SIFROL 1.57 mg prolonged-release tablets Pramipexole Dihydro - United Kingdom[英国药品]

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SIFROL 1.57 mg prolonged-release tablets Pramipexole Dihydro

2015-02-28 21:32:13 来源: 作者: 【大中小】浏览:436次评论:0条

For doctors

What is it and how is it used?

SIFROL belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

SIFROL is used to treat the symptoms of primary Parkinson’s disease. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).

What do you have to consider before using it?

Do not take SIFROL

Take special care with SIFROL
Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:

Children and adolescents
SIFROL is not recommended for use in children or adolescents under 18 years.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking SIFROL together with antipsychotic medicines.

Take care if you are taking the following medicines:

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases SIFROL may affect your ability to drive and operate machinery.

Taking SIFROL with food and drink
You should be cautious while drinking alcohol during treatment with SIFROL.
SIFROL can be taken with or without food.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant. Your doctor will then discuss with you if you should continue to take SIFROL.

The effect of SIFROL on the unborn child is not known. Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so.

SIFROL should not be used during breast-feeding. SIFROL can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of SIFROL is unavoidable, breast-feeding should be stopped.

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

Driving and using machines
SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

How is it used?

Always take SIFROL exactly as your doctor has told you. The doctor will advise you on the right dosing.

Take SIFROL prolonged-release tablets only once a day and each day at about the same time.

You can take SIFROL with or without food. Swallow the tablets whole with water.

Do not chew, divide or crush the prolonged-release tablets. If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.

During the first week, the usual daily dose is 0.26 mg pramipexole. The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose mg Number of tablets 1 0.26 One SIFROL 0.26 mg prolonged-release tablet. 2 0.52 One SIFROL 0.52 mg prolonged-release tablet, OR two SIFROL 0.26 mg prolonged-release tablets. 3 1.05 One SIFROL 1.05 mg prolonged-release tablet, OR two SIFROL 0.52 mg prolonged-release tablets, OR four SIFROL 0.26 mg prolonged-release tablets.

The usual maintenance dose is 1.05 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your dose up to a maximum of 3.15 mg of pramipexole a day. A lower maintenance dose of one SIFROL 0.26 mg prolonged-release tablet a day is also possible.

Patients with kidney disease
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets only every other day for the first week. After that, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet every day. If a further dose increase is necessary, your doctor may adjust it in steps of 0.26 mg pramipexole.

If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.

If you are switching from SIFROL (immediate release) tablets
Your doctor will base your dose of SIFROL prolonged-release tablets on the dose of SIFROL (immediate release) tablets you were taking.

Take your SIFROL (immediate release) tablets as normal the day before you switch. Then take your SIFROL prolonged-release tablets next morning and do not take any more SIFROL (immediate release) tablets.

If you take more SIFROL than you should
If you accidentally take too many tablets,

If you forget to take SIFROL
If you forget to take a dose of SIFROL, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.

If you stop taking SIFROL
Do not stop taking SIFROL without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with SIFROL abruptly. 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:

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, SIFROL can cause side effects, although not everybody gets them. eva luation of these side effects is based on the following frequencies:

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

You may experience the following side effects:

Very common:

Common:

Uncommon:

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 take SIFROL after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Sifrol is a medicine that contains the active substance pramipexole. It is available as ‘immediate-release’ white tablets (round: 0.088, 0.7 and 1.1mg; oval: 0.18 and 0.35mg) and as ‘prolonged-release’ white tablets (round: 0.26 and 0.52mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15mg). Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours.

What is it used for?

Sifrol is used to treat the symptoms of the following diseases:

Parkinsons disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Sifrol can be used either on its own or in combination with levodopa another medicine for Parkinsons disease, at any stage of 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. Sifrol 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?

For Parkinson’s disease, the starting dose is either one 0.088-mg immediate-release tablet three times a day or one 0.26-mg prolonged-release tablet once a day. The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is three 1.1-mg immediate-release tablets or one 3.15-mg prolonged-release tablet. Patients can be switched from the immediate- to the prolonged-release tablets overnight, but the dose might need to be adjusted depending on the patient’s response. Sifrol must be given less often in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually.

For restless legs syndrome, Sifrol immediate-release tablets should be taken once a day, two to three hours before going to bed. The recommended starting dose is 0.088mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54mg. The patient’s response and the need for further treatment should be eva luated after three months. The prolonged-release tablets are not suitable for restless legs syndrome.

Sifrol tablets should be swallowed with water. The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.For more information, see the package leaflet.

How does it work?

The active substance in Sifrol, pramipexole, is a dopamine agonist (a substance that 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. Pramipexole 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 shaking, stiffness and slowness of movement.

The way pramipexole 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 corrected by pramipexole.

How has it been studied?

In Parkinson’s disease, Sifrol immediate-release tablets have been studied in five main studies. Four studies compared Sifrol with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa. The main measure of effectiveness was the change in the severity of Parkinson’s disease. The fifth study compared Sifrol with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.

To support the use of the prolonged-release tablets, the company presented the results of studies showing that the immediate- and prolonged-release tablets produced the same levels of the active substance in the body. It also presented studies comparing the two tablets in early and advanced Parkinson’s disease, and looking at switching patients from immediate- to prolonged-release tablets.

In restless legs syndrome, Sifrol immediate-release tablets have also been studied in two main studies. The first compared Sifrol with placebo over 12 weeks in 344 patients and measured the improvement in symptoms. The second included 150 patients who took Sifrol for six months, and compared the

effects of remaining on Sifrol with switching to placebo. The main measure of effectiveness was the time until symptoms got worse.

What benefits has it shown during the studies?

In the study of patients with advanced Parkinson’s disease, patients taking Sifrol immediate-release tablets had larger improvements after 24 weeks of steady-dose treatment than those taking placebo. Similar results were seen in the first three studies of early Parkinson’s disease, with greater improvements after four or 24 weeks. Sifrol was also more effective that levodopa at improving movement symptoms in early disease.

The additional studies showed that the prolonged-release tablets were as effective as the immediate-release tablets in treating Parkinson’s disease. They also showed that patients can be safely switched from immediate- to prolonged-release tablets, although dose adjustments were needed in a small number of patients.

In restless legs syndrome, Sifrol immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Sifrol was greatest after four weeks before getting smaller. The results of the second study were insufficient to prove the long-term effectiveness of Sifrol.

What is the risk associated?

The most common side effect with Sifrol (seen in more than 1 patient in 10) is nausea (feeling sick). In patients with Parkinson’s disease, the following side effects are also seen in more than 1 patient in 10:dizziness, dyskinesia (difficulty controlling movement) andsomnolence (sleepiness). For the full list of all side effects reported with Sifrol, see the package leaflet.

Sifrol should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.

Why has it been approved?

The CHMP decided that Sifrol’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 Sifrol to Boehringer Ingelheim International GmbH on 14 October 1997. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Sifrol, 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

SIFROL 1.57 mg prolonged-release tablets

Composition

Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.

Please note:
Pramipexole doses as published in the literature refer to the salt form.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Prolonged-release tablet.

The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).

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