Patient Medication Information: uses, side effects, how to take - Novahistine Dh

Serious Warnings and Precautions

Even if you take NOVAHISTINE 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 NOVAHISTINE 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 NOVAHISTINE DH. They could die from taking it. If a person has not been prescribed NOVAHISTINE DH, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took NOVAHISTINE 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

Seek immediate medical help for your baby.

Taking NOVAHISTINE 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.

What is NOVAHISTINE DH used for?

NOVAHISTINE DH contains two ingredients, hydrocodone bitartrate and phenylephrine HCl.

Hydrocodone bitartrate belongs to the family of cough medicines (cough suppressants) and phenylephrine HCl belongs to the family of decongestants (relieves congestion).

NOVAHISTINE DH is not for use in patients younger than 18 years of age. In patients this age, the risks of life-threatening breathing problems outweigh the benefits of treating the cough with hydrocodone.

How does NOVAHISTINE DH work?

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.

What are the ingredients in NOVAHISTINE DH?

Medicinal ingredients: Hydrocodone bitartrate and phenylephrine HCl

Non-medicinal ingredients: Artificial and natural grape flavor, citric acid, D&C Green #5, D&C Red #33, liquid glucose, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium cyclamate and xylitol. Alcohol free.

NOVAHISTINE DH comes in the following dosage forms:

Syrup, hydrocodone bitartrate 1.7 mg and phenylephrine HCl 10 mg per 5 mL

Do not use NOVAHISTINE DH if:

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 NOVAHISTINE DH (see What are the ingredients in NOVAHISTINE 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 are at risk for having 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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NOVAHISTINE 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:

Some people metabolize hydrocodone at a much faster rate than the general population. This may lead to accidental overdose especially in patients younger than 18 years of age. Stop taking NOVAHISTINE DH 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 NOVAHISTINE DH and consult with your healthcare professional if:

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

These could be signs of a serious condition.

Use in children under the age of 6 18:

Young children are at greater risk of the sedating effects of narcotic cough drugs. The use of hydrocodone in children less than 6 years of age has led to slow, shallow or weak breathing that has been fatal. DO NOT give NOVAHISTINE DH to children under the age of 18.

Opioid dependence and addiction:

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

Pregnancy, nursing, labour and delivery:

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

If you are pregnant and are taking NOVAHISTINE 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 NOVAHISTINE 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 NOVAHISTINE DH. NOVAHISTINE DH 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 NOVAHISTINE DH.

Serotonin Syndrome:

NOVAHISTINE 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 NOVAHISTINE 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.

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 NOVAHISTINE DH:

alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking NOVAHISTINE DH. 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 NOVAHISTINE 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 NOVAHISTINE 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)
anti-retroviral drugs (use to treat viral infections)
anti-fungal drugs (used to treat fungal infections)
antibiotic drugs (used to treat bacterial infections)
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

How to take NOVAHISTINE DH:

Your doctor will prescribe the lowest dose that works to control your symptoms.
It is recommended that you only take NOVAHISTINE DH for up to 7 days. If you need to take NOVAHISTINE DH 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.
NOVAHISTINE DH may be taken with or without food.

Usual Dose:

Adults:

10 mL every 4 hours. Do not use for longer than 7 days.

Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

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

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

Stopping your Medication

If you have been taking NOVAHISTINE DH for more than a few days you may experience some of the following uncomfortable symptoms when you stop taking it:

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

Refilling your Prescription for NOVAHISTINE DH:

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

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:

If you think you have taken too much NOVAHISTINE DH, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

unusually slow or weak breathing
dizziness
confusion
extreme drowsiness
convulsion
tachycardia (heart palpitations)
constriction of the pupils
nausea
vomiting

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 NOVAHISTINE DH?

These are not all the possible side effects you may feel when taking NOVAHISTINE DH. 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
light headedness
sweating
constipation
low sex drive, impotence (erectile dysfunction), infertility
mild mental stimulation
convulsions
urinary retention

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

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
RARE
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		✓
Fast, Slow or Irregular Heartbeat: heart palpitations		✓
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.

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 (https://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.

Storage:

Keep unused or expired NOVAHISTINE DH in a secure place to prevent theft, misuse or accidental exposure to children and pets.
Keep NOVAHISTINE 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 NOVAHISTINE DH, get emergency help right away.
Store at room temperature (15-30^oC).

Disposal:

NOVAHISTINE 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.

If you want more information about NOVAHISTINE DH:

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 (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.

Rx or OTC	Prescription (Rx)?
DIN	02049473
Schedule(s)	NARCOTICS (CDSA I)
Risk Management Plans	A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
Active ingredient(s)	Hydrocodone bitartrate 1.7 MG, Phenylephrine hydrochloride 10 MG
Dosage form(s)	Syrup
Route(s) of administration	Oral
Drug class (WHO ATC)	R Respiratory system drugs R05 Cough and cold preparations R05D Cough suppressants, excl. combinations with expectorants R05DA Opium alkaloids and derivatives, cough suppressants R05DA20 Combinations
Company	SANOFI-AVENTIS CANADA INC
Current status	Cancelled Post Market
Current status date	July 10, 2020

Novahistine Dh: Uses, Side Effects and Dosage