Codeine Phosphate Syrup: Uses, Side Effects and Dosage

SERIOUS WARNINGS AND PRECAUTIONS

• Even if you take CODEINE PHOSPHATE SYRUP 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 CODEINE

  PHOSPHATE SYRUP. 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 CODEINE PHOSPHATE SYRUP. They could die from taking it. If a person has not been prescribed CODEINE PHOSPHATE SYRUP, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP used for?

• CODEINE PHOSPHATE SYRUP is a pain medication used in adults to control pain

How does CODEINE PHOSPHATE SYRUP work?

CODEINE PHOSPHATE SYRUP contains codeine which is a pain medication belonging to the class of drugs known as opioids which includes codeine, fentanyl, morphine and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in CODEINE PHOSPHATE SYRUP?

Medicinal ingredients: Codeine phosphate

Non-medicinal ingredients: Purified water, sucrose, alcohol, methylparaben, caramel color, tartrazine (FD&C yellow #5)

CODEINE PHOSPHATE SYRUP comes in the following dosage forms:

This product is a liquid syrup for oral use.

Do not use CODEINE PHOSPHATE SYRUP if:

• your doctor did not prescribe it for you

• you are allergic to Codeine, or any of the other ingredients in CODEINE PHOSPHATE

  SYRUP (see What are the ingredients in CODEINE PHOSPHATE SYRUP?)

• 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 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 sulfate, tranylcypromine sulfate, moclobemide or selegiline)

• you are going to have, or recently had, a planned surgery
• have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose
• you are pregnant or planning to become pregnant or you are in labour
• you are breastfeeding The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take CODEINE PHOSPHATE SYRUP, seek immediate medical care for your baby if they are overly drowsy, sedated, have difficulty breast-feeding, have breathing difficulties, and are floppy (have decreased muscle tone). This is very serious for the baby and can lead to death. Tell the baby’s doctor that you are breastfeeding and took CODEINE PHOSPHATE SYRUP.
• you are less than 12 years old
• 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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CODEINE PHOSPHATE SYRUP. 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 adrenal or prostate gland
• have, or had in the past, hallucinations or other severe mental problems
• suffer from migraines
• are planning to become pregnant.

Other warnings you should know about

Some people metabolize codeine at a much faster rate than the general population, which may lead to accidental overdose, if this should happen to you, seek help immediately (see Overdose, for symptoms of overdose and what to do if it happens). If you know that you metabolize codeine rapidly, tell your doctor BEFORE starting this medication.

CODEINE PHOSPHATE SYRUP 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

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 CODEINE PHOSPHATE SYRUP while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. CODEINE PHOSPHATE SYRUP can then cause life-threatenin breathing problems in your unborn bay or nursing infant.

If you are pregnant and are taking CODEINE PHOSPHATE SYRUP, 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 T CODEINE PHOSPHATE SYRUP. 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 CODEINE PHOSPHATE SYRUP. CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP.

Serotonin Syndrome:

CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking CODEINE PHOSPHATE SYRUP. 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 CODEINE

  PHOSPHATE SYRUP;

• 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 CODEINE PHOSPHATE SYRUP 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
• some heart medications (such as beta blockers)
• grapefruit juice
• drugs used to treat migraines (e.g. triptans)
• St. John’s Wort.

How to take CODEINE PHOSPHATE SYRUP:

You should not consume alcohol while taking CODEINE PHOSPHATE SYRUP, as it may increase the chance of experiencing dangerous side effects.

Keep CODEINE PHOSPHATE SYRUP out of sight and reach of children. You should not give CODEINE PHOSPHATE SYRUP to anyone as inappropriate use may have severe medical consequences, including death.

Take CODEINE PHOSPHATE SYRUP orally:

• usually every 4 to 6 hours, or as directed by your doctor.
• with a full glass of water

You can take your dose of CODEINE PHOSPHATE SYRUP with or without food. To improve the taste, you can dilute CODEINE PHOSPHATE SYRUP in a glass of fruit juice just before taking your dose.

Usual Adult 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 CODEINE PHOSPHATE SYRUP for up to 7 days. If you need to take CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP. Be sure to use CODEINE PHOSPHATE SYRUP only for the condition for which it was prescribed.

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

Stopping your Medication:

If you have been taking CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP. 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 CODEINE PHOSPHATE SYRUP.

Refilling your Prescription for CODEINE PHOSPHATE SYRUP:

A new written prescription is required from your doctor each time you need more CODEINE PHOSPHATE SYRUP. 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:

If you think you have taken too much CODEINE PHOSPHATE SYRUP, immediately 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

Missed Dose:

If you miss one oral solution 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 CODEINE PHOSPHATE SYRUP?

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

Side effects may include:

• Drowsiness
• Insomnia
• Dizziness
• Fainting
• Nausea, or 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

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

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

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.

3 ways to report:

• Online at MedEffect (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html)
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C

    Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html)

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

Storage:

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

Disposal:

CODEINE PHOSPHATE SYRUP 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 CODEINE PHOSPHATE SYRUP:

• 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) or by contacting Laboratoire Atlas Inc. at: Phone (Toll free) : 1-844-284-7890; Fax: 524-254-3006; Email: info@laboratoireatlas.com

Last Revised: August 30, 2018