Amlodipine and telmisartan

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food, at the same time each day.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood pressure will need to be checked often. You may also need frequent blood tests.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat. Keep each tablet in the blister pack until you are ready to take one.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Commonly reported side effects of amlodipine/telmisartan include: edema. Other side effects include: fatigue and palpitations. See below for a comprehensive list of adverse effects.

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration advice: May take with or without food.

General: Telmisartan plasma concentrations are generally 2 to 3 times higher in females; however, in clinical trials, no significant increases in blood pressure response or orthostatic hypotension were found in women.

Monitoring: Closely monitor patients with heart failure or biliary obstructive disorders who are taking this drug.

Patient advice:
-Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible.
-Advise patients to immediately report any signs or symptoms of angioedema (breathing difficulty or swelling of face, eyes, lips, or tongue) and to stop taking this drug until consulting a physician.
-Encourage patients to report any lightheadedness that may occur during treatment initiation and to stop taking this drug until consulting a physician if syncope occurs.
-Dehydration may lead to excess blood pressure reduction; inform patients to contact their healthcare provider if they experience excessive perspiration, vomiting, or diarrhea.