Sifrol® ER

extended-release tablets
pramipexole hydrochloride monohydrate
Consumer Medicine Information
What is in this leaflet Do not give this medicine to a child or • other medicines that can cause
adolescent under the age of 18 years. drowsiness or sleepiness (e.g.
This leaflet answers some common questions Safety and effectiveness in children younger antihistamine or some cough and cold
about Sifrol ER. than 18 years have not been established. preparations).
It does not contain all the available Do not take this medicine after the expiry These medicines may be affected by Sifrol
information. It does not take the place of date printed on the pack or if the ER or may affect how well it works. You
talking to your doctor or pharmacist. packaging is torn or shows signs of may need different amounts of the medicine,
All medicines have risks and benefits. Your tampering. or you may need to take different medicines.
doctor has weighed the risks of you taking If it has expired or is damaged, return it to Your doctor and pharmacist have more
Sifrol ER against the benefits it is expected your pharmacist for disposal. information on medicines to be careful with
to have for you. If you are not sure whether you should or avoid while taking Sifrol ER.
If you have any concerns about taking this start taking this medicine, talk to your
medicine, ask your doctor or pharmacist. doctor. How to take Sifrol ER
This leaflet was last updated on the date at Before you start to take it Follow all directions given to you by your
the end of this leaflet. More recent Tell your doctor if you have allergies to doctor or pharmacist carefully.
information may be available. The latest any other medicines, foods, preservatives They may differ from the information
Consumer Medicine Information is available or dyes. contained in this leaflet.
from your pharmacist, doctor, or from
www.medicines.org.au and may contain Tell your doctor if you have, or have had, Sifrol ER is available in a number of tablet
important information about the medicine any of the following medical conditions: strengths. Your doctor or pharmacist will tell
and its use of which you should be aware. • kidney problems you how many tablets you will need to take
• mental illnesses each day. This depends on your condition
Keep this leaflet with the medicine.
and whether or not you are taking any other
You may need to read it again. • low blood pressure medicines.
• trouble controlling your muscles If you do not understand the instructions
What Sifrol ER is used for (dyskinesia). on the label, ask your doctor or
Sifrol ER is used to treat the symptoms of Tell your doctor if you are pregnant, or pharmacist for help.
Parkinson's disease. plan to become pregnant.
How much to take
Parkinson's disease is a disease of the brain Your doctor can discuss with you the
benefits and risks involved. The usual dose is one tablet a day.
that affects body movement. The symptoms Depending on how you respond to the
of Parkinson's disease are caused by a lack of Tell your doctor if you are breastfeeding,
treatment, your doctor may suggest a higher
dopamine, a naturally occurring chemical or plan to breastfeed.
or lower dose.
produced by certain brain cells. Dopamine Sifrol ER is not recommended during
binds to dopamine receptors and relays breastfeeding, as it may pass into breast milk If you are switching from the immediate-
messages in the part of the brain that controls and there is a possibility that your baby may release Sifrol tablets:
movement. When too little dopamine is be affected. Your doctor will base your dose of Sifrol ER
produced, this results in Parkinson's disease. tablets on the dose of the immediate-release
If you have not told your doctor or
Sifrol ER works by having a similar effect as Sifrol tablets you were taking.
pharmacist about any of the above, tell
dopamine in the brain. them before you start taking Sifrol ER. Take your immediate-release Sifrol tablets
as normal the day before you switch. Then
How Sifrol ER works Taking other medicines take your extended-release Sifrol ER
Sifrol ER contains the active ingredient Tell your doctor or pharmacist if you are tablets the next morning and do not take
pramipexole hydrochloride monohydrate. It taking any other medicines, including any any more of the immediate-release Sifrol
belongs to a group of medicines known as that you get without a prescription from tablets.
dopamine agonists, which bind to dopamine your pharmacy, supermarket or health
receptors. How to take it
food shop.
Ask your doctor if you have any questions Swallow the tablet whole with a full glass
Some medicines and Sifrol ER may interfere
about why Sifrol ER has been prescribed of water.
with each other. These include:
for you. Do not chew, divide or crush Sifrol ER.
• levodopa, levodopa/carbidopa
Your doctor may have prescribed it for combination, or other medicines used to Sifrol ER tablets can be taken with or
another reason. treat Parkinson's disease (e.g. without food.
Sifrol ER is not addictive. amantadine) When to take it
This medicine is available only with a • medicines used to treat high blood Take Sifrol ER at about the same time
doctor's prescription. pressure or heart problems (e.g. digoxin, each day.
diltiazem, procainamide, quinidine, Taking it at the same time each day will have
Before you take Sifrol ER triamterene, verapamil, the best effect. It will also help you
hydrochlorothiazide) remember when to take it.
When you must not take it
• medicines used to treat mental How long to take it
Do not take Sifrol ER if you have an illness/psychoses
allergy to: Continue taking Sifrol ER for as long as
• metoclopramide, a medicine used to your doctor tells you.
