. You should stick Neupro 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.

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 Neupro than you should

Using higher doses of Neupro 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 your doctor 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 Neupro

Do not stop using Neupro 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 Neupro should be reduced gradually

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

What are possible side effects?

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

You may experience nausea (feeling sick) and vomiting at 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 Neupro for Restless Legs Syndrome the following side effects may occur:

Very common side effects

Common side effects

Uncommon side effects

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.

How should it be stored?

Keep out of the reach and sight of children.
Do not use Neupro 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.

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For doctors

What is it?

Neupro is a range of transdermal patches (patches that deliver a medicine across the skin). Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.

What is it used for?

Neupro is used to treat the symptoms of the following diseases in adults:

Parkinsons disease. Neupro is used on its own in early-stage disease, or in combination with levodopa another medicine used in Parkinsons disease at any stage of the disease, including the later stages when levodopa starts becoming less effective

moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Neupro is used when a specific cause for the disorder cannot be identified.

The medicine can only be obtained with a prescription.

How is it used?

Neupro is applied once a day at about the same time every day. The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm. The patch remains on the skin for 24 hours and is then replaced by a new one in a different place. The same place must not be used again until two weeks later. The strength of patch to use at the start of treatment depends on the type and stage of the disease being treated. The dose can then be increased every week until an effective dose is reached. A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson’s disease. The maximum dose is 8 mg/24 h for early-stage Parkinson’s disease and 16 mg/24 h for advanced disease. For restless legs syndrome, the maximum dose is 3 mg/24 h.

How does it work?

The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine. Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination. In patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Neupro delivers a constant supply of rotigotine through the skin into the bloodstream. Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s disease, such as stiffness and slowness of movement. The way rotigotine works in restless legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.

How has it been studied?

In Parkinson’s disease, Neupro has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease. Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease). The studies in early-stage disease looked at the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire. The studies in advanced disease measured the length of time during the day that the patients recorded as ‘off’ (when they had too many Parkinson’s disease symptoms to be able to live normally). In moderate to severe restless legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients. The main measure of effectiveness was the change in symptoms between the start of the study and after six months of treatment with a stable dose, measured using two standard scales.

What benefits has it shown during the studies?

Neupro was more effective than placebo in treating Parkinson’s disease. In early-stage disease, 48 to 52% of the patients using Neupro had an improvement in symptoms, compared with 19 to 30% of those using placebo. Neupro was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole. In advanced Parkinson’s disease, patients using Neupro had a greater decrease in their ‘off’ time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo). The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).

In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.

What is the risk associated?

The most common side effects with Neupro in patients with Parkinson’s disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin. In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, asthenic conditions (conditions such as tiredness, weakness and feeling unwell) and headache. It is important to use the patch as instructed to limit skin reactions. Somnolence can affect the ability of the patient to drive. For the full list of all side effects reported with Neupro, see the package leaflet.

Neupro should not be used in people who may be hypersensitive (allergic) to rotigotine or any of the other ingredients. The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart’s normal rhythm).

Why has it been approved?

The CHMP decided that Neupro’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Neupro to Schwarz Pharma Ltd. on 15 February 2006. After five years, the marketing authorisation was renewed for a further five years. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Neupro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2010.

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Name

Neupro 3 mg/24 h transdermal patch

Composition

Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm contains 6.75 mg of rotigotine.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Transdermal patch.
Thin, matrix-type, square-shaped with rounded edges, consisting of three layers. The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 3 mg/24 h’.

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