SOTYLIZE (Sotalol Hydrochloride) Solution [Arbor Pharmaceuticals, Inc.]

SOTYLIZE (so-tih-lize)
(sotalol hydrochloride)
oral solution

Read this Patient Information before you start taking SOTYLIZE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about SOTYLIZE?

SOTYLIZE contains sotalol. Sotalol can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, that can lead to death.

Treatment with SOTYLIZE must be started or re-started in a hospital. You must have continuous monitoring of the electrical activity of your heart by electrocardiogram (ECG) and tests of your kidney function for at least the first 3 days of treatment. This will allow your doctor to determine the right dose of SOTYLIZE for you. It is important that when you go home, you take the exact dose of SOTYLIZE that your doctor prescribes for you.

Your doctor will continue to do ECGs to monitor your heart and check your kidney function, and also check the levels of body salts (electrolyte) in your blood, as needed during treatment with SOTYLIZE.

Call your doctor right away if you have any of the following symptoms that may be signs of an irregular heartbeat:

• fainting
• dizziness
• fast heartbeat

What is SOTYLIZE?

SOTYLIZE is a prescription medicine used:

• to treat life-threatening heart rhythm problems called ventricular arrhythmias.
  Medicines used to treat life-threatening heartbeat problems may not help you live longer.
• to increase the amount of time between having symptoms of heart rhythm disorders called atrial fibrillation or atrial flutter

Who should not take SOTYLIZE?

Do not take SOTYLIZE if you:

• have a very slow heartbeat or certain heart conditions called sick sinus syndrome or heart block, and you do not have an implanted pacemaker
• have a heart problem called congenital long QT syndrome, or develop long QT syndrome
• have uncontrolled heart failure
• have certain kidney problems
• have been told by your doctor that you have a low level of potassium in your blood
• have asthma or other lung or breathing problems that cause shortness of breath or wheezing
• are allergic to sotalol

What should I tell my doctor before taking SOTYLIZE?

Before you take SOTYLIZE, tell your doctor if you:

• have had a severe allergic reaction to anything in the past. See "What are the possible side effects of SOTYLIZE?"
• have heart problems
• have kidney problems
• have asthma, or other lung or breathing problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if SOTYLIZE will harm your unborn baby. Talk to your doctor about if SOTYLIZE is right for you during pregnancy.
• are breastfeeding or plan to breastfeed. SOTYLIZE can pass into your milk and may harm your baby. You and your doctor should decide if you will take SOTYLIZE or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SOTYLIZE with other medicines can cause serious side effects. Tell your doctor if you take another medicine that contains sotalol. You should not take SOTYLIZE if you also take another medicine that contains sotalol.

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

How should I take SOTYLIZE?

• Take SOTYLIZE exactly as your doctor tells you to take it.
• Do not stop taking or change your dose of SOTYLIZE unless your doctor tells you to. If you stop taking SOTYLIZE suddenly, your heart problems may become worse.
• When it is time to stop taking SOTYLIZE, your doctor will give you instructions on how to slowly reduce your dose over a period of 1 to 2 weeks.
• Do not run out of your supply of SOTYLIZE. When you are discharged from the hospital after starting treatment with SOTYLIZE, it is important for you to have enough SOTYLIZE to take until you are able to fill your prescription for SOTYLIZE.
• If you miss a dose of SOTYLIZE, take your next dose at the usual time. Do not take 2 doses at the same time.
• It is important to accurately measure each SOTYLIZE dose. To measure the correct amount of SOTYLIZE to give, use an appropriate measuring device such as an oral syringe for children and infants. You can get oral syringes at your pharmacy. Do not use a teaspoon or tablespoon to measure SOTYLIZE doses since this may lead to confusion and the wrong dose.
• If you take an antacid medicine that contains aluminum oxide or magnesium hydroxide during treatment with SOTYLIZE, take the antacid at least 2 hours before or at least 2 hours after you take SOTYLIZE.
• If you overdose or take too much SOTYLIZE, take your SOTYLIZE medicine bottle with you and go to the nearest emergency room right away. Overdoses can potentially cause life-threatening abnormal heart beats and possibly death.

What are the possible side effects of SOTYLIZE?

SOTYLIZE can cause serious side effects, including:

• See "What is the most important information I should know about SOTYLIZE?"
• Slow heartbeat (bradycardia) is common with SOTYLIZE. A slow heartbeat increases your risk of developing a serious abnormal heartbeat. See "What is the most important information I should know about SOTYLIZE?" Your doctor will check you for this problem, especially if you take the medicine digoxin.
• New or worsening heart failure can happen in people who take SOTYLIZE. Symptoms of worsening heart failure include shortness of breath and fatigue. If these occur, contact your doctor.
• If you have diabetes, SOTYLIZE can make it more difficult for you to tell if you have low blood sugar (hypoglycemia). Certain important signs of low blood sugar, such as a fast heartbeat, may be hidden.
• If you have an overactive thyroid gland (hyperthyroidism), SOTYLIZE can make it more difficult for you to tell if you are having symptoms of too much thyroid hormone in your blood. Certain signs of having too much thyroid hormone in your blood, such as a fast heartbeat, may be hidden. If you stop taking SOTYLIZE suddenly, your symptoms of having too much thyroid hormone in your blood may become much worse, and could be life-threatening.
• Severe allergic reactions. People who have had severe allergic reactions in the past to other things may have a more severe allergic reaction when taking medicines like SOTYLIZE.
• Possible side effects to anesthesia. SOTYLIZE may cause severe low blood pressure and heart rhythm problems in people who receive anesthesia for major surgery. Tell your doctor that you are taking SOTYLIZE if you need to have surgery during treatment with SOTYLIZE.

The most common side effects of SOTYLIZE include:

• tiredness
• slow heart rate
• dizziness
• headache

Changes in the level of body salts (electrolytes) in your blood can lead to serious side effects during treatment with SOTYLIZE. Call your doctor if you have any of the following symptoms:

• severe diarrhea
• unusual sweating
• vomiting
• less appetite than normal
• increased thirst (drinking more than normal)

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SOTYLIZE. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SOTYLIZE?

• Store SOTYLIZE at room temperature between 68°F to 77°F (20°C to 25°C).

Keep SOTYLIZE and all medicines out of the reach of children.

General information about the safe and effective use of SOTYLIZE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOTYLIZE for a condition for which it was not prescribed. Do not give SOTYLIZE to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about SOTYLIZE that is written for health professionals.

For more information, go to www.SOTYLIZE.com or call 1-866-516-4950.

What are the ingredients in SOTYLIZE?

Active ingredient: sotalol hydrochloride

Inactive ingredients: sodium citrate, citric acid, sucralose, sodium benzoate, and purified water

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
arbor
PHARMACEUTICALS, LLC
Atlanta, GA 30328

Manufactured by:
Patheon Inc.
Whitby Region Operations
111 Consumers Drive
Whitby, ON L1N 5Z5 Canada

Distributed by: Arbor Pharmaceuticals, LLC, Atlanta, GA 30328

Issued: 07/2015

SOTYLIZE is a registered trademark of Arbor Pharmaceuticals, LLC
© 2015 Arbor Pharmaceuticals, LLC

SOT-PPI-02

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SOTYLIZE (Sotalol Hydrochloride) Solution [Arbor Pharmaceuticals, Inc.]