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PIPEXUS 2.62 MG PROLONGED-RELEASE TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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INFORMATION FOR THE USER

Pipexus® 0.26 mg prolonged-release tablets
Pipexus® 0.52 mg prolonged-release tablets
Pipexus® 1.05 mg prolonged-release tablets
Pipexus® 1.57 mg prolonged-release tablets
Pipexus® 2.1 mg prolonged-release tablets
Pipexus® 2.62 mg prolonged-release tablet
Pipexus® 3.15 mg prolonged-release tablets
pramipexole
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Pipexus is and what it is used for
2. What you need to know before you take Pipexus
3. How to take Pipexus
4. Possible side effects
5. How to store Pipexus
6. Contents of the pack and other information

1. What Pipexus is and what it is used for
Pipexus contains the active substance pramipexole and 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.
Pipexus is used to treat the symptoms of primary Parkinson’s
disease in adults. It can be used alone or in combination with
levodopa (another medicine for Parkinson’s disease).

2. What you need to know before you take Pipexus
Do not take Pipexus
- if you are allergic to pramipexole or to any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Pipexus. Tell your doctor if
you have (had) or develop any medical conditions or symptoms,
especially any of the following:
- Kidney disease.
- Hallucinations (seeing, hearing or feeling things that are not
there). Most hallucinations are visual.
- Dyskinesia (e.g. abnormal, uncontrolled movements of the
limbs). If you have advanced Parkinson’s disease and are also
taking levodopa, you might develop dyskinesia during the up-
titration of Pipexus.
- Sleepiness and episodes of suddenly falling asleep.
- Psychosis (e.g. comparable with symptoms of schizophrenia).
- Vision impairment. You should have regular eye examinations
during treatment with Pipexus.
- Severe heart or blood vessels disease. You will need to have
your blood pressure checked regularly, especially at the
beginning of treatment. This is to avoid postural hypotension
(a fall in blood pressure on standing up).
Tell your doctor if you or your family/carer notices that you are
developing urges or cravings to behave in ways that are unusual for
you and you cannot resist the impulse, drive or temptation to carry
out certain activities that could harm yourself or others. These are
called impulse control disorders and can include behaviours such
as addictive gambling, excessive eating or spending, an abnormally
high sex drive or preoccupation with an increase in sexual thoughts
or feelings. Your doctor may need to adjust or stop your dose.
Tell your doctor if you or your family/carer notices that you are
developing mania (agitation, feeling elated or over-excited) or
delirium (decreased awareness, confusion, loss of reality).
Your doctor may need to adjust or stop your dose.
Children and adolescents
Pipexus is not recommended for use in children or adolescents
under 18 years.
Other medicines and Pipexus
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines, herbal
remedies, health foods or supplements that you have obtained
without a prescription.
You should avoid taking Pipexus together with antipsychotic
medicines.
Take care if you are taking the following medicines:
- cimetidine (to treat excess stomach acid and stomach ulcers);
- amantadine (which can be used to treat Parkinson’s disease);
- mexiletine (to treat irregular heartbeats, a condition known as
ventricular arrhythmia);
- zidovudine (which can be used to treat the acquired immune



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deficiency syndrome (AIDS), a disease of the human immune
system);
cisplatin (to treat various types of cancers);
quinine (which can be used for the prevention of painful night-
time leg cramps and for the treatment of a type of malaria
known as falciparum malaria (malignant malaria));
procainamide (to treat irregular heart beat).

If you are taking levodopa, the dose of levodopa is recommended
to be reduced when you start treatment with Pipexus.
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
Pipexus may affect your ability to drive and operate machinery.
Pipexus with food, drink and alcohol
You should be cautious while drinking alcohol during treatment
with Pipexus.
Pipexus can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. Your doctor will then discuss
with you if you should continue to take Pipexus.
The effect of Pipexus on the unborn child is not known. Therefore,
do not take Pipexus if you are pregnant unless your doctor tells you
to do so.
Pipexus should not be used during breast-feeding. Pipexus
can reduce the production of breast milk. Also, it can pass into
the breast milk and can reach your baby. If use of Pipexus is
unavoidable, breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Pipexus can cause hallucinations (seeing, hearing or feeling things
that are not there). If affected, do not drive or use machines.
Pipexus 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.

3. How to take Pipexus
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The doctor will advise you on the right dosing.
Take Pipexus prolonged-release tablets only once a day and each
day at about the same time.
You can take Pipexus 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 Pipexus prolonged-release tablets
Week

Daily
dose
(mg)

Number of tablets

1

0.26

One Pipexus 0.26 mg prolonged-release tablet.

2

0.52

One Pipexus 0.52 mg prolonged-release tablet,
OR
two Pipexus 0.26 mg prolonged-release tablets.

3

1.05

One Pipexus 1.05 mg prolonged-release tablet,
OR
two Pipexus 0.52 mg prolonged-release tablets,
OR
four Pipexus 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 Pipexus 0.26
mg prolonged-release tablet a day is also possible.

