Rabada

Leaflet attached to the packaging: Patient Information

RABADA, 2.5 mg + 1.25 mg, hard capsules
RABADA, 2.5 mg + 2.5 mg, hard capsules
RABADA, 5 mg + 2.5 mg, hard capsules

RABADA, 5 mg + 5 mg, hard capsules

RABADA, 10 mg + 5 mg, hard capsules

RABADA, 10 mg + 10 mg, hard capsules

ramipril + bisoprolol fumarate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is RABADA and what is it used for

RABADA contains two active substances - bisoprolol fumarate and ramipril - in one capsule.

• Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. It works by widening the blood vessels, making it easier for the heart to pump blood to the body.
• Bisoprolol fumarate belongs to a group of medicines called beta-blockers (beta-adrenergic blocking agents). Beta-blockers slow the heart rate and increase the efficiency of the heart in pumping blood throughout the body.

RABADA is used to treat high blood pressure (hypertension) and/or chronic heart failure with left ventricular dysfunction (a condition in which the heart is not able to pump enough blood to meet the body's needs, resulting in shortness of breath and swelling) and/or to reduce the risk of cardiac events, such as heart attack, in patients with chronic coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) who have already had a heart attack and/or have undergone a procedure to improve blood flow to the heart by widening the blood vessels that supply it.

2. Important information before taking RABADA

When not to take RABADA:

• if you are allergic to bisoprolol or any other beta-blocker, ramipril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6),
• if you have heart failure that has suddenly worsened and may require hospital treatment,
• if you have cardiogenic shock (a serious heart condition caused by very low blood pressure),
• if you have a heart condition characterized by a slow or irregular heart rate (second or third degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• if you have a slow heart rate,
• if you have very low blood pressure,
• if you have severe asthma or severe chronic obstructive pulmonary disease (COPD),
• if you have serious blood circulation problems in your limbs (such as Raynaud's syndrome) that may cause tingling, pallor, or cyanosis of the fingers and toes,
• if you have an untreated pheochromocytoma (a rare tumor of the adrenal gland),
• if you have metabolic acidosis, a condition in which the blood contains too much acid,
• if you have had angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) during previous treatment with an ACE inhibitor, or if you or a member of your family have had angioedema in any other circumstances,
• if you are pregnant more than three months (it is also not recommended to take RABADA in early pregnancy - see "Pregnancy"),
• if you have diabetes or kidney problems and are taking aliskiren, a medicine used to lower blood pressure,
• if you are on dialysis or undergoing another type of blood filtration. Depending on the device used, RABADA may not be suitable for you,
• if you have kidney problems where blood flow to the kidneys is reduced (renal artery stenosis),
• if you are taking sacubitril/valsartan, a combination medicine used to treat heart failure (see "Warnings and precautions" and "Other medicines and RABADA")

Warnings and precautions

Before starting to take RABADA, you should discuss it with your doctor or pharmacist if:

• you have diabetes,
• you have kidney problems (including a transplanted kidney) or are on dialysis,
• you have liver problems,
• you have a narrowing of the aortic valve and mitral valve (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying the kidneys with blood),
• you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism),
• you have heart failure or any other heart problems, such as minor arrhythmias or severe chest pain at rest (Prinzmetal's angina),
• you have a collagen vascular disease (a disease of the connective tissue) such as systemic lupus erythematosus or scleroderma,
• you are on a low-salt diet or taking salt substitutes that contain potassium (too much potassium in the blood can cause changes in heart rate),
• you have recently had diarrhea or vomiting or are dehydrated (RABADA may cause a drop in blood pressure),
• you are going to have apheresis (a procedure in which cholesterol is removed from the blood using a special device),
• you are undergoing desensitization treatment or plan to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• you are on a strict diet or fasting,
• you are going to have anesthesia and/or major surgery,
• you have circulation problems in your limbs,
• you have asthma or COPD,
• you have (or have had) psoriasis,
• you have an adrenal gland tumor (pheochromocytoma),
• you have thyroid disorders (RABADA may mask the symptoms of hyperthyroidism),
• you have angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This can occur at any time during treatment. If you experience such symptoms, you should stop taking RABADA and contact your doctor immediately.
• you are black, as you may be at higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in non-black patients,
• you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonists (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly in patients with diabetic kidney disease.
• aliskiren. Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under "When not to take RABADA".
• you are taking any of the following medicines - the risk of angioedema increases:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent the rejection of transplanted organs),
• sacubitril (available in a fixed-dose combination with valsartan), used to treat chronic heart failure.

