MEDICATION GUIDE

Who should not take methamphetamine hydrochloride tablets?

Methamphetamine hydrochloride tablets 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 agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
• are sensitive to, allergic to, or had a reaction to other stimulant medicines

Methamphetamine hydrochloride tablets are not recommended for use in children less than 6 years old in the treatment of ADHD.

Methamphetamine hydrochloride tablets may not be right for you or your child. Before starting methamphetamine hydrochloride tablets tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• thyroid problems
• diabetes
• seizures or have had an abnormal brain wave test (EEG)
• circulation problems in fingers and toes

Tell your or your child's doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can methamphetamine hydrochloride tablets be taken with other medicines?

Tell your or your child's doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Methamphetamine hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methamphetamine hydrochloride tablets.

Your or your child's doctor will decide whether methamphetamine hydrochloride tablets can be taken with other medicines.

Especially tell your or your child's doctor if you or your child takes:

• anti-depression medicines including MAOIs
• anti-psychotic medicines
• blood pressure medicines
• insulin
• seizure medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking methamphetamine hydrochloride tablets without talking to your or your child's doctor first.

How should methamphetamine hydrochloride tablets be taken?

• Take methamphetamine hydrochloride tablets exactly as prescribed.Your or your child's doctor may adjust the dose until it is right for you or your child.
• Methamphetamine hydrochloride tablets are usually taken 1 or 2 times each day.
• From time to time, your or your child's doctor may stop methamphetamine hydrochloride tablets treatment for a while to check ADHD symptoms.
• Your or your child's doctor may do regular checks of the blood, heart, and blood pressure while taking methamphetamine hydrochloride tablets. Children should have their height and weight checked often while taking methamphetamine hydrochloride tablets. Methamphetamine hydrochloride tablets treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much methamphetamine hydrochloride tablets or overdoses, call your or your child's doctor or poison control center right away, or get emergency treatment.

What are possible side effects of methamphetamine hydrochloride tablets?

See " What is the most important information I should know about methamphetamine hydrochloride tablets?" for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

fast heart beat tremors trouble sleeping stomach upset dry mouth

decreased appetite headache dizziness weight loss

Methamphetamine hydrochloride tablets may affect your or your child's ability to drive or do other dangerous activities.

Talk to your or your child's doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects.

Ask your or your child's doctor or pharmacist for more information.

Call your or your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Mayne Pharma at 1-844-825-8500.

How should I store methamphetamine hydrochloride tablets?

• Store methamphetamine hydrochloride tablets in a safe place. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
• Keep methamphetamine hydrochloride tablets and all medicines out of the reach of children.

General information about methamphetamine hydrochloride tablets:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methamphetamine hydrochloride tablets for a condition for which it was not prescribed. Do not give methamphetamine hydrochloride tablets to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about methamphetamine hydrochloride tablets. If you would like more information, talk with your or your child's doctor. You can ask your or your child's doctor or pharmacist for information about methamphetamine hydrochloride tablets that was written for healthcare professionals.

For more information about methamphetamine hydrochloride tablets, contact Mayne Pharma at 1-844-825-8500.

What are the ingredients in methamphetamine hydrochloride tablets?

Active Ingredient:methamphetamine hydrochloride, USP

Inactive Ingredients:Corn starch, lactose monohydrate, stearic acid and talc

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guides available at products.maynepharma.com or call 1-844-825-8500.

Manufactured by:
Mayne Pharma
Greenville, NC 27834

61169
Rev. 03/2022