Carvedil 12.5 mg. 28 tablets
Carvedil 12.5 mg. 28 tablets
Active substance: carvedilol
The active ingredient is carvedilol
Each tablet contains 12.5 mg carvedilol.
Crospovidone, lactose monohydrate, magnesium stearate (Ph.Eur), povidone K25, colloidal anhydrous silica, sucrose.
Carvedil 12.5 mg is available in packs of 28, 50 and 100 tablets.
1 What is Carvedil 12.5 mg and what is it used?
1.1 Carvedil 12.5 mg beta-receptor blocker.
1.3 Carvedil 12.5 mg is used:
- For the treatment of high blood pressure without the clarified cause (essential hypertension)
- A disease of the arteries supplying blood to the heart (chronic angina)
- For additional therapy secondary to severe chronic heart failure (II- IV functional class classification NYHA).
2 What you should consider before taking Carvedil 12.5 mg?
2.1 Do not take Carvedil 12.5 rag:
- If you suffer from severe heart failure requiring treatment with intravenous medications that increase the force of contraction of the heart muscle (NYHA class IV heart failure requiring parenteral inotropic therapy)
- If you suffer from respiratory disease characterized by narrowing of bronchi (chronic obstructive pulmonary disease associated with bronhoobstruktsiya)
- If you suffer from severe impairment of liver function
- If you suffer from asthma
- If you suffer from disorders of impulse conduction from the atria to the chambers of the heart (second and third degree AV block)
- If your heart rate at rest is below 50 beats per minute (severe bradycardia)
- If you suffer from any sinus node disease (sick sinus syndrome assembly including sino-atrial block)
- If you are in the cardio-vascular shock
- If your blood pressure is very low (systolic blood pressure below 85 mmHg)
- If you suffer from Prinzmetal variant angina (a rare form of angina)
- If you suffer from untreated hormone-dependent tumor of the adrenal medulla (pheochromocytoma)
- If you are allergic to carvedilol or any of the excipients
- If your blood is very acidic pH (metabolic acidosis)
- If you suffer from severe narrowing artery disease and toes
- If you are currently treated with intravenous verapamil or diltiazem.
2.2 Special warnings when taking Carvedil 12.5 mg:
Special precautions which must be taken into account, especially in patients with cardiac failure
In patients with chronic heart failure, Carvedil 12.5 mg may be used as adjunctive therapy to the existing therapy with other drugs (ACE inhibitors, digitalis, and / or vasodilators). Therapy should be initiated in hospital and monitored by a doctor. Treatment should not be initiated before the patient is stabilized with other drugs for at least 4 weeks.
Patients with severe heart failure, shortage of water and salts, geriatric patients and patients with low blood pressure should be monitored for at least 2 hours after the first dose Carvedil 12.5 mg or increasing the dose due to the possibility of a decrease in blood pressure. Please discuss this with your doctor.
Symptoms of heart failure may worsen at the beginning of treatment or when increasing the dose of Carvedil 12.5 mg. If this happens, your doctor may increase the dose of diuretic (water tablets). However, it is sometimes necessary to reduce the dose or stopping Carvedil 12.5 mg. Your doctor will increase the dose of Carvedil, until symptoms of heart failure or symptoms of low blood pressure is not controlled.
Patients with heart failure and low blood pressure (systolic blood pressure below 100 mmHg) may experience a temporary worsening strength renal function during treatment with Carvedil-12.5 mg. This is especially true for patients with additional 'diseases such as coronary heart disease, arteriosclerosis and / or existing depressed renal function. Renal function should be carefully monitored in these patients during the adjustment of the dose of Carvedil 12.5. If renal function deteriorates significantly, the dose of carvedilol should be reduced or treatment stopped.
Carvedil 12.5 mg should be used with caution in patients with chronic heart failure treated with digitalis as digitalis and its Carvedil may extend conduction time of the pulses from the upper to the lower chambers of the heart.
Other warnings Carvedil 12.5 mg in the whole beta-blockers: Patients with respiratory diseases and a tendency to bronchospasm (chronic obstructive pulmonary disease) should be closely monitored during initiation of treatment and during dose adjustments. Dose Carvedil 12.5 mg should be reduced if you have symptoms of bronchospasm. Discuss with your doctor if you suffer from bronchial illness.
Patients with diabetes mellitus (diabetes) must regularly monitor the level of blood glucose and if necessary to adjust the dose of a drug to reduce blood sugar, while on therapy with Carvedil 12.5 mg, and particularly a change in dosage. Blood glucose should be measured during prolonged starvation.
Carvedil can mask or suppress the symptoms associated with overactivity of the thyroid gland.
Carvedil can cause a slow heart rate (bradycardia). If your heart rate is below 55 beats per minute, your doctor may reduce the dose of Carvedil 12.5 mg.
