Prospect: information for the patient

Carevalan 6,25 mg/5 mg film-coated tablets

Carevalan 6,25 mg/7,5 mg film-coated tablets

Carevalan 12,5 mg/5 mg film-coated tablets

Carevalan 25 mg/5 mg film-coated tablets

Carvedilol/ivabradina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Carevalanis used in adult patients to treat:

• Stable angina pectoris (which causes chest pain).
• Chronic heart failure.

Instead of taking carvedilol and ivabradina in separate tablets, you will be given a Carevalan tablet that contains both active ingredients at the same dose.

Carevalanis an association of two active ingredients, carvedilol and ivabradina. Carvedilol is a beta-blocker. Beta-blockers reduce heart rate, decreasing the force with which the heart muscle contracts and reducing the contraction of blood vessels in the heart, brain, and throughout the body. The specific action of ivabradina in reducing heart rate helps to:

• Control and reduce the number of angina attacks by decreasing the heart's need for oxygen,
• Improve heart function and vital prognosis in patients with chronic heart failure.

Do not take Carevalan

• if you are allergic to carvedilol, ivabradina or any of the other ingredients of this medicine (listed in section 6), or to another beta-blocker,
• if you have severe liver problems,
• if you have started to suffer from heart failure, if heart failure is not controlled in a stable manner, or if it has recently worsened,
• if you have unstable angina (a severe type of angina in which chest pain occurs very frequently, with or without exercise),
• if you have Prinzmetal's angina (chest pain that occurs at rest and in cycles),
• if you have a heart rhythm disorder(sick sinus syndrome, sinoatrial block, 2nd and 3rd degree AV block),
• if your heart rate is too slow (below 50 beats per minute)or if you feel weak, if you have a decrease in level of consciousness, difficulty breathing, hypotension or chest pain (due to symptomatic or severe bradycardia),
• if you are having a heart attack,
• if you have cardiogenic shock (a heart problem treated in the hospitaland caused by very low blood pressure),
• if your heart rate is exclusively regulated by your pacemaker,
• if you have a severe vascular disorder (for example, Raynaud's phenomenon),
• if you have very low blood pressure;
• if you have chronic obstructive pulmonary disease or COPD (lung disease with symptoms such as wheezing, difficulty breathing and chronic cough),
• if you have already experienced respiratory problems such as asthma or bronchospasm (difficulty breathing due to narrowing of the airways),
• if you have too much acid in your blood (metabolic acidosis),
• if you have high blood pressure due to an un-treated tumor near the kidney (pheochromocytoma),
• if you are taking:

• antifungal medicines (such as ketoconazole, itraconazole),
• antibiotics used for bacterial infections (such as clarithromycin, erythromycin administered orally, josamycin and telithromycin),
• protease inhibitors for treating HIV infections (such as nelfinavir, ritonavir),
• nefazodone (medicine for treating depression),
• diltiazem, verapamil: used for treating high blood pressure or angina pectoris,
• cimetidine (medicine used for treating heartburn or stomach ulcers),
• class I antiarrhythmics such as quinidine, disopyramide (medicine used for treating heart rhythm disorders),

• if you are a fertile woman and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCarevalan.

You must inform your doctor if you suffer or have suffered from any of the following conditions:

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation, or an ECG anomaly called “prolonged QT syndrome”,
• if you suffer from severe heart failure or heart failure with an ECG anomaly called “branch block”,
• if you suffer from heart failure with an inability to perform any physical activity without discomfort (the symptoms may be present even at rest and physical activity increases the discomfort),
• if you suffer from symptoms of atrial fibrillation (unusual high or irregular pulse at rest (above 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure),
• if you suffer from uncontrolled high blood pressure, especially after a change in your antihypertensive treatment,
• if you suffer from long-term heart failure along with: a low blood pressure (<100
• if you have symptoms such as fatigue, dizziness or difficulty breathing (this could mean that your heart rate is decreasing too much, for example, below 50 beats per minute),
• if you are about to have a cardioversion (a medical procedure that can reverse a fast or irregular heart rhythm to a normal rhythm),
• if you have had a recent stroke (cerebral infarction),
• if you have low blood pressure,
• if you have fluctuating blood pressure that abruptly and repeatedly changes,
• if you have high blood pressure due to another condition,
• if you experience a decrease in blood pressure while standing,
• if you have myocarditis, narrowing of the heart valves that affects blood flow, end-stage circulatory disease in which narrowed arteries reduce blood flow to extremities,
• if you are already taking an α1 receptor antagonist or an α2 receptor agonist,
• if you suffer from chronic retinal disease or if your vision deteriorates,
• if you are diabetic,
• if you have circulation problems such as Raynaud's phenomenon (generally affects fingers) or peripheral vascular disease that causes cold hands and feet or cramps,
• if you are about to undergo surgery that requires general anesthesia,
• if you have a history of abnormally low platelet count (blood cells that help the body to stop bleeding),
• if you have an overactive thyroid gland (symptoms are tremors, rapid heart rate, sweating or weight loss),
• if you use contact lenses,
• if you have a history of hypersensitivity reactions or are undergoing desensitization treatment,
• if you have psoriasis (severe skin eruptions),
• if you have or suspect you have a tumor in the adrenal glands (pheochromocytoma).

