Read this Medication Guide before you start using SEMAGLUTIDE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about SEMAGLUTIDE?
SEMAGLUTIDE may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, SEMAGLUTIDE and medicines that work like SEMAGLUTIDE, caused thyroid tumors, including thyroid cancer. It is not known if SEMAGLUTIDE will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

• Do not use SEMAGLUTIDE if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

 

What is SEMAGLUTIDE?
SEMAGLUTIDE is a prescription medicine used along with diet and exercise to suppress appetite in adults.

• It is not known if SEMAGLUTIDE can be used in people who have had pancreatitis.

• SEMAGLUTIDE is not for use in patients with type 1 diabetes.

 

It is not known if SEMAGLUTIDE is safe and effective for use in children under 18 years of age.

 

Do not use SEMAGLUTIDE if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• you have had a serious allergic reaction to SEMAGLUTIDE or any of the ingredients in SEMAGLUTIDE. See the end of this Medication Guide for a complete list of ingredients in SEMAGLUTIDE.

Symptoms of a serious allergic reaction include:

• swelling of your face, lips, tongue or throat

• problems breathing or swallowing

• severe rash or itching

• fainting or feeling dizzy

• very rapid heartbeat

 

Before using SEMAGLUTIDE, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys.

• have a history of vision problems related to your diabetes.

• are pregnant or plan to become pregnant. It is not known if SEMAGLUTIDE will harm your unborn baby. You should stop using SEMAGLUTIDE two months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.

• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with SEMAGLUTIDE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEMAGLUTIDE may affect the way some medicines work and some medicines may affect the way SEMAGLUTIDE works. Before using SEMAGLUTIDE, tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.

 

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

 

How should I take SEMAGLUTIDE?
Take SEMAGLUTIDE exactly as your healthcare provider tells you to.

Take SEMAGLUTIDE on an empty stomach when you first wake up.

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1. Place SEMAGLUTIDE under the tongue and hold in your mouth for 5 minutes.

2. Swish, then swallow the SEMAGLUTIDE suspension.

3. After 30 minutes, you can eat, drink, or take other oral medicines.

 

If you miss a dose of SEMAGLUTIDE, skip the missed dose and go back to your regular schedule.

Your dose of SEMAGLUTIDE and other diabetes medicines may need to change because of: change in level of physical activity or
exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines
you take.

What are the possible side effects of SEMAGLUTIDE?
SEMAGLUTIDE may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using SEMAGLUTIDE and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

• changes in vision. Tell your healthcare provider if you have changes in vision during treatment with SEMAGLUTIDE.

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use SEMAGLUTIDE with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:

• dizziness or light-headedness

• blurred vision

• anxiety, irritability, or mood changes

• sweating

• slurred speech

• hunger

• confusion or drowsiness

• shakiness

• weakness

• headache

• fast heartbeat

• feeling jittery

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluid (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

• serious allergic reactions. Stop using SEMAGLUTIDE and get medical help right away, if you have any symptoms of a serious allergic reaction including:

  • swelling of your face, lips, tongue or throat

  • problems breathing or swallowing

  • severe rash or itching

  • fainting or feeling dizzy

  • very rapid heartbeat

  • gallbladder problems. Gallbladder problems have happened in some people who take SEMAGLUTIDE. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:

    • pain in your upper stomach (abdomen)

    • yellowing of skin or eyes (jaundice)

    • fever

    • clay-colored stools

The most common side effects of SEMAGLUTIDE may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start SEMAGLUTIDE. Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of SEMAGLUTIDE.

Call your doctor for medical advice about side effects.
 

How should I store SEMAGLUTIDE?
Store SEMAGLUTIDE at room temperature between 68°F and 77°F (20°C to 25°C).
Store in a dry place away from moisture.
Store suspension in the original closed SEMAGLUTIDE bottle until you are ready to take. Do not store in any other container.
Keep SEMAGLUTIDE and all medicines out of the reach of children.
 

General information about the safe and effective use of SEMAGLUTIDE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SEMAGLUTIDE for a condition for which it was not prescribed. Do not give SEMAGLUTIDE to other people, even if they have the same symptoms that you have. It may harm them.
 

What are the ingredients in SEMAGLUTIDE?
Active Ingredient: SEMAGLUTIDE
Inactive Ingredients: Sublingual anhydrous base, peppermint oil and spearmint oil