Teva-Lenoltec No. 1: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TEVA-LENOLTEC No. 1 used for?

• the short-term relief of mild to moderate pain.

TEVA-LENOLTEC No. 1 should not be taken for pain for more than 5 days, unless directed by your healthcare professional.

How does TEVA-LENOLTEC No. 1 work?

TEVA-LENOLTEC No. 1 combines the effects of the pain reliever, codeine, which acts on the brain and spinal cord, with the pain reliever, acetaminophen. TEVA-LENOLTEC No. 1 also contains caffeine. Caffeine is a stimulant that increases activity in the brain and generally makes people feel more alert. It also affects the kidneys by causing an increased production of urine, and can increase your heart rate.

What are the ingredients in TEVA-LENOLTEC No. 1?

Medicinal ingredients: acetaminophen, caffeine and codeine phosphate.

Non-medicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silica colloidal anhydrous.

TEVA-LENOLTEC No. 1 comes in the following dosage forms:

Acetaminophen 300 mg, Caffeine 15 mg and Codeine Phosphate 8 mg, caplets or tablets.

Do not use TEVA-LENOLTEC No. 1 if:

• you are allergic to acetaminophen, caffeine, codeine or other opioids or any of the other ingredients in TEVA-LENOLTEC No. 1
• you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
• you have asthma, trouble breathing, chronic lung disease or other chronic breathing problems
• you have any heart problems
• you have bowel blockage or narrowing of the stomach or intestines or have been told that you are at risk for this
• you have severe pain in your abdomen
• you have a head injury
• you suffer from severe reduction in functions controlled by the brain such as breathing, heart rate and consciousness or you have increased pressure in your head or spinal cord
• you suffer from seizures

• you suffer from alcoholism or severe alcohol withdrawal

• 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
• you are in labour
• you are breastfeeding
• you have serious liver or kidney problems
• you have slow or shallow breathing, elevated carbon dioxide levels in the blood or a condition called “cor pulmonale” in which part of the heart is enlarged or does not work correctly due to high blood pressure in the lungs
• you convert codeine into its active metabolite more rapidly and completely than other people (see Ultra-Rapid Metabolizers of Codeine)
• you are less than 18 years old

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-LENOLTEC No. 1. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or consume 3 or more alcoholic beverages per day
• 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 thyroid, adrenal or prostate gland
• have difficulty urinating
• have, or had in the past hallucinations or other severe mental problems
• develop allergic reactions such as wheezing, rash or itching
• feel sedated or drowsy, are confused or have slow, shallow breathing

• have redness or swelling present in an area of pain, if symptoms do not improve or if they worsen, or if new symptoms such as high fever, rash, itching, wheezing or persistent

  headache occur

• have pain that lasts more than 5 days or for fever more than 3 days
• have difficulty breathing, asthma or chronic lung disease
• are pregnant or are planning to get pregnant
• suffer from migraines
• are elderly or debilitated
• take tranquilizers, sedatives, sedating antihistamines or other depressants, salicylates, other pain and fever relief medications or nonsteroidal anti-inflammatory drugs (NSAIDs)
• take, or plan to take a serotonergic drug, or are not sure whether you are taking a serotonergic drug (e.g. anti-depressants, migraine medications)
• have recently had surgery under general anesthesia

Other Warnings you should know about:

Ultra-Rapid Metabolizers of Codeine:

Some individuals process codeine more rapidly and completely than others. This rapid processing in the body results in higher than expected drug levels. Even at the recommended doses, people whose bodies are ultra-rapid processors may have life-threatening or fatal effects on their breathing or experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

Drug Abuse and Dependence and Tolerance

Like any opioid, if you use TEVA-LENOLTEC No. 1 for a long time, it may cause mental and physical dependence. Codeine also has the potential to cause addiction. There are important differences between physical dependence and addiction. If you use opioids for a long time, you may develop tolerance. This means that you may need higher doses of TEVA-LENOLTEC No. 1 to feel the same level of pain relief. It is important that you talk to your doctor if you have questions or concerns about addiction, physical dependence, or tolerance.

Your healthcare professional should give you TEVA-LENOLTEC No. 1 with the same level of caution as other oral opioid drugs. It is not recommended to use this drug for a long period of time.

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-LENOLTEC No. 1 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.).

Pregnancy, nursing, labour and delivery: Do not use TEVA-LENOLTEC No. 1 while nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while it is still in the womb. TEVA-LENOLTEC No. 1 can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant, your doctor will determine if the benefits of using TEVA-LENOLTEC No. 1 outweigh the risks to your unborn baby. In addition, if you are pregnant and are taking this medication, it is important that you don’t stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking TEVA-LENOLTEC No. 1. 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-LENOLTEC No. 1.

TEVA-LENOLTEC No. 1 can cause:

• drowsiness
• dizziness or
• lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Serotonin Syndrome: TEVA-LENOLTEC No. 1 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-LENOLTEC No. 1 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.

Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices you stop breathing from time to time while sleeping.

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. If you develop any of the above symptoms, seek medical help right away.

Worsened Pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia), even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your doctor if you notice a change like this in your pain while you are taking TEVA-LENOLTEC No. 1.

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 medications may interact with TEVA-LENOLTEC No. 1:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TEVA-LENOLTEC No. 1. 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-LENOLTEC No. 1.
• 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-LENOLTEC No. 1 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)
• drugs used to treat migraines (e.g., triptans)
• 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)
• anti-retroviral drugs (used to treat viral infections)
• anti-fungal drugs (used to treat fungal infections)
• antibiotic drugs (used to treat bacterial infections)
• some heart medication (such as beta blockers)
• St. John’s Wort

How to take TEVA-LENOLTEC No. 1:

Use the smallest effective dose for the shortest period of time. Only take this medication when you need it, and never more often than every 4 to 6 hours.

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 tablet. This can be dangerous and can lead to death or seriously harm you.

Usual dose (Adults ≥ 18 years of age):

TEVA-LENOLTEC No. 1 caplets or tablets:

Take 1 caplet/tablet every 4-6 hours as required, not to exceed 12 caplets/tablets in 24 hours. If pain does not respond to 1 caplet/tablet, take 2 caplets/tablets at next dose.

Overdose:

Overdose may result in severe or possibly fatal liver damage.

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-LENOLTEC No. 1?

These are not all of the possible side effects you may feel when taking TEVA-LENOLTEC No. 1. 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, or uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Low sex drive, impotence (erectile dysfunction), or infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using TEVA-LENOLTEC No. 1.

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:

• TEVA-LENOLTEC No. 1 caplets and tablets: Protect from light. Store between 15°C – 30°C.
• Keep out of reach and sight of children.

If you want more information about TEVA-LENOLTEC No. 1:

• Talk to your healthcare professional
• Find the full Prescribing Information 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: October 12, 2022