Skip to Content

RASAGILINE 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Rasagiline 1mg Tablets
Rasagiline tartrate
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 or pharmacist.
•  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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
•  The full name of this medicine is Rasagiline
1mg Tablets but within the leaflet it will be
referred to as Rasagiline Tablets.

• the antibiotic ciprofloxacin used against
infections
• the cough suppressant dextromethorphan
• sympathomimetics such as those present
in eye drops, nasal and oral decongestants
and cold medicine containing ephedrine or
pseudoephedrine.

What is in this leaflet
1 What Rasagiline Tablets are and what
they are used for
2 What you need to know before you
take Rasagiline Tablets
3 How to take Rasagiline Tablets
4 Possible side effects
5 How to store Rasagiline Tablets
6 Contents of the pack and other
information

Tell your doctor if you or your family/carer notices
that you are developing unusual behaviours where
you cannot resist the impulse, urges or cravings
to carry out certain harmful or detrimental
activities to yourself or others. These are called
impulse control disorders. In patients taking
Rasagiline Tablets and/or other medications used
to treat Parkinson’s disease, behaviours such
as compulsions, obsessive thoughts, addictive
gambling, excessive spending, impulsive
behaviour and an abnormally high sex drive or an
increase in sexual thoughts or feelings have been
observed. Your doctor may need to adjust or stop
your dose.

1 What Rasagiline Tablets are and what

they are used for

Rasagiline Tablets are used for the treatment of
Parkinson’s disease. It can be used together with or
without Levodopa (another medicine that is used
to treat Parkinson’s disease).
With Parkinson’s disease, there is a loss of cells
that produce dopamine in the brain. Dopamine
is a chemical in the brain involved in movement
control. Rasagiline Tablets helps to increase and
sustain levels of dopamine in the brain.

2  What you need to know before you

take Rasagiline Tablets

The use of Rasagiline Tablets together with
the antidepressants containing fluoxetine or
fluvoxamine should be avoided.
If you are starting treatment with Rasagiline
Tablets, you should wait at least 5 weeks after
stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or
fluvoxamine, you should wait at least 14 days after
stopping Rasagiline Tablets treatment.

Rasagiline Tablets with food and drink
Rasagiline Tablets may be taken with or without
food.

Pregnancy and breast-feeding
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.

Driving and using machines
No studies on the effects on the ability to drive
and use machines have been performed. Ask
your doctor for advice prior to driving or using
machines.

Do not take Rasagiline Tablets
• if you are allergic to rasagiline or any of the other
ingredients of this medicine (listed in section 6)
• if you have severe liver problems.
Do not take the following medicines while taking
Rasagiline Tablets:
• monoamine oxidase (MAO) inhibitors (e.g. for
treatment of depression or Parkinson’s disease,
or used for any other indication), including
medicinal and natural products without
prescription e.g. St. John’s Wort
• pethidine (a strong pain killer).
You must wait at least 14 days after stopping
Rasagiline Tablets treatment and starting
treatment with MAO inhibitors or pethidine.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Rasagiline Tablets
• if you have mild to moderate liver problems.
You should speak with your doctor about any
suspicious skin changes.

Children and adolescents
Rasagiline Tablets are not recommended for use
under the age of 18.

Other medicines and Rasagiline Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Including medicines obtained without
prescription or if you are smoking or intend to stop
smoking.
Ask your doctor for advice before taking any of
the following medicines together with Rasagiline
Tablets:
• certain antidepressants (selective serotonin
reuptake inhibitors, selective serotoninnorepinephrine reuptake inhibitors, tricyclic or
tetracyclic antidepressants)

3 How to take Rasagiline Tablets
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is 1 tablet of 1mg taken
by mouth once daily. Rasagiline Tablets may be
taken with or without food.

If you take more Rasagiline Tablets than
you should
If you think that you may have taken too many
Rasagiline Tablets, contact your doctor or
pharmacist immediately. Take the Rasagiline
Tablets carton with you to show the doctor or
pharmacist.
Symptoms of overdosing could include: unease,
behaviour where patients are unable to resist
the impulse, drive or temptation to perform an
action that could be harmful to themselves or
others, high blood pressure (hypertension crises),
serotonin syndrome including the following:
feeling confused, feeling restless, sweating,
shaking, shivering, hallucinations (strange visions
or sounds), sudden jerks of the muscles or a fast
heartbeat.