If you present any of these conditions, consult your doctor immediately before or while takingCarevalan.

Do not stop taking Carevalan suddenly, as this can cause severe changes in heart rhythm or frequency and increase the risk of a heart attack.

Athletes

This medicine contains the active ingredientcarvedilolwhich can produce a positive result in doping control tests.

Children and adolescents

Do not administer this medicine tochildren and adolescents under 18years. Available data are insufficient in this age group.

Taking Carevalan with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

The treatment with Carevalan may be affected by other medicines. Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to have special monitoring:

• fluconazole (used to treat fungal infections),
• rifampicin (used to treat infections),
• medicines called protease inhibitors to treat HIV infections (such as nelfinavir, ritonavir),
• nefazodone (medicine for treating depression),
• diltiazem, verapamil: used for treating high blood pressure or angina pectoris,
• cimetidine (medicine used for treating heartburn or stomach ulcers),
• class I antiarrhythmics such as quinidine, disopyramide (medicine used for treating heart rhythm disorders),

• if you are a fertile woman and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

• fluconazole (used to treat fungal infections),
• rifampicin (used to treat infections),
• medicines that prolong the QT interval to treat heart rhythm disorders or other abnormalities:

• sotalol, ibutilide, amiodarone (to treat heart rhythm disorders),
• bepridil (to treat angina pectoris),
• pimozide, ziprasidone, sertindole, haloperidol (used to treat anxiety, schizophrenia or other psychoses),
• mefloquine and halofantrine (medicines to treat malaria),
• intravenous erythromycin (an antibiotic),
• pentamidine (used to treat infections by parasites),
• cisapride (used to treat digestive problems).

• fingolimod (used to treat multiple sclerosis),
• clonidine (used to treat high blood pressure),
• dihydropyridine (used to treat high blood pressure, chest pain associated with angina and Raynaud's phenomenon),
• some types of diuretics that can reduce potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (often used to treat high blood pressure, edema and heart failure),
• galantamine, donepezil, rivastigmine, tacrine (used to treat Alzheimer's disease),
• neostigmine, pyridostigmine, ambenonium (used to treat myasthenia gravis),
• other medicines to treat high blood pressure,
• tricyclic antidepressants, neuroleptics (used to treat mental disorders),
• nitrates (used to treat chest pain associated with angina),
• sympathomimetics (for example, medicines to increase blood pressure or heart rate or to dilate the trachea, such as adrenaline/epinephrine used in the treatment of severe allergic reactions and beta 2 agonists used in the treatment of asthma)
• barbiturates (used to treat epilepsy and difficulty sleeping),
• phenytoin (used for epilepsy),
• fluoxetine or paroxetine (used to treat depression),
• Hypericum perforatumor St. John's Wort (herbal treatment used for depression),
• reserpine, guanetidine, 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),
• ciclosporin or tacrolimus (used after organ transplantation),
• insulin and antidiabetic agents(used to treat diabetes),
• muscle relaxants used in anesthesia or anesthetics (inform your doctor before surgery),
• beta-agonist bronchodilators (used to treat asthma),
• non-steroidal anti-inflammatory agents/antirheumatics (used to reduce inflammation, fever and pain),
• estrogens (female hormones used for contraception or hormone replacement therapy),
• corticosteroids (used to treat various diseases such as asthma, skin dermatitis, etc.),
• ergotamine (used to treat migraines),
• other beta-blockers (in the form of eye drops),
• lidocaine (used to treat heart rhythm disorders or to produce local anesthesia),
• pilocarpine (used to treat certain forms of glaucoma).

