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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 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.