Do not stop taking RABADA suddenly, as this can cause serious worsening of your heart condition. Do not stop treatment suddenly, especially in patients with coronary artery disease.

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

Children and adolescents

RABADA is not recommended for use in children and adolescents under 18 years of age.

Other medicines and RABADA

You should tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.

• medicines used to control blood pressure or heart diseases (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil),
• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also the information under "When not to take RABADA" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day,
• sympathomimetic medicines used to treat shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine),
• estramustine used in cancer therapy,
• medicines that are most commonly used to treat diarrhea (racecadotril) or to prevent the rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors). See "Warnings and precautions".
• sacubitril/valsartan (used to treat chronic heart failure). See "When not to take RABADA" and "Warnings and precautions".
• lithium used to treat mania or depression,
• certain medicines used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors),
• certain medicines used to treat schizophrenia (antipsychotic medicines),
• certain medicines used to treat epilepsy (phenytoin, barbiturates such as phenobarbital),
• anesthetics used in surgical procedures,
• vasodilators, including nitrates,
• trimethoprim used to treat infections,
• immunosuppressive medicines (medicines that weaken the body's defense mechanisms), such as cyclosporine, tacrolimus, used to treat autoimmune disorders or after organ transplantation,
• allopurinol used to treat gout,
• parasympathomimetic medicines used to treat diseases such as Alzheimer's disease or glaucoma,
• beta-adrenergic blockers used topically to treat glaucoma (increased pressure in the eye),
• mefloquine used to prevent or treat malaria,
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis),
• medicines used to treat diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen or diclofenac, or high doses of aspirin used to treat arthritis, headache, pain, or inflammation.

Taking RABADA with food, drink, and alcohol

It is recommended to take RABADA before a meal.

Pregnancy and breastfeeding

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

Pregnancy

You should tell your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking RABADA before you become pregnant or as soon as you find out you are pregnant, and will prescribe a different medicine instead of RABADA. It is not recommended to take RABADA in early pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm the baby.

Breastfeeding

You should tell your doctor if you are breastfeeding or planning to breastfeed. RABADA is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

RABADA usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure, especially at the beginning of treatment or when changing the medicine, as well as in combination with alcohol. If you experience these changes, your ability to drive or operate machinery may be impaired.

Lactose

RABADA 2.5 mg + 1.25 mg contains 40.97 mg of lactose (20.49 mg of glucose and 20.49 mg of galactose) per dose. This should be taken into account in patients with diabetes.

RABADA 2.5 mg + 2.5 mg contains 40.97 mg of lactose (20.49 mg of glucose and 20.49 mg of galactose) per dose. This should be taken into account in patients with diabetes.

RABADA 5 mg + 2.5 mg contains 81.94 mg of lactose (40.97 mg of glucose and 40.97 mg of galactose) per dose. This should be taken into account in patients with diabetes.

RABADA 5 mg + 5 mg contains 81.94 mg of lactose (40.97 mg of glucose and 40.97 mg of galactose) per dose. This should be taken into account in patients with diabetes.

RABADA 10 mg + 5 mg contains 163.88 mg of lactose (81.94 mg of glucose and 81.94 mg of galactose) per dose. This should be taken into account in patients with diabetes.

RABADA 10 mg + 10 mg contains 163.88 mg of lactose (81.94 mg of glucose and 81.94 mg of galactose) per dose. This should be taken into account in patients with diabetes.

Sodium

RABADA contains less than 1 mmol of sodium (23 mg) per capsule, which means the medicine is considered "sodium-free".

3. How to take RABADA

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

The recommended dose is one capsule per day. The capsule should be swallowed in the morning before a meal, with a glass of water.

Patients with kidney disease

Your doctor will adjust the dose of RABADA if you have moderate kidney disease. It is not recommended to take RABADA if you have severe kidney disease.

Patients with liver function disorders

Your doctor will closely monitor you if you have mild or moderate liver disease when starting treatment with RABADA.

Use in children and adolescents

RABADA is not recommended for use in children and adolescents.

Taking a higher dose of RABADA than prescribed

If you have taken more capsules than prescribed, you should contact your doctor or pharmacist immediately.

The most likely effect of an overdose is low blood pressure, which can cause dizziness or fainting (in such cases, lying down with your legs raised may help), severe breathing difficulties, tremors (due to low blood sugar), and a slow heart rate.

Missing a dose of RABADA

It is important to take the medicine every day, as regular treatment is more effective. However, if you miss a dose of RABADA, you should take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with RABADA

You should not stop taking RABADA suddenly or change the dose without consulting your doctor, as this can cause serious worsening of your heart condition. Do not stop treatment suddenly, especially in patients with coronary artery disease.

If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, RABADA can cause side effects, although not everybody gets them.

You should stop taking the medicine and contact your doctor immediately if you experience any of the following side effects:

• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• worsening of heart failure causing increased shortness of breath and/or fluid retention (common - may affect up to 1 in 10 people),
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema) (uncommon - may affect up to 1 in 100 people),
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people),
• abnormal or irregular heartbeats, chest pain (angina pectoris), or heart attack (uncommon - may affect up to 1 in 100 people),
• weakness or numbness in the arms or legs, or problems with speech, which may be signs of a possible stroke (frequency not known - cannot be estimated from the available data),
• inflammation of the pancreas, which can cause severe abdominal pain radiating to the back, accompanied by a very poor general condition (rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (rare - may affect up to 1 in 1,000 people),
• a skin rash that often starts with red, itchy patches on the face, hands, or feet (erythema multiforme) (frequency not known - cannot be estimated from the available data).

RABADA is usually well tolerated, but like all medicines, it can cause side effects, especially at the beginning of treatment.

If you notice any of the following side effects, or any other side effects not mentioned here, you should tell your doctor or pharmacist:

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

• slow heart rate.

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

• headache,
• dizziness,
• fainting, low blood pressure, especially when standing up quickly or sitting down,
• numbness in the hands or feet,
• feeling cold in the hands or feet,
• cough,
• shortness of breath,
• sinusitis or bronchitis,
• chest pain,
• gastrointestinal disorders, such as nausea, vomiting, abdominal pain, difficulty swallowing, or indigestion, diarrhea, constipation,
• allergic reactions, such as skin rashes, itching,
• muscle cramps, muscle pain (myalgia),
• feeling weak,
• fatigue,
• blood tests showing high levels of potassium in the blood.

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

• peripheral dizziness,
• taste disorders,
• tingling (paresthesia),
• vision disorders,
• tinnitus (a feeling of ringing in the ears),
• stuffy nose, difficulty breathing, or worsening of asthma,
• inflammation of the nasal mucosa, nasal congestion,
• sudden flushing (especially of the face),
• mood swings,
• sleep disorders,
• depression,
• dry mouth,
• sweating,
• kidney problems,
• increased urine production during the day than usual,
• impotence,
• high levels of eosinophils (a type of white blood cell),
• drowsiness,
• palpitations,
• rapid heart rate (tachycardia),
• irregular heart rhythm (arrhythmias),
• muscle weakness,
• joint pain (arthralgia),
• localized swelling (peripheral edema),
• fever,
• loss of appetite (anorexia),
• changes in laboratory parameters: increased levels of certain white blood cells (eosinophilia), increased levels of urea in the blood, increased levels of creatinine in the blood, increased activity of liver enzymes, increased levels of bilirubin in the serum,
• high levels of protein in the urine,
• mouth ulcers,
• breast enlargement in men.

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

• nightmares, hallucinations,
• reduced tear secretion (dry eyes),
• redness, itching, swelling, or tearing of the eyes,
• hearing problems,
• liver inflammation, which can cause yellowing of the skin or eyes,
• inflammation of blood vessels,
• changes in laboratory parameters: increased levels of fat, decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels.

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

• confusion,
• pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain radiating to the back),
• hair loss,
• appearance or worsening of a scaly skin rash (psoriasis), psoriatic rash,
• increased sensitivity of the skin to sunlight (photosensitivity reaction),

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

• discoloration, numbness, and pain in the fingers and toes (Raynaud's phenomenon),
• low levels of sodium, very low levels of sugar in the blood (hypoglycemia) in patients with diabetes,
• inflammation of the tongue.

When taking ACE inhibitors, the following side effects may occur: dark urine (concentrated urine), nausea or vomiting, muscle cramps, and confusion or convulsions, which may be caused by abnormal secretion of antidiuretic hormone (ADH). If you experience these symptoms, you should contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, 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

• Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, email: [website URL] Side effects can also be reported to the marketing authorization holder.

5. How to store RABADA

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.

The expiry date refers to the last day of the month stated.

Do not store above 30°C. Do not store in the refrigerator or freeze.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What RABADA contains

• The active substances of RABADA are ramipril and bisoprolol fumarate.
• The other ingredients are: Contents of the capsule:lactose monohydrate, polyvinyl alcohol, sodium croscarmellose (E468), sodium stearyl fumarate, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, crospovidone type A, colloidal anhydrous silica, magnesium stearate

Coating: AquaPolish P yellow: hypromellose (E464), hydroxypropylcellulose (E463), medium-chain triglycerides, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).
Cap: titanium dioxide (E171), gelatin, red iron oxide (E172) - [in capsules 10 mg+10 mg, 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg], yellow iron oxide (E172) - [in capsules 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg, 2.5 mg+2.5 mg, 2.5 mg+1.25 mg], quinoline yellow (E104) - [in capsules 5 mg+2.5 mg, 2.5 mg+2.5 mg, 2.5 mg+1.25 mg].
Ink: shellac (E904), black iron oxide (E172), propylene glycol, ammonia, concentrated, potassium hydroxide.

What RABADA looks like and contents of the pack

RABADA 2.5 mg + 1.25 mg, hard capsules
The capsule has a yellow cap with black printing "2.5 mg" and a white body with black printing "1.25 mg".
RABADA 2.5 mg + 2.5 mg, hard capsules
The capsule has a yellow cap with black printing "2.5 mg" and a yellow body with black printing "2.5 mg".
RABADA 5 mg + 2.5 mg, hard capsules
The capsule has an orange cap with black printing "5 mg" and a yellow body with black printing "2.5 mg".
RABADA 5 mg + 5 mg, hard capsules
The capsule has an orange cap with black printing "5 mg" and an orange body with black printing "5 mg".
RABADA 10 mg + 5 mg, hard capsules
The capsule has a reddish-brown cap with black printing "10 mg" and an orange body with black printing "5 mg".
RABADA 10 mg + 10 mg, hard capsules
The capsule has a reddish-brown cap with black printing "10 mg" and a reddish-brown body with black printing "10 mg".
Contents of the capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, coated, round tablet.
BOPA/Aluminum/PVC/Aluminum blisters.
Blisters and patient information leaflet are packaged in a cardboard box.
Capsules are available in packs of:

10, 30, 60, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: