This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
Diclo Gel with Xrylix Sheets [DSC]; Diclo Gel [DSC]; Diclozor; DST Plus Pak [DSC]; EnovaRX-Diclofenac Sodium; Flector; Klofensaid II [DSC]; Lexixryl [DSC]; Licart; Pennsaid; Rexaphenac [DSC]; Solaraze [DSC]; VennGel One; Voltaren; Voltaren [OTC]; Vopac MDS [DSC]; Xrylix
JAMP Diclofenac; Pennsaid; PMS-Diclofenac; TARO-Diclofenac
- This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
- This drug 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.
- It is used to ease pain.
All other products:
- This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
- If your child has ever had asthma caused by a salicylate drug like aspirin or a drug like this one like NSAIDs.
- If your child has any of these health problems: Dehydration, GI (gastrointestinal) bleeding, heart failure (weak heart), kidney disease, or liver disease.
- If your child has had a recent heart attack.
- If your child is taking any other NSAID, a salicylate like aspirin, or pemetrexed.
- If your child is having her fertility checked.
If your child is pregnant:
- Avoid giving this drug to your child if she is at 20 weeks or later in pregnancy unless the doctor tells you otherwise. Do not give this drug to your child if she is more than 30 weeks pregnant.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s 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 child’s blood pressure checked as you have been told by the doctor.
- If your child smokes, talk with the doctor.
- If your child has asthma, talk with the doctor. Your child may be more sensitive to this drug.
- Alcohol may interact with this drug. Be sure your child does not 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.
- 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 your child is taking aspirin to help prevent a heart attack, talk with the doctor.
- This drug is not approved for use in children. Talk with the doctor.
- This drug may cause harm if chewed or swallowed. If this drug has been put in the mouth, call a doctor or poison control center right away.
- A severe and sometimes deadly reaction has happened with drugs like this one. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
If your child is or may be sexually active:
- NSAIDs like this drug may affect egg release (ovulation). This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
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 child’s doctor or get medical help right away if your child has 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.
- Skin irritation.
- 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.
- Swollen gland.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has 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.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Dizziness or headache.
- Constipation, diarrhea, stomach pain, upset stomach, or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Do not give by mouth. Use on your child’s skin only. Keep out of your child’s mouth, nose, and eyes (may burn).
- Wash your hands before and after use.
- Put patch on clean, dry, healthy skin. Move the site with each new patch.
- Clean affected part before use. Make sure to dry well.
- Do not put on cuts, scrapes, eczema, or damaged skin.
- Do not let your child bathe, shower, or swim after putting on.
- If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.
- If the patch does not stick well, talk with your pharmacist about what to do. Certain things can be done to help hold it in place.
- If the patch falls off, put a new one on.
- If you get this drug in your child’s eyes, wash right away with water. If your child has eye irritation that lasts or a change in eyesight, call the doctor.
- Skip the missed dose and go back to your child’s normal time unless your child’s doctor tells you to do something else.
- Do not put on 2 doses at the same time or extra doses.
- Store at room temperature.
- Protect from heat.
- Store in the envelope that this drug comes in to help keep away from children. Do not open the envelope until you are ready to use this drug.
- After opening, be sure you know how long the product is good for and how to store it. Ask the doctor or pharmacist if you are not sure.
- After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
- Throw away unused patches when they are no longer needed. Take them from the pouch, take off liner, and fold the sticky side of the patch together.
- 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.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, 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.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.
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