Patient Medication Information: uses, side effects, how to take - PMS-Acetaminophen with Codeine Elixir
Serious Warnings and Precautions
- Even if you take pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. They could die from taking it. If a person has not been prescribed pms-ACETAMINOPHEN WITH CODEINE ELIXIR, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR used for?
Pain: pms-ACETAMINOPHEN WITH CODEINE ELIXIR is used for adults for short-term relief of mild to moderate pain of various causes.
pms-ACETAMINOPHEN WITH CODEINE ELIXIR should not be taken for pain for more than 5 days, or fever for more than 3 days, unless directed by your healthcare professional.
How does pms-ACETAMINOPHEN WITH CODEINE ELIXIR work?
Codeine: Codeine belongs to a class of drugs which is commonly referred to as opiates, opioids or narcotics, and also includes fentanyl, hydromorphone, morphine and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
Acetaminophen: Acetaminophen belongs to a group of medicines called analgesics (pain relievers) and antipyretics (fever reducers). The exact mechanism of action of acetaminophen is not known.
What are the ingredients in pms-ACETAMINOPHEN WITH CODEINE ELIXIR?
Medicinal ingredients: Acetaminophen and Codeine phosphate
Non-medicinal ingredients: Alcohol, Artificial Butterscotch Flavour, Artificial Cherry Flavour, Caramel Colour, Citric Acid (for pH adjustment), FD & C Red No.40, Glycerin, Methylparaben, Propylparaben, Purified Water, Natural Orange Extract, Propylene Glycol, Sodium Citrate (for pH adjustment), Sodium Saccharin, Sucrose.
pms-ACETAMINOPHEN WITH CODEINE ELIXIR comes in the following dosage forms:
Oral solution: 160 mg / 8 mg per 5 mL
Do not use pms-ACETAMINOPHEN WITH CODEINE ELIXIR if:
- your doctor did not prescribe it for you
- your pain is mild
- you are allergic to acetaminophen or codeine phosphate or any of the other ingredients in pms-ACETAMINOPHEN WITH CODEINE ELIXIR
- 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 slow or shallow breathing, elevated carbon dioxide levels in the blood or a condition called “cor pulmonale” in which part of the heart is enlarged or does not work correctly due to high blood pressure in the lungs
- 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 suffer from alcoholism
- you have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen, or are at risk of blocked intestines;
- you had surgery less than 24 hours ago;
- 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
- 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR, 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR
- 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 persistent or chronic cough (as occurs with smoking), high blood pressure
- 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 under a physician’s care
Other warnings you should know about:
Some people metabolize codeine 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR and seek immediate medical help if you start feeling confused, have shallow breathing, or extreme sleepiness. If you know that you metabolize codeine at a much faster rate, tell your doctor BEFORE starting this medication.
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. As with all opioids, taking codeine may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.
Breathing problems:
Avoid taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR if you are under 18 years of age and you are at risk for a breathing problem because you:
- have obstructive sleep apnea
- are obese
- have an existing lung problem
Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.
Pregnancy, nursing, labour and delivery:
Do not use pms-ACETAMINOPHEN WITH CODEINE ELIXIR while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. pms-ACETAMINOPHEN WITH CODEINE ELIXIR can then cause life-threatening breathing problems in your unborn baby or nursing infant.
If you are pregnant and are taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR, 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. pms-ACETAMINOPHEN WITH CODEINE ELIXIR can cause:
- drowsiness
- dizziness or
- lightheadedness
This can usually occur after you take your first dose and when your dose is increased.
Serious skin reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensitivity Syndrome):
Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is life-threatening. Stop taking pms-ACETAMINOPHEN WITH CODEINE and contact your healthcare professional immediately if you develop a rash during treatment (see table of Serious side effects and what to do about them, below).
Liver injury:
Taking acetaminophen in doses higher than recommended may result in liver injury, including the risk of severe liver disease and death. Do not exceed the maximum recommended daily dose of acetaminophen including all routes of administration (intravenous, oral and rectal) and all products containing acetaminophen (oral solutions/drops, syrup, pills, capsules, suppositories etc.).
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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR.
Serotonin Syndrome:
pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR with certain anti-depressants, muscle relaxants 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR:
Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR
- 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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)
- warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots)
- some anti-retroviral drugs (used to treat viral infections)
- some anti-fungal drugs (used to treat fungal infections)
- some antibiotic drugs (used to treat bacterial infections)
- some heart medication (such as beta blockers)
- tranquilizers, sedatives, sedating antihistamines, other depressants
- grapefruit juice
- St. John’s Wort
How to take pms-ACETAMINOPHEN WITH CODEINE ELIXIR:
- Your doctor will prescribe the lowest dose that works to control your pain symptoms.
- It is recommended that you only take pms-ACETAMINOPHEN WITH CODEINE ELIXIR for up to 3 days for fever, and up to 5 days for pain. If you need to take pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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.
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.
Review your pain regularly with your doctor to determine if you still need pms-ACETAMINOPHEN WITH CODEINE ELIXIR. Be sure to use pms-ACETAMINOPHEN WITH CODEINE ELIXIR only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR, tell your doctor immediately.
Usual dose (Adults):
Adults: 10 mL to 20 mL every 4 hours as required if necessary. Do not take more than 5 doses in a 24-hour period.
Your doctor should prescribe pms-ACETAMINOPHEN WITH CODEINE ELIXIR at the lowest effective dose for the shortest period of time. Take pms-ACETAMINOPHEN WITH CODEINE ELIXIR every 4-6 hours as needed
Stopping your Medication
If you have been taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 pms-ACETAMINOPHEN
WITH CODEINE ELIXIR.
Refilling your Prescription for pms-ACETAMINOPHEN WITH CODEINE ELIXIR:
A new written prescription is required from your doctor each time you need more pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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 illness.
Overdose:
Overdose may result in severe or possibly fatal liver damage.
| If you think you have taken too much pms-ACETAMINOPHEN WITH CODEINE ELIXIR., 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 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 pms-ACETAMINOPHEN WITH CODEINE
ELIXIR?
These are not all the possible side effects you may feel when taking pms-ACETAMINOPHEN WITH CODEINE ELIXIR. 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
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using pms-ACETAMINOPHEN WITH CODEINE ELIXIR.
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 | ✓ | ||
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 toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38°C), or rigid | ✓ | ||
| muscles | |||
| Serious Skin Reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensitivity Syndrome): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or joint pain, yellowing of the skin or eyes, dark urine. | ✓ | ||
| VERY RARE | |||
| Liver Injury: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | ✓ | ||
| Redness or swelling in the area of pain, symptoms that do not improve, or if new symptoms appear such as fever, rash, itching, wheezing or persistent headache. | ✓ | ||
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:
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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR in a secure place to prevent theft, misuse or accidental exposure.
- Keep pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR, get emergency help right away.
- Store between 15°C and 30°C in tight, light-resistant containers.
Disposal:
pms-ACETAMINOPHEN WITH CODEINE ELIXIR 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 pms-ACETAMINOPHEN WITH CODEINE ELIXIR:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Heath Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.
Pharmascience Inc.
Montréal, Québec
H4P 2T4
www.pharmascience.com