Continued over page

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 pramipexole (immediate release) tablets
Your doctor will base your dose of pramipexole prolonged-release
tablets on the dose of pramipexole (immediate release) tablets you
were taking.
Take your pramipexole (immediate release) tablets as normal the
day before you switch. Then take your pramipexole prolongedrelease tablets next morning and do not take any more pramipexole
(immediate release) tablets.
If you take more Pipexus than you should
If you accidentally take too many tablets,
- Contact your doctor or nearest hospital casualty department
immediately for advice.
- You may experience vomiting, restlessness, or any of the side
effects as described in Section 4 “Possible side effects”.
If you forget to take Pipexus
If you forget to take a dose of Pipexus, 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 Pipexus
Do not stop taking Pipexus 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 Pipexus 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:
- akinesia (loss of muscle movement),
- rigid muscles,
- fever,
- unstable blood pressure,
- tachycardia (increased heart rate),
- confusion,
- depressed level of consciousness (e.g. coma).
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 everybody gets them. Evaluation of these side effects is based
on the following frequencies:
Very common

may affect more than 1 in 10 people

Common

may affect up to 1 in 10 people

Uncommon

may affect up to 1 in 100 people

Rare

may affect up to 1 in 1,000 people

You may experience the following side effects:
Very common:
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
- Sleepiness
- Dizziness
- Nausea (sickness)
Common:
- Urge to behave in an unusual way
- Hallucinations (seeing, hearing or feeling things that are not there)
- Confusion
- Tiredness (fatigue)
- Sleeplessness (insomnia)
- Excess of fluid, usually in the legs (peripheral oedema)
- Headache
- Hypotension (low blood pressure)
- Abnormal dreams
- Constipation
- Visual impairment
- Vomiting (being sick)
- Weight loss including decreased appetite
Uncommon:
- Paranoia (e.g. excessive fear for one’s own well-being)
- Delusion
- Excessive daytime sleepiness and suddenly falling asleep
- Amnesia (memory disturbance)
- Hyperkinesia (increased movements and inability to keep still)
- Weight increase
- Allergic reactions (e.g. rash, itching, hypersensitivity)
- Fainting
- Cardiac failure (heart problems which can cause shortness of
breath or ankle swelling)*
- Inappropriate antidiuretic hormone secretion*
- Restlessness
- Dyspnoea (difficulties to breathe)
- Hiccups
- Pneumonia (infection of the lungs)

- Inability to resist the impulse, drive or temptation to perform an
action that could be harmful to you or others, which may include:
- Strong impulse to gamble excessively despite serious
personal or family consequences.
- Altered or increased sexual interest and behaviour of
significant concern to you or to others, for example, an
increased sexual drive.
- Uncontrollable excessive shopping or spending
- Binge eating (eating large amounts of food in a short time
period) or compulsive eating (eating more food than normal
and more than is needed to satisfy your hunger)*
- Delirium (decreased awareness, confusion, loss of reality)
Rare:
- Mania (agitation, feeling elated or over-excited)
Tell your doctor if you experience any of these behaviors; he will
discuss ways of managing or reducing the symptoms.
For the side effects marked with * a precise frequency estimation
is not possible, since these side effects were not observed in
clinical studies among 2,762 patients treated with pramipexole. The
frequency category is probably not greater than “uncommon”.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Pipexus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the blister and carton after EXP. The expiry date refers to the last
day of that month.
This medicine does not require any special temperature storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Pipexus prolonged-release tablets contains
The active substance is pramipexole.
Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg,
2.62 mg, or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg,
2.25 mg, 3 mg, 3.75 mg, or 4.5 mg pramipexole dihydrochloride
monohydrate, respectively.
The other excipient(s) are hypromellose, anhydrous calcium hydrogen
phosphate, magnesium stearate and colloidal anhydrous silica.
What Pipexus prolonged-release tablets looks like and contents
of the pack
Pipexus 0.26 mg prolonged-release tablets: The round tablets of
9 mm diameter are white or nearly white, have a flat surface with
beveled edges and are marked with 026 on one side
Pipexus 0.52 mg prolonged-release tablets: The round tablets of 10
mm diameter are white or nearly white, biconvex and are marked
with 052 on one side
Pipexus 1.05 mg prolonged-release tablets: The round tablets of 10
mm diameter are white or nearly white, biconvex, and are marked
with 105 on one side
Pipexus 1.57 mg prolonged-release tablets: The round tablets of 10
mm diameter are white or nearly white, biconvex and are marked
with 157 on one side
Pipexus 2.1 mg prolonged-release tablets: The round tablets of 10
mm diameter are white or nearly white, biconvex and are marked
with 210 on one side
Pipexus 2.62 mg prolonged-release tablets: The round tablets of 10
mm diameter are white or nearly white, biconvex and are marked
with 262 on one side
Pipexus 3.15 mg prolonged-release tablets: The round tablets of
11 mm diameter are white or nearly white, have a flat surface with
beveled edges and are marked with 315 on one side
Pipexus is available in packs containing 10, 30 and 100 prolongedrelease tablets in aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DB Ashbourne Limited
The Rectory, Braybrooke Road
Arthingworth, Market Harborough
LE16 8JT, United Kingdom
Telephone: (01858) 525643
Fax: (01858) 525383
Email: enquiries@medinformation.co.uk
Manufacturer
Ferrer Internacional, S.A.
Joan Buscallà, 1-9
Sant Cugat del Vallès 08173
Spain
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, Tres Cantos
Madrid 28760
Spain
This leaflet was last revised in March 2016

Pipexus (pramipexole) 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, 3.15 mg PIL - UK
Dimensions: 170mm x 330mm
Proof Date: 22/03/16

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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