What is Subsys: Uses, Warnings & Interactions

How to take Subsys

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.

• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.

• Use this medicine only when needed for breakthrough pain. Never use more than your doctor told you to use.

• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.

• Keep the medicine in the original blister or foil package. Open the package right before you need to use it.

• Abstral® tablets: Place the tablet under the tongue until it dissolves. Do not chew, suck, or swallow the tablet. Do not eat or drink anything until the tablet has dissolved. If your mouth is dry, use water to rinse your mouth before you place the tablet under your tongue.

• Actiq® lozenges: Place the lozenge in your mouth between the cheek and lower gum. Use the handle to move the lozenge from one side to the other every now and then. Suck the medicine for 15 minutes, and do not chew it.

• Fentora® tablets: Peel the blister back to remove the tablet. Do not push the tablet through the blister because this may damage the tablet. Place the tablet between your upper cheek and gum, above a back molar, until it dissolves. Do not chew, suck, or swallow the tablet. You may swallow the tablet with a glass of water if it does not dissolve completely after 30 minutes.

• Onsolis® film: Use your tongue to wet the side of your cheek, or rinse your mouth with water in the area where you will place the film. Do not cut or tear the film. Hold the film on a clean, dry finger with the pink side facing up. Press the film against your cheek and hold it there for 5 seconds. Leave the film in place until it dissolves, and do not touch or move the film. Do not chew or swallow the film. Place the second film on the other side of your mouth, if you must use more than one film. Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.

• Subsys® spray: Carefully spray the medicine under your tongue. Hold the medicine under your tongue for 30 to 60 seconds. Do not rinse your mouth and do not spit out any medicine.

• Drink plenty of liquids to help avoid constipation.

• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

• Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit. Empty the bottle each day.

• Ask your pharmacist about the best way to dispose of medicine you do not use.

• Keep the medicine in the original blister or foil package. Do not use the medicine if the package has been damaged or opened.

• Subsys® spray: Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this right after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children.

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

• Subsys® spray: Carefully spray the medicine under your tongue. Hold the medicine under your tongue for 30 to 60 seconds. Do not rinse your mouth and do not spit out any medicine.

• Use this medicine only when needed for breakthrough pain. Never use more than your doctor told you to use.

• Ask your pharmacist about the best way to dispose of medicine you do not use.

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.

• Actiq® lozenges: Place the lozenge in your mouth between the cheek and lower gum. Use the handle to move the lozenge from one side to the other every now and then. Suck the medicine for 15 minutes, and do not chew it.

• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.

• Fentora® tablets: Peel the blister back to remove the tablet. Do not push the tablet through the blister because this may damage the tablet. Place the tablet between your upper cheek and gum, above a back molar, until it dissolves. Do not chew, suck, or swallow the tablet. You may swallow the tablet with a glass of water if it does not dissolve completely after 30 minutes.

• Drink plenty of liquids to help avoid constipation.

• Keep the medicine in the original blister or foil package. Open the package right before you need to use it.

• Subsys® spray: Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this right after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children.

• Keep the medicine in the original blister or foil package. Do not use the medicine if the package has been damaged or opened.

• Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit. Empty the bottle each day.

• Abstral® tablets: Place the tablet under the tongue until it dissolves. Do not chew, suck, or swallow the tablet. Do not eat or drink anything until the tablet has dissolved. If your mouth is dry, use water to rinse your mouth before you place the tablet under your tongue.

• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.

• Onsolis® film: Use your tongue to wet the side of your cheek, or rinse your mouth with water in the area where you will place the film. Do not cut or tear the film. Hold the film on a clean, dry finger with the pink side facing up. Press the film against your cheek and hold it there for 5 seconds. Leave the film in place until it dissolves, and do not touch or move the film. Do not chew or swallow the film. Place the second film on the other side of your mouth, if you must use more than one film. Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.

What to do if you miss a dose of Subsys

Subsys contraindications

• This medicine is not right for everyone. Do not use it if you had an allergic reaction to fentanyl, if you are not taking pain medicine for around-the-clock pain control, or have stomach or bowel blockage (including paralytic ileus).

Subsys warnings

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung or breathing problems (such as COPD, apnea), mucositis (sores in your mouth), adrenal problems, gallbladder or pancreas problems, seizures, or a slow heart rate. Tell your doctor if you have had a head injury or brain surgery, or a history of drug or alcohol abuse. Do not use this medicine for minor aches and pains, such as headaches, dental pain, or migraines, or after surgery or injuries.

• This medicine may cause the following problems:High risk of overdose, which can lead to deathRespiratory depression (serious breathing problem that can be life-threatening)Serotonin syndrome, when used with certain medicines

• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.

• This medicine can cause serious harm or death to a child. Always keep this medicine out of the reach of children. Carefully and properly dispose of both used units and medicine that has not been used.

• Actiq® contains 2 grams of sugar in each unit. Schedule regular dentist visits. Be careful if you need to keep track of your sugar intake.

• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.

• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

• Subsys® spray: Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this right after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children.

• Keep all medicine out of the reach of children. Never share your medicine with anyone.

• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.

• Keep all medicine out of the reach of children. Never share your medicine with anyone.

• 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.

Subsys interactions

• Some medicines can affect how fentanyl works. Tell your doctor if you are using any of the following:Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, or trazodoneBlood pressure medicineDiuretic (water pill)Medicine to treat depressionPhenothiazine medicine

• Do not use this medicine if you have used an MAO inhibitor within the past 14 days.

• Do not drink alcohol while you are using this medicine.

• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer.

• Actiq® contains 2 grams of sugar in each unit. Schedule regular dentist visits. Be careful if you need to keep track of your sugar intake.

• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.

• 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.

• Ask your pharmacist about the best way to dispose of medicine you do not use.

• Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit. Empty the bottle each day.

• Keep all medicine out of the reach of children. Never share your medicine with anyone.

• Subsys® spray: Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this right after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children.