Consumer Information for: FENTANYL INJECTION BP

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Fentanyl Injection BP.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 past or current depression
• suffer from chronic or severe constipation
• are an elderly person
• have a condition with any part of your body, such as your heart, lung, liver, orthyroid
• have problems with your adrenal or prostate gland
• are taking any medication, such as blood thinners, and/or pain killers
• are pregnant or planning to become pregnant
• have a known allergic reaction to this drug or any other pain medications or any other general anesthetics
• have had a head injury (history and/or current), or if you experience difficulties breathing
• suffer from migraines
• have severe kidney, liver, lung disease
• have heart disease
• have low blood pressure
• have, or had in the past, hallucinations or other severe mental problems

Other warnings you should know about

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:

Opioids can be transferred to your baby while still in the womb, or through breast milk. Fentanyl Injection BP can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Fentanyl Injection BP outweigh the risks to your unborn baby or nursing infant.

If you are pregnant and are taking Fentanyl Injection BP, 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 Fentanyl Injection BP. 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 Fentanyl Injection BP. Fentanyl Injection BP 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 Fentanyl Injection BP.

Serotonin Syndrome: Fentanyl Injection BP 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 Fentanyl Injection BP 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.