Rasagiline Zentiva 1mg Tablet
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If any of the side effects get serious, 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 is and what it is used for
2. What you need to know before you take rasagiline
3. How to take rasagiline
4. Possible side effects
5. How to store rasagiline
6. Contents of the pack and other information
1. WHAT RASAGILINE 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
Do not take rasagiline if:
• you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
• 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:
• 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. This includes medicines obtained without a prescription, including herbal medicines. This is because rasagiline and other medicines can affect the way each other work. Also tell your doctor or pharmacist 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 medicines 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 breastfeeding, think you might be pregnant or 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
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 is 1 tablet of 1 mg taken by mouth once daily. 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 may happen with this medicine:
Very common side effects (affects more than 1 in 10 people)
• abnormal movements (dyskinesia)
• headache
Common side effects (affects less than 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 side effects (affects less than 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 internet at www.mhra.aov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE RASAGILINE
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 blister pack and the carton. 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 protect the environment.
50mm
sentido de lectura
v
What rasagiline contains:
8 • The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline
tartrate).
• The other ingredients are pregelatinized maize starch, microcrystalline cellulose, maize starch, silica colloidal anhydrous, citric acid monohydrate, stearic acid (50), talc.
What rasagiline looks like and contents of the pack:
Rasagiline 1mg tablets are round, biconvex, white or nearly white. The diameter is 8mm.
They are supplied in blister packs of 7,10, 28, 30,100 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Manufacturer: Ferrer Internacional, S.A. Joan Busculla 1-9, Sant Cugat del Valles, Barcelona, 08173, Spain
This leaflet was last updated in November 2015