Latuda

Helstu upplýsingar

  • Heiti vöru:
  • Latuda
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Latuda
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Psycholeptics,
  • Lækningarsvæði:
  • Schizophrenia
  • Ábendingar:
  • Treatment of schizophrenia in adults aged 18 years and over.,
  • Vörulýsing:
  • Revision: 15

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002713
  • Leyfisdagur:
  • 19-03-2014
  • EMEA númer:
  • EMEA/H/C/002713
  • Síðasta uppfærsla:
  • 25-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/60300/2014

EMEA/H/C/002713

EPAR summary for the public

Latuda

lurasidone

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

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Latuda.

For practical information about using Latuda, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Latuda and what is it used for?

Latuda is a medicine that contains the active substance lurasidone. It is used to treat adults with

schizophrenia, a mental illness that has a number of symptoms including disorganised thinking and

speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions

(mistaken beliefs).

How is Latuda used?

Latuda is available as tablets (18.5, 37 and 74 mg) and can only be obtained with a prescription. The

recommended starting dose is 37 mg once a day, taken with food at approximately the same time of

the day. Depending on the patient’s response and the judgement of the treating doctor, the dose can

be increased up to a maximum dose of 148 mg once a day. Lower doses should be used in patients

with moderately or severely reduced kidney or liver function and in patients taking certain other

medicines that may affect the levels of Latuda in the blood.

For further information, see the package leaflet.

Latuda

EMA/60300/2014

Page 2/3

How does Latuda work?

The active substance in Latuda, lurasidone, is an antipsychotic medicine. It attaches to and affects

several different receptors for neurotransmitters on the surface of nerve cells in the brain.

Neurotransmitters are chemicals that allow nerve cells to communicate with each other.

Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5-

hydroxytryptamine (also called serotonin) and noradrenaline. Since dopamine, 5-hydroxytryptamine

and noradrenaline play a role in schizophrenia, by blocking their receptors lurasidone helps to

normalise the activity of the brain, reducing symptoms.

What benefits of Latuda have been shown in studies?

Latuda has been investigated in six main studies. Three short-term studies compared Latuda with

placebo (a dummy treatment) over six weeks in a total of 1,466 patients. The main measure of

effectiveness was the change in the patient’s symptoms, measured using a standard scale for

schizophrenia called ‘positive and negative syndrome scale’ (PANSS). In these studies, different doses

of Latuda were shown to be more effective than placebo, lowering the PANSS score by up to 16 points

more than placebo; however, this effect was not consistently demonstrated for each dose and it was

not possible to observe a consistent dose-response relationship. Further analyses of the results were

carried out by the company, which supported the short-term benefits of treatment with Latuda.

One of the short-term studies was continued to 12 months (extension study) to look at the

maintenance of the effect of Latuda in 292 patients, compared with quetiapine; two other studies,

involving 914 patients, looked at the long-term effects of Latuda compared with another schizophrenia

medicine, risperidone, or placebo, respectively. In these long-term studies, the effectiveness of Latuda

was measured by the percentage of patients who relapsed and had symptoms of schizophrenia coming

back during treatment. In the extension study, 21% of patients treated with Latuda had a relapse

within one year, compared with 27% of patients treated with quetiapine, showing that Latuda was at

least as effective as quetiapine. Latuda was not shown to be as effective as risperidone in the second

study, although the available data supported a long-term benefit. The last study showed that 30% of

patients treated with Latuda relapsed within one year, compared with 41% of patients treated with

placebo.

What are the risks associated with Latuda?

The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia

(a constant urge to move) and somnolence (sleepiness). For the full list of all side effects reported with

Latuda, see the package leaflet.

Latuda must not be used together with medicines known as ‘strong CYP3A4 inhibitors’ or ‘strong

CYP3A4 inducers’, which may affect the levels of lurasidone in the blood. For the full list of restrictions,

see the package leaflet.

