Patient information: uses, side effects, how to take - Atoncy

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

ATONCY can cause serious side effects, including:

Suicidal thoughts and actions in children 6 years of age and older.ATONCY increases the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.
How can I watch for and try to prevent suicidal thoughts and actions?
- Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when ATONCY is started or when the dose is changed.
- Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns.

Tell your healthcare provider right away if any of the following symptoms develop during treatment, especially if they are new, worse, or worry you:

anxiety
trouble sleeping
acting aggressive
extreme increase in activity or talking (mania)
unusual decrease in activity (hypomania)

feeling agitated or restless
irritability
impulsivity
depression
panic attacks
restlessness or feeling like you have to move

panic attacks
hostility or being angry or violent
suicide attempts
thoughts about suicide or dying
other unusual changes in mood or behavior

See “What are the possible side effects of ATONCY?”for more information about side effects.

What is ATONCY?

ATONCY is a prescription medicine used to treat ADHD in adults and children 6 years of age and older. ATONCY may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

ATONCY should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

It is not known if ATONCY is safe and effective in children less than 6 years old.

Who should not take ATONCY?

Do not take ATONCY if you or your child:

are allergic to atomoxetine or any of the ingredients in ATONCY. See the end of this Medication Guide for a complete list of ingredients in ATONCY.
are taking or have stopped taking within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI).
have an eye problem called narrow angle glaucoma.
have or had a rare tumor called pheochromocytoma.
have severe heart or blood vessel problems that could get worse if your blood pressure or heart rate increases.

Before taking ATONCY, tell your healthcare provider about all medical conditions, including if you or your child:

have, or have a family history of, suicide thoughts or attempts, bipolar disorder, depression, mania, or hypomania.
have liver problems.
have, or have a family history of, heart problems, heart defects, irregular heartbeat, or sudden death.
have high blood pressure or low blood pressure.
have problems urinating such as trouble starting urination, weak stream, or not fully emptying the bladder.
have glaucoma.
are pregnant or plan to become pregnant. It is not known if ATONCY will harm the unborn baby.
- Tell your healthcare provider right away if you or your child become pregnant or plan to become pregnant during treatment with ATONCY.
- There is a pregnancy exposure registry for women who are exposed to ADHD medicines, including ATONCY, during pregnancy. The purpose of the registry is to collect information about the health of women exposed to ATONCY and their baby. If you or your child become pregnant during treatment with ATONCY, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/ .
are breastfeeding or plan to breastfeed. It is not known if ATONCY passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with ATONCY.

Tell your healthcare provider about all the medicines that you or your child take including prescription and over-the-counter medicines, vitamins, and herbal supplements.ATONCY and some medicines may interact with each other and cause serious side effects. Your healthcare provider will decide whether ATONCY can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

a MAOI, including linezolid and intravenous methylene blue
medicines that increase or decrease blood pressure
asthma medicines

Know the medicines that you or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. Do not start any new medicines during treatment with ATONCY without talking to your healthcare provider first.

How should I take ATONCY?

Take ATONCY exactly as your healthcare provider tells you. Your healthcare provider may adjust the dose until it is right for you or your child.
See the detailed “ Instructions for Use” for more information on how to prepare and take ATONCY.
Take ATONCY with or without food.
ATONCY is usually taken 1 time a day in the morning or 2 times a day, in the morning and in the late afternoon or early evening.
If you miss a dose of ATONCY, take the dose as soon as possible. Do not take more ATONCY than your healthcare provider prescribes in a 24-hour period.
Use only the oral dosing syringe and bottle adapter that come with ATONCY to measure and take the dose.
If you take too much ATONCY, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking ATONCY?

Do notdrive or operate heavy machinery until you know how ATONCY affects you. ATONCY can cause sleepiness.
Do notget ATONCY in or near the eyes. ATONCY can irritate the eyes. If ATONCY gets into the eyes, rinse them with water right away and tell your healthcare provider. Avoid touching ATONCY. Wash your hands and any surfaces that ATONCY comes in contact with as soon as possible.

What are possible side effects of ATONCY?

