Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local ( ), or emergency room immediately. Symptoms may include dizziness on standing; lightheadedness; severe nausea or vomiting.
Proper storage of Hemsamic tablet:
Store Hemsamic tablet at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hemsamic tablet out of the reach of children and away from pets.
Overdose of Hemsamic in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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There are no known cases of intentional overdose with Hemsamic Tablets and no subjects in the clinical program took more than 2 times the prescribed amount of Hemsamic Tablets in a 24-hour period (>7800 mg/day). However, cases of overdose of Hemsamic have been reported. Based on these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment; mental status changes; myoclonus; or rash. No specific information is available on the treatment of overdose with Hemsamic Tablets. In the event of overdose, employ the usual supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patient's clinical status.
What should I avoid while taking Hemsamic?
This medication may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Hemsamic warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Thromboembolic Risk
Concomitant Use of Hormonal Contraceptives
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because Hemsamic Tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when hormonal contraceptives are administered with Hemsamic Tablets. This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.
Women using hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of Hemsamic Tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of Hemsamic Tablets with hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used Hemsamic Tablets concomitantly with combination hormonal contraceptives. For this reason, concomitant use of Hemsamic with combination hormonal contraceptives is contraindicated..
Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates
Hemsamic Tablets are not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased.
All-Trans Retinoic Acid (Oral Tretinoin)
Exercise caution when prescribing Hemsamic Tablets to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.
Ocular Effects
Retinal venous and arterial occlusion has been reported in patients using Hemsamic. Patients should be instructed to report visual and ocular symptoms promptly. In the event of such symptoms, patients should be instructed to discontinue Hemsamic Tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion.
Severe Allergic Reaction
A case of severe allergic reaction to Hemsamic Tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of Hemsamic.
Subarachnoid Hemorrhage
Cerebral edema and cerebral infarction may be caused by use of Hemsamic Tablets in women with subarachnoid hemorrhage.
Ligneous Conjunctivitis
Ligneous conjunctivitis has been reported in patients taking Hemsamic. The conjunctivitis resolved following cessation of the drug.
What should I discuss with my healthcare provider before taking Hemsamic?
Some medical conditions may interact with Hemsamic tablet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have kidney disease, upper respiratory tract bleeding, certain blood problems (disseminated intravascular coagulation [DIC]), or a history of blood clots
Some MEDICINES MAY INTERACT with Hemsamic tablet. Tell your health care provider if you are taking any other medicines, especially any of the following:
Anti-inhibitor coagulant concentrates, factor IX complex concentrates, or tretinoin because risk of blood clots may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hemsamic tablet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Hemsamic precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Patients with irregular menstrual bleeding should not use Hemsamic until the cause of the irregularity has been established. If menstrual bleeding is not adequately reduced by Hemsamic, an alternative treatment should be considered.
Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use Hemsamic only if there is a strong medical indication and under strict medical supervision.
Patients with disseminated intravascular coagulation, who require treatment with Hemsamic, must be under the strict supervision of a physician experienced in treating this disorder.
The blood levels are increased in patients with renal insufficiency. Therefore, a dose reduction is recommended, see Dosage & Administration.
In haematuria from the upper urinary tract blood clots can, in a few cases, lead to ureteric obstruction.
Convulsions have been reported in association with Hemsamic treatment.
Effects on the Ability to Drive or Operate Machinery: Hemsamic may cause dizziness and therefore, may influence the ability to drive or use machines.
Impairment of Fertility: There are no clinical data in humans supporting the impact of Hemsamic on fertility. Fertility was not affected in male or female rats at high oral doses up to approximately 850-880 mg/kg/day.
Use in pregnancy: Hemsamic crosses the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Clinical experience of use in pregnant women is limited. Animal studies have not supplied any evidence of an increased incidence of foetal damage.
Use in lactation: Hemsamic is excreted into breast milk.
Use in children: Clinical experience with Hemsamic in menorrhagic children <15 years is not available.
What happens if I miss a dose of Hemsamic?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you miss a dose.
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References
DailyMed. "TRANEXAMIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
