Ramipril + Bisoprolol fumarate Aristo

Leaflet attached to the packaging: patient information

Ramipril + Bisoprolol fumarate Aristo, 2.5 mg + 1.25 mg, hard capsules
Ramipril + Bisoprolol fumarate Aristo, 2.5 mg + 2.5 mg, hard capsules
Ramipril + Bisoprolol fumarate Aristo, 5 mg + 2.5 mg, hard capsules

Ramipril + Bisoprolol fumarate Aristo, 5 mg + 5 mg, hard capsules

Ramipril + Bisoprolol fumarate Aristo, 10 mg + 5 mg, hard capsules

Ramipril + Bisoprolol fumarate Aristo, 10 mg + 10 mg, hard capsules

Ramipril + Bisoprolol fumarate

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ramipril + Bisoprolol fumarate Aristo and what is it used for

Ramipril + Bisoprolol fumarate Aristo contains two active substances: bisoprolol fumarate and ramipril in one capsule:

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

Ramipril + Bisoprolol fumarate Aristo 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, causing shortness of breath and swelling) and/or reduces 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) and who have previously had a heart attack and/or coronary artery bypass grafting, which improves blood flow to the heart, or in patients with diabetes with at least one cardiovascular risk factor.

2. Important information before taking Ramipril + Bisoprolol fumarate Aristo

When not to take Ramipril + Bisoprolol fumarate Aristo:

• if the patient is allergic to bisoprolol or another beta-blocker, ramipril or another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has suddenly worsening heart failure and/or may require hospital treatment;
• if the patient has cardiogenic shock (a serious heart condition caused by very low blood pressure);
• if the patient has a heart condition characterized by slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);
• if the patient has a slow heart rate;
• if the patient has very low blood pressure;
• if the patient has severe asthma or severe chronic obstructive pulmonary disease;
• if the patient has serious circulation problems in the limbs (such as Raynaud's syndrome), which can cause tingling or blanching or cyanosis of the fingers and toes;
• if the patient has an untreated pheochromocytoma, a rare tumor of the adrenal gland;
• if the patient has metabolic acidosis, a condition in which the blood contains too much acid;
• if the patient has had symptoms such as wheezing, facial swelling, tongue or throat swelling, intense itching, or severe skin rash during previous treatment with an ACE inhibitor, or if the patient or a family member has had such symptoms in any other circumstances (a condition called angioedema);
• if the patient is pregnant for more than 3 months (it is also not recommended to take Ramipril + Bisoprolol fumarate Aristo during early pregnancy - see "Pregnancy");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or another type of blood filtration. Depending on the device used, Ramipril + Bisoprolol fumarate Aristo may not be suitable for the patient;
• if the patient has kidney problems, with reduced blood flow to the kidneys (renal artery stenosis);
• if the patient is taking a combination medicine containing sacubitril + valsartan, a medicine used in heart failure (see "Contraindications" and "Special warnings and precautions for use").

Special warnings and precautions for use

Before starting treatment with Ramipril + Bisoprolol fumarate Aristo, the patient should discuss it with their doctor or pharmacist:

• if the patient has diabetes;
• if the patient has kidney problems (including kidney transplantation) or is undergoing dialysis;
• if the patient has liver problems;
• if the patient has a narrowing of the aorta and mitral valve (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has heart failure or any other heart problems, such as minor arrhythmias or severe chest pain at rest (Prinzmetal's angina),
• if the patient has a collagen vascular disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient is on a low-salt diet or is taking potassium-sparing medicines (too much potassium in the blood can cause changes in heart rate);

if the patient has recently had diarrhea or vomiting, or is dehydrated (Ramipril + Bisoprolol fumarate Aristo may cause a drop in blood pressure),

• if the patient is undergoing LDL apheresis (i.e., removal of cholesterol from the blood by a medical device),
• if the patient is being treated with allergy shots or desensitization therapy to reduce the effects of allergies to bee stings or wasp stings;
• if the patient is on a strict diet or fasting;
• if the patient is scheduled for anesthesia and/or major surgery;
• if the patient has circulation problems in the limbs;
• if the patient has asthma or chronic obstructive pulmonary disease;
• if the patient has (or has had) psoriasis,
• if the patient has a pheochromocytoma (a tumor of the adrenal gland);
• if the patient has thyroid disorders (Ramipril + Bisoprolol fumarate Aristo may mask symptoms of hyperthyroidism);
• if the patient has angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). This can occur at any time during treatment. If such symptoms occur, the patient should stop taking Ramipril + Bisoprolol fumarate Aristo and contact their doctor immediately;
• if the patient is black, as they may be at higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races,
• if the patient is taking any of the following medicines for high blood pressure:
• an "angiotensin II receptor antagonist" (ARB) (also known as a sartan - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. Please also see the information under "Do not take Ramipril + Bisoprolol fumarate Aristo" and "Special warnings and precautions for use".
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to avoid rejection of transplanted organs);
• sacubitril/valsartan (used to treat chronic heart failure). See "Contraindications" and "Special warnings and precautions for use".

Do not stop taking Ramipril + Bisoprolol fumarate Aristo suddenly, as this can cause serious worsening of heart disease. Do not stop treatment suddenly, especially in patients with coronary artery disease.

A female patient must tell her doctor if she is pregnant (or thinks she may be pregnant). Ramipril + Bisoprolol fumarate Aristo is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see "Pregnancy").

Children and adolescents

Ramipril + Bisoprolol fumarate Aristo is not recommended for use in children and adolescents under 18 years of age.

Ramipril + Bisoprolol fumarate Aristo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

There are certain medicines that may affect the action of Ramipril + Bisoprolol fumarate Aristo or their action may be affected by Ramipril + Bisoprolol fumarate Aristo. This type of interaction can make one or both medicines less effective. Alternatively, it can increase the risk or severity of side effects.

The patient should remember to inform their doctor if they are taking any of the following medicines:

• 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 an angiotensin II receptor antagonist (ARB), aliskiren (see "Contraindications" and "Special warnings and precautions for use"), 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 clinical shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine);
• estramustine, which is used in cancer therapy;
• medicines that are most commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors). See "Special warnings and precautions for use";
• sacubitril/valsartan (used to treat chronic heart failure). See "Contraindications" and "Special warnings and precautions for use".
• 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 (vasodilating products),
• trimethoprim, which is 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 transplantation;
• allopurinol, which is 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, which is used to prevent or treat malaria;
• baclofen, which is used to treat muscle stiffness in diseases such as multiple sclerosis;
• gold salts, especially those administered 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 Ramipril + Bisoprolol fumarate Aristo with food, drink, and alcohol

Ramipril + Bisoprolol fumarate Aristo should be taken before a meal.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

The patient must tell their doctor if they think they are (or may be) pregnant. The doctor will usually advise stopping Ramipril + Bisoprolol fumarate Aristo before becoming pregnant or as soon as pregnancy is confirmed and will prescribe another medicine instead of Ramipril + Bisoprolol fumarate Aristo.

Ramipril + Bisoprolol fumarate Aristo is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Ramipril + Bisoprolol fumarate Aristo is not recommended for breastfeeding mothers, and the doctor may choose another treatment for the patient if they want to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Ramipril + Bisoprolol fumarate Aristo 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 when consuming alcohol. If this applies to the patient, their ability to drive or operate machines may be impaired.

Lactose

Ramipril + Bisoprolol fumarate Aristo 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.

Ramipril + Bisoprolol fumarate Aristo 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.

Ramipril + Bisoprolol fumarate Aristo 5 mg + 2.5 mg contains 81.94 mg of lactose (40.47 mg of glucose and 40.97 mg of galactose) per dose. This should be taken into account in patients with diabetes.

Ramipril + Bisoprolol fumarate Aristo 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.

Ramipril + Bisoprolol fumarate Aristo 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.

Ramipril + Bisoprolol fumarate Aristo 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

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

3. How to take Ramipril + Bisoprolol fumarate Aristo

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.

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

Patients with kidney disease

The doctor will adjust the dose of Ramipril + Bisoprolol fumarate Aristo if the patient has moderate kidney disease. It is not recommended to take Ramipril + Bisoprolol fumarate Aristo in patients with severe kidney disease.

Patients with liver disease

The doctor will closely monitor patients with mild or moderate liver disease when starting treatment with Ramipril + Bisoprolol fumarate Aristo.

Use in children and adolescents

Ramipril + Bisoprolol fumarate Aristo is not recommended for use in children and adolescents.

Taking a higher dose of Ramipril + Bisoprolol fumarate Aristo than recommended

If the patient has taken more capsules than prescribed, they should contact their doctor or pharmacist immediately. The most likely symptoms of overdose are: low blood pressure, which can cause dizziness or fainting (if this happens, lying down with legs raised may help), severe breathing difficulties, tremors (due to low blood sugar), and slow heart rate.

Missing a dose of Ramipril + Bisoprolol fumarate Aristo

It is important to take the medicine every day, as regular treatment works better. However, if a dose of Ramipril + Bisoprolol fumarate Aristo is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Ramipril + Bisoprolol fumarate Aristo

Do not stop taking Ramipril + Bisoprolol fumarate Aristo suddenly or change the dose without consulting the doctor, as this can cause worsening of heart disease. Treatment should not be stopped suddenly, especially in patients with coronary artery disease.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ramipril + Bisoprolol fumarate Aristo can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and contact their doctor immediately if they experience any of the following side effects:

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

Ramipril + Bisoprolol fumarate Aristo is usually well tolerated, but like any medicine, patients may experience various side effects, especially at the beginning of treatment.

If the patient notices any of the following side effects or any other side effects not mentioned below, they should tell their doctor or pharmacist:

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

• slow heart rate.

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

• headache,
• dizziness of central origin,
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up,
• numbness in hands or feet,
• feeling of cold in 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 rash, itching,
• muscle cramps, muscle pain (myalgia),
• feeling of tiredness,
• fatigue,
• blood tests showing higher than normal potassium levels in the blood.

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

• dizziness of peripheral origin,
• disturbances of taste,
• tingling (paresthesia),
• vision disturbances,
• ringing in the ears (feeling of ringing in the ears),
• stuffy nose, difficulty breathing, or worsening of asthma,
• common cold, nasal congestion,
• sudden flushing (especially of the face),
• mood swings,
• sleep disturbances,
• depression,
• dry mouth,
• sweating,
• kidney problems,
• passing more urine than usual during the day,
• impotence,
• excessive eosinophils (a type of white blood cell),
• drowsiness,
• palpitations,
• rapid heartbeat,
• irregular heartbeat (conduction disturbances),
• muscle weakness,
• joint pain,
• local swelling (peripheral edema),
• fever,
• loss of or decreased appetite (anorexia),
• changes in laboratory test results: increased levels of certain white blood cells (eosinophilia), increased urea levels in the blood, increased creatinine levels in the blood, increased liver enzyme activity, increased bilirubin levels in serum,
• increased protein levels in urine,
• mouth ulcers,
• breast enlargement in men.

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

• 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 test results: abnormal fat levels in the blood, decreased red blood cell count, white blood cell count, or platelet count, or hemoglobin levels.

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

• disorientation,
• pancreatitis (which can cause severe abdominal and back pain),
• hair loss,
• appearance or worsening of psoriatic or psoriasis-like skin rash,
• increased sensitivity of the skin to sunlight (photosensitivity reaction).

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

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

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

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell 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:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ramipril + Bisoprolol fumarate Aristo

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 "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. 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 packaging and other information

What Ramipril + Bisoprolol fumarate Aristo contains

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

Aqua Polish P yellow coating:hypromellose, hydroxypropyl cellulose, medium-chain triglycerides, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

Capsule shell:titanium dioxide (E 171), gelatin, red iron oxide (E 172) - [in 10 mg + 10 mg; 10 mg + 5 mg; 5 mg + 5 mg; 5 mg + 2.5 mg capsules],yellow iron oxide (E 172) - [in 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 capsules],quinoline yellow (E 104) - [in 5 mg + 2.5 mg; 2.5 mg + 2.5 mg; 2.5 mg + 1.25 mg capsules]

Printing ink:shellac, black iron oxide (E 172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

What Ramipril + Bisoprolol fumarate Aristo looks like and contents of the pack

Ramipril + Bisoprolol fumarate Aristo, 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’.

Contents of the 2.5 mg + 1.25 mg 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.

Ramipril + Bisoprolol fumarate Aristo, 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’.

Contents of the 2.5 mg + 2.5 mg 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.

Ramipril + Bisoprolol fumarate Aristo, 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’.

Contents of the 5 mg + 2.5 mg 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.

Ramipril + Bisoprolol fumarate Aristo, 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’.

Contents of the 5 mg + 5 mg 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.

Ramipril + Bisoprolol fumarate Aristo, 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’.

Contents of the 10 mg + 5 mg 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.

Ramipril + Bisoprolol fumarate Aristo, 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 10 mg + 10 mg 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

The blisters and patient leaflet are packaged in a cardboard box.

Ramipril + Bisoprolol fumarate Aristo is available in packs containing 10, 30, 60, or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

tel. +48 22 855 40 95

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

This medicinal product has been authorized in the Member States of the EEA under the following names:

Germany

Ramiprolol 2.5 mg/1.25 mg Hartkapseln

Ramiprolol 2.5 mg/2.5 mg Hartkapseln

Ramiprolol 5 mg/2.5 mg Hartkapseln

Ramiprolol 5 mg/5 mg Hartkapseln

Ramiprolol 10 mg/5 mg Hartkapseln

Ramiprolol 10 mg/10 mg Hartkapseln

Poland

Ramipril + Bisoprolol fumarate Aristo

Date of last revision of the leaflet:July 2023