Selegiline Hydrochloride 5mg Tablets
Patient Information Leaflet
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Selegiline Hydrochloride 5mg Tablets but will be referred to as Selegiline Hydrochloride throughout the leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Selegiline Hydrochloride 10mg Tablets, Selegiline Hydrochloride 10mg/5ml Syrup.
In this leaflet:
Q What Selegiline Hydrochloride is and what it is used for Q Before you take Selegiline Hydrochloride Q How to take Selegiline Hydrochloride Q Possible side effects Q How to store Selegiline Hydrochloride Q Further information
Q What Selegiline Hydrochloride is and what it is used for
Selegiline Hydrochloride is available as a 5 mg and 10 mg Tablet and as Selegiline Hydrochloride 10 mg/5 ml Syrup. Selegiline Hydrochloride is a monoamine oxidase-B inhibitor, and is used in the treatment of Parkinson's disease. Selegiline Hydrochloride may be taken alone in the early stages of your condition, delaying the need for the addition of other medicines. Selegiline Hydrochloride 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.
Q Before you take Selegiline Hydrochloride
Do not take Selegiline Hydrochloride
* if you are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Selegiline Hydrochloride (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 Selegiline Hydrochloride, speak to your doctor for further advice
* if you are taking pethidine or any other opioid painkillers such as codeine or tramadol
* if you are taking any monoamine oxidase (MAO) inhibitors e.g. the antibiotic linezolid
* if you are taking any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan
* if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion
* if you suffer from stomach or duodenal ulcers
* if you suffer from a movement or muscle disorder not connected to Parkinson's disease.
Taking Selegiline Hydrochloride with Levodopa
Do not take Selegiline Hydrochloride together with Levodopa if you suffer
from any of the following conditions:
* major heart or blood vessel problems (cardiovascular disease)
* 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 Selegiline Hydrochloride Talk to your doctor or
pharmacist if any of the following applies to you:
* if you have uncontrolled high blood pressure, chest pain (angina), the sensation of feeling your heartbeat (palpitations) or an abnormal or erratic heartbeat (arrhythmia)
* if you have kidney or liver problems
* if you are being treated for any mental illness, anxiety or sleep problems
* if you have a history of stomach ulcers
* if you are already taking a medicine called Levodopa as it can cause agitation and uncontrollable movements. Your doctor may need to monitor you closely and alter your dose
* if you are going to have surgery as Selegiline Hydrochloride may interfere with some of the medicines used as part of a general anaesthetic
* if you have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour). See section 4.
* if you are taking Selegiline Hydrochloride Syrup and you have been told by your doctor that you have an intolerance to certain kinds of sugar.
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 cannot be taken with Selegiline Hydrochloride
* pethidine or any other opioid painkillers such as codeine or tramadol cannot be taken with Selegiline Hydrochloride
* the antibiotic linezolid cannot be taken with Selegiline Hydrochloride
* if you are taking any sympathomimetic medicines e.g. medicines used in the treatment of asthma or to relieve nasal congestion - these medicines cannot be taken with Selegiline Hydrochloride
* any medicines for migraine e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan cannot be taken with Selegiline Hydrochloride
* medicines for high or low blood pressure
* medicines for mood or mental illness
* medicines to treat anxiety, sleep problems or to relax the gut muscles (medicines that act on the central nervous system)
* medicines used as part of an anaesthetic
* medicines to treat heart problems (e.g. digitalis) as you may need more frequent check-ups with your doctor
* medicines to thin the blood (anticoagulants) as you may need more frequent check-ups with your doctor
* HRT (hormone replacement therapy)
* altretamine (used to treat ovarian cancer)
* oral contraceptives (The ‘pill', other forms of contraception should be discussed with your doctor).
Selegiline Hydrochloride needs a period of time to be completely removed from the body before starting certain other medicines. Please talk to your doctor for advice if you are thinking about starting other medication.
Taking Selegiline Hydrochloride with food and drink
You may take Selegiline Hydrochloride with food and drink.
Alcohol should be avoided whilst you are taking Selegiline Hydrochloride. Your doctor may recommend that you avoid certain foods containing tyramine such as mature cheese, broad beans, Bovril, yeast extracts or fermented soya bean products.
Pregnancy and breast-feeding
* You should not take Selegiline Hydrochloride if you are pregnant, planning to become pregnant or if you think you may be pregnant.
* You should not take Selegiline Hydrochloride if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Selegiline Hydrochloride may make you feel dizzy, drowsy or slow your reactions, therefore your ability to drive or operate machinery may be affected. If you experience these side effects then do not drive, use tools or operate machinery.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
* Do not drive while taking this medicine until you know how it affects you.
* It is an offence to drive if this medicine affects your ability to drive.
* However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Children
Selegiline Hydrochloride should not be given to children.
Important information about some of the ingredients of Selegiline Hydrochloride 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.
O How to take Selegiline Hydrochloride
Always take Selegiline Hydrochloride 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 10 mg Selegiline
Hydrochloride each day.
This may be taken either as one 10 mg or two 5 mg tablets, or one 5 ml
spoonful of syrup.
* Selegiline Hydrochloride 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.
* Selegiline Hydrochloride 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.
Patient Information Leaflet (continued)
Make sure you ask your pharmacist if the label on your medicine does not tell you how to take Selegiline Hydrochloride.
If you take more Selegiline Hydrochloride 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 Selegiline Hydrochloride immediately contact your doctor or contact your nearest hospital casualty department. Symptoms of an overdose include agitation, feeling irritable, restless or tired, severe headache, shaking, high or low blood pressure, difficulty breathing, shortness of breath, experiencing situations, visions or sounds which are not real (hallucinations), dizziness, fast irregular heartbeat, chest pain, severe muscle spasms, fever, excessive sweating, loss of consciousness and fits.
If you forget to take Selegiline Hydrochloride
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 24 hours.
If you stop taking Selegiline Hydrochloride
Do not stop taking Selegiline Hydrochloride 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.
* a feeling of sickness, dizziness, feeling faint, dry mouth, loss of appetite and problems passing urine
* low blood pressure leading to a feeling of light-headedness, particularly when standing up
* hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)
* low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections and temporary liver problems
* headache, skin reaction and loss of hair.
These side 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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
Q Possible side effects
Like all medicines, Selegiline Hydrochloride can cause side effects, although not everybody gets them.
Very Common (affecting more than 1 person in 10)
* Sore mouth and swollen gums (stomatitis).
Common (affecting more than 1 person in 100, but less than 1 in 10)
* Difficulty controlling your movements or loss of balance (dyskinesias, akinesia, bradykinesia), fall
* slow heart beat (bradycardia)
* dizziness, feeling faint, headache, shaking
* sleep disorders, confusion, experiencing situations, visions or sounds which are not real (hallucinations)
* feeling down (depressed)
* high or low blood pressure
* abnormal liver tests due to increase in liver enzymes
* feeling sick, constipation, diarrhoea, mouth ulcers
* blocked nose, sore throat
* back pain, joint pain (arthralgia), muscle cramps
* tiredness
* ear disorders giving the sensation of dizziness (vertigo)
* excessive sweating.
Uncommon (affecting more than 1 person in 1,000 but less than 1 person in 100)
* Chest pain (angina pectoris), irritability, swelling of the ankles
* irregular, erratic or fast heart beat, the sensation of feeling your heart beat (palpitations)
* problems sleeping, strange dreams, feeling anxious or agitated, changes in mood, altered mental state / loss of contact with reality (psychoses)
* shortness of breath (dyspnoea)
* blurred vision
* low blood pressure leading to a feeling of light-headedness particularly when standing up (orthostatic hypotension)
* problems starting, passing and stopping urination or altered frequency of urination (micturition disorders)
* abnormal liver tests due to increase in liver enzymes (transient rise of serum alanine aminotransferase (ALAT))
* muscle weakness (myopathy)
* low level of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may increase the risk of bleeding, bruising or infections
* loss of appetite
* sore throat (pharyngitis), dry mouth
* hair loss, blisters or spots on skin.
Rare (affecting more than 1 person in 10,000 but less than 1 in 1,000)
* Low blood pressure leading to a feeling of light-headedness, dizziness or fainting, particularly when standing up (postural hypotension)
* skin reactions.
Not Known (frequency cannot be estimated from the available data) However these events can be considered to be very rare
* Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others)
* unusual urges and/or behaviours (such as excessive gambling or other behaviours)
* inability or difficulty passing urine
Side effects when Selegiline Hydrochloride is used with Levodopa When Selegiline Hydrochloride is taken with levodopa this may increase the side effects of levodopa such as:
* excessive, uncontrollable movements after taking your medicine
* confusion, hallucinations, problems sleeping, agitation, feeling restless
* feeling your heartbeat (palpitations), irregular, erratic heart beat, chest pain, swollen ankles and shortness of breath
Q How to store Selegiline Hydrochloride
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* keep container tightly closed.
* Do not take selegiline hydrochloride after the expiry date shown on the carton and blister label. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal.
Only keep this medicine 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 that are no longer required. These measures will help to protect the environment.
* If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
Q Further information
What Selegiline Hydrochloride contains
The active substance is selegiline hydrochloride.
Each tablet contains 5mg of selegiline hydrochloride.
The other ingredients are: mannitol, maize starch, microcrystalline cellulose, povidone and magnesium stearate.
What Selegiline Hydrochloride looks like and contents of the pack
Selegiline Hydrochloride are white, round tablets.
Selegiline Hydrochloride 5mg Tablets are available in packs of 3 x 20 tablets and 2 x 50 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Orion Corporation, Turku, Finland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1485 Selegiline Hydrochloride 5mg Tablets
Revision date: 20/05/15
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