Skip to Content

IVABRADINE 5 MG FILM COATED TABLETS

Active substance(s): IVABRADINE ADIPATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TEVA UK Ref:

231-30-05781-A LEA IVABRADINE 5mg & &.5mg FC TABS TUK Dimensions:

Length:
Width:

Depth:

Version:

4

Colours Used:

460 mm
160 mm
-

Foil Width:

Perforated:

Shelf Ready Pack:

Yes/No

IVABRADINE 5 mg AND 7.5 mg
FILM-COATED TABLETS

treat HIV infections (such as nelfinavir,
ritonavir) or nefazodone (medicine to treat
depression) or diltiazem, verapamil (used
Package leaflet: Information for the patient
for high blood pressure or angina pectoris)

you are a woman able to have children and
Read all of this leaflet carefully before you
not
using reliable contraception
start taking this medicine because it contains

you
are pregnant or trying to become
important information for you.
pregnant
• Keep this leaflet. You may need to read it
• you are breast-feeding.
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.

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’
• have symptoms such as tiredness, dizziness
or shortness of breath (this could mean that
What is in this leaflet:
your heart is slowing down too much)
• suffer from symptoms of atrial fibrillation
1. What Ivabradine is and what it is used for
(pulse rate at rest unusually high (over 110
2. What you need to know before you take
beats per minute) or irregular, without any
Ivabradine
apparent reason, making it difficult to
3. How to take Ivabradine
measure)
4. Possible side effects
• have had a recent stroke (cerebral attack)
5. How to store Ivabradine
6. Contents of the pack and other information • suffer from mild to moderate low blood
pressure
Ivabradine is and what it is
1 What
• suffer from uncontrolled blood pressure,
used for
especially after a change in your
antihypertensive treatment
Ivabradine is a heart medicine used to treat:

suffer from severe heart failure or heart
• symptomatic stable angina pectoris (which
failure with abnormality of ECG called
causes chest pain) in adult patients whose
‘bundle branch block’
heart rate is over or equal to 70 beats per
• suffer from chronic eye retinal disease
minute. It is used in adult patients who do
not tolerate or cannot take heart medicines • suffer from moderate liver problems
• suffer from severe renal problems.
called beta-blockers. It is also used in
If any of the above applies to you, talk
combination with beta-blockers in adult
straight away to your doctor before or while
patients whose condition is not fully
taking Ivabradine.
controlled with a beta-blocker
• chronic heart failure in adult patients whose Children and adolescents
heart rate is over or equal to 75 beats per
Ivabradine is not intended for use in children
minute. It is used in combination with
and adolescents younger than 18 years.
standard therapy, including beta-blocker
Other medicines and Ivabradine
therapy or when beta-blockers are
Tell your doctor or pharmacist if you are
contraindicated or not tolerated.
taking, have recently taken or might take any
About stable angina pectoris (usually referred other medicines.
to as “angina”):
Make sure to tell your doctor if you are taking
Stable angina is a heart disease which
any of the following medicines, as a dose
happens when the heart does not receive
adjustment of Ivabradine or monitoring
enough oxygen. It usually appears between
should be required:
40 and 50 years of age. The most common
• fluconazole (an antifungal medicine)
symptom of angina is chest pain or
• rifampicin (an antibiotic)
discomfort. Angina is more likely to happen
when the heart beats faster in situations such • barbiturates (for difficult sleeping or
epilepsy)
as exercise, emotion, exposure to the cold or
• phenytoin (for epilepsy)
after eating. This increase in heart rate can
• Hypericum perforatum or St John’s Wort
cause the chest pain in people who suffer
(herbal treatment for depression)
from angina.
• QT prolonging medicines to treat either
About chronic heart failure:
heart rhythm disorders or other conditions:
Chronic heart failure is a heart disease which
• quinidine, disopyramide, ibutilide,
happens when your heart cannot pump
sotalol, amiodarone (to treat heart
enough blood to the rest of your body. The
rhythm disorders)
most common symptoms of heart failure are
• bepridil (to treat angina pectoris)
breathlessness, fatigue, tiredness and ankle
• certain types of medicines to treat
swelling.
anxiety, schizophrenia or other
psychoses (such as pimozide,
How does Ivabradine work?
ziprasidone, sertindole)
Ivabradine mainly works by reducing the
• anti-malarial medicines (such as
heart rate by a few beats per minute. This
mefloquine or halofantrine)
lowers the heart’s need for oxygen especially
• intravenous erythromycin (an antibiotic)
in the situations when an angina attack is
• pentamidine (an antiparasitic medicine)
more likely to happen. In this way Ivabradine
• cisapride (against the
helps to control and reduce the number of
gastro-oesophageal reflux)
angina attacks.
• some types of diuretics which may cause
Furthermore as elevated heart rate adversely
decrease in blood potassium level, such as
affects the heart functioning and vital
furosemide, hydrochlorothiazide,
prognosis in patients with chronic heart
indapamide (used to treat oedema, high
failure, the specific heart rate lowering action
blood pressure).
of ivabradine helps to improve the heart
Ivabradine with food and drink
functioning and vital prognosis in these
Avoid grapefruit juice during treatment with
patients.
Ivabradine.

