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IVABRADINE LICONSA 7.5 MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / IVABRADINE HYDROCHLORIDE

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

1.

What Ivabradine Liconsa is and what it is used for

Ivabradine Liconsa (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 Liconsa work?
Ivabradine Liconsa 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 Liconsa 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.

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2. What you need to know before you take Ivabradine Liconsa
Do not take Ivabradine Liconsa:
- 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine Liconsa
- 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
Liconsa
Children
Ivabradine Liconsa is not intended for use in children and adolescents younger than 18 years.
Other medicines and Ivabradine Liconsa
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 Liconsa or monitoring should be required:
- fluconazole (an antifungal medicine)

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-

-

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 Liconsa with food, drink and alcohol
Avoid grapefruit juice during treatment with Ivabradine Liconsa.
Pregnancy and breast-feeding
Do not take Ivabradine Liconsa if you are pregnant or are planning to have a baby (see “Do not take
Ivabradine Liconsa”).
If you are pregnant and have taken Ivabradine Liconsa, talk to your doctor.
Do not take Ivabradine Liconsa if you are able to become pregnant unless you use reliable contraceptive
measures (see “Do not take Ivabradine Liconsa”).
Do not take Ivabradine Liconsaif you are breast-feeding (see “Do not take Ivabradine Liconsa”). Talk
to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be
discontinued if you take Ivabradine Liconsa.
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 Liconsa 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 Liconsa 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 Liconsa

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 Liconsa should be taken during meals.
The tablet can be divided into equal doses
If you are being treated for stable angina pectoris

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The starting dose should not exceed one tablet of Ivabradine Liconsa 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 Liconsa 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 Liconsa 5 mg twice daily
increasing if necessary to one tablet of Ivabradine Liconsa 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 Liconsa 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 Liconsa than you should:
A large dose of Ivabradine Liconsa 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 Liconsa:
If you forget to take a dose of Ivabradine Liconsa, 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 Liconsa:
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 Liconsa 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

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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 MHRA 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 Liconsa

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 Liconsa 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

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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 Liconsa looks like and contents of the pack
Film-coated tablet.
Ivabradine Liconsa 5 mg film-coated tablets
Ivabradine Liconsa 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 Liconsa 7.5 mg film-coated tablets
Ivabradine Liconsa o 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
Laboratorios Liconsa S.A.
Gran Via Carlos III, 98 7th floor
08080 Barcelona, Spain
Laboratorios Liconsa, S.A.
Avda. Miralcampo 7
Poligono Industrial Miralcampo.
19200 Azuqueca de Henares – Guadalajara
Spain
J. Uriach y Compania, S.A.
Av. Cami Reial 51-57
Poligono Industrial Riera de Caldes
08184 Palau-solita I Plegamans - Barcelona
Spain

This leaflet was last revised in June 217

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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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