Patient Medication Information: uses, side effects, how to take - Ratio-Codeine

Serious Warnings and Precautions

Even if you take ratio-CODEINE as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
When you take ratio-CODEINE it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
You may get life-threatening breathing problems while taking ratio-CODEINE. This is less likely to happen if you take it as prescribed by your doctor.
You should never give anyone your ratio-CODEINE. They could die from taking it. If a person has not been prescribed ratio-CODEINE, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took ratio-CODEINE 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 ratio-CODEINE 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 ratio-CODEINE used for?

ratio-CODEINE is used for adults and children 12 years and older to relieve:

mild to moderate pain
non-productive cough that does not respond to other cough medicines

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 ratio-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.

ratio-CODEINE 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.

ratio-Codeine is indicated for the symptomatic treatment of mild to moderate pain of various causes and the control of exhausting, nonproductive cough which does not respond to non-opioid antitussives.

What are the ingredients in ratio-CODEINE?

Medicinal ingredients: Codeine phosphate

Non-medicinal ingredients:

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

Syrup - ethyl alcohol, purified water, sodium benzoate, sodium bisulfite and sucrose.

ratio-CODEINE comes in the following dosage forms:

Tablet: 15mg and 30 mg

Syrup: 5 mg/mL

Do not use ratio-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 ratio-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 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 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 a planned surgery
you are pregnant or planning to become pregnant or you are in labour
your are breastfeeding
you are less than 12 years old
you are less than 18 years old and are having (or have recently had) your tonsils or adenoids removed because of frequent interruption of breathing during sleep

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ratio-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 disease
have severe liver disease
have low blood pressure
have or had depression
suffer from chronic or severe constipation
have problems with your thyroid, adrenal or prostate gland
have, or had in the past hallucinations or other severe mental problems
are pregnant or planning to become pregnant
are breastfeeding
are suffer from migraines

Other warnings you should know about:

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to ratio-CODEINE. ratio-CODEINE can cause:

drowsiness
dizziness or
lightheadedness

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

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 ratio-CODEINE:

Alcohol. This includes prescription and non-prescription medications that contain alcohol.Do not drink alcohol while you are taking ratio-CODEINE. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
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 ratio-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)
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)
grapefruit juice

How to take ratio-CODEINE:

ratio-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.

You should not consume alcohol while taking ratio-CODEINE, as it may increase the chance of experiencing dangerous side effects.

Keep ratio-CODEINE out of sight and reach of children. You should not give ratio-CODEINEto anyone as inappropriate use may have severe medical consequences, including death.

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 ratio-CODEINE. Be sure to use ratio-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 ratio-CODEINE, tell your doctor immediately.

ratio-CODEINE is not recommended for rectal administration.

Usual dose (Adults and children 12 years of age or older):

Pain:

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

Syrup: 3 to 12 mL every 3 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.

Syrup: 1 teaspoonful (5 mL) every 6 to 8 hours if necessary.

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

Stopping your Medication

If you have been taking ratio-CODEINE for more than a few days you should not stop taking it all of a sudden. You should check with your doctor for directions on how to slowly stop taking it. You should do it slowly to avoid uncomfortable symptoms such as having:

body aches
diarrhea
gooseflesh
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
an unexplained fever
weakness
yawning

Refilling your Prescription for ratio-CODEINE:

A new written prescription is required from your doctor each time you need more ratio-CODEINE. Therefore, it is important that you contact your doctor before your current supply runs out.

Overdose:

If you think you have taken too much ratio-CODEINE, 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 succession, talk to your doctor before restarting your medication.

What are possible side effects from using ratio-CODEINE?

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

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
RAREOverdose: 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.

Reporting Side Effects

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.

3 ways to report:

Online at MedEffect;

By calling 1-866-234-2345 (toll-free);

By completing a Consumer Side Effect Reporting Form and sending it by:

Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature 15 – 30⁰C.

Keep unused or expired ratio-CODEINE in a secure place to prevent theft, misuse or accidental exposure.

Keep ratio-CODEINE out of sight and reach of children and pets.

Disposal:

ratio-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 ratio-CODEINE:

Talk to your healthcare professional

Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website; This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited at:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com ; or

Fax: 1-416-335-4472

Rx or OTC	Prescription (Rx)?
DIN	00779474
Schedule(s)	NARCOTICS (CDSA I)
Active ingredient(s)	Codeine phosphate 5 MG
Dosage form(s)	Syrup
Route(s) of administration	Oral
Drug class (WHO ATC)	R Respiratory system drugs R05 Cough and cold preparations R05D Cough suppressants, excl. combinations with expectorants R05DA Opium alkaloids and derivatives, cough suppressants R05DA04 Codeine
Company	TEVA CANADA LIMITED
Current status	Cancelled Post Market
Current status date	May 1, 2017

Ratio-Codeine: Uses, Side Effects and Dosage