Adverse Event (AE) frequency:
AE's occuring at ≥10% are described as very common;
AE's occurring at ≥1% and <10% are described as common;
AE's occurring at ≥0.1% and <1% are described as uncommon;
AE's occurring at ≥0.01% and <0.1% are described as rare;
AE's occurring at ≥0.01% are described as very rare including isolated cases.
The frequency of adverse experiences is not dose-dependent, with the exception of dizziness, abnormal vision and bradycardia.
Undesirable effects in chronic heart failure:
Adverse experiences most frequently observed in the Vacodil group in clinical trials in chronic heart failure patients and not seen at an equivalent incidence among placebo treated patients are described as follows.
Central nervous system:
Very common: dizziness, headaches are usually mild and occur particularly at the start of treatment. Asthenia (including fatigue) also occurs very commonly.
Common: bradycardia, postural hypotension, hypotension, edema (including generalized, peripheral, dependent and genital edema, edema of the legs, hypervolemia and fluids overload).
Uncommon: syncope (including presyncope), AV block and cardiac failure during uptitration.
Commonly, nausea, diarrhea and vomiting.
Leucopenia has been reported in isolated cases.
Commonly, weight increase and hypercholesterolemia. Hyperglycemia, hypoglycemia and worsening control of blood glucose are also common in patients with pre-exisitng diabetes mellitus (see Precautions).
Commonly, vision abnormalities. Rarely, renal failure and renal function abnormalities in patients with diffuse vascular disease and/or impairment renal function (see Precautions).
Undesirable effects in hypertension and the long term management of coronary heart disease:
The profile of adverse events associated with the use of Vacodil in the treatment of hypertension and the long-term management of coronary heart disease is consistent with that observed in chronic heart failure. The incidence of adverse events in these patient populations is lower, however, Adverse experiences reported in clinical trials in patients with hypertension and coronary heart diseases are: Central nervous system:
Commonly, dizziness, headaches and fatigue, which are usually mild and occur particularly at the beginning of treatment. Uncommonly, depressed mood, sleep disturbances, paresthesia.
Commonly, bradycardia, postural hypotension and uncommonly syncope, especially at the beginning of treatment. Uncommonly, disturbances of peripheral circulation (cold extremities, PVD, exacerbation of intermittent claudication and Raynauds phenomenon), AV block, angina pectoris (including chest pain), symptoms of heart failure and peripheral edema.
Commonly, asthma and dyspnea in predisposed patients. Rarely, stuffy nose.
Commonly, gastro-intestinal upset (with symptoms such as nausea, abdominal pain, diarrhea). Uncommonly, constipation and vomiting.
Skin and appendages:
Uncommonly, skin reactions (e.g. allergic exanthema, dermatitis, urticaria and pruritus).
Blood chemistry and hematology:
Isolated cases of increases in ALAT, ASAT and gamma GT, thrombocytopenia and leucopenia.
Commonly, pain in the extremities. Commonly, reduced lacrimation and eye irritation. Uncommon cases of sexual impotence and disturbed vision. Rarely, dryness of the mouth and disturbances of micturition.
Isolated cases of allergic reactions have been reported.
Due to the beta-blocking properties, it is also possible for latent diabetes mellitus to become manifest, manifest diabetes to be aggravated, and blood glucose counter-regulation to be inhibited.