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

Serious Warnings and Precautions

What is TUSSIONEX used for?

TUSSIONEX is used for the temporary relief, in adults, of coughs, runny nose, and stuffy nose associated with:

• allergies, or
• the common cold

TUSSIONEX is not for use in patients younger than 18 years of age.

How does TUSSIONEX work?

TUSSIONEX contains two ingredients, hydrocodone bitartrate and phenyltoloxamine citrate.

Hydrocodone belongs to the family of cough medicines. It acts on the brain to suppress cough. Phenyltoloxamine belongs to the family of antihistamines. It relieves allergy symptoms.

What are the ingredients in TUSSIONEX?

Medicinal ingredients: hydrocodone bitartrate and phenyltoloxamine citrate

Non-medicinal ingredients: alcohol 95%, D&C yellow No. 10, FD&C yellow No. 6, glycerin, methylparaben, peach flavour, pineapple flavour, propylene glycol, propylparaben, sorbitol solution 70%, washed hydrogen cycle resin, water, xanthan gum.

TUSSIONEX comes in the following dosage forms:

Suspension, 5 mg hydrocodone bitartrate and 10 mg phenyltoloxamine citrate, per 5 mL

Do not use TUSSIONEX if:

• your doctor did not prescribe it for you
• you are allergic to hydrocodone, phenyltoloxamine, or any of the other ingredients in TUSSIONEX
• you have severe asthma, trouble breathing, or other breathing 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 have a brain tumor
• 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 have uncontrolled high blood pressure
• you are under 6 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TUSSIONEX. 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 heart disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have problems with your thyroid, adrenal or prostate gland
• have, or had in the past hallucinations or other severe mental problems
• suffer from migraines
• have diabetes
• have glaucoma
• are planning to become pregnant

Other warnings you should know about:

Some people metabolize hydrocodone at a much faster rate than the general population. This may lead to accidental overdose. Stop taking TUSSIONEX and seek immediate medical help if you start feeling confused, have shallow breathing, or extreme sleepiness. If you know that you metabolize hydrocodone at a much faster rate, tell your doctor BEFORE starting this medication.

Stop taking TUSSIONEX and consult with your healthcare professional if:

• you get a high fever, rash or persistent headache along with the cough.
• your symptoms or cough worsen or continue for more than 7 days.

These could be signs of a serious condition.

Opioid dependence and addiction:

As with all opioids, taking TUSSIONEX may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor. 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.

Breathing Problems:

TUSSIONEX is not recommended for anyone who has or is at risk for breathing problems such as:

• lung infections, or respiratory conditions
• neuromuscular disorders
• severe heart problems
• recent multiple traumas or extensive surgical procedures

Pregnancy, nursing, labour and delivery:

Opioids can be transferred to your baby through breast milk, or while still in the womb. TUSSIONEX can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using TUSSIONEX outweigh the risks to your unborn baby or nursing infant.

If you are pregnant and are taking TUSSIONEX, 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 TUSSIONEX. 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 TUSSIONEX. TUSSIONEX can cause:

• drowsiness
• dizziness or
• lightheadedness

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

Serotonin Syndrome: TUSSIONEX 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 TUSSIONEX with certain antidepressants 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.

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 TUSSIONEX.

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 TUSSIONEX:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TUSSIONEX. 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 TUSSIONEX
• 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 TUSSIONEX 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 to prevent vomiting)
• drugs used to treat muscle spasms and back pain
• some heart medication (such as beta blockers)
• drugs used to treat migraines (e.g. triptans)
• St. John’s Wort
• warfarin (such as coumadin) and other anticoagulants (used to prevent or treat blood clots)
• anti-retroviral drugs (used to treat viral infections)
• anti-fungal drugs (used to treat fungal infections)
• antibiotic drugs (used to treat bacterial infections)
• grapefruit juice

How to take TUSSIONEX:

• TUSSIONEX suspension should not be diluted with fluids or mixed with other drugs. Shake well before using.
• Your doctor will prescribe the lowest dose that works to control your symptoms.
• It is recommended that you only take TUSSIONEX for up to 7 days. If you need to take TUSSIONEX 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.

• TUSSIONEX may be taken with or without food.

Usual Dose:

Adults: 5 mL (1 teaspoonful) of suspension every 8 to 12 hours. Maximum daily dose is 10 mL of suspension. May be adjusted to individual requirements. Do not use TUSSIONEX for more than 7 days.

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

If you develop any side effect as a result of taking TUSSIONEX, tell your doctor immediately.

Stopping your Medication

If you have been taking TUSSIONEX 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 TUSSIONEX. 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 TUSSIONEX treatment, your body will become less used to TUSSIONEX. 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 TUSSIONEX.

Refilling your Prescription for TUSSIONEX:

A new written prescription is required from your doctor each time you need more TUSSIONEX.

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.

Overdose:

Signs of overdose may include:

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

Missed Dose:

If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time

What are possible side effects from using TUSSIONEX?

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

Side effects may include:

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

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

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 TUSSIONEX in a secure place to prevent theft, misuse or accidental exposure.
• Keep TUSSIONEX 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 TUSSIONEX, get emergency help right away.
• Store at room temperature (15˚- 30˚C).

Disposal:

TUSSIONEX 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 TUSSIONEX:

• Talk to your healthcare professional
• Find the full prescribing information that is prepared for healthcare professionals and includes this consumer 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.sanofi.ca, or by calling 1-800-265-7927.

Last Revised: August 1, 2019