How to use
See also section Warnings.
Read the Medication Guide and, if available, the package insert from your pharmacist before you start taking this medicine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medicine by mouth as directed by your doctor. You can take this medicine with or without food. If you have nausea, it may help to take this medicine with food. Ask your doctor or pharmacist about other ways to reduce nausea (for example, lying down for 1 to 2 hours with as little head movement as possible).
If you are using a liquid form of this medicine, use a dosing meter to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. You must not increase the dose, take the medicine more often or take it for longer than prescribed. Stop taking the medicine properly when told to do so.
Pain medication works best if used when the first signs of pain appear. If you wait until the pain has worsened, the medicine may not work as well.
If you have persistent pain (due to cancer, for example), your doctor may ask you to also take long-acting opioid medications. In that case, this medicine can only be used for sudden (breakthrough) pain as needed. Other pain relievers (such as ibuprofen, naproxen) may also be prescribed. Ask your doctor or pharmacist about the safe use of this product together with other medicines.
Stopping this medicine suddenly can cause withdrawal, especially if you have been using it for a long time or in high doses. To prevent withdrawal, your doctor may reduce your dose slowly. Tell your doctor or pharmacist right away if you have withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, suicidal thoughts), watery eyes, runny nose, nausea, diarrhea, sweating, muscle pain, or sudden changes in behavior.
When this medicine is used for a long time, it may not work as well. Talk to your doctor if this medicine stops working well.
Although it helps many people, this medication can sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse or dependence on drugs/alcohol). Take this medicine exactly as prescribed to reduce the risk of addiction. Ask your doctor or pharmacist for more information.
Tell your doctor if your pain does not improve or if it gets worse.
Side effects
See also section Warnings.
Nausea, vomiting, constipation, dizziness, lightheadedness or drowsiness may occur. Some of these side effects may subside after you have used this medicine for a while. If any of these side effects persist or worsen, tell your doctor or pharmacist immediately.
To prevent constipation, you should eat dietary fibre, drink enough water and exercise. It may also be necessary to take a laxative. Ask your pharmacist which type of laxative is right for you.
To reduce the risk of dizziness and lightheadedness, stand up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medicine because he or she has judged that the benefits for you are greater than the risk of side effects. Many people who use this medicine do not have serious side effects.
Tell your doctor right away if you get any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as restlessness, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, signs that your adrenal glands are not working properly (such as loss of appetite, unusual tiredness, weight loss).
Get immediate medical help if you experience very serious side effects, including: fainting, seizures, slow/shallow breathing, severe drowsiness/difficulty waking up.
A very serious allergic reaction to this medicine is rare. However, seek medical help right away if you notice symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, difficulty breathing.
This is not a complete list of possible side effects. If you notice other side effects not mentioned above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Consult your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.
Warnings and precautions
Storage
Store at room temperature protected from light and moisture. Different brands of this medicine have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medicines away from children and pets.
Do not flush medicines down the toilet or pour them down the drain unless you are told to do so. Dispose of this product properly when it has expired or is no longer needed. For more information, read the Medication Guide, or contact the pharmacy or local waste management company.
Interactions with medicinal products
See also section Warnings.
Drug interactions can change how your medicines work or increase your risk of serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/over-the-counter and herbal medicines) and share it with your doctor and pharmacist. Do not start, stop or change the dosage of any medication without your doctor’s approval.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist/antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.
The risk of serious side effects (eg, slow/shallow breathing, severe drowsiness/dizziness) may increase if this medicine is taken with other medicines that can also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other medicines such as other opioid medicines for pain or cough (eg codeine, oxycodone), alcohol, marijuana (cannabis), medicines for sleep or anxiety (eg alprazolam, lorazepam, zolpidem) , muscle relaxants (eg carisoprodol, cyclobenzaprine) or antihistamines (eg cetirizine, diphenhydramine).
Check the labels of all your medications (such as allergy or cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist how to use these products safely.
Other medicines can affect the excretion of hydrocodone/paracetamol from your body, which may affect how hydrocodone/paracetamol works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristone, HIV drugs (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin) .
This medication may interfere with certain laboratory tests (including amylase/lipase levels), which may cause false test results. Make sure laboratory personnel and all your doctors know that you are using this medicine.
Overdose
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Missed doses:
If you take this product regularly and miss a dose, take it as soon as you remember. If it is close to the time for the next dose, skip the missed dose. Take the next dose at the usual time. Do not double the dose to make up for what was lost.
Notes:
Do not share this medicine with others. Sharing it is against the law.
This medication is only prescribed for your current condition. Do not use it later for another condition unless your doctor tells you to. In that case, another medicine may be needed.
Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Educate your family or household members about the signs of an opioid overdose and how to treat them.
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