Teva-Codeine: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TEVA-CODEINE used for?

Pain: TEVA-CODEINE is used for adults to relieve mild to moderate pain of various causes.

Cough: TEVA-CODEINE is used for adults to relieve non-productive cough that does not respond to other cough medicines.

TEVA-CODEINE is not for use in patients younger than 18 years of age. In patients this age, the risks of life-threatening breathing problems outweigh the benefits of treating the cough with codeine.

Your pain may increase or decrease from time to time and your doctor may need to change the amount of codeine you take daily (daily dosage).

How does TEVA-CODEINE work?

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. Codeine acts on the brain to suppress cough.

What are the ingredients in TEVA-CODEINE?

Medicinal ingredients: Codeine phosphate

Non-medicinal ingredients:

Tablets - microcrystalline cellulose, lactose, stearic acid, magnesium stearate, dioxide silicon. Sulfite- Sodium-Parabens-Gluten-Free.

TEVA-CODEINE comes in the following dosage forms:

Tablet: 15mg and 30 mg

Do not use TEVA-CODEINE if:

• your doctor did not prescribe it for you
• your pain is mild
• you are allergic to codeine phosphate or any of the other ingredients in TEVA-CODEINE
• 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 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 TEVA-CODEINE, 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 TEVA-CODEINE.

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

Stop taking TEVA-CODEINE and consult with your healthcare professional if:

• you get a high fever, rash or persistent headache along with the cough.
• your symptoms or cough worsen or continue for more than 7 days.

These could be signs of a serious condition.

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 TEVA-CODEINE 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

Pregnancy, nursing, labour and delivery:

Do not use TEVA-CODEINE while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. TEVA-CODEINE can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking TEVA-CODEINE, 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 TEVA-CODEINE. 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 TEVA-CODEINE. TEVA-CODEINE 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 TEVA-CODEINE.

Serotonin Syndrome: TEVA-CODEINE 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 TEVA-CODEINE 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 TEVA-CODEINE:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TEVA-CODEINE. 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 TEVA-CODEINE
• 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 TEVA-CODEINE 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 TEVA-CODEINE:

• Your doctor will prescribe the lowest dose that works to control your pain symptoms.
• It is recommended that you only take TEVA-CODEINE for up to 7 days. If you need to take TEVA-CODEINE 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.

• TEVA-CODEINE may be taken with or without food, with a glass of water.

TEVA-CODEINE tablets must be swallowed whole and should not be chewed, dissolved or crushed, since this can cause the release of too much codeine that can seriously harm you. The 30 mg strength has a score line to facilitate halving, if directed by your doctor. The half tablets should also be swallowed intact.

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 TEVA-CODEINE. Be sure to use TEVA-CODEINE only for the condition for which it was prescribed.

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

TEVA-CODEINE is not recommended for rectal administration.

Usual dose (Adults):

Pain:

Tablets: 15 to 60 mg every 4 to 6 hours if necessary.

Cough:

Tablets: 15 to 30 mg every 6 to 8 hours if necessary to a maximum of 120 mg daily.

Your doctor should prescribe TEVA-CODEINE at the lowest effective dose for the shortest period of time. Take TEVA-CODEINE every 4-6 hours as needed.

Stopping your Medication

If you have been taking TEVA-CODEINE 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 TEVA-CODEINE. 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 TEVA-CODEINE.

Refilling your Prescription for TEVA-CODEINE:

A new written prescription is required from your doctor each time you need more TEVA-CODEINE. 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:

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 TEVA-CODEINE?

These are not all the possible side effects you may feel when taking TEVA-CODEINE. 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 TEVA-CODEINE.

Serious side effects and what to do about them

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

Storage:

• Keep unused or expired TEVA-CODEINE in a secure place to prevent theft, misuse or accidental exposure.
• Keep TEVA-CODEINE 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 TEVA-CODEINE, get emergency help right away.
• Store at room temperature 15 – 30°C. Keep in a dry place.

Disposal:

TEVA-CODEINE 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 TEVA-CODEINE:

• 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); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last Revised: November 5, 2019