Selegiline Hydrochloride 5mg Tablets
PACKAGE LEAFLET : INFORMATION FOR THE USER Selegiline hydrochloride 5 mg Tablets
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 further questions, ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Selegiline hydrochloride Tablets are and what they are used for
2. Before you take Selegiline hydrochloride Tablets
3. How to take Selegiline hydrochloride Tablets
4. Possible side effects
5. How to store Selegiline hydrochloride Tablets
6. Further information
1. What Selegiline hydrochloride Tablets are and what they are used for
Selegiline hydrochloride belongs to a group of medicines called Monoamine oxidase-B Inhibitors (MAOI’s). It works by preventing the break down of dopamine (a chemical in the brain).
On its own this medicine can treat the early stages of Parkinson’s disease, delaying the need for additional medicines. This medicine can also be used together with other treatments 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.
2. Before you take Selegiline hydrochloride Tablets Do not take this medicine if:
• You have ever suffered an allergic reaction from selegiline hydrochloride or any of the other inactive ingredients in this medicine (see section 6. Further information).
• You suffer from a stomach or duodenal ulcer - an ulcer (a hole in the lining) of the duodenum (the first part of the small intestine).
• You are taking pethidine (a strong painkiller) or any other opioid (e.g. codeine, morphine).
• You are taking or have recently taken, within the last 5 weeks, any antidepressant medicine, particularly tricyclic antidepressants such as amitriptyline, protriptyline, clomipramine, dosulepin or lofepramine.
• You are taking or have taken, within the last 1-2 weeks, any of the following medicines for depression: sertraline, paroxetine, moclobemide, fluoxetine, citalopram, escitalopram, fluvoxamine or venlafaxine.
• You have a disorder of movement other than that caused by Parkinson’s disease.
• You are taking other drugs which are non-specific Monoamine oxidase Inhibitors (MAOI’s) (e.g. linezolid).
• You are taking sympathomimetics (for the treatment of asthma or allergic reactions e.g. epinephrine, dopamine).
• You are receiving treatment with serotonin-agonists (e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan).
Do not take this medicine if you are also taking levodopa (another drug used for Parkinson’s disease) and you have any of the following conditions:
• High blood pressure, severe angina (chest pain), fast heart beat, an arrhythmia (abnormal heart rhythm) or other heart problems.
• A serious psychiatric disorder.
• An overactive thyroid.
• Narrow-angle glaucoma (eye pain due to sudden increases in eye pressure. Between the pain attacks the eye pressure is normal).
• A tumour of the prostate which restricts urination.
• A tumour of the adrenal gland which produces adrenaline (phaeochromocytoma).
• Advanced dementia.
Take special care with Selegiline hydrochloride Tablets
Please consult your doctor before taking this medicine if:
• You suffer from liver or kidney disease.
• You have ever had a stomach ulcer.
• You suffer from an abnormal heart rhythm, angina, high blood pressure or a serious mental illness (psychosis).
• Agitation develops when you take selegiline and levodopa (another drug used for Parkinson’s disease) together.
• You are taking other centrally acting medicines.
• If you are going to have surgery, make sure your doctor knows you are taking Selegiline hydrochloride Tablets.
Taking other medicines
You should always tell your doctor about any medicines you are taking, including those obtained without a prescription.
If you are already taking other medicines for your Parkinsons disease, your doctor may want you to reduce the dose of these when you start taking this medicine.
Do NOT take Selegiline hydrochloride Tablets in combination with:
• pethidine (a strong painkiller) or any other opioid (e.g. codeine, morphine).
• other drugs which are non-specific Monoamine oxidase Inhibitors (MAOI’s) (e.g. linezolid).
• sympathomimetics (for the treatment of asthma or allergic reactions e.g. epinephrine, dopamine).
• serotonin-agonists (e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan).
Please tell your doctor if you are taking any of the following medicines:
• Non-specific Monoamine oxidase Inhibitors (MAOI’s) such as phenelzine, tranylcypromine, isocarboxazid.
• Levodopa, another drug used for Parkinson’s disease.
• Digoxin or warfarin (or other anticoagulant drugs).
• Nasal decogestants (to ease a blocked nose).
• Hypertensive or antihypertensive medicines (medicines used for the treatment of high blood pressure e.g. captopril, enalapril, lisinopril or perindopril).
• Sedatives or hypnotics (for sleeping disorders e.g. zolpidem or zopiclone).
