Ivabradine Anpharm

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  • Ivabradine Anpharm
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  • Meðferðarhópur:
  • OTHER CARDIAC PREPARATIONS
  • Lækningarsvæði:
  • Angina Pectoris, Heart Failure
  • Ábendingar:
  • Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
  • Vörulýsing:
  • Revision: 4

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/004187
  • Leyfisdagur:
  • 07-09-2015
  • EMEA númer:
  • EMEA/H/C/004187
  • Síðasta uppfærsla:
  • 24-03-2019

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

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+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, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/785493/2018

EMEA/H/C/004187

Ivabradine Anpharm (ivabradine)

An overview of Ivabradine Anpharm and why it is authorised in the EU

What is Ivabradine Anpharm and what is it used for?

Ivabradine Anpharm is a heart medicine used to treat the symptoms of long-term stable angina (pains

to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease

(disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart

muscle). The medicine is used in patients who have a normal heart rhythm and whose heart rate is at

least 70 beats per minute. It is used in those who cannot be treated with beta blockers (another type

of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not

controlled by beta blockers alone.

Ivabradine Anpharm is also used in patients with long-term heart failure (when the heart cannot pump

enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at

least 75 beats per minute. It is used in combination with standard therapy including beta blockers, or

in patients who cannot be treated with beta blockers.

Ivabradine Anpharm contains the active substance ivabradine.

How is Ivabradine Anpharm used?

Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a

prescription. The recommended starting dose is 5 mg twice a day with meals, which the doctor may

increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on

the patient’s heart rate and symptoms. In patients over 75 years old, a lower starting dose of 2.5 mg

twice a day can be used. Treatment must be stopped if the heart rate is persistently below 50 beats

per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction. When

used for angina, treatment should be stopped if symptoms do not improve after 3 months. Also, the

doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina

symptoms or reducing the heart rate within 3 months.

For more information about using Ivabradine Anpharm, see the package leaflet or contact your doctor

or pharmacist.

Ivabradine Anpharm (ivabradine)

EMA/785493/2018

Page 2/3

How does Ivabradine Anpharm work?

The symptoms of angina are caused by the heart not receiving enough oxygenated blood. In stable

angina, these symptoms appear during physical effort. The active substance in Ivabradine Anpharm,

ivabradine, works by blocking the ‘I

currents’ in the sinus node, the natural ‘pacemaker’ that controls

the heart’s contractions and regulates the heart rate. When these currents are blocked, the heart rate

is lowered, so that the heart has less work to do and needs less oxygenated blood. Ivabradine

Anpharm therefore reduces or prevents the symptoms of angina.

The symptoms of heart failure are caused by the heart not pumping enough blood around the body. By

lowering the heart rate, Ivabradine Anpharm reduces the stress on the heart, thereby slowing the

progression of heart failure and improving symptoms.

What benefits of Ivabradine Anpharm have been shown in studies?

Angina

Ivabradine Anpharm was compared with placebo (a dummy treatment) and other treatments in five

main studies involving over 4,000 adults with long-term stable angina. The main measure of

effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at

the start and the end of each study. Each study lasted three to four months.

Results showed that the medicine was more effective than placebo in one of the studies in 360

patients. It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as

amlodipine (another medicine used to treat angina) in a study of 1,195 patients. In a fourth study in

889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.

However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not

provide an additional benefit.

A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery

disease and without clinical heart failure. The main measure of effectiveness was a reduction in the risk

of death due to heart problems and non-fatal heart attack. In this study, a specific subgroup of

patients who had symptomatic angina had a small but significant increase in the combined risk of

cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared with placebo (3.4%

vs 2.9% yearly incidence rates). However it should be noted that patients in this study were given

doses higher than the recommended dose (up to 10 mg twice a day).

Heart failure

Ivabradine Anpharm was compared with placebo in one main study involving over 6,500 patients with

long-term moderate to severe heart failure. Results showed that it was more effective than placebo at

preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart

failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were

hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients

receiving placebo.

What are the risks associated with Ivabradine Anpharm?

The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is

luminous phenomena or ‘phosphenes’ (a temporary brightness in the field of vision). Bradycardia (slow

heart rate) is common (it may affect up to 1 in 10 people). For the full list of all side effects reported

with Ivabradine Anpharm, see the package leaflet.

Ivabradine Anpharm (ivabradine)

EMA/785493/2018

Page 3/3

Ivabradine Anpharm must not be used in patients who have a resting heart rate below 70 beats per

minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm

disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver

problems. It must not be used in women who are pregnant, breastfeeding or by women who could

become pregnant and who are not using appropriate contraceptives. Ivabradine Anpharm must not be

taken with a number of other medicines.

For the full list of restrictions with Ivabradine Anpharm, see the package leaflet.

Why is Ivabradine Anpharm authorised in the EU?

The European Medicines Agency concluded that Ivabradine Anpharm was shown to be effective in long-

term angina with an acceptable safety profile for it to provide an alternative treatment for patients who

cannot take beta blockers or whose disease is not controlled with them. It also concluded that

Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile. The

Agency decided that Ivabradine Anpharm’s benefits are greater than its risks and it can be authorised

for use in the EU.

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

Ivabradine Anpharm?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Ivabradine Anpharm have been included in the summary of product characteristics

and the package leaflet.

As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored. Side effects

reported with this medicine are carefully evaluated and any necessary action taken to protect patients.

Other information about Ivabradine Anpharm

Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.

This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent’).

Further information on Ivabradine Anpharm can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm

This overview was last updated in 11-2018.

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

B. PACKAGE LEAFLET

Package leaflet: information for the patient

Ivabradine Anpharm 5 mg film-coated tablets

Ivabradine Anpharm 7.5 mg film-coated tablets

ivabradine

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. 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 Ivabradine Anpharm is and what it is used for

What you need to know before you take Ivabradine Anpharm

How to take Ivabradine Anpharm

Possible side effects

How to store Ivabradine Anpharm

Contents of the pack and other information

1.

What Ivabradine Anpharm is and what it is used for

Ivabradine Anpharm (ivabradine) is a heart medicine used to treat:

Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is

over or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take

heart medicines called beta-blockers. It is also used in combination with beta-blockers in adult

patients whose condition is not fully controlled with a beta-blocker.

Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute. It

is used in combination with standard therapy, including beta-blocker therapy or when beta-

blockers are contraindicated or not tolerated.

About stable angina pectoris (usually referred to as “angina”):

Stable angina is a heart disease which happens when the heart does not receive enough oxygen. It

usually appears between 40 and 50 years of age. The most common symptom of angina is chest pain

or discomfort. Angina is more likely to happen when the heart beats faster in situations such as

exercise, emotion, exposure to the cold or after eating. This increase in heart rate can cause the chest

pain in people who suffer from angina.

About chronic heart failure :

Chronic heart failure is a heart disease which happens when your heart cannot pump enough blood to

the rest of your body. The most common symptoms of heart failure are breathlessness, fatigue,

tiredness and ankle swelling.

How does Ivabradine Anpharm work?

Ivabradine Anpharm mainly works by reducing the heart rate by a few beats per minute. This lowers

the heart’s need for oxygen especially in the situations when an angina attack is more likely to

happen. In this way Ivabradine Anpharm helps to control and reduce the number of angina attacks.

Furthermore as elevated heart rate adversely affects the heart functioning and vital prognosis in

patients with chronic heart failure, the specific heart rate lowering action of ivabradine helps to

improve the heart functioning and vital prognosis in these patients.

2.

What you need to know before you take Ivabradine Anpharm

Do not take Ivabradine Anpharm

if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section

if your resting heart rate before treatment is too slow (below 70 beats per minute);

if you are suffering from cardiogenic shock (a heart condition treated in hospital);

if you suffer from a heart rhythm disorder;

if you are having a heart attack;

if you suffer from very low blood pressure;

if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and

with or without exertion);

if you have heart failure which has recently become worse;

if your heartbeat is exclusively imposed by your pacemaker;

if you suffer from severe liver problems;

if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,

itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or

erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or

nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or

angina pectoris);

if you are a woman able to have children and not using reliable contraception;

if you are pregnant or trying to become pregnant;

if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ivabradine Anpharm

if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in

chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of

electrocardiogram (ECG) called ‘long QT syndrome’,

if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that

your heart is slowing down too much),

if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats

per minute) or irregular, without any apparent reason, making it difficult to measure),

if you have had a recent stroke (cerebral attack),

if you suffer from mild to moderate low blood pressure,

if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive

treatment,

if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle

branch block’,

if you suffer from chronic eye retinal disease,

if you suffer from moderate liver problems,

if you suffer from severe renal problems.

If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine

Anpharm.

Children

Ivabradine Anpharm is not intended for use in children and adolescents younger than 18 years.

Other medicines and Ivabradine Anpharm

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

medicines.

Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of

Ivabradine Anpharm or monitoring should be required:

fluconazole (an antifungal medicine)

rifampicin (an antibiotic)

barbiturates (for difficult sleeping or epilepsy)

phenytoin (for epilepsy)

Hypericum perforatum or St John’s Wort (herbal treatment for depression)

QT prolonging medicines to treat either heart rhythm disorders or other conditions :

quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)

bepridil (to treat angina pectoris)

certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide,

ziprasidone, sertindole)

anti-malarial medicines (such as mefloquine or halofantrine)

intravenous erythromycin (an antibiotic)

pentamidine (an antiparasitic medicine)

cisapride (against the gastro-oesophageal reflux)

Some types of diuretics which may cause decrease in blood potassium level, such as furosemide,

hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Ivabradine Anpharm with food and drink

Avoid grapefruit juice during treatment with Ivabradine Anpharm.

Pregnancy and breast-feeding

Do not take Ivabradine Anpharm if you are pregnant or are planning to have a baby (see “Do not take

Ivabradine Anpharm”).

If you are pregnant and have taken Ivabradine Anpharm, talk to your doctor.

Do not take Ivabradine Anpharm if you are able to become pregnant unless you use reliable

contraceptive measures (see “Do not take Ivabradine Anpharm”).

Do not take Ivabradine Anpharm if you are breast-feeding (see “Do not take Ivabradine Anpharm”).

Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be

discontinued if you take Ivabradine Anpharm.

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.

Driving and using machines

Ivabradine Anpharm may cause temporary luminous visual phenomena (a temporary brightness in the

field of vision, see “Possible side effects”). If this happens to you, be careful when driving or using

machines at times when there could be sudden changes in light intensity, especially when driving at

night.

Ivabradine Anpharm 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 Ivabradine Anpharm

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

or pharmacist if you are not sure.

Ivabradine Anpharm should be taken during meals.

If you are being treated for stable angina pectoris

The starting dose should not exceed one tablet of Ivabradine Anpharm 5 mg twice daily. If you still

have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be

increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the

right dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some

cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of

Ivabradine Anpharm 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg

tablet in the evening.

If you are being treated for chronic heart failure

usual

recommended

starting

dose is

tablet of

Ivabradine

Anpharm

5 mg

twice daily

increasing if necessary to one tablet of Ivabradine Anpharm 7.5 mg twice daily. Your doctor will

decide the right dose for you. The usual dose is one tablet in the morning and one tablet in the

evening. In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half

5 mg tablet of Ivabradine Anpharm 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one

half 5 mg tablet in the evening.

If you take more Ivabradine Anpharm than you should:

A large dose of Ivabradine Anpharm could make you feel breathless or tired because your heart slows

down too much. If this happens, contact your doctor immediately.

If you forget to take Ivabradine Anpharm:

If you forget to take a dose of Ivabradine Anpharm, take the next dose at the usual time. Do not take a

double dose to make up for the forgotten dose.

The calendar printed on the blister containing the tablets should help you remember when you last

took a tablet of Ivabradine Anpharm.

If you stop taking Ivabradine Anpharm:

As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your

doctor before stopping this medicinal product.

If you think that the effect of Ivabradine Anpharm is too strong or too weak, talk to your doctor or

pharmacist.

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.

The frequency of possible side effects listed below is defined using the following convention:

very common: may affect more than 1 in 10 people

common: may affect up to 1 in 10 people

uncommon: may affect up to 1 in 100 people

rare: may affect up to 1 in 1,000 people

very rare: may affect up to 1 in 10,000 people

not known: frequency cannot be estimated from the available data

The most common adverse reactions with this medicine are dose dependent and related to its mode of

action:

Very common:

Luminous visual phenomena (brief moments of increased brightness, most often caused by sudden

changes

light

intensity).

They

also

described

halo,

coloured

flashes,

image

decomposition or multiple images. They generally occur within the first two months of treatment after

which they may occur repeatedly and resolve during or after treatment

Common:

Modification in the heart functioning (the symptoms are a slowing down of the heart rate). They

particularly occur within the first 2 to 3 months of treatment initiation.

Other side effects have also been reported:

Common:

Irregular

rapid

contraction

heart,

abnormal

perception

heartbeat,

uncontrolled

blood

pressure, headache, dizziness and blurred vision (cloudy vision).

Uncommon:

Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain,

spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, changes in laboratory

parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and

elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen

face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of

tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.

Rare:

Urticaria, itching, skin reddening, feeling unwell.

Very rare:

Irregular heart beats.

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 Ivabradine Anpharm

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.

This medicine does not require any special storage conditions.

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

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

6.

Content of the pack and other information

What Ivabradine Anpharm contains

The active substance is ivabradine (as hydrochloride).

