Consumer Information for: TEVA-EMTEC-30

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Pain: TEVA-EMTEC-30 is used to manage pain in adults.
Cough: TEVA-EMTEC-30 is used as an alternative of non-aspirin type medication for acute colds and other acute respiratory diseases in adults.

TEVA-EMTEC-30 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.

What it does

TEVA-EMTEC-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. Codeine acts on the brain to suppress cough.

When it should not be used

  • your doctor did not prescribe it for you
  • you are allergic to acetaminophen or codeine phosphate or any of the other ingredients in TEVA-EMTEC-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 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 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 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. The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take TEVA-EMTEC-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 TEVA-EMTEC-30
What the medicinal ingredient is

Acetaminophen and codeine phosphate

What the non-medicinal ingredients are

FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate

What dosage form it comes in

Tablets: 300 mg acetaminophen and 30 mg codeine phosphate

Warnings and precautions

Serious Warnings and Precautions

  • Even if you take TEVA-EMTEC-30 as prescribed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
  • When you take TEVA-EMTEC-30, it must be swallowed whole. Do not cut, break, crush, chew or 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 TEVA-EMTEC-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 TEVA-EMTEC-30. They could die from taking it. If a person has not been prescribed TEVA-EMTEC-30, taking even one dose can cause a fatal overdose. This is especially true for children.
  • If you took TEVA-EMTEC-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 TEVA-EMTEC-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.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-EMTEC-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 or lung disease
  • have heart 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-EMTEC-30 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-EMTEC-30 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-EMTEC-30 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-EMTEC-30 while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. TEVA-EMTEC-30 can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking TEVA-EMTEC-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 TEVA-EMTEC-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 TEVA-EMTEC-30. TEVA-EMTEC-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 TEVA-EMTEC-30.

Serotonin Syndrome: TEVA-EMTEC-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 TEVA-EMTEC-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.

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 TEVA-EMTEC-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.

Interactions with this medication
  • Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TEVA-EMTEC-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 TEVA-EMTEC-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 TEVA-EMTEC-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)
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (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)
  • 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)
  • drugs used to treat migraines (eg. triptans)
  • grapefruit juice
  • St. John’s Wort

Proper use of this medication
  • Your doctor will prescribe the lowest dose that works to control your symptoms.
  • It is recommended that you only take TEVA-EMTEC-30 for up to 7 days. If you need to take TEVA-EMTEC-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.
  • TEVA-EMTEC-30 may be taken with or without food, with a 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 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

Review your pain regularly with your doctor to determine if you still need TEVA-EMTEC-30. Be sure to use TEVA-EMTEC-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 TEVA-EMTEC-30, tell your doctor immediately.

Stopping your Medication

If you have been taking TEVA-EMTEC-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 TEVAEMTEC-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 TEVA-EMTEC-30.

Refilling your Prescription for TEVA-EMTEC-30

A new written prescription is required from your doctor each time you need more TEVAEMTEC-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 illness.

Overdose

If you think you have taken too much TEVA-EMTEC-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.

Side effects and what to do about them

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

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional 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.

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

Disposal

TEVA-EMTEC-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.

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.

More information

This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9

Last Revised: November 1, 2019

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