• any medicine containing pramipexole treat nausea and vomiting
hydrochloride monohydrate (the active This medicine helps to control your
ingredient) or • some medicines used to treat stomach or condition, but does not cure it. It is important
duodenal ulcers (e.g. cimetidine or to keep taking your medicine even if you feel
• any of the ingredients listed at the end of ranitidine)
this leaflet. well.
• quinine, a medicine used to prevent If you forget to take it
Some of the symptoms of an allergic reaction malaria
may include: If it is almost time for your next dose, skip
• some antibiotics (e.g. trimethoprim, the dose you missed and take the next dose
• rash, itching or hives on the skin cephalosporins, penicillins) when you are meant to.
• swelling of the face, lips, tongue or other • indomethacin, a medicine used to treat
parts of the body Otherwise, take it as soon as you
arthritis remember, then go back to taking it as you
• shortness of breath • chlorpropamide, a medicine used to treat would normally.
• wheezing or difficulty breathing. diabetes

Sifrol® ER
Published by MIMS January 2018 1
Do not take a double dose to make up for Things to be careful of • forward bending of the head and neck.
the dose that you have missed. Be careful driving or operating machinery Some of these side effects are more common
This may increase the chance of you getting until you know how Sifrol ER affects you. at the start of treatment and lessen or
an unwanted side effect. disappear with time.
This medicine may cause drowsiness,
If you are not sure what to do, ask your hallucinations and episodes of sudden onset Tell your doctor immediately if you or
doctor or pharmacist. of sleep in some people. your family notice any of the following
If you have trouble remembering to use Make sure you know how you react to side effects:
your medicine, ask your pharmacist for Sifrol ER before you engage in any • loss of memory (amnesia)
some hints. activities where impaired alertness may • fainting
put yourself or others at risk of serious • signs of allergy such as rash or hives on
If you take too much (overdose) injury. the skin; swelling of the face, lips,
Immediately telephone your doctor, If you experience excessive drowsiness or tongue or other parts of the body;
pharmacist or Poisons Information Centre an episode of sudden onset of sleep (while wheezing or difficulty breathing
(telephone 13 11 26) for advice, or go to performing daily activities), do not drive • excessive sleepiness or sudden onset of
Emergency at your nearest hospital if you or perform any potentially dangerous sleep during normal daily activities
think that you or anyone else may have activities, and contact your doctor.
• compulsive behaviour such as gambling,
taken too much Sifrol ER. Do this even if Be careful when drinking alcohol while hypersexuality, shopping, eating,
there are no signs of discomfort or taking Sifrol ER. medication use and repetitive
poisoning. Combining Sifrol ER and alcohol can make purposeless activities
You may need urgent medical attention. you more drowsy or sleepy.
• mental illness causing severe
If you take too much Sifrol ER you may have Be careful getting up from a sitting or suspiciousness (paranoia)
nausea, vomiting, abnormal uncontrolled lying position.
movements, hallucinations, agitation and • shortness of breath or tightness in the
You may feel dizzy or lightheaded while
dizziness or light-headedness. chest
taking Sifrol ER, especially during the first
few weeks of treatment. If you wish to stand • shortness of breath, swelling of the feet
While you are taking Sifrol ER up, you should do so slowly. or legs due to fluid build-up (heart
failure).
Things you must do You should monitor your skin and see
your doctor in case of any concerns. These are serious side effects. You may need
Tell all doctors and pharmacists who are urgent medical attention or hospitalisation.
Patients with Parkinson's disease may have
treating you that you are taking Sifrol ER. These side effects are rare.
an increased risk of developing melanoma.
Tell your doctor or pharmacist if you feel Tell your doctor if you notice anything else
that Sifrol ER is not helping your Side effects that is making you feel unwell.
condition. Other side effects not listed above may also
Tell your doctor if, for any reason, you Tell your doctor or pharmacist as soon as occur in some people.
have not used Sifrol ER exactly as possible if you do not feel well while you
prescribed. are taking Sifrol ER.
After taking Sifrol ER
Otherwise, your doctor may think that it was Sifrol ER helps most people with Parkinson's
not effective and change your treatment disease, but it may have unwanted side Storage
unnecessarily. effects in a few people. All medicines can Keep Sifrol ER in the pack until it is time
Tell your doctor as soon as possible if have side effects. Sometimes they are to take it.
there is any worsening of your condition. serious, most of the time they are not. You If you take the tablets out of the pack they
may need medical treatment if you get some may not keep well.
If you or your family notices an increase of the side effects.
in compulsive behaviour, seek immediate Keep Sifrol ER in a cool dry place where
medical advice. Do not be alarmed by these lists of the temperature stays below 30°C.
possible side effects. Do not store Sifrol ER or any other
Tell your doctor if you notice parts of You may not experience any of them.
Sifrol ER tablets in your stool (faeces). medicine in the bathroom or near a sink.
This may look like whole tablets. Ask your doctor or pharmacist to answer Do not leave it in the car or on window
Your doctor may need to assess your any questions you may have. sills.
response to therapy. Tell your doctor if you notice any of the Heat and dampness can destroy some
following and they worry you: medicines.
