Consumer Medicine Information
What is in this leaflet
1. What Sifrol is used for
2. Before you take Sifrol
1. When you must not take Sifrol
2. Before you start to take Sifrol
3. Taking Sifrol
1. How to take Sifrol
2. If you forget to take a dose
3. If you have taken too much Sifrol (overdose)
4. While you are taking Sifrol
1. Things you must do
2. Things to be careful of
5. Side effects
6. After taking Sifrol
7. Product description
1. What is Sifrol
Sifrol® is a registered trademark of Boehringer Ingelheim Pty Limited.This leaflet answers some common questions about Sifrol. It does not contain all available information, nor does it take the place of talking to your doctor or pharmacist.Keep this information with your Sifrol. You may need to read it again later.
To find out more about Sifrol
You should ask your doctor or pharmacist if you have any questions about Sifrol or if you have any trouble before, during or after using Sifrol.
1. What Sifrol is used forSifrol is used in the treatment of Parkinson’s disease. Parkinson’s disease is a disease of the brain that affects body movement.
The symptoms of Parkinson’s disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine relays messages in the part of the brain that controls movement. When too little dopamine is produced, this results in Parkinson’s disease. Sifrol works by having a similar effect as dopamine in the brain.
Sifrol is also used in the treatment of Restless Legs Syndrome (RLS). RLS is a neurological disorder characterised by unpleasant sensations in the legs and the compelling need to move the legs (in an effort to relieve these feelings). The sensations range in severity from uncomfortable to irritating to painful and typically occur when sitting or lying down – which often leads to problems falling or staying asleep. Occasionally the arms may also be affected. Current evidence suggests that RLS may be due to impaired transmission of dopamine signals in certain area(s) of the brain. Sifrol works by having a similar effect as dopamine in the brain.
Sifrol contains the active ingredient Pramipexole hydrochloride. Pramipexole hydrochloride belongs to a group of medicines known as “dopamine agonists”.
Ask your doctor if you have any questions about why Sifrol has been prescribed for you. Your doctor may have prescribed Sifrol for another reason.
2. Before you take Sifrol2a) When you must not take Sifrol
Only use Sifrol if it has been prescribed for you by a doctor.
Never give it to someone else even if their symptoms seem to be the same as yours.
Do not take Sifrol if you are allergic to pramipexole or any of the other ingredients in Sifrol. These ingredients are: mannitol, starch-maize, silicacolloidal anhydrous, povidone and magnesium stearate.
If you are not sure if you have these allergies, you should raise those concerns with your doctor. Signs of an allergic reaction may include itching of skin, shortness of breath and swelling of the tongue or face.
You should not use Sifrol after the EXPIRY DATE on the carton or blister strips, or if the packaging is torn or damaged.
2b) Before you start to take Sifrol
It is essential that your doctor knows your medical history before prescribing Sifrol.
Before taking Sifrol, you must tell your doctor if you have, or have had, any of the following conditions:
blood pressure problems,
If you are not sure if you have, or have had, any of these conditions, you should raise those concerns with your doctor.
Before using Sifrol, it is important to tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription.
In particular, you should tell your doctor if you are taking:
any other medicines for the treatment of Restless Legs Syndrome
levodopa, or other medicines used to treat Parkinson’s disease (e.g. amantadine)
medicines used in the treatment of high blood pressure or heart problems (e.g. digoxin, diltiazem, procainamide, quinidine, triamterene, verapamil)
certain medicines used in the treatment of mental illness/psychosis (antipsychotics or neuroleptics).
metoclopramide - commonly used to help control nausea and vomiting
cimetidine or ranitidine - used to treat stomach ulcer or refluxquinine - used to treat malariatrimethoprim - an antibiotic
medicines used to produce calmness or help you sleep e.g. sleeping tablets, sedatives or tranquillisers, and pain relievers.
These medicines may be affected by Sifrol or may affect how well it works. You may need different amounts of the medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.2c) Pregnancy
Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication. Special care is recommended during pregnancy. The benefits of Sifrol must be assessed against the possible effects on your unborn child.
Sifrol is not recommended during breastfeeding.Ask for your doctor's advice if you are breastfeeding, or likely to breastfeed during your course of medication. In animal studies, Sifrol was shown to pass into breast milk, and can stop the production of milk.
The use of Sifrol is not recommended in children below 18 years of age.3. Taking Sifrol3a) How to take Sifrol
It is important to take your Sifrol tablets as directed by your doctor.
A number of tablet strengths of Sifrol are available (see section 7, Product Description). Make sure that you only take the tablet strength that your doctor has prescribed.
Your doctor may reduce your daily dose if you have another medical condition such as a kidney problem, or if you are currently taking other medicines.The tablets should be swallowed whole with a glass of water. Sifrol can be taken with or without food.
The recommended initial dose for adults is one Sifrol 125 microgram tablet three times per day. Your daily dose will be increased every week by your doctor until a suitable daily dose is reached. The maximum recommended daily dose for Sifrol is 4.5 mg pramipexole hydrochloride.Restless Legs Syndrome
The recommended initial dose for adults over 18 years of age is one Sifrol 125 microgram tablet once daily (2 to 3 hours before bedtime). If this dose is not sufficient to relieve symptoms, your doctor may increase the dose gradually (every 4 to 7 days) until a suitable dose is reached. The maximum recommended dose for Sifrol is 750 microgram pramipexole hydrochloride per day.Ask your doctor for more information if you have been advised to take a different dose to that referred to above.
