Ramipril + bisoprolol fumarate aristo

Poland
Brand name Ramipril + bisoprolol fumarate aristo
Form capsules, hard
Active substance / Dosage
ramipril · 5 mg
bisoprolol · 5 mg
Prescription type Prescription only
ATC code
C09BX
Registration number 100445532
Manufacturer Adamed Pharma S.A.

Table of Contents

Package leaflet: Information for the patient

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
Ramiprilum + Bisoprololi fumaras
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

  • 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

  1. What Ramipril + Bisoprolol fumarate Aristo is and what it is used for
  2. What you need to know 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 pack and other information

1. What Ramipril + Bisoprolol fumarate Aristo is and what it is 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 widening blood vessels, making it easier for the heart to pump blood through them.
  • Bisoprolol fumarate belongs to a group of medicines called beta-blockers (beta-adrenolytics). Beta-adrenolytics slow down the heartbeat and improve the heart's efficiency in pumping blood around 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 cannot pump enough blood to meet the body's needs, causing breathlessness and swelling) and/or to reduce the risk of cardiovascular 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 previously had a heart attack and/or undergone a procedure to widen blood vessels to improve blood flow to the heart, or in patients with diabetes and at least one cardiovascular risk factor.
Instead of taking bisoprolol fumarate and ramipril in separate capsules, you will take only one capsule of Ramipril + Bisoprolol fumarate Aristo, which contains both active substances at the same strength as in the individual capsules.

2. What you need to know before taking Ramipril + Bisoprolol fumarate Aristo

Do not take Ramipril + Bisoprolol fumarate Aristo:

  • if you are allergic to bisoprolol or any other beta-blocker, ramipril or any other medicine in the group of ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6);
  • if you have heart failure that has suddenly worsened and/or 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 causing slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);
  • if you have a slow heartbeat;
  • if you have very low blood pressure;
  • if you have severe asthma or severe chronic lung disease;
  • if you have serious circulation problems in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of fingers and toes;
  • if you have untreated phaeochromocytoma, a rare tumour of the adrenal gland (adrenal medulla);
  • if you have metabolic acidosis, a condition in which the blood contains too much acid;
  • if you previously experienced symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or severe skin rash during treatment with an ACE inhibitor, or if you or a family member have ever had such symptoms under any circumstances (a condition called angioedema);
  • if you are pregnant for more than 3 months (it is also not recommended to use Ramipril + Bisoprolol fumarate Aristo in early pregnancy - see section “Pregnancy”);
  • if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren;
  • if you are undergoing dialysis or another type of blood filtration. Depending on the device used, Ramipril + Bisoprolol fumarate Aristo may not be suitable for you;
  • if you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis);
  • if you are taking a combination medicine containing sacubitril + valsartan, a medicine used for heart failure (see “Warnings and precautions” and “Other medicines and Ramipril + Bisoprolol fumarate Aristo”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril + Bisoprolol fumarate Aristo:

