FusePaq Synapryn

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach fullness
• abnormal or decreased touch sensation
• blisters under the skin
• bloating
• blood in the urine
• blood pressure increased
• blurred vision
• change in walking and balance
• chest pain or discomfort
• chills
• convulsions (seizures)
• darkened urine
• difficult urination
• dizziness or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• frequent urge to urinate
• gaseous abdominal or stomach pain
• indigestion
• irregular heartbeat
• loss of memory
• numbness and tingling of the face, fingers, or toes
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale bluish-colored or cold hands or feet
• recurrent fever
• seeing, hearing, or feeling things that are not there
• severe cramping
• severe nausea
• severe redness, swelling, and itching of the skin
• sweats
• trembling and shaking of the hands or feet
• trouble performing routine tasks
• weak or absent pulses in the legs
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Change in consciousness
• decreased awareness or responsiveness
• difficulty with breathing
• lack of muscle tone
• lightheadedness
• loss of consciousness
• pinpointed pupils of the eyes
• severe sleepiness
• slow or irregular heartbeat
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• agitation
• constipation
• cough
• diarrhea
• discouragement
• drowsiness
• dry mouth
• feeling of warmth
• feeling sad or empty
• feeling unusually cold
• fever
• general feeling of discomfort or illness
• headache
• heartburn
• irritability
• itching or skin rash
• joint pain
• loss of appetite
• loss of interest or pleasure
• loss of strength or weakness
• muscle aches and pains
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• runny nose
• shivering
• sleepiness or unusual drowsiness
• sore throat
• stuffy nose
• sweating
• tiredness
• trouble concentrating
• unusual feeling of excitement
• weakness

• Abnormal dreams
• appetite decreased
• back pain
• bladder pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• body aches or pain
• change in hearing
• clamminess
• cold flu-like symptoms
• confusion
• cough producing mucus
• cracked, dry, or scaly skin
• decreased interest in sexual intercourse
• difficult, burning, or painful urination
• difficulty with moving
• disturbance in attention
• ear congestion
• ear drainage
• earache or pain in ear
• excessive gas
• fall
• false or unusual sense of well-being
• feeling hot
• feeling jittery
• flushing or redness of the skin
• general feeling of bodily discomfort
• goosebumps
• headache, severe and throbbing
• hoarseness
• hot flashes
• inability to have or keep an erection
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• joint sprain
• joint stiffness
• joint swelling
• loss in sexual ability, desire, drive, or performance
• loss of voice
• lower back or side pain
• muscle aching or cramping
• muscle injury
• muscle pain or stiffness
• muscle spasms or twitching
• nasal congestion
• neck pain
• night sweats
• pain
• pain in the limbs
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• skin discoloration
• swelling
• swelling of the hands, ankles, feet, or lower legs
• tightness of the chest
• trouble in holding or releasing urine
• trouble with sleeping
• weight increased or decreased

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You should not take tramadol if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines;

• if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications; or

• if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).

Tramadol should not be given to a child younger than 12 years old. Ultram ER should not be given to anyone younger than 18 years old.

Do not give tramadol to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have ever had:

• a head injury, epilepsy or other seizure disorder;

• drug or alcohol addiction;

• a metabolic disorder; or

• if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

If you use tramadol while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking tramadol. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

To make sure tramadol is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• a stomach disorder;

• mental illness, or suicide attempt; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Take tramadol exactly as prescribed. Follow all directions on your prescription label. Tramadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take tramadol in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tramadol may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away this medicine is against the law.

Stop taking all other around-the-clock narcotic pain medications when you start taking tramadol.

Tramadol can be taken with or without food, but take it the same way each time.

Do not crush, break, or open an extended-release tablet or capsule (ConZip, Ultram ER). Swallow it whole to avoid exposure to a potentially fatal dose.

Never crush or break a tramadol tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

If you use the extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Immediate-release:
-Patients with cirrhosis: 50 mg orally every 12 hours

Extended-release:
-Severe hepatic impairment (Child-Pugh Class C): Use is not recommended

Hemodialysis patients can receive their regular dose on dialysis days since only 7% of dose is removed
Peritoneal dialysis: No data available

• Tramadol may be used for the treatment of moderate-to-severe pain such as that caused by cancer, osteoarthritis, and other musculoskeletal diseases. Tramadol is often prescribed postoperatively.
• Tramadol may also be effective against nerve-type pain.
• Tramadol may be less likely than other narcotic analgesics to cause respiratory depression.
• Generic tramadol is available.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• A headache, nausea, dizziness, constipation, vomiting, joint pains, dry mouth, sweating, and an itchy skin are commonly reported side effects.
• Sedation, which may affect a person's ability to drive or operate machinery, or perform hazardous tasks is also commonly reported. Alcohol may enhance this effect.
• May cause dependence, addiction, and slowed breathing. Tramadol may be misused and sought after by drug abusers. Tolerance may develop to its effect.
• Seizures have been reported with tramadol use. The risk is increased in people taking certain types of antidepressants (such as SSRIs, SNRIs, TCAs, MAO inhibitors), other opioids, antipsychotics, other drugs that reduce the seizure threshold, with a pre-existing seizure disorder, head trauma, excessive alcohol use or a metabolic disorder predisposing to an increased risk of seizures.
• Do not take tramadol if you are also using alcohol, drugs with sedative properties, or other narcotic medications; dangerous or fatal side effects, such as slowed breathing, can occur.
• Seniors over the age of 65 years may be more sensitive to the side effects of tramadol. Tramadol should be initiated cautiously, and extended-release tramadol is best avoided.
• May not be suitable for some people including those with a history of depression or prone to addiction. Tramadol may increase the risk of suicidal thoughts or behaviors.
• Tramadol may also not be appropriate for people at risk for respiratory depression, with head trauma or increased intracranial pressure, or with an acute abdominal disease.
• The dosage of tramadol may require adjusting in liver or kidney disease.
• Withdrawal symptoms (such as anxiety, sweating, insomnia, nausea, diarrhea, pain, piloerection [bristling of hairs]) have been reported when tramadol has been abruptly stopped following dosing for extended periods of time. The dosage of tramadol should always be tapered off slowly on discontinuation.
• Tramadol may interact with a number of other drugs including antidepressants, antipsychotics, St John's Wort, bupropion, triptans, or other drugs that are metabolized by CYP 2D6 or CYP3A4 hepatic enzymes.
• The metabolism of tramadol may be slowed by people who are poor metabolizers at CYP 2D6. While concentrations of tramadol may be higher in these people, concentrations of the active metabolite of tramadol may be lower, resulting in insufficient pain relief.
• Interaction or overdosage may cause serotonin syndrome (symptoms include mental status changes [such as agitation, hallucinations, coma, delirium]), fast heart rate, dizziness, flushing, muscle tremor or rigidity and stomach symptoms (including nausea, vomiting, and diarrhea).
• Rarely, anaphylaxis (a potentially fatal allergic reaction) has occurred with tramadol use, usually following the initial dose. Itchy skin, a rash, difficulty breathing, and other allergy-type symptoms may be more common. Do not use in people with a history of an allergic reaction to codeine or another opioid.
• Tramadol is not FDA-approved for use in children under the age of 12 (immediate-release capsules) or 18 (extended-release capsules).

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.