CARVEDIGAMMA 12.5 mg. 30 tablets
Chronic stable angina (appearing tightness in the chest under load) .
CARVEDIGAMMA 12.5 mg. 30 tablets
Carvedigamma 12,5 mg Filmtabletten apply to:
- Essential hypertension (high blood pressure with no identifiable organic cause)
- Chronic stable angina (appearing tightness in the chest under load)
- Concomitant treatment with moderate to severe heart failure stabilized (weakness of the heart muscle)
2 What you should have in mind before you start taking Carvedigamma 25 mg Filmtabletten?
2.1. Carvedieamma 12,5 mg Filmtabletten shall not apply to:
- Hypersensitivity (allergy) to carvedilol or excipients of Carvedigamma 12,5 mg Filmtabletten;
- Severe weakness of the heart muscle (IV heart failure class NYHA-classification of heart failure according to New York Heart Association), which requires intravenous increase the conductivity of the heart muscle.
- Chronic obstructive disease with narrowing of the bronchi (see. 2.2. "Cases that require special attention when taking Carvedigamma 12,5 mg film-coated tablets);
- Severe disturbances of liver function.
- Bronchial asthma.
- Interference in the conduct of excitatory signals in the heart between the atrial and ventricular (AV-block II and III degree);
- Very slow heart rate (heart rate <50 beats per minute at rest);
- Cardiogenic shock;
- Sick sinus syndrome (a disorder of the heart rhythm disturbance due to sinus node function, including interference in the conduct of excitatory signals in the heart between the sinus node and atria [sino-atrial block]);
- Very low blood pressure (severe hypotension, systolic blood pressure below 85 mm Hg);
- Acidification of the blood (metabolic acidosis);
- Angina that occurs at rest (Prinzmetal angina);
- Untreated adrenal gland tumor (pheochromocytoma);
- Serious disturbances in peripheral arterial blood flow;
- Simultaneous intravenous treatment with verapamil or diltiazem (see 2.3. "Interactions with other medicinal products").
2.2. Particular attention when taking 123 mg Filmtabletten Carvedisamma® necessary in the following cases
Instructions that must be observed in patients with heart failure Carvedigamma 12,5 mg Filmtabletten generally should be used in addition to diuretics, ACE inhibitors, digitalis preparations and / or vasodilators. Therapy should be started only when the patient is assigned a basic therapy for heart failure for more than four weeks. Patients with marked weakness of the heart muscle (decompensation) should be stabilized before treatment. Patients with severe heart failure, salt and volume depletion, elderly patients and patients with lower baseline blood pressure should be monitored for about 2 hours after the first dose, or increasing the dose, as they may be show a fall in blood pressure (hypotension). In hypotension resulting from excessive vasodilation is first to reduce the dose of diuretic. In the event that symptoms resolved can be reduced to the prescribed dose ACE inhibitor. In the event that it is necessary can be reduced dose Carvedigamma ® 12,5 mg or temporarily discontinue it. Dose of carvedilol should not be raised until they seize control of the symptoms associated with worsening of heart failure, or vazodilatatsiyata.Pri patients with heart failure and reduced blood pressure (systolic 100 mm Hg), disturbances in blood flow to the heart muscle (coronary heart disease) and generalized vascular disease and / or renal failure, essential, under the effect of the therapy Carvedigamma 12,5 mg reversible deterioration of renal function. In patients with heart failure and with these risk factors should be monitored for renal function during introduction of dosage Carvedigamma 12,5 mg. In marked deterioration of renal function should reduce the dose of carvedilol or interrupt therapy Carvedigamma 12,5 mg Filmtabletten.
Concomitant use of Carvedigamma 12,5 mg Filmtabletten and digitalis should be borne in mind that both digitalis and carvedilol extended time required to perform the excitatory signals between atrial and ventricular heart (atrioventricular transit time of excitation ). See 2.3. "Interactions with other medicinal products."
Other warnings concerning Carvedigamma 12,5 mg Filmtabletten and beta-blockers in patients with chronic obstructive pulmonary disease, which is not treated with the drug should not be administered Carvedigamma® 12,5 mg, as the potential risks are greater compared to the benefit of its use. These patients should be monitored carefully in the beginning of therapy and during dose escalation. Carvedilol dose should be reduced if during treatment signs of bronchoconstriction (bronhoobstruktsiya).
Karvedolol can mask the symptoms and signs of a sharp drop in blood sugar (severe hypoglycemia). In patients who suffer from both diabetes and heart failure, the application of Carvedigamma 12,5 mg may be temporarily associated with worsening of blood sugar levels. In patients with diabetes mellitus who are taking Carvedigamma® 12,5 mg, should be very closely monitored through regular checks of blood sugar and antidiabetic treatment / see. point 2.3. "Interactions with other medicinal products" /. Carvedilol may mask signs and symptoms of overactive thyroid gland (hyperthyroidism) .Carvedigamma® 12,5 mg Filmtabletten can cause a slow heart rate (bradycardia). If pulse rate drops below 55 beats per minute and occur symptoms associated with bradycardia, the dose of carvedilol should be reduced.
