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IVABRADINE AMNEAL 5 MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / IVABRADINE HYDROCHLORIDE

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Ivabradine film-coated tablets - UK - PIL

Package leaflet: Information for the user

Ivabradine 5 mg
film-coated tablets
Ivabradine 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
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
1. What Ivabradine is and what it is used for
2. What you need to know before you take
Ivabradine
3. How to take Ivabradine
4. Possible side effects
5. How to store Ivabradine
6. Contents of the pack and other information

1. What Ivabradine is and what it is
used for
Ivabradine (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 work?
Ivabradine 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 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
Do not take Ivabradine:
- if you are allergic to ivabradine or any of the
other ingredients of this medicine (listed in
section 6);
- 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 heart beat 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.

PIL Size : 140 x 540 mm Text area : 126 x 528 mm
Final folding Size: 140 x 34mm
Printed Colour:
Black
Non-Printed Colours:
Key-Line,
Text Area
Min. Font Size: 9 pt
Date: 01/06/17

Review - 2
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ivabradine
- 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
Children
Ivabradine is not intended for use in children and
adolescents younger than 18 years.
Other medicines and Ivabradine
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 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 with food, drink and alcohol
Avoid grapefruit juice during treatment with
Ivabradine.
Pregnancy and breast-feeding
Do not take Ivabradine if you are pregnant or are
planning to have a baby (see “Do not take
Ivabradine”).
If you are pregnant and have taken Ivabradine, talk
to your doctor.
Do not take Ivabradine if you are able to become
pregnant unless you use reliable contraceptive
measures (see “Do not take Ivabradine”).
Do not take Ivabradineif you are breast-feeding
(see “Do not take Ivabradine”). Talk to your doctor
if you are breast-feeding or intending to
breast-feed as breastfeeding should be
discontinued if you take Ivabradine.
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 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 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
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 should be taken during meals. The
tablet can be divided into equal doses
If you are being treated for stable angina pectoris
The starting dose should not exceed one tablet of
Ivabradine 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 5 mg (corresponding
to 2.5 mg ivabradine) in the morning and one half
5 mg tablet in the evening.

Front Side

Ivabradine film-coated tablets - UK - PIL
If you are being treated for chronic heart failure
The usual recommended starting dose is one
tablet of Ivabradine 5 mg twice daily increasing if
necessary to one tablet of Ivabradine 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 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 than you should:
A large dose of Ivabradine 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:
If you forget to take a dose of Ivabradine, take the
next dose at the usual time. Do not take a double
dose to make up for the forgotten dose.
If you stop taking Ivabradine:
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 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 in light intensity). They can also
be described as a 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

Review - 2
6. Contents of the pack and other
information What Ivabradine contains
- The active substance is ivabradine (as
hydrochloride).
One film-coated tablet contains ivabradine
hydrochloride equivalent to 5 mg of ivabradine
One film-coated tablet contains ivabradine
hydrochloride equivalent to 7.5 mg of ivabradine
The other ingredients in the tablet core are:
lactose monohydrate, magnesium stearate (E 470
B), maize starch, maltodextrin, colloidal anhydrous
silica (E 551), and in the tablet coating: lactose
monohydrate, hypromellose (E 464), titanium
dioxide (E 171), macrogol (E-1521), yellow iron
oxide (E 172), red iron oxide (E 172).
What Ivabradine looks like and contents of the
pack
Film-coated tablet.
Ivabradine 5 mg film-coated tablets
Ivabradine 5 mg is pale orange, capsule shape
(8,4 x 3,4 mm ), biconvex film-coated tablet
scored in one side.
The tablet can be divided into equal doses.
Ivabradine 7.5 mg film-coated tablets
Ivabradine 7.5 mg is pale orange, round
(7,1 mm x 3,8 mm ), biconvex film-coated tablet.
The tablets are available in blisters containing
packs of 14, 28, 56, 84, 98, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturers
J.Uriach and Cia. S.A.
Avda Camì Reial, 51-57
Palau-Solita I Plegamans
Barcelona 08184
Spain
Laboratorios Liconsa S.A.
Avda. Miralcampo. No 7
Polìgono Industrial Miralcampo
Azuqueca de Henares
Guadalajara 19200
Spain
This leaflet was last revised in May 2017

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 of the heart, abnormal
perception of 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 cramps, 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 or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Ivabradine
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.

PIL Size : 140 x 540 mm Text area : 126 x 528 mm
Final folding Size: 140 x 34mm
Printed Colour:
Black
Non-Printed Colours:
Key-Line,
Text Area
Min. Font Size: 9 pt
Date: 01/06/17

Back Side

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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