3b) If you forget to take a dose
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.Parkinson’s Disease
Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Restless Legs Syndrome
If you forget to take Sifrol before you go to bed and you wake up late in the night or early morning, do not take any Sifrol as you may have trouble waking in the morning. If you have any questions about this, ask your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time.
If you are not sure what to do, check with your doctor or pharmacist.
3c) If you have taken too much Sifrol (overdose)
Immediately telephone your doctor, pharmacist or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Sifrol.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Signs of overdose may include nausea, vomiting, abnormal uncontrolled movements, hallucinations, agitation and dizziness/light-headedness.4.While you are taking Sifrol4a) Things you must do
Do not stop taking Sifrol or change the dose without checking with your doctor.
It is important not to suddenly stop taking your Sifrol tablets, unless advised to do so by your doctor, since your condition may worsen.
If your doctor asks you to stop taking Sifrol, the dose will normally need to be reduced gradually over several days.Restless Legs Syndrome
In patients treated with doses up to 750 microgram of Sifrol can be stopped without tapering off. However, worsening of symptoms after abrupt discontinuation of treatment may occur in isolated cases.Tell your doctor as soon as possible if there is any worsening of your condition.
If you or your family notices an increase in compulsive behaviour, seek immediate medical advice.
4b) Things to be careful of
Do not drive a car, operate machinery, or do anything else that could be dangerous (after taking Sifrol) until you know how Sifrol affects you. Sifrol may cause drowsiness, hallucinations and episodes of sudden onset of sleep, in some people. Make sure you know how you react to Sifrol before you engage in any activities where impaired alertness may put yourself or others at risk of serious injury.
If you experience excessive drowsiness or an episode of sudden onset of sleep (while performing daily activities), do not drive or perform any potentially dangerous activities, and contact your doctor.
Be careful when drinking alcohol while taking Sifrol. Combining Sifrol and alcohol can make you more drowsy/sleepy.
Be careful getting up from a sitting or lying position. You may feel dizzy or lightheaded while taking Sifrol, especially during the first few weeks of treatment. If you wish to stand up, you should do so slowly.
Patients with Parkinson’s Disease may have an increased risk of developing melanoma. You should monitor your skin and see your doctor in case of any concerns.
5. Side effectsYou should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing.Your doctor has weighed the risks of your taking Sifrol against the expected benefits.Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of taking Sifrol.
The most common side effects of Sifrol include nausea, constipation, drowsiness, hallucinations, confusion, dizziness and swelling of hands, ankles or feet (peripheral oedema). In patients also taking other medicines to treat Parkinson’s disease, abnormal uncontrolled movements can occur.
These side effects tend to appear at the start of treatment and lessen or disappear with time.Sudden onset of sleep episodes (while engaged in daily activities) have been reported with/without prior warning signs, such as excessive drowsiness.Other reported side effects include hypersensitivity, diarrhoea, dry mouth, fatigue, visual disturbance including blurred vision and reduced visual acuity, vomiting, headache, lightheadedness or low blood pressure (hypotension), trouble sleeping (insomnia), amnesia, restlessness, dream abnormalities, delusion, paranoia, weight gain, weight decrease.Compulsive behaviour such as gambling, hypersexuality, shopping, eating, medication use and repetitive purposeless activities have been reported in patients taking dopamine agonists for the treatment of Parkinson’s disease, especially at high doses.
If you or your family notice an increase in compulsive behaviour, seek immediate medical advice. Your doctor may consider reducing/ceasing your treatment.
Tell your doctor as soon as possible if you experience any side effects during or after taking Sifrol, so that these effects may be properly treated. Other side effects not yet known or listed above, may also occur in some patients.
You should tell your doctor or pharmacist if you notice anything unusual, during or after taking Sifrol.
6.After taking Sifrol6a) Storage
Sifrol should be kept in a cool dry place where the temperature stays below
Do not store your Sifrol in direct sunlight or heat.
For example, do not leave your Sifrol in the car on hot days.
Keep your Sifrol where children cannot reach it.
Return any unused medicine to your pharmacist so that it can be disposed of safely.
7.Product Description7a) What is Sifrol
Sifrol is the brand name of your medicine.Sifrol 125 microgram tablets are round, white tablets with ‘P6’ on one side and company symbol on the other.
Sifrol 250 microgram tablets are oval, white, scored tablets with ‘P7’ on one side and company symbol on the other.
Sifrol 1 mg tablets are round, white, scored tablets with ‘P9’ on one side and company symbol on the other.
Sifrol tablets are available in blister packs of 100 tablets except for the 125 microgram tablets which are available in packs of 30 tablets.The following Australian Registration Numbers appear on the carton:Sifrol 125 microgram tablets AUST R 67238Sifrol 250 microgram tablets AUST R 66484Sifrol 1 mg tablets AUST R 664857b) Ingredients
Each Sifrol 125 microgram tablet contains pramipexole hydrochloride 125 microgram.Each Sifrol 250 microgram tablet contains pramipexole hydrochloride 250 microgram.Each Sifrol 1 mg tablet contains pramipexole hydrochloride 1 mg.The other ingredients found in all strengths are: mannitol, starch-maize, silica-colloidal anhydrous, povidone and magnesium stearate.7c) Manufacturer
Sifrol tablets are made in Germany and supplied in Australia by:
BOEHRINGER INGELHEIM PTY LIMITED
(ABN 52 000 452 308)
85 Waterloo Road
North Ryde NSW 2113
This leaflet was prepared on 23 October 2008© Boehringer Ingelheim Pty Limited 2008.