Rasagiline 1Mg Tablets Rasagiline Tartrate

Package leaflet: Information for the user Rasagiline 1mg Tablets Rasagiline tartrate

Read all of this leaflet carefully before you • the antibiotic ciprofloxacin used against start taking this medicine because it contains infections important information for you. • the cough suppressant dextromethorphan • Keep this leaflet. You may need to read it • sympathomimetics such as those present again. in eye drops, nasal and oral decongestants • If you have any further questions, ask your and cold medicine containing ephedrine or doctor or pharmacist. pseudoephedrine. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm The use of Rasagiline Tablets together with them, even if their signs of illness are the the antidepressants containing fluoxetine or same as yours. fluvoxamine should be avoided. • If you get any side effects, talk to your doctor If you are starting treatment with Rasagiline or pharmacist. This includes any possible side Tablets, you should wait at least 5 weeks after effects not listed in this leaflet. See section 4. stopping fluoxetine treatment. • The full name of this medicine is Rasagiline If you are starting treatment with fluoxetine or 1mg Tablets but within the leaflet it will be fluvoxamine, you should wait at least 14 days after referred to as Rasagiline Tablets. stopping Rasagiline Tablets treatment.

What is in this leaflet Tell your doctor if you or your family/carer notices 1 What Rasagiline Tablets are and what that you are developing unusual behaviours where they are used for you cannot resist the impulse, urges or cravings 2 What you need to know before you to carry out certain harmful or detrimental take Rasagiline Tablets activities to yourself or others. These are called 3 How to take Rasagiline Tablets impulse control disorders. In patients taking Rasagiline Tablets and/or other medications used 4 Possible side effects to treat Parkinson’s disease, behaviours such 5 How to store Rasagiline Tablets as compulsions, obsessive thoughts, addictive 6 Contents of the pack and other gambling, excessive spending, impulsive information 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 1 What Rasagiline Tablets are and what your dose. they are used for Rasagiline Tablets with food and drink Rasagiline Tablets are used for the treatment of Rasagiline Tablets may be taken with or without Parkinson’s disease. It can be used together with or food. without Levodopa (another medicine that is used to treat Parkinson’s disease). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you With Parkinson’s disease, there is a loss of cells may be pregnant or are planning to have a baby, that produce dopamine in the brain. Dopamine ask your doctor or pharmacist for advice before is a chemical in the brain involved in movement taking this medicine. control. Rasagiline Tablets helps to increase and sustain levels of dopamine in the brain. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Ask 2 What you need to know before you take Rasagiline Tablets your doctor for advice prior to driving or using machines. Do not take Rasagiline Tablets • if you are allergic to rasagiline or any of the other 3 How to take Rasagiline Tablets ingredients of this medicine (listed in section 6) • if you have severe liver problems. Always take this medicine exactly as your doctor Do not take the following medicines while taking has told you. Check with your doctor or pharmacist Rasagiline Tablets: if you are not sure. • monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, The recommended dose is 1 tablet of 1mg taken or used for any other indication), including by mouth once daily. Rasagiline Tablets may be medicinal and natural products without taken with or without food. prescription e.g. St. John’s Wort • pethidine (a strong pain killer). If you take more Rasagiline Tablets than you should You must wait at least 14 days after stopping If you think that you may have taken too many Rasagiline Tablets treatment and starting Rasagiline Tablets, contact your doctor or treatment with MAO inhibitors or pethidine. pharmacist immediately. Take the Rasagiline Tablets carton with you to show the doctor or Warnings and precautions pharmacist. Talk to your doctor or pharmacist before taking Rasagiline Tablets Symptoms of overdosing could include: unease, • if you have mild to moderate liver problems. behaviour where patients are unable to resist the impulse, drive or temptation to perform an You should speak with your doctor about any action that could be harmful to themselves or suspicious skin changes. others, high blood pressure (hypertension crises), serotonin syndrome including the following: Children and adolescents feeling confused, feeling restless, sweating, Rasagiline Tablets are not recommended for use shaking, shivering, hallucinations (strange visions under the age of 18. or sounds), sudden jerks of the muscles or a fast heartbeat. Other medicines and Rasagiline Tablets Tell your doctor or pharmacist if you are taking, If you forget to take Rasagiline Tablets have recently taken or might take any other Do not take a double dose to make up for a medicines. Including medicines obtained without forgotten dose. Take the next dose normally, when prescription or if you are smoking or intend to stop it is time to take it. smoking. Ask your doctor for advice before taking any of If you stop taking Rasagiline Tablets the following medicines together with Rasagiline Do not stop taking Rasagiline Tablets without first Tablets: talking to your doctor. • certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin- If you have any further questions on the use of this norepinephrine reuptake inhibitors, tricyclic or medicine, ask your doctor or pharmacist. tetracyclic antidepressants)

