Consumer Information for: TEVA-COTRIDIN

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups. 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 high or low blood pressure, heart disease or a heart condition, liver or kidney problems, diabetes, glaucoma, thyroid disease, gallbladder disease including gallstones, enlarged prostate or difficulty in urinating, ulcers, bowel obstruction or abdominal pain or infections (such as an inflamed appendix or pancreas), or epilepsy
• suffer from migraines
• have severe kidney, liver or lung disease
• have chronic or severe constipation
• are older than 65 years old, or suffer from a long-term illness
• have asthma, a persistent or chronic cough or any other respiratory complications (i.e., difficulty breathing)
• are planning to become pregnant
• have or had depression
• are going to have, or recently had surgery
• are taking tranquilizers, sedatives, sedating antihistamines or other depressants
• are taking any other drug including over the counter drugs
• have diabetes, as TEVA-COTRIDIN Syrup contains sucrose
• have problems with your adrenal gland

Other warnings you should know about:
Accidentally taking TEVA-COTRIDIN or TEVA-COTRIDIN EXPECTORANT Syrup can result in a fatal overdose. This is especially true if a child accidently takes it. Keep TEVACOTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups out of sight and reach of children.

As with all opioids, taking TEVA-COTRIDIN or TEVA-COTRIDIN EXPECTORANT Syrup may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.

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.

Pregnancy, nursing, labour and delivery:

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

If you took TEVA-COTRIDIN or TEVA-COTRIDIN EXPECTORANT Syrup 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.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to TEVA-COTRIDIN or TEVA-COTRIDIN EXPECTORANT Syrups. TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups can cause:

• drowsiness,
• dizziness, or
• lightheadedness

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

TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups are not recommended for anyone who has or is at risk for breathing problems such as:

• lung infections, or respiratory conditions
• neuromuscular disorders
• severe heart problems
• recent multiple traumas or extensive surgical procedures

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-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups.

Serotonin Syndrome: TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups 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-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups 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.

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 ultrarapid 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:
Codeine can produce drug dependence and has the potential for being abused. Tolerance, psychological and physical dependence may develop over time with repeated use of TEVACOTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups. Your healthcare professional should prescribe and administer TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups with the same degree of caution appropriate to the use of other oral opioid medications. Using these products for a prolonged period of time is not recommended.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.