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RASAGILINE RIVOPHARM 1MG TABLETS

Active substance(s): RASAGILINE HEMITARTRATE / RASAGILINE HEMITARTRATE / RASAGILINE HEMITARTRATE

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Package leaflet: Information for the user
Rasagiline Rivopharm 1 mg tablets
Rasagiline
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.

Pharmacode

- 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.
What is in this leaflet:
1. What Rasagiline tablets is and what it is 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
1. What Rasagiline tablets is and what it is used for
The full name of your medicine is "Rasagiline Rivopharm 1
mg tablets". It is referred to as "Rasagiline tablets" in the rest
of the leaflet.
Rasagiline tablets is 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
Do not take Rasagiline tablets:
- if you are allergic (hypersensitive) 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.
- 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 Rasagiline tablets
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 is 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 serotonin-norepinephrine reuptake
inhibitors, tricyclic or tetracyclic antidepres-sants)
- the antibiotic ciprofloxacin used against infections
- the cough suppressant dextromethorphan
- sympathomimetics such as those present in eye drops, nasal
and oral decongest ants and cold medicine containing
ephedrine or pseudoephedrine
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.
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.
Rasagiline tablets with food, drink and alcohol
Rasagiline tablets may 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.

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

5. How to store Rasagiline tablets

3. How to take Rasagiline tablets

Keep this medicine out of the sight and reach of childrenDo not
use this medicine after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that
month.

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

For blisters: ‘This medicinal product does not require any
special temperature storage conditions. Store in the original
immediate package to protect from light.’

The usual dose of Rasagiline tablets is 1 tablet of 1 mg taken
by mouth once daily.

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.

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 tablets, contact your doctor or pharmacist immediately.
Take the Rasagiline tablets carton with you to show the
doctor or pharmacist.
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.
4. Possible side effects

6. Contents of the pack and other information
What Rasagiline tablets contains
- The active substance is rasagiline. Each tablet contains 1
mg rasagiline (as hemitartrate).
- The other ingredients are cellulose microcrystalline,
(maize) starch (partially) pregelatinised, silica colloidal
anhydrous, magnesium stearate.
What Rasagiline tablets looks like and contents of the
pack
Rasagiline tablets tablets are presented white to off white
round, flat tablets with bevelled edges and engraved with “1”
in one side, with a diameter of 8 mm.
The tablets are available in blister packs of 28 tablets.

Like all medicines, Rasagiline tablets 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) (pancreatitis),
- 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/light-headedness (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 con-trolled 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.
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 tempta-tion 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 conse-quences.
- 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 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 at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

Marketing Authorisation Holder
Rivopharm UK Ltd
30th Floor
40 Bank Street
Canary Wharf
London, E14 5NR
United Kingdom
Manufacturer
Genepharm S.A.
18 km Marathon Avenue
153 51 Pallini
Greece

This medicinal product is authorised in the Member States of the EEA under the
following names:
Portugal:
United Kingdom:

Rasagilina Rivopharm
Rasagiline Rivopharm 1mg tablets

This leaflet was last revised in 09/2016
R/MA/0041/PIL/001

Expand Transcript

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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