Levoxyl®(levothyroxine sodium)

Do not use LEVOXYL to treat weight problems or weight loss. Do not take more LEVOXYL than your healthcare provider prescribes for you to take. Overdosage or taking too much LEVOXYL may cause life-threatening side effects or death.

LEVOXYL is a prescription medicine that contains a hormone called levothyroxine, which is similar to the hormone produced by your thyroid gland.

LEVOXYL is used to treat children and adults:

• To replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone
• Who need surgery and radioiodine therapy to manage a type of thyroid cancer called well-differentiated thyroid cancer

LEVOXYL should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.

Do not use LEVOXYL if your adrenal glands are not working well and you have not been treated for this problem.

Before you take LEVOXYL, tell your healthcare provider if you:

• Have or had heart problems
• Have or had thyroid nodules
• Have adrenal or pituitary gland problems
• Have any food or drug allergies
• Have a low red blood cell count (anemia)
• Have diabetes
• Have weak bones (osteoporosis)
• Have or had a history of blood clotting problems
• Have recently received radiation therapy with iodine (such as I-131)
• Are pregnant or plan to become pregnant (your healthcare provider may need to increase your LEVOXYL while you are pregnant)

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Take LEVOXYL exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much LEVOXYL to take each day.

Take your dose of LEVOXYL on an empty stomach, at least 30 minutes to 1 hour before breakfast with a full glass of water to avoid choking or gagging.

For infants and children who cannot swallow tablets:

• Crush the tablet and place the freshly crushed tablet in a small amount (5 mL to 10 mL or 1 teaspoon to 2 teaspoons) of water
• Immediately give the medicine by spoon or dropper
• Do not store the mixed medicine

Take LEVOXYL at least 4 hours before or after medicines that contain calcium carbonate or iron (ferrous sulfate), and at least 4 hours before medicines that contain bile acid sequestrants or ion exchange resins.

LEVOXYL can cause serious side effects, including:

• Heart problems – you may experience an increased heart rate, chest pain and irregular heartbeat
• Worsening diabetic control – it may be harder to control your blood sugar levels causing hyperglycemia while taking LEVOXYL
• Weak or brittle bones – your risk may be greater if you are post-menopausal and are taking high doses of LEVOXYL for a long period

The most common side effects include:

• Irregular heartbeat, chest pain, shortness of breath
• Leg cramps, headache, nervousness, irritability
• Sleep problems (insomnia), tremors, muscle weakness
• Change in appetite, weight loss, vomiting, diarrhea
• Sweating a lot, heat intolerance, fever
• Changes in menstrual period, hives or skin rash

Partial hair loss may occur rarely during the first few months of LEVOXYL therapy; this usually lasts a short period of time.

• Store LEVOXYL at room temperature between 68°F to 77°F (20°C to 25°C)
• Store LEVOXYL away from heat, light and moisture
• Keep LEVOXYL and all other medicines out of the reach of children

Active ingredient: levothyroxine sodium

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, calcium sulfate dihydrate, sodium bicarbonate, coloring additives

This product is gluten-free.