Telmisartan & Amlodipine

Telmisartan/amlodipine is a prescription medication used to treat high blood pressure. It is a single tablet containin 2 medicines, telmisartan and amlodipine.

Telmisartan belongs to a group of drugs called angiotensin II receptor blockers or ARBs. Amlodipine is a calcium channel blocker. Both telmisartan and amlodipine work by relaxing the blood vessels which lowers blood pressure and improves blood flow.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of telmisartan/amlodipine include swelling, back pain, and flushing of the face or neck.

Telmisartan/amlodipine may be used to treat high blood pressure (hypertension):

• when one of these medicines (or a similar one) is not enough to lower your high blood pressure
• as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Telmisartan & Amlodipine may be found in some form under the following brand names:

• Twynsta

Telmisartan/amlodipine may cause serious side effects, including:

• Injury or death to your unborn baby. See "Drug Precautions".
• Low blood pressure (hypotension) is most likely to happen if you also:
  • take water pills (diuretics)
  • are on a low-salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea
  If you feel faint or dizzy, lie down and call your doctor right away. 
• Kidney problems.  Kidney problems may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of telmisartan/amlodipine. Call your doctor if you get:
  • swelling in your feet, ankles, or hands
  • unexplained weight gain
  Call your doctor right away if you get any of the symptoms listed above.

• Heart problems or heart attack. Heart problems may get worse in people that already have heart disease. This may happen when you start telmisartan/amlodipine or when there is an increase in your dose of telmisartan/amlodipine. Get emergency help if you get worse chest pain or chest pain that does not go away.
• High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

• swelling of face, tongue, throat
• difficulty breathing
• skin rash

The most common side effects of telmisartan/amlodipine include:

• swelling in your hands, ankles, or feet
• feeling like your heart is pounding or racing
• flushing or sudden redness of the face and neck
• dizziness
• back pain
• feeling tired or sleepy
• abdominal pain, nausea, or diarrhea
• low blood pressure or a sudden drop in blood pressure with fainting

These are not all the possible side effects of telmisartan/amlodipine. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Telmisartan/amlodipine may affect the way other medicines work, and other medicines may affect how telmisartan/amlodipine works. Especially tell your doctor if you take:

• digoxin (Lanoxin, Lanoxicaps)
• lithium (Eskalith, Lithobid)
• medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
• ramipril (Altace) or other medicines that may be used to treat high blood pressure or a heart problem
• simvastatin (Zocor, Vytorin)
• water pills (diuretics)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

Telmisartan/amlodipine can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan/amlodipine, tell your doctor right away.

You should not take telmisartan/amlodipine if you are allergic (hypersensitive) to the active ingredients (telmisartan or amlodipine) or any of the other ingredients.

Do not use salt substitutes containing potassium without talking to your doctor.

Before you take telmisartan/amlodipine, tell your doctor if you:

• have liver problems
• have kidney problems
• have heart problems
• have any other medical conditions
• are pregnant or are planning to become pregnant. 
• are breastfeeding or plan to breastfeed. It is not known if telmisartan/amlodipine passes into your breast milk. You and your doctor should decide if you will take telmisartan/amlodipine or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan/amlodipine.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Telmisartan/amlodipine can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan/amlodipine, tell your doctor right away.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if telmisartan/amlodipine passes into your breast milk. You and your doctor should decide if you will take telmisartan/amlodipine or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan/amlodipine.

• Take telmisartan/amlodipine exactly as your doctor tells you to take it.
• Your doctor will tell you how much telmisartan/amlodipine to take and when to take it. Your doctor may change your dose if needed.
• Take telmisartan/amlodipine one time each day at the same time.
• Take telmisartan/amlodipine with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much telmisartan/amlodipine, call your doctor or go to the nearest hospital emergency room right away.

The telmisartan/amlodipine dose must be individualized. Your doctor will determine the best dose for you. Follow the directions on your prescription label carefully. Your doctor may start you on a low dose and increase it after two weeks. 

The maximum recommended dose of telmisartan/amlodipine is 80/10 mg once daily.

If you take too much telmisartan/amlodipine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store telmisartan/amlodipine tablets between 59° to 86°F (15° to 30°C).
• Do not remove telmisartan/amlodipine tablets from blisters until right before you take them.
• Keep telmisartan/amlodipine tablets out of the light and away from moisture.
• Keep telmisartan/amlodipine tablets and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue telmisartan/amlodipine as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus