Get emergency medical help if you have signs of an allergic reaction to Tensivask: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, when you first start taking Tensivask, your angina may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.
Call your doctor at once if you have:
pounding heartbeats or fluttering in your chest;
worsening chest pain;
swelling in your feet or ankles;
severe drowsiness; or
a light-headed feeling, like you might pass out.
Common Tensivask side effects may include:
stomach pain, nausea; or
flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Tensivask in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tensivask has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Tensivask was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Tensivask were of mild or moderate severity. In controlled clinical trials directly comparing Tensivask (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Tensivask because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:
Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Tensivask treatment as shown in the following table:
The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Tensivask therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
In the CAMELOT and PREVENT studies, the adverse event profile was similar to that reported previously, with the most common adverse event being peripheral edema.
These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of Tensivask.
Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and Tensivask.
Tensivask has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.
What is the most important information I should know about Tensivask?
Tensivask may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tensivask with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Tensivask may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
If you are taking Tensivask for angina, it will not relieve the pain of an acute attack if it is taken at the time of an acute attack. It prevents or reduces the number of angina attacks only if you take it on regular schedule.
If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
While you are using Tensivask, it is important to brush and floss your teeth carefully to reduce swelling and tenderness of your gums.
Although rare, Tensivask has been known to increase chest pain and increase the risk of a heart attack, especially in patients with severe heart disease.
Lab tests, including blood pressure checks, may be performed while you use Tensivask. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Tensivask with caution in the ELDERLY; they may be more sensitive to its effects.
Tensivask should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Tensivask while you are pregnant. It is not known if Tensivask is found in breast milk. Do not breast-feed while taking Tensivask.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
Before taking Tensivask, tell your doctor if you have congestive heart failure or liver disease.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Tensivask.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Tensivask is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Tell your doctor about all other heart or blood pressure medications you are taking.
Your chest pain may become worse when you first start taking Tensivask or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.
European Chemicals Agency - ECHA. "3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
NCIt. "Amlodipine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Tensivask are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tensivask. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
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