Medication Guide
Tramadol Hydrochloride Extended-Release Capsules, CIV |
Tramadol Hydrochloride Extended-Release Capsules are:
- 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 (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.
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Important information about Tramadol Hydrochloride Extended-Release Capsules:
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Get emergency help right away if you take too much Tramadol Hydrochloride Extended-Release Capsules (overdose). When you first start taking Tramadol Hydrochloride Extended-Release Capsules, 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 Tramadol Hydrochloride Extended-Release Capsules 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 Tramadol Hydrochloride Extended-Release Capsules. They could die from taking it. Store Tramadol Hydrochloride Extended-Release Capsules away from children and in a safe place to prevent stealing or abuse. Selling or giving away Tramadol Hydrochloride Extended-Release Capsules are against the law.
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Important Information Guiding Use in Pediatric Patients:
- Do not give Tramadol Hydrochloride Extended-Release Capsules to a child younger than 12 years of age.
- Do not give Tramadol Hydrochloride Extended-Release Capsules to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
- Avoid giving Tramadol Hydrochloride Extended-Release Capsules to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not take Tramadol Hydrochloride Extended-Release Capsules if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
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| Before taking Tramadol Hydrochloride Extended-Release Capsules, tell your healthcare provider if you have a history of: |
| • head injury, seizures | • liver, kidney, thyroid problems |
| • problems urinating | • pancreas or gallbladder problems |
| • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
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Tell your healthcare provider if you are:
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pregnant or planning to become pregnant. Prolonged use of Tramadol Hydrochloride Extended-Release Capsules during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
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breastfeeding. Not recommended; it may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Tramadol Hydrochloride Extended-Release Capsules with certain other medicines can cause serious side effects that could lead to death.
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When taking Tramadol Hydrochloride Extended-Release Capsules:
- Do not change your dose. Take Tramadol Hydrochloride Extended-Release Capsules exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
- Swallow Tramadol Hydrochloride Extended-Release Capsules whole. Do not split, break, chew, crush, dissolve, snort, or inject Tramadol Hydrochloride Extended-Release Capsules because this may cause you to overdose and die.
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Call your healthcare provider if the dose you are taking does not control your pain.
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Do not stop taking Tramadol Hydrochloride Extended-Release Capsules without talking to your healthcare provider.
- After you stop taking Tramadol Hydrochloride Extended-Release Capsules, dispose the unused Tramadol Hydrochloride Extended-Release Capsules in accordance with the local state guidelines and/or regulations.
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While taking Tramadol Hydrochloride Extended-Release Capsules DO NOT:
- Drive or operate heavy machinery, until you know how Tramadol Hydrochloride Extended-Release Capsules affects you. Tramadol Hydrochloride Extended-Release Capsules 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 Tramadol Hydrochloride Extended-Release Capsules may cause you to overdose and die.
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The possible side effects of Tramadol Hydrochloride Extended-Release Capsules:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure. 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 Tramadol Hydrochloride Extended-Release Capsules. Call your doctor for medical advice about side effects. You may report side effects to SA3, LLC at Vertical Pharmaceuticals, LLC at (877) 958-3784 or FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured for: SA3, LLC, Los Angeles, CA 90064 USA, call 1-877-958-3784 |