⢠stroke and heart attack in adults
⢠increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting Mixed Salts of a Single Entity Amphetamine Product.
Your doctor should check your or your childâs blood pressure and heart rate regularly during treatment with Mixed Salts of a Single Entity Amphetamine Product.
Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Mixed Salts of a Single Entity Amphetamine Product.
2. Mental (Psychiatric) Problems:
All Patients
⢠new or worse behavior and thought problems
⢠new or worse bipolar illness
⢠new or worse aggressive behavior or hostility
Children and Teenagers
⢠new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Mixed Salts of a Single Entity Amphetamine Product, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
3. Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaudâs Phenomenon]:
Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Mixed Salts of a Single Entity Amphetamine Product.
What are Mixed Salts of a Single Entity Amphetamine Product?
Mixed Salts of a Single Entity Amphetamine Product are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder(ADHD). Mixed Salts of a Single Entity Amphetamine Product may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Mixed Salts of a Single Entity Amphetamine Product should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Mixed Salts of a Single Entity Amphetamine Product are also used in the treatment of a sleep disorder called narcolepsy.
Mixed Salts of a Single Entity Amphetamine Product are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Mixed Salts of a Single Entity Amphetamine Product in a safe place to prevent misuse and abuse. Selling or giving away Mixed Salts of a Single Entity Amphetamine Product may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Mixed Salts of a Single Entity Amphetamine Product?
Mixed Salts of a Single Entity Amphetamine Product should not be taken if you or your child:
⢠have heart disease or hardening of the arteries
⢠have moderate to severe high blood pressure
⢠have hyperthyroidism
⢠have an eye problem called glaucoma
⢠are very anxious, tense, or agitated
⢠have a history of drug abuse
⢠are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
⢠are sensitive to, allergic to, or had a reaction to other stimulant medicines
Mixed Salts of a Single Entity Amphetamine Product
Mixed Salts of a Single Entity Amphetamine Product may not be right for you or your child. Before starting Mixed Salts of a Single Entity Amphetamine Product tell your or your childâs doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child are pregnant, planning to become pregnant, or breastfeeding.
Can Mixed Salts of a Single Entity Amphetamine Product be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Mixed Salts of a Single Entity Amphetamine Product
Sometimes the doses of other medicines will need to be adjusted while taking Mixed Salts of a Single Entity Amphetamine Product.
Your doctor will decide whether Mixed Salts of a Single Entity Amphetamine Product can be taken with other medicines.
Especially tell your doctor if you or your child take:
Know the medicines that you or your child take. Keep a ul of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Mixed Salts of a Single Entity Amphetamine Product without talking to your doctor first.
How should Mixed Salts of a Single Entity Amphetamine Product be taken?
What are possible side effects of Mixed Salts of a Single Entity Amphetamine Product?
See âWhat is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product?â for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Mixed Salts of a Single Entity Amphetamine Product may affect you or your childâs ability to drive or do other dangerous activities.
Talk to your doctor if you or your child have side effects that are bothersome or do not go away.
This is not a complete ul of possible side effects. Ask your doctor or pharmacist for more information.
How should I store Mixed Salts of a Single Entity Amphetamine Product?
General information about Mixed Salts of a Single Entity Amphetamine Product.
Medicines are sometimes prescribed for purposes other than those uled in a Medication Guide. Do not use Mixed Salts of a Single Entity Amphetamine Product
This Medication Guide summarizes the most important information about Mixed Salts of a Single Entity Amphetamine Product. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Mixed Salts of a Single Entity Amphetamine Product that was written for healthcare professionals. For additional information on Mixed Salts of a Single Entity Amphetamine Product, please contact Sandoz Inc. at 1-800-525-8747.
What are the ingredients in Mixed Salts of a Single Entity Amphetamine Product?
Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate USP, amphetamine sulfate USP
Inactive Ingredients: lactose monohydrate, pregelatinized starch (corn) and magnesium stearate.Â
In addition the 5 mg and 10 mg tablets contain FD&C blue No. 1 aluminum lake and the 20 mg and 30 mg tablets contain FD&C yellow No. 6 aluminum lake as color additives.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured for
Sandoz Inc.
Princeton, NJ 08540
Manufactured by
Epic Pharma, LLC
Laurelton, NY 11413
OS7848
REV. 04/17
MF0084REV04/17