17.1 Medication Guide
Medication Guide
Methadone Hydrochloride Tablets USP, CII
Methadone hydrochloride tablets are:
- A strong prescription pain medicine that contains methadone, an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain.
- Used to manage drug addiction.
Important information about methadone hydrochloride tablets:
- Get emergency help right away if you take too many methadone hydrochloride tablets (overdose). Methadone hydrochloride tablets overdose can cause life-threatening breathing problems that can lead to death.
- Never give anyone else your methadone hydrochloride tablets. They could die from taking it. Store methadone hydrochloride tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away methadone hydrochloride tablets is against the law.
Do not take methadone hydrochloride tablets 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 tablets, tell your healthcare provider if you have a history of:
- head injury, seizures
- heart, liver, kidney, thyroid problems
- problems urinating
- 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. Methadone hydrochloride tablets may harm your unborn baby.
- breastfeeding. Methadone hydrochloride passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
When taking methadone hydrochloride tablets:
- Do not change your dose. Take methadone hydrochloride tablets exactly as prescribed by your healthcare provider.
- Do not take more than your prescribed dose in 24 hours. If you take methadone hydrochloride tablets for pain and miss a dose, take methadone hydrochloride tablets 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 tablets for opioid addiction, 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 hydrochloride builds up in your body over time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking methadone hydrochloride tablets without talking to your healthcare provider.
- After you stop taking methadone hydrochloride tablets, flush any unused tablets down the toilet.
While taking methadone hydrochloride tablets Do Not:
- Drive or operate heavy machinery, until you know how methadone hydrochloride tablets affect you. Methadone hydrochloride tablets can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
The possible side effects of methadone hydrochloride tablets are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness. 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, or you are feeling faint.
These are not all the possible side effects of methadone hydrochloride tablets. 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
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Issued 07/2012
Mallinckrodt