METHADONE HYDROCHLORIDE- methadone hydrochloride concentrate 
West-Ward Pharmaceuticals Corp.

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MEDICATION GUIDE

Methadone Hydrochloride

Intensol™, CII

(Oral Concentrate USP)

(METH a done)

Rx Only

Methadone hydrochloride oral concentrate is:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting opioid pain medicine 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.
Not for use to treat pain that is not around-the-clock.
Also used to manage drug addiction.

Important information about methadone hydrochloride oral concentrate:

Get emergency help right away if you take too much methadone hydrochloride oral concentrate (overdose). When you first start taking methadone hydrochloride oral concentrate, 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.
Never give anyone your methadone hydrochloride oral concentrate. They could die from taking it. Store methadone hydrochloride oral concentrate away from children and in a safe place to prevent stealing or abuse. Selling or giving away methadone hydrochloride oral concentrate is against the law.

Do not take methadone hydrochloride oral concentrate if you have:

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

Before taking methadone hydrochloride oral concentrate, tell your healthcare provider if you have a history of:

head injury, seizures
liver, kidney, thyroid problems
problems urinating
heart rhythm problems (Long QT syndrome)
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 methadone hydrochloride oral concentrate during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Methadone passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking methadone hydrochloride oral concentrate with certain other medicines may cause serious side effects.

When taking methadone hydrochloride oral concentrate:

Do not change your dose. Take methadone hydrochloride oral concentrate exactly as prescribed by your healthcare provider.
Do not take more than your prescribed dose in 24 hours. If you take methadone hydrochloride oral concentrate for pain and miss a dose, take methadone hydrochloride oral concentrate as soon as possible and then take your next dose 8 or 12 hours later as directed by your healthcare provider. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you take methadone hydrochloride oral concentrate for opioid addiction and miss a dose, take your next dose the following day as scheduled. Do not take extra doses. Taking more than the prescribed dose may cause you to overdose because methadone builds up in your body over time.
Do not dissolve, snort or inject methadone hydrochloride oral concentrate because this may cause you to overdose and die.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking methadone hydrochloride oral concentrate without talking to your healthcare provider.
After you stop taking methadone hydrochloride oral concentrate, flush any unused methadone hydrochloride oral concentrate down the toilet.

While taking methadone hydrochloride oral concentrate DO NOT:

Drive or operate heavy machinery, until you know how methadone hydrochloride oral concentrate affects you. Methadone hydrochloride oral concentrate 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 methadone hydrochloride oral concentrate may cause you to overdose and die.

The possible side effects of methadone hydrochloride oral concentrate are:

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, or you are feeling faint.

These are not all the possible side effects of methadone hydrochloride oral concentrate. 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.

Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, or call 1-800-962-8364

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

4056351//11

Issue: April 2014

Revised: 9/2016
West-Ward Pharmaceuticals Corp.