RAENOM 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Raenom, 5 mg, coated tablets
3. Raenom, 7.5 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Raenom and what is it used for
5. Important information before taking Raenom
   1. When not to take Raenom
   2. Warnings and precautions
   3. Children and adolescents
   4. Raenom and other medicines
   5. Taking Raenom with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Raenom contains lactose and sodium
6. How to take Raenom
   1. Taking a higher dose of Raenom than recommended
   2. Missing a dose of Raenom
   3. Stopping treatment with Raenom
7. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Common (may affect up to 1 in 10 people):
   4. Uncommon (may affect up to 1 in 100 people):
   5. Rare (may affect up to 1 in 1,000 people):
   6. Very rare (may affect up to 1 in 10,000 people):
   7. Reporting side effects
8. How to store Raenom
9. Contents of the pack and other information
   1. What Raenom contains
   2. What Raenom looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: April 2022

Package Leaflet: Information for the Patient

Raenom, 5 mg, coated tablets

Raenom, 7.5 mg, coated tablets

Ivabradine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor. See section 4.

Table of Contents of the Leaflet:

• 1. What is Raenom and what is it used for
• 2. Important information before taking Raenom
• 3. How to take Raenom
• 4. Possible side effects
• 5. How to store Raenom
• 6. Contents of the pack and other information

1. What is Raenom and what is it used for

The active substance of Raenom is ivabradine.
Raenom is a heart medicine used to treat:

• symptomatic stable angina (which causes chest pain) in adult patients whose heart rate is 70 or more beats per minute. It is used in adults who do not tolerate or cannot take heart medicines called beta-adrenergic blockers. It is also used in combination with beta-adrenergic blockers in adults whose condition is not fully controlled with a beta-adrenergic blocker.
• chronic heart failure in adult patients whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including beta-adrenergic blockers or when beta-adrenergic blockers are contraindicated or not tolerated.

About stable angina (usually referred to as "angina")
Stable angina is a heart disease that occurs when the heart muscle does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.
About chronic heart failure
Chronic heart failure is a heart disease that occurs when the heart cannot pump enough blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.
How Raenom works
Raenom's specific action of reducing heart rate helps:

• control and reduce the number of angina attacks by reducing the heart's oxygen demand,
• improve heart function and survival prognosis in patients with chronic heart failure.

2. Important information before taking Raenom

When not to take Raenom

• if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• in patients whose resting heart rate is too low (below 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in the hospital);
• in patients with rhythm disorders (sick sinus syndrome, atrioventricular block, third-degree atrioventricular block);
• in patients with recent myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina (a severe form with very frequent chest pains related or unrelated to exertion);
• in patients with recently worsened heart failure;
• if the heart rhythm is controlled solely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking antifungal medicines (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV medicines (such as nelfinavir, ritonavir), or nefazodone (an antidepressant) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if the patient is of childbearing age and does not use adequate contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Raenom, the patient should discuss it with their doctor or pharmacist:

• if the patient has rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or a prolonged QT interval (a certain abnormality in the ECG);
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a too-low heart rate);
• if the patient has symptoms of atrial fibrillation [extremely high resting heart rate (over 110 beats per minute) or irregular heartbeat, without apparent cause, difficult to measure];
• if the patient has recently had a stroke;
• if the patient has mild or moderate low blood pressure;
• if the patient has uncontrolled high blood pressure, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with a certain ECG abnormality, called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderate liver disease;
• if the patient has severe kidney disease.

If any of the above conditions apply to the patient, they should contact their doctor immediately before or during treatment with Raenom.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age. There is insufficient data for this age group.

Raenom and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor about taking any of the following medicines, as it may be necessary to adjust the dose of Raenom or closely monitor its use:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for sleep disorders or epilepsy);
• phenytoin (used for epilepsy);
• St. John's Wort (Hypericum perforatum) preparations (herbal medicines used to treat depression);
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat rhythm disorders);
• bepridil (a medicine used to treat angina);
• certain types of medicines used to treat 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 (a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat swelling, high blood pressure).

Taking Raenom with food and drink

The patient should avoid drinking grapefruit juice while taking Raenom.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Raenom should not be taken during pregnancy or when planning to have a child (see "When not to take Raenom").
The patient should inform their doctor if they become pregnant while taking Raenom.
A woman of childbearing age should not take Raenom unless she uses adequate contraception (see "When not to take Raenom").
Raenom should not be taken during breastfeeding (see "When not to take Raenom"). The patient should consult their doctor if they are breastfeeding or plan to breastfeed, as breastfeeding should be stopped if the patient is taking Raenom.

Driving and using machines

Raenom may cause transient vision disturbances (temporary sensations of seeing strong light, see "Possible side effects"). If these occur, the patient should be cautious while driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Raenom contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Raenom

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Raenom should be taken with meals.
Raenom, 5 mg, coated tablets
The tablet can be divided into equal doses.
If the patient is being treated for stable angina
The initial dose should not be more than one 5 mg Raenom tablet twice a day. If the patient still has symptoms of angina and tolerates the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice a day. The doctor will prescribe the appropriate dose for the patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if the patient is 75 years or older), the doctor may prescribe half the dose, i.e., half a 5 mg Raenom tablet (equivalent to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.
If the patient is being treated for chronic heart failure
The usual initial dose is one 5 mg Raenom tablet twice a day; if necessary, the dose can be increased to one 7.5 mg Raenom tablet twice a day.
The doctor will determine the appropriate dose for the patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if the patient is 75 years or older), the doctor may recommend half the dose, i.e., half a 5 mg Raenom tablet (equivalent to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Raenom than recommended

After taking a large dose of Raenom, shortness of breath or fatigue may occur, as the heart rate slows down excessively. In such a case, the patient should immediately consult their doctor.

Missing a dose of Raenom

If a dose of Raenom is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Raenom

Since treatment for angina or chronic heart failure is usually long-term, the patient should consult their doctor before stopping treatment with this medicine.
If the patient feels that the effect of Raenom is too strong or too weak, they should consult their doctor or pharmacist.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Raenom can cause side effects, although not everybody gets them.
The most common side effects of Raenom depend on the dose and are related to the way the medicine works:

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

Vision disturbances (temporary sensations of seeing strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colored flashes, split images, or multiple images. They usually occur within the first two months of treatment and may recur and disappear during therapy or after treatment.

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

Changes in heart rate (symptoms of slowed heart rate). Symptoms occur especially within the first 2 to 3 months of starting treatment.
Other side effects have also been reported:

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

Irregular, rapid heartbeats (atrial fibrillation), unusual sensations of heartbeat (bradycardia, extrasystoles, first-degree atrioventricular block (prolonged PQ interval in the ECG)), uncontrolled high blood pressure, headaches, dizziness, and blurred vision.

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

Palpitations and extrasystoles, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (vertigo), breathing difficulties (dyspnea), muscle cramps, high levels of uric acid in the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a muscle breakdown product), rash, angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of weakness, abnormal ECG, double vision, impaired vision.

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

Hives, itching, skin redness, malaise.

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

Irregular heartbeat (second-degree or third-degree atrioventricular block, sick sinus syndrome).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Raenom

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the "EXP" abbreviation. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Raenom contains

• The active substance of Raenom is ivabradine. Raenom, 5 mg, coated tablets: each coated tablet contains 5 mg ivabradine (as hydrobromide). Raenom, 7.5 mg, coated tablets: each coated tablet contains 7.5 mg ivabradine (as hydrobromide).
• Other ingredients are: Tablet corelactose (see section 2 "Raenom contains lactose"), mannitol (E421), maltodextrin, croscarmellose sodium, colloidal anhydrous silica (E551), magnesium stearate, Tablet coatingOpadry 200F240001 Pink: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), methacrylic acid and ethyl acrylate copolymer (1:1), yellow iron oxide (E172), red iron oxide (E172), sodium bicarbonate (E500).

What Raenom looks like and contents of the pack

Raenom, 5 mg, coated tablets:
Light orange, oval, biconvex coated tablets, approximately 8.6 mm x 4.5 mm in size, with "CK3" engraved on one side and a score line on the other side.
Raenom tablets can be divided into equal doses.
Raenom, 7.5 mg, coated tablets:
Light orange, round, biconvex coated tablets, approximately 6 mm in diameter, with "CK4" engraved on one side and no markings on the other side.
56 or 112 coated tablets in PA/Aluminum/PVC//Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter Romania S.A.
Str. Cuza Voda Nr. 99-105
540306 Târgu-Mureş
Romania
To obtain more detailed information about the medicine and its names in other European Economic Area member states, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: April 2022