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Cophylac

(normethadone - hydroxyephedrine)

How does this medication work? What will it do for me?

This combination product contains two medications: normethadone and hydroxyephedrine. Normethadone - hydroxyephedrine belongs to the class of medications called antitussives. This medication is used to treat coughs that have not responded to other treatments. It works by blocking pain signals that are sent out by the brain to various areas of the body and reduces cough by acting in the brain to dull the cough reflex.

Note that a cough is a symptom. Before taking a cough suppressant, it is important to assess the underlying cause of the cough.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For adults and adolescents over 14 years of age, the usual recommended dose is 15 drops twice daily, preferably after breakfast and at bedtime.

For children between 6 and 14 years of age , the usual recommended dose is 5 to 10 drops 2 times daily, preferably after breakfast and at bedtime.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

You should always use the dropper that comes with the bottle of normethadone - hydroxyephedrine. To take the medication, turn the drop-dispensing bottle upside down.

This medication can be taken on its own or with some sugar. It can also be added to a drink (e.g., juice); if this is done, make sure you consume all of the drink to ensure you get the full dose of the medication.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, and keep it out of the reach of children. Accidental ingestion of this medication by a child can be fatal.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Normethadone - hydroxyephedrine is no longer being manufactured for sale in Canada and is no longer available under any brand names. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.

Who should NOT take this medication?

Do not take normethadone - hydroxyephedrine if you:

  • are allergic to normethadone, hydroxyephedrine, or any ingredients of the medication
  • are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the past 2 weeks
  • have a head injury, increased intracranial pressure (pressure inside the head), or severe central nervous system depression (a slowing of the central nervous system leading to decreased heart rate, decreased breathing rate, or loss of consciousness)
  • have asthma, chronic obstructive airway disease, or dangerously slow or shallow breathing (respiratory depression)
  • are pregnant, in labour, or breast-feeding
  • have paralysis of the gut or a suspected bowel obstruction
  • have convulsions or a seizure disorder

Do not give this medication to children under the age of 6 years.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • itching
  • nausea
  • sweating
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fainting
  • fast, slow or irregular heartbeat
  • severe dizziness when getting up from a sitting or lying position
  • symptoms of a bowel blockage (e.g., abdominal pain, severe constipation, nausea)
  • vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a severe allergic reaction (e.g., hives; difficulty breathing; and swelling of the tongue, face, mouth, or throat)
  • slow, shallow, or weak breathing
  • symptoms of too much medication (e.g., pinpoint pupils, vomiting, extreme sleepiness, a fast heartbeat, cold, clammy skin, feeling faint or confused, being unable walk or talk normally, hallucinations, trouble breathing, or shallow breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

August 24, 2020

Health Canada has issued new restrictions concerning the use of etafedrine - doxylamine - hydrocodone. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

A previous advisory on codeine was issued on February 18, 2019. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People taking this medication should not consume alcohol since doing so can increase the risk of serious side effects, or a potentially fatal overdose. It is not recommended for people with alcohol abuse problems.

Breathing: Normethadone - hydroxyephedrine can suppress breathing. This effect on breathing may be more pronounced for people who have breathing problems or brain damage, or who are taking other medications that suppress breathing. If you have breathing problems, such as COPD, asthma or respiratory depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: Normethadone - hydroxyephedrine can be very constipating. If you develop constipation easily, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with chronic constipation should take this medication only if the benefit outweighs the risks.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of normethadone. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: Normethadone - hydroxyephedrine may cause drowsiness. Do not drive, operate machinery, or perform any potentially hazardous tasks until you have made sure that this medication does not make you drowsy.

Head injury: Normethadone - hydroxyephedrine can cause increased pressure inside the head. If you have acute head injuries or other conditions which increase intracranial pressure (pressure inside the head), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: This medication can cause low blood pressure or make low blood pressure worse. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

Pregnancy: This medication can cross the placenta and reach the developing baby during pregnancy. It should not be used during pregnancy unless the benefits outweigh the risks. Babies born to mothers who have taken this medication during pregnancy can experience life-threatening withdrawal symptoms. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking normethadone - hydroxyephedrine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Children are at greater risk of experiencing breathing difficulty with the use of this medication. This medication should not be used in children under the age of 6.

Seniors: Seniors may be more at risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction normethadone - hydroxyephedrine and any of the following:

  • alcohol
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • beta-blockers (e.g., atenolol, metoprolol)
  • monoamine oxidase inhibitors (MAOIs; e.g., linezolid, moclobemide, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
  • zolpidem
  • zopiclone

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Cophylac

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