Free Brunei: FusePaq Synapryn

Generic Name: tramadol (Oral route)

TRAM-a-dol

Commonly used brand name(s)

In the U.S.

ConZip

FusePaq Synapryn

Rybix ODT

Ryzolt

Ultram

Ultram ER

Available Dosage Forms:

Capsule, Extended Release

Tablet, Extended Release

Tablet, Disintegrating

Tablet

Suspension

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For FusePaq Synapryn

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release or long-acting tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.

This medicine is available only with your doctor's prescription.

Before Using FusePaq Synapryn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Rybix™ ODT, Ryzolt™, and Ultram® tablets in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Ultram® ER extended-release tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., constipation; lightheadedness, dizziness, or fainting; stomach upset; weakness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tramadol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rasagiline

Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetophenazine

Amitriptyline

Amoxapine

Bromperidol

Carbamazepine

Chlorpromazine

Chlorprothixene

Citalopram

Clobazam

Clomipramine

Clorgyline

Clovoxamine

Clozapine

Cyclobenzaprine

Desipramine

Desvenlafaxine

Dothiepin

Doxepin

Duloxetine

Escitalopram

Ethopropazine

Femoxetine

Fluoxetine

Flupenthixol

Fluphenazine

Fluvoxamine

Haloperidol

Imipramine

Isocarboxazid

Ketamine

Linezolid

Lofepramine

Loxapine

Melperone

Mesoridazine

Methotrimeprazine

Milnacipran

Mirtazapine

Moclobemide

Molindone

Nortriptyline

Olanzapine

Paroxetine

Penfluridol

Perphenazine

Phenelzine

Pimozide

Pipotiazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Protriptyline

Remoxipride

Risperidone

Sertraline

Sulpiride

Tapentadol

Thiethylperazine

Thioridazine

Thiothixene

Tranylcypromine

Trifluoperazine

Triflupromazine

Trimeprazine

Trimipramine

Venlafaxine

Vilazodone

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Digoxin

Quinidine

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of tramadol

This section provides information on the proper use of a number of products that contain tramadol. It may not be specific to FusePaq Synapryn. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole with liquids. Do not break, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For chronic pain:
- For oral dosage form (extended-release tablets):
  - Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
  - Children younger than 16 years of age—Use and dose must be determined by your doctor.

For moderate to severe pain:
- For oral dosage form (disintegrating tablets):
  - Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
  - Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults and teenagers 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
  - Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using FusePaq Synapryn

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor or dentist before taking any of these medicines while you are using this medicine.

Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures. (convulsions) and may cause a serious condition called serotonin syndrome.

This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your doctor. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures); difficult or troubled breathing; irregular, fast or slow, or shallow breathing; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, or shortness of breath.

Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

FusePaq Synapryn Side Effects

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:

Less common or rare

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

heart rate increased

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

shortness of breath

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:

Symptoms of overdose

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

shortness of breath

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:

More common

Abdominal or stomach pain

agitation

anxiety

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 of the skin

joint pain

loss of appetite

loss of interest or pleasure

loss of strength or weakness

muscle aches and pains

nausea

nervousness

redness of the face, neck, arms, and occasionally, upper chest

restlessness

runny nose

shivering

skin rash

sleepiness or unusual drowsiness

sore throat

stuffy nose

sweating

tiredness

trouble concentrating

unusual feeling of excitement

weakness

Less common or rare

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

troubled breathing

weight increased or decreased

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Gooseflesh

high blood pressure

increased sweating

increased yawning

shivering or trembling

unusually large pupils

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.

See also: FusePaq Synapryn side effects (in more detail)

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More FusePaq Synapryn resources

FusePaq Synapryn Side Effects (in more detail)
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Tuesday, October 11, 2016

FusePaq Synapryn