Talwin (Sanofi-Aventis Canada): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TALWIN used for?

TALWIN is used to manage your pain.

How does TALWIN work?

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

What are the ingredients in TALWIN?

Medicinal ingredient: pentazocine hydrochloride

Non-medicinal ingredients: Aerosil, avicel, cornstarch, dibasic calcium phosphate, magnesium stearate, kolliphor, sodium metabisulphite.

TALWIN comes in the following dosage forms:

• Tablets, 50 mg

Do not use TALWIN if:

• your doctor did not prescribe it for you

• you are allergic to pentazocine hydrochloride or any of the other ingredients in TALWIN

  (see What are the ingredients in TALWIN?)

• you can control your pain by the occasional use of other pain medications. This includes 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 a head injury
• you are at risk for seizures

• you suffer from alcoholism

• 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 going to have, or recently had, a planned surgery
• you are pregnant or planning to become pregnant
• you are breastfeeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TALWIN. 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 severe kidney, liver or lung disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have acute inflammation of the gallbladder or inflammation in the pancreas
• have blockage that inhibits the flow of urine through its normal path (the urinary tract)
• have porphyria (genetic disease in which your body builds-up chemicals with skin, nervous system or other symptoms)
• have chronic inflammation or blockage of all or part of your digestive tract or narrowing of the stomach.
• have problems with your thyroid, adrenal or prostate gland
• have, or had in the past, hallucinations or other severe mental problems
• suffer from migraines

Other warnings you should know about:

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, labor and delivery:

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

If you are pregnant and are taking TALWIN, 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 doctor will monitor and guide you on how to slowly stop taking TALWIN. This may help avoid serious harm to your unborn baby.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to TALWIN. TALWIN can cause:

• drowsiness
• dizziness or
• lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

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 doctor may do tests, give you another medication, and slowly take you off TALWIN.

Serotonin Syndrome: TALWIN can cause Serotonin Syndrome, 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 Syndrome if you take TALWIN with certain anti-depressants or migraine medications.

Serotonin Syndrome 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.

Sexual Function/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.

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 TALWIN:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TALWIN. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or
  • a fatal overdose
• other sedative drugs which may enhance the drowsiness caused by TALWIN
• other opioid analgesics (drugs used to treat pain)
• general anesthetics (drugs used during surgery)
• benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
• antidepressants (for depression and mood disorders). Do not take TALWIN with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• antihistamines (drugs used to treat allergies)
• anti-emetics (drugs used for the prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• drugs used to treat migraines (e.g. triptans)
• St. John’s Wort

How to take TALWIN:

Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

Usual Adult Starting Dose:

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take TALWIN for up to 7 days. If you need to take TALWIN for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need TALWIN. Be sure to use TALWIN only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking TALWIN, tell your doctor immediately.

Stopping your Medication

If you have been taking TALWIN for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking TALWIN. You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• goosebumps
• 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
• heart palpitations
• 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 TALWIN.

Refilling your Prescription for TALWIN:

A new written prescription is required from your doctor each time you need more TALWIN. 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 overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using TALWIN?

These are not all the possible side effects you may feel when taking TALWIN. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness
• Insomnia
• Sleepiness
• Dizziness
• Fainting
• Nausea, vomiting, or a poor appetite
• Dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using TALWIN.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep unused or expired TALWIN in a secure place to prevent theft, misuse or accidental exposure.
• Store between 15 and 30°C.
• Keep TALWIN under lock, out of sight and reach of children and pets.
• Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes TALWIN, get emergency help right away.

Disposal:

TALWIN 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 TALWIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada’s website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sanofi.ca, or by calling 1-800-265-7927.

Last Revised: May 22, 2018