ATONCYcan cause serious side effects, including:

See “What is the most important information I should know about ATONCY?”
Severe liver damage. Your healthcare provider will check the blood levels of liver enzymes if symptoms of liver damage develop. Tell your healthcare provider right away if any of the following symptoms develop at any time during treatment:

itching
the skin or the white part of the eyes turns yellow

right upper stomach pain
unexplained flu-like symptoms

dark urine

Serious heart-related side effects.ATONCY may increase the risk of serious heart problems including sudden death, heart attack, and stroke in adults and children who have serious heart problems or heart defects. Your healthcare provider should check for heart problems before starting treatment with ATONCY. Stop taking ATONCY and tell your healthcare provider or get medical help right away if any of the following symptoms develop during treatment:

chest pain
loss of consciousness (fainting)
shortness of breath
heart palpitations or fast heart rate

numbness of weakness, especially on one side of the body
slurred speech
vision changes
severe headache

Increases in blood pressure and heart rate.Your healthcare provider should check blood pressure and heart rate before starting treatment, if the dose is increased, and as needed during treatment.
New psychotic problems, manic symptoms, or mania episodes.People with bipolar disorder, or who have a higher risk of developing bipolar disorder, have an increased risk of developing mania. Tell your healthcare provider if any of the following symptoms develop during treatment:

greatly increased energy
racing thoughts
unusually grand ideas
talking more or faster than usual
unusual decrease in activity

severe trouble sleeping
reckless behavior
excessive happiness or irritability
seeing or hearing things that are not real (hallucinations)
depression

Aggressive behavior or hostility.New or worsening aggressive behavior or hostility can happen during treatment.
Allergic reactions.Tell your healthcare provider right away if trouble breathing, hives, rash, or swelling of the face, eyes, lips, or throat develop during treatment.
Problems with urination.ATONCY may cause problems with urination including decreased urine flow or trouble starting urination (urinary hesitation) or being unable to pass any urine (urinary retention). Tell your healthcare provider if any problems with urination develop during treatment.
Painful and prolonged erections (priapism).Priapism has happened in male children and adults who take atomoxetine medicines. Priapism is a serious problem that can cause lasting damage to the penis and may require surgery. Tell your healthcare provider and get medical help right away if priapism develops during treatment.
Effect on growth (height and weight) in children.Children should have their height and weight checked often during treatment.

The most common side effects of ATONCY in children include:

nausea
vomiting
tiredness

decreased appetite
stomach (abdominal) pain
sleepiness

The most common side effects of ATONCY in adults include:

constipation
dry mouth
nausea
decreased appetite

dizziness
erectile dysfunction
urinary hesitation

ATONCY may cause sexual problems (dysfunction).Talk to your healthcare provider if any of the following symptoms develop during treatment:

Symptoms in males may include:

delayed ejaculation or inability to have an ejaculation
decreased sex drive
problems getting or keeping an erection

Symptoms in females may include:

decreased sex drive
delayed orgasm or inability to have an orgasm

Your healthcare provider may stop ATONCY treatment if serious side effects develop during treatment.

These are not all of the possible side effects of ATONCY. 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 ATONCY?

Store ATONCY at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused ATONCY 45 days after first opening the bottle. Write the discard date in the space provided on the bottle and carton.

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

General information about the safe and effective use of ATONCY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ATONCY for a condition for which it was not prescribed. Do not give ATONCY to other people, even if they have the same condition. It may harm them. You can ask your pharmacist or healthcare provider for information about ATONCY that is written for health professionals.

What are the ingredients in ATONCY?

Active ingredient: atomoxetine hydrochloride

Inactive ingredients:grape flavor, maltitol solution, monobasic sodium phosphate, phosphoric acid, purified water, sodium benzoate, sodium hydroxide, sorbitol crystallizing solution, sucralose, and xylitol

Manufactured by:

Rubicon Research Limited,

Satara, 415004, India

Distributed by:

Validus Pharmaceuticals LLC

Parsippany, NJ 07054

www.validuspharma.com

For more information about ATONCY call Validus Pharmaceutical at 1-866-982-5438.

This Medication Guide has been approved by the US Food and Drug Administration. Issued: 3/2026

