Details for: NOVAHISTEX DH
Company: SANOFI-AVENTIS CANADA INC
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02049481||NOVAHISTEX DH||PHENYLEPHRINE HYDROCHLORIDE; HYDROCODONE BITARTRATE||20 MG / ML; 5 MG / ML||SYRUP||ORAL|
Summary Safety Review -Opioid-containing cough and cold products - Assessing the potential risk of opioid use disorder and related harms in children and adolescents
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
NOVAHISTEX DH is a prescription medicine, for adults and for children 12 and over, used to treat cough associated with colds that is not responding to other medications.
What it does
NOVAHISTEX DH contains two ingredients, hydrocodone bitartrate and phenylephrine HCl.
Hydrocodone bitartrate helps suppress cough by acting on the cough center in the brain. Phenylephrine HCl works by constricting blood vessels in the nasal passages, helping to relieve nasal congestion.
When it should not be used
- your doctor did not prescribe it for you
- you are allergic to hydrocodone bitartrate and phenylephrine HCl or to any of the other ingredients in NOVAHISTEX DH (see What are the ingredients in NOVAHISTEX DH?), or other opioid analgesics
- 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 have a brain tumor
- you are at risk for having seizures
- you suffer from alcoholism
- you are going to have, or recently had, a planned surgery
- 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)
What the medicinal ingredient is
Hydrocodone bitartrate and phenylephrine HCl
What the non-medicinal ingredients are
Amaranth color, artificial raspberry flavour, artificial taste modifier, citric acid, liquid glucose, glycerine, menthol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate and xylitol. Alcohol free.
What dosage form it comes in
Syrup, hydrocodone bitartrate 5 mg and phenylephrine HCl 20 mg per 5 mL
Warnings and precautions
Serious Warnings and Precautions
- Even if you take NOVAHISTEX DH as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
- You may get life-threatening breathing problems while taking NOVAHISTEX DH. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
- You should never give anyone your NOVAHISTEX DH. If a person has not been prescribed NOVAHISTEX DH, they could die from taking it. This is especially true for children.
- If you took NOVAHISTEX DH while you were pregnant, whether for short or long
periods of time or in small or large doses, your baby can suffer life-threatening
withdrawal symptoms after birth. This can occur in the days after birth and for up to 4
weeks after delivery. If your baby has any of the following symptoms:
- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever
- Taking NOVAHISTEX DH with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NOVAHISTEX DH. 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 diabetes
- have glaucoma
- have heart problems or peripheral vascular disease (problems with your blood vessels)
- have low blood pressure
- have high 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
- are pregnant or planning to become pregnant
Other warnings you should know about:
Use in Children
Young children are at greater risk of the sedating effects of narcotic cough drugs. The use of hydrocodone in young children has led to slow, shallow or weak breathing that has been fatal. NOVAHISTEX DH should be given with caution to children. This is especially true for children who have difficulty breathing. NOVAHISTEX DH is not recommended for children under 12.
Opioid dependence and addiction:
As with all opioids, taking NOVAHISTEX DH 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.
Pregnancy, nursing, labour and delivery:
Opioids can be transferred to your baby through breast milk, or while still in the womb. NOVAHISTEX DH can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using NOVAHISTEX DH outweigh the risks to your unborn baby or nursing infant.
If you are pregnant and are taking NOVAHISTEX DH, 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 NOVAHISTEX DH. 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 NOVAHISTEX DH. NOVAHISTEX DH can cause:
- dizziness or
This can usually occur after you take your first dose and when your dose is increased.
Serotonin Syndrome: NOVAHISTEX DH 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 NOVAHISTEX DH 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 NOVAHISTEX DH.
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.
Interactions with this medication
- alcohol. This includes prescription and non-prescription medications that contain alcohol.
Do not drink alcohol while you are taking NOVAHISTEX DH. It can lead to:
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other sedative drugs which may enhance the drowsiness caused by NOVAHISTEX DH
- 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 NOVAHISTEX DH 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
Proper use of this medication
Adults and children over 12 years:
5 mL every 4 hours.
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 cough. Higher doses can lead to more side effects and a greater chance of overdose. Review your symptoms regularly with your doctor to determine if you still need NOVAHISTEX DH. Be sure to use NOVAHISTEX DH only for the condition for which it was prescribed.
If you develop any side effect as a result of taking NOVAHISTEX DH, tell your doctor immediately.
Stopping your Medication
If you have been taking NOVAHISTEX DH for more than a few days you may experience some of the following uncomfortable symptoms when you stop taking it:
- body aches
- loss of appetite
- feeling nervous or restless
- runny nose
- tremors or shivering
- stomach cramps
- rapid heart rate (tachycardia)
- having trouble sleeping
- an unusual increase in sweating
- heart palpitations
- an unexplained fever
Refilling your Prescription for NOVAHISTEX DH
A new written prescription is required from your doctor each time you need more
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.
Signs of overdose may include:
- unusually slow or weak breathing
- extreme drowsiness
- tachycardia (heart palpitations)
- constriction of the pupils
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking NOVAHISTEX DH. If you
experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- nausea, vomiting, or a poor appetite
- dry mouth
- problems with vision
- weakness, uncoordinated muscle movement
- mild mental stimulation
- urinary retention
- low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using NOVAHISTEX DH.
|Symptom / effect||Talk to your healthcare professional Only if severe||Talk to your healthcare professional In all cases||Stop taking drug and get immediate medical help|
|Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone cold and clammy skin, convulsion.||✔|
|Respiratory Depression: slow, shallow or weak breathing.||✔|
|Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing||✔|
|Bowel Blockage (impaction): abdominal pain, severe constipation, nausea||✔|
|Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating.||✔|
|Low Blood Pressure: dizziness, fainting, light-headedness.||✔|
|Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea||✔|
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.
How to store
- Keep unused or expired NOVAHISTEX DH in a secure place to prevent theft,
misuse or accidental exposure to children and pets.
Store between 15 – 30°C.
Keep NOVAHISTEX DH 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 NOVAHISTEX DH, get emergency help right away.
NOVAHISTEX DH should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html ) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
- 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 website (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.
This leaflet was prepared by sanofi-aventis Canada Inc.
Last Revised: May 30, 2018