Inevica 7,5 mg. 60 tablets

1. What Inevika is and what it is used for

Inevika (ivabradine) is a heart medication used for the treatment of:

symptomatic stable angina (which causes chest pain) in adult patients with a heart rate of 70 beats per minute or more. This medication is used in adult patients who are intolerant to, or cannot take, heart medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled by a beta-blocker.

chronic heart failure in adult patients with a heart rate of 75 beats per minute or more. It is used in combination with standard treatment—including beta-blockers—or in cases where beta-blockers are contraindicated or not tolerated.

Regarding stable angina (commonly referred to as “stable angina pectoris”):

Stable angina is a heart condition that occurs when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.

Regarding chronic heart failure:

Chronic heart failure is a heart condition that occurs when the heart is unable to pump enough blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, weakness, and swelling of the ankles.

How does Inevika work?

The specific heart-rate-lowering action of ivabradine helps to:

control and reduce the number of angina attacks by decreasing the heart's demand for oxygen;

improve heart function and the prognosis for patients with chronic heart failure.

2. What you need to know before you take Inevika

Do not take Inevika:

if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);

if your resting heart rate is very low before starting treatment (below 70 beats per minute);

if you are suffering from cardiogenic shock (a heart condition requiring hospital treatment);

if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, or third-degree AV block);

if you have had a myocardial infarction (heart attack);

if you have very low blood pressure;

if you suffer from unstable angina (a severe form where chest pain occurs very frequently, both during physical exertion and at rest);

if you have heart failure that has recently worsened;

if your heart rate is determined solely by a pacemaker;

if you have severe liver problems; if you are currently taking medications for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or erythromycin taken orally), medications for the treatment of HIV/AIDS (such as nelfinavir, ritonavir), nefazodone (a medication for the treatment of depression), or diltiazem or verapamil (used for high blood pressure or angina);

if you are a woman of childbearing potential and are not using reliable contraception; if you are pregnant or trying to become pregnant; if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Inevika:

if you suffer from heart rhythm disorders (such as an irregular heartbeat, heart palpitations, or worsening chest pain), persistent atrial fibrillation (a type of heart rhythm disorder), or an abnormality on an electrocardiogram (ECG) known as "prolonged QT interval syndrome";

if you experience symptoms such as easy fatigability, dizziness, or shortness of breath (this could indicate that your heart rate is too slow);

if you experience symptoms of atrial fibrillation (an abnormally high heart rate at rest—over 110 beats per minute—or an irregular rhythm that occurs without a clear cause and is difficult to measure); if you have recently had a stroke;

if you suffer from mild to moderate low blood pressure;

if you suffer from uncontrolled blood pressure, especially following a change in your antihypertensive treatment;

if you suffer from severe heart failure or heart failure accompanied by an ECG change known as a "bundle branch block";

if you suffer from a chronic disease of the retina;

if you suffer from moderate liver impairment;

if you suffer from severe renal (kidney) impairment.

Consult your doctor immediately—either before starting or while taking Inevika—if any of the above conditions apply to you.

Children and adolescents

Do not give this medicine to adolescents under 18 years of age. There is insufficient data available for this age group.

Other medicines and Inevika

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Be sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to adjust your Inevika dose or provide medical monitoring:

fluconazole (an antifungal medicine);

rifampicin (an antibiotic);

barbiturates (used for sleep difficulties or epilepsy); phenytoin (used for epilepsy)

;

*Hypericum perforatum* or St. John’s wort (herbal remedy for depression); medicines that prolong the QT interval and are used to treat heart rhythm disorders or other conditions:

quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders);

bepridil (for the treatment of angina);

certain types of medicines for the treatment of anxiety, schizophrenia, or other

psychoses (such as pimozide, ziprasidone, sertindole);

antimalarial medicines (such as mefloquine or halofantrine);

intravenous erythromycin (an antibiotic);

pentamidine (an antiparasitic medicine);

cisapride (for gastroesophageal reflux).

Certain types of diuretics that can cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, and indapamide (used to treat edema and high blood pressure).

Inevika with food and drink

Avoid consuming grapefruit juice while being treated with Inevika.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Do not take Inevika if you are pregnant or planning a pregnancy (see “Do not take Inevika”). If you are pregnant and have taken Inevika, speak to your doctor.

Do not take Inevika if there is a possibility that you could become pregnant, unless you are using reliable methods of contraception (see “Do not take Inevika”).

Do not take Inevika if you are breastfeeding (see “Do not take Inevika”). Tell your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you are taking Inevika.

Driving and using machines

Inevika may cause temporary visual phenomena related to light (temporary flashes in the field of vision; see “Possible side effects”). If this occurs, exercise caution when driving or operating machinery in situations where sudden changes in light intensity might arise—particularly when driving at night.

Inevika contains lactose

If you have been told by your doctor that you have an intolerance to certain sugars, contact them before taking this medicinal product.

3. How to take Inevika

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure about anything, ask your doctor or pharmacist.

Inevika should be taken with food.

Inevika 5 mg film-coated tablets can be divided into equal doses. If you are being treated for stable angina

The starting dose must not exceed one 5 mg Inevika tablet twice daily. If you still experience symptoms of angina and tolerate the 5 mg twice-daily dose well, the dose may be increased. The maintenance dose must not exceed 7.5 mg twice daily. Your doctor will prescribe the exact dose that is appropriate 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 75 years of age or older), your doctor may prescribe half the dose—that is, half of a 5 mg Inevika tablet (corresponding to 2.5 mg of ivabradine) in the morning and half of a 5 mg tablet in the evening.

If you are being treated for chronic heart failure

The usual recommended starting dose is one 5 mg Inevika tablet twice daily, which may be increased, if necessary, to one 7.5 mg tablet twice daily. Your doctor will decide which dose is appropriate 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 75 years of age or older), your doctor may prescribe half the dose—that is, half of a 5 mg Inevika tablet (corresponding to 2.5 mg of ivabradine) in the morning and half of a 5 mg tablet in the evening. If you have taken more Inevika than you should

A high dose of Inevika could cause shortness of breath or weakness, due to an excessive slowing of your heart rate. If this happens, contact your doctor immediately.

If you forget to take Inevika

If you forget to take Inevika, take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

The calendar printed on the blister pack containing the tablets should help you remember when you last took an Inevika tablet.

If you stop taking Inevika

Since treatment for angina or chronic heart failure is usually lifelong, you should consult your doctor before stopping the use of this medicinal product.

If you feel that the effect of Inevika 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.

If you experience the following serious side effects, stop taking Inevika and seek medical help immediately:

swelling of the face, tongue, or throat, difficulty breathing, or...

swelling (angioedema) – this occurs uncommonly (may affect up to 1 in 100 people).

The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:

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

Luminous visual phenomena (brief moments of brightness, most often triggered by sudden changes in light intensity). These may also be described as a halo, colored flashes, image fragmentation, or multiple images. They typically appear during the first two months of treatment; subsequently, they may recur and then resolve either during or after the course of treatment.

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

Changes in heart activity (symptoms include a slowing of the heart rate). These occur primarily within the first 2 to 3 months after starting treatment.

Other adverse reactions have also been observed:

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

Irregular, rapid heart contractions (atrial fibrillation), an abnormal sensation of the heartbeat (bradycardia, ventricular extrasystoles, first-degree AV block (prolonged QT interval on an ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision. Uncommon (may affect up to 1 in 100 people):

Palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, a sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, high levels of uric acid in the blood, an increased number of eosinophils (a type of white blood cell), elevated creatinine in the blood (a breakdown product of muscle contraction), skin rash, low blood pressure, fatigue, weakness, abnormal changes on an ECG (electrocardiogram), double vision, impaired vision.

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

Hives (urticaria), itching, skin redness, general malaise.

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

Irregular heart rhythm (second-degree AV block, third-degree AV block, sick sinus syndrome).

5. How to store Inevika

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after "EXP:". The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Inevika contains

The active substance is ivabradine (as hydrochloride).

Inevika 5 mg: each film-coated tablet contains 5 mg of ivabradine (as hydrochloride). Inevika 7.5 mg: each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

The other ingredients in the tablet core are: magnesium stearate (E 470 B), colloidal anhydrous silica (E 551), maltodextrin, maize starch, lactose monohydrate; and in the tablet film-coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b). What Inevika looks like and contents of the pack

Inevika 5 mg tablets are white or almost white, oval, biconvex, film-coated tablets, marked with “A274” on one side and a score line on the other; the tablet dimensions are 8.2 x 4.1 mm.

Inevika 7.5 mg tablets are white or almost white, triangular, biconvex, film-coated tablets, marked with “A267” on one side; the tablet dimensions are 7.5 x 7.2 mm.

OPA-aluminium-PE-desiccant/aluminium-PE blister packs. The desiccant is incorporated into the polyolefin sealing layer. The multilayer foil prevents contact between the desiccant and the tablets. The blisters are packed in cartons containing 14, 28, 30, 56, 60, 84, 90, 112, and 120 film-coated tablets.

OPA-aluminium-PE-desiccant/aluminium-PE calendar blister packs. The desiccant is incorporated into the polyolefin sealing layer. The multilayer foil prevents contact between the desiccant and the tablets. The blister packs are packaged in cardboard boxes containing 14, 28, 30, 56, 60, 84, 90, 112, and 120 film-coated tablets.

Not all pack sizes may be marketed.