Why is Latuda approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Latuda’s benefits

are greater than its risks and recommended that it be approved for use in the EU. While both short-

and long-term effectiveness of Latuda have been sufficiently demonstrated, the CHMP noted that in the

short-term studies its effectiveness was found to be moderate. Regarding safety, the side effects of

Latuda were considered similar to those of other medicines of the same type, but it seemed to have

Latuda

EMA/60300/2014

Page 3/3

fewer effects on body metabolism (such as effects on blood levels of sugar and fat, and body weight)

and might have less effect on the activity of the heart than some other available treatments.

What measures are being taken to ensure the safe and effective use of

Latuda?

A risk management plan has been developed to ensure that Latuda is used as safely as possible. Based

on this plan, safety information has been included in the summary of product characteristics and the

package leaflet for Latuda, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan

Other information about Latuda

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

Latuda on 21 March 2014.

The full EPAR and risk management plan summary for Latuda 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 Latuda, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 03-2014.

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

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Latuda 18.5 mg film-coated tablets

Latuda 37 mg film-coated tablets

Latuda 74 mg film-coated tablets

lurasidone

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 Latuda is and what it is used for

What you need to know before you take Latuda

How to take Latuda

Possible side effects

How to store Latuda

Contents of the pack and other information

1.

What Latuda is and what it is used for

Latuda contains the active substance lurasidone and belongs to a group of medicines called

antipsychotics. It is used to treat symptoms of schizophrenia in adults aged 18 years or over.

Lurasidone works by blocking receptors in the brain to which the substances dopamine and serotonin

attach. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to

communicate with each other) that are involved in the symptoms of schizophrenia. By blocking their

receptors, lurasidone helps to normalise the activity of the brain, reducing the symptoms of

schizophrenia.

Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not

there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech and

behaviour and emotional flatness. People with this disorder may also feel depressed, anxious, guilty,

or tense. This medicine is used to improve your symptoms of schizophrenia.

2.

What you need to know before you take Latuda

Do NOT take Latuda if you:

are allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)

are taking medicines which may affect the level of lurasidone in your blood such as:

medicines for fungal infections such as itraconazole, ketoconazole (except as a shampoo),

posaconazole or voriconazole

medicines for an infection such as the antibiotic clarithromycin or telithromycin

medicines for HIV infections such as cobicistat, indinavir, nelfinavir, ritonavir, and

saquinavir

boceprevir, and telaprevir (medicines for chronic hepatitis)

nefazodone (a medicine for depression)

rifampicin (a medicine for tuberculosis)

carbamazepine, phenobarbital and phenytoin (medicines for seizures)

St John’s wort (Hypericum

perforatum

) (herbal medicine for depression).

Warnings and precautions

It may take several days or even weeks before this medicine will have a full effect. Contact your

doctor if you have questions on this medicine.

Talk to your doctor or pharmacist before taking this medicine, or during treatment, especially if you

have:

Suicidal thoughts or behaviour

Parkinson’s disease or dementia

ever been diagnosed with a condition whose symptoms include high temperature and muscle

stiffness (also known as neuroleptic malignant syndrome) or if you have ever experienced

rigidity, tremors or problems moving (extrapyramidal symptoms) or abnormal movements of

the tongue or face (tardive dyskinesia). You should be aware that these conditions may be

caused by this medicine

heart disease or heart disease treatment that makes you prone to low blood pressure or have a

family history of irregular heart beat (including QT prolongation)

a history of seizures (fits) or epilepsy

a history of blood clots, or if someone else in your family has a history of blood clots, as

medicines for schizophrenia have been associated with formation of blood clots

enlarged breasts in male (gynecomastia), milky nipple discharge (galactorrhea), absence of

menstruation (amenorrhea) or erectile dysfunction

diabetes or are prone to diabetes

decreased kidney function

decreased liver function

an increase in your weight

blood pressure dropping upon your standing up which may cause fainting.

