Consumer Information for: TEVA-TECNAL C 1/4

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-TECNAL C. 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 heart disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• are allergic to ASA as it can cause anaphylactic shock and other severe allergic reactions
• have nasal polyps or asthma
• have a history of blocked bowels, stomach ulcers, sores in your stomach or bowel or any other serious stomach problems
• have a history of bleeding
• will be having surgery
• have a blood clotting disorder or are taking blood thinners
• have recently suffered a head injury or elevated pressure in your brain
• have problems with your thyroid gland
• have narrowing of the urethra caused by injury or disease
• have Addison’s disease
• have an enlarged prostate gland
• have softening or weakening of bones or osteoporosis
• have any allergies to any medicines, food, dyes or preservatives
• have the flu, or chickenpox
• suffer from migraines
• are planning to become pregnant
• have reacted strongly to other codeine-containing drugs in the past (i.e. got sleepy, confused and/or had trouble breathing) even when taking the dose recommended by your doctor.

Other warnings you should know about:
TEVA-TECNAL C 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 problems
• recent multiple traumas or extensive surgical procedures

Some people metabolize codeine at a much faster rate than the general population, which may lead to accidental overdose, if this should happen to you, seek help immediately (see Overdose, for symptoms of overdose and what to do if it happens). If you know that you metabolize codeine rapidly, tell your doctor BEFORE starting this medication.

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.

TEVA-TECNAL C is a controlled medication. Butalbital and codeine are both habit-forming (tolerance, mental and physical dependence) and potentially abusable. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking barbiturate- or opioid-containing products, such as TEVA-TECNAL C. Physical dependence may lead to withdrawal side effects when you stop taking this medicine. Continuous daily use of TEVA-TECNAL C should be avoided as medication overuse (rebound) headaches may result in addition to the tolerance and dependence risks. Patients should take TEVA-TECNAL C only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Reye's syndrome: ASA may increase the risk of Reye's syndrome, a rare but often fatal condition. Caution should be used in administering ASA-containing medications to young adults who have fever, flu or chicken pox. TEVA-TECNAL C should not be administered to children.

Medical tests: Before you have any medical tests done, tell the person in charge that you are taking TEVA-TECNAL C. ASA and codeine may interfere with the results of certain tests done in blood and urine.

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

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

• drowsiness
• dizziness or
• light-headedness

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 TEVA-TECNAL C.

Serotonin Syndrome: TEVA-TECNAL C can cause Serotonin Syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take TEVA-TECNAL C 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.