Sunday, October 16, 2016

Eldepryl





Eldepryl Tablets 5mg



Eldepryl Tablets 10mg



Eldepryl Syrup 10 mg / 5 ml



(Selegiline hydrochloride)




Read all of this leaflet carefully before you start taking this medicine.



  • 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 symptoms are the same as yours.

  • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:



  • 1. What Eldepryl is and what it is used for

  • 2. Before you take Eldepryl

  • 3. How to take Eldepryl

  • 4. Possible side effects

  • 5. How to store Eldepryl

  • 6. Further information





What Eldepryl Is And What It Is Used For



Eldepryl is available as a 5mg and 10mg Tablet and as Eldepryl Syrup 10 mg / 5 ml. Eldepryl is a monoamine oxidase-B inhibitor, and is used in the treatment of Parkinson’s disease. Eldepryl may be taken alone in the early stages of your condition, delaying the need for the addition of other medicines. Eldepryl however can also be used in conjunction with other treatments such as Levodopa to reduce the on-off symptoms or uncontrolled movements you may experience. This happens especially when the effects of the other treatments are wearing-off.



Your doctor will explain why this medicine has been chosen for you.





Before You Take Eldepryl




Do not take Eldepryl



  • if you are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Eldepryl (see Section 6: Further Information)


  • if you are taking any antidepressants (see Taking other medicines). Antidepressants should be stopped a number of weeks before taking Eldepryl, speak to your doctor for further advice.


  • if you are taking pethidine or any other painkillers such as codeine or tramadol


  • if you are taking the antibiotic linezolid


  • if you are taking any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan




Taking Eldepryl with Levodopa



Do not take Eldepryl together with Levodopa if you suffer from any of the following conditions:



  • major heart problems

  • chest pain (angina)

  • high blood pressure (arterial hypertension)

  • an erratic or fast heartbeat (e.g. tachycardia or arrhythmias)

  • an overactive thyroid gland (hyperthyroid disease)

  • an eye condition called narrow angle glaucoma

  • a tumour of your adrenal gland (phaeochromocytoma) or prostate (prostatic adenoma)

  • major mental health problems (e.g. schizophrenia or advanced dementia).




Take special care with Eldepryl



  • If you have uncontrolled high blood pressure, angina, feeling your heartbeat(palpitations) or an arrhythmia (abnormal heart rhythm)

  • if you have kidney or liver problems

  • if you suffer from stomach or duodenal ulcers or bleeding from your gut

  • if you are being treated for any mental illness

  • syrup if you have been told you have an intolerance to certain kinds of sugar.

Tell your doctor or pharmacist if any of the above applies to you.





Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular it is important that you tell your doctor if you are taking any of the following:



  • amantadine, dopamine or levodopa (used to treat Parkinson’s disease)

  • any type of antidepressant e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline and protriptyline

  • pethidine or any other painkillers such as codeine or tramadol

  • the antibiotic linezolid

  • nasal decongestants

  • any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan

  • medicines for high or low blood pressure

  • medicines for mood or mental illness

  • medicines to treat anxiety or sleep problems

  • medicines to treat heart problems (e.g. digitalis)

  • medicines to thin the blood (anticoagulants)

  • HRT (hormone replacement therapy)

  • altretamine (used to treat ovarian cancer)

  • oral contraceptives (The ‘pill’, other forms of contraception should be discussed with your doctor).




Taking Eldepryl with food and drink



You may take Eldepryl with food and drink.


Alcohol should be avoided whilst you are taking Eldepryl.


Your doctor may recommend that you avoid certain foods, such as mature cheese, broad beans, Bovril, yeast extracts or fermented soya bean products.





Pregnancy and breast-feeding



  • You should not take Eldepryl if you are pregnant, planning to become pregnant or if you think you may be pregnant.

  • You should not take Eldepryl if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.





Driving and using machines



Eldepryl should not affect your ability to drive or operation machinery.





Children



Eldepryl should not be given to children.





Important information about some of the ingredients of Eldepryl Syrup



The syrup form of this medicine contains the sugar sucrose. If your doctor has told you that you do not tolerate certain kinds of sugar, contact your doctor before taking this medicine. This applies only to the syrup. Syrup may be harmful to the teeth.






How To Take Eldepryl



Always take Eldepryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Your doctor will normally start you on a dose of 10mg Eldepryl each day.



This may be taken either as one 10mg or two 5mg tablets, or one 5ml spoonful of syrup.



  • Eldepryl can be taken as a single daily dose in the morning, or the prescribed daily dose taken in two parts, half dose in the morning and half-dose at lunchtime. If you take your tablets in the evening or before going to bed they may keep you awake at night.


  • Eldepryl syrup should be shaken well before use. Always replace the cap after use.


  • Your doctor will tell you how long you should continue to take this medicine.

Make sure you ask your pharmacist if the label on your medicine does not tell you how to take Eldepryl.




If you take more Eldepryl than you should



Your doctor has carefully chosen the correct dosage for you so do not take more than the prescribed dose. However, if you accidentally take too much Eldepryl immediately contact your doctor or contact your nearest hospital casualty department.





If you forget to take Eldepryl



If you forget to take a dose, take a dose as soon as you remember, but do not take more than the recommended dose every 24hours.





If you stop taking Eldepryl



Do not stop taking Eldepryl unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.





If someone else takes your medicine



If someone else has swallowed any of your medicine, contact your nearest hospital casualty department or tell a doctor immediately.






Eldepryl Side Effects



Like all medicines, Eldepryl can cause side effects, although not everybody gets them.




Common (affecting more than 1 person in 100, but less than 1 in 10)



  • Dry mouth.

  • Sleep Disturbances, confusion, experiencing situations, visions or sounds, which are not real (hallucinations).




Rare (affecting more than 1 person in 10,000 but less than 1 in 1,000)



  • Skin reactions or irritation.

  • Difficulty passing urine.

If the effects persist, or are causing you a lot of discomfort talk with your doctor.





Very Rare (affecting less than 1 person in 10,000)



Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others).





Side effects with Eldepryl is used with Levodopa



When Eldepryl is taken with levodopa this may increase the side-effects of levodopa such as,



  • confusion, hallucinations, insomnia, agitation

  • a feeling of sickness

  • headache

  • feeling your heartbeat (palpitations)

  • low blood pressure leading to a feeling of light-headedness, particularly when standing up

  • excessive, uncontrollable movements after taking your medicine.

  • Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others).

These effects will usually stop when the amount of levodopa you are taking is reduced.



Talk to your doctor about reducing the dose if you experience any of these effects.




If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How To Store Eldepryl



Keep out of the reach and sight of children. Your medicine could harm children. Do not use Eldepryl after the expiry date which is stated on the carton.



  • Syrup: There are no special storage precautions.


  • Tablets: Store your tables at a temperature below 25ÂșC, in a dry safe place. Tablets provided in plastic bottles should be kept in the container with the lid tightly closed, and tablets provided in blister packs should be stored in the original carton, in order to protect them from moisture.


  • If your doctor decides to stop treatment, return any left-over medicine to your pharmacist. Only keep it if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further Information




What Eldepryl contains



The active substance is Selegiline hydrochloride. The tablets contain either 5mg or 10mg of the active ingredient and 5ml of syrup contains 10mg of the active ingredient.



The other ingredients are as follows;



  • Tablets: mannitol, maize starch, microcrystalline cellulose, povidone and magnesium stearate.

  • Syrup: Methyl, Butyl and Propyl Parahydroxybenzoates, Sucrose, Xanthan Gum T, Saccharin Sodium, Mango Flavour and Purified Water.




What Eldepryl looks like and contents of the pack.



Eldepryl Tables are white in colour. Eldepryl 5mg Tablets are available in a bottle of 100 tablets or blister-packs of 30, 50, 60 or 100 tablets. Eldepryl 10mg Tablets are available in a bottle of 50 or 100 tablets or blister-packs of 30, 50, 60 or 100 tablets.



Eldepryl Syrup is available in bottles of 200ml.





Marketing Authorisation Holder




Orion Corporation

Orionintie 1

FIN-02200 Espoo

Finland





Manufactured by




Orion Corporation

FIN-20101 Turku

Finland





Distributed in the UK by




Orion Pharma (UK) Ltd

Oaklea Court

22 Park Street

Newbury Berkshire

RG14 1EA





This leaflet was last revised in February 2010.



For information on Parkinson’s disease and help available please contact:




Parkinson’s disease Society

215 Vauxhall

Bridge Road

SW1V 1EJ







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