  • if you have diabetes;
  • if you have kidney problems (including kidney transplant) or are undergoing dialysis;
  • if you have liver problems;
  • if you have aortic or mitral valve stenosis (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 blood to the kidneys);
  • if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism);
  • if you have heart failure or any other heart problems, such as minor heart rhythm disturbances or severe chest pain at rest (Prinzmetal's angina);
  • if you have a connective tissue disease (collagen vascular disease), such as systemic lupus erythematosus or scleroderma;
  • if you are on a low-salt diet or use salt substitutes containing potassium (too much potassium in the blood may cause changes in heart rate);
  • if you have recently had diarrhoea or vomiting, or if you are dehydrated (Ramipril + Bisoprolol fumarate Aristo may cause low blood pressure);
  • if you are undergoing LDL apheresis (removal of cholesterol from the blood by a medical device);
  • if you are receiving allergy treatment or are scheduled for desensitisation therapy to reduce allergic reactions to bee or wasp stings;
  • if you are on a strict fast or diet;
  • if you are scheduled for anaesthesia and/or major surgery;
  • if you have circulation problems in the limbs;
  • if you have asthma or chronic lung disease;
  • if you have (or have had) psoriasis;
  • if you have a tumour of the adrenal gland (phaeochromocytoma);
  • if you have thyroid problems (Ramipril + Bisoprolol fumarate Aristo may mask symptoms of hyperthyroidism);
  • if you develop angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing). This may occur at any time during treatment. If such symptoms occur, stop taking Ramipril + Bisoprolol fumarate Aristo and contact your doctor immediately;
  • if you are of Black African origin, as you may have a higher risk of angioedema and the medicine may be less effective in lowering blood pressure compared to patients of other ethnicities;
  • if you are 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 you have kidney problems related to diabetes;
    • aliskiren. Your doctor may monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. Please also refer to the information under “Do not take Ramipril + Bisoprolol fumarate Aristo”.
  • if you are taking any of the following medicines, which increase the risk of angioedema:
    • racecadotril (used to treat diarrhoea);
    • sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs);
    • sacubitril (available in combination with valsartan), used to treat chronic heart failure.

Do not suddenly stop taking Ramipril + Bisoprolol fumarate Aristo, as this may cause a serious worsening of your heart condition. Do not stop treatment abruptly, especially if you have coronary artery disease.
You must tell your doctor if you are pregnant (or think you might be pregnant). Ramipril + Bisoprolol fumarate Aristo is not recommended in early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken during this period (see section “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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may alter the effect of Ramipril + Bisoprolol fumarate Aristo or their effect may be altered by Ramipril + Bisoprolol fumarate Aristo. Such interactions may make one or both medicines less effective. Alternatively, they may increase the risk or severity of side effects.
Please remember to inform your doctor if you are taking any of the following medicines:

  • medicines used to control blood pressure or medicines used for heart conditions (e.g. amiodarone, amlodipine, clonidine, cardiac 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 information under “Do not take Ramipril + Bisoprolol fumarate Aristo” 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, and other medicines that may increase potassium levels in the body (e.g. heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole);
  • potassium-sparing medicines used in 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, used in cancer therapy;
  • medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other mTOR inhibitors). See section “Warnings and precautions”;
  • sacubitril/valsartan (used to treat chronic heart failure). See sections “Do not take Ramipril + Bisoprolol fumarate Aristo” 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 (antipsychotics);
  • certain medicines used to treat epilepsy (phenytoin, barbiturates such as phenobarbital);
  • anaesthetics used during surgical procedures;
  • vasodilators, including nitrates (vasodilating agents);
  • trimethoprim, used to treat infections;
  • immunosuppressive medicines (medicines that suppress the body's immune system), such as: cyclosporine, tacrolimus, used to treat autoimmune disorders or after organ transplantation;
  • allopurinol, used to treat gout;
  • parasympathomimetic medicines, used to treat conditions such as Alzheimer's disease or glaucoma;
  • beta-adrenolytics used locally to treat glaucoma (increased eye pressure);
  • mefloquine, used to prevent or treat malaria;
  • baclofen, used to treat muscle stiffness in conditions 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 drugs (NSAIDs) such as: ibuprofen or diclofenac or high doses of aspirin used to treat joint inflammation, headache, pain or inflammatory conditions.

Taking Ramipril + Bisoprolol fumarate Aristo with food, drink and alcohol
It is recommended to take Ramipril + Bisoprolol fumarate Aristo before a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise stopping Ramipril + Bisoprolol fumarate Aristo before becoming pregnant or immediately after pregnancy is confirmed and will recommend an alternative medicine instead of Ramipril + Bisoprolol fumarate Aristo.
Ramipril + Bisoprolol fumarate Aristo is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Ramipril + Bisoprolol fumarate Aristo is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

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 after a dose change, and also when consuming alcohol. If this applies to you, your ability to drive or operate machinery may be impaired.

Lactose
Ramipril + Bisoprolol fumarate Aristo 2.5 mg + 1.25 mg contains 40.97 mg of lactose (20.49 mg glucose and 20.49 mg 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 glucose and 20.49 mg 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 glucose and 40.97 mg 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 glucose and 40.97 mg 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 glucose and 81.94 mg 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 glucose and 81.94 mg galactose) per dose. This should be taken into account in patients with diabetes.

Sodium
Ramipril + Bisoprolol fumarate Aristo contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is considered "sodium-free".

3. How to use Ramipril + Bisoprolol fumarate Aristo

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose is one capsule once daily. The capsule should be swallowed with a glass of water,
in the morning before food.
Patients with kidney disease
Your doctor will adjust the dose of Ramipril + Bisoprolol fumarate Aristo if you have moderate kidney
impairment. Use of Ramipril + Bisoprolol fumarate Aristo is not recommended in patients with severe
kidney disease.
Patients with liver disease
Your doctor will monitor patients with mild to moderate liver disease very closely when starting
treatment with Ramipril + Bisoprolol fumarate Aristo.
Use in children and adolescents
Use of Ramipril + Bisoprolol fumarate Aristo is not recommended in children and adolescents.
Taking more Ramipril + Bisoprolol fumarate Aristo than recommended
If you have taken more capsules than prescribed, contact your doctor or pharmacist immediately.
The most likely symptoms of overdose are: low blood pressure, which may cause dizziness or fainting
(if this occurs, lying down with legs raised may help), severe breathing difficulties, tremors (due to
low blood sugar levels), 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 best. However, if you
miss a dose of Ramipril + Bisoprolol fumarate Aristo, take the next dose at your usual time. Do not
take a double dose to make up for a missed dose.
Stopping Ramipril + Bisoprolol fumarate Aristo
Do not stop treatment with Ramipril + Bisoprolol fumarate Aristo suddenly or change the dose
without consulting your doctor, as this may worsen heart condition. Treatment should not be stopped
abruptly, especially in patients with coronary heart disease.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking this medicine and contact your doctor immediately if any of the following
adverse effects occur:

  • severe dizziness or fainting due to low blood pressure (common – may affect up to 1 in 10 patients);
  • worsening of heart failure causing severe shortness of breath and/or fluid retention (common – 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);
  • unusually fast or irregular heartbeat, chest pain (angina) or heart attack (uncommon – may affect up to 1 in 100 patients);
  • weakness in arms or legs or problems with speech, which may be signs of a possible stroke (frequency cannot be determined from available data);
  • pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition (very rare – may affect up to 1 in 10,000 patients);
  • yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (rare – may affect up to 1 in 1,000 patients);
  • skin rash, which often starts with red, itchy spots on the face, hands or feet (erythema multiforme) (unknown – frequency cannot be determined from available data).

The medicine Ramipril + Bisoprolol fumarate Aristo is generally well tolerated, but as with any
medicine, patients may experience various adverse effects, particularly at the beginning of
treatment.
If you notice any of the listed or unlisted adverse effects below, you should immediately inform
your doctor or pharmacist:
Very common (may affect more than 1 in 10 patients):

  • slow heartbeat.

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

  • headache,
  • central dizziness,
  • fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly,
  • numbness of hands or feet,
  • feeling of coldness in hands or feet,
  • cough,
  • shortness of breath,
  • sinusitis or bronchitis,
  • chest pain,
  • gastrointestinal disturbances such as: nausea, vomiting, abdominal pain, indigestion or dyspepsia, diarrhoea, constipation,
  • allergic reactions such as skin rashes, itching,
  • muscle cramps, muscle pain (myalgia),
  • feeling of fatigue,
  • fatigue,
  • blood tests showing higher than usual potassium levels in the blood.

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

  • peripheral dizziness,
  • taste disturbances,
  • tingling (paraesthesia),
  • visual disturbances,
  • ringing in the ears (tinnitus),
  • nasal congestion, difficulty breathing or worsening of asthma,
  • runny nose, nasal mucosa 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,
  • eosinophilia (an increased number of a type of white blood cells),
  • drowsiness,
  • palpitations,
  • tachycardia,
  • irregular heartbeat (atrioventricular conduction disorders),
  • muscle weakness,
  • joint pain,
  • localised swelling (peripheral oedema),
  • fever,
  • loss or decrease of appetite (anorexia),
  • changes in laboratory test results: increased number of certain white blood cells (eosinophilia), increased blood urea levels, increased blood creatinine levels, increased liver enzyme activity, increased serum bilirubin levels,
  • elevated protein levels in urine,
  • mouth ulcers,
  • breast enlargement in men.

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

  • nightmares, hallucinations,
  • reduced tear production (dry eyes),
  • redness, itching, swelling or watering of the eyes,
  • hearing problems,
  • liver inflammation, which may cause yellowing of the skin or whites of the eyes,
  • vasculitis (inflammation of blood vessels),
  • changes in laboratory test results: blood lipid levels outside the normal range, decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin levels.

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

  • disorientation,
  • pancreatitis (causing severe pain radiating to the abdomen and back),
  • hair loss,
  • appearance or worsening of scaly skin rash (psoriasis), psoriasiform rash,
  • increased sensitivity of the skin to sunlight (photosensitivity reaction).

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

  • discoloration, numbness and pain in fingers of hands or feet (Raynaud's phenomenon),
  • low sodium levels, very low blood sugar levels (hypoglycaemia) in diabetic patients,
  • inflammation of the tongue.

When taking ACE inhibitors, the following may occur: concentrated urine (dark colour), nausea
or vomiting, muscle cramps, confusion and seizures, which may be caused by abnormal
ADH (antidiuretic hormone) secretion. If such symptoms occur, contact your doctor as soon as possible.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor,
pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Ramipril + Bisoprolol fumarate Aristo

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 pack following:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not store in the refrigerator or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ramipril + Bisoprolol fumarate Aristo contains

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

Coating Aqua Polish P yellow: hypromellose, hydroxypropylcellulose, medium-chain triglycerides, talc, titanium dioxide (E 171), iron oxide yellow (E 172).
Capsule shell: titanium dioxide (E 171), gelatin, iron oxide red (E 172) – [in capsules
10 mg + 10 mg; 10 mg + 5 mg; 5 mg + 5 mg; 5 mg + 2.5 mg], iron oxide yellow (E 172) –
[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 (E 104) - [in capsules 5 mg + 2.5 mg; 2.5 mg + 2.5 mg; 2.5 mg + 1.25 mg]
Printing ink: shellac, iron oxide black (E 172), propylene glycol, concentrated ammonium hydroxide, 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 print '2.5 mg' and a white body with black print '1.25 mg'.
Contents of the 2.5 mg + 1.25 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as 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 print '2.5 mg' and a yellow body with black print '2.5 mg'.
Contents of the 2.5 mg + 2.5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as 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 print '5 mg' and a yellow body with black print '2.5 mg'.
Contents of the 5 mg + 2.5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Ramipril + Bisoprolol fumarate Aristo 5 mg + 5 mg, hard capsules
The capsule has an orange cap with black print '5 mg' and an orange body with black print '5 mg'.
Contents of the 5 mg + 5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as 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 print '10 mg' and an orange body with black print '5 mg'.
Contents of the 10 mg + 5 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as 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 print '10 mg' and a reddish-brown body with black print '10 mg'.
Contents of the 10 mg + 10 mg capsule: ramipril as a white or almost white powder and bisoprolol fumarate as one yellow, biconvex, coated, round tablet.

Blisters BOPA/Aluminium/PVC/Aluminium
Ramipril + Bisoprolol fumarate Aristo is available in packs containing 10, 30, 60 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warszawa
tel. +48 22 855 40 95

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

This medicinal product has been authorised for marketing in EEA Member States 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