Durela: Uses, Side Effects and Dosage

What is DURELA used for?

DURELA is used in adults to manage moderate to moderately severe pain. It is used when continuous treatment is required for several days or more.

How does DURELA work?

DURELA is a painkiller belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

Serious Warnings and Precautions

What are the ingredients in DURELA?

Medicinal ingredient: Tramadol hydrochloride.

Non-medicinal ingredients: Corn starch, D & C Red #7 calcium lake (E180), D & C Yellow #10 aluminum lake, Eudragit NE 30D, FD & C Blue #2 aluminum lake (E132), gelatin, hypromellose, lactose monohydrate 200 mesh, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone K30, propylene glycol, shellac, simethicone emulsion, sodium starch glycolate, sucrose stearate, talc and titanium dioxide.

DURELA comes in the following dosage forms:

Extended-release capsules: 100 mg, 200 mg, and 300 mg of tramadol hydrochloride. DURELA capsules are white and marked as follows:

• 100 mg: “G 252” on cap and “100” between lines on the body in blue ink.
• 200 mg: “G 253” on cap and “200” between lines on the body in violet ink.
• 300 mg: “G 254” on cap and “300” between lines on the body in red ink.

Do not use DURELA if:

• your doctor did not prescribe it for you.
• you are allergic to tramadol, other opioids, or any of the other ingredients of DURELA.
• your pain can be controlled by the occasional use of painkillers including those available without a prescription.
• you have severe asthma, trouble breathing, or other breathing problems.
• you have any heart problems.
• you have bowel blockage or narrowing of the stomach or intestines.
• you have severe pain in your abdomen.
• you have increased pressure in your skull or have a head injury.
• you have or have a history with epilepsy.
• you have severe kidney problems.
• you have severe liver problems.
• you suffer from alcoholism or alcohol withdrawal.
• you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOI) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
• you are less than 18 years old and are having (or have recently had) your tonsils or adenoids removed because of frequent interruption of breathing during sleep.
• you are less than 12 years old.
• you are pregnant or plan to become pregnant, or you are in labour or delivery.
• you are breastfeeding or plan to breastfeed.
• you have recently taken alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs. Ask your healthcare professional if you are unsure.
• you are going to have, or recently had, a planned surgery.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DURELA. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or alcohol abuse.
• have low blood pressure.
• have past or current depression.
• suffer from chronic or severe constipation.
• have been told that you metabolize tramadol or other pain medications rapidly.
• have problems with your thyroid, adrenal or prostate gland.
• have diabetes.
• have liver problems.
• have kidney problems.
• have, or had in the past hallucinations or other severe mental problems.
• have a central nervous system (CNS) infection.
• are dependent on opioids.
• are planning on drinking alcohol. Drinking alcohol while taking DURELA may cause dangerous side effects, including death. Do not drink alcohol while taking DURELA.
• have suicidal thoughts or actions.
• have circulatory problems (e.g., body does not get enough oxygen and nutrients to function properly due to a lack of blood flow).
• have been told you are at risk of having heart problems, hyponatremia (low sodium levels in the blood), or seizures.
• have a condition that causes weakness or frailty.
• have difficulty urinating.
• have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea).
• are 65 years of age and older.

Other warnings you should know about:

Taking DURELA can cause the following serious side effects:

• Allergic reactions: Serious and rarely fatal allergic reactions (e.g., swelling of lips and throat, blistering of skin and/or lips or neck) have been reported in patients receiving therapy with tramadol. Seek medical attention immediately.

• Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

  • nausea, vomiting
  • feeling tired, weak or dizzy
  • decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your healthcare professional may do tests, give you another medication, and slowly take you off DURELA.

• Hypoglycemia (low blood sugar): DURELA can decrease your blood sugar levels. Diabetic patients may need to monitor their blood sugar more often. If you notice changes, discuss this with your healthcare professional.
• Seizure risk: Seizures have been experienced by patients taking DURELA at the doses prescribed. This risk may increase with higher doses.

• Serotonin toxicity (also known as Serotonin Syndrome): DURELA can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious

  • changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take DURELA with certain anti-depressants or migraine medications. Serotonin toxicity symptoms include:

    • fever, sweating, shivering, diarrhea, nausea, vomiting;
    • muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
    • fast heartbeat, changes in blood pressure;
    • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
• Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.

See the Serious side effects and what to do about them table below for more information on these and other serious side effects

Adolescents (12 to 18 years old): You should not use DURELA if your child:

• is overweight (obese),
• has obstructive sleep apnea (a condition where your breathing starts and stops while you sleep),
• has severe lung disease.

