Carvedilol, ivabradine hydrochloride.
The active substances are carvedilol and ivabradine (as hydrochloride): Carivalan 6.25mg/5 mg: each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of ivabradine equivalent to 5.390 mg ivabradine as hydrochloride.
Carivalan 6.25 mg/7.5 mg: each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of ivabradine equivalent to 8.085 mg ivabradine as hydrochloride.
Carivalan 12.5 mg/5 mg: each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of ivabradine equivalent to 5.390 mg ivabradine as hydrochloride.
Carivalan 12.5 mg/7.5 mg: each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of ivabradine equivalent to 8.085 mg ivabradine as hydrochloride.
Carivalan 25 mg/5 mg: each film-coated tablet contains 25 mg of carvedilol and 5 mg of ivabradine equivalent to 5.390 mg ivabradine as hydrochloride.
Excipients/Inactive Ingredients: The other ingredients are: In the tablet core: pregelatinised starch (maize), lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), maltodextrin, colloidal anhydrous silica (E551) and magnesium stearate (E470b).
In the tablet film-coating: glycerol (E422), hypromellose (E464), magnesium stearate (E470b), titanium dioxide (E171), iron oxide yellow (E172) (for 6.25/7.5 mg, 12.5/17.5 mg) and macrogol 6000 (E1521).
Instead of taking carvedilol and ivabradine as separate tablets, the patient will receive one tablet of Carivalan which contains both ingredients at the same strength. Carivalan is a combination of two active ingredients, carvedilol and ivabradine. Carvedilol is a beta-blocker. Beta-blockers slow the heartbeat, lessen the force with which the heart muscle contracts and reduces the blood vessel contraction in the heart, brain and throughout the body. lvabradine works mainly 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, carvedilol and ivabradine help to control and reduce the number of angina attacks.
Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients; the treatment of chronic heart failure (II-IV NYHA-class) with systolic dysfunction.
Always take this medicine exactly as the doctor or pharmacist has prescribed. Check with the doctor or pharmacist if the patient is not sure.
The tablet must be taken twice daily, once in the morning and once in the evening during meals.
If the patient takes more Carivalan than he/she should: If the patient takes more tablets than prescribed, contact the nearest accident and emergency department or tell the doctor immediately. The most likely effects are dizziness, feeling faint, tired and difficulty in breathing due to the heart rate slowing down.
If the patient forgets to take Carivalan: If the patient forgets to take a dose of Carivalan, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If the patient stops taking Carivalan: As the treatment for angina or chronic heart failure is usually life-long, the patient should discuss with the doctor before stopping the treatment with this medicine.
Do not suddenly stop taking Carivalan tablets since this can cause severe changes in the rhythm or rate of the heart and increase the risk of a heart attack. Only change the dose or stop the treatment in consultation with the doctor.
If the patient thinks that the effect of Carivalan is too strong or too weak, talk to the doctor or pharmacist.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take Carivalan: if the patient is allergic to carvedilol, ivabradine or any of the other ingredients of this medicine (listed in Description), or to other beta blockers; if the patient suffers from severe liver problems; if the patient started to suffer from heart failure, if the heart failure is not stably controlled, or recently became worse; if the patient suffers from unstable angina (a severe form of angina in which chest pain occurs very frequently, with or without exercise); if the patient suffers from Prinzmetal's angina (chest pain that occurs at rest and in cycles); if the patient suffers from a heart rhythm disorder; if the heart rate is too low (under 50 beats per minute) or if the patient feels weak, has decreased level of consciousness, shortness of breath, hypotension or chest pain (due to symptomatic or severe bradycardia); if the patient is having a heart attack; if the patient is suffering from cardiogenic shock (a serious heart condition treated in hospitals and caused by very low blood pressure); if the heartbeat is exclusively regulated by a pacemaker; if the patient has a severe blood vessel disorder (for example Raynaud's phenomenon); if the patient has very low blood pressure; if the patient suffers from chronic obstructive pulmonary disease or COPD (lung disease with symptoms such as wheeziness, difficulty in breathing and chronic cough); if the patient has already experienced breathing problems such as asthma or bronchospasm (difficulty in breathing due to the narrowing of the airways); if the patient has too much acid in the blood (metabolic acidosis); if the patient has high blood pressure due to a tumour near the kidney (untreated phaeochromocytoma); if the patient is taking: medicines for treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics used for bacterial infections (such as clarithromycin, erythromycin given orally, josamycin and telithromycin), medicines called protease inhibitors used to treat HIV (such as nelfinavir, ritonavir), nefazodone (medicine to treat depression), diltiazem or verapamil: medicines used to treat high blood pressure or angina pectoris; if the patient is a woman able to have children and not using reliable contraception; if the patient is pregnant or trying to become pregnant; if the patient is breast-feeding.
Talk to the doctor or pharmacist before taking Carivalan.
The patient should inform the doctor if he/she has or has had any of the following conditions: if the patient suffers from heart rhythm disorders (such as irregular heartbeat, palpitations, increase in chest pain), sustained atrial fibrillation (a type of irregular heartbeat) or an abnormality of electrocardiogram (ECG) called 'long QT syndrome'; if the patient suffers from severe heart failure or heart failure with abnormality of ECG called 'bundle branch block'; if the patient is suffering from heart failure with an inability to carry on any physical activity without discomfort (symptoms may be present even at rest and physical activity increases discomfort); if the patient suffers 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 the patient suffers from uncontrolled blood pressure, especially after a change in the antihypertensive treatment; if the patient suffers from long-standing heart failure together with: a low blood pressure(< 100mmHg), or heart disease caused by reduced blood flow in the blood vessels of the heart muscle, or a condition with damage to the large and/or small blood vessels, or kidney problems; if the patient has symptoms such as tiredness, dizziness or shortness of breath (this could mean that the heart rate is slowing down too much for example under 50 beats per minute); if the patient is going to have a cardioversion (a medical procedure that can restore a fast or irregular heartbeat to a normal rhythm); if the patient has had a recent stroke (cerebral attack); if the patient has a low blood pressure; if the patient has a blood pressure that fluctuates abruptly and repeatedly; if the patient has high blood pressure caused by another condition; if the patient experiences a drop in blood pressure whilst standing up; if the patient has an inflammation of the heart muscle, narrowing of the heart valves impacting the blood flow, final stage circulatory condition in which narrowed arteries reduce blood flow to the limbs; if the patient is taking already α1-receptor antagonist or α2-receptor agonist; if the patient suffers from chronic eye retinal disease or if the eyesight deteriorates; if the patient has diabetes; if the patient has circulation problems such as Raynaud's syndrome (usually affecting the fingers) or peripheral vascular disease causing cold hands and feet or pins-and-needles; if the patient is going to have a surgery which requires a general anaesthesia; if the patient has an overactive thyroid gland (the symptoms are tremors, a fast heart rate, sweating or weight loss); if the patient wears contact lenses; if the patient has a history of hypersensitive reactions or is undergoing desensitisation therapy; if the patient has psoriasis (severe skin rashes); if the patient has or is suspected to have a tumour on the adrenal glands (phaeochromocytoma).
If any of the previously mentioned applies to the patient, talk straight away to the doctor before or while taking Carivalan.
Do not suddenly stop taking Carivalan since this can cause severe changes in the rhythm or rate of the heart and increase the risk of a heart attack.
Carivalan contains lactose: If the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicine. If the patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, he/she should not take this medicine.
Effects on Ability to Drive or Operate Machinery: Carivalan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision), (see Side Effects). If this happen, the patient should be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
The patient should also be careful when taking Carivalan together with alcohol or changing to another medicine since this may affect the ability to drive or use machines.
If the tablets make the patient feels dizzy or tired or give him/her a headache, do not drive or use machinery.
Use in Children: Children and adolescents: Carivalan is not intended for use in children and adolescents younger than 18.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
If the patient is pregnant and has taken Carivalan, talk to the doctor.
Do not take Carivalan if the patient is able to become pregnant unless she uses reliable contraceptive measures (see Contraindications).
Do not take Carivalan if the patient is breast-feeding (see Contraindications). Talk to the doctor if the patient is breast-feeding or intending to breast-feed as breast-feeding should be stopped if she takes Carivalan.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people): luminous visual phenomena (brief moment 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; headache; dizziness; heart problem which can cause shortness of breath or swelling of the feet or legs due to fluid build-up (heart failure); low blood pressure (the signs include feeling dizzy or light-headed), generalised weakness, feeling of tiredness.
Common (may affect up to 1 in 10 people): lung or chest infections such as bronchitis or pneumonia and upper respiratory tract infection; infections of the urinary tract; decreased number of red blood cells (the signs include feeling tired, pale skin, a fluttering sensation in the heart (palpitations) and being short of breath when exercising); increased levels of cholesterol in the blood; increased levels of blood sugar (diabetes), loss of control of blood sugar in people with diabetes; weight gain; being or feeling depressed; lacrimation decreased (dry eyes), impaired vision, eye irritation, blurred vision (cloudy vision); fluid retention (the signs include overall swelling of the body, swelling of parts of the body for example the hands, feet, ankles and legs and an increase in the volume of blood the patient has in the body); build-up of fluid in the lungs; modification in the heart functioning (the symptoms are a slowing down of the heart rate); heart block (irregular heartbeats); irregular rapid contraction of the heart; feeling dizzy, light-headed or faint when the patient stands or sits up quickly; problems with blood circulation such as cold hands and feet, obstruction of the large arteries in the arms of legs, worsening of symptoms in patients with Raynaud's disease (tingling and colour change (white, blue then red) in fingers and toes when exposed to the cold) or claudication (pain in the leg which gets worse when the patient walks); uncontrolled blood pressure; shortness of breath, asthma; feeling sick (nausea), stomach pain, indigestion, diarrhoea, vomiting; pain in the extremities; disease with painful, swollen joints caused by uric acid crystals (gout); problems with the kidneys including problems starting, passing and stopping urination or altered frequency of urination; pain.
Uncommon (may affect up to 1 in 100 people): increased level of some white blood cells; increased level of uric acid in the blood; sleep disturbance including nightmares, confusion; fainting (syncope), light-headedness, muscular weakness, blurred vision and feeling faint (pre-syncope), tingling or numbness of the hands or feet; double vision, spinning sensation (vertigo); a pain or uncomfortable feeling in the chest, palpitations, changes in heart rate (fast, slow or irregular); low blood pressure (possibly related to slow heart rate); constipation; certain skin reactions (such as skin rash, hives, itching, increased sweating, psoriatic or lichen planus like skin lesions); hair loss; swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing (angioedema), rash; muscle cramps; elevated creatinine in blood (a breakdown product of muscles), abnormal ECG heart traces; sexual dysfunction, impotence (inability to get or maintain an erection).
Rare (may affect up to 1 in 1,000 people): bleeding or bruising more easily than normal (low blood platelets count); stuffy nose, wheezing; dry mouth; redness of the skin; feeling unwell.
Very rare (may affect up to 1 in 10,000 people): low number of white blood cells; abnormal liver tests; an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives); problems with the heart rhythm (second or third degree AtrioVentricular block, sick sinus syndrome); severe skin reactions: circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis); inability to control the flow of urine in women.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist.
This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects the patient can help provide more information on the safety of this medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Treatment with Carivalan can be affected by other medicines. Make sure to tell the doctor if the patient is taking any of the following medicines as special care may be required for: fluconazole (used to treat fungal infections); rifampicin (used to treat infections); QT prolonging medicines to treat either heart rhythm disorders or other conditions: quinidine, disopyramide, sotalol, ibutilide, amiodarone (used to treat heart rhythm problems), bepridil (used to treat chest pain associated to angina), pimozide, ziprasidone, sertindole (used to treat anxiety, schizophrenia or other psychoses), mefloquine and halofantrine (used to treat malaria), intravenous erythromycin (an antibiotic), pentamidine (used to treat parasitic infection), cisapride (used to treat digestion problems); clonidine (used to treat high blood pressure); dihydropyridines (used to treat high blood pressure, chest pain associated with angina or Raynaud's phenomenon); some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (often used to treat high blood pressure, oedema and heart failure); other medicines used to treat high blood pressure; nitrates (used to treat chest pain associated with angina); sympathomimetics (for example medicines to increase blood pressure or heart frequency or widen the windpipes such as epinephrine used in the treatment of severe allergic reactions and beta-2-agonists used in the treatment of asthma); class IA and IC intravenous antiarrhythmics (used to treat heart rhythm problems); barbiturates (used to treat epilepsy or difficult sleeping); phenytoin (used for epilepsy); cimetidine (used for heartburn or stomach ulcers); fluoxetine (used to treat depression); Hypericum perforatum or St John's Wort (herbal treatment used for depression); reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors (used to treat conditions such as depression and Parkinson's disease); digoxin and digitoxin (used to treat heart diseases); cyclosporin (used following an organ transplant); insulin and antidiabetic agents (used to treat diabetes); muscle relaxants used in anaesthesia or anaesthetics (the patient should tell the doctor before surgery); beta-agonist bronchodilators (used to treat asthma); non-steroidal anti-inflammatory/antirheumatic agents (NSAIDs) (used to reduce inflammation, fever and pain); oestrogens (female hormones used for contraception or hormone replacement therapy); corticosteroids (used to treat different types of diseases such as asthma, skin dermatitis, etc.); ergotamine (used to treat migraine); other beta-blockers (in the form of eye drops).
Inform the doctor that Carivalan is being taken if the patient is going to have an operation needing an anaesthetic.
Carivalan with food and drink: Avoid grapefruit juice during treatment with Carivalan.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient no longer uses. These measures will help protect the environment.
C07FX06 - carvedilol and ivabradine ; Belongs to the class of beta-blocking agents in combination with other cardiac drugs. Used in the treatment of cardiovascular diseases.
6.25/5 mg FC tab (white, hexagonal, longest diagonal 7.3 mm, engraved with
Click on icon to see table/diagram/image on one face and
Click on icon to see table/diagram/image on the other face) 14's, 56's. 6.25/7.5 mg FC tab (yellow, hexagonal, longest diagonal 7.3 mm, engraved with
Click on icon to see table/diagram/image on one face and
Click on icon to see table/diagram/image on the other face) 14's, 56's. 12.5/5 mg FC tab (white, elliptic, 10.6 mm x 5.3 mm, engraved with
Click on icon to see table/diagram/image on one face and
Click on icon to see table/diagram/image on the other face) 14's, 56's. 12.5/7.5 mg FC tab (yellow, elliptic, 10.6 mm x 5.3 mm, engraved with
Click on icon to see table/diagram/image on one face and
Click on icon to see table/diagram/image on the other face) 14's, 56's. 25/5 mg FC tab (white, octagonal, diameter 7.8 mm, engraved with
Click on icon to see table/diagram/image on one face and
Click on icon to see table/diagram/image on the other face) 14's, 56's.
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