Inform your doctor that you are taking Carevalan if you are about to undergo surgery that requires anesthesia.

Carevalanwith food, drinks and alcohol

Avoid grapefruit juice during treatmentwithCarevalan.

Grapefruit or grapefruit juice may increase the active ingredients carvedilol and ivabradina in the blood and cause unpredictable side effects.

Do not drink alcohol while taking Carevalan. It may cause your blood pressure to drop too low and increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

If you are pregnant and have taken Carevalan, consult your doctor.

Do not take Carevalan if you are fertile unless you use reliable contraceptive methods (see "Do not take Carevalan").

Do not take Carevalan if you are breastfeeding (see "Do not take Carevalan"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop it if you take Carevalan.

Driving and using machines

Carevalanmay cause transient 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 machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

You should also be careful if you takeCarevalanwith alcohol or when changing treatment as this may affect your ability to drive or use machines.

If the tablets make you feel dizzy or tired or give you a headache, do not drive or use machines.

Carevalancontains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Carevalan contains sodium

This medicine contains less than 1mmolof sodium (23 mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be taken twice a day, once in the morning and once at night during meals.

If you take more Carevalan than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. The most likely effects are sinus arrest, dizziness, feeling of fainting, extreme fatigue, and difficulty breathing due to decreased heart rate or arrest.

If you forgot to takeCarevalan

If you forgot to take a dose of Carevalan, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withCarevalan

Generally, the treatment for angina pectoris or chronic heart failure is lifelong, so you should consult with your doctor before stopping this medication.

Do not stop taking Carevalan abruptlyCarevalan as this may cause severe changes in your heart rhythm or frequency and increase the risk of a heart attack. Only change the dose or interrupt treatment after consulting with your doctor.

If you think the action of Carevalan is too strong or too weak, inform your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common(may affect more than 1 in 10people):

• Photopsia (brief moments of increased brightness, usually caused by sudden changes in light intensity). They can also be described as a halo, flashes of color, image decomposition, or multiple images. These usually appear during the first two months of treatment and may occur repeatedly and resolve during or after treatment.
• Headache,
• Dizziness,
• Cardiac problems that may cause shortness of breath or swelling of the feet or legs due to fluid accumulation (heart failure),
• Low blood pressure (possibly related to slow heart rate, symptoms include dizziness or lightheadedness), generalized weakness, feeling tired.

Common(may affect up to 1 in 10people):

• Pulmonary or thoracic infections such as bronchitis or pneumonia and upper respiratory tract infections,
• Urinary tract infections,
• Decreased red blood cell count (symptoms include feeling tired, pale skin, sensation of fluttering in the heart (palpitations), and shortness of breath during exercise),
• Increased blood cholesterol levels,
• Increased blood sugar levels (diabetes), loss of blood sugar control in people with diabetes,
• Weight gain,
• Feeling or being depressed,
• Fainting (syncope) and feeling like fainting (presyncope),
• Decreased tear production (dry eyes), blurred vision, eye irritation, blurred vision (hazy vision),
• Fluid retention (symptoms include general swelling of the body, swelling of body parts, for example, hands, feet, ankles, and legs, and an increase in blood volume in the body),
• Liquid accumulation in the lungs,
• Modification of heart function (symptoms include decreased heart rate),
• Abnormal perception of heartbeats (bradycardia, ventricular extrasystoles, first-degree AV block (prolonged PQ interval on ECG)),
• Irregular and rapid heart contractions (atrial fibrillation),
• Feeling dizzy, lightheaded, or weak when standing or standing quickly,
• Circulatory problems, such as cold hands and feet, obstruction of large arteries in the arms or legs, worsening of symptoms in patients with Raynaud's syndrome (tingling and color change (white, blue, and then red) in fingers and toes with exposure to cold) or claudication (pain in the legs that worsens with walking),
• High blood pressure,
• Uncontrolled blood pressure,
• Difficulty breathing, asthma,
• Feeling sick (nausea), stomach pain, indigestion, diarrhea, vomiting,
• Pain in the extremities,
• Joint disease with painful and swollen joints caused by uric acid crystals (gout),
• Problems with your kidneys, including difficulty starting, performing, and stopping urination or altered frequency of urination,
• Pain.

