What is Sobycor and what is it used for?
The medicine in Sobycor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These drugs affect the body's response to some nervous impulses, especially in the heart. As a result, bisoprolol slows the heart rate and thus increases the efficiency of the heart when pumping blood. At the same time, the need for oxygen and blood supply to the myocardium is decreasing.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Sobycor is used for:
increased blood pressure (hypertension)
treatment of angina pectoris
treatment of stable, chronic heart failure.
It is used in combination with other medicines that are appropriate for this condition (such as ACE inhibitors, diuretics and cardiac glycosides).
2. What do you need to know before taking Sobycor ?
Do not use Sobycor:
Do not use Sobycor if any of the following applies to you: allergy to the active substance or to any of the other ingredients of this medicine (described in section 6),
severe asthma,
serious problems related to the circulation of your limbs (such as Raynaud's syndrome) that may cause them to become numb, pale or bruised,
an untreated phaeochromocytoma, which is a rare tumor of the adrenal gland, metabolic acidosis, which is a state of increased acidity of the blood.
Do not take Sikicor if you have any of the following heart ailments:
acute heart failure
aggravated heart failure requiring intravenous therapy with agents that increase the strength of cardiac contractions;
lowering of blood pressure
some heart conditions leading to slow or uneven heartbeat cardiogenic shock, which is an acute cardiac condition that leads to low blood pressure and circulatory insufficiency.
Warnings and precautions
Tell your doctor or pharmacist before taking Sikicor. If any of the following conditions apply to you, tell your doctor, special precautions may be required (eg, appointment of additional treatment or more frequent research):
diabetes, starvation,
some heart disease such as heart rhythm disturbances or severe chest pain at rest (Prinzmetal's angina), kidney or liver problems,
circulatory problems of middle-weight extremities, moderate-to-moderate bronchial asthma or chronic pulmonary disease, history of scaly skin rash (psoriasis), adrenocortical tumor (pheochromocytoma), thyroid disease,
first degree cardiac block (a condition where nerve signals to the heart are disturbed, possibly leading to trabecular leakage from time to time or beating irregularly).
In addition, tell your doctor if you are going to:
desensitization therapy (for example, to prevent hay fever), as Sobicor may cause an allergic reaction or increase its severity; anesthesia (eg due to surgery), as Sikicor can affect your body's response to this procedure.
Other medications and Sobicor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take the following medicines with Siskocor tablets without special advice from your doctor:
Some medicines used to treat irregular or abnormal heart rhythm (Class I antiarrhythmic drugs such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone).
Some medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as verapamil and diltiazem).
Some medicines used to treat high blood pressure such as clonifine, methyldopa, moxinodine, rilmenidine. However, do not stop taking these medicines without consulting your doctor.
Check with your doctor before taking the following medicines with Sicicor tablets: Your doctor may need to check your condition more often:
Some medicines used to treat high blood pressure or angina pectoris or heart rhythm disorders (dihydropyridine type calcium antagonists such as nifedipine, felodipine and amlodipine).
some medicines used to treat irregular or irregular heartbeat (Class III Antiarrhythmic Medicines such as Amiodarone) Some medicines used to treat irregular or abnormal heart rhythm (Class III antiarrhythmic medicines such as amiodarone).
Topical beta-blockers (eg eye drops to treat glaucoma)
Some medicines used to treat Alzheimer's disease or to treat glaucoma (parasympathomimetics such as tacrine or carbachol) or used in critical situations to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
Antidiabetic drug
Hypertension and angina
Adults, including the elderly
The dose should be adjusted individually. The usual daily dose is 10 mg of bisoprolol.
Depending on how well you respond to your medicine, your doctor may decide to reduce the dose to 5 mg or may decide to increase it to 20 mg. The dose should not exceed 20 mg in one day.
Stable chronic heart failure
Adults, including the elderly
Bisoprolol should be started at a low dose and gradually increased.
Your doctor will decide how to increase the dose, and this is usually done as follows:
1.25 mg bisoprolol once daily for one week
2.5 mg bisoprolol once daily for one week 3.75 mg bisoprolol once daily for one week
5 mg bisoprolol once daily for four weeks
7.5 mg bisoprolol once daily for four weeks 10 mg bisoprolol once daily for maintenance (ongoing) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you take the medicine, your doctor may decide to extend the time between dose increases. If your condition gets worse or the medicine is not tolerated, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose of less than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do. If you have to stop treatment altogether, your doctor will usually advise you to reduce your dose gradually, otherwise your condition may get worse.
Use in patients with hepatic and / or renal impairment
In patients with mild to moderate impairment of renal or hepatic function, no dose adjustment is usually required.
In patients with severe renal impairment (creatinine clearance <20 ml / min) and in patients with severe hepatic impairment, it is recommended that a daily dose of 10 mg of bisoprolol is not exceeded.
Use in children and adolescents
Sobicor is not recommended for use in children.
If you take more Sobicor than you should
If you take more Sobicar than you should, tell your doctor immediately. Your doctor will decide what measures are needed.
Symptoms of overdose may include slowing of heart rate, difficulty in breathing, dizziness or trembling (due to decreased blood sugar).
If you forget to take Sobicor
Do not take a double dose to make up for the missed dose. Take the usual dose the next morning.
If you stop taking Sikoric
Never stop taking Sobicor except as a doctor. Otherwise, your condition may get worse. Especially in patients with ischemic heart disease, treatment should not be abruptly discontinued. If you are considering stopping treatment, your doctor will advise you to reduce the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
To prevent serious reactions, talk to a doctor straight away if any of the side effects are severe, suddenly or quickly get worse. The most serious side effects are related to heart function:
Delay in heart rate (may affect up to 1 in 10 people)
Worsening of heart failure (may affect up to 1 in 10 people)
Slow or irregular heartbeat (may affect up to 1 in 100 people)
If you feel dizzy or faint or have difficulty breathing, please contact your doctor as soon as possible.
Other side effects are listed below depending on how often they may occur:
Common (seen in less than 1 in 10 people):
fatigue, weakness, dizziness, headache
feeling cold or tingling the arms or lower limbs low blood pressure
stomach or intestinal complaints such as nausea, vomiting, diarrhea or constipation
Uncommon (occurring in less than 1 in 100 people)
sleep depression disorders
dizziness when standing up
breathing difficulties in patients with asthma or chronic airway disease
muscle weakness, muscle spasms
Rare (occurring in less than 1 in 1,000 people):
hearing disorders allergic rhinitis
decreased tear (dry eyes)
inflammation of the liver which may cause yellowing of the skin or whites of the eyes
defined blood test results that show liver function or fat levels other than normal allergic skin reactions such as itching, flushing, rash, impaired erection nightmares, hallucination seizures
Packaging content and other information
What does Sobycore contain?
The active substance is bisoprolol fumarate (bisoprolol).
Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.
Each film-coated tablet contains 5 mg of bisoprolol fumarate.
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
The other ingredients are microcrystalline cellulose, starch sodium glycolate type A, povidone K30, colloidal anhydrous silica and magnesium stearate (E470b) in the tablet core and hypromellose 2910, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide E172) - Only for 5 mg and 10 mg film-coated tablets and red iron oxide (E172) - for 5 mg and 10 mg film-coated tablets in the film.
What does Sobicore look like and what does it contain?
2.5 mg: White to off-white, oval, slightly biconvex film-coated tablets (tablets), scored on one side (length: 8.3-8.7 mm, width: 5.5 mm, 2-3.7 mm). The tablet can be divided into two equal doses.
5 mg: Light brownish, oval, slightly biconvex film-coated tablets (tablets), scored on one side (length: 8,3-8,7 mm, width: 5,5 mm, thickness: 3,2-3 , 7 mm). The tablet can be divided into two equal doses.
10 mg: Light brownish yellow, round, slightly biconvex, film-coated tablet (s) with bevelled edges, scored on one side (diameter: 10.0-10.3 mm, thickness: 3.1-3.5 mm) . The tablet can be divided into two equal doses.
Blisters (Alu / Aluminum Foil): 10, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets per carton. Not all types of packaging may be placed on the market.