5 mg and 10 mg tablets Selegiline
1. What Eldepryl is and what it is used for
Eldepryl is a drug used to treat Parkinson’s disease. It can be used alone in the early stages of the disease or later with medicines containing levodopa or other Parkinson’s treatment. Medicines containing levodopa are given to most patients with Parkinson’s disease.
Eldepryl relieves Parkinson’s symptoms in the early stages of the disease and prolongs the time until it is necessary to start treatment with levodopa. In patients with the newly diagnosed disease, a combination of Eldepryl and levodopa will delay the development of the disease. At a later stage, when Eldepryl is used as a supplement to levodopa, Eldepryl prolongs the effect of levodopa. This makes it possible to reduce the dose of levodopa.
What you need to know before taking Eldepryl
Do not take Eldepryl:
– if you are allergic to selegiline or any of the other ingredients of this medicine (listed in section 6)
– if you have an active duodenum – or stomach ulcer
– in combination with:
– certain antidepressants so-called selective serotonin reuptake inhibitors ( SSRIs )
– certain antidepressants called serotonin -noradrenaline reuptake inhibitors ( SNRIs )
( venlafaxine )
– tricyclic antidepressant drug
– sympathomimetics (drugs that act on the sympathetic nervous system)
monoamine oxidase inhibitors ( MAOIs ) eg linezolid
– opioid s (pethidine).
Warnings and cautions
if you have:
– had stomach ulcers
unstable high blood pressure
– cardiac arrhythmia s
– severe angina ( angina pectoris )
– severe hepatic impairment
– severe renal impairment
– psychos.
In patients with Parkinson’s disease treated with dopamine agonists and other dopaminergic therapy such as selegiline, impulse control disorders and compulsive behaviors such as pathological gambling, increased libido, increased sexuality, binge eating, compulsive buying behavior, and various repetitive compulsions have been reported.
Other medicines and Eldepryl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines not to be used with Eldepryl:
The effect of the treatment can be affected if Eldepryl is combined with pethidine, a strong painkiller that is often used in surgery. If you are going to have a surgical procedure, you should tell your doctor that you are taking Eldepryl.
Eldepryl should not be taken with sympathomimetics (medicines that work on the sympathetic nervous system).
Eldepryl may also potentiate the effects of certain medicines used to treat depression.
This applies to so-called tricyclic antidepressants, serotonin reuptake inhibitors ( SSRIs ), and serotonin noradrenaline reuptake inhibitors ( SNRIs ). If you are being treated for depression, you must tell your doctor that you are also taking Eldepryl.
Eldepryl can affect the effect of so-called MAO inhibitors (monoamine oxidase inhibitors) and concomitant use should be avoided.
Painkillers containing tramadol may affect the effect of Eldepryl and should not be combined with Eldepryl.
Medicines that may require dose adjustment by your doctor:
Dopamine, which is used in shock conditions and severe heart disease, should be used with caution when using Eldepryl.
Talk to your doctor if you are taking birth control pills. These may enhance the effect of Eldepryl.
Concomitant use of Eldepryl and medicines containing digitalis and anticoagulants(blood thinners) requires careful monitoring and extra caution.
An electric gadget with food, drink, and alcohol
During concomitant treatment with moclobemide ( MAO inhibitor for depression), avoid tyramine-rich foods, such as stored cheese and yeast products. Alcohol should be avoided when using Eldepryl.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Limited experience of use during pregnancy. Electric gadgets should not be used during pregnancy.
It is unknown if selegiline passes into breast milk. Electric gadgets should not be used during breast-feeding.
Driving and using machines
Electric gadgets can cause dizziness and thus affect the ability to drive or use machines. If you experience dizziness while using Eldepryl, you should avoid driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, read all the information in this leaflet
guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to take Eldepryl
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults: as a single dose in the morning: 1 tablet of 10 mg or 2 tablets of 5 mg.
The usual dose for combination therapy with other Parkinson’s medicines:
1-2 tablets of 5 mg (1 tablet of 10 mg) can be taken as a single dose in the morning or divided into a morning and lunch dose.
If you use more Eldepryl then you should
If you have taken too much medicine, always consult a doctor, hospital or
Poison Information Center If you forget to use Eldepryl
If you forget to take a tablet, take it as soon as you remember. If it has been more than 12 hours since you were to take the tablet, do not take it but continue with the next tablet as usual. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Eldepryl can cause side effects, although not everybody gets them.
Common ( may affect up to 1 in 10 people ):
Dizziness, involuntary movements, dry mouth, nausea, transient and/or slightly elevated liver values may occur, confusion, anxiety, hallucinations, mental reactions, headache, slow heartbeat.
Uncommon ( may affect up to 1 in 100 people ):
Mood swings, fast heartbeat, dry mouth, mild transient sleep disturbances.
Rare ( may affect up to 1 in 1,000 people ):
Skin rash, restlessness, difficulty throwing water, falling blood pressure when changing position.
Has been reported ( occurs in an unknown number of users ):
Impulse control disorders and compulsive behaviors such as pathological gambling, increased libido, hypersexuality, binge eating, compulsive buying behavior, and various repetitive compulsions, urinary retention.
In combination with levodopa:
Eldepryl increases the effect of levodopa and allows the side effects of levodopa to be intensified. The most common of these are restlessness, abnormal movements, confusion, hallucinations, low blood pressure (dizziness when getting up), and irregular heartbeat. The side effects usually disappear when the levodopa dose is reduced.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
5. How to store Eldepryl
Keep out of sight and reach of children. Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton.
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.
6. Contents of the packaging and other information
Content declaration
– The active substance is selegiline. The tablets contain 5 mg and 10 mg respectively
selegiline hydrochloride.
– The other ingredients are mannitol, magnesium stearate, povidone, microcrystalline cellulose, and corn starch.
What the medicine looks like and the contents of the pack
5 mg: The tablets are white, round, cupped, diameter 6 mm.
Plastic jar with 100 tablets.
10 mg: The tablets are white, round, cupped with a notch, diameter 8 mm.
Plastic jar with 100 tablets.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com