Calmylin ACE: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take CALMYLIN ACE as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
• You may get life threatening breathing problems while taking CALMYLIN ACE. 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 CALMYLIN ACE. They could die from taking it. If a person has not been prescribed CALMYLIN ACE, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took CALMYLIN ACE 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 CALMYLIN ACE 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.

What is CALMYLIN ACE used for?

CALMYLIN ACE is used for the temporary relief, in adults, of dry coughs, chest congestion, runny nose and sneezing associated with:

• the common cold

CALMYLIN ACE 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.

How does CALMYLIN ACE work?

Codeine Phosphate acts on the brain to suppress cough.

Guaifenesin helps relieve chest congestion.

Pheniramine Maleate helps relieve runny nose and sneezing.

What are the ingredients in CALMYLIN ACE?

Medicinal ingredients: Guaifenesin, Codeine Phosphate and Pheniramine Maleate

Non-medicinal ingredients: Alcohol, amaranth, artificial coloring and flavoring, caramel, citric acid, FD&C yellow #6, glycerine, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate dehydrate, sodium cyclamate and sucrose. Alcohol: 4.1 % v/v. Sucrose: 45 %.

CALMYLIN ACE comes in the following dosage forms:

Syrup, each 5 mL of which contains: guaifenesin 100 mg, codeine phosphate 10 mg and pheniramine maleate 7.5 mg

Do not use CALMYLIN ACE if you:

• your doctor did not prescribe it for you
• are allergic to guaifenesin, codeine phosphate and pheniramine maleate or to any of the other ingredients in CALMYLIN ACE
• have severe asthma, trouble breathing, or other breathing problems
• you have acute respiratory depression, elevated carbon dioxide levels in the blood and
• cor pulmonale
• have bowel blockage or narrowing of the stomach or intestines
• have a head injury
• are at risk for having seizures
• have diabetes
• have heart or thyroid problems
• have glaucoma
• suffer from alcoholism

• are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi)

  (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)

• have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose.
• are pregnant or planning to become pregnant or you are in labour
• are breastfeeding. The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take CALMYLIN ACE, 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 CALMYLIN ACE

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CALMYLIN ACE. 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 adrenal or prostate gland
• have, or had in the past hallucinations or other severe mental problems
• 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. Stop taking CAMYLIN ACE 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 CALMYLIN ACE 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 any 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.

Pregnancy, nursing, labour and delivery:

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

If you are pregnant and are taking CALMYLIN ACE, 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 CALMYLIN ACE. 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 CALMYLIN ACE. CALMYLIN ACE 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 CALMYLIN ACE.

Serotonin Syndrome: Codeine, one of the ingredients of CALMYLIN ACE 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 CALMYLIN ACE with certain antidepressants 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 CALMYLIN ACE:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking CALMYLIN ACE. 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 CALMYLIN ACE
• 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 CALMYLIN ACE 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 to treat allergies)
• antitussives
• decongestants
• expectorants
• anti-emetics (drugs used to prevent 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, other salicylates
• drugs used to treat migraines (eg. triptans)
• grapefruit juice
• St. John’s Wort

How to take CALMYLIN ACE:

• Your doctor will prescribe the lowest dose that works to control your symptoms.
• It is recommended that you only take CALMYLIN ACE for up to 7 days. If you need to take CALMYLIN ACE 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.
• CALMYLIN ACE may be taken with or without food, with a glass of water.

Usual Dose:

Take every 4–6 hours or as directed by a physician. Maximum 6 doses daily (60 mL). Adults: 2 teaspoons (10 mL)

Stopping your Medication

If you have been taking CALMYLIN ACE 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 CALMYLIN ACE. 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 CALMYLIN ACE.

Refilling your Prescription for CALMYLIN ACE

A new written prescription is required from your doctor each time you need more CALMYLIN ACE. 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 CALMYLIN ACE, 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:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

What are possible side effects from using CALMYLIN ACE?

These are not all the possible side effects you may feel when taking CALMYLIN ACE. 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

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

✓

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

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 CALMYLIN ACE in a secure place to prevent theft, misuse or accidental exposure.
• Keep CALMYLIN ACE 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 CALMYLIN ACE, get emergency help right away.

• Store at room temperature (15°-30°C).protect from light.

Disposal:

CALMYLIN ACE 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 CALMYLIN ACE:

• 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: September 02, 2020