"The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites."...
Helidac Consumer (continued)
Your tongue may turn dark in color while taking this medication. This is harmless and the effect will disappear when you stop the medication.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: ringing in the ears, sore mouth, joint pain, numbness/tingling of arms/legs, frequent/painful urination, discolored teeth, mental/mood changes (e.g., nervousness, irritability, depression).
Tell your doctor immediately if any of these rare but very serious side effects occur: severe headache, stiff/painful neck, difficult/painful swallowing, heartburn, unusual tiredness, change in the amount of urine, dark urine, unusual weakness, yellowing eyes/skin, persistent nausea/vomiting, severe constipation, severe stomach/abdominal pain, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.
Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest/jaw/left arm pain, confusion, slurred speech, vision changes.
This product can commonly cause dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any dark stools.
Tetracycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tetracycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: persistent/severe headache, vision changes (such as blurred/double vision, decreased vision, sudden blindness), persistent nausea/vomiting.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Tell your doctor immediately if you develop persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Helidac (bismuth subsalicylate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Side Effects section.
Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subsalicylate, metronidazole, or tetracycline; or to aspirin or salicylates; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, diabetes, brain/spinal cord disorders (e.g., seizures), trouble swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), asthma, growths in the nose (nasal polyps).
Before having surgery, tell your doctor or dentist that you are using this product.
Tetracycline may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages or alcohol-containing products (e.g., certain cough-and-cold products) while taking this product and for at least 1 day afterward because alcohol may increase dizziness or cause a severe reaction with metronidazole (including abdominal cramping, nausea, vomiting, headache, and flushing).
The elderly may be at greater risk for side effects while using this product.
Children should not take this product because it contains an aspirin-related drug (bismuth subsalicylate) and tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Use of aspirin-related drugs in children, especially if they have chickenpox, flu, or any undiagnosed illness or if they have received the flu vaccine inhaled through the nose, has been associated with Reye's syndrome, a rare but serious illness. Consult your doctor for more information.
This product is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective, non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking this medication. Consult your doctor for more details. See also Drug Interactions.
This combination product contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Additional Helidac Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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