Skip to Content

IVABRADINE CHANELLE MEDICAL 5 MG FILM COATED TABLETS

Active substance(s): IVABRADINE OXALATE / IVABRADINE OXALATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ivabradine 5 mg film-coated tablets
Ivabradine 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. 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 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

1.

What Ivabradine is and what it is used for

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 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.
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
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 heartbeat 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:


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.
Children and adolescents
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).

Ivabradine with food and drink
Avoid grapefruit juice during treatment with Ivabradine.
Pregnancy, breast-feeding and fertility
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 breast-feeding should be discontinued if you take Ivabradine.
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 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 Chanelle Medical contains hydrogenated castor oil.
This may cause stomach upset and diarrhoea

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 5 mg 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.
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.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine.
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:
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. This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the UK Yellow Card Scheme, Website: www.mhra.goc.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
The active substance is ivabradine (as ivabradine oxalate). Ivabradine 5 mg: one film-coated tablet contains 5 mg ivabradine
(equivalent to 5.96 mg ivabradine oxalate). Ivabradine 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.94
mg ivabradine oxalate).
The other ingredients in the tablet core are: microcrystalline cellulose (E460), Crospovidone, Type A (E1202) colloidal anhydrous
silica (E551), hydrogenated castor oil and in the tablet coating: Opadry orange containing hypromellose (E464), microcrystalline
cellulose (E460), titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172) and red iron oxide (E172). Polishing agent:
Carnauba wax.
What Ivabradine looks like and contents of the pack
Ivabradine 5 mg film-coated tablets are Salmon coloured, oblong shaped, biconvex, film-coated tablet with a breakline on one side and
plain on other. Approximately 8.1 mm long and 4.3 mm wide.
Ivabradine 7.5 mg tablets are Salmon coloured, triangular shaped, biconvex, film-coated tablet plain on both sides. Approximately
7.1 mm x 7.1 mm x 7.1 mm. The tablets are available in blisters (composed of rigid clear transparent PVC film coated with PCTFE
clear and Aluminium Foil) of calendar packs containing 14, 28, 56, 84, 98 or 112 film-coated tablets or blister pack size 100.
Not all pack sizes may be marketed
Marketing Authorisation Holder Chanelle Medical, Loughrea, Co. Galway, Ireland
Manufacturer Chanelle Medical, Loughrea, Co. Galway, Ireland
Ind-Swift Limited, Village Jawaharpur, Derabassi, District SAS Nagar (Mohali)-140507, Punjab, India.
JSC Grindeks, 53 Krustpils street, Riga, LV-1057, Latvia
Distributed by Chanelle Medical U.K. Limited
This leaflet was last revised in 03/2017

LA12259

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