"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(hydromorphone hydrochloride) Extended-release capsules
- 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, in people who are already regularly using opioid pain medicine, 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 (extended-release) 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.
Important information about PALLADONE:
- Get emergency help right away if you take too much PALLADONE (overdose). When you first start taking PALLADONE, 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 PALLADONE. They could die from taking it. Store PALLADONE away from children and in a safe place to prevent stealing or abuse. Selling or giving away PALLADONE is against the law.
Do not take PALLADONE if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking PALLADONE, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- allergy to sulfites
- 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. Prolonged use of PALLADONE during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. PALLADONE passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking PALLADONE with certain other medicines can cause serious side effects.
When taking PALLADONE:
- Do not change your dose. Take PALLADONE exactly as prescribed by your healthcare provider.
- Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
- Swallow PALLADONE whole. Do not cut, break, chew, crush, dissolve, snort, or inject PALLADONE 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 PALLADONE without talking to your healthcare provider.
- After you stop taking PALLADONE, flush any unused tablets down the toilet.
While taking PALLADONE DO NOT:
- Drive or operate heavy machinery until you know how PALLADONE affects you. PALLADONE can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with PALLADONE may cause you to overdose and die.
The possible side effects of PALLADONE 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 PALLADONE. 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
Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Palladone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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