Ramipril+bisoprolol fumarate Sandoz

Patient Information Leaflet: Ramipril+Bisoprolol fumarate Sandoz

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

Ramipril+ Bisoprolol fumarate:
:

Read the patient information leaflet carefully before taking the medication, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medication has been prescribed to a specific person. Do not pass it on to others.
The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents:

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

Ramipril+Bisoprolol fumarate Sandoz contains two active substances, bisoprolol fumarate and ramipril, in one capsule:
Ramipril is an angiotensin-converting enzyme inhibitor (ACEI). It works by dilating blood vessels, making it easier for the heart to pump blood.
Bisoprolol fumarate belongs to a group of medications called beta-blockers. Beta-blockers slow the heart rate and make the heart pump blood more efficiently.
Ramipril+Bisoprolol fumarate Sandoz is used to treat high blood pressure (hypertension) and/or chronic heart failure with left ventricular dysfunction (a condition where 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 where the blood supply to the heart is reduced or blocked) who have had a heart attack and/or have undergone surgical procedures to improve blood supply to the heart.
Instead of taking bisoprolol fumarate and ramipril in separate capsules, the patient takes 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 taking Ramipril+Bisoprolol fumarate Sandoz

When not to take Ramipril+Bisoprolol fumarate Sandoz

Warnings and precautions

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

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if the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;

• if the patient experiences angioedema (a severe allergic reaction characterized by swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Ramipril+Bisoprolol fumarate Sandoz and contact their doctor immediately.
• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. See also the information in section "When not to take Ramipril+Bisoprolol fumarate Sandoz" and "Warnings and precautions".
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medications belonging to the class of mTOR inhibitors (used to prevent organ rejection);
• sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure (see sections "When not to take Ramipril+Bisoprolol fumarate Sandoz" and "Warnings and precautions").

Do not stop taking Ramipril+Bisoprolol fumarate Sandoz suddenly, as this may cause severe worsening of heart function. Treatment should not be interrupted suddenly, especially in patients with coronary artery disease.
The patient should inform their doctor if they think they may be pregnant. Ramipril+Bisoprolol fumarate Sandoz is not recommended during early pregnancy and should not be taken if the patient is pregnant for more than 3 months, as it may cause serious harm to the fetus if taken 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 medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Other medications may affect the action of Ramipril+Bisoprolol fumarate Sandoz, or Ramipril+Bisoprolol fumarate Sandoz may affect the action of other medications. This type of interaction may cause one or both medications to be less effective or may increase the risk or severity of side effects.
The patient should inform their doctor if they are taking any of the following medications:

• medications used to regulate blood pressure or treat heart conditions (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil);
• other medications used to treat high blood pressure, including angiotensin receptor blockers (ARBs), aliskiren (see also the information in section "When not to take Ramipril+Bisoprolol fumarate Sandoz" and "Warnings and precautions"), or diuretics (medications that increase urine production);
• potassium-sparing medications (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medications that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as a combination medication containing trimethoprim and sulfamethoxazole);
• potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• sympathomimetic medications used to treat shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine);
• estramustine used to treat cancer;
• medications commonly used to treat diarrhea or to prevent organ rejection (racecadotril, sirolimus, everolimus, temsirolimus, and other medications belonging to the class of mTOR inhibitors). See section "Warnings and precautions".
• a combination medication containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Ramipril+Bisoprolol fumarate Sandoz" and "Warnings and precautions".
• lithium used to treat mania or depression;
• certain medications used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs; except for MAO-B inhibitors);
• certain medications used to treat schizophrenia (antipsychotic medications);
• certain medications used to treat epilepsy (phenytoin, barbiturates, such as phenobarbital);
• anesthetics used during surgical procedures;
• vasodilators, including nitrates (medications that cause blood vessels to dilate);
• trimethoprim used to treat infections;
• immunosuppressive medications (medications that reduce the body's immune response), such as cyclosporine, tacrolimus, used to treat autoimmune disorders or after organ transplantation;
• allopurinol used to treat gout;
• parasympathomimetic medications used to treat conditions such as Alzheimer's disease or glaucoma;
• topical beta-blockers used to treat glaucoma (increased pressure in the eye);
• mefloquine used to prevent or treat malaria;
• baclofen used to treat muscle stiffness in conditions such as multiple sclerosis;
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
• medications used to treat diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin;
• nonsteroidal anti-inflammatory medications (NSAIDs), such as ibuprofen, diclofenac, or high doses of acetylsalicylic acid, used to treat arthritis, headache, pain, or inflammation.

Ramipril+Bisoprolol fumarate Sandoz with food, drink, and alcohol

It is recommended to take Ramipril+Bisoprolol fumarate Sandoz before a meal.

Pregnancy and breastfeeding

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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 medication.
Pregnancy
The patient should inform their doctor if they think they may be pregnant. The doctor will usually recommend stopping Ramipril+Bisoprolol fumarate Sandoz before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend taking a different medication instead of Ramipril+Bisoprolol fumarate Sandoz. Ramipril+Bisoprolol fumarate Sandoz is not recommended during early pregnancy and should not be taken if the patient is pregnant for more than 3 months, as it may cause serious harm to the fetus if taken during this period.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Ramipril+Bisoprolol fumarate Sandoz is not recommended for breastfeeding women. The doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Ramipril+Bisoprolol fumarate Sandoz 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 medication or in combination 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 of glucose and 20.49 mg of 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 of glucose and 20.49 mg of 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 of glucose and 40.97 mg of 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 of glucose and 40.97 mg of 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 of glucose and 81.94 mg of 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 of glucose and 81.94 mg of 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, which means the medication is considered "sodium-free".

3. How to take Ramipril+Bisoprolol fumarate Sandoz

Take this medication exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule per day. Swallow the capsule with a glass of water, in the morning before breakfast.
Patients with kidney disease
For patients with moderate kidney disease, the 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 disease
The 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.

Overdose of Ramipril+Bisoprolol fumarate Sandoz

If the patient has taken more capsules than prescribed, they should contact their doctor or pharmacist immediately.
The most likely symptom of overdose is low blood pressure, which may cause dizziness or fainting (if this happens, the patient should lie down with their legs elevated), severe difficulty breathing, tremors (due to low blood sugar), and slow heart rate.

Missed dose of Ramipril+Bisoprolol fumarate Sandoz

It is important to take the medication regularly, every day, for it to work best. If a dose 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 Sandoz

Do not stop taking Ramipril+Bisoprolol fumarate Sandoz suddenly or change the dose without consulting your doctor, as this may cause severe worsening of heart function. Do not stop treatment suddenly, especially in patients with coronary artery disease.
If you have any further doubts about taking this medication, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Ramipril+Bisoprolol fumarate Sandoz can cause side effects, although not everyone will experience them.

Stop taking the medication and contact your doctor immediately if you experience any of the following side effects:

• severe dizziness or fainting due to low blood pressure (common - occurs in less than 1 in 10 people);
• worsening of heart failure, causing severe shortness of breath and/or fluid retention (common - occurs in less than 1 in 10 people);
• swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema; uncommon - occurs in less than 1 in 100 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - occurs in less than 1 in 100 people);
• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - occurs in less than 1 in 10,000 people);
• weakness or paralysis of the arms or legs, or difficulty speaking, which may be a sign of a stroke (very rare - occurs in less than 1 in 10,000 people);
• pancreatitis, which may cause severe abdominal pain, radiating to the back, and very poor general condition (very rare - occurs in less than 1 in 10,000 people);
• jaundice (yellowing of the skin or eyes), which may be a sign of liver inflammation (very rare - occurs in less than 1 in 10,000 people);
• a rash that often starts with red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - occurs in less than 1 in 10,000 people).

Ramipril+Bisoprolol fumarate Sandoz is generally well-tolerated, but like other medications, it can cause side effects, especially at the beginning of treatment.
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Inform your doctor or pharmacist immediately if you experience any of the following side effects:

very common (occurs in more than 1 in 10 people):

• slow heart rate;

common (occurs in less than 1 in 10 people):

• headache;
• dizziness of central origin;
• fainting, abnormally low blood pressure, especially when standing up or changing position quickly;
• numbness of the hands or feet;
• feeling of coldness in the hands or feet;
• cough;
• shortness of breath;
• sinusitis or bronchitis;
• chest pain;
• gastrointestinal disorders, such as nausea, vomiting, abdominal pain, indigestion, or difficulty digesting food, diarrhea, constipation;
• allergic reactions, such as rash, itching;
• muscle cramps, muscle pain;
• feeling of fatigue;
• weakness;
• high levels of potassium in blood test results.

uncommon (occurs in less than 1 in 100 people):

• dizziness of peripheral origin;
• disturbances of taste;
• tingling sensation (paresthesia);
• vision disturbances;
• tinnitus (feeling of noise in the ears);
• nasal congestion, difficulty breathing, or worsening of asthma;
• common cold, nasal congestion;
• hot flashes;
• mood changes;
• sleep disturbances;
• depression;
• dry mouth;
• sweating;
• kidney disease;
• increased urine production during the day;
• impotence;
• increased levels of eosinophils (a type of white blood cell);
• drowsiness;
• palpitations;
• rapid heartbeat;
• irregular heart rhythm (atrioventricular conduction disturbances);
• muscle weakness;
• joint pain;
• peripheral edema;
• fever;
• loss of appetite (anorexia);
• changes in laboratory test results: increased levels of eosinophils, increased levels of urea in the blood, increased levels of creatinine in the blood, increased liver enzyme activity, high levels of bilirubin in the blood;
• increased levels of protein in the urine;

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• mouth ulcers;
• breast enlargement in men.

rare (occurs in less than 1 in 1,000 people):

• nightmares, hallucinations;
• reduced tear production (dry eyes);
• redness, itching, or tearing of the eyes;
• hearing disturbances;
• liver inflammation, which may cause yellowing of the skin or eyes;
• vasculitis (inflammation of blood vessels);
• changes in laboratory test results: changes in lipid levels, increased red blood cell count, white blood cell count, or platelet count, or changes in hemoglobin levels.

very rare (occurs in less than 1 in 10,000 people):

• disorientation;
• pancreatitis (which may cause severe abdominal pain, radiating to the back);
• hair loss;
• onset or worsening of psoriasis, psoriasis-like rash;
• increased sensitivity of the skin to sunlight (phototoxic reactions)

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

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

Concentrated urine (dark-colored urine), nausea, or vomiting, muscle cramps, disorientation, and seizures, which may be caused by inappropriate secretion of antidiuretic hormone, may occur with the use of angiotensin-converting enzyme inhibitors. If such symptoms occur, the patient should contact their doctor immediately.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Ramipril+Bisoprolol fumarate Sandoz

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after 'EXP'.
The expiration date refers to the last day of the month stated.
Do not store the medication above 30°C. Do not store in the refrigerator or freeze.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This 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 of Ramipril+Bisoprolol fumarate Sandoz are ramipril and bisoprolol fumarate.
The other ingredients are:
Contents of the capsule: lactose monohydrate, polyvinyl alcohol, sodium croscarmellose, sodium stearyl fumarate, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, crospovidone type A, colloidal anhydrous silica, magnesium stearate.
AquaPolish 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) - [capsules of 10 mg+10 mg, 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg], yellow iron oxide (E 172) - [capsules of 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 5 mg+2.5 mg, 2.5 mg + 2.5 mg, 2.5 mg + 1.25 mg].
Ink:shellac, black iron oxide (E 172), propylene glycol, concentrated ammonia solution, 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
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 capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, film-coated, round tablet.
Ramipril+Bisoprolol fumarate Sandoz, 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 capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, film-coated, round tablet.
Ramipril+Bisoprolol fumarate Sandoz, 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 capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, film-coated, round tablet.
Ramipril+Bisoprolol fumarate Sandoz, 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 capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, film-coated, round tablet.
Ramipril+Bisoprolol fumarate Sandoz, 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 capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of one yellow, biconvex, film-coated, round tablet.
Ramipril+Bisoprolol fumarate Sandoz, 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".
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Contents of the capsule: ramipril in the form of a white or almost white powder and bisoprolol fumarate in the form of two yellow, biconvex, film-coated, round tablets.
Blisters of BOPA/Aluminum/PVC/Aluminum
The blisters and leaflet are packaged in a carton.
The 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
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 medication is authorized in the European Economic Area under the following names:

Croatia
Byol Combi 1.25 mg/2.5 mg hard capsules
Byol Combi 2.5 mg/2.5 mg hard capsules
Byol Combi 2.5 mg/5 mg hard capsules
Byol Combi 5 mg/5 mg hard capsules
Byol Combi 5 mg/10 mg hard capsules
Byol Combi 10 mg/10 mg hard capsules
Poland
Ramipril+Bisoprolol fumarate Sandoz

For more information about this medication, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:11/2023
Sandoz logo
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