Patient Medication Information: uses, side effects, how to take - Atasol 15
Serious Warnings and Precautions
Seek immediate medical help for your baby.
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What is ATASOL-15 & ATASOL-30 used for?
ATASOL-15 & ATASOL-30 is used in adults for the relief of mild to moderate pain associated with conditions such as headache, dental pain, muscle pain, rheumatic pain, menstrual pain and the discomfort of fevers due to colds and/or flu.
How does ATASOL-15 & ATASOL-30 work?
ATASOL-15 and ATASOL-30 consist of codeine, acetaminophen, 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.
Acetaminophen reduces pain and fever. Caffeine is a mild stimulant which may enhance pain-relieving effects.
What are the ingredients in ATASOL-15 & ATASOL-30?
ATASOL-15
Medicinal ingredients: Acetaminophen 325 mg, caffeine citrate 30 mg, codeine phosphate 30 mg
Non-medicinal ingredients: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Crospovidone, D&C Yellow 10 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Stearic Acid, Water.
ATASOL-30
Medicinal ingredients: Acetaminophen 325 mg, caffeine citrate 30 mg, codeine phosphate 30 mg
Non-medicinal ingredients: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Crospovidone, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, FD&C Red 40 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Stearic Acid, Water.
ATASOL-15 & ATASOL-30 comes in the following dosage forms:
ATASOL-15
Bottle 100 tablets
ATASOL-30
Bottle 100 tablets
Do not use ATASOL-15 & ATASOL-30 if:
- Your doctor did not prescribe it for you
- you are allergic to acetaminophen, caffeine citrate, and codeine phosphate or any of the other ingredients in ATASOL-15 & ATASOL-30 (see What are the ingredients in ATASOL-15 & ATASOL-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 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
- 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 ATASOL-15 & ATASOL-30, 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 ATASOL-15 & ATASOL-30.
- 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.you have suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
- You have acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale.
- You have severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ATASOL-15 & ATASOL-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 low blood pressure
- have past or current depression
- suffer from chronic or severe constipation
- have problems with your adrenal or prostate gland
- have persistent or chronic cough (as occurs with smoking), glaucoma, high blood pressure
- have problems with your thyroid, adrenal or prostate gland
- have, or had in the past, hallucinations or other severe mental problems
- 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. This may lead to accidental overdose. Stop taking ATASOL-15 & ATASOL-30 and seek immediate medical helps 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 ATASOL -15 & ATASOL 30 if you are under 18 years of age and you are at risk for breathing problems because you:
- have obstructive sleep apnea
- are obese
- have an existing lung problem
Pregnancy, nursing, labour and delivery: Do not use ATASOL-15 & ATASOL-30 while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. ATASOL-15 & ATASOL-30 can then cause life-threatening breathing problems in your unborn baby or nursing infant.
If you are pregnant and are taking ATASOL-15 & ATASOL-30, 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 ATASOL-15 & ATASOL-30. 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 ATASOL-15 & ATASOL-30. ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30.
Serotonin Syndrome: ATASOL-15 & ATASOL-30can 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 ATASOL-15 & ATASOL-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.
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 ATASOL-15 & ATASOL-30:
alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30 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 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
- drugs used to treat migraines (e.g. triptans)
- St. John’s Wort
How to take ATASOL-15 & ATASOL-30:
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:
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 ATASOL-15 & ATASOL-30 for up to 7 days. If you need to take ATASOL-15 & ATASOL-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.
Take 1-2 tablets every 4 to 6 hours as needed, up to a maximum of 4 tablets daily or as recommended by a physician or a dentist.
Review your pain regularly with your doctor to determine if you still need ATASOL-15 & ATASOL-30. Be sure to use ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30, tell your doctor immediately.
Stopping your Medication
If you have been taking ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30. 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 ATASOL-15 & ATASOL-30.
Refilling your Prescription for ATASOL-15 & ATASOL-30:
A new written prescription is required from your doctor each time you need more ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30?
These are not all the possible side effects you may feel when taking ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30.
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 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:
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 ATASOL-15 & ATASOL-30 in a secure place to prevent theft, misuse or accidental exposure.
- Keep ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30, get emergency help right away.
- Store tablets at room temperature (15˚- 25˚C). Keep in a dry place.
Disposal:
ATASOL-15 & ATASOL-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 ATASOL-15 & ATASOL-30:
- 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.atasol.ca or by calling 1-800-268-3186.