There is a higher risk of serious breathing problems if your child takes DURELA and has any of the above conditions.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to DURELA. DURELA can cause:

• drowsiness
• dizziness, or
• lightheadedness

This can usually occur after the first dose and when the dose is increased.

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Do not use DURELA while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. DURELA can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking DURELA, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your healthcare professional will monitor and guide you on how to slowly stop taking DURELA. This may help avoid serious harm to your unborn baby.

Sexual function and reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Testing and check-ups:

• DURELA can cause abnormal blood test results including decreased blood sugar. Your healthcare professional will decide when to perform blood tests and will interpret the results.
• Your healthcare professional will also regularly monitor you for signs of misuse and abuse.

Worsening pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your doctor if you notice a change like this in your pain while you are taking DURELA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DURELA:

• anticoagulants used to thin the blood and prevent blood clots (e.g., warfarin and coumadin).
• antiretrovirals used to treat viral infections (e.g., ritonavir).
• antifungals used to treat fungal infections (e.g., ketoconazole, fluconazole, and voriconazole).
• antibiotics used to treat bacterial infections (e.g., rifampin, erythromycin, clarithromycin, azithromycin, tacrolimus, moxifloxacin, levofloxacin, ciprofloxacin, and pentamidine);
• carbamazepine, used to treat certain types of seizures.
• medicines that can affect the heart (e.g., digoxin, quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, propafenone, sunitinib, nilotinib, ceritinib, vandetanib, salmeterol and formoterol).
• antimalarials used to treat malaria (e.g.,quinine and chloroquine).
• medicines used to treat cancer (e.g., vorinostat and arsenic trioxide).
• grapefruit juice
• medicines used to decrease electrolyte levels in the body (e.g., diuretics, laxatives, enemas, amphotericin B, high doses of corticosteroids, and proton pump inhibitors).

If you are unsure about the medications you are taking, ask your healthcare professional.

How to take DURELA:

• DURELA must be taken orally, by mouth.

• Take DURELA every 24 hours as prescribed with a glass of water. It can be taken with or without food.

• Swallow whole. Do not break, crush, chew or dissolve the capsule. This can be dangerous and can lead to death or seriously harm you.
• Review your pain regularly with your healthcare professional to determine if you still need DURELA. Be sure to use DURELA only for the condition for which it was prescribed.

Usual dose:

Your dose is tailored/personalized just for you, take it exactly as your healthcare professional has told you to. Do not increase or decrease your dose without consulting your doctor. Taking higher doses can lead to more side effects and a greater chance of overdose.

The usual starting dose of DURELA is 100 mg per day.

You should not take more than the maximum recommended dose of 300 mg of DURELA per day. Exceeding this recommendation can result in respiratory depression (shallow, slow breathing), seizures, coma, heart stoppage and death.

Stopping your Medication: If you have been taking DURELA for more than a few days you should not stop taking it all of a sudden. You should check with your doctor for directions on how to slowly stop taking it. You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• gooseflesh
• loss of appetite
• nausea
• feeling nervous or restless
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble sleeping
• an unusual increase in sweating
• an unexplained fever
• weakness
• yawning

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking DURELA.

Refilling your Prescription for DURELA: A new written prescription is required from your doctor each time you need more DURELA. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

Signs of an overdose with DURELA may include:

• unusually slow or weak breathing,
• dizziness,
• confusion,
• extreme drowsiness,
• fits (seizures),
• irritation and discomfort in the stomach and gut,
• nausea,
• vomiting,
• feeling unwell,
• pale color and sweating,
• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter),
• QT prolongation (abnormal electrical activity in the heart),
• lack of muscle shape and tone,
• cold and clammy skin,
• shrinking of pupils,
• slow heart rate,
• low blood pressure.

Missed Dose:

It is very important that you do not miss any doses. If you miss one dose, skip the missed dose and take your next dose as scheduled. Do not take two doses at once to make up for a missed dose. If you miss several doses in a row, talk to your healthcare professional before restarting your medication.

What are possible side effects from using DURELA?

These are not all the possible side effects you may have when taking DURELA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• drowsiness
• insomnia
• dizziness
• fainting
• nausea, vomiting, poor appetite
• dry mouth
• headache
• problems with vision
• weakness, uncoordinated muscle movement
• itching
• sweating
• constipation; talk with your healthcare professional about ways to prevent constipation when you start using DURELA.
• low sex drive, impotence (erectile dysfunction), infertility.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store DURELA at room temperature (15°C to 30°C). Protect from light, moisture and high humidity.
• Keep unused or expired DURELA in a secure place to prevent theft, misuse or accidental exposure.
• Keep DURELA out of sight and reach of children and pets.
• DURELA should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about DURELA:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.cipherpharma.com, or by calling 1-888-361-7207.

Last Revised: March 3, 2022