Uncommon(may affect up to 1 in 100people):

• Increased levels of some white blood cells,
• Increased uric acid levels in the blood,
• Sleep disorders including nightmares, confusion,
• Sensation of dizziness, muscle weakness, tingling, or numbness in hands or feet,
• Dual vision, sensation of spinning (vertigo),
• Pain or uncomfortable sensation in the chest, palpitations, changes in heart rhythm (fast, slow, or irregular),
• Constipation,
• Certain skin reactions (such as skin rashes, urticaria, itching, increased sweating, psoriatic or lichen planus skin lesions),
• Hair loss,
• Swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema), skin rash,
• Muscle spasms,
• Elevated creatinine levels in the blood (a product of muscle breakdown), abnormal cardiac tracings on ECG,
• Sexual dysfunction, impotence (inability to achieve or maintain an erection).

Rare(may affect up to 1 in 1,000people):

• Bleeding or petechiae that occur more easily than normal (low platelet count),
• Conjunctivitis, rhinitis, and flu-like symptoms,
• Dry mouth,
• Redness of the skin,
• Indisposition.

Very rare(may affect up to 1 in 10,000people):

• Low white blood cell count,
• Abnormal liver function tests,
• Severe allergic reaction (swelling of the lips, face, or neck that leads to severe difficulty breathing, skin rash, or hives),
• Cardiac rhythm problems (second- or third-degree AV block, sick sinus syndrome),
• Severe skin reactions:

• Red, circular, and irregular patches on the skin of the hands and arms (erythema multiforme),

Severe skin rash with redness, fever, blisters, or ulcers (Stevens-Johnson syndrome), severe skin rash that includes redness, peeling, and swelling of the skin that resembles severe burns (toxic epidermal necrolysis),

• Urinary incontinence in women.

Frequency not known(cannot be estimated from available data):

• Some cases of hallucinations have been reported in patients taking carvedilol.
• It may cause a heart block, which means your heartbeats may become very slow or stop. You may also feel dizzy, unusually tired, and short of breath. This may occur especially in patients over 65 years old or in patients with other heart rhythm problems.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after EXP. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carevalan

• The active principles are carvedilol and ivabradina (as hydrochloride):

• Carevalan 6.25mg/5 mg film-coated tablets: each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of ivabradina in the form of hydrochloride.
• Carevalan 6.25 mg/7.5 mg film-coated tablets: each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of ivabradina in the form of hydrochloride.
• Carevalan 12.5 mg/5 mg film-coated tablets: each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of ivabradina in the form of hydrochloride.
• Carevalan 25 mg/5 mg film-coated tablets: each film-coated tablet contains 25 mg of carvedilol and 5 mg of ivabradina in the form of hydrochloride.

• The other components are:

• Core tablet: pregelatinized maize starch, lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose (E-468), maltodextrin, anhydrous colloidal silica (E-551), and magnesium stearate (E-470b).
• Coating: glycerol (E-422), hypromellose (E-464), magnesium stearate (E-470b), titanium dioxide (E-171), yellow iron oxide (E-172) (for 6.25/7.5 mg), and macrogol 6000 (E-1521).

Appearance of the product and contents of the package

Film-coated tablet, white, hexagonal, (6.25/5 mg) (major diagonal 7.3 mm) engraved with CI2 on one face and on the other face.

[Film-coated tablet, yellow, hexagonal, (6.25/7.5 mg) (major diagonal 7.3 mm) engraved with CI3 on one face and on the other face.]

[Film-coated tablet, white, elliptical, (12.5/5 mg) (10.6 mm x 5.3 mm) engraved with CI4 on one face and on the other face.]

[Film-coated tablet, white, octagonal, (25/5 mg) (diameter 7.8 mm) engraved with CI6 on one face and on the other face.]

The tablets are presented in calendar packaging (Aluminum/PVC blisters) of 14, 28, 56, 98, or 112 tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Responsible for manufacturing:

Les Laboratoires Servier Industrie

905, route de Saran

45520 Gidy

France

Servier (Ireland) Industries Ltd.

Gorey Road

Arklow - Co. Wicklow – Ireland

Przedsiebiorstwo Farmaceutyczne ANPHARM S.A.

ul. Annopol 6B – 03-236 Warszawa – Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )