160 mm 20 mm
Package Leaflet: Information for the User Symptoms reported following overdose of Rasagiline Not known: frequency cannot be estimated from the included slightly euphoric mood (light form of mania), available data Rasagiline 1 mg Tablets extremely high blood pressure and serotonin syndrome • elevated blood pressure (see section 4). • excessive drowsiness Rasagiline 35 mm • sudden onset of sleep If you forget to take Rasagiline Read all of this leaflet carefully before you start taking this medicine because it contains important Do not take a double dose to make up for a forgotten dose. Reporting of side effects information for you. Take the next dose normally, when it is time to take it. • Keep this leaflet. You may need to read it again. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not • If you have any further questions, ask your doctor or pharmacist. If you stop taking Rasagiline • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their listed in this leaflet. You can also report side effects Do not stop taking Rasagiline without first talking to directly via the Yellow Card Scheme, website signs of illness are the same as yours. your doctor. • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in www.mhra.gov.uk/yellowcard or search for MHRA Yellow this leaflet. See section 4. Card in the Google Play or Apple App Store. By reporting If you have any further questions on the use of this side effects you can help provide more information on the What is in this leaflet Children and adolescents medicine, ask your doctor or pharmacist. safety of this medicine. 1. What Rasagiline is and what it is used for There is no relevant use of Rasagiline in children and 35 mm 2. What you need to know before you adolescents. Therefore, Rasagiline is not 4. Possible side effects 5. How to store Rasagiline take Rasagiline recommended for use under the age of 18. 3. How to take Rasagiline Like all medicines, this medicine can cause side effects, Keep this medicine out of the sight and reach of children. Other medicines and Rasagiline although not everybody gets them. 4. Possible side effects Tell your doctor or pharmacist if you are taking, have Do not use this medicine after the expiry date which is 5. How to store Rasagiline recently taken or might take any other medicines. Contact you doctor right away if you notice any of the stated on the carton and blister after EXP. The expiry date 6. Contents of the pack and other information following symptoms. You may need urgent medical advice refers to the last day of that month. Especially tell your doctor if you are taking any of the or treatment: 1. What Rasagiline is and what it is following medicines: • if you develop unusual behaviours such as compulsions, This medicine does not require any special storage • certain antidepressants (selective serotonin obsessive thoughts, addictive gambling, excessive conditions.
used for reuptake inhibitors, selective 35 mm shopping or spending, impulsive behaviour and an serotonin-norepinephrine reuptake inhibitors, abnormally high sex drive or an increase in sexual Do not throw away any medicines via wastewater or Rasagiline contains the active substance rasagiline and tricyclic or tetracyclic antidepressants) household waste. Ask your pharmacist how to throw away it is used for the treatment of Parkinson’s disease. It can thoughts (impulse control disorders) (see section 2) • the antibiotic ciprofloxacin used against infections • if you see or hear things which are not there medicines you no longer use. These measures will help be used together with or without Levodopa (another • the cough suppressant dextromethorphan protect the environment. medicine that is used to treat Parkinson’s disease). (hallucinations) • sympathomimetics such as those present in eye • any combination of hallucinations, fever, restlessness, With Parkinson’s disease, there is a loss of cells that drops, nasal and oral decongestants and cold tremor and sweating (serotonin syndrome) 6. Contents of the pack and other information produce dopamine in the brain. Dopamine is a chemical medicine containing ephedrine or • if you notice any suspicious skin changes because in the brain involved in movement control. Rasagiline pseudoephedrine. there is a higher risk of skin cancer (not exclusively What Rasagiline tablets contain helps to increase and sustain levels of dopamine in The use of Rasagiline together with the antidepressants melanoma) in patients with Parkinson’s disease (see • The active substance is rasagiline. Each tablet contains the brain. containing fluoxetine or fluvoxamine should be avoided. section 2). 