Patient Medication Information: uses, side effects, how to take - Ran-Fentanyl Transdermal System

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed RAN-FENTANYL TRANSDERMAL SYSTEM to help control the moderate to severe chronic (long-lasting) pain you are experiencing.

What it does:

What is RAN-FENTANYL TRANSDERMAL SYSTEM ?

RAN-FENTANYL TRANSDERMAL SYSTEM is a thin, adhesive, rectangular patch that is placed on your skin. RAN-FENTANYL TRANSDERMAL SYSTEM delivers an opioid medicine called fentanyl continuously through the skin and into the bloodstream to control your pain around the clock.

What to expect from RAN-FENTANYL TRANSDERMAL SYSTEM?

Because the medicine in RAN-FENTANYL

TRANSDERMAL SYSTEM is gradually released from the patch and slowly absorbed through the skin, do not expect immediate pain relief after you apply your first patch. During this initial period, your doctor may ask you to take additional pain medication until you experience the full benefits of RAN-FENTANYL TRANSDERMAL SYSTEM.

While most patients obtain adequate pain relief with RAN-FENTANYL TRANSDERMAL SYSTEM, your pain may vary and occasionally break through. This is not unusual. If

this occurs, your doctor may prescribe additional pain medication.

It is important to let your doctor know whether or not your pain is under control. If you frequently need additional short-acting pain medication, or if pain is waking you at night, you may need a change in your RAN-FENTANYL TRANSDERMAL SYSTEM dose. If you continue to have pain, call your doctor.

Always follow your doctor's instructions carefully and do not change or stop your RAN-FENTANYL

TRANSDERMAL SYSTEM medication without first consulting with your doctor.

When it should not be used:

Because life-threatening decreases in breathing rate could occur, RAN-FENTANYL TRANSDERMAL SYSTEM should not be used:

for the relief of pain following surgery.
for the relief of pain which is only mild, or expected to last less than several weeks.
if you have acute or severe bronchial asthma.
if you have severe difficulty in breathing

For the same reason, do not start on RAN-FENTANYL TRANSDERMAL SYSTEM unless you have already been taking a strong opioid medication.

Because constipation is a side-effect of opioids, RAN-FENTANYL TRANSDERMAL SYSTEM should not be used if you have a type of intestinal blockage known as “paralytic ileus”.

RAN-FENTANYL TRANSDERMAL SYSTEM is not for children under 18 years of age unless your doctor has decided otherwise.

Do not use RAN-FENTANYL TRANSDERMAL SYSTEM if you know you are hypersensitive to fentanyl or the other ingredients (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

fentanyl

What the nonmedicinal ingredients are:

Backing Layer: polyester film

Drug Reservoir: alcohol, hydroxyethyl cellulose Release Membrane: ethylene-vinyl acetate

Contact Adhesive: silicone adhesive

What dosage forms it comes in:

RAN-FENTANYL TRANSDERMAL SYSTEM fentanyl patch is supplied in cartons containing 5 individually packaged systems.

RAN-FENTANYL TRANSDERMAL SYSTEM comes in

four strengths: 2.5 mg, 5 mg, 7.5 mg, and 10 mg fentanyl per patch, delivering 25, 50, 75, and 100 mcg fentanyl per hour respectively for 72 hours.

WARNINGS AND PRECAUTIONS

Before using RAN-FENTANYL TRANSDERMAL SYSTEM be sure to tell your doctor if:

you have any other medical conditions (such as diseases
of the heart, lung, brain, liver and kidney),
you have pancreatitis, or other biliary tract diseases,
you are pregnant or plan to become pregnant, or are
breastfeeding,
you are taking any other medications (see
INTERACTIONS WITH THIS MEDICATION),
you have ever had an allergic reaction to any other
medication,
you have a head injury or brain tumour,
you have a history of drug abuse,
you have chronic and severe constipation,
you suffer from alcoholism.

This will help your doctor decide whether you should use RAN-FENTANYL TRANSDERMAL SYSTEM and what extra care should be taken during its use.

You should already be taking some type of strong opioid medication before you begin using RAN-FENTANYL TRANSDERMAL SYSTEM patches.

Do not use RAN-FENTANYL TRANSDERMAL SYSTEM if the pouch is torn upon purchasing, or if the patch is cut, damaged, or changed in any way as you may be exposed to a potentially fatal dose of medicine.

Do not drive a car or operate machinery until you are sure that using the patch does not make you drowsy.

While wearing RAN-FENTANYL TRANSDERMAL SYSTEM you should not expose the patch area to sources of heat such as heating pads, electric blankets, heated waterbeds, heat lamps, saunas and hot tubs, intensive sunbathing, etc., as this may increase the drug's ability to go through the skin and therefore result in an overdose . This may also occur if you develop a fever.

Tolerance

RAN-FENTANYL TRANSDERMAL SYSTEM may lead to tolerance in the long run. It is therefore possible that your doctor will prescribe a higher dose of RAN-FENTANYL TRANSDERMAL SYSTEM after some time to produce the same result.

Dependence

There is a possibility that you may become dependent on RAN-FENTANYL TRANSDERMAL SYSTEM (fentanyl) with longer term use. Discuss with your doctor.

Disposing of RAN-FENTANYL TRANSDERMAL SYSTEM

Before putting on a new RAN-FENTANYL

TRANSDERMAL SYSTEM patch, remove the patch you have been wearing. Fold the used patch in half so the sticky side sticks to itself, and flush down the toilet immediately. Wash your hands, with water only, after removing the patch.

Dispose of any patches that are left over from your prescription as soon as they are no longer needed. Remove the left-over patches from their protective pouches and remove the protective liners. Fold the patches in half and flush down the toilet. Do not flush the pouch or protective liner.

RAN-FENTANYL TRANSDERMAL SYSTEM contains fentanyl, a drug with a high potential for abuse. Your discarded patches contain a considerable amount of drug, and flushing is an effective way to prevent theft or misuse by others.

INTERACTIONS WITH THIS MEDICATION

It is extremely important to avoid alcohol and such medications as tranquilizers and sleeping pills when you are using RAN-FENTANYL TRANSDERMAL SYSTEM since their combined effect may cause drowsiness, depressed breathing, low blood pressure and possibly coma.

To avoid any potential drug interactions, be sure to inform your doctor when taking any other medications while you are using RAN-FENTANYL TRANSDERMAL SYSTEM, including

certain antifungal drugs (e.g. ketoconazole),
certain antiviral drugs (e.g. ritonavir),
some antibiotics (e.g. clarithromycin),
monoamine (MAO) inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline),
over-the-counter medications that may cause
drowsiness (e.g. antihistamines),
muscle relaxants,
anaesthetics,
sedatives or hypnotics,
phenothiazines,
other opioid pain medication.

Drugs that cause a decrease in the ability of the liver to break down drugs including opioids can result in high levels of opioid in the bloodstream when taken at the same time as the patch is used. These drugs include some anti-fungals, some antibiotics, and some anti-viral medications. Talk to

your doctor before starting RAN-FENTANYL TRANSDERMAL SYSTEM if you are on one of these drugs.

PROPER USE OF THIS MEDICATION

Your doctor will determine the strength of RAN-FENTANYL TRANSDERMAL SYSTEM you need based on your own particular needs. Each patch can be used for up to 72 hours (3 days).

Where to apply RAN-FENTANYL TRANSDERMAL SYSTEM

Select a dry, non-hairy area on your chest, back, flank or upper arm. If the area you choose has body hair, clip (do not shave) the hair close to the skin with scissors.

Do not put the patch on skin that is excessively oily, burned, broken out, cut, irritated or damaged in any way. If you need to clean the skin where the patch will be applied, use only clear water. Soaps, oils, lotions, alcohol or other products may irritate the skin under the patch.

How to apply RAN-FENTANYL TRANSDERMAL SYSTEM

Step 1.

Each patch is sealed in its own protective pouch. Do not remove the patch from the pouch until you are ready to use it. When you are ready, tear open the pouch at the notched corner.

Step 2.

A stiff protective liner covers the sticky side of the patch - the side that will be put on your skin. Hold the liner at the edge and pull the patch from the liner. Try not to touch the sticky side of the patch. Throw away the liner.

Step 3.

Immediately after you have removed the liner, apply the sticky side of the patch to a dry area of your chest, back, flank or upper arm. Press the patch firmly on your skin with the palm of your hand for about 30 seconds.

Not all adhesive products stick to all patients. If the patch does not stick well, or loosens after application, tape the edges down with first aid tape. In the event that the patch falls off, discard it and put a new one on at a different skin site. (See Disposing of RAN-

FENTANYL

TRANSDERMAL SYSTEM.)

Step 4. Wash your hands, with water only, when you have finished applying the patch.

Step 5.

Special labels are provided to help you remember when you last put on your patch. After putting on the patch, write the date and time on a label, then stick the label on the patch.

Step 6.

After wearing the patch for 3 days, or as directed by your doctor, remove it (see

Disposing of RAN-FENTANYL

TRANSDERMAL SYSTEM). Then choose a different place on your skin to apply a new patch and repeat steps 1 to 5 in order.

Water and RAN-FENTANYL TRANSDERMAL SYSTEM

You can bathe, swim, or shower while you are wearing RAN-FENTANYL TRANSDERMAL SYSTEM. If the patch falls off, apply a new one, making sure the new skin area you choose is dry.

Safety and handling

RAN-FENTANYL TRANSDERMAL SYSTEM is sealed to keep the gel from getting on your hands or body. If the gel from the drug reservoir accidentally touches the skin, wash the area with large amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may increase the drug’s ability to go through the skin.

Do not cut, damage or chew RAN-FENTANYL TRANSDERMAL SYSTEM. RAN-FENTANYL TRANSDERMAL SYSTEM will not work properly, or may not be safe, if it is damaged in any way, as it may lead to uncontrolled release of RAN-FENTANYL TRANSDERMAL SYSTEM (fentanyl) and life-threatening consequences.

Do not let anyone else use your RAN-FENTANYL

TRANSDERMAL SYSTEM. RAN-FENTANYL TRANSDERMAL SYSTEM contains fentanyl, a drug with a high potential for abuse. Your patches must be protected from theft or misuse in the home or work environment.

Serious medical consequences, including death, have occurred when patches were accidentally transferred to other people, for example while hugging, sharing a bed or moving a patient. If your patch dislodges and accidentally sticks to the skin of another person, take the patch off immediately and call a doctor. This is true for both fresh and used patches, as a considerable amount of drug remains in the patch after use.

Do not exceed the dose recommended by your doctor.

Overdose:

The most important sign of overdose is suppressed breathing. If a person is breathing abnormally slowly or weakly, remove the patch and call the doctor immediately.

Meanwhile, keep the person awake by talking or by shaking him/her every now and then.

Other signs of fentanyl overdose may include tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.

Missed Dose:

If a patch is left on for more than three days (72 hours), remove patch and apply a new patch following instructions given (see PROPER USE OF THIS MEDICATION).

Discontinuation of RAN-FENTANYL TRANSDERMAL SYSTEM:

Please do not suddenly stop taking RAN-FENTANYL TRANSDERMAL SYSTEM as it may cause unwanted side effects. Your doctor can discuss the best way for you to stop taking RAN-FENTANYL TRANSDERMAL SYSTEM.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, RAN-FENTANYL TRANSDERMAL SYSTEM may cause unwanted effects. Most unwanted effects appear during the first month of treatment. These effects may be more pronounced if you have a fever. If you develop a fever while using the patch, contact your doctor right away.

The most frequently reported unwanted effects are nausea, vomiting, tiredness, constipation, sweating, dizziness, headache, dry mouth, confusion, depression and skin irritation at the application site.

Slowed breathing has been reported by a small number of patients using RAN-FENTANYL TRANSDERMAL SYSTEM. If this occurs, contact your doctor immediately.

Be aware that removing the patch does not completely remove the source of drug, as drug is deposited under the skin and will continue to be released into the bloodstream over the next hours after the patch is removed.

Opioid Withdrawal Symptoms

Opioid withdrawal symptoms, such as nausea, vomiting, diarrhea, anxiety and shivering are possible after converting from your previous opioid analgesic to RAN-FENTANYL TRANSDERMAL SYSTEM, or converting from RAN-FENTANYL TRANSDERMAL SYSTEM to another opioid. Contact your doctor if you experience these symptoms when switching to or from RAN-FENTANYL TRANSDERMAL SYSTEM.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

There have been very rare reports of serious allergic reactions, such as Stevens-Johnson syndrome (rash and fever or sore eyes/mouth), airway constriction, swelling, and anaphylactic shock. In one case, it was the patient caretaker who experienced the allergic reaction, from applying the patch to the patient. If these symptoms develop, contact your doctor immediately.

There have been rare reports of seizures (convulsions) in people using RAN-FENTANYL TRANSDERMAL SYSTEM. If you notice anything unusual, please contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking RAN-FENTANYL TRANSDERMAL SYSTEM, contact your doctor or pharmacist.

HOW TO STORE IT

Keep RAN-FENTANYL TRANSDERMAL SYSTEM out of the reach of children.

Keep RAN-FENTANYL TRANSDERMAL SYSTEM in its protective pouch until you are ready to use it. Store RAN-FENTANYL TRANSDERMAL SYSTEM between 15° and 25°C. Do not refrigerate or freeze. Remember, the inside of your car can reach temperatures much higher than 25°C (77°F) on a sunny day.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Health Canada

Address Locator: 0701C

Ottawa, ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full Product Monograph can be obtained by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc., at:

1-866-840-1340

Company Logo

Ranbaxy Pharmaceuticals Canada Inc.

Mississauga, Ontario L5R 3Y4

Last revised: August 18, 2006