Tegretol XR

Tegretol XR is an anticonvulsant that is used to treat certain types of seizures and the nerve pain of trigeminal neuralgia.

Tegretol XR is not approved to treat diabetic nerve pain or bipolar disorder, although carbamazepine is sometimes prescribed off-label for these conditions. A different extended-release form of carbamazepine, Equetro, is approved for bipolar disorder.

Tegretol XR may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

• Take with food.
• Tegretol XR is an extended-release tablet (100 mg, 200 mg, and 400 mg). Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you cannot swallow a pill whole.
• The empty tablet shell may be visible in your stool. This is normal and does not mean the medicine did not work.
• It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and call your doctor promptly if Tegretol XR seems to stop working as well in preventing your seizures.

You will need frequent medical tests, such as blood counts and liver function tests.

Store at room temperature away from moisture, heat, and light.

Do not stop using Tegretol XR suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

You should not take Tegretol XR if you have a history of bone marrow suppression or if you are allergic to this medicine or to certain antidepressant medications.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Tegretol XR may cause serious blood problems or a life-threatening skin rash or allergic reaction. Call your doctor if you have a fever, unusual weakness, bleeding, bruising, or a skin rash that causes blistering and peeling.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop taking Tegretol XR without asking your doctor first, even if you feel fine.

Do not take Tegretol XR if you have a history of bone marrow suppression, if you take nefazodone, or if you are allergic to this medicine or to an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

Do not take Tegretol XR if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Tegretol XR may cause a severe or life-threatening skin rash. The risk is highest in people of Asian ancestry who carry a gene variant called HLA-B*1502, and your doctor may recommend a blood test before you start this medicine to check for it. A second variant, HLA-A*3101, also raises the risk of rash and other reactions, and it is found in people of many backgrounds, including Japanese, Native American, European, Latin American, Indian, Korean, Chinese, and African American ancestry.

Tegretol XR should generally be avoided if you have a history of hepatic porphyria (acute intermittent porphyria, variegate porphyria, or porphyria cutanea tarda).

Tell your doctor if you have ever had:

• heart problems;
• liver, kidney, or blood problems;
• glaucoma;
• depression, mood disorder; or
• suicidal thoughts or actions.

You may have thoughts about suicide while taking Tegretol XR. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Tegretol XR may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risk. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of carbamazepine on the baby.

Tegretol XR can make birth control pills or implants less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy. Carbamazepine passes into breast milk. Talk with your doctor about whether you should take Tegretol XR or breastfeed; you should not do both.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, a red or purple skin rash that spreads and causes blistering and peeling, or round or oval patches that blister).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include a skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Tegretol XR may cause serious side effects. Call your doctor at once if you have:

• a skin rash, no matter how mild;
• loss of appetite, right-sided upper stomach pain, dark urine;
• slow, fast, or pounding heartbeats;
• anemia or other blood problems—fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
• low levels of sodium in the body—headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common side effects of Tegretol XR may include:

• dizziness, loss of coordination, problems with walking;
• nausea, vomiting; or
• drowsiness.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, weak or shallow breathing, and loss of consciousness.

Drinking alcohol with Tegretol XR can cause side effects and can also increase your risk of seizures.

Grapefruit may interact with Tegretol XR and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Tegretol XR could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using Tegretol XR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Other medications that may interact with carbamazepine include those that:

• Raise carbamazepine levels Macrolides: erythromycin, clarithromycin Azole antifungals: ketoconazole, itraconazole, fluconazole, voriconazole Protease inhibitors Antidepressants: fluoxetine, fluvoxamine, trazodone Calcium channel blockers: diltiazem, verapamil Antipsychotics: loxapine, quetiapine, olanzapine Acetazolamide, aprepitant, cimetidine, ciprofloxacin, danazol, dantrolene, ibuprofen, isoniazid, niacinamide, omeprazole, oxybutynin, ticlopidine, valproic acid, brivaracetam, grapefruit juice
• Lower carbamazepine levels Other anticonvulsants: phenytoin, fosphenytoin, phenobarbital, primidone, felbamate, methsuximide Chemotherapy agents: cisplatin, doxorubicin Xanthines: theophylline, aminophylline Rifampin
• Levels lowered by Tegretol Hormonal contraceptives: oral and levonorgestrel implants Anticoagulants: rivaroxaban, apixaban, dabigatran, edoxaban, warfarin Immunosuppressants: cyclosporine, tacrolimus, sirolimus, everolimus, temsirolimus Antipsychotics: aripiprazole, clozapine, olanzapine, risperidone, paliperidone, haloperidol, ziprasidone Antidepressants: nefazodone (contraindicated), sertraline, citalopram, mianserin, trazodone, tricyclics (imipramine, amitriptyline, nortriptyline) Benzodiazepines: alprazolam, clonazepam, midazolam Anticonvulsants: lamotrigine, topiramate, phenytoin, valproate, ethosuximide, zonisamide, tiagabine, oxcarbazepine, eslicarbazepine Opioids: methadone, tramadol, buprenorphine Corticosteroids: prednisolone, dexamethasone Tyrosine kinase inhibitors: imatinib, lapatinib Acetaminophen, albendazole, aprepitant, bupropion, dicumarol, doxycycline, felodipine, itraconazole, levothyroxine, praziquantel, protease inhibitors, tadalafil, theophylline
• Other interactions Lithium: neurotoxicity risk Isoniazid: liver toxicity risk Cyclophosphamide: increased toxicity Nondepolarizing neuromuscular blockers: pancuronium, vecuronium, rocuronium, cisatracurium.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Active ingredient: carbamazepine

Inactive ingredients: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only).

Tegretol XR is distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. For more information, go to www.novartis.us or call 1-888-669-6682.