Concomitant use of Carvedil 12.5 mg of calcium channel blockers of the verapamil and diltiazem (medicines to reduce blood pressure) or other medicines used to treat irregular heart rhythm (antiarrhythmics), especially amiodarone requires careful monitoring of blood pressure and ECG. Simultaneous intravenous administration of these drugs should be avoided.
Attention should be paid when Carvedil used together with cimetidine (a medicine inhibit the production of hydrochloric acid), because it may increase the effects of Carvedil 12.5 mg.
People using contact lenses should consider the possibility of reduced lacrimation (tear reduced).
Patients with a history of severe hypersensitivity reactions and patients undergoing allergen specific immunotherapy (hiposensitivna therapy) may experience worsening of allergic (anaphylactic) reactions.
Patients with psoriasis should use Carvedil 12.5 mg with caution because of the possibility of worsening symptoms of skin disease.
Carvedil 12.5-mg should be used with caution in patients with peripheral vascular disease (eg Raynaud's phenomenon) as the beta-blockers such as carvedilol may worsen the symptoms of the disease.
If you know that you are slow metabolisers of debrisoquine, you should be closely monitored especially in, the start of therapy. Because there is not enough clinical experience, Carvedil 12.5 mg should not be used in patients with high blood pressure (secondary hypertension or unstable), drop in blood pressure upon standing (orthostatic hypotension), acute inflammatory disease of the heart (with hemodynamic disorder) narrowing of the heart valves, severe arterial vascular disease of the legs or simultaneous use of alpha-1 blocker or alpha-2 blocker.
In patients with tumor adrenal medulla (pheochromocytoma), alpha-blocker medication should be initiated prior to initiation of therapy with carvedilol. Should be carefully monitored these patients when taking Carvedil 12.5 mg.
Carvedil 12.5 mg should be used with caution in patients with impaired impulse conduction from the atria to the cameras (first degree AV block).
Attention should be paid to both the use of certain anesthetics, due to an increased risk of a drop in blood pressure.
Like other beta-blockers, Carvedil 12.5 mg should not be stopped suddenly. This is especially true for patients with coronary heart disease. Treatment with Carvedil 12.5 mg should be withdrawn gradually over a period of 2 weeks, the dose was reduced by half an interval of 3 days. Discuss this with your doctor.
The safety and efficacy have not been established in children and adolescents under 18 years of age. Carvedil 12.5 mg should be used in this group of patients.
Geriatric patients may be more sensitive to the effects of Carvedil 12.5 mg and should be carefully monitored.
Carvedil should be used during pregnancy only after careful assessment of the benefit / risk ratio.
Beta-blockers reduce placental perfusion, which can lead to intra-uterine fetal death and stillbirth. In addition, can be adverse effects on the fetus and newborn (especially low blood sugar - hypoglycemia and slow heart rate - bradycardia). There is an increased risk of cardiac and respiratory complications in the newborn period slednatalniya. Treatment should be stopped 2-3 days before the expected birth, but if this is not possible, the infant should be monitored during the first 2-3 days of life.
Carvedil accumulates in breast milk, even in larger concentrations than in maternal blood. Therefore should not breast-feed during treatment with Carvedil 12.5 mg.
e) Effects on ability to drive and use machines
Use of this medication requires regular medical examinations. There are different individual reactions that reduce the ability of active attention and quick reactions required for driving, operating machinery or unsafe work. This is especially true at the start of treatment when increasing the dose, add new medication or if it is used simultaneously with alcohol.
1) Important information about some of the ingredients Carvedil 12.5 mg
This medicine contains lactose and sucrose. If you know you have an intolerance to lactose and sucrose should not take Carvedil 12.5 before you consult with your doctor. 23
Interactions with other drugs
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor.
Interactions with medicines to treat abnormal heart rhythm (antiarrhythmics)
Co-administration of Carvedil 12.5 mg of calcium channel blockers (such as verapamil, diltiazem), amiodarone or class I antiarrhythmic drugs requires careful monitoring of blood pressure and ECG. There are cases of a slow heart rate (bradycardia), cardiac arrest and ventricular fibrillation, soon after beta-blocker therapy in patients receiving concomitant amiodarone. Concomitant use of Class IV 1a or 1c antiarrhythmics, class is associated with increased risk of heart failure.
Concomitant therapy Carvedil 12.5 mg medicines reduce blood pressure reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors (except MAO-B inhibitors) may lead to further delays in heart rate. Your doctor should closely monitor your cardio-vascular function.
Some drugs that reduce high blood pressure (dihydropyridines, such as nifedipine)
Co-administration of dihydropyridines and Carvedil 12.5 mg requires careful monitoring because there are cases of heart failure and severe hypotension.
Drugs expanding coronary arteries (nitrates)
These drugs and Carvedil 12.5 mg mutually reinforcing effects of reducing blood pressure.
Cardiac glycosides, medicines to treat heart failure (digoxin and digitoxin)
Concomitant use with Carvedil 12.5 mg may enhance the effects of cardiac glycosides. Blood levels of glycoside should be measured prior to initiation of therapy, a change in the dose or discontinuation of therapy Carvedil 12.5 mg.
Other medicines to lower blood pressure
Carvedil 12.5 mg may enhance the effects of other drugs for lowering blood pressure (such as alpha-1 receptor antagonists) and drugs whose side effect is a decrease in blood pressure (barbiturates, phenothiazines, tricyclic antidepressants, vasodilators).
Drugs suppress the immune response (gshtklosporin)
Concomitant use of tsiklosporii and Carvedil 12.5 mg may cause elevated blood levels of anti cyclosporine.
Drugs to reduce blood sugar (antidiabetic agents, including insulin)
Carvedil 12.5 mg may enhance the reduction of blood sugar. Symptoms of low blood sugar (hypoglycemia) can be masked. Patients with diabetes need to regularly check your blood sugar levels.
In case of discontinuation of clonidine and Carvedil, Carvedil 12.5 mg should be stopped several days before starting the gradual withdrawal of clonidine.
Anestetishti (inhalational anesthetics)
Anaesthetic agents may enhance the reduction of blood pressure by Carvedil 12.5 mg during anesthesia. Please tell the anesthetist that you are taking Carvedil 12.5 mg.
Drugs for the treatment of rheumatic diseases and pain (NSAIDs), corticosteroids and estrogens
The antihypertensive effect of Carvedil 12.5 mg is reduced due to the retention of water and sodium (an adverse effect of these drugs).
Drugs are metabolized by the same enzyme systems in the liver (cytochrome P450)
The following medicines may influence the effects of Carvedil 12.5 mg: rifampicin (antibiotic), barbiturates (to help you sleep medicines), cimetidine (a medicine inhibit the production of hydrochloric acid), ketoconazole (medicine for fungal infections), fluoxetine (an antidepressant), haloperidol (an antipsychotic) , verapamil (a medicine to treat abnormal heart rhythms), erythromycin (an antibiotic). Patients taking any of these medicines together with Carvedil 12.5 mg should be carefully monitored.
When these drugs are used concomitantly with carvedilol, an increased risk of high blood pressure and slow heart rate (severe bradycardia).
Antimigraine drugs (ergotamine)
When these drugs are used concomitantly with carvedilol, the risk of a rise in blood pressure due to narrowing of the blood vessels.
Carvedil 12.5 mg increases muscle-relaxing effect.
2.4 When Carvedil 12.5 mg be taken with food or drinks
Alcohol: Carvedil 12.5 mg may enhance the effects of alcohol.
3 How to take Carvedil 12.5 mg?
Always take Carvedil 12.5 mg as just follow the instructions of your doctor. Counsel with your doctor or pharmacist if anything you do not understand.
3.1 Method of administration
For oral use
The tablets should be taken with sufficient voda.Ne need to take the tablets with food.
Patients with heart failure, however, should not take Carvedil 12.5 mg with food to slow absorption, thereby reducing the risk of a sharp drop in blood pressure upon standing (orthostatic hypotension).
There are other tablets Carvedil in doses that are not covered by Carvedil 12.5 mg.
3.2 If your doctor has prescribed another dose to treat high blood pressure without a specific cause (essential hypertension) is:
For the treatment of hypertension, Carvedil 12.5 mg may be used alone or in combination with other blood pressure lowering drugs, and especially water tablets (thiazide diuretics).
Recommended once-daily dosing; maximum single dose is 25 mg and the maximum daily dose - 50 mg.
The recommended starting dose is 1 tablet Carvedil 12.5 mg (equivalent to 12.5 mg carvedilol) once daily for the first 2 days.
Treatment can then continue with 2 tablets Carvedil 12.5 mg (equivalent to 25 mg carvedilol) once daily. If necessary, the dose may be escalated gradually in the range of not less than 2 weeks.
The recommended starting dose for the treatment of hypertension is one tablet Carvedil 12.5 mg (equivalent to 12.5 mg carvedilol) once daily. This dose may suffice for long-term therapy.
If this dose does not achieve adequate control of blood pressure, it is necessary to gradually increase the dosage over, an interval of not less than 2 weeks.
For the treatment of diseases of the arteries supplying blood to the heart (angina chronic): Recommended dose 2 times a day.
The recommended starting dose for the treatment of hypertension is 1 tablet Carvedil 12.5 mg (equivalent to 12.5 mg carvedilol) 2 times daily for the first 2 days. Then treatment should be continued with two tablets Carvedil 12.5 mg (equivalent to 25 mg carvedilol) two times a day; there are appropriate dosage tablets Carvedil for this purpose. If necessary, the dose may be escalated gradually in an interval of at least 2 weeks up to a maximum recommended daily dose of 100 mg, divided into 2 daily administration.
The recommended starting dose for the treatment of hypertension is one tablet Carvedil 12.5 mg (equivalent to 12.5 mg carvedilol) 2 times daily for the first 2-dni. then treatment can be continued with two tablets Carvedil 12.5 mg (equivalent to 25 mg carvedilol) 2 times daily.