"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Sumycin Consumer (continued)
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 right away if you have any serious side effects, including: sunburn (sun sensitivity), nail discoloration, muscle pain, difficult or painful swallowing, change in the amount of urine, brown/gray tooth discoloration, numbness/tingling of the hands/feet, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever, chills), hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
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 resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped.. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool..
Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection (oral or vaginal fungal 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, chest pain, fast/irregular heartbeat.
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 Sumycin (tetracycline) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Side Effects section.
Before taking tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).
This drug 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. Limit alcoholic beverages.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Before having surgery, tell your doctor or dentist that you are using tetracycline.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.
This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.
This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details.
This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Additional Sumycin Information
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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