Ramipril+bisoprolol fumarate sandoz

Poland
Brand name Ramipril+bisoprolol fumarate sandoz
Form capsules, hard
Active substance / Dosage
ramipril · 5 mg
bisoprolol · 2.5 mg
Prescription type Prescription only
ATC code
C09BX
Registration number 100445466
Manufacturer Adamed Pharma S.A. Lek Pharmaceuticals d.d.

Table of Contents

Package leaflet: Information for the patient

Ramipril+Bisoprolol fumarate Sandoz, 2.5 mg + 1.25 mg, hard capsules
Ramipril+Bisoprolol fumarate Sandoz, 2.5 mg + 2.5 mg, hard capsules
Ramipril+Bisoprolol fumarate Sandoz, 5 mg + 2.5 mg, hard capsules
Ramipril+Bisoprolol fumarate Sandoz, 5 mg + 5 mg, hard capsules
Ramipril+Bisoprolol fumarate Sandoz, 10 mg + 5 mg, hard capsules
Ramipril+Bisoprolol fumarate Sandoz, 10 mg + 10 mg, hard capsules
Ramiprilum+ Bisoprololi fumaras :
:
Please read this leaflet carefully before taking the medicine, as it contains important
information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any possible adverse effects not listed in this
leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Leaflet contents:

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

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

Ramipril+Bisoprolol fumarate Sandoz contains two active substances, bisoprolol fumarate and
ramipril, in a single capsule:
Ramipril is an angiotensin-converting enzyme inhibitor (ACEI). It works by dilating blood vessels, which makes it easier for the heart to pump blood.
Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers reduce heart rate and help the heart pump blood more effectively throughout the body.
Ramipril+Bisoprolol fumarate Sandoz is used to treat high blood pressure (hypertension) and (or) chronic heart failure with left ventricular dysfunction (a condition in which the heart is unable to pump sufficient blood to meet the body's needs, resulting in breathlessness and swelling), and (or) to reduce the risk of cardiovascular events such as myocardial infarction in patients with chronic coronary artery disease (a condition in which blood supply to the heart is reduced or blocked), who have previously had a heart attack and (or) undergone a surgical procedure to improve blood supply to the heart by widening the blood vessels that supply it, or 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 Sandoz, which contains both active substances in the same amounts.
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2. Important information before using Ramipril+Bisoprolol fumarate Sandoz

When not to use Ramipril+Bisoprolol fumarate Sandoz

  • if the patient is allergic to bisoprolol or any other beta-blocking agent, to ramipril or any other ACE inhibitor, or to any of the other components of this medicine (listed in section 6);
  • if the patient has heart failure which has suddenly worsened and (or) requires hospital treatment;
  • if the patient has cardiogenic shock (a severe heart condition caused by very low blood pressure);
  • if the patient has a heart disease characterized by slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);
  • if the patient has a slow heartbeat;
  • if the patient has very low blood pressure;
  • if the patient has severe asthma or severe chronic lung disease;
  • if the patient has severe circulatory problems in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness of the fingers of the hands and feet;
  • if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland;
  • if the patient has metabolic acidosis, a condition in which the blood contains too much acid;
  • if during previous treatment with an ACE inhibitor the patient experienced symptoms such as: wheezing, swelling of the face, tongue or throat, intense itching, or severe skin rashes, or if such symptoms occurred in a blood relative under any circumstances (a condition called angioedema);
  • if the patient is more than 3 months pregnant (it is also advisable to avoid using Ramipril+Bisoprolol fumarate Sandoz during early pregnancy – see section “Pregnancy”);
  • if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren;
  • if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Ramipril+Bisoprolol fumarate Sandoz may not be suitable for the patient;
  • if the patient has kidney disorders which reduce blood supply to the kidneys (renal artery stenosis);
  • if the patient is being treated with a medicine containing sacubitril and valsartan, used in the treatment of heart failure (see “Warnings and precautions” and “Ramipril+Bisoprolol fumarate Sandoz and other medicines”).

Warnings and precautions
Before starting treatment with Ramipril+Bisoprolol fumarate Sandoz, discuss with your doctor or pharmacist if:

  • the patient has diabetes;
  • the patient has kidney disorders (including patients after kidney transplantation) or is undergoing dialysis;
  • the patient has liver disease;
  • the patient has been diagnosed with aortic or mitral valve stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the arteries supplying blood to the kidneys);
  • the patient has abnormally increased levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
  • the patient has heart failure or any other heart disease, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina);
  • the patient has been diagnosed with a collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
  • the patient is on a low-salt diet or uses salt substitutes containing potassium (high potassium levels in the blood may cause changes in heart rate);
  • the patient has recently had diarrhoea or vomiting, or is dehydrated (Ramipril+Bisoprolol fumarate Sandoz may cause a drop in blood pressure);
  • the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
  • the patient is undergoing allergen immunotherapy to reduce allergic reactions to bee or wasp stings;
  • the patient is fasting or on a diet;
  • the patient is undergoing anaesthesia and/or surgery;
  • the patient has circulatory disorders in the limbs;
  • the patient has asthma or chronic lung disease;
  • the patient has (or has had) psoriasis;
  • the patient has a tumour of the adrenal gland (phaeochromocytoma);
  • the patient has thyroid disorders (Ramipril+Bisoprolol fumarate Sandoz may mask symptoms of hyperthyroidism);
  • angioedema (a severe allergic reaction characterized by swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing) occurs. This reaction may occur at any time during treatment. If such symptoms occur, the patient should stop taking Ramipril+Bisoprolol fumarate Sandoz and contact a doctor immediately;
  • the patient is of Black race, as there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races;
  • the patient is 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), especially if the patient has kidney disorders related to diabetes;
  • aliskiren. The doctor may monitor kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals. See also information in the section “When not to use Ramipril+Bisoprolol fumarate Sandoz”;
  • the patient is 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 group of drugs known as mTOR inhibitors (used to prevent rejection of transplanted organs);
  • sacubitril (available in a combination medicine containing sacubitril and valsartan), used in the treatment of chronic heart failure.

Do not stop taking Ramipril+Bisoprolol fumarate Sandoz suddenly, as this may cause a severe worsening of heart function. Treatment should not be stopped abruptly, especially in patients with coronary artery disease.
The patient should inform the doctor if she thinks she is (or might be) pregnant. Ramipril+Bisoprolol fumarate Sandoz is not recommended during early pregnancy and must not be taken if the patient is more than 3 months pregnant, as the medicine may cause serious harm to the unborn child if used during this period (see section “Pregnancy”).

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

Ramipril+Bisoprolol fumarate Sandoz and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Other medicines may affect the action of Ramipril+Bisoprolol fumarate Sandoz, or Ramipril+Bisoprolol fumarate Sandoz may alter the effect of other medicines. Such interactions may cause one or both medicines to be less effective. There may also be an increased risk or severity of adverse effects.

Tell your doctor if the patient is taking any of the following medicines:

  • medicines used to regulate blood pressure or heart conditions (such as 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 also information in the sections “When not to use Ramipril+Bisoprolol fumarate Sandoz” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys);
  • potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, or other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole);
  • potassium-sparing medicines used in heart failure treatment: 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 the treatment of cancer;
  • medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the group known as mTOR inhibitors). See section “Warnings and precautions”;
  • a combination medicine containing sacubitril and valsartan (used in the treatment of chronic heart failure). See sections “When not to use Ramipril+Bisoprolol fumarate Sandoz” and “Warnings and precautions”;
  • lithium used to treat mania or depression;
  • certain medicines used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAO inhibitors; 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;
  • vasodilating medicines, including nitrates (medicines that cause blood vessels to widen);
  • trimethoprim used to treat infections;
  • immunosuppressive medicines (reducing the body's immune response), such as cyclosporine, tacrolimus, used in the treatment of autoimmune disorders or after organ transplantation;
  • allopurinol used to treat gout;
  • parasympathomimetic medicines used to treat diseases such as Alzheimer's disease or glaucoma;
  • locally administered beta-blockers used to treat glaucoma (increased eye pressure);
  • mefloquine used to prevent or treat malaria;
  • baclofen used to treat muscle stiffness in diseases such as multiple sclerosis;
  • gold salts, particularly when 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, diclofenac or high doses of acetylsalicylic acid, used to treat joint inflammation, headache, pain or inflammatory conditions.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient should inform the doctor if she thinks she is (or might be) pregnant. Usually, the doctor will recommend discontinuing Piramil Biso before conception or as soon as pregnancy is confirmed, and will recommend another medicine instead of Piramil Biso. Piramil Biso is not recommended during early pregnancy and must not be taken if the patient is more than 3 months pregnant, as the medicine may cause serious harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
The patient should inform the doctor if she is breastfeeding or intends to breastfeed. Ramipril+Bisoprolol fumarate Sandoz is not recommended for breastfeeding women. The doctor may choose another treatment method if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and operating machinery
Ramipril+Bisoprolol fumarate Sandoz usually does not affect alertness, but some patients may experience dizziness or weakness related to low blood pressure, especially at the beginning of treatment, after a dose change, or when combined with alcohol. In such cases, the ability to drive or operate machinery may be impaired.

Lactose
Ramipril+Bisoprolol fumarate Sandoz, 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 Sandoz, 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 Sandoz, 5 mg + 2.5 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 Sandoz, 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 Sandoz, 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 Sandoz, 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 Sandoz contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to use Ramipril+Bisoprolol fumarate Sandoz

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The recommended dose is one capsule once daily. Swallow the capsule with a glass of water,
in the morning before food.

Patients with kidney disease
For patients with moderate kidney disease, your doctor will adjust the dose of Ramipril+Bisoprolol
fumarate Sandoz. Ramipril+Bisoprolol fumarate Sandoz is not recommended for patients with severe
kidney disease.

Patients with liver function disorders
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Your doctor will closely monitor patients with mild or moderate liver disease when starting treatment
with Ramipril+Bisoprolol fumarate Sandoz.

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

Taking more than the recommended dose of Ramipril+Bisoprolol fumarate Sandoz
If you take more capsules than prescribed, contact your doctor or pharmacist immediately.
The most likely symptom of overdose is low blood pressure, which may cause dizziness or fainting
(if this occurs, placing the patient with legs raised may help), severe breathing difficulties, tremors
(due to low blood sugar levels), and slow heart rate.

Missed dose of Ramipril+Bisoprolol fumarate Sandoz
It is important to take this medicine regularly every day for optimal effectiveness. If you miss a dose
of Ramipril+Bisoprolol fumarate Sandoz, 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 Sandoz
Do not stop treatment with Ramipril+Bisoprolol fumarate Sandoz suddenly or change the dose
without consulting your doctor, as this may significantly worsen heart function. Therapy should
not be stopped abruptly, especially in patients with coronary artery disease.

If you have any further questions about the use of this medicine, please 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 caused by low blood pressure (common – occurs in up to 1 in 10 people);
  • Worsening of heart failure causing significant shortness of breath and/or fluid retention in the body (common – occurs in up to 1 in 10 people);
  • Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; uncommon – occurs in up to 1 in 100 people);
  • Sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; uncommon – occurs in up to 1 in 100 people);
  • Extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – occurs in fewer than 1 in 10,000 people);
  • Weakness in the arms or legs, or difficulty speaking, which may be signs of stroke (very rare – occurs in fewer than 1 in 10,000 people);
  • Inflammation of the pancreas, which may cause severe abdominal pain radiating to the back and a very poor general condition (very rare – occurs in fewer than 1 in 10,000 people);
  • Yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – occurs in fewer than 1 in 10,000 people);
  • Skin rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme; very rare – occurs in fewer than 1 in 10,000 people).

Ramipril+Bisoprolol fumarate Sandoz is generally well tolerated, but as with other
medicines, patients may experience various adverse effects, especially at the beginning of treatment.
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You should immediately inform your doctor or pharmacist if any of the following adverse effects occur:
Very common (affects more than 1 in 10 people):

  • Slow heartbeat;

Common (affects up to 1 in 10 people):

  • Headache;
  • Central origin dizziness;
  • Fainting, abnormally low blood pressure, especially when standing or changing quickly to a standing position;
  • 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 difficulty digesting, diarrhoea, constipation;
  • Allergic reactions such as skin rashes, itching;
  • Muscle cramps, muscle pain;
  • Feeling of fatigue;
  • Tiredness;
  • Higher than usual potassium levels in blood laboratory tests.

Uncommon (affects up to 1 in 100 people):

  • Peripheral origin dizziness;
  • Taste disturbances;
  • Tingling sensation (paraesthesia);
  • Visual disturbances;
  • Tinnitus (ringing or noise in the ears);
  • Nasal congestion, difficulty breathing or worsening of asthma;
  • Runny nose, nasal mucosa congestion;
  • Hot flushes;
  • Mood changes;
  • Sleep disturbances;
  • Depression;
  • Dry mouth;
  • Sweating;
  • Kidney disorders;
  • Passing more urine than usual during the day;
  • Impotence;
  • Increased number of eosinophils (a type of white blood cell);
  • Drowsiness;
  • Palpitations;
  • Tachycardia;
  • Irregular heart rate (atrioventricular conduction disorders);
  • Muscle weakness;
  • Joint pain;
  • Peripheral oedema;
  • Fever;
  • Loss of or reduced appetite (anorexia);
  • Changes in laboratory test results: increased number of a type of white blood cells (eosinophilia), increased blood urea levels, increased blood creatinine levels, increased liver enzyme activity, high bilirubin levels in blood serum;
  • Increased protein levels in urine;

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  • Mouth ulcers;
  • Breast enlargement in men.

Rare (affects up to 1 in 1,000 people):

  • Nightmares, hallucinations;
  • Reduced tear secretion (dry eyes);
  • Redness, itching or watering of the eyes;
  • Hearing disturbances;
  • Liver inflammation, which may cause yellowing of the skin or whites of the eyes;
  • Vasculitis (inflammation of blood vessels);
  • Changes in laboratory test results: changes in lipid levels, increased number of red blood cells, white blood cells or platelets, or changes in haemoglobin levels.

Very rare (affects fewer than 1 in 10,000 people):

  • Disorientation;
  • Pancreatitis (which may cause severe upper abdominal pain radiating to the back);
  • Hair loss;
  • Occurrence or worsening of psoriasis or psoriasis-like rash;
  • Increased sensitivity of the skin to sunlight (photosensitivity reactions).

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

  • Change in colour, numbness and pain in fingers of hands and feet (Raynaud's phenomenon);
  • Low sodium levels, very low blood sugar (hypoglycaemia) in diabetic patients;
  • Inflammation of the tongue.

Concentrated urine (dark-coloured urine), nausea or vomiting, muscle cramps, disorientation,
and seizures, which may be caused by inappropriate secretion of antidiuretic hormone,
may occur during treatment with angiotensin-converting enzyme (ACE) inhibitors. 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 Adverse Drug Reactions 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, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ramipril+Bisoprolol fumarate Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
package after '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 and do not 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.
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6. Contents of the pack and other information

What Ramipril+Bisoprolol fumarate Sandoz contains
The active substances are ramipril and bisoprolol fumarate.
The other components are:
Capsule contents: monohydrate lactose, polyvinyl alcohol, sodium croscarmellose, sodium
stearyl fumarate, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, crospovidone
type A, anhydrous colloidal silicon dioxide, magnesium stearate.
AquaPolish P yellow coating: hypromellose, hydroxypropylcellulose, 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) – [capsules of strength 10 mg+10 mg, 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg], yellow iron oxide (E 172) – [capsules of strength 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) – [capsules of strength 5 mg+2.5 mg, 2.5 mg + 2.5 mg, 2.5 mg + 1.25 mg].
Printing ink: shellac, black iron oxide (E 172), propylene glycol, concentrated ammonium hydroxide, potassium hydroxide.

What Ramipril+Bisoprolol fumarate Sandoz looks like and contents of the pack
Ramipril+Bisoprolol fumarate Sandoz, 2.5 mg + 1.25 mg, hard capsules
Capsule with yellow cap printed in black with “2.5 mg” and white body printed in black with “1.25 mg”.
Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as one yellow, biconvex, film-coated, round tablet.

Ramipril+Bisoprolol fumarate Sandoz, 2.5 mg + 2.5 mg, hard capsules
Capsule with yellow cap printed in black with “2.5 mg” and yellow body printed in black with “2.5 mg”.
Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as one yellow, biconvex, film-coated, round tablet.

Ramipril+Bisoprolol fumarate Sandoz, 5 mg + 2.5 mg, hard capsules
Capsule with orange cap printed in black with “5 mg” and yellow body printed in black with “2.5 mg”.
Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as one yellow, biconvex, film-coated, round tablet.

Ramipril+Bisoprolol fumarate Sandoz, 5 mg + 5 mg, hard capsules
Capsule with orange cap printed in black with “5 mg” and orange body printed in black with “5 mg”.
Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as one yellow, biconvex, film-coated, round tablet.

Ramipril+Bisoprolol fumarate Sandoz, 10 mg + 5 mg, hard capsules
Capsule with reddish-brown cap printed in black with “10 mg” and orange body printed in black with “5 mg”.
Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as one yellow, biconvex, film-coated, round tablet.

Ramipril+Bisoprolol fumarate Sandoz, 10 mg + 10 mg, hard capsules
Capsule with reddish-brown cap printed in black with “10 mg” and reddish-brown body printed in black with “10 mg”.
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Capsule contents: ramipril as white or almost white powder and bisoprolol fumarate as two yellow, biconvex, film-coated, round tablets.

Blister packs made of BOPA/Aluminium/PVC/Aluminium
Blister packs and package leaflet are enclosed in a cardboard box.
Capsules are available in packs of 10, 30, 60 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer:
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Croatia Byol Combi 1.25 mg/2.5 mg tvrde kapsule
Byol Combi 2.5 mg/2.5 mg tvrde kapsule
Byol Combi 2.5 mg/5 mg tvrde kapsule
Byol Combi 5 mg/5 mg tvrde kapsule
Byol Combi 5 mg/10 mg tvrde kapsule
Byol Combi 10 mg/10 mg tvrde kapsule
Poland Ramipril+Bisoprolol fumarate Sandoz

For further information about this medicinal product, contact the local representative of the
Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
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