When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to fentanyl. You should not use this medicine until after you have tried other narcotic medicines. Do not use this medicine if you need pain medicine for just a short time, such as during a headache or migraine attack, tooth pain, or when recovering from surgery or an injury.

How to Use This Medicine:
Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release four sprays into the pouch. Now it is ready to use.
• Before using the medicine, gently blow your nose to clear the nostrils.
• Insert the tip of the bottle into the nose. Point towards the bridge of the nose and tilt the bottle slightly.
• Press down firmly on the finger grips until you hear a "click" sound and the number in the dose counter window adds up. This confirms a spray has been taken.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way. Lazanda® works differently than other fentanyl products, even at the same dose (number of milligrams). Do not substitute or convert it to other products containing fentanyl.
• This medicine is available only under a registered distribution program called Lazanda® REMS (Risk Evaluation and Mitigation Strategy) Program. You will be asked to sign an agreement form before you take this medicine. This form tells you about the benefits and risks of using this medicine. Make sure you understand what is on the form before you sign it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using clarithromycin (Biaxin®), itraconazole (Sporanox®), ketoconazole (Nizoral®), or nefazodone (Serzone®). Tell your doctor if you are also using aprepitant (Emend®), cimetidine (Tagamet®), diltiazem (Cardizem®, Dilacor XR®), erythromycin (Ery-Tab®), fluconazole (Diflucan®), telithromycin (Ketek®), or verapamil (Calan®, Isoptin®, Verelan®). Make sure your doctor knows if you have used an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
• Make sure your doctor knows if you are also using St. John's wort, modafinil (Provigil®), pioglitazone (Actos®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), troglitazone (Rezulin®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), medicine for HIV or AIDS (such as efavirenz, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Sustiva®, Viracept®, or Viramune®), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), muscle relaxants, or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
• Tell your doctor if you are using other nasal decongestants (such as oxymetazoline, Afrin®, or Sudafed OM®).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, lung disease or breathing problems such as asthma or chronic obstructive pulmonary disease (COPD), heart disease, heart rhythm problems (such as slow heart rate), low blood pressure, or if you have had a recent head injury or other problems that could increase the pressure in your head. Tell your doctor if you also have a history of drug or alcohol abuse or addiction.
• Do not breastfeed while you are using this medicine.
• This medicine may cause problems with breathing, which can be serious and life-threatening. This is more likely in patients with lung disorders, the elderly, very weak patients, or those who use large doses of this medicine. Call your doctor right away if you have shortness of breath, or irregular, fast, slow, or shallow breathing after using this medicine.
• After you have been using this medicine for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of nasal fentanyl or other narcotic that you are using without first checking with your doctor.
• This medicine can cause serious illness or even death if used by a child or by anyone who is not already using prescription medicine on a regular schedule for cancer pain.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, severe drowsiness, or fainting.
• Pain on urination, change in how much or how often you urinate.
• Pain, redness, or swelling in your arm or leg.
• Pale or blue lips, fingernails, or skin.
• Shortness of breath, or irregular, fast, slow, or shallow breathing.
• Sores or white patches on your lips, mouth, or throat.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Agitation, confusion, or depression.
• Back or joint pain.
• Change or loss of taste.
• Constipation, diarrhea, nausea, vomiting, or stomach pain or upset.
• Dry mouth.
• Headache.
• Increased sweating.
• Loss of appetite.
• Trouble sleeping.
• Weight loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088