With concomitant Carvedigamma 12,5 mg Filmtabletten with calcium channel blockers such as verapamil and diltiazem, or other products dekarstveni lechnie disturbances in heart rhythm (antiarrhythmics), especially amiodarone should monitor blood pressure and ECG. Should be avoided both intravenous /vzh.t.2.3. "Interaction with other medicinal products' /.
Co-administration of Carvedigamma 12,5 mg Filmtabletten cimetidine should be performed with caution as the effect of carvedilol can be enhanced / t see. 2.3. "Interaction with other medicinal products' /.
Patients who wear contact lenses can reduce the tear fluid.
In patients who have previously exhibited severe hypersensitivity reactions, as well as in patients undergoing desensitization therapy is recommended, particular attention as beta-blockers may increase sensitivity to substances that can cause an allergy (called an allergen) as well as to increase the power of the hypersensitivity reaction (anaphylactic reaction). Prescribing Carvedigamma 12,5 mg Filmtabletten in patients with PSORIASIS should be done with caution, as the skin reaction may be exacerbated. As a vasodilatory beta-blocker is less likely to cause deterioration in lesion of peripheral blood vessels as compared to the conventional beta-blockers. The same applies to patients with vascular cramps in the fingers and toes. However, worsening of symptoms.
As it has only limited clinical data, Carvedigamma® 12,5 mg Filmtabletten should not be used in patients with unstable or organic (secondary hypertension), decrease to a drop in blood pressure on change in body position (orthostasis), acute inflammatory heart disease, hemodynamically active obstruction of the heart valves or the outflow tract of the cameras last stage of peripheral arterial disease, concomitant treatment with certain blood pressure-lowering drugs (alpha 1-receptor antagonists, or alpha 2-receptor antagonists) .Because carvedilol slower conduction of excitation pulses to the heart (negative dromotropic effect) must be administered with caution to patients with AV-block I stepen.Po during narcosis beta-blockers decrease the risk of arrhythmias, but can improve the risk of the occurrence of hypotension. Therefore, caution is advised when certain anesthetics and Carvedigamma® 12,5 mg Filmtabletten. In more recent studies, however, indicate that beta-blockers reduce cardiac morbidity operations and reduce the potential for complications of the cardiovascular system.
As with other beta-blockers, treatment with Carvedigamma 12,5 mg Filmtabletten should not be stopped suddenly. This is especially true for patients with disturbances in blood supply to the heart muscle (coronary artery disease). Treatment with Carvedigamma 12,5 mg should be stopped stepwise in two weeks, e. by reducing the daily dose by half every three days. At the same time, we need to introduce replacement therapy that will prevent worsening of angina pectoris.
a) Children and young people under 18 years
Data on the activity and safety of carvedilol in this age group are insufficient. So Carvedigamma 12,5 mg Filmtabletten should be given to children and young people only after consulting a doctor.
Older patients may exhibit increased sensitivity to Carvedigamma 12,5 mg Filmtabletten and should be monitored carefully.
Not recommended intake Carvedigamma 12,5 mg Filmtabletten during bremennost.Tay not there are reasonable safety data in pregnant women and may appear harmful to the fetus / newborn, Carvedigamma® 12,5 mg may applies only if the potential benefit outweighs the potential risk to the fetus / newborn. Treatment should be discontinued 2-3 days before the expected date of birth. If this is not possible, the infant was observed during the first 2-3 days after birth.
Since carvedilol is excreted in breast milk during treatment with Carvedigamma 12,5 mg Filmtabletten mothers should not breastfeed.
e) Effects on ability to drive and operate machines
Can be reduced alertness, especially at the beginning of therapy and dose-range finding. It is not known Carvedigamma 12,5 mg Filmtabletten influence on the ability to drive and operate the machine if the therapy is well kontrolirana.Vazhni warning labels on certain ingredients Carvedigamma® 12,5 mg Filmtabletten.
Carvedigamma 12,5 mg contains the excipient lactose monohydrate. If you established with lactose intolerance should not take Carvedigamma 12,5 mg only after further consultation with your doctor.
2.3. Interactions with other medicinal products
Please tell your doctor or pharmacist if you are taking or recently have started taking another medicine. This also applies to medicinal products not subject to prescription.
