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The following safety information outlines important precautions and potential risks associated with the use of Diltiazem ER. Please review these warnings carefully and discuss any concerns with your healthcare provider.

• Slow Heart Rate or Heart Block: Diltiazem ER may cause or worsen conditions that slow the heart rate, such as heart block. This can result in symptoms like weakness, lightheadedness, or fainting. Those at increased risk include individuals taking digoxin (Lanoxin) or beta-blockers (e.g., propranolol (Inderal)), or those with pre-existing conditions that slow the heart rate. Ensure your healthcare provider is fully informed of your medical history before starting this medication.

• Worsening Heart Failure: This medication can exacerbate heart failure, particularly in patients with existing heart problems that impair blood flow. Notify your healthcare provider immediately if you experience symptoms such as chest pain, difficulty breathing, dizziness, fatigue, swollen legs and feet, or abdominal bloating.

• Severely Low Blood Pressure: Diltiazem ER may significantly lower blood pressure, leading to dizziness, fatigue, or lightheadedness, especially when initiating treatment or adjusting doses. If you experience severe dizziness, sit down slowly and hold onto something for support. Contact your healthcare provider if the symptoms persist or if you fall and hit your head.

• Liver Problems: While rare, diltiazem ER can increase liver enzyme levels, potentially leading to liver issues. This typically occurs within 1 to 8 weeks of starting treatment. Your provider may conduct liver function tests prior to and during treatment. Seek medical attention if you experience severe nausea, vomiting, right-sided abdominal pain, fatigue, loss of appetite, or yellowing of the skin or eyes.

• Severe Skin Reactions (Extended-Release Tablets Only): In rare cases, Diltiazem ER can cause serious skin reactions like Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If you notice skin changes, such as a sore throat, fever, fatigue, rash, painful blisters, skin reddening, or peeling, or if you have facial swelling or trouble breathing, discontinue use and seek immediate medical care.

Contraindications: Diltiazem ER should not be used if you have any of the following conditions, as it may pose serious health risks. Consult your healthcare provider if any of these apply to you:

• Sick sinus syndrome (unless a ventricular pacemaker is present)
• Second- or third-degree AV block (unless a ventricular pacemaker is present)
• Uncontrolled hypotension (systolic blood pressure less than 90 mm Hg)
• Active heart attack with lung congestion

Always ensure your healthcare provider is informed of your full medical history and any other medications you are taking to avoid potential interactions or complications.

When taking this medication, some individuals may experience common side effects such as dizziness, lightheadedness, weakness, nausea, flushing, constipation, headache, or a sore throat. These effects are usually mild and may diminish as your body adjusts to the medication. To minimize dizziness or lightheadedness, rise slowly from sitting or lying positions. If any of these side effects persist or worsen, it is advisable to consult your healthcare provider for guidance.

In some cases, other side effects like low heart rate, swelling, pain, shortness of breath, or indigestion may occur. Swelling and dizziness have been reported more frequently, with some users experiencing these symptoms at varying levels. If you notice these effects and they become bothersome, reaching out to your healthcare provider is recommended.

Serious side effects are rare but require immediate medical attention. These include persistent nausea or vomiting, fainting, new or worsening heart failure symptoms (like shortness of breath, swollen ankles, unusual tiredness, or sudden weight gain), irregular or fast heartbeat, mental or mood changes, severe stomach pain, dark urine, or yellowing of the eyes or skin. Additionally, a severe allergic reaction, though rare, warrants urgent care if symptoms such as rash, severe dizziness, swelling of the face/tongue/throat, or trouble breathing occur. Always report any unlisted or severe side effects to your healthcare provider.

When taking Diltiazem ER, be aware that it may interact with various medications, potentially altering how it or the other drugs work. Inform your doctor and pharmacist about all medications and supplements you are currently using, including prescription, over-the-counter, vitamins, and herbal products.

Certain drugs should not be combined with Diltiazem ER, such as cisapride, Colchicine, eliglustat, Flibanserin, and lomitapide, as the interactions can be harmful. Your doctor might choose alternative treatments in such cases.

Some medications, although not recommended to be used with Diltiazem ER, might still be necessary. In these situations, your healthcare provider may adjust the dosage or frequency of these medicines. This list includes drugs like abametapir, acalabrutinib, Acebutolol, Amiodarone, and Atorvastatin, among others.

Additionally, combining Diltiazem ER with certain medications can increase the risk of side effects, but may still be the optimal choice for your treatment. Examples include alfuzosin, apixaban, Buspirone, and Cimetidine. In such cases, your doctor may modify how you use these medications.

Always consult your healthcare provider to ensure the safe use of Diltiazem ER alongside your other medications.