Procet-30: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take PROCET-30 as prescribed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
• When you take PROCET-30, it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablets. This can be dangerous and can lead to death or seriously harm you.
• You may get life-threatening breathing problems while taking PROCET-30. 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 PROCET-30. They could die from taking it. If a person has not been prescribed PROCET-30, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took PROCET-30 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 PROCET-30 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 PROCET-30 used for?

PROCET-30 is used to manage your pain and as an alternative of non-aspirin type medication for acute colds and other acute respiratory diseases.

How does PROCET-30 work?

PROCET-30 is a painkiller belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in PROCET-30?

Medicinal ingredients: Acetaminophen and codeine phosphate

Non-medicinal ingredients: Colloidal Silicon Dioxide, Crospovidone, Lactose, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid, Sunset Yellow FCF (FD&C Yellow No.6) Aluminium Lake and Talc.

PROCET-30 comes in the following dosage forms:

Tablets: 300 mg acetaminophen and 30 mg codeine phosphate

Do not use PROCET-30 if:

• your doctor did not prescribe it for you

• you are allergic to acetaminophen or codeine phosphate or any of the other ingredients in

  PROCET-30

• 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 acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale
• you have any heart problems
• you have severe liver problems or severe active liver disease
• you have suspected surgical abdomen (e.g., acute appendicitis or pancreatitis)
• 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 suffer from alcoholism
• you have severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury

• 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 are pregnant or planning to become pregnant or you are in labour
• you are breastfeeding
• 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
• you are under 12 years old

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PROCET-30. 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:

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 PROCET-30 while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. PROCET-30 can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to PROCET-30. PROCET-30 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 PROCET-30.

Serotonin Syndrome: PROCET-30 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 PROCET-30 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.

Ultra-Rapid Metabolizers of Codeine:

Some individuals process codeine more rapidly and completely than others. This rapid processing in the body results in higher than expected drug levels. Even at the recommended doses, people whose bodies are ultra-rapid processors may have life-threatening or fatal effects on their breathing or experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

Drug Abuse and Dependence:

Codeine can produce drug dependence and has the potential for being abused. Tolerance, psychological and physical dependence may develop over time with repeated use of PROCET-

1. 30. Your healthcare professional should prescribe and administer PROCET-30 with the same degree of caution appropriate to the use of other oral opioid medications. Using these products for a prolonged period of time is not recommended.

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 PROCET-30 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.).

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 PROCET-30:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking PROCET-30. 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 PROCET-30
• 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 PROCET-30 with

  MAO inhibitors (MAOI) or if you have taken MAOIs in the last 14 days.

• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• drugs used to treat migraines (e.g. triptans)
• antihistamines (drugs used to treat allergies)
• antiemetics (drugs used for the prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots)
• grapefruit juice
• St. John’s Wort

How to take PROCET-30:

• usually 1 to 2 tablets every 6 hours, or as directed by your doctor.
• with a full glass of water

Do not take with other drugs containing acetaminophen.

Do not exceed the maximum recommended dose. Overdose may result in severe or possibly fatal liver damage.

Swallow whole. Do not cut, break, crush, chew or dissolve the tablets. This can be dangerous and can lead to death or seriously harm you.

Usual Adult Starting Dose:

Take 1 tablet every 4-6 hours as required, not to exceed 12 tablets in 24 hours. If pain does not respond to 1 tablet, take 2 tablets at next 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 PROCET-30 for up to 7 days. If you need to take PROCET-30 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 PROCET-30. Be sure to use PROCET-30 only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking PROCET-30, tell your doctor immediately.

Stopping your Medication

If you have been taking PROCET-30 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 PROCET-30. You should check with your doctor for directions on how to slowly stop taking it. 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 PROCET-30.

Refilling your Prescription for PROCET-30:

A new written prescription is required from your doctor each time you need more PROCET-30. 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 PROCET-30, 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 PROCET-30?

These are not all the possible side effects you may feel when taking PROCET-30. 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 PROCET-30.

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

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/adverse-reaction-reporting.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 PROCET-30 in a secure place to prevent theft, misuse or accidental exposure.
• Store tablets at room temperature (15 – 30°C). Keep in a dry place.
• Keep PROCET-30 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 PROCET-30, get emergency help right away.

Disposal:

PROCET-30 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 PROCET-30:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient 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 Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée

Laval, Québec H7L 3W9

Last Revised: February 7, 2019