1 mg rasagiline (as hemitartrate). If you are starting treatment with Rasagiline, you should 35 mm • The other ingredients are microcrystalline cellulose, 2. What you need to know before you take wait at least 5 weeks after stopping fluoxetine treatment. Other side effects pregelatinised starch (from maize starch), maize starch, If you are starting treatment with fluoxetine or talc and stearic acid. Rasagiline fluvoxamine, you should wait at least 14 days after Very common (may affect more than 1 in 10 people) stopping Rasagiline treatment. • involuntary movements (dyskinesia) Do not take Rasagiline: • headache What Rasagiline tablets look like and contents of • if you are allergic to rasagiline or any of the other Tell your doctor or pharmacist if you are smoking or the pack 280 mm ingredients of this medicine (listed in section 6) intend to stop smoking. Smoking could decrease the Common (may affect up to 1 in 10 people) The tablets are white to off-white, round, flat, bevel edged, • if you have severe liver problems. amount of Rasagiline in the blood. • abdominal pain 8 mm in diameter, debossed with ‘R’ on one side and ‘1’ • fall on the other side. Do not take the following medicines while taking Pregnancy, breast-feeding and fertility • allergy Rasagiline: • fever Rasagiline tablets are available in pack sizes of 28, 30, 60
If you are pregnant or breast-feeding, think you may be 35 mm • monoamine oxidase (MAO) inhibitors (e.g. for pregnant or are planning to have a baby, ask your doctor • flu (influenza) or 100 tablets. treatment of depression or Parkinson’s disease, or or pharmacist for advice before taking this medicine. • general feeling of being unwell (malaise) Not all pack sizes may be marketed. used for any other indication), including medicinal You should avoid taking Rasagiline if you are pregnant, • neck pain and natural products without prescription e.g. as the effects of Rasagiline on pregnancy and the • chest pain (angina pectoris) Marketing Authorisation Holder and Manufacturer St. John's Wort unborn child are not known. • low blood pressure when rising to a standing position Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, • pethidine (a strong pain killer). with symptoms like dizziness/light-headedness Beverley, East Yorkshire, HU17 0LD, United Kingdom You must wait at least 14 days after stopping Driving and using machines (orthostatic hypotension) Rasagiline treatment and starting treatment with MAO Ask your doctor for advice before you drive and operate • decreased appetite This leaflet was last revised in 01/2018 inhibitors or pethidine. machines, since Parkinson’s disease itself as well as • constipation the treatment with Rasagiline may influence your ability • dry mouth Warnings and precautions to do so. Rasagiline can make you feel dizzy or drowsy; • nausea and vomiting Talk to your doctor or pharmacist before taking it can also cause episodes of sudden sleep onset. 35 mm • flatulence Rasagiline: • abnormal results of blood tests (leucopenia) • if you have any liver problems. This might be enhanced if you take other medicines to • joint pain (arthralgia) You should speak with your doctor about any treat the symptoms of your Parkinson’s disease, or if • musculoskeletal pain suspicious skin changes. you take medicines which can make you feel drowsy, or • joint inflammation (arthritis) if you drink alcohol while taking Rasagiline. If you have • numbness and muscle weakness of the hand (carpal Tell your doctor if you or your family/carer notices that experienced somnolence and/or episodes of sudden tunnel syndrome) you are developing unusual behaviours where you sleep onset before, or while taking Rasagiline do not • decreased weight cannot resist the impulse, urges or cravings to carry out drive or operate machinery (see section 2). • abnormal dreams certain harmful or detrimental activities to yourself or • difficulty in muscular coordination (balance disorder) others. These are called impulse control disorders. In 3. How to take Rasagiline • depression patients taking Rasagiline and/or other medicines used 35 mm • dizziness (vertigo) to treat Parkinson’s disease, behaviours such as Always take this medicine exactly as your doctor has • prolonged muscle contractions (dystonia) compulsions, obsessive thoughts, addictive gambling, told you. Check with your doctor or pharmacist if you • runny nose (rhinitis) excessive spending, impulsive behaviour and an are not sure. • irritation of the skin (dermatitis) abnormally high sex drive or an increase in sexual The recommended dose of Rasagiline is 1 tablet of • rash thoughts or feelings have been observed. Your doctor • bloodshot eyes (conjunctivitis) may need to adjust or stop your dose (see section 4). 1mg taken by mouth once daily. Rasagiline may be taken with or without food. • urinary urgency Rasagiline may cause drowsiness and may cause you If you take more Rasagiline than you should Uncommon (may affect up to 1 in 100 people) to suddenly fall asleep during day time activities, If you think that you may have taken too many - stroke (cerebrovascular accident) especially if you are taking other dopaminergic - heart attack (myocardial infarction)
Rasagiline tablets, contact your doctor or pharmacist 35 mm medicinal products (used for the treatment of immediately. Take the Rasagiline carton/blister with you - blistering rash (vesiculobullous rash) Parkinson’s disease). For further information please to show the doctor or pharmacist. refer to section driving and using machines.
Artwork Brand: Dr Reddy’s Product Name: Rasagiline Strength 1 mg Form: Tablets
Component: Leaflet Pack Size: Various Country: UK Date Created: 06/02/2018 Date Modified: 07/02/2018 Version: 1.1 Technical Information
Die Cut Guides
Dimensions: 160 x 280 mm Colours
Process Black
1.0 160 mm
20 mm
Symptoms reported following overdose of Rasagiline Not known: frequency cannot be estimated from the included slightly euphoric mood (light form of mania), available data extremely high blood pressure and serotonin syndrome • elevated blood pressure (see section 4). • excessive drowsiness • sudden onset of sleep If you forget to take Rasagiline Do not take a double dose to make up for a forgotten dose. Reporting of side effects Take the next dose normally, when it is time to take it. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not If you stop taking Rasagiline listed in this leaflet. You can also report side effects Do not stop taking Rasagiline without first talking to directly via the Yellow Card Scheme, website your doctor. www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting If you have any further questions on the use of this side effects you can help provide more information on the What is in this leaflet Children and adolescents medicine, ask your doctor or pharmacist. safety of this medicine. 1. What Rasagiline is and what it is used for There is no relevant use of Rasagiline in children and 2. What you need to know before you adolescents. Therefore, Rasagiline is not 4. Possible side effects 5. How to store Rasagiline take Rasagiline recommended for use under the age of 18. 3. How to take Rasagiline Like all medicines, this medicine can cause side effects, Keep this medicine out of the sight and reach of children. Other medicines and Rasagiline although not everybody gets them. 4. Possible side effects Tell your doctor or pharmacist if you are taking, have Do not use this medicine after the expiry date which is 5. How to store Rasagiline recently taken or might take any other medicines. Contact you doctor right away if you notice any of the stated on the carton and blister after EXP. The expiry date 6. Contents of the pack and other information following symptoms. You may need urgent medical advice refers to the last day of that month. Especially tell your doctor if you are taking any of the or treatment: 1. What Rasagiline is and what it is following medicines: • if you develop unusual behaviours such as compulsions, This medicine does not require any special storage • certain antidepressants (selective serotonin obsessive thoughts, addictive gambling, excessive conditions. used for reuptake inhibitors, selective shopping or spending, impulsive behaviour and an serotonin-norepinephrine reuptake inhibitors, abnormally high sex drive or an increase in sexual Do not throw away any medicines via wastewater or Rasagiline contains the active substance rasagiline and tricyclic or tetracyclic antidepressants) household waste. Ask your pharmacist how to throw away it is used for the treatment of Parkinson’s disease. It can thoughts (impulse control disorders) (see section 2) • the antibiotic ciprofloxacin used against infections • if you see or hear things which are not there medicines you no longer use. These measures will help be used together with or without Levodopa (another • the cough suppressant dextromethorphan protect the environment. medicine that is used to treat Parkinson’s disease). (hallucinations) • sympathomimetics such as those present in eye • any combination of hallucinations, fever, restlessness, With Parkinson’s disease, there is a loss of cells that drops, nasal and oral decongestants and cold tremor and sweating (serotonin syndrome) 6. Contents of the pack and other information produce dopamine in the brain. Dopamine is a chemical medicine containing ephedrine or • if you notice any suspicious skin changes because in the brain involved in movement control. Rasagiline pseudoephedrine. there is a higher risk of skin cancer (not exclusively What Rasagiline tablets contain helps to increase and sustain levels of dopamine in The use of Rasagiline together with the antidepressants melanoma) in patients with Parkinson’s disease (see • The active substance is rasagiline. Each tablet contains the brain. containing fluoxetine or fluvoxamine should be avoided. section 2). 1 mg rasagiline (as hemitartrate). If you are starting treatment with Rasagiline, you should • The other ingredients are microcrystalline cellulose, 2. What you need to know before you take wait at least 5 weeks after stopping fluoxetine treatment. Other side effects pregelatinised starch (from maize starch), maize starch, If you are starting treatment with fluoxetine or talc and stearic acid. Rasagiline fluvoxamine, you should wait at least 14 days after Very common (may affect more than 1 in 10 people) stopping Rasagiline treatment. • involuntary movements (dyskinesia) Do not take Rasagiline: • headache What Rasagiline tablets look like and contents of • if you are allergic to rasagiline or any of the other Tell your doctor or pharmacist if you are smoking or the pack ingredients of this medicine (listed in section 6) intend to stop smoking. Smoking could decrease the Common (may affect up to 1 in 10 people) The tablets are white to off-white, round, flat, bevel edged, 280 mm • if you have severe liver problems. amount of Rasagiline in the blood. • abdominal pain 8 mm in diameter, debossed with ‘R’ on one side and ‘1’ • fall on the other side. Do not take the following medicines while taking Pregnancy, breast-feeding and fertility • allergy Rasagiline: If you are pregnant or breast-feeding, think you may be • fever Rasagiline tablets are available in pack sizes of 28, 30, 60 • monoamine oxidase (MAO) inhibitors (e.g. for pregnant or are planning to have a baby, ask your doctor • flu (influenza) or 100 tablets. treatment of depression or Parkinson’s disease, or or pharmacist for advice before taking this medicine. • general feeling of being unwell (malaise) Not all pack sizes may be marketed. used for any other indication), including medicinal You should avoid taking Rasagiline if you are pregnant, • neck pain and natural products without prescription e.g. as the effects of Rasagiline on pregnancy and the • chest pain (angina pectoris) Marketing Authorisation Holder and Manufacturer St. John's Wort unborn child are not known. • low blood pressure when rising to a standing position Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, • pethidine (a strong pain killer). with symptoms like dizziness/light-headedness Beverley, East Yorkshire, HU17 0LD, United Kingdom You must wait at least 14 days after stopping Driving and using machines (orthostatic hypotension) Rasagiline treatment and starting treatment with MAO Ask your doctor for advice before you drive and operate • decreased appetite This leaflet was last revised in 01/2018 inhibitors or pethidine. machines, since Parkinson’s disease itself as well as • constipation the treatment with Rasagiline may influence your ability • dry mouth Warnings and precautions to do so. Rasagiline can make you feel dizzy or drowsy; • nausea and vomiting Talk to your doctor or pharmacist before taking it can also cause episodes of sudden sleep onset. • flatulence Rasagiline: • abnormal results of blood tests (leucopenia) • if you have any liver problems. This might be enhanced if you take other medicines to • joint pain (arthralgia) You should speak with your doctor about any treat the symptoms of your Parkinson’s disease, or if • musculoskeletal pain suspicious skin changes. you take medicines which can make you feel drowsy, or • joint inflammation (arthritis) if you drink alcohol while taking Rasagiline. If you have • numbness and muscle weakness of the hand (carpal Tell your doctor if you or your family/carer notices that experienced somnolence and/or episodes of sudden tunnel syndrome) you are developing unusual behaviours where you sleep onset before, or while taking Rasagiline do not • decreased weight cannot resist the impulse, urges or cravings to carry out drive or operate machinery (see section 2). • abnormal dreams certain harmful or detrimental activities to yourself or • difficulty in muscular coordination (balance disorder) others. These are called impulse control disorders. In 3. How to take Rasagiline • depression patients taking Rasagiline and/or other medicines used • dizziness (vertigo) to treat Parkinson’s disease, behaviours such as Always take this medicine exactly as your doctor has • prolonged muscle contractions (dystonia) compulsions, obsessive thoughts, addictive gambling, told you. Check with your doctor or pharmacist if you • runny nose (rhinitis) excessive spending, impulsive behaviour and an are not sure. • irritation of the skin (dermatitis) abnormally high sex drive or an increase in sexual The recommended dose of Rasagiline is 1 tablet of • rash thoughts or feelings have been observed. Your doctor • bloodshot eyes (conjunctivitis) may need to adjust or stop your dose (see section 4). 1mg taken by mouth once daily. Rasagiline may be taken with or without food. • urinary urgency Rasagiline may cause drowsiness and may cause you If you take more Rasagiline than you should Uncommon (may affect up to 1 in 100 people) to suddenly fall asleep during day time activities, If you think that you may have taken too many - stroke (cerebrovascular accident) especially if you are taking other dopaminergic Rasagiline tablets, contact your doctor or pharmacist - heart attack (myocardial infarction) medicinal products (used for the treatment of immediately. Take the Rasagiline carton/blister with you - blistering rash (vesiculobullous rash) Parkinson’s disease). For further information please to show the doctor or pharmacist. refer to section driving and using machines.
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