Consumer Information for: DALMACOL

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DALMACOL. 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 heart or thyroid problems
• 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 hydrocodone at a much faster rate than the general population. This may lead to accidental overdose especially in patients younger than 18 years of age. Stop taking DALMACOL and seek immediate medical help if you start feeling confused, have shallow breathing, or extreme sleepiness. If you know that you metabolize hydrocodone at a much faster rate, tell your doctor BEFORE starting this medication.

Stop taking DALMACOL 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.

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 questions or concerns about abuse, addiction or physical dependence. As with all opioids, taking hydrocodone bitartrate may cause you to become dependent on it. Do not take more than the dose prescribed to you by your doctor.

Breathing problems: DALMACOL is not recommended for anyone who has or is at risk for breathing problems such as:

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

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

If you are pregnant and are taking DALMACOL, 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 DALMACOL. 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 DALMACOL. DALMACOL 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 DALMACOL.

Serotonin Syndrome: Hydrocodone bitartrate, one of the ingredients of DALMACOL 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 DALMACOL 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.

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.