INSTRUCTIONS FOR USE ATONCYTM (ah TON see) (atomoxetine) oral solution
This Instructions for Use contains information on how to take ATONCY. Important Information You Need to Know Before Taking ATONCY: Read these instructions carefully to learn how to prepare and take ATONCY the right way. ATONCY is for oral use only (taken by mouth). Take ATONCY with or without food. Use only the oral dosing syringe and bottle adapter that come with ATONCY to measure and take a dose of the medicine. Do not get ATONCY in or near the eyes. If ATONCY gets into the eyes, rinse them with water right away and tell the healthcare provider. Check the expiration date on the ATONCY bottle and carton. Do not take ATONCY after the expiration date has passed. Throw away (discard) any unused ATONCY 45 days after first opening the bottle. Write the discard date in the space provided on the bottle and carton. See “ Disposing of ATONCY.” Storing ATONCY Store ATONCY at room temperature between 68°F to 77°F (20°C to 25°C). Keep the child-resistant cap tightly closed. Keep ATONCY and all medicines out of the reach of children.
	Supplies included in the ATONCY Carton
		A press-in bottle adapterthat you push into the neck of the bottle. After it is inserted, the bottle adapter must always stay in the bottle. A bottlecontaining medicine, with a child-resistant cap. Always put the child-resistant cap back on the bottle and close it tightly after use. A 10 milliliter (mL) oral dosing syringethat fits into the bottle adapter to withdraw and measure the prescribed dose of medicine from the bottle.
	Hand Washing
		Wash and dry your hands. Remove the ATONCY bottle and bottle adapter from the carton. Tell your pharmacist right away if you are missing supplies from the carton.
	Step 1: Preparing the Bottle
		Remove the child-resistant cap by pushing it firmlydown and turning it to the left (counterclockwise) as shown on the top of the child-resistant cap. Note:Save the child-resistant cap so you can close the bottle after each use. Hold the open bottle upright on a table and push the bottle adapter firmlyinto the neck of the bottle as far as you can. Put the child-resistant cap back on the bottle and close it tightly by turning it to the right (clockwise) to make sure that the bottle adapter has been fully forced into the neck of the bottle. Note: You may not be able to push the bottle adapter fully down, but it will be forced into the bottle when you screw the child-resistant cap back on. Now the bottle is ready to use with the syringe. The bottle adapter must always stay in the bottle. Do notremove the bottle adapter. The child-resistant cap should seal the bottle in between use.
	Step 2: Measuring the Dose of ATONCY
		Push and turn the child-resistant cap counterclockwise to open the bottle. Note: Always put the child-resistant cap tightly back on the bottle after use.
		Check that the plunger is pushed all the way down inside the barrel of the syringe. Keep the bottle upright and push the tip of the syringe firmlyinto the hole in the bottle adapter.
	Step 3:
		Hold the syringe in place and carefully turn the bottle upside down. Check the oral dosing syringe to find the right dose in milliliters (mL) that has been prescribed by the healthcare provider. Slowly pull the plunger out to fill the oral dosing syringe so that the top edge of the plunger is slightly past the prescribed dose line to help remove any air bubbles.
	Step 4:
		Tap the syringe barrel to move air bubbles to the top. Doing this helps set the correct dose. Push the plunger down slowly just far enough to completely push out any large or small air bubbles that may be trapped in the syringe.
	Step 5:
		Slowly pull the plunger out until the top edge of the plunger is exactly level with the marker on the syringe barrel for the prescribed dose. See the Figure for an example of a dose of 2.5 mL. The prescribed dose may be different. Note:If the prescribed dose is more than 10 mL, you will need to repeat steps 2 through 7 to refill the syringe and to take the full dose. Ask your pharmacist or healthcare provider to show you how to measure the dose if you are not sure.
	Step 6:
		Carefully turn the bottle upright. Place the bottle on the table. Take out the syringe by gently twisting it out of the bottle adapter. The bottle adapter should stay in the bottle. Check that the correct dose in mL is in the oral dosing syringe. If the correct dose is not in the oral dosing syringe: Put the tip of the syringe back into the bottle adapter and push the plunger to the bottom of the barrel to empty the contents of the syringe. Repeat steps 2 through 6.
	Step 7: Taking the dose of ATONCY
		Important: Sit in an upright position when taking ATONCY. Place the oral dosing syringe gently into the mouth and close the mouth tightly around the barrel of the syringe. Push the plunger down slowlyto make sure that all the medicine is swallowed. Check to make sure that there is no medicine left in the oral dosing syringe. If the prescribed dose is more than 10 mL, repeat steps 2 through 7. Put the child-resistant cap tightly back on the bottle to close the bottle after use.
	Step 8: Cleaning up After the dose of medicine is taken, rinse the syringe with warm water and allow it to dry thoroughly before you use it again. After touching ATONCY, wash your hands and any surfaces that ATONCY comes in contact with as soon as possible. Step 9: Disposing of ATONCY Throw away any unused ATONCY 45 days after first opening the bottle. Throw away medicine that is expired or no longer needed. Manufactured by: Rubicon Research Limited, Satara, 415004, India. Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued 3/2026