When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to telmisartan or amlodipine, or if you are pregnant.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine works best when you take it at the same time every day and do not miss any doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not remove a tablet from the blister pack until you are ready to take your medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with aliskiren if you have diabetes.
• Some foods and medicines can affect how telmisartan/amlodipine works. Tell your doctor knows if you are using any of the following:
  
  • Aliskiren, digoxin, diltiazem, lithium, ritonavir, simvastatin, St John's wort
  • Other blood pressure medicine, including ramipril or other ACE inhibitors
  • Diuretic (water pill)
  • Medicine that weakens your immune system (including cyclosporine, tacrolimus)
  • Medicine to treat an infection (including itraconazole, ketoconazole, rifampicin)
  • Medicine to treat seizures (including carbamazepine, phenobarbital, phenytoin, primidone)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney problems, liver disease, angina, heart failure, heart or blood vessel problems, or a recent heart attack.
• This medicine may cause the following problems:
  
  • Increased risk of heart attack or angina
  • High levels of potassium in the blood
  • Kidney problems
• This medicine could lower your blood pressure too much, especially when you first use it or if you are dehydrated. Stand or sit up slowly if you feel lightheaded or dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine without asking your doctor, even if you feel well. This medicine will not cure your high blood pressure, but it will help keep it in the normal range. You may have to take blood pressure medicine for the rest of your life.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain that may spread, trouble breathing, nausea, unusual sweating
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips
• Fast, pounding, or uneven heartbeat
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088