Azilect

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  • Azilect
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Staðsetning

  • Fáanlegt í:
  • Azilect
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  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Anti Parkinson drugs
  • Lækningarsvæði:
  • Parkinson Disease
  • Ábendingar:
  • Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations.
  • Vörulýsing:
  • Revision: 20

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000574
  • Leyfisdagur:
  • 20-02-2005
  • EMEA númer:
  • EMEA/H/C/000574
  • Síðasta uppfærsla:
  • 29-05-2019

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United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/271560/2016

EMEA/H/C/000574

EPAR summary for the public

Azilect

rasagiline

This is a summary of the European public assessment report (EPAR) for Azilect. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Azilect.

What is Azilect?

Azilect is a medicine that contains the active substance rasagiline. It is available as tablets (1 mg).

What is Azilect used for?

Azilect is used to treat Parkinson’s disease. Parkinson’s disease is a progressive brain disorder that

causes shaking, slow movement and muscle stiffness. Azilect can be used either alone, or as an add-on

to levodopa (another medicine used in Parkinson’s disease) in patients who are having ‘fluctuations’

towards the end of the period between levodopa doses. Fluctuations are linked to a reduction in the

effects of levodopa, when the patient experiences sudden switches between being ‘on’ and able to

move, and being ‘off’ and immobile.

Azilect can only be obtained with a prescription.

How is Azilect used?

The standard dose of Azilect is one tablet once a day.

How does Azilect work?

The active substance in Azilect, rasagiline, is a ‘monoamine oxidase-B inhibitor’. It blocks the enzyme

monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.

Azilect

EMA/271560/2016

Page 2/3

Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells. In

patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of

dopamine in the brain decreases. The patients then lose their ability to control their movements

reliably. By increasing levels of dopamine in the parts of the brain that control movement and

co-ordination, Azilect improves the signs and symptoms of Parkinson’s disease, such as stiffness and

slowness of movement.

How has Azilect been studied?

Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson’s

disease. In the first study, two different doses of Azilect taken alone were compared with placebo (a

dummy treatment) in 404 patients with early-stage disease. The main measure of effectiveness was

the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson’s Disease

Rating Scale, UPDRS).

The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was

added to the patients’ existing treatment including levodopa. It was compared with placebo or

entacapone (another medicine for Parkinson’s disease). The studies lasted 26 and 18 weeks,

respectively. The main measure of effectiveness was the time spent in the ‘off’ state during the day, as

recorded in patients’ diaries.

What benefit has Azilect shown during the studies?

Azilect was more effective than placebo in all of the studies. In the study where Azilect was used alone,

patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points

over the 26-week study from a starting value of 24.69. This was compared with a rise of 4.07 points in

the patients taking placebo from a starting value of 24.54. A fall in the UPDRS score indicates an

improvement in symptoms, while a rise indicates a worsening of symptoms.

When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off’ state more than

placebo did. In both studies, patients adding Azilect spent an average of around one hour less in the

‘off’ state than those adding placebo. A similar decrease in time spent in the ‘off’ state was seen in

patients taking entacapone.

What is the risk associated with Azilect?

The most common side effect with Azilect (seen in more than 1 patient in 10) is headache. For the full

list of all side effects reported with Azilect, see the package leaflet.

Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal

preparations obtained without prescription such as St John’s wort. It must also not be used with

pethidine (a painkiller). There should be at least 14 days between stopping treatment with Azilect and

starting treatment with another monoamine oxidase inhibitor or with pethidine. Azilect must not be

used in patients who have severe problems with their liver. For the full list of restrictions, see the

package leaflet.

Why has Azilect been approved?

The CHMP decided that Azilect’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Azilect

EMA/271560/2016

Page 3/3

Other information about Azilect

The European Commission granted a marketing authorisation valid throughout the European Union for

Azilect on 21 February 2005.

The full EPAR for Azilect can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Azilect,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

AZILECT 1 mg tablets

rasagiline

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What AZILECT is and what it is used for

What you need to know before you take AZILECT

How to take AZILECT

Possible side effects

How to store AZILECT

Contents of the pack and other information

1.

What AZILECT is and what it is used for

AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson’s

disease in adults. It can be used together with or without Levodopa (another medicine that is used to

treat Parkinson’s disease).

With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a

chemical in the brain involved in movement control. AZILECT helps to increase and sustain levels of

dopamine in the brain.

2.

What you need to know before you take 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 (e.g. for treatment of depression or Parkinson’s disease,

or used for any other indication), including medicinal and natural products without prescription

e.g. St. John's Wort.

Pethidine (a strong pain killer).

You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO

inhibitors or pethidine.

Warnings and precautions

Talk to your doctor before taking AZILECT

If you have any liver problems

You should speak with your doctor about any suspicious skin changes.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where

you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to

yourself or others. These are called impulse control disorders. In patients taking AZILECT and/or

other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive

thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex

drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust

or stop your dose (see section 4).

AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day

time activities, especially if you are taking other dopaminergic medicinal products (used

for the treatment of Parkinson’s disease). For further information please refer to section

driving and using machines.

Children and adolescents

There is no relevant use of AZILECT in children and adolescents. Therefore, AZILECT is not

recommended for use under the age of 18.

Other medicines and AZILECT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

Especially tell your doctor if you are taking any of the following medicines:

Certain antidepressants

(selective serotonin reuptake inhibitors, selective serotonin-

norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)

The antibiotic ciprofloxacin used against infections

The cough suppressant dextromethorphan

Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold

medicine containing ephedrine or pseudoephedrine

The use of AZILECT together with the antidepressants containing

fluoxetine or fluvoxamine should

be avoided.

If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine

treatment.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after

stopping AZILECT treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking.

Smoking could decrease

the amount of AZILECT in the blood.

Pregnancy, breast-feeding 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.

You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and

the unborn child are not known.

Driving and using machines

Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as

well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel

dizzy or drowsy; it can also cause episodes of sudden sleep onset.

This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease,

or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking

AZILECT. If you have experienced somnolence and/or episodes of sudden sleep onset before, or

while taking AZILECT do not drive or operate machinery (see section 2).

3.

How to take AZILECT

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily. AZILECT may

be taken with or without food.

If you take more AZILECT than you should

If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist

immediately. Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of

mania), extremely high blood pressure and serotonin 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 normally, when it is

time to take it.

If you stop taking AZILECT

Do not stop taking AZILECT without first talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

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

Contact you doctor right away

if you notice any of the following symptoms. You may need urgent

medical advice or treatment:

If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive

gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex

drive or an increase in sexual thoughts (impulse control disorders) (see section 2).

If you see or hear things which are not there (hallucinations).

Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin

syndrome)

If you notice any suspicious skin changes because there is a higher risk of skin cancer (not

exclusively melanoma) in patients with Parkinson’s disease (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)

Involuntary movements (dyskinesia)

Headache

Common (may affect up to 1 in 10 people)

Abdominal pain

Fall

Allergy

Fever

Flu (influenza)

General feeling of being unwell (malaise)

Neck pain

Chest pain (angina pectoris)

Low blood pressure when rising to a standing position with symptoms like dizziness/light-

headedness (orthostatic hypotension)

Decreased appetite

Constipation

Dry mouth

Nausea and vomiting

Flatulence

Abnormal results of blood tests (leucopenia)

Joint pain (arthralgia)

Musculoskeletal pain

Joint inflammation (arthritis)

Numbness and muscle weakness of the hand (carpal tunnel syndrome)

Decreased weight

Abnormal dreams

Difficulty in muscular coordination (balance disorder)

Depression

Dizziness (vertigo)

Prolonged muscle contractions (dystonia)

Runny nose (rhinitis)

Irritation of the skin (dermatitis)

Rash

Bloodshot eyes (conjunctivitis)

Urinary urgency

Uncommon (may affect up to 1 in 100 people)

Stroke (cerebrovascular accident)

Heart attack (myocardial infarction)

Blistering rash (vesiculobullous rash)

Not known: frequency cannot be estimated from the available data

Elevated blood pressure

Excessive drowsiness

Sudden onset of sleep

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

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, bottle or blister after EXP.

The expiry date refers to the last day of that month.

Do not store above 30

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What AZILECT contains

The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate).

The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised

maize starch, stearic acid, talc.

What AZILECT looks like and contents of the pack

AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with

“GIL” and “1” underneath on one side and plain on the other side.

The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing

30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturers

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Teva Operations Poland Sp.z o.o.

ul. Mogilska 80

31-546 Krakow

Poland

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB "Sicor Biotech"

Tel: +370 5 266 0203

България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG,

Belgique/Belgien

Tél/Tel: +32 3 820 73 73

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 6400

Danmark

Teva Denmark A/S

Tlf: +45 4498 5511

Malta

Teva Pharmaceuticals Ireland

L-Irlanda

Tel: +353 51 321 740

Deutschland

Teva GmbH

Tel: +800 53 23 66 48

Nederland

Teva Nederland B.V.

Tel: +31 (0) 800 0228400

Eesti

Teva Eesti esindus

UAB Sicor Biotech Eesti filiaal

Tel: +372 6610801

Norge

Teva Norway AS

Tlf:

+47 66775590

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel.: +43 (0)1 97007

España

Teva Pharma, S.L.U.

Tel: +34 91 387 32 80

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

France

Teva Santé

Tél: +33 1 55 91 7800

Portugal

Teva Pharma - Produtos

Farmacêuticos Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel.: + 385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

Actavis Pharmaceuticals Iceland ehf.

Sími: +354 550 3300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 572 679 11

Italia

Teva Italia S.r.l.

Tel: +39 028917981

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: + 46 42 12 11 00

Latvija

UAB "Sicor Biotech" filiāle Latvijā

Tel: +371 67 323 666

United Kingdom

Teva UK Limited

Tel: +44(0) 1977 628500

This leaflet was last revised in {month YYYY}.