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RASAGILINE TORRENT 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user
Rasagiline Torrent 1 mg Tablets
Rasagiline
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 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 Torrent is and what it is used for
2. What you need to know before you take Rasagiline Torrent
3. How to take Rasagiline Torrent
4. Possible side effects
5. How to store Rasagiline Torrent
6. Contents of the pack and other information
1. What Rasagiline Torrent is and what it is used for
Rasagiline 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 helps to increase and sustain levels of
dopamine in the brain.
2. What you need to know before you take Rasagiline Torrent
Do not take Rasagiline
- 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:
- 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 treatment and
starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagiline
- if you have mild to moderate liver problems
- You should speak with your doctor about any suspicious skin
changes.
Children and adolescents
Rasagiline is not recommended for use in children and adolescents
under the age of 18 years.
Other medicines and Rasagiline
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines 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:
- Certain antidepressants (selective serotonin reuptake inhibitors,
selective serotonin-norepinephrine 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 together with the antidepressants containing
fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with Rasagiline, 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 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 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.
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 Torrent
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 of Rasagiline is 1 tablet of 1 mg once daily.
Oral use.
Rasagiline may be taken with or without food.
If you take more Rasagiline than you should
If you think that you may have taken too many Rasagiline tablets,
contact your doctor or pharmacist immediately. Take the Rasagiline
carton with you to show the doctor or pharmacist.
If you forget to take Rasagiline
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
Do not stop taking Rasagiline 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/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 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.
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 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the national reporting system 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 Torrent
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. The expiry date refers to the last day of that
month.
This medicinal product does not require any special 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 to protect the environment.
6. Contents of the pack and other information
What Rasagiline Torrent contains
- The active substance is rasagiline. Each tablet contains 1 mg
rasagiline (as rasagiline tartrate).
- The other ingredients are Cellulose, Microcrystalline; Maize
starch; Starch, Pregalatinised (from maize); Talc; Sodium Stearyl
Fumarate.
What Rasagiline Torrent looks like and contents of the pack
Rasagiline tablets are presented as white to off-white, round, flat,
bevelled tablets (6.5 mm).
Pack sizes of 7, 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90,
98, 100, 112 tablets in blisters

Pack sizes of 30, 100 tablets in tablet containers with child-resistant
screw caps containing desiccant (silica gel). The desiccant, used to
keep the tablets dry, should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way,
Crawley,
West Sussex
RH11 7XA
United Kingdom
Manufacturer
Iberfar, Indústria Farmacêutica, S.A.
R. Consiglieri Pedroso, n.º 121-123, Queluz de Baixo
2734-501 Barcarena
PORTUGAL
This leaflet was last revised in 10/2015

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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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