SOBYCOR 5 mg. 30 tablets
The active substance in Sobycor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These drugs affect the body's response to certain nerve impulses in particular in the heart. As a result, bisoprolol slows down the heart rate and thus increases the efficiency of the heart to pump blood. At the same time the need of oxygen and blood supply to the myocardium are decreasing.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Sobycor apply to:
high blood pressure (hypertension);
treatment of angina pectoris;
treatment of stable chronic heart failure. It is used in combination with other drugs suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).
2. What you should know before using 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 (listed in section 6);
severe asthma or severe chronic obstructive pulmonary disease;
serious problems relating to the circulation of your limbs (such as Raynaud's syndrome), which may lead to their numbness, whitening or bruising;
untreated pheochromocytoma, which is a rare tumor of the adrenal gland;
metabolic acidosis, which is a condition of increased acidity of the blood.
Do not use Sobycor if you have any of the following heart diseases:
acute heart failure;
worsening heart failure requiring intravenous therapy with agents that increase the strength of heart contractions;
lowering blood pressure;
certain heart conditions, leading to delayed or irregular heartbeat and were not equipped with a pacemaker;
cardiogenic shock, which is an acute serious heart condition, leading to low blood pressure and circulatory failure.
Warnings and Precautions
Tell your doctor or pharmacist before taking Sobycor. If any of the conditions listed below apply to you, tell your doctor may require special precautions (eg recruitment of additional treatment or perform more frequent):
certain heart diseases such as heart rhythm disorders or severe chest pain at rest (angina of Prinzmetal);
kidney or liver problems;
blood circulation problems in the extremities with an average weight;
asthma or chronic bronchial disease with an average weight;
history of scaly skin rash (psoriasis);
an adrenal gland tumor (pheochromocytoma);
first degree heart block (a condition in which nerve signals are violated to the heart, possibly leading to missed tract occasionally or beat irregularly).
Furthermore, tell your doctor if you are:
desensitization therapy (for example for the prevention of hay fever), as Sobycor can result in an allergic response, or to increase its pressure;
anesthesia (eg. due to surgery) as Sobycor can affect the body's response to this procedure.
Other medicines and Sobycor
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 Sobycor tablets without special advice from your doctor:
Some medicines used to treat irregular or abnormal heartbeat (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);
Certain drugs used to treat high blood pressure such as clonidine, methyldopa, moksonodin, rilmenidine. However, do not stop taking these medications without consulting your doctor.
Consult your doctor before taking the following medicines with Sobycor tablets; may be necessary for your doctor to check your condition more frequently:
Some medicines used to treat high blood pressure or angina pectoris or irregular heartbeat (dihydropyridine calcium channel blockers such as nifedipine, felodipine and amlodipine);
some medicines used to treat irregular or irregular heartbeat (Anti-arrhythmic drugs class III eg. amiodarone);
Some medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic drugs such as amiodarone);
Beta-blockers, administered topically (e. Eye drops for the treatment of glaucoma);
Certain drugs used to treat Alzheimer's disease or for the treatment of glaucoma (parasympathomimetics such as tacrine or carbachol) or used in emergency situations to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine);
Antidiabetic drugs, including insulin;
Anesthetics (eg. During surgical operations);
Digitalis, used in the treatment of heart failure;
Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis, pain or inflammation (eg., Ibuprofen, diclofenac);
Any drug that can lower blood pressure as a desired or undesired effect such as antihypertensives, some medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain drugs that are used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital ), or certain medicines to treat mental diseases, which are characterized by a lack of reality (phenothiazines such levomepromazine);
Mefloquine, used for prevention or treatment of malaria;
Drugs used to treat depression called monoamine oxidase inhibitors (except MAO-B) inhibitors, such as moclobemide;
Moksisilit used for the treatment of circulatory problems, such as Raynaud's syndrome.
Pregnancy and lactation
There is a risk that the use of Sobycor during pregnancy can harm the baby. If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist before you start taking this medicine. He or she will decide whether you can take Sobycor during pregnancy.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Sobycor.
Children and adolescents
Not recommended for use Sobycor in children and adolescents.
Driving and using machines
The ability to drive or operate machinery may be affected depending on your tolerance to the drug.
Please pay special attention at the beginning of treatment, increasing the dose or switching to another drug as well as the concomitant use of alcohol.
3. How to take Sobycor
Always take this medicine exactly as your doctor has told you.
Consult your doctor or pharmacist if you are not sure.
Take the tablet with water in the morning, with or without food. Do not crush or chew the tablet.
Sobycor treatment requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during the dose escalation, and also when you stop treatment.
Sobycor treatment is usually long-term.
Hypertension and angina
Adults, including the elderly
The dose should be adjusted individually. The usual daily dose is 10 mg bisoprolol.
Depending on how well you respond to the 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 per day.
Stable chronic heart failure
Adults including the elderly
Treatment with bisoprolol must be started at a low dose and gradually increase.
Your doctor will decide how to increase the dose, and this is usually done in the following way:
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 (current) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may decide to extend the time between increasing the dose. If your condition deteriorates or the drug is not tolerated, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will tell you what to do. If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may get worse.
Use in patients with hepatic and / or renal impairment
In patients with mild to moderate renal or hepatic function is not usually require dose adjustment.
In patients with severe renal impairment (creatinine clearance <20 ml / min) and in patients with severe hepatic impairment is recommended not to exceed a daily dose of 10 mg bisoprolol.
Use in children and adolescents
Sobycor not recommended for use in children.
If you take more than the amount Sobycor
If you take more Sobikar than you should, tell your doctor. Your doctor will decide what measures are necessary.
Symptoms of overdose may include slow heart rate, severe difficulty breathing, dizziness or trembling (due to decreased blood sugar).
If you forget to take Sobycor
Do not take a double dose to make up the missed dose. Take your normal dose the next morning.
If you stop taking Sobycor
Never stop taking Sobycor, except on medical advice. Otherwise, your condition may get worse. Particularly in patients with ischemic heart disease, treatment should not be stopped abruptly. If you are considering stopping treatment, your doctor will ask 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 everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurs suddenly or gets worse rapidly. The most serious adverse reactions associated with the function of the heart:
Slow heart rate (may affect up to 1 in 10 people);
Worsening 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 weak, or having difficulty breathing, contact your doctor as soon as possible.
Other side effects are listed below according to how frequently they may occur:
Common (occurs in less than 1 in 10 people):
fatigue, weakness, dizziness, headache;
feeling cold or numbness in the arms or legs;
stomach or intestinal complaints such as nausea, vomiting, diarrhea or constipation.
Uncommon (affects less than 1 in 100 people):
dizziness upon standing;
breathing difficulties in patients with asthma or chronic airway disease;
muscle weakness and muscle cramps.
Rare (affects less than 1 in 1000 people):
decreased tears (dry eyes);
inflammation of the liver which can cause yellowing of the skin or the whites of the eyes;
certain blood test results that indicate liver function or fat levels other than normal;
skin reactions like allergies, such as itching, redness, rash;
Very rare (affects less than 1 in 10,000 people):
inflammation and redness of the eyes (conjunctivitis);
onset or worsening of scaly skin rash (psoriasis);
5. How to store Sobycor
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EHR". The expiry date refers to the last day of the month.
Store in the original package to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.