In patients taking Carvedigamma 12,5 mg Filmtabletten and diltiazem, verapamil and / or amiodarone, single cases of disturbances in conduction excitement rarely accompanied by abnormalities in hemodynamics. As with other beta-blockers, when both apply kaltseivi blockers of the verapamil or diltiazem, with particular attention should be monitored blood pressure and ECG as increased risk of violations of AV-conduction and the risk of cardiac arrest activity / synergy /. In both prlagane of carvedilol and antiarrhythmics class 1 or amiodarone, the patient should be carefully monitored. In patients who received amiodarone, reported bradycardia, cardiac arrest and ventricular fibrillation shortly after induction therapy with beta-blockers. By concomitant therapy with intravenous antiarrhythmics class 1a or 1c risk of cardiac arrest.
Simultaneous treatment and reserpine, guanethidine, methyldopa, guanfacine (medicine lowering the blood pressure) and monoamine oxidase inhibitors / except MAO-B-inhibitors / may lead to a further decrease in heart rate. Monitoring of vital functions.
Concomitant administration of dihydropyridine Carvedigamma 12,5 mg Filmtabletten should be monitored with particular care, as has been reported to stop sadechnata activity and very low blood pressure.
Concomitant administration of nitrates and Carvedigamma 12,5 mg Filmtabletten leads to enhanced hypotensive effect.
With concomitant Carvedigamma 12,5 mg Filmtabletten and digoxin high blood pressure, an increase digoxin levels. It is recommended to monitor the plasma concentrations of digoxin at the beginning of treatment, after completion and dose adjustment Carvedigamma® 12,5 mg Filmtabletten.
Carvedigamma 12,5 mg Filmtabletten can enhance the effects of other concomitant medications to lower blood pressure (e.g.. Alpha1-receptor antagonists), and drugs whose side effect is to reduce the blood pressure, for example. some tranquilizers (barbiturates, phenothiazines), drugs for the treatment of depression (tricyclic antidepressants), and vasodilatory drugs (vasodilators) and alcohol.
Concomitant Carvedigamma 12,5 mg Filmtabletten, leading to increased plasma levels of cyclosporine. Careful monitoring concentrations tsiklosporin.Antidiabetni agents including insulin.
Can be enhanced effect of the hypoglycaemic effect of insulin and oral antidiabetic agents. Symptoms of hypoglycemia (lowering blood sugar) can be masked. In diabetic patients, it is imperative that regular monitoring of blood zahar.Klonidin. If completed combination therapy with carvedilol and clonidine, Carvedigamma® 12,5 mg should be discontinued several days before stepwise reduction of the dose of clonidine.
In narcosis should be careful about possible mutually enhancing effects of Carvedigamma 12,5 mg and anesthetic on cardiac activity (negative inortopno action) and on lowering blood pressure. Therefore, in case of need for anesthesia, tell the doctor that you are taking Carvedigamma 12,5 mg.
NSAIDs, estrogens, and corticosteroids. The antihypertensive action of carvedilol decreases due to retention of water and sodium.
Agents that induce shi inhibit cytochrome P450 enzymes. Patients taking drugs that induce cytochrome P450 enzymes (napr.rifampitsin and barbiturates) or oppress them (eg. Cimetidine, ketoconazole, fluoxetine, haloperidol, verapamil, erythromycin) should be closely monitored if taken at the same time and Carvedigamma ® 12,5 mg, as serum concentrations of carvedilol can be reduced by enzyme inducers and increase of enzyme inhibitors.
Adrenergic alpha-and beta-mimetic mimetic action.
In concomitant Carvedigamma 12,5 mg Filmtabletten these drugs increase the risk of blood pressure and severe bradycardia.
In concomitant Carvedigamma 12,5 mg Filmtabletten with ergotamine occurs strengthen sadosvivashtato action (vasoconstriction).
In concomitant Carvedigamma 12,5 mg Filmtabletten with muscle relaxants increases neuromuscular block (strengthening and extending the relaxing effect on the muscles).
3 How to take Carvedigamma 12,5 mg Filmtabletten?
Take Carvedigamma 12,5 mg always only as prescribed by your doctor. Please consult your doctor or pharmacist if you have any doubts.
3.1. Method of administration
Oral (tablets drinking).
Taking the tablets can be carried out regardless of meals with sufficient fluid. However, in patients with heart failure are advised to take the tablets with food to carvedilol may be absorbed more slowly and reduce the risk of a drop in blood pressure a change in body position (orthostatic hypotension) .Carvedigamma available at four concentrations in tablets containing 3,125 mg, 6,25 mg, 12,5 mg, and 25 mg. Carvedigamma 12,5 mg and 25 mg film-coated tablets are supplied in the form of divisible tablets.
3.2. In the event that your doctor has prescribed otherwise, the usual doses are:
Carvedilol may be used to treat hypertension either alone or in combination with other drugs that lower blood pressure, particularly with a thiazide diuretic. Recommended dosage once daily. The recommended maximum daily dose is two tablets Carvedigamma® 12,5 mg (corresponding to 25 mg carvedilol), and the maximum recommended daily dose amounts to four tablets Carvedigamma® 12,5 mg (corresponding to 50 mg carvedilol).