Tell your doctor if you experience
symptoms such as depression, apathy, • feeling sick (nausea) Keep Sifrol ER where young children
anxiety, fatigue, sweating or pain after • vomiting cannot reach it.
stopping or reducing your Sifrol ER A locked cupboard at least one-and-a-half
• constipation
treatment. If the problems persist for metres above the ground is a good place to
• diarrhoea store medicines.
more than a few weeks, your doctor may
need to adjust your treatment. • dry mouth Disposal
Tell your doctor if you develop an inability • drowsiness If your doctor tells you to stop taking this
to keep your body and neck straight and • tiredness medicine or the expiry date has passed,
upright. For example, you may experience • confusion or hallucinations (seeing, ask your pharmacist what to do with any
abnormal posture such as forward feeling or hearing things that are not medicine that is left over.
bending of the head and neck, forward there)
bending of the lower back or sidewards • restlessness Product description
bending of the back.
• dizziness What it looks like
Things you must not do • headache Sifrol ER is the brand name of your
Do not give Sifrol ER to anyone else, even medicine.
• light-headedness on standing up,
if they have the same condition as you.
especially when getting up from a sitting Sifrol ER 0.375 mg extended-release tablets
Do not stop taking Sifrol ER or change the or lying position (hypotension) are white to off-white, round, biconvex,
dose without checking with your doctor. bevel-edged tablets, with 'P1' on one side and
• blurred vision
It is important not to suddenly stop taking BI company symbol on the other.
• swelling of hands, ankles or feet
your Sifrol ER tablets, unless advised to do Sifrol ER 0.75 mg extended-release tablets
so by your doctor, since your condition may • uncontrollable twitching, jerking or
writhing movements are white to off-white, round, biconvex,
worsen. bevel-edged tablets, with 'P2' on one side and
If your doctor asks you to stop taking Sifrol • difficulty sleeping or unusual dreams
BI company symbol on the other.
ER, the dose will normally need to be • weight gain or loss
Sifrol ER 1.5 mg extended-release tablets are
reduced gradually over several days. • loss or gain of sexual drive white to off-white, oval, biconvex, tablets,

Sifrol® ER
Published by MIMS January 2018 2
with 'P3' on one side and BI company Sifrol ER 2.25 mg extended-release tablets
symbol on the other. AUST R 173901
Sifrol ER 2.25 mg extended-release tablets Sifrol ER 3 mg extended-release tablets
are white to off-white, oval, biconvex tablets AUST R 158763
with 'P12' on one side and BI company Sifrol ER 3.75 mg extended-release tablets
symbol on the other. AUST R 173921
Sifrol ER 3 mg extended-release tablets are Sifrol ER 4.5 mg extended-release tablets
white to off-white, oval, biconvex, tablets, AUST R 158764
with 'P4' on one side and BI company
symbol on the other.
Sifrol ER 3.75 mg extended-release tablets
are white to off-white, oval, biconvex tablets
with 'P13' on one face and BI company
symbol on the other.
Sifrol ER 4.5 mg extended-release tablets are
white to off-white, oval, biconvex, tablets,
with 'P5' on one side and BI company
symbol on the other.
Sifrol ER are available in blister packs of 30
extended-release tablets, except for Sifrol ER
0.375 mg and 0.75 mg which are also
available in blister packs of 10 (sample
pack)* extended-release tablets.
*Not currently distributed in Australia.
Ingredients
Each Sifrol ER 0.375 mg extended-release
tablet contains 0.375 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER 0.75 mg extended-release
tablet contains 0.75 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER 1.5 mg extended-release
tablet contains 1.5 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER 2.25 mg extended-release
tablet contains 2.25 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER 3 mg extended-release tablet
contains 3 mg pramipexole hydrochloride
monohydrate.
Each Sifrol ER 3.75 mg extended-release
tablet contains 3.75 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER 4.5 mg extended-release
tablet contains 4.5 mg pramipexole
hydrochloride monohydrate.
Each Sifrol ER tablet also contains the
following ingredients:
• hypromellose
• maize starch
• carbomer 941
• colloidal anhydrous silica
• magnesium stearate.
Supplier
Sifrol ER tablets are supplied in Australia by:
BOEHRINGER INGELHEIM PTY
LIMITED
ABN 52 000 452 308
78 Waterloo Road
North Ryde NSW 2113
This Consumer Medicine Information was
updated in October 2017.
® Sifrol is a registered trademark of
Boehringer Ingelheim Pty Limited
© Boehringer Ingelheim Pty Limited 2017.
Australian Registration Numbers
Sifrol ER 0.375 mg extended-release tablets
AUST R 158754
Sifrol ER 0.75 mg extended-release tablets
AUST R 158755
Sifrol ER 1.5 mg extended-release tablets
AUST R 158757

Sifrol® ER
Published by MIMS January 2018 3