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IVABRADINE ACTAVIS 7.5MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / 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 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 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
1

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 heart beat 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:
2

-

-

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”).
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 breastfeeding 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.
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.

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.

3

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.
The calendar printed on the blister containing the tablets should help you remember when you last
took a tablet of Ivabradine Tablets.
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
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.
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,
4

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.
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.
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 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 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.

Content 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 (E 470 B), colloidal anhydrous
silica (E 551), 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: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated
tablets.
OPA-Aluminium-PE-Desiccant/Aluminium-PE calendar 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: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated
tablets.

5

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Merckle GmbH
Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg
89143
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25, Zagreb
10000
Croatia
This leaflet was last revised in April 2017.

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

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK

Pil Spec no

6

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.

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