- ivabradine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0080.
Ivabradine Aspire 2.5mg 5mg, 7.5mg film-coated tablets
Package leaflet: Information for the patient
Ivabradine 2.5mg film-coated tablets
Ivabradine 5mg film-coated tablets
Ivabradine 7.5mg film-coated tablets
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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:
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
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine
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:
Ivabradine with food and drink
Avoid grapefruit juice during treatment with Ivabradine.
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 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 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.
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 tablet of Ivabradine 2.5mg in the morning and one tablet of Ivabradine 2.5mg 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 tablet of Ivabradine 2.5mg in the morning and one tablet of Ivabradine 2.5mg 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.
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:
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.
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).
Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, 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.
Urticaria, itching, skin reddening, feeling unwell.
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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). 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 Content of the pack and other information
What Ivabradine contains
Ivabradine 2.5mg: one film-coated tablet contains 2.5mg ivabradine (equivalent to 2.695mg ivabradine as hydrochloride).
Ivabradine 5mg: one film-coated tablet contains 5mg ivabradine (equivalent to 5.39mg ivabradine as hydrochloride).
Ivabradine 7.5mg: one film-coated tablet contains 7.5mg ivabradine (equivalent to 8.085mg ivabradine as hydrochloride).
What Ivabradine looks like and contents of the pack
Ivabradine 2.5mg tablets are yellow, round, biconvex film-coated tablet 5mm in diameter and 2.2 ± 0.2mm in thickness.
Ivabradine 5mg tablets are light salmon, capsule shape (8.25 x 4mm), biconvex film-coated tablet scored on one side and 3.0 ± 0.2mm in thickness.
Ivabradine 7.5mg tablets are light salmon, round, biconvex film-coated tablet 7mm in diameter and 3.9 ± 0.2mm in thickness.
The tablets of Ivabradine 2.5mg are available in blisters containing packs of 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.
The tablets of Ivabradine 5mg and Ivabradine 7.5mg are available in blisters containing packs of 14, 28, 56, 84, 98, 100, 112 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
This leaflet was last revised in 10/2018.
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
+44 (0)1730 231148