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Ralivia (tramadol HCl) is an extended-release oral tablet that slowly releases tramadol (an opioid analgesic) over a 24-hour period to manage continuous pain that is expected to persist for several days or more.

Ralivia (tramadol hydrochloride) is indicated for the management of pain of moderate severity in adults who require continuous treatment for several days or more. Ralivia (Tramadol HCl) is the brand name for once-daily extended-release tablets of a medication called tramadol. Ralivia (Tramadol HCl) belongs to a class of pain medications known as opioids. Unlike other opioids, it also changes the level of two chemicals in the brain: norepinephrine and serotonin. Changes in the amounts of these two chemicals can also provide pain relief. Ralivia (Tramadol HCl) is different from other pain medications,

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. It has no association with heart disease or stomach ulcers,

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.

Do not take Ralivia (Tramadol HCl) if:

1. your doctor did not prescribe it for you
2,

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. you are allergic to tramadol, opioids or any other ingredient in the tablets
3,

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. you are consuming large amounts of alcohol or taking excessive amounts of other drugs that can depress respiration/breathing and consciousness
4. you are taking, or have taken within the past three weeks, a monoamine oxidase inhibitor medication (e.g.,

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,
Nardil®, Parnate®)
5. you have kidney or liver disease

Ralivia (Tramadol HCl) should not be used for minor pain that can be relieved by available (over-the-counter) pain killers.

Children under 18 years of age should not take Ralivia (Tramadol HCl) tablets.

Use of Ralivia (Tramadol HCl) tablets in pregnant women is not recommended.

If you have had seizures (convulsions) or have a condition that may put you at increased risk of seizures (epilepsy, head injury,

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,
metabolic disorders, alcohol or drug withdrawal), taking monoamine oxidase inhibitors, infection of the central nervous system (brain and spine),

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,
or are taking antidepressant medication, do not take Ralivia (Tramadol HCl) before discussing your history with your doctor.

Remember that Ralivia (Tramadol HCl) may be habit forming. Tell your doctor and pharmacist if you have a history of substance abuse or addiction.

Medicinal ingredient of Ralivia Extended Release Tablets:

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,

Tramadol hydrochloride

Unsafe Raliva & Tramadol interactions:

Drugs that may interact with RALIVIA include:

alcohol or other sedative drugs may enhance the drowsiness caused by tramadol;

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;

carbamazepine (Tegretol®) may increase the metabolism of tramadol and reduce the analgesic effect
tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), antipsychotics used concomitantly can lower the seizure threshold
protease inhibitors (e.g., ritonavir) co-administration may increase the blood levels of tramadol
- digoxin (Lanoxin®), warfarin or warfarin-like medications -rare reports of toxicity have been reported when taken with tramadol

Symptoms or Signs of Ralivia/Tramadol Overdose:

The most important sign of overdose is decreased breathing (abnormally slow or weak breathing),

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or extreme drowsiness. If you accidentally take an overdose of RALIVIA, contact your doctor and/or the nearest hospital and/or Emergency Room and/or Poison Control Centre immediately, even though you may not feel sick,

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.

Raliva (Tramadol) Side Effects include dizziness, nausea, constipation and headache.



Generic Name: Tramadol Tablets (TRA-ma-dole)
Brand Name: Ultram

Tramadol hydrochloride tablets helps relieve different types of pain. Tramadol is the Generic form of Ultram. ULTRAN ® (tranadol hydrochloride tablets) is a prescription medication indicated for the management of moderate to moderately severe pain.

ULTRAM received U.S. Food and Drug Administration (FDA) approval in March, 1995. Tramadol has been prescribed to more than 55 million patients worldwide and ULTRAM has been prescribed to more than 21 million patients in the United States alone.

Tramadol is used for:

Treating moderate to moderately severe pain.
Tramadol is an analgesic,

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. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tramadol if:

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; you are allergic to any ingredient in Tramadol

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;
you have severe diarrhea due to taking an antibiotic

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;
you are intoxicated with alcohol, other opioids or narcotics (eg,

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,
morphine, codeine), sedatives or sleeping medicines (eg, temazepam, zolpidem), or other medicines

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;
you are taking nefazodone, carbamazepine, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tramadol:

Some medical conditions may interact with Tramadol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to codeine, a codeine-related medicine (eg, hydrocodone, dihydrocodeine, oxycodone), morphine,

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, or a morphine-related medicine (eg, hydromorphone)
• if you have a history of alcohol abuse, substance abuse, or suicidal thoughts or behaviors
• if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
• if you have a history of stomach or intestinal problems, asthma or other lung or breathing problems, epilepsy, seizures, or chronic inflammation or ulceration of the bowels
• if you have had recent abdominal surgery
• if you have heart problems,

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,
liver problems (eg,

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,
hepatitis), kidney problems, thyroid problems, enlargement of the prostate gland, or urinary problems

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tramadol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tramadol:

Use Tramadol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tramadol by mouth with or without food.
• If you miss a dose of Tramadol , take it as soon as possible,

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. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions that you may have about how to use Tramadol.

Important Safety Information:

• Tramadol may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tramadol with caution,

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. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

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; Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tramadol ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

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; Tramadol may cause dizziness; alcohol,

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,
hot weather, exercise,

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,
or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.

• Tell your doctor or dentist that you take Tramadol before you receive any medical or dental care, emergency care, or surgery.

• Use Tramadol with caution in the ELDERLY; they may be more sensitive to its effects.

• Tramadol should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.

• PREGNANCY and BREAST-FEEDING: Tramadol has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tramadol while you are pregnant. Tramadol is found in breast milk. Do not breast-feed while taking Tramadol.

When used for long periods of time or at high doses, Tramadol may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tramadol stops working well,

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. Do not take more than prescribed.

Some people who use Tramadol for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Tramadol ,

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,
you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing,

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hearing or feeling things that are not there;

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;
shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Tramadol:

All medicines may cause side effects, but many people have no,

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, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation;

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;
diarrhea;

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;
dizziness; drowsiness; increased sweating; loss of appetite; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; fainting; fever; incoordination; muscle stiffness or tremor; seizures.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider.

Proper storage of Tramadol:

Store Tramadol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light,

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. Do not store in the bathroom,

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. Keep Tramadol out of the reach of children and away from pets.

General Information:

• If you have any questions about Tramadol , please talk with your doctor, pharmacist, or other health care provider.
• Tramadol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only,

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. It does not contain all information about Tramadol. If you have questions about the medicine you are taking or would like more information,

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,
check with your doctor, pharmacist, or other health care provider.

This information is a summary only,

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. It does not contain all information about Tramadol. If you have questions about the medicine you are taking or would like more information,

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,
check with your doctor, pharmacist, or other health care provider.




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