Pronunciation:

tel-mi-SAR-tan, am-LOE-di-peen BES-i-late

Brand Names:

• Twynsta

Dosage Forms:

• Tablet

Warnings:

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

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Angiotensin II Receptor Antagonist

Chemical—

Amlodipine

Uses of This Medicine:

Telmisartan and amlodipine is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, the blood vessels relax and this decreases blood pressure. When blood pressure is lowered, the amount of blood and oxygen that go to the heart is increased.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of telmisartan and amlodipine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telmisartan and amlodipine combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Sparsentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Atazanavir
• Benazepril
• Captopril
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Domperidone
• Droperidol
• Enalapril
• Enalaprilat
• Epirubicin
• Fedratinib
• Fexinidazole
• Fosinopril
• Fosnetupitant
• Furosemide
• Itraconazole
• Lacosamide
• Lisinopril
• Lithium
• Mavacamten
• Melphalan
• Moexipril
• Mycophenolate Mofetil
• Netupitant
• Omaveloxolone
• Perindopril
• Phenobarbital
• Piperaquine
• Potassium Citrate
• Potassium Phosphate
• Primidone
• Quinapril
• Ramipril
• Rifampin
• Ritonavir
• Simvastatin
• Tacrolimus
• Tegafur
• Telaprevir
• Trandolapril
• Trimethoprim

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aprepitant
• Boceprevir
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Cobicistat
• Crizotinib
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyrone
• Dronedarone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Letermovir
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Posaconazole
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rifapentine
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Sodium Salicylate
• Sulindac
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Verapamil
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or
• Electrolyte imbalances (e.g., low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart attack, recent or
• Heart problems (e.g., aortic stenosis, heart failure) or
• Kidney problems—Use with caution. May make these conditions worse.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetes patients or those with kidney problems who are also taking aliskiren (Tektuna®)—Should not be used in these patients.

• Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.

• Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Take this medicine at the same time each day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, one tablet containing 40 milligrams (mg) of telmisartan and 5 mg of amlodipine once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of telmisartan and 10 mg of amlodipine once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the tablets from moisture and do not remove from the blister pack until you are ready to use them.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

This medicine may worsen the symptoms of angina (chest pain) or increase risk of heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you have chest pain that is worse than usual, trouble breathing, nausea or vomiting, pain or discomfort in your arms, jaw, back, or neck, feel faint, or you are sweating.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

chills

cough

difficulty breathing

ear congestion

fever

headache

loss of voice

nasal congestion

rapid weight gain

runny nose

sneezing

sore throat

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Less common

Bladder pain

bloody or cloudy urine

blurred vision

chest pain

diarrhea

difficult, burning, or painful urination

dizziness

frequent urge to urinate

general feeling of discomfort or illness

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea

nervousness

pounding in the ears

shivering

slow or fast heartbeat

sweating

trouble sleeping

vomiting

Rare

Abdominal or stomach pain

arm, back, or jaw pain

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness or heaviness

cold sweats

confusion

constipation

cough or hoarseness

dark urine

difficult or labored breathing

difficulty swallowing

dry mouth

extreme fatigue

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

flushed, dry skin

fruit-like breath odor

hives

increased hunger

increased sweating

increased thirst

increased volume of pale, dilute urine

irregular heartbeat

irritation in the mouth

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lightheadedness, dizziness, or fainting

loss of consciousness

muscle cramps or stiffness

pale, bluish-colored, or cold hands or feet

pinpoint red spots on the skin

rash

redness and swelling of the gums

redness, soreness, or itching skin

severe or sudden headache

sudden loss of coordination

sudden slurring of speech

swollen glands

tightness in the chest

trembling or shaking of the hands or feet

unexplained weight loss

unusual bleeding or bruising

vomiting of blood

weakness in the arms, hands, legs, or feet

weight gain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

difficulty with moving

heartburn

indigestion

pain or tenderness around the eyes and cheekbones

sleepiness or unusual drowsiness

Rare

Abnormal dreams

ankle, knee, or great toe joint pain

anxiety

bad, unusual, or unpleasant (after) taste

bleeding after defecation

blistering, crusting, irritation, itching, or reddening of the skin

bloody nose

burning feeling in the chest or stomach

burning, dry, or itching eyes

changes in vision

cold and clammy skin

continuing ringing or buzzing or other unexplained noise in the ears

cough producing mucus

cracked, dry, or scaly skin

decreased sexual performance or desire

depression

dry mouth

earache

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

feeling of warmth

full feeling

hair loss or thinning of the hair

headache, severe and throbbing

hearing loss

hives or welts

hyperventilation

inability to have or keep an erection

increased appetite

irritability

lack of feeling or emotion

lack or loss of strength

loose stools

loss of memory

redness of the skin

redness or swelling in the ear

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

restlessness

tenderness in the stomach area

toothache

uncomfortable swelling around the anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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