2

What you need to know before you
take Ivabradine

Pregnancy and breast-feeding
Do not take Ivabradine if you are pregnant or
Do not take Ivabradine if:
are planning to have a baby (see “Do not take
• you are allergic to ivabradine or any of the Ivabradine”).
other ingredients of this medicine (listed in If you are pregnant and have taken
section 6)
Ivabradine, talk to your doctor.
• your resting heart rate before treatment is
Do not take Ivabradine if you are able to
too slow (below 70 beats per minute)
become pregnant unless you use reliable
• you are suffering from cardiogenic shock (a contraceptive measures (see “Do not take
heart condition treated in hospital)
Ivabradine”).
• you suffer from a heart rhythm disorder
Do not take Ivabradine if you are
• you are having a heart attack
breast-feeding (see “Do not take Ivabradine”).
• you suffer from very low blood pressure
Talk to your doctor if you are breast-feeding
• you suffer from unstable angina (a severe
or intending to breast-feed as breast-feeding
form in which chest pain occurs very
should be discontinued if you take
frequently and with or without exertion)
Ivabradine.
• you have heart failure which has recently
become worse
If you are pregnant or breast-feeding, think
• your heart-beat is exclusively imposed by
you may be pregnant or are planning to have
your pacemaker
a baby, ask your doctor or pharmacist for
• you suffer from severe liver problems
advice before taking this medicine.
• you are already taking medicines for the
Driving and using machines
treatment of fungal infections (such as
Ivabradine may cause temporary luminous
ketoconazole, itraconazole), macrolide
visual phenomena (a temporary brightness in
antibiotics (such as josamycin,
the field of vision, see “Possible side
clarithromycin, telithromycin or
effects”). If this happens to you, be careful
erythromycin given orally), medicines to

24 October 2016

TEVA UK Ref:

231-30-05781-A LEA IVABRADINE 5mg & &.5mg FC TABS TUK Dimensions:

Length:
Width:

Depth:

4

Colours Used:

460 mm
160 mm
-

Foil Width:

Perforated:

Shelf Ready Pack:

when driving or using machines at times
when there could be sudden changes in light
intensity, especially when driving at night.

3

Version:

How to take Ivabradine

PANTONE® GREEN C

-

BLACK

-

Template

Yes/No

difficulty in breathing or swallowing), low
blood pressure, fainting, feeling of tiredness,
feeling of weakness, abnormal ECG heart
tracing, double vision, impaired vision.

Rare: may affect up to 1 in 1,000 people
Urticaria, itching, skin reddening, feeling
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with unwell.
your doctor or pharmacist if you are not sure.
Very rare: may affect up to 1 in 10,000 people
Irregular heartbeats.
Ivabradine should be taken during meals.
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.
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.

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 Yellow Card
Scheme at: 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 medicinal product does not require any
special storage conditions.
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 Ivabradine contains
• The active substance is ivabradine (as
adipate).
The 5 mg tablet can be divided into equal
Each 5 mg film-coated tablet contains 5 mg
doses.
ivabradine (equivalent to 6.56 mg
ivabradine adipate).
If you take more Ivabradine than you should
Each 7.5 mg film-coated tablet contains
A large dose of Ivabradine could make you
7.5
mg ivabradine (equivalent to 9.84 mg
feel breathless or tired because your heart
ivabradine
adipate).
slows down too much. If this happens,
• The other ingredients in the tablet core are
contact your doctor immediately.
microcrystalline cellulose, croscarmellose
If you forget to take Ivabradine
sodium, colloidal anhydrous silica,
If you forget to take a dose of Ivabradine, take
magnesium stearate
the next dose at the usual time. Do not take a • Film-coating contains hypromellose,
double dose to make up for the forgotten
macrogol 4000, titanium dioxide (E171),
dose.
red iron oxide (E172) and yellow iron oxide
(E172).
If you stop taking Ivabradine
As the treatment for angina or chronic heart
What Ivabradine looks like and contents of
failure is usually life-long, you should discuss the pack
with your doctor before stopping this
Ivabradine 5 mg tablets are beige to
medicinal product.
pale-orange oval, biconvex film-coated
If you think that the effect of Ivabradine is too tablets with breaking score on one side and
strong or too weak, talk to your doctor or
embossing “5” on other side and are approx.
pharmacist.
9 mm x 4.5 mm in size.
Ivabradine 7.5 mg tablets are beige to
If you have any further questions on the use
pale-orange round, biconvex film-coated
of this medicine, ask your doctor or
tablets with embossing “7.5” on one side and
pharmacist.
are approx. 8 mm in size.

4

Possible side effects

Ivabradine 5 mg tablets are available in
PVC/PVdC/Al blister packs of 14, 28, 30, 56, 60,
Like all medicines, this medicine can cause
84, 98, 100, 112 and 120 tablets, perforated
side effects, although not everybody gets
unit dose packs of 56x1 tablets and calendar
them.
packs of 56 tablets.
Ivabradine 7.5 mg tablets are available in
The most common adverse reactions with
this medicine are dose dependent and related PVC/PVdC/Al blister packs of 28, 30, 56, 60, 84,
98, 100, 112 and 120 tablets, perforated unit
to its mode of action:
dose packs of 56x1 tablets and calendar packs
Very common: may affect more than 1 in 10
of 56 tablets.
people
Luminous visual phenomena (brief moments Not all pack sizes may be marketed.
of increased brightness, most often caused
Marketing Authorisation Holder
by sudden changes in light intensity). They
TEVA UK Limited, Eastbourne, BN22 9AG, UK
can also be described as a halo, coloured
Manufacturer
flashes, image decomposition or multiple
TEVA Gyógyszergyár Zrt., Pallagi út 13,
images. They generally occur within the first
Debrecen, H-4042, Hungary
two months of treatment after which they
may occur repeatedly and resolve during or
This leaflet was last revised in 10/2016
after treatment.
PL 00289/2038
Common: may affect up to 1 in 10 people
PL 00289/2039
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: may affect up to 1 in 10 people
Irregular rapid contraction of the heart,
abnormal perception of heartbeat,
uncontrolled blood pressure, headache,
dizziness and blurred vision (cloudy vision).
Uncommon: may affect up to 1 in 100 people
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,

24 October 2016

05781-A

Expand Transcript

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.

Hide