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:
:
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, pharmacist, or nurse.
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 disease symptoms are the same.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
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 medicines called beta-blockers. Beta-blockers slow down 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 in which the heart is not able to pump enough blood to meet the body's needs, resulting in shortness of breath and swelling) and/or to reduce the risk of heart events, such as heart attack, in patients with chronic coronary artery disease (a condition in which the heart's blood supply is reduced or blocked) who have had a heart attack and/or have undergone surgery to improve blood flow to the heart by widening the blood vessels that supply it, or with diabetes with at least one other cardiovascular risk factor.
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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Before starting treatment with Ramipril+Bisoprolol fumarate Sandoz, the patient should discuss it with their doctor or pharmacist if:
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the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
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 tell their doctor if they think they are (or may be) pregnant. Ramipril+Bisoprolol fumarate Sandoz is not recommended in 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 baby if taken during this period (see "Pregnancy").
Ramipril+Bisoprolol fumarate Sandoz is not recommended for use in children and adolescents under 18 years of age.
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. Other medicines may affect the action of Ramipril+Bisoprolol fumarate Sandoz, or Ramipril+Bisoprolol fumarate Sandoz may affect the action of other medicines. This type of interaction may cause one or both medicines to be less effective. It may also increase the risk or severity of side effects.
The patient should tell their doctor if they are taking any of the following medicines:
Ramipril+Bisoprolol fumarate Sandoz should be taken before a meal.
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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 medicine.
Pregnancy
The patient should tell their doctor if they think they are (or 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 medicine instead of Ramipril+Bisoprolol fumarate Sandoz. Ramipril+Bisoprolol fumarate Sandoz is not recommended in 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 baby if taken during this period.
Breastfeeding
The patient should tell 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.
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 start of treatment or when changing the medicine 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 medicine is considered "sodium-free",
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 per day. The capsule should be swallowed with a glass of water, in the morning before a meal.
Patients with kidney disease
In 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 function disorders
The doctor will closely monitor patients with mild or moderate liver disease when starting treatment with Ramipril+Bisoprolol fumarate Sandoz.
Ramipril+Bisoprolol fumarate Sandoz is not recommended for use in children and adolescents.
In case of taking too many capsules, the patient 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 be laid down with their legs elevated), severe difficulty breathing, tremors (due to low blood sugar), and slow heart rate.
It is important to take the medicine regularly, every day, for it to work best. If a dose of Ramipril+Bisoprolol fumarate Sandoz is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for a missed dose.
The patient should not stop taking Ramipril+Bisoprolol fumarate Sandoz suddenly or change the dose without consulting their doctor, as this may cause significant worsening of heart function. Treatment should not be interrupted suddenly, especially in patients with coronary artery disease.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.
Like all medicines, Ramipril+Bisoprolol fumarate Sandoz can cause side effects, although not everybody gets them.
Ramipril+Bisoprolol fumarate Sandoz is usually well tolerated, but like other medicines, it can cause side effects, especially at the start of treatment.
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very common (occurs in more than 1 in 10 people):
common (occurs in less than 1 in 10 people):
uncommon (occurs in less than 1 in 100 people):
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rare (occurs in less than 1 in 1,000 people):
very rare (occurs in less than 1 in 10,000 people):
frequency not known (frequency cannot be estimated from the available data):
Concentrated urine (dark 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 ACE inhibitors. If such symptoms occur, the patient should contact their doctor as soon as possible.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, 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 medicine.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after 'EXP'.
The expiry date refers to the last day of the month stated.
Do not store the medicine at temperatures 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.
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The active substances of the medicine 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 with a strength of 10 mg+10 mg, 10 mg+5 mg, 5 mg+5 mg, 5 mg+2.5 mg], yellow iron oxide (E 172) - [capsules with a strength 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 with a strength 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.
Ramipril+Bisoprolol fumarate Sandoz, 2.5 mg + 1.25 mg, hard capsules
A capsule with 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
A capsule with 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
A capsule with 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
A capsule with 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
A capsule with 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
A capsule with 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 foil
The blisters and leaflet are placed in a carton box.
The capsules are available in packs of 10, 30, 60, or 100 capsules.
Not all pack sizes may be marketed.
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
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
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
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