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This document provides crucial safety and warning information regarding the use of diltiazem ER. It is essential that you understand these risks and discuss any concerns with your healthcare provider.

• Slow Heart Rate or Heart Block: Diltiazem ER may cause or exacerbate heart block, leading to a slower heart rate. This can result in symptoms such as weakness, lightheadedness, or fainting. Your risk increases if you are taking digoxin (Lanoxin), beta-blockers like propranolol (Inderal), or have conditions that already slow your heart rate. Inform your healthcare provider of your full medical history before starting this medication.

• Worsening Heart Failure: This medication can aggravate heart failure, notably in individuals with existing heart problems affecting blood circulation. Report any symptoms such as chest pain, shortness of breath, dizziness, fatigue, swollen extremities, or bloating to your provider promptly.

• Severely Low Blood Pressure: Diltiazem ER may significantly lower blood pressure, causing dizziness, fatigue, or lightheadedness. These effects are more common when beginning treatment or increasing dosage. If you experience severe dizziness, sit down carefully and hold onto something for support. Contact your healthcare provider for a possible dose adjustment, and seek immediate medical help if you fall and sustain a head injury.

• Liver Problems: Although rare, diltiazem ER can elevate liver enzymes, potentially leading to liver issues. Regular liver function tests may be conducted by your provider. Seek immediate medical attention if you experience severe nausea, vomiting, right-sided stomach pain, fatigue, loss of appetite, or jaundice (yellowing of the skin or eyes).

• Severe Skin Reactions (Extended-Release Tablets Only): In rare instances, serious skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) may occur. Discontinue use and seek immediate medical care if you notice skin changes like a sore throat, fever, fatigue, rash, painful blisters, skin reddening or peeling, facial swelling, or difficulty breathing.

Contraindications: Do not use diltiazem ER if you have the following conditions, unless directed by a healthcare provider:

• Sick sinus syndrome, unless you have a ventricular pacemaker.
• Second- or third-degree AV block, unless you have a ventricular pacemaker.
• Uncontrolled low blood pressure (systolic under 90 mm Hg).
• Active heart attack with lung congestion.

Please consult your healthcare provider for guidance tailored to your health needs.

When taking this medication, you might experience some common side effects such as dizziness, lightheadedness, weakness, nausea, flushing, constipation, and headache. These side effects are generally mild and often manageable. To mitigate dizziness and lightheadedness, try getting up slowly from sitting or lying down. If any of these symptoms persist or worsen, it is advisable to consult your healthcare provider.

There are also some other side effects that have been reported, including sore throat, pain, shortness of breath, indigestion, and low heart rate. While these are less common, it is important to monitor your symptoms and contact your healthcare provider if they become concerning.

On a more serious note, there are rare but severe side effects that require immediate medical attention. These include persistent nausea or vomiting, fainting, new or worsening symptoms of heart failure like unusual tiredness, swelling in the ankles or feet, sudden weight gain, severe stomach or abdominal pain, severe constipation, dark urine, yellowing of the eyes or skin, mental or mood changes, and unusual dreams. Moreover, a very serious allergic reaction, although rare, could occur, characterized by rash, itching, swelling, severe dizziness, and difficulty breathing. Seek urgent medical assistance should you notice any of these serious symptoms. Always stay informed about how your body is responding to the medication and keep in touch with your healthcare provider for any concerns.

When taking Diltiazem ER, be aware that it can interact with various medications and supplements. It's crucial to inform your doctor and pharmacist about all the drugs you are using, including prescription, over-the-counter medications, vitamins, and herbal supplements. Below is a summary of potential interactions:

1. Medications Generally Not Recommended with Diltiazem ER:

   • Cisapride, Colchicine, Eliglustat, Flibanserin, Lomitapide.

2. Medications That May Require Adjusted Doses or Monitoring:

   • Abametapir, Acalabrutinib, Acebutolol, Alfentanil, Alprazolam, Alprenolol, Amiodarone, Aprepitant, Atazanavir, Atenolol, Atorvastatin, Avapritinib, Benzhydrocodone, Betaxolol, Bevantolol, Bisoprolol, Bosutinib, Brexpiprazole, Brigatinib, Bucindolol, Buprenorphine, Carbamazepine, Carteolol, Carvedilol, Celiprolol, Ceritinib, Cilostazol, Clarithromycin, Clonidine, Clopidogrel, Clozapine, Cobimetinib, Codeine, Conivaptan, Crizotinib, Cyclosporine, Dantrolene, Deflazacort, Digoxin, Dihydrocodeine, Dilevalol, Domperidone, Doxorubicin, Doxorubicin Hydrochloride Liposome, Dronedarone, Droperidol, Elexacaftor, Encorafenib, Entrectinib, Epirubicin, Eplerenone, Erythromycin, Esmolol, Fentanyl, Fingolimod, Fosaprepitant, Fosnetupitant, Hydrocodone, Ibrutinib, Ifosfamide, Ivabradine, Ivacaftor, Ivosidenib, Labetalol, Lacosamide, Lemborexant, Levobunolol, Lovastatin, Lumateperone, Lurasidone, Lurbinectedin, Meperidine, Mepindolol, Methadone, Metipranolol, Metoprolol, Morphine, Morphine Sulfate Liposome, Nadolol, Naloxegol, Nebivolol, Netupitant, Nilotinib, Olaparib, Oxprenolol, Oxycodone, Pemigatinib, Penbutolol, Pentazocine, Pexidartinib, Pindolol, Piperaquine, Pixantrone, Ponesimod, Propranolol, Ranolazine, Rimegepant, Selpercatinib, Selumetinib, Simeprevir, Simvastatin, Siponimod, Sonidegib, Sotalol, St John's Wort, Sufentanil, Tacrolimus, Talinolol, Tazemetostat, Tertatolol, Tezacaftor, Timolol, Tolvaptan, Tramadol, Ubrogepant, Venetoclax, Voclosporin, Zanubrutinib.

3. Medications That May Increase Side Effects but Could Be Necessary:

   • Alfuzosin, Apixaban, Buspirone, Cimetidine, Colestipol, Dalfopristin, Digitoxin, Dutasteride, Efavirenz, Enflurane, Fosphenytoin, Guggul, Indinavir, Lithium, Methylprednisolone, Midazolam, Moricizine, Nevirapine, Phenytoin, Quinupristin, Rifampin, Rifapentine, Rivaroxaban, Sirolimus, Suvorexant, Triazolam.

Additionally, Diltiazem ER may alter how other medications are eliminated from your body, potentially affecting their efficacy. Be cautious with products that could increase your heart rate or blood pressure, such as certain cough-and-cold products, diet aids, or NSAIDs like Ibuprofen or Naproxen. Always consult your healthcare provider for guidance tailored to your specific health needs.