Patient leaflet - Rasagiline Accord 1 mg tablets
1. What Rasagiline Accord is and what it is used for
Rasagiline Accord contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. 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 Accord helps to increase and sustain levels of dopamine in the brain.
2. What you need to know before you take Rasagiline Accord
Do not take Rasagiline Accord
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 Accord :
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 Accord treatment and starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagiline Accord
- if you have any liver problems
You should speak with your doctor about
any suspicious skin changes. Treatment with Rasagiline Accord may possibly increase the risk of skin cancer.
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 Accord and/or
other medicines 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 (see section 4).
Rasagiline Accord may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s disease). For further information please refer to section driving and using machines.
Children and adolescents
There is no relevant use of Rasagiline Accord in children and adolescents. Therefore, Rasagiline Accord is not recommended for use under the age of 18.
Other medicines and Rasagiline Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially tell your doctor if you are taking any of the following medicines:
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 Accord together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with Rasagiline Accord , 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 Accord treatment.
Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of Rasagiline Accord in the blood.
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.
You should avoid taking Rasagiline Accord if you are pregnant, as the effects of Rasagiline Accord on pregnancy and the unborn child are not known.
Driving and using machines
Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with Rasagiline Accord may influence your ability to do so. Rasagiline Accord can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset. This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline Accord. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline Accord do not drive or operate machinery (see section 2).
Rasagiline Accord contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Rasagiline Accord
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 recommended dose of Rasagiline Accord is 1 tablet of 1 mg taken by mouth once daily.
Rasagiline Accord may be taken with or without food.
If you take more Rasagiline Accord than you should
If you think that you may have taken too many Rasagiline Accord tablets, contact your doctor or pharmacist immediately. Take the Rasagiline Accord carton/blister or bottle with you to show the doctor or pharmacist.
Symptoms reported following overdose of Rasagiline Accord included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
If you forget to take Rasagiline Accord
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 Accord
Do not stop taking Rasagiline Accord 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.
Contact you doctor right away if you notice any of the following symptoms. You may need urgent medical advice or treatment:
- If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
- If you see or hear things which are not there (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)
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Contact your doctor if you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).
Other side effects
Very common (may affect more than 1 in 10 people)
- involuntary 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)
Not known: frequency cannot be estimated from the available data
- Elevated blood pressure
- Excessive drowsiness
- Sudden onset of sleep
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 (see contact details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
5. How to store Rasagiline Accord
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.
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 Accord 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 Accord looks like and contents of the pack
Rasagiline Accord tablets are presented as white to off-white, round, flat, bevelled tablets (6.5 mm).
Pack sizes of 7, 10, 28, 30, 60,100, 112 tablets in blisters and unit dose blister containing 7x1, 10x1, 28x1, 30x1, 60x1, 100x1 and 112x1 tablet.
Pack sizes of 30 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
United Kingdom
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom
Ireland
Accord Healthcare Ireland Limited Euro House
Euro Business Park
Little Island Cork T45 K857
Ireland
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area, 2643 Ergates Lefkosia, Cyprus
Iberfar – Indústria Farmaĉeutica, S.A. Rua Consiglieri Pedroso, no. 121-123 Queluz de Baixo, Barcarena, Portugal
This medicinal product is authorised in the Member States of the EEA under the following names:
Name of the Member State
Name of the medicinal product
Germany Rasagilin Accord 1mg
Tabletten
Austria Rasagilin Accord 1mg
Tabletten
Bulgaria Rasagiline Accord 1mg
таблетки
Denmark Rasagilin Accord Estonia Rasagiline Accord
Finland Rasagiline Accord 1mg
Tabletti
France Rasagiline Accord 1mg comprimé
Ireland Rasagiline Accord 1mg tablets
Italy Rasagilina Accord
Lithuania Rasagiline Accord 1mg tabletės
Latvia Rasagiline Accord 1mg tabletes
Norway Rasagilin Accord 1mg tabletter
Poland Poland Rasagiline
Accord
Sweden Rasagiline Accord 1mg tabletter
Slovak Republic Rasagiline Accord 1mg tablety
United Kingdom Rasagiline Accord 1mg tablets
This leaflet was last revised in 08/2022.
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