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IVABRADINE MILPHARM 5 MG FILM COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / IVABRADINE HYDROCHLORIDE

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Package leaflet: Information for
the user

Material Leaflet Drawing #:
type:
_ 1 mm
Dimensions: 140 x 540 +
Launch:

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231 Scale: 100%
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LICONSA
LEON FARMA
Internal change:

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Laetus #: ****
Version:

A

Folded:

YES
NO

Date: ****
Pantones:

black

Substitutes *****
mat. #:

112

358

140 x 34mm

(*) Please, do not delete the layer “TECHNICAL DATA”

(*) Customer:

FOLDED

Signature:
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Quality Assurance:
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ivabradine

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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 section4.

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

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

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).

Pharma Code Read Directions

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.

Ivabradine with food, drink and alcohol
Avoid grapefruit juice during treatment with
Ivabradine.

540

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.

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 Ivabradine if 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.

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.

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.

Pharma Code Read Directions

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.

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.
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.

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Pharma Code Read Directions

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.

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’,

Pharma Code Read Directions

Material #/
Product :

Customer change:

Ivabradine 5 mg filmcoated tablets
Ivabradine 7.5 mg filmcoated tablets

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.

Material Leaflet Drawing #:
type:
_ 1 mm
Dimensions: 140 x 540 +
Launch:

X

Material #/
Product :

Laetus #:

Customer change:

****
A

Folded:

YES
NO

Date: ****
Pantones:

(*) Customer:

Signature:
Date:

Quality Assurance:

Drawed by:
Signature:
Date:

black

140 x 34mm

(*) Please, do not delete the layer “TECHNICAL DATA”

Date:

X

LICONSA
LEON FARMA
Internal change:

****

Version:

Signature:

231 Scale: 100%

Substitutes *****
mat. #:

112

358

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
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 national
reporting system listed in 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.
6. Contents of the pack and other
information
What Ivabradine contains
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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.
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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
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
J. Uriach y Compañía, S.A.
Av. Camí Reial 51-57
08184 Palau-solità I Plegamans
Spain
And
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo. Avda.
Miralcampo, 7
19200 Azuqueca de Henares –
Guadalajara
Spain
This leaflet was last revised in
05/2017

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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