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Rasagiline 1mg 28 Tablets PIL - UK

approved for print/date Item no: BBBA0201 Colours Non Printing Colours 1. Black 1. Originator: S.Anson Dimensions: 170 x 440 Origination Date: 04.11.16 Min Body Text Size: 9pts 2. 2. Revision Date: 10.11.16 Supplier: Actavis Iceland 3. 3. Revised By: Proof Round S.Anson 4. 5. 2 Date sent: 04.11.16 Technical 6. [email protected] Approval Date received: 10.11.16

* Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 4 Possible side effects Reporting of side effects If you get any side effects, talk to your doctor Like all medicines, this medicine can cause side or pharmacist. This includes any possible side effects, although not everybody gets them. effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme The following side effects have been reported in Website: placebo controlled clinical trials: www.mhra.gov.uk/yellowcard

Very common (may affect more than 1 in 10 people) By reporting side effects you can help provide • abnormal movements (dyskinesia) more information on the safety of this medicine. • headache.

Common (may affect up to 1 in 10 people) 5 How to store Rasagiline Tablets • abdominal pain • fall Keep this medicine out of the sight and reach of • allergy children. • fever • flu (influenza) Do not use this medicine after the expiry date • general feeling of being unwell (malaise) which is stated on the carton or blister after • neck pain EXP. The expiry date refers to the last day of that • chest pain (angina pectoris) month. • low blood pressure when rising to a standing position with symptoms like dizziness/light- Store in the original package in order to protect headedness (orthostatic hypotension) from light. • decreased appetite • constipation Do not throw away any medicines via wastewater • dry mouth or household waste. Ask your pharmacist how to • nausea and vomiting throw away medicines you no longer use. These • flatulence measures will help protect the environment. • abnormal results of blood tests (leucopenia) • joint pain (arthralgia) • musculoskeletal pain 6 Contents of the pack and other • joint inflammation (arthritis) information • numbness and muscle weakness of the hand (carpal tunnel syndrome) What Rasagiline Tablets contain • decreased weight • The active substance is rasagiline. Each tablet • abnormal dreams contains 1mg rasagiline (as tartrate). • difficulty in muscular coordination (balance • Calcium sulfate dehydrate, Pregelatinised disorder) starch, Maize starch, Stearic acid Talc, Citric acid • depression anhydrous, Silica colloidal anhydrous. • dizziness (vertigo) • prolonged muscle contractions (dystonia) What Rasagiline Tablets look like and • runny nose (rhinitis) contents of the pack • irritation of the skin (dermatitis) White, round bevel edge, debossed with “A486” • rash on one side and plain on the other side. • bloodshot eyes (conjunctivitis) • urinary urgency. The tablets are available in blister packs of 28 tablets. Uncommon (may affect up to 1 in 100 people) • stroke (cerebrovascular accident) Marketing Authorisation Holder • heart attack (myocardial infarction) Caduceus Pharma Ltd. • blistering rash (vesiculobullous rash). 2 Martin House 179-181 North End Road In addition, skin cancer was reported in around London 1% of patients in the placebo controlled clinical W14 9NL trials. Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in Manufacturer particular, is associated with a higher risk of skin Actavis ehf. cancer (not exclusively melanoma). You should Reykjavikurvegur 78 speak with your doctor about any suspicious skin Hafnarfjörður changes. IS-220 Iceland Parkinson’s disease is associated with symptoms of hallucinations and confusion. In post marketing experience these symptoms have also been This leaflet was last revised in November 2016. observed in Parkinson’s disease patients treated with Rasagiline Tablets.

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 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 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.

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Rasagiline 1mg 28 Tablets PIL - UK

* Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes.