Actiq


Read the Medication Guide that comes with Actiq before you start taking it.

What is the most important information I should know about Actiq?

1. Actiq can cause life threatening breathing problems which can lead to death:
âEUR¢ if it is used by anyone who is not already taking other opioid pain medicines and their body is not used to these medicines (not opioid tolerant) if it is not used exactly as prescribed.

2. Your doctor will prescribe a starting dose of Actiq that is different than other fentanyl containing medicines you may have been taking. Do not substitute Actiq for other fentanyl medicines without talking with your doctor.

What is Actiq?

Actiq is a prescription medicine that contains the medicine fentanyl. Actiq is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.

Actiq is to be used only to treat breakthrough pain in adult patients with cancer (16 years of age and older) who are already taking other opioid pain medicines for their constant (around-the- clock) cancer pain. Actiq is started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). Do not use Actiq if you are not opioid tolerant.

âEUR¢ You must stay under your doctorâEUR(TM)s care while taking Actiq.

âEUR¢ Actiq must not be used for short-term pain from injuries and surgery.

âEUR¢ Prevent theft and misuse. Keep Actiq in a safe place to protect it from being stolen since it can be a target for people who abuse narcotic medicines or street drugs. Never give Actiq to anyone else, even if they have the same symptoms you have. It may harm them and even cause death.

Who should not take Actiq?

Do Not Take Actiq if you:
âEUR¢ are not already taking other opioid pain medicines for your constant (around-the-clock) cancer
pain. Never use Actiq for short-term pain from injuries or surgery or pain that will go away
in a few days, such as pain from doctor or dentist visits, or any short-lasting pain.

âEUR¢ are allergic to anything in Actiq. The active ingredient in Actiq is fentanyl. See the end of this
Medication Guide for a complete list of ingredients in Actiq.

What should I tell my doctor before I start taking Actiq?

Tell your doctor about all of your medical and mental problems, especially the ones listed below:
âEUR¢ Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
âEUR¢ A head injury or brain problem
âEUR¢ Liver or kidney problems
âEUR¢ Seizures (convulsions or fits)
âEUR¢ Slow heart rate or other heart problems
âEUR¢ Low blood pressure
âEUR¢ Mental problems including major depression or hallucinations (seeing or hearing things that are
not there)
âEUR¢ A past or present drinking problem or alcoholism, or a family history of this problem
âEUR¢ A past or present drug abuse or addiction problem, or a family history of this problem
âEUR¢ If you are diabetic. Each Actiq unit contains about 1â,,2 teaspoon (2 grams) of sugar.

Tell your doctor if you are:

âEUR¢ pregnant or planning to become pregnant. Actiq may harm your unborn baby

âEUR¢ breast feeding. Fentanyl passes through your breast milk and it can cause serious harm to your
baby. You should not use Actiq while breast feeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening
medical problems when taken with Actiq. Sometimes, the doses of certain medicines and Actiq need to
be changed if used together. Do not take any medicine while using Actiq until you have talked to
your doctor. Your doctor will tell you if it is safe to take other medicines while you are using
Actiq. Be especially careful about other medicines that make you sleepy such as other pain
medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or
tranquilizers.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I use Actiq?
âEUR¢ Use Actiq exactly as prescribed. Do not take Actiq more often than prescribed. Talk to your
doctor about your pain. Your doctor can decide if your dose of Actiq needs to be changed.

What should I avoid while taking Actiq?

âEUR¢ Do not drive, operate heavy machinery, or do other dangerous activities until you know
how Actiq affects how alert you are. Actiq can make you sleepy. Ask your doctor when it is
okay to do these activities.

âEUR¢ Do not drink alcohol while using Actiq. It can increase your chance of getting dangerous side
effects.

âEUR¢ Do not take any medicine while using Actiq until you have talked to your doctor. Your
doctor will tell you if it is safe to take other medicines while you are using Actiq. Be
especially careful about medicines that make you sleepy such as other pain medicines,
anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or
tranquilizers.

What are the possible or reasonably likely side effects of Actiq?

âEUR¢ Actiq can cause serious breathing problems that can become life-threatening, especially if
used the wrong way. See âEURoeWhat is the most important information I should know about
Actiq?âEUR

âEUR¢ Call your doctor or get emergency medical help right away if you:

o have trouble breathing
o have extreme drowsiness with slowed breathing
o have slow shallow breathing (little chest movement with breathing)
o feel faint, very dizzy, confused, or have unusual symptoms

These can be symptoms that you have taken too much (overdose) Actiq or the dose is too high
for you. These symptoms may lead to serious problems or death if not treated right away.

âEUR¢ Actiq can cause your blood pressure to drop. This can make you feel dizzy if you get up too
fast from sitting or lying down.

âEUR¢ Actiq can cause physical dependence. Do not stop taking Actiq or any other opioid without
talking to your doctor. You could become sick with uncomfortable withdrawal symptoms
because your body has become used to these medicines. Physical dependency is not the same as
drug addiction.

âEUR¢ There is a chance of abuse or addiction with Actiq. The chance is higher if you are or have
been addicted to or abused other medications, street drugs, or alcohol, or if you have a history
of mental problems.

The most common side effects of Actiq are nausea, vomiting, dizziness and sleepiness. Other side
effects include headache, low energy and constipation. Constipation (not often enough or hard bowel
movements) is a very common side effect of pain medicines (opioids) including Actiq and is unlikely
to go away without treatment. Talk to your doctor about dietary changes, and the use of laxatives
(medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Actiq.

Actiq contains sugar. Cavities and tooth decay have occurred in patients taking Actiq. When taking
Actiq, you should talk to your dentist about proper care of your teeth.

Talk to your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects of Actiq. For a complete list, ask your doctor.


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