RAENOM 7.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Raenom, 5 mg, Film-Coated Tablets
3. Raenom, 7.5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package 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, Film-Coated Tablets

Raenom, 7.5 mg, Film-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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor. See section 4.

Contents of the Package 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 beats per minute or more. 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 alone.
• chronic heart failure in adult patients whose heart rate is 75 beats per minute or more. 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 heart rate-lowering effect 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 you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• in patients with a resting heart rate of less than 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 severe hypotension;
• in patients with unstable angina (a severe form with very frequent chest pain related or unrelated to exertion);
• in patients with recently worsened heart failure;
• if the heart rhythm is controlled exclusively by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV infection medicines (such as nelfinavir, ritonavir), or nefazodone (a medicine for depression) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a woman of childbearing age and do not use effective contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before taking Raenom, discuss with your doctor or pharmacist:

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

If any of the above conditions apply to you, you should contact your 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 limited data available for this age group.

Raenom and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Inform your 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 insomnia or epilepsy);
• phenytoin (used for epilepsy);
• St. John's Wort (Hypericum perforatum) preparations (herbal medicines used for 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

Avoid drinking grapefruit juice while taking Raenom.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Raenom during pregnancy or if you are planning to have a baby (see "When not to take Raenom").
Inform your doctor if you become pregnant while taking Raenom.
Women of childbearing age should not take Raenom unless they use effective contraception (see "When not to take Raenom").
Do not take Raenom during breastfeeding (see "When not to take Raenom"). If you are breastfeeding or plan to breastfeed, consult your doctor, as breastfeeding should be stopped if you are taking Raenom.

Driving and using machines

Raenom may cause temporary vision disturbances (transient sensations of strong light in the field of vision, see "Possible side effects"). If they occur, 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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Raenom

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Raenom should be taken during meals.
Raenom,5 mg, film-coated tablets
The tablet can be divided into equal doses.
If you are being treated for stable angina
The initial dose should not exceed one 5 mg Raenom tablet twice a day. If you still have symptoms of angina and tolerate 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. Your doctor will prescribe the appropriate 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 75 years or older), your 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 you are being treated for chronic heart failure
The usual initial dose is one 5 mg Raenom tablet twice a day; if necessary, the dose may be increased to one 7.5 mg Raenom tablet twice a day.
Your doctor will determine the appropriate 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 75 years or older), your 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

If you take a high dose of Raenom, you may experience shortness of breath or fatigue, as the heart rate slows down too much. In this case, contact your doctor immediately.

Missing a dose of Raenom

If you miss a dose of Raenom, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Raenom

Because treatment for angina or chronic heart failure is usually long-term, do not stop taking this medicine without consulting your doctor.
If you feel that the effect of Raenom is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your 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 are dose-dependent and related to its mechanism of action:

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

Vision disturbances (transient sensations of strong light in the field of vision, usually caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, double vision, 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 after 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, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval in the electrocardiogram)), uncontrolled hypertension, headaches, dizziness, and blurred vision.

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

Palpitations and ventricular 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 tiredness, feeling of weakness, abnormal electrocardiogram, double vision, impaired vision.

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

Urticaria, 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 to gather more information on the safety of this medicine.

5. How to store Raenom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Raenom contains

• The active substance is ivabradine. Raenom, 5 mg, film-coated tablets: each film-coated tablet contains 5 mg ivabradine (as hydrobromide). Raenom, 7.5 mg, film-coated tablets: each film-coated tablet contains 7.5 mg ivabradine (as hydrobromide).
• The other ingredients are: tablet corelactose (see section 2 "Raenom contains lactose"), mannitol (E421), maltodextrin, croscarmellose sodium, colloidal silica anhydrous (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, film-coated tablets:
Light orange, oval, biconvex film-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, film-coated tablets:
Light orange, round, biconvex film-coated tablets, approximately 6 mm in diameter, with "CK4" engraved on one side and no markings on the other side.
56 or 112 film-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 on this medicine and its names in other EU member states, please 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