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What Neupro is and what it is used for
Neupro belongs to a group of medicines called dopamine agonists that stimulate a certain type of dopamine receptor in the brain.
Neupro is used to treat:
manifestations and symptoms of Restless Legs Syndrome, a condition characterized by an irresistible need for foot movement;
manifestations and symptoms of Parkinson's disease as monotherapy or in combination with a medicine called levodopa.
2. What you need to know before using Neupro
Do not use Neupro:
if you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6);
if you need magnetic resonance imaging (a method of displaying internal organs and body tissues) or cardioversion (treatment of heart rhythm disturbances). Before such procedures, you should remove the patch. After the end of the procedures, you can paste a new patch.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Neupro:
This medicine can affect blood pressure, so it should be measured regularly, especially at the beginning of treatment;
Regular eye examinations are recommended when administering Neupro. If you notice a visual disturbance between your examinations, tell your doctor immediately.
If you have severe liver damage, your doctor may adjust the dose. Tell your doctor immediately if liver problems get worse;
If you feel extremely sleepy or notice that you fall asleep suddenly, please tell your doctor (see also "Driving and using machines");
Tell your doctor if you or your family / caregiver notice that you are getting the urge or urgency to behave in a way unusual for you and you can not resist the impulse, the urge, or the temptation to do certain activities that could harm to you or others. This is called impulse control disorder, and can include behavior such as gambling addiction, excessive eating or spending, unusually intense sexual desire, or compulsive sexual thoughts or imaginations. Your doctor may need to adjust your dose or stop treatment;
Neupro can cause pathological thinking and behavior. This pathological thinking and behavior can include one or more different manifestations, including unusual thoughts about reality, hallucinations (seeing or hearing non-existent things), confusion, disorientation, aggressive behavior, excitement and delirium. Tell your doctor if you notice such effects;
You may feel that the symptoms of Restless Legs Syndrome start earlier than usual, be more intense and include the hands;
Like any patch or bandage, Neupro can cause skin reactions such as redness and itching. They are usually mild or moderate and only affect the area of the skin on which the patch is attached. Tell your doctor if the skin reaction lasts for more than a few days and is severe or spreading outside the area of the skin where the patch has been stuck. Avoid exposure to sunlight or sunburn on areas of the skin that indicate a reaction caused by Neupro. To avoid skin reactions, it is recommended that you stick the patch to a different place every other day. Do not stick a patch again on the same place within the next 14 days;
Neupro should not be used in children because its safety and efficacy have not been studied in children.
Using other medicines and Neupro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take the following medicines while you are taking Neupro because it may reduce its effect: antipsychotics (used to treat certain mental conditions) or metoclopramide (used to treat nausea and vomiting).
If you take Neupro and levodopa at the same time, some side effects may become more serious, such as seeing or hearing unreal things (hallucinations), involuntary movements associated with Parkinson's disease (dyskinesia) and swelling of the feet and feet.
Please ask your doctor if it is safe to:
you use alcohol;
take sedative medicines (eg benzodiazepine, medicines to treat mental disorders and depression) while using Neupro.
Neupro with food, drinks and alcohol
As rotigotine enters the bloodstream through the skin, the intake of food and drink does not affect the way the medicine works. Please ask your doctor whether it is safe to drink alcohol while you are being treated with Neupro.
Pregnancy, breastfeeding and fertility
You should not use Neupro during pregnancy because there is no data on the effects of rotigotine on pregnancy or the unborn child. Breast-feeding is not recommended during treatment with Neupro. Rotigotine may pass into breast milk and may affect your baby as well as may reduce the amount of breast milk. If you are breastfeeding
Driving and using machines
Neupro may be asleep or fall asleep suddenly. If you have such a sensation, you should not drive or engage in activities where wakefulness may create a threat of serious injury to you or others, such as operating machinery.
There are isolated cases of people sleeping while driving, which has caused road accidents.
Neupro contains sodium metabisulphite (E223)
Sodium metabisulphite (E223) may rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to use Neupro
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Neupro is mainly used for long-term treatment. Usually you will begin a low-dose regimen, and if necessary, your doctor or pharmacist will increase it each week until the appropriate dose is reached. You will continue to be treated with this so-called maintenance dose.
Replace the Neupro patch once a day. To reach the required doses, there are different Neupro patches releasing a different amount of active substance per day: 1 mg / 24 h, 2 mg / 24 h, 3 mg / 24 h, 4 mg / 24 h, 6 mg / 24 h and 8 mg / 24 h. For multiple doses, several patches, e.g. a dose of 10 mg can be achieved by sticking a patch of 6 mg / 24 h and a patch of 4 mg / 24 h.
Treatment of Restless Legs Syndrome
At the beginning of treatment you will start using Neupro 1 mg / 24 h every day. If necessary, the daily dose may be increased by 1 mg per week until you reach the appropriate (maintenance) dose. The maximum dose is 3 mg per day.
Treatment of Parkinson's Disease
Patients not taking levodopa (an early stage of Parkinson's disease)
You will start using a Neupro 2 mg / 24 h daily patch. Next week, this dose will be increased by 2 mg / 24 hrs per week until the right (maintenance) dose is reached. For most patients, this dose is between 6 mg and 8 mg daily (reaching for 3 to 4 weeks). The maximum dose is 8 mg daily.
Patients taking levodopa (advanced stage of Parkinson's disease)
You will start using a Neupro 4 mg / 24 h daily patch. Next week, this dose will be increased by 2 mg per week until the right (maintenance) dose is reached. For most patients this dose is between 8 mg and 16 mg per day (reaching for 3 to 4 weeks). The maximum dose is 16 mg daily.
If you need to stop taking the medicine, see section 3 "If you stop using Neupro".
Observe the following instructions when using Neupro:
Neupro is for transdermal use, a patch for placing on the skin.
Apply a new Neupro patch once a day to the skin. The patch should remain stuck for 24 hours and then replaced with a new one. Make sure that you remove the old patch before you paste the new patch by placing the new patch in a different place.
Replace patches at approximately the same time each day. Patches should not be cut into pieces.
Where to stick the patch
Place the patch with the adhesive surface on clean, dry and healthy skin in one of the following areas, indicated in gray in the diagram:
hip (place between ribs and hips).
To avoid irritation of the skin:
Stick the patch every day to a different place on the skin (for example, one day on the right side, the next on the left, one day in the upper half of the body, then the lower one);
Do not stick Neupro again over the same place in the next 14 days;
Do not stick the patch on injured or damaged skin or if it is red or irritated.
If you still have skin problems due to the patch, please read section 4 "Possible side effects" for more detailed information.
To avoid peeling or dropping the patch:
Do not stick the patch in areas where it will rub in tight clothing;
Do not use creams, oils, lotions, powders or other skin products in the area where you plan to stick the patch or near the already glued;
If you need to stick the patch to a hairy area of the skin, you need to shave them at least 3 days in advance.
If the patch falls, a new patch must be added for the rest of the day. Perform the next patch change at the usual time.
Bathing, taking a shower or doing sports should not change the effect of Neupro. However, check that the patch has not fallen afterwards;
Avoid external heat (eg exposure to strong sun rays, sauna, hot bath, electric pillows or gaiters) in the area of the patch;
If the patch has irritated your skin, you must protect the affected area from direct sunlight as they may cause a change in skin color.
How To Use Patches
Each patch is sealed in a separate sachet. Glue Neupro to the skin as soon as you open the sachet and remove the release layer.
1. Open the sachet by holding it on both ends. Unzip the foil and open the sachet.
2. Remove the patch from the sachet.
3. The adhesive surface of the patch is covered with a transparent release layer. Grab the two-handed patch with the transparent release layer facing you.
4. Bend the patch through the middle so as to dissolve the S-shaped slot of the layer.
5. Peel one half of the release layer. Do not touch the adhesive surface with your fingers.
6. Hold the patch for the other half of the release layer and place the adhesive surface on the skin. Press firmly the adhesive on the patch.
7. Bend back the other half of the patch and remove the second half of the release layer.
8. Press the patch strongly for 20-30 seconds to make sure the patch sticks to the skin well with all its surface and edges.
Wash your hands with soap and water immediately after placing the patch.
How to Remove the Used Pattern
Slowly and gently peel the used patch.
Careful washing of the area with warm water and soft soap should remove the remaining glue on the skin after removing the patch. You can use a small amount of baby oil to clean the residue of the glue that has not been washed.
Do not use alcohol or other solvents (such as varnish) as they can irritate your skin.
Choose a new place on the skin to place the new patch, following the above instructions.
If you use more Neupro than you should
Taking higher doses of Neupro than prescribed by your doctor may cause side effects such as nausea, vomiting, low blood pressure, hallucinations (vision and hearing of non-existent things), confusion, excessive sleepiness, involuntary movements and convulsions.
If you have put more patches of your recommended than your doctor immediately contact your doctor or hospital for advice and follow their patch removal guidelines.
If you forget to replace the patch at the usual time
If you have forgotten to replace the patch at the usual time, replace it as soon as you remember: remove the old patch and stick a new patch. If you have forgotten to stick a new patch after removing the old patch, place the new as soon as you remember.
In either case, replace the patch at the usual time the next day. Do not take a double dose to make up for the missed dose.
If you stop using Neupro
Do not stop using Neupro suddenly without telling your doctor. Sudden braking may cause a medical condition called neuroleptic malignant syndrome, which can pose a significant health risk. Symptoms include: akinesia (loss of muscle mobility), muscle stiffness, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed consciousness (eg coma).
Your daily dose of Neupro should be reduced gradually:
1 mg a day - if you are taking Neupro for the treatment of Restless Legs Syndrome;
2 mg a day - if you are taking Neupro to treat Parkinson's disease.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
At the beginning of treatment, you may experience nausea and vomiting. These reactions are usually mild to moderate and resolve rapidly. Tell your doctor if they continue longer or worry you.
Skin reactions caused by the patch
It is possible for the patch to cause skin reactions such as redness and itching. They are usually mild to moderate and only affect the area of the skin to which the patch is applied. Reactions usually resolve within a few hours after removal of the patch.
Tell your doctor if the reactions persist for more than a few days if they worsen or spread beyond the site of sticking to the patch.
You may experience the following side effects:
Inability to resist the impulse, urge, or temptation to perform an action that may be harmful to you or others, which may include:
a strong impulse to gamble overly, despite serious personal or family consequences;
changed or increased sexual interest and behavior causing serious concern to you or others, for example, increased sexual desire;
uncontrolled excessive shopping or spending;
overeating (eating large amounts of food for a short period of time), or eating incontinence (consuming more food than normal and more needed to satisfy hunger).
Tell your doctor if you experience such behavior to discuss how to control or reduce the symptoms.
You may get swollen face, tongue and / or lips. Tell your doctor if you develop these symptoms.
If you use Neupro to treat Restless Legs Syndrome, the following side effects may occur:
Very common side effects: may affect more than 1 in 10 people:
skin irritation under the patch, such as redness and itching;
Common side effects: may affect up to 1 in 10 people:
drowsiness, unexpected and sudden sleep, difficulty falling asleep, sleep disturbances, unusual dreams;
increased sexual desire;
high blood pressure.
Uncommon side effects: may affect up to 1 in 100 people:
impossibility to withstand impulse desire to commit harmful action including excessive gambling and repetitive meaningless actions;
feeling dizzy when standing up due to drop in blood pressure;
unusual thoughts about reality and unusual behavior;
unwanted and uncontrolled thoughts and behavior, such as excitement.
Rare side effects: may affect up to 1 in 1,000 people:
aggressive behavior / aggression;
over-eating and uninterrupted eating.
If you use Neupro to treat Parkinson's disease, the following side effects may occur:
Very common side effects: may affect more than 1 in 10 people:
drowsiness, dizziness and headache;
nausea (feeling sick), vomiting;
skin irritation under the patch, such as redness and itching.
Common side effects: may affect up to 1 in 10 people:
seeing or hearing non-existent things (hallucinations);
difficulty falling asleep, sleep disturbances, restless sleep, nightmares, unusual dreams;
loss of consciousness, involuntary movements associated with Parkinson's disease (dyskinesia), dizziness after standing or sitting due to falls in blood pressure;
vertigo (a sense of vertigo);
feeling of heartbeat (palpitation);
low blood pressure when standing up, high blood pressure;
constipation, dry mouth, stomach acids;
redness, increased sweating, itching;
swelling of the legs and feet;
feeling weak, feeling tired;
Uncommon side effects: may affect up to 1 in 100 people:
unexpected and suddenly falling asleep;
misconception of reality and unusual behavior;
increased sexual desire, inability to resist the impulse to commit detrimental actions, including excessive gambling and repetitive meaningless actions;
visual disturbances such as vision of colors or lights;
decreased blood pressure;
discomfort and pain in the stomach;
generalized itching, skin irritation;
inability to receive or retain an erection;
elevated or non-linear liver function indicators;
increased heart rate.
Rare side effects: may affect
This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the National Reporting System. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Neupro
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and the carton.
Do not store above 25 ° C.
What to do with the used and unused patches
The patches used still contain the active substance, which may be harmful to others. Fold the already used patch with the adhesive layer in. Put the patch back into the sachet so discard it in a place unobstructed for children.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Neupro contains
The active substance is rotigotine.
Each patch releases 2 mg of rotigotine per 24 hours. Each 10 cm2 patch contains 4.5 mg of rotigotine.
The other ingredients are: poly (dimethylsiloxane, trimethylsilyl silicate) - copolymerizate, povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Coating layer: polyester foil with silicone and aluminum coating, colored, pigmented layer (titanium dioxide (E171) yellow pigment 95, red pigment 166) and imprinted inscription (red pigment 144, yellow pigment 95, black pigment 7).
Release layer: transparent polyester foil coated with fluoropolymer.
What Neupro looks like and contents of the pack
Neupro is a transdermal patch. It is slim and consists of three layers. It has square shape and rounded corners. The outside is beige in color, imprinted with Neupro 2 mg / 24 h.
Neupro is available in the following packs:
Cardboard packs containing 7, 20, 28, 30, 56, 60, 84 (multipack containing 42 packs of 42), 90 or 100 (single pack containing 50 packs of 50) patches sealed individually in sachets.
Not all pack sizes may be marketed.
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