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IVABRADINE ACTAVIS 5MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Ivabradine 5mg and 7.5mg
Film-coated Tablets
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.
• The full name of this medicine is Ivabradine 5mg and
7.5mg Film-coated Tablets but within the leaflet it will
be referred to as Ivabradine Tablets.

What is in this leaflet
1 What Ivabradine Tablets are and what they
are used for
2 What you need to know before you take
Ivabradine Tablets
3 How to take Ivabradine Tablets
4 Possible side effects
5 How to store Ivabradine Tablets
6 Contents of the pack and other information
1 What Ivabradine Tablets are and what they

are used for

Ivabradine Tablets contain the active substance
ivabradine. Ivabradine Tablets 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 betablockers 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 Tablets work
Ivabradine Tablets 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 Tablets 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 Tablets

Do not take Ivabradine Tablets
• 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 are having a heart attack
• if you suffer from very low blood pressure
• if you suffer from severe liver problems
• if you suffer from a heart rhythm disorder

• if you have heart failure which has recently become
worse
• if your heartbeat is exclusively imposed by your
pacemaker
• if you suffer from unstable angina (a severe form in
which chest pain occurs very frequently and with or
without exertion)
• if you are already taking medicines for the treatment of
fungal infections (such as ketoconazole, itraconazole),
macrolide antibiotics (such as clarithromycin, josamycin,
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
Tablets
• 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 Tablets.
Children and adolescents
Ivabradine Tablets are not intended for use in children and
adolescents younger than 18 years.
Other medicines and Ivabradine Tablets
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
Tablets or monitoring should be required:
• QT prolonging medicines to treat either heart rhythm
disorders or other conditions:
- quinidine, disopyramide, sotalol, ibutilide, 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)
- pentamidine (an antiparasitic medicine)
- cisapride (against the gastro-oesophageal reflux)
- intravenous erythromycin (an antibiotic)
- 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)
• 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 Tablets with food and drink
Avoid grapefruit juice during treatment with Ivabradine
Tablets.
Pregnancy and breast-feeding
Do not take Ivabradine Tablets if you are pregnant or are
planning to have a baby (see “Do not take Ivabradine
Tablets”).
If you are pregnant and have taken Ivabradine Tablets, talk
to your doctor.
Do not take Ivabradine Tablets if you are able to become
pregnant unless you use reliable contraceptive measures
(see “Do not take Ivabradine Tablets”).
Continued over page

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Ivabradine 5mg and 7.5mg PIL UK
BBBA1025

05

190x380 mm

C.Grant
05/07/17
26/07/17
C.Grant

9pt
Actavis Bulgaria Dupnitsa
05/07/17
14/07/17

1. Black

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Uncommon (may affect up to 1 in 100 people):
Fainting, double vision, impaired vision, spinning
sensation (vertigo), palpitations and cardiac extra beats,
low blood pressure, difficulty breathing (dyspnoea),
feeling sick (nausea), constipation, diarrhoea, abdominal
pain, skin rash, muscle cramps, feeling of tiredness,
feeling of weakness, changes in laboratory parameters:
an excess of eosinophils (a type of white blood cell), high
blood levels of uric acid, elevated creatinine in blood
(a breakdown product of muscle), abnormal ECG heart
tracing.

Do not take Ivabradine Tablets if you are breast-feeding
(see “Do not take Ivabradine Tablets”). Talk to your doctor
if you are breast-feeding or intending to breast-feed
as breast-feeding should be discontinued if you take
Ivabradine Tablets.
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 Tablets 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.

Rare (may affect up to 1 in 1,000 people):
Skin reddening, itching, urticaria, feeling unwell.
Very rare (may affect up to 1 in 10,000 people):
Irregular heartbeats.

Ivabradine Tablets contain 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

Reporting of side effects
If you get any side effects, talk to your doctor, 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

How to take Ivabradine Tablets

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 Tablets should be taken during meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one tablet of
Ivabradine 5mg twice daily. If you still have angina
symptoms and if you have tolerated the 5mg twice daily
dose well, the dose may be increased. The maintenance
dose should not exceed 7.5mg 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 5mg tablet of
Ivabradine 5mg (corresponding to 2.5mg ivabradine) in
the morning and one half 5mg tablet in the evening.
If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of
Ivabradine 5mg twice daily increasing if necessary to one
tablet of Ivabradine 7.5mg 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 5mg tablet of Ivabradine 5mg
(corresponding to 2.5mg ivabradine) in the morning and
one half 5mg tablet in the evening.
If you take more Ivabradine Tablets than you should
A large dose of Ivabradine Tablets 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 Tablets
If you forget to take a dose of Ivabradine Tablets, 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 Tablets
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 Tablets 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.
If you experience the following serious side effect
stop taking Ivabradine Tablets and seek medical help
immediately:
• Swollen face, tongue or throat, difficulty in breathing
or swallowing (angioedema) – this occurs uncommonly
(may affect up to 1 in 100 people).
The most common adverse reactions with this medicine
are dose dependent and related to its mode of action:
Very common (may affect more than 1 in 10 people):
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.

By reporting side effects you can help provide more
information on the safety of this medicine.

5

How to store Ivabradine Tablets

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 Contents of the pack and other information
What Ivabradine Tablets contain
• The active substance is ivabradine (as hydrochloride).
Ivabradine 5mg: each Film-coated tablet contains 5mg
ivabradine (as hydrochloride).
Ivabradine 7.5mg: each Film-coated tablet contains
7.5mg ivabradine (as hydrochloride).
• The other ingredients in the tablet core are: magnesium
stearate (E470 B) colloidal anhydrous silica (E551),
maltodextrin, maize starch, lactose monohydrate and in
the tablet coating: polyvinyl alcohol (E1203), titanium
dioxide (E171), macrogol 3350 (E1521), talc (E553b).
What Ivabradine Tablets look like and contents of the
pack
Ivabradine 5mg Film-coated Tablets are white or almost
white, oval, biconvex, Film-coated tablet, marked with
“A274” on one side and score on the other side, tablet
dimensions 8.2 x 4.1mm.
Ivabradine 7.5mg Film-coated Tablets are white or almost
white, triangular, biconvex, Film-coated tablet, marked
with “A267” on one side, tablet dimensions 7.5 x 7.2mm.
OPA-Aluminium-PE-Desiccant/Aluminium-PE blister
packs. The desiccant is embedded in a polyolefin sealant
layer. Multi-layered foil does not allow contact between
desiccant and tablets. The blisters are packed in cardboard
boxes containing: 56 film-coated tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in July 2017.

If you would like a
leaflet with larger text,
please contact
01271 385257.

Common (may affect up to 1 in 10 people):
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):
Headache, dizziness, blurred vision (cloudy vision),
irregular rapid contraction of the heart, abnormal
perception of heartbeat and uncontrolled blood pressure.
Continued top of next column
BBBA1025

Actavis, Barnstaple, EX32 8NS, UK

Ivabradine 5mg and 7.5mg PIL UK
BBBA1025

05

190x380 mm

C.Grant
05/07/17
26/07/17
C.Grant

9pt
Actavis Bulgaria Dupnitsa
05/07/17
14/07/17

1. Black

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2.

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3.

3.

4.

4.

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5.

6.

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