Patient Medication Information: uses, side effects, how to take - 292 Tablets

Serious Warnings and Precautions

Even if you take 282 and 292 as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.

o When you take 282 and 292, it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

You may get life-threatening breathing problems while taking 282 and 292. 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 282 and 292. They could die from taking it. If a person has not been prescribed 282 and 292, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took 282 and 292 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:
o has changes in their breathing (such as weak, difficult or fast breathing)
o is unusually difficult to comfort
o has tremors (shakiness)
o has increased stools, sneezing, yawning, vomiting, or fever Seek immediate medical help for your baby.
Taking 282 and 292 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 are 282 and 292 used for?

282 and 292 are used to manage your pain in adults.

How does 282 and 292 works?

282 and 292 consist of codeine, acetylsalicylic acid (ASA), and caffeine.

Codeine 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. ASA reduces pain, fever and inflammation. Caffeine is a mild stimulant which may enhance pain-relieving effects.

What are the ingredients in 282 and 292?

282 tablets

Medicinal ingredients:

Acetylsalicylic add 375 mg

Caffeine 15 mg (equivalent to 30 mg caffeine citrate) Codeine phosphate 15 mg

Non-medicinal ingredients (in alphabetical order): Corn Starch, Disodium EDTA, Ethylcellulose, FD&C Yellow No. 6 and D&C Yellow No. 10, Guar Gum, Hydrogenated Vegetable Oil, Monopotassium Citrate and Sodium Lauryl Sulfate.

292 tablets

Medicinal ingredients

Acetylsalicylic add 375 mg

Caffeine 15 mg (equivalent to 30 mg caffeine citrate) Codeine phosphate 30 mg

Non-medicinal ingredients (in alphabetical order): Corn Starch, Disodium EDTA, Ethylcellulose, FD&C Yellow No. 6 Lake, Guar Gum, Hydrogenated Vegetable Oil, Monosodium Citrate and Sodium Lauryl Sulfate.

282 and 292 comes in the following dosage forms:

Tablets

Do not use 282 and 292 if:

your doctor did not prescribe it for you
you are allergic to Acetylsalicylic acid, Codeine Phosphate, Caffeine or any of the other ingredients in 282 and 292
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 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 allergic to any other non-steroidal anti-inflammatory drugs (NSAIDs) or other pain relievers/fever reducers
you have an ulcer or a history of ulcers
you are prone to bleeding
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 282 and 292, 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 282 and 292.
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 less than 12 years old

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take 282 and 292. 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
suffer from migraines
are pregnant or planning to become pregnant
are planning to become pregnant
Suffer from migraines

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.

282 and 292 are 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

If contraindicated, add: Do not use 282 and 292 while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. 282 and 292 can then cause life-threatening breathing problems in your unborn baby or nursing infant. If you are pregnant and are taking 282 and 292, 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 taking282 and 292. 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 282 and 292. 282 and 292 can cause:

drowsiness
dizziness or
light-headedness

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 282 and 292.

Serotonin Syndrome

282 and 292 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 282 and 292 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 282 and 292:

Alcohol. This includes prescription and non-prescription medications that contain alcohol.
Do not drink alcohol while you are taking 282 or 292. 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 282 or 292
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 282 and 292 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)
St. John’s Wort

How to take 282 and 292:

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

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.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take 282 and 292 for up to 7 days. If you need to take 282 and 292 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 Dose:

One (1) or two (2) tablets with a large glass of water (250 mL) every 4 to 6 hours, as required.

Review your pain regularly with your doctor to determine if you still need 282 or 292. Be sure to use 282 and 292 only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking 282 and 292, tell your doctor immediately.

Stopping your Medication

If you have been taking 282 or 292 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 282 and 292. 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 282 and 292.

Refilling your Prescription for 282 and 292

A new written prescription is required from your doctor each time you need more 282 and 292. 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 282 or 292, 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 282 and 292?

These are not all the possible side effects you may feel when taking 282 or 292. 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 282 or 292.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional		Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases	Stop taking drug and get immediate medical help
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 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/adverse-reaction-reporting.html#a1) 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 282 and 292 in a secure place to prevent theft, misuse or accidental exposure.
Store between 15°C - 30°C. Protect from light and moisture
Keep 282 and 292 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 282 and 292, get emergency help right away.

Disposal:

282 and 292 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 282 and 292:

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.pendopharm.ca, or by calling 1-888-550-6060.

292 Tablets: Uses, Side Effects and Dosage