MEDICATION GUIDE

Tramadol Hydrochloride (tram a dol hye droe klor ide) Extended-Release Tablets, CIV

Tramadol hydrochloride extended-release tablet 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 (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 tramadol hydrochloride extended-release tablets:

·    Get emergency help right away if you take too much tramadol hydrochloride extended-release tablets (overdose). When you first start taking tramadol hydrochloride extended-release tablets, 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 tablets 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 tablets. They could die from taking it. Store tramadol hydrochloride extended-release tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away tramadol hydrochloride extended-release tablets is against the law.

Important Information Guiding Use in Pediatric Patients:

• Do not give tramadol hydrochloride extended-release tablets to a child younger than 12 years of age.
• Do not give tramadol hydrochloride extended-release tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving tramadol hydrochloride extended-release tablets 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 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 tramadol hydrochloride extended-release tablets, 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.

Tell your healthcare provider if you are:

·    pregnant or planning to become pregnant. Prolonged use of tramadol hydrochloride extended-release tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

·    breastfeeding. Not recommended; it may harm your baby.

·    taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol hydrochloride extended-release tablets with certain other medicines can cause serious side effects that could lead to death.

When taking tramadol hydrochloride extended-release tablets:

·    Do not change your dose. Take tramadol hydrochloride extended-release tablets 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 tablet whole. Do not cut, break, chew, crush, dissolve, snort, or inject tramadol hydrochloride extended-release tablet 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 tramadol hydrochloride extended-release tablets without talking to your healthcare provider.

·    After you stop taking tramadol hydrochloride extended-release tablets, dispose the unused tramadol hydrochloride extended-release tablets in accordance with the local state guidelines and/or regulations.

While taking tramadol hydrochloride extended-release tablets DO NOT:

· Drive or operate heavy machinery, until you know how tramadol hydrochloride extended-release tablets affect you. Tramadol hydrochloride extended-release tablets 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 tablets may cause you to overdose and die.

The possible side effects of tramadol hydrochloride extended-release tablets:

· 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 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 or call 1-800-818-4555.

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

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat, India.

ISS: 09/2017

PJPI0279F