Ivabradine

Anpharm

5 mg:

film-coated

tablet

contains

5 mg

ivabradine

(equivalent

5.390 mg ivabradine as hydrochloride).

Ivabradine Anpharm 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to

8.085 mg ivabradine as hydrochloride).

The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B),

maize

starch,

maltodextrin,

colloidal

anhydrous

silica

551),

tablet

coating:

hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium

stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).

What Ivabradine Anpharm looks like and contents of the pack

Ivabradine Anpharm 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both

sides, engraved with “5” on one face and

on the other.

Ivabradine Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with

“7.5” on one face and

on the other.

The tablets are available in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B

03–236 Warszawa - Poland

Manufacturer:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy – France

Servier (Ireland) Industries Ltd

Gorey Road

Arklow - Co. Wicklow – Ireland

Przedsiebiorstwo Farmaceutyczne ANPHARM S.A.

ul. Annopol 6B – 03-236 Warszawa – Poland

Laboratorios Servier, S.L.

Avda. de los Madroños, 33

28043 Madrid

Spain

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

Authorisation Holder.

België/Belgique/Belgien

S.A. Servier Benelux N.V.

Tél/Tel: +32 (0)2 529 43 11

Lietuva

UAB ”SERVIER PHARMA”

Tel: +370 (5) 2 63 86 28

България

Сервие Медикал ЕООД

Тел.: +359 2 921 57 00

Luxembourg/Luxemburg

S.A. Servier Benelux N.V.

Tél/Tel: +32 (0)2 529 43 11

Česká republika

Servier s.r.o.

Tel: +420 222 118 111

Magyarország

Servier Hungaria Kft.

Tel.: + 36 1 238 77 99

Danmark

Servier Danmark A/S

Tlf: +45 36 44 22 60

Malta

GALEPHARMA Ltd

Tel: +(356) 21 247 082

Deutschland

Servier Deutschland GmbH

Tel: +49 (0)89 57095 01

Nederland

Servier Nederland Farma B.V.

Tel: +31 (0)71 5246700

Eesti

Servier Laboratories OÜ

Tel:+ 372 664 5040

Norge

Servier Danmark A/S

Tlf: +45 36 44 22 60

Ελλάδα

ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ

Τηλ: +30 210 939 1000

Österreich

Servier Austria GmbH

Tel: +43 (1) 524 39 99

España

Laboratorios Servier S.L.

Tel: +34 91 748 96 30

Polska

Servier Polska SP. Z O.O.

Tel.: + 48 (0) 22 594 90 00

France

Les Laboratoires Servier

Tél: +33 (0)1 55 72 60 00

Portugal

Servier Portugal, Lda

Tel: +351 21 312 20 00

Hrvatska

Servier Pharma, d. o. o.

Tel.: +385 (0)1 3016 222

România

Servier Pharma SRL

Tel: +4 021 528 52 80

Ireland

Servier Laboratories (Ireland) Ltd.

Tel: +353 (0)1 663 8110

Slovenija

Servier Pharma d.o.o.

Tel: + 386 (0)1 563 48 11

Ísland

Servier Laboratories

C/o Icepharma hf

Sími: +354 540 8000

Slovenská republika

Servier Slovensko spol. s r.o.

Tel: +421 (0) 2 5920 41 11

Italia

Servier Italia S.p.A.

Tel: +39 06 669081

Suomi/Finland

Servier Finland Oy

P. /Tel: +358 (0)9 279 80 80

Κύπρος

C.A. Papaellinas Ltd.

Τηλ: +357 22741741

Sverige

Servier Sverige AB

Tel: +46(8)5 225 08 00

Latvija

SIA Servier Latvia

Tel: + 371 6750 2039

United Kingdom

Servier Laboratories Ltd

Tel: +44 (0)1753 666409

This leaflet was last revised in

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

http://www.ema.europa.eu

Annex IV

Scientific conclusions and grounds for the variation to the terms of the

marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final

study report for the medicinal product(s) mentioned above, the scientific conclusions of CHMP

are as follows:

The results of this DUS study showed an increase in adherence to the SmPC guidelines in the

post-RMM period compared to the pre-RMM period. This increase in adherence was measured for

all the four criteria under study. Therefore, in view of available data regarding the PASS final

study report, the PRAC considered that changes to the conditions of the marketing authorisation

were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for the results of the study for the medicinal product(s)

mentioned above, the CHMP is of the opinion that the benefit-risk balance of these medicinal

product(s) is unchanged, subject to the proposed changes to the product information.

The CHMP is of the opinion that the terms of the marketing authorisation(s) of the medicinal

product(s) mentioned above should be varied.