Rasagiline Flynn 1 Mg Tablets
Package leaflet: Information for the user
Rasagiline Flynn 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 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 Flynn is and what it is used for
2. What you need to know before you take Rasagiline Flynn
3. How to take Rasagiline Flynn
4. Possible side effects
5. How to store Rasagiline Flynn
6. Contents of the pack and other information
1 What Rasagiline Flynn is and what it is used for
Rasagiline Flynn 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 Flynn helps to increase and sustain levels of dopamine in the brain.
2 What you need to know before you take Rasagiline Flynn
Do not take Rasagiline Flynn:
■ 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 Flynn:
■ 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.
Take special care with Rasagiline Flynn
■ if you have mild to moderate liver problems
■ You should speak with your doctor about any suspicious skin changes.
Children and adolescents
Rasagiline Flynn is not recommended for use under the age of 18.
Other medicines and Rasagiline Flynn
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a 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 Flynn:
■ 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 Flynn together with the antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with Rasagiline Flynn, 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 Flynn 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 Flynn 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 Flynn with food and drink
Rasagiline Flynn 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 Flynn
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 usual dose of Rasagiline Flynn is 1 tablet of 1mg taken by mouth once daily. Rasagiline Flynn may be taken with or without food.
If you take more Rasagiline Flynn than you should
If you think that you may have taken too many Rasagiline Flynn tablets, contact your doctor or pharmacist immediately. Take the carton/bottle with you to show the doctor or pharmacist.
If you forget to take Rasagiline Flynn
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 Flynn
Do not stop taking Rasagiline Flynn 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:
The frequency of possible side effects listed below is defined using the following convention:
■ Very common (affects more than 1 user in 10)
■ Common (affects 1 to 10 users in 100)
■ Uncommon (affects 1 to 10 users in 1,000)
■ Rare (affects 1 to 10 users in 10,000)
■ Very rare (affects less than 1 user in 10,000)
■ Not known (frequency cannot be estimated from the available data)
Very common:
■ abnormal movements (dyskinesia)
■ headache Common:
■ 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:
■ 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 Flynn.
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 Flynn 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 in the UK via the Yellow Card Scheme, (Website: www.mhra.gov.uk/yellowcard) or in Ireland via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Rasagiline Flynn
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 after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Flynn contains
■ The active substance is rasagiline. Each tablet contains 1mg rasagiline (as rasagiline tartrate).
■ The other ingredient(s) are mannitol, maize starch, pregelatinised maize starch, talc, colloidal anhydrous silica and stearic acid.
What Rasagiline Flynn looks like and contents of the pack
Rasagiline Flynn tablets are presented as white or almost white, round, flat and unmarked tablets with a diameter of 8mm ± 0.8mm.
The tablets are available in blister packs of 7, 10, 28, 30, 100 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Flynn Pharma Limited Alton House,
4 Herbert Street,
Dublin 2,
Republic of Ireland
Manufacturer
Laboratorios Normon SA Ronda de Valdecarrizo,
6 - 28760 Tres Cantos,
Madrid,
Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany Rasagilin Inresa 1mg Tabletten
Ireland Rasagiline Flynn 1mg Tablets
United Kingdom Rasagiline Flynn 1mg Tablets