HYDROMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride suppository 
Padagis US LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Medication Guide

Hydromorphone Hydrochloride (hy-dro-MOR-fone hy-dro-KLOR-id) Suppositories, CII

Hydromorphone hydrochloride suppositories are:

Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
Opioid pain medicines that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about hydromorphone hydrochloride suppositories:

Get emergency help right away if you take too much hydromorphone hydrochloride suppositories (overdose). When you first start taking hydromorphone hydrochloride suppositories, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking hydromorphone hydrochloride suppositories with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your hydromorphone hydrochloride suppositories. They could die from taking it. Store hydromorphone hydrochloride suppositories away from children and in a safe place to prevent stealing or abuse. Selling or giving away hydromorphone hydrochloride suppositories is against the law.
Store hydromorphone hydrochloride suppositories securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take hydromorphone hydrochloride suppositories if you have:

severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.

Before taking hydromorphone hydrochloride suppositories, tell your healthcare provider if you have a history of:

head injury, seizures
problems urinating
liver, kidney, thyroid problems
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

Pregnant or planning to become pregnant. Prolonged use of hydromorphone hydrochloride suppositories during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Breastfeeding. Hydromorphone hydrochloride passes into breast milk and may harm your baby.
Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydromorphone hydrochloride with certain other medicines can cause serious side effects that could lead to death.

When taking hydromorphone hydrochloride:

Do not change your dose. Take hydromorphone hydrochloride exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking hydromorphone hydrochloride suppositories regularly, do not stop taking hydromorphone hydrochloride suppositories without talking to your healthcare provider.
Dispose of expired, unwanted, or unused hydromorphone hydrochloride suppositories by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking hydromorphone hydrochloride DO NOT:

Drive or operate heavy machinery, until you know how hydromorphone hydrochloride suppositories affects you. Hydromorphone hydrochloride can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydromorphone hydrochloride suppositories may cause you to overdose and die.

The possible side effects of hydromorphone hydrochloride suppositories:

constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of hydromorphone hydrochloride suppositories. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by: Perrigo, Minneapolis, MN 55427, www.perrigorx.com or call 1-866-634-9120

Issued: 03/2020

Revised: 12/2021
Padagis US LLC