If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose,

monitor you more closely or stop treatment with Latuda.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years due to the lack of data

in these patients.

Other medicines and Latuda

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

medicines. This is especially important if you are taking:

any medicines that also work in the brain, as their effects could be additive in a negative way

with the effects of Latuda on your brain

medicines that lower blood pressure, as this medicine can also lower blood pressure

medicines for Parkinson’s disease and restless legs syndrome (e.g. levodopa) as this medicine

can reduce their effects

medicines containing ergot alkaloid derivatives (used for treating migraines), and other

medicines including terfenadine and astemizole (used for treating hay fever and other allergic

conditions), cisapride (used for treating digestive problems), pimozide (used to treating

psychiatric illnesses), quinidine (used for treating heart conditions), bepridil (used for treating

chest pain).

Tell your doctor if you take any of these medicines since your doctor may have to change the dose of

that medicine during treatment with Latuda.

The following medicines may increase the level of lurasidone in your blood:

diltiazem (to treat high blood pressure)

erythromycin (to treat infections)

fluconazole (to treat fungal infections)

verapamil (to treat high blood pressure or chest pain).

The following medicines may decrease the level of lurasidone in your blood:

amprenavir, efavirenz, etravirine (to treat HIV infection)

aprepitant (to treat nausea and vomiting)

armodafinil, modafinil (to treat sleepiness)

bosentan (to treat high blood pressure or ulcers of the fingers)

nafcillin (to treat infections)

prednisone (to treat inflammatory disease)

rufinamide (to treat seizures).

Tell your doctor if you take any of these medicines since your doctor may change your dose of Latuda.

Latuda with food, drink and alcohol

Alcohol should be avoided when taking this medicine. This is because alcohol will have an additive

negative effect.

Do not drink grapefruit juice while you are taking this medicine. Grapefruit can affect the way this

medicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your

doctor for advice before taking this medicine.

You should not take this medicine during pregnancy unless this has been agreed with your doctor.

If your doctor decides that the potential benefit of treatment during pregnancy justifies the potential

risk to your unborn baby, your doctor will monitor your baby closely after birth. This is because the

following symptoms may occur in newborn babies of mothers that have used lurasidone in the last

trimester (last three months) of their pregnancy:

shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and

difficulty in feeding.

If your baby develops any of these symptoms you should contact your doctor.

It is not known if lurasidone passes into breast milk. Talk to your doctor if you are breast-feeding, or if

you plan to breast-feed.

Driving and using machines

Sleepiness, dizziness and vision problems may occur during treatment with this medicine (see section

4, Possible side effects). Do not drive or use any tools or machines until you know that this medicine

does not affect you in a negative way.

3.

How to take Latuda

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

or pharmacist if you are not sure.

Your dose will be decided by your doctor and may depend on:

how well you respond to a dose

if you are taking some other medicines (see section 2, Other medicines and Latuda)

if you have kidney or liver problems.

The recommended starting dose is 37 mg once a day.

The dose may be increased or decreased by your doctor within the dose range of 18.5 mg to 148 mg

once a day. The maximum dose should not exceed 148 mg once a day.

Swallow your tablet(s) whole with water, in order to mask the bitter taste. You should take your dose

regularly every day at the same time of the day, so that it is easier to remember it. You must take this

medicine with food or just after eating, as this helps the body to take up the medicine and allows it to

work better.

If you take more Latuda than you should

If you take more of this medicine than you should, contact your doctor immediately. You may

experience sleepiness, tiredness, abnormal body movements, problems with standing and walking,

dizziness from low blood pressure, and abnormal heart beats.

If you forget to take Latuda

Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose

on the day after the missed dose. If you miss two or more doses, contact your doctor.

If you stop taking Latuda

If you stop taking this medicine you will lose the effects of the medicine. You should not stop this

medicine unless told to do so by your doctor as your symptoms may return.

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.