• Amantadine and anticholinergic drugs used to treat for example Parkinson’s, asthma, chronic bronchitis, cystitis, gastritis.
• Oral contraceptives (e.g. “the Pill”)
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine. Avoid taking this medicine if you are pregnant, planning to become pregnant or breast-feeding.
Taking with food and drink
Your doctor may recommend that you avoid certain foods containing tyramine (a naturally occurring substance in the body that supports blood pressure) e.g. mature cheese, broad beans, Bovril, yeast extracts, fermented soya bean products - contained in some Chinese foods, whilst taking Selegiline hydrochloride Tablets, as there is a risk of hypertension (high blood pressure).
Do not drink alcohol when you are being treated with this medicine.
Driving and using machines
This medicine may affect your ability to react and to drive or operate machinery safely, particularly at the start of treatment or while changing medication. You should not drive or operate machinery unless you are sure you are not affected.
The 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.
Important information about some of the ingredients of Selegiline hydrochloride Tablets
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Selegiline hydrochloride Tablets
Please take your medicine as instructed by your doctor.
Remember to take your medicine according to directions given otherwise your medicine cannot work effectively. Your doctor will normally start you on a dose of 10 mg (two tablets). This medicine can be taken as a single daily dose in the morning or taken in two parts, halfdose 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.
Your doctor will tell you how long you should continue to take this medicine.
If you feel unwell after taking this medicine, tell your doctor immediately.
If you take more Selegiline hydrochloride Tablets than you should
contact your nearest casualty department or tell your doctor/pharmacist immediately. Take this leaflet and any left over tablets with you, so that the doctor knows what you have taken.
If you forget to take Selegiline hydrochloride Tablets take your dose as soon as you remember unless it is almost time for your next dose, in which case just take this next dose when it is due and forget the missed dose.
Do not take more than the recommended dose in 24 hours.
4. Possible side effects
Like all medicines, this medicine can cause side effects in, although not everybody gets them.
Tell your doctor immediately if you notice any of the following serious side effects:
• depression
• chest pain
• low blood pressure (hypotension)
• muscle pain or weakness
• diarrhoea
Very common side effects (affect more than 1 in 10 people):
• abnormal involuntary movements (hyperkinesia)
Common side effects (affect less than 1 in 10 people):
• confusion, hallucinations, serious psychiatric symptoms
• light-headedness (dizziness), headache
• low blood pressure
• dry mouth, feeling sick (nausea)
• changes in liver values (abnormal liver function tests)
• slow heart beat (bradycardia)
Uncommon side effects (affect less than 1 in 100 people):
• difficulty sleeping
• fast heart rate (supraventricular tachycardia)
• mood swings
Rare side effects (affect less than 1 in 1,000 people):
• skin reactions
• dizziness on standing (“head rush”) (postural hypotension)
The following side effects have also been reported:
• excessive perspiration
• depression, anxiety, irritability
• tiredness, difficulty sleeping (insomnia), agitation, a sensation of spinning (vertigo), loss of balance, muscle weakness
• blurred vision
• irregularity of pulse, palpitations, chest pain, high blood pressure, fainting (syncope)
• swelling of the ankles
• shortness of breath
• loss of appetite, other gastrointestinal disorders, diarrhoea
• loss of hair
• an increased need to pass urine, problems urinating
• increased sexual urges (hypersexuality)
When this medicine is taken with levodopa (another drug used for Parkinson’s disease) this may increase the side effects of levodopa. Please tell your doctor if the following side effects occur:
• agitation, confusion, hallucination, sleeplessness, restlessness, dizziness on standing (“head rush”) (postural hypotension), irregular heartbeart
• excessive uncontrollable movements after taking this medicine
If you suffer from any of these unwanted side effects or any other effects not mentioned in this leaflet, please talk to your doctor.
5. How to store Selegiline hydrochloride Tablets Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use after the expiry date printed on the blister strip or carton.
If you notice any defects or signs of deterioration in the tablets (such as broken tablets), please inform your pharmacist.
6. Further information
What Selegiline hydrochloride Tablets contain
The active ingredient is selegiline hydrochloride.
Each tablet contains 5 mg of selegiline hydrochloride and also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, povidone and stearic acid.
What Selegiline hydrochloide Tablets look like and the contents of the pack The white tablets are round and flat with a breakline on one side.
This medicine is available in blister packs containing 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany.