1 mg rasagiline tablets
1. What AZILECT is and what it is used for
AZILECT contains the active substance rasagiline and is used to treat Parkinson’s disease in adults. It can be used with or without levodopa (another medicine to treat Parkinson’s disease ).
In Parkinson’s disease, there is a lack of cells that produce dopamine in the brain. Dopamine is a substance in the brain involved in movement control. AZILECT helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking AZILECT
Do not take AZILECT
- if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6)
- if you have severe liver problems.
Do not take the following medicines while taking AZILECT:
- Monoamine oxidase (MAO) inhibitors (medicines used to treat depression or Parkinson’s disease or any other indication), including herbal medicines and over-the-counter medicines, e.g. St. John’s wort.
- Pethidine (a powerful painkiller).
You must wait at least 14 days after stopping AZILECT treatment before starting treatment with an MAOI or pethidine.
Warnings and cautions
Talk to your doctor before taking AZILECT
- if you have liver problems
- if you have any kind of suspected skin change. Treatment with AZILECT may increase the risk of skin cancer.
Tell your doctor if you or your family/caregiver notices that you are developing an unusual behavior where you can not resist impulses urges or temptations to engage in certain activities that may harm yourself or others. This behavior is called impulse control disorder. In patients taking AZILECT and / or other medicines for Parkinson’s disease, obsessive-compulsive behavior, obsessive-compulsive disorder, gambling addiction, excessive spending, impulsive behavior, and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust your dose or stop treatment (see section 4).
AZILECT can cause drowsiness and cause you to suddenly fall asleep in connection with everyday activities during the day. This is especially true if you are also taking other dopaminergic medicines (used to treat Parkinson’s disease ). For further information, see section Driving and using machines.
Children and young people
It is not relevant to use AZILECT in children and adolescents. AZILECT is therefore not recommended for use under 18 years of age.
Other medicines and AZILECT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important that you tell your doctor if you are taking any of the following medicines:
- Certain antidepressant drugs (selective serotonin reuptake inhibitors, selective serotonin noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- Antibiotics -läkemedlet ciprofloxacin against infection s
- The antitussive dextromethorphan
- Sympathomimetics of the type found in eye drops, nasal decongestants, and cold medicines containing ephedrine or pseudoephedrine
The use of AZILECT in combination with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you start treatment with AZILECT, you should wait at least five weeks after stopping treatment with fluoxetine. If you start treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking can reduce the amount of AZILECT in the blood.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As it is not known how AZILECT affects the pregnancy and the unborn baby, you should avoid taking AZILECT if you are pregnant.
Driving and using machines
Consult a physician before driving or using machines, as both Parkinson’s disease itself and treatment with AZILECT may affect your ability to do so. AZILECT can make you feel dizzy and drowsy. It can also cause sudden sleep attacks.
This may be worse if you are taking other medicines to treat the symptoms of Parkinson’s disease, if you are taking medicines that may cause drowsiness or if you drink alcohol while taking AZILECT. If you have experienced drowsiness ( somnolence) and/or sudden sleep attacks before or in connection with taking AZILECT, do not drive or use machines (see section 2).
3. How to take AZILECT
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of AZILECT is 1 tablet of 1 mg daily, taken orally. AZILECT can be taken with or without food.
If you take more AZILECT than you should
If you think you have taken too many AZILECT tablets, contact your doctor or pharmacist immediately. Bring the carton/blister pack or jar of AZILECT to see your doctor or pharmacist.
Reported symptoms due to overdose of AZILECT include mild euphoric mood (a mild form of mania), extremely high blood pressure, and serotonergic syndrome (see section 4).
If you forget to take AZILECT
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual when it’s time to take it.
If you stop taking AZILECT
Do not stop taking AZIELCT without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you notice any of the following symptoms. You may need urgent medical advice or treatment:
- if you develop abnormal behaviors such as obsessive-compulsive behavior, obsessive-compulsive disorder, gambling addiction, excessive shopping or spending, impulsive behavior, an abnormally high sex drive, or increase in sexual thoughts (impulse control disorders) (see section 2)
- if you see or hear things that do not exist (hallucinations)
- if you experience hallucinations, fever, restlessness, tremors, and sweating in any combination (serotonergic syndrome)
- Contact your doctor if you notice any suspected skin change as there may be an increased risk of skin cancer ( melanoma ) when using this medicine (see section 2).
Other side effects ar
Very common (may affect more than 1 user in 10)
- Involuntary movements ( dyskinesia )
- Headache
Common (may affect up to 1 in 10 people)
- Stomach pain
- Case
- Allergy
- Fever
- Influenza
- Feeling sick
- Nackont
- Chest pain (angina)
- Drop-in blood pressure when getting up with symptoms such as dizziness ( orthostatic hypotension )
- Decreased appetite
- Constipation
- Dry mouth
- Nausea and vomiting
- Gases in the stomach ( flatulence )
- Abnormal blood test results ( leukopenia )
- Joint pain ( arthralgia )
- Muscle / skeletal pain
- Arthritis ( arthritis )
- Numbness and weakening of the muscles in the hand ( carpal tunnel syndrome )
- Reduced weight
- Dream disorders
- Difficulty coordinating muscles (balance disorder)
- Depression
- Dizziness (fraud)
- Abnormal muscle tension ( dystonia )
- Rinnsnuva ( rhinitis )
- Irritated skin ( dermatitis )
- Rash
- Eye inflammation ( conjunctivitis )
- Urination
Uncommon (may affect up to 1 in 100 people)
- Stroke ( cerebrovascular event)
- Heart attack (heart attack)
- Skin rash with blisters (vesicular bullous rash)
Has been reported (occurs in an unknown number of users)
- High blood pressure
- Excessive drowsiness
- Sudden sleep attack
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store AZILECT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, jar, or blister after EXP. date / EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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 rasagiline. Each tablet contains 1 mg rasagiline (as mesylate).
- The other ingredients are mannitol, silica ( colloidal, anhydrous), corn starch, pregelatinized corn starch, stearic acid, talc.
What the medicine looks like and the contents of the pack
AZILECT tablets are white to off-white, round, flat tablets with a beveled edge, marked with “GIL” and “1” on one side and smooth on the other side.
The tablets are available in blister packs of 7, 10, 28, 30, 100, and 112 tablets or in a can containing 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holders of marketing authorization:
Teva BV
Swensen 5
2031 GA Haarlem
Netherlands
Manufacturer:
Teva Pharmaceuticals Europe BV
Swensen 5
2031 GA Haarlem
Netherlands
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Teva Operations Poland Sp.z oo
ul. Mogilska 80,
31-546 Krakow, Poland
Poland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203 |
| BulgariaTeva Pharmaceuticals Bulgaria ЕООДTel: +359 2 489 95 82 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG, Belgium / BelgiumTel: +32 3 820 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 6400 |
| DenmarkTeva Denmark A / STel: +45 4498 5511 | MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +353 51 321 740 |
| GermanyTeva GmbHTel: +800 53 23 66 48 | The NetherlandsTeva Nederland BVTel: +31 (0) 800 0228400 |
| EestiTeva Eesti esindusUAB Sicor Biotech Eesti subsidiaryTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66775590 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 72 79 099 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel .: +43 (0) 1 97007 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| France Teva HealthTel: +33 1 55 91 7800 | PortugalTeva Pharma – ProductsPharmacists LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel .: + 385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +4021 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 51 321 740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 572 679 11 |
| ItalyTeva Italia SrlTel: +39 028917981 | Finland / Finlandratiopharm OyPuh / Tel: +358 20 180 5900 |
| ΚύπροςTeva Αλλάς Α.Ε., .λλάδα:Ηλ: +30 210 72 79 099 | |
| LatviaUAB “Sicor Biotech” branch of LatviaTel: +371 67 323 666 | United KingdomTeva UK LimitedTel: +44 (0) 1977 628500 |