If you notice any of the following symptoms

seek medical attention immediately

a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath,

itching, skin rash and sometimes a drop in blood pressure. These reactions are seen rarely (may

affect up to 1 in 1,000 people).

A serious blistering rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson

syndrome)

Fever, sweating, muscle stiffness, and reduced consciousness. These could be symptoms of a

condition known as neuroleptic malignant syndrome. These reactions are seen rarely (may

affect up to 1 in 1,000 people).

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in

the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in

breathing. If you notice any of these symptoms seek medical advice immediately.

The following side effects may also happen:

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

feeling of restlessness and inability to sit still

sleepiness.

Common (may affect up to 1 in 10 people):

Parkinsonism: This is a medical term that describes many symptoms which include increase in

saliva secretion or watery mouth, drooling, jerks when bending the limbs, slow, reduced or

impaired body movements, no expression in the face, muscle tightness, stiff neck, muscle

stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking,

persistent blinking in response to tapping of the forehead (an abnormal reflex)

speech problems, unusual muscle movements; a collection of symptoms known as

extrapyramidal symptoms (EPS) which typically will involve unusual purposeless involuntary

muscle movements.

dizziness

muscle spasms and stiffness

nausea (feeling sick), vomiting (being sick)

rash and itching

indigestion

dry mouth or excess saliva

abdominal pain

difficulty sleeping, tiredness, agitation and anxiety

weight gain

increase in creatine phosphokinase (an enzyme in muscles) seen in blood tests

increase in creatinine (a marker of kidney function) seen in blood tests.

Uncommon (may affect up to 1 in 100 people):

slurred speech

nightmares

muscle aches

joint pains

problems walking

rigid posture

increased blood prolactin, increased blood glucose (blood sugar), increase in some liver

enzymes, seen in blood tests

increased blood pressure

blood pressure dropping upon standing up which may cause fainting

fast heart beat

common cold

hot flush

blurred vision

reduced appetite

sweating

pain when passing urine.

uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)

low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and

coma (hyponatremia).

lack of energy (lethargy)

gas (flatulence)

neck pain

back pain

Rare (may affect up to 1 in 1,000 people):

Rhabdomyolysis which is the breakdown of muscle fibres that leads to the release of muscle

fibre contents (myoglobin) into the bloodstream, seen as muscle pain, being sick, being

confused, an abnormal heart rate and rhythm, and possibly dark urine

increase in eosinophils (a type of white blood cell).

swelling beneath the skin surface (angioedema)

Not known (frequency cannot be estimated from the available data):

reduced levels of white blood cells (which fight infection) and red blood cells (which carry

oxygen around the body)

deliberate injury to oneself

sudden feelings of anxiety

sleep disorder

spinning sensation

seizure (fits)

chest pain

abnormal nerve impulses in the heart

slow heart rate

diarrhoea

difficulty swallowing

irritation to lining of stomach

kidney failure

newborn babies may show the following: agitation, increase or decreases in muscle tone, tremor,

sleepiness, breathing or feeding problems

abnormal breast enlargement, breast pain, milk secretion from breasts

problems with erections

painful or absence of menstrual periods

sudden death associated with heart disease.

In elderly people with dementia, a small increase in the number of deaths has been reported for

patients taking medicines for schizophrenia compared with those not receiving these medicines.

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 Latuda

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 and blister after EXP. The

expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

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 Latuda contains

The active substance is lurasidone.

Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg lurasidone.

Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.

Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.

The other ingredients are mannitol, pregelatinised starch, croscarmellose sodium, hypromellose,

magnesium stearate (E470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172)

(present in 74 mg tablets), indigotine (E132) (present in 74 mg tablets) and carnauba wax

(E903).

What Latuda looks like and contents of the pack

Latuda 18.5 mg film-coated tablets are white to off-white, film-coated round tablets debossed

with “LA”

Latuda 37 mg film-coated tablets are white to off-white, film-coated round tablets debossed

with “LB”

Latuda 74 mg film-coated tablets are pale green, film-coated oval tablets debossed with “LD”.

Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,

90 x 1 or 98 x 1 film-coated tablet in aluminium/aluminium perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181

Rome - Italy

Manufacturer

AndersonBrecon (UK) Ltd.

Units 2-7

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford

HR3 5PG

United Kingdom

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA

Via Vecchia del Pinocchio, 22 60100

Ancona (AN), Italy

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/ Belgique/ Belgien

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Lithuania/ Lietuva

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Bulgaria/ България

Анджелини Фарма България ЕООД

бул. Асен Йорданов 10

София 1592

Teл.: + 359 2 975 1395

office@angelini.bg

Luxembourg/ Luxemburg

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Czech Republic/ Česká republika

Angelini Pharma Česká republika s.r.o.

Páteřní 1216/7

635 00 Brno, CZ

Tel: + 420 546 123 111

info@angelini.cz

Hungary/ Magyarország

Angelini Pharma Magyarország Kft

Dayka Gábor u. 3., 214-215. számú iroda

H-1118 Budapest

Tel: + 36 1 336 1614

office@angelini.hu

Denmark/ Danmark

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Malta

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Germany/ Deutschland

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Netherlands/ Nederland

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Estonia/ Eesti

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Norway/ Norge

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Greece/ Ελλάδα

ANGELINI PHARMA HELLAS ABEE

ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ

Aχαίας 4 & Τροιζηνίας

GR-14564 Νέα Κηφισιά

Τηλ: + 30 210 626 9200

info@angelinipharma.gr

Austria/ Österreich

Angelini Pharma Österreich GmbH

Brigittenauer Lände 50-54

1200 Wien

Tel: + 43 5 9606 0

office@angelini.at

Spain/ España

Angelini Farmacéutica S.A.

C. Osi, 7

E-08034 Barcelona

Tel: + 34 93 253 45 00

Poland/ Polska

Angelini Pharma Polska Sp. z o.o.

ul. Podleśna 83

05-552 Łazy

Tel.: + 48 22 70 28 200

angelini@angelini.pl

France

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Portugal

Angelini Farmacêutica, Lda

Rua João Chagas, 53, Piso 3

1499-040 Cruz Quebrada- Dafundo

Tel: + 351 21 414 8300

apoio.utente@angelini.pt

Croatia/ Hrvatska

Angelini Pharma Österreich GmbH,

Podružnica za promidžbu Zagreb

Hektorovićeva 2/5

HR-10000 Zagreb

Tel: + 385 1 644 8232

Romania/ România

Angelini Pharmaceuticals România SRL

Str. Carol Davila, Nr. 9, Sector 5

RO-București 050451

Tel: + 40 21 331 6767

office@angelini.ro

Ireland

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Slovenia/ Slovenija

Angelini Pharma d.o.o.

Koprska ulica 108 A

SI-1000 Ljubljana

Tel: +386 1 544 65 79

info@angelini.si

Iceland/ Ísland

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Slovak republic/ Slovenská republika

Angelini Pharma Slovenská republika s.r.o.

Júnová 33

SK-831 01 Bratislava

Tel: + 421 2 59 207 320

office@angelini.sk

Italy/ Italia

Angelini S.p.A

Viale Amelia 70

I-00181 Roma

Tel: + 39 06 78 0531

Suomi/ Finland

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Cyprus/Κύπρος

ANGELINI PHARMA HELLAS ABEE

ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ

Aχαίας 4 & Τροιζηνίας

GR-14564 Νέα Κηφισιά

Τηλ: + 30 210 626 9200

info@angelinipharma.gr

Sweden/ Sverige

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

Latvia/ Latvija

Sunovion Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam, Netherlands

med.infoeu@sunovion.com

United Kingdom

Sunovion Pharmaceuticals Europe Ltd.

Tel: +44 (0) 207 821 2899

This leaflet was last revised in MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.