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RASAGILINE SIGILLATA 1MG TABLETS

Active substance(s): RASAGILINE

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Package leaflet: Information for the user

 
Rasagiline Sigillata 1mg Tablets
 

 
 

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.
The full name of this medicine is Rasagiline Sigillata 1mg Tablets but within the leaflet it
will be referred to as Rasagiline Sigillata Tablets.
 

 
 

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

 
 

1.

What Rasagiline Sigillata Tablets are and what they are used for

 
Rasagiline Sigillata 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 Sigillata Tablets helps to increase and
sustain levels of dopamine in the brain.
 

 
 

2.

What you need to know before you take Rasagiline Sigillata Tablets

 
Do not take Rasagiline Sigillata 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 Sigillata 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 Sigillata Tablets treatment and starting
treatment with
MAO inhibitors or pethidine.

 
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rasagiline Sigillata Tablets
if you have mild to moderate liver problems
 

 
1

You should speak with your doctor about any suspicious skin changes.

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

 
Other medicines and Rasagiline Sigillata 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
Sigillata
Tablets:
Certain antidepressants (selective serotonin reuptake inhibitors, selective serotoninnorepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
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

 
The use of Rasagiline Sigillata Tablets together with the antidepressants containing fluoxetine or
fluvoxamine should be avoided.
If you are starting treatment with Rasagiline Sigillata 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 Sigillata Tablets treatment.

 
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 Sigillata
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.

 
Rasagiline Sigillata Tablets with food and drink
Rasagiline Sigillata 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.
 

 
 

3.

How to take Rasagiline Sigillata Tablets

 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
or if you are not sure.

 
The recommended dose is 1 tablet of 1mg taken by mouth once daily. Rasagiline Sigillata
Tablets may be taken with or without food.

If you take more Rasagiline Sigillata Tablets than you should
If you think that you may have taken too many Rasagiline Sigillata Tablets, contact your doctor or
pharmacist immediately. Take the Rasagiline Sigillata Tablets carton with you to show the doctor or
pharmacist.

 
If you forget to take Rasagiline Sigillata 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 Sigillata Tablets
Do not stop taking Rasagiline Sigillata Tablets without first talking to your doctor.

 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
 

 
 

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 Sigillata Tablets.

 
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 Sigillata 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.

 
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
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 Sigillata 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, bottle 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 Sigillata Tablets contains

 
-

The active substance is rasagiline. Each tablet contains 1mg rasagiline (as tartrate).
Calcium sulfate dehydrate, Starch, pregelatinised (maize), Maize starch, Stearic acid 50, Talc,
Citric acid anhydrous, Silica colloidal anhydrous.

 

 
 

What Rasagiline Sigillata Tablets looks like and contents of the pack

 
White, round bevel edge, 7mm, debossed with “A486” on one side and plain on the other side.

 
The tablets are available in blister packs of 30 or 100 tablets.

 
Not all pack sizes may be marketed.

 
Marketing Authorisation Holder
Sigillata Limited
Suite 23, Park Royal House
Park Royal Road, London, NW10, 7JH, UK

 
Manufacturer
Actavis ehf.
Reykjavikurvegur 78
Hafnarfjörður
IS-220
Iceland
 

 
 
 

This leaflet was last revised in December 2015.

 
 
 
 
 

 
 
 
 
 

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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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