Xrylix

Generic name: Diclofenac Topical Solution (dye KLOE fen ak)
Brand name: Klofensaid II, Pennsaid, Vopac MDS, Xrylix
Drug class: Topical non-steroidal anti-inflammatories

Warning

• This medicine may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using Xrylix (diclofenac topical solution) and may be greater with higher doses or long-term use. Do not use Xrylix (diclofenac topical solution) right before or after bypass heart surgery.
• This medicine may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.

Uses of Xrylix:

• It is used to treat arthritis.

What do I need to tell my doctor BEFORE I take Xrylix?

• If you have an allergy to diclofenac or any other part of Xrylix (diclofenac topical solution).
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to Xrylix (diclofenac topical solution); any part of Xrylix (diclofenac topical solution); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had asthma caused by a salicylate drug like aspirin or a drug like this one like NSAIDs.
• If you have any of these health problems: Dehydration, GI (gastrointestinal) bleeding, heart failure (weak heart), kidney disease, or liver disease.
• If you have had a recent heart attack.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take Xrylix (diclofenac topical solution) if you are in the third trimester of pregnancy. You may also need to avoid Xrylix (diclofenac topical solution) at other times during pregnancy. Talk with your doctor to see when you need to avoid taking Xrylix (diclofenac topical solution) during pregnancy.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Xrylix (diclofenac topical solution).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xrylix (diclofenac topical solution) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Xrylix?

• Tell all of your health care providers that you take Xrylix (diclofenac topical solution). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• If you smoke, talk with your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to Xrylix (diclofenac topical solution).
• Talk with your doctor before you drink alcohol.
• Do not use on skin that has any problems.
• Do not use more than told. Unsafe side effects may happen.
• Do not use longer than you have been told by the doctor.
• Avoid sunlight on treated area.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may cause harm if swallowed. If Xrylix (diclofenac topical solution) is swallowed, call a doctor or poison control center right away.
• This medicine is not approved for use in children. Talk with the doctor.
• If you are 65 or older, use Xrylix (diclofenac topical solution) with care. You could have more side effects.
• NSAIDs like Xrylix (diclofenac topical solution) may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when Xrylix (diclofenac topical solution) is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Xrylix (diclofenac topical solution), call your doctor right away.

How is this medicine (Xrylix) best taken?

Use Xrylix (diclofenac topical solution) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Xrylix (diclofenac topical solution) by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• If you get Xrylix (diclofenac topical solution) in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.
• Put on clean, dry, healthy skin.
• Use 10 drops at a time. Repeat until a total of 40 drops has been put on knee. You may put right on the knee or on the hand and then onto the knee.
• Spread evenly on front, back, and side of knee.
• Let dry before covering with clothing.
• Do not bathe, shower, or swim for 30 minutes after applying.
• You may use cosmetics, lotions, insect repellant, sunscreen, or other skin drugs after the skin has dried.
• Do not use heat or bandages on the treated part.
• Let the treated skin dry before touching it or letting it touch anyone else's skin.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Chest pain or pressure or a fast heartbeat.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling very tired or weak.
• Flu-like signs.
• Very bad back pain.
• Very bad belly pain.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Xrylix?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Xrylix?

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Xrylix (diclofenac topical solution) is refilled. If you have any questions about Xrylix (diclofenac topical solution), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.