If you forget to take Rasagiline Tablets
Do not take a double dose to make up for a
forgotten dose. Take the next dose normally, when
it is time to take it.

If you stop taking Rasagiline Tablets
Do not stop taking Rasagiline Tablets without first
talking to your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Continued top of next column
AAAI0886

Continued over page

colours/plates:

Rasagiline 1mg 28 Tablets PIL - UK

1. Black

item no: AAAI0886

dimensions: 170 x 440

print proof no: 4

pharmacode:

origination date: 24.06.15

min pt size: 9pt

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 26.06.15

Technical Approval

revised by: BW

date sent: 24.06.15

supplier: Actavis Iceland

technically app. date:

Non Printing Colours
1.
2.
3.

Reporting of side effects

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects have been reported in
placebo controlled clinical trials:
Very common (may affect more than 1 in 10 people)
• abnormal movements (dyskinesia)
• headache.
Common (may affect up to 1 in 10 people)
• abdominal pain
• fall
• allergy
• fever
• flu (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• low blood pressure when rising to a standing
position with symptoms like dizziness/lightheadedness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal results of blood tests (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• joint inflammation (arthritis)
• numbness and muscle weakness of the hand
(carpal tunnel syndrome)
• decreased weight
• abnormal dreams
• difficulty in muscular coordination (balance
disorder)
• depression
• dizziness (vertigo)
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• irritation of the skin (dermatitis)
• rash
• bloodshot eyes (conjunctivitis)
• urinary urgency.
Uncommon (may affect up to 1 in 100 people)
• stroke (cerebrovascular accident)
• heart attack (myocardial infarction)
• blistering rash (vesiculobullous rash).
In addition, skin cancer was reported in around
1% of patients in the placebo controlled clinical
trials. Nevertheless, scientific evidence suggests
that Parkinson’s disease, and not any medicine in
particular, is associated with a higher risk of skin
cancer (not exclusively melanoma). You should
speak with your doctor about any suspicious skin
changes.
Parkinson’s disease is associated with symptoms
of hallucinations and confusion. In post marketing
experience these symptoms have also been
observed in Parkinson’s disease patients treated
with Rasagiline Tablets.

If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
Website:
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 Rasagiline Tablets
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 carton or blister after
EXP. The expiry date refers to the last day of that
month.
Store in the original package in order to protect
from light.
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 Rasagiline Tablets contain
• The active substance is rasagiline. Each tablet
contains 1mg rasagiline (as tartrate).
•C
 alcium sulfate dehydrate, Pregelatinised
starch, Maize starch, Stearic acid Talc, Citric acid
anhydrous, Silica colloidal anhydrous.

What Rasagiline Tablets look like and
contents of the pack
White, round bevel edge, debossed with “A486”
on one side and plain on the other side.
The tablets are available in blister packs of
28 tablets.
Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th floor, 94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Actavis ehf.
Reykjavikurvegur 78
Hafnarfjörður
IS-220
Iceland

This leaflet was last revised in June 2015.

There have been cases of patients who, while
taking one or more medications for the treatment
of Parkinson’s disease, were unable to resist the
impulse, drive or temptation to perform an action
that could be harmful to themselves or others.
These are called impulse control disorders.
In patients taking Rasagiline Tablets and/or other
medications used to treat Parkinson’s disease, the
following have been observed:
• Obsessive thoughts or impulsive behaviour.
• 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.
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing the symptoms.

Continued top of next column
AAAI0886

colours/plates:

Rasagiline 1mg 28 Tablets PIL - UK

1. Black

item no: AAAI0886

dimensions: 170 x 440

print proof no: 4

pharmacode:

origination date: 24.06.15

min pt size: 9pt

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 26.06.15

Technical Approval

revised by: BW

date sent: 24.06.15

supplier: Actavis Iceland

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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.

Hide