Telmisartan and amlodipine (Oral)

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 increases the strain on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can lower 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 narrow. This helps the blood vessels relax, which lowers blood pressure. When blood pressure is lowered, more blood and oxygen can reach the heart.

Amlodipine is a calcium channel blocker (CCB). It affects how calcium moves into the cells of the heart and blood vessels. As a result, amlodipine helps relax the blood vessels and increases blood and oxygen flow to the heart while decreasing its workload.

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

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

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

Dizziness, lightheadedness, or fainting may occur, especially when you get up from lying down or sitting, or if you have been taking a diuretic (water pill). Make sure you know how this medicine affects you before you drive, operate machinery, or do anything that could be dangerous if you feel dizzy or are not alert. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from coming back.

Contact your doctor right away if you become sick while taking this medicine, especially if you have severe or ongoing nausea, vomiting, or diarrhea. These conditions can 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 some people taking this medicine. Contact your doctor right away if you experience any of the following symptoms: abdominal or stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in your hands, feet, or lips, shortness of breath, or weakness or heaviness in your legs. Ask your doctor before using any medicines, supplements, or salt substitutes that contain potassium.

This medicine may worsen the symptoms of angina (chest pain) or increase the risk of heart attack in some patients with severe heart or blood vessel disease. Contact 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 are sweating.

Do not take other medicines unless you have discussed them with your doctor. This is especially true for over-the-counter medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as they may raise your blood pressure.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been suitable studies on how telmisartan and amlodipine combination affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the usefulness of telmisartan and amlodipine combination.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there might be an interaction. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen because they might be significant and are not necessarily all-inclusive.

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

• Aliskiren
• Sparsentan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

• Abametapir
• Atazanavir
• Benazepril
• Captopril
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Domperidone
• Droperidol
• Enalapril
• Enalaprilat
• Epirubicin
• Erythromycin
• 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 increase the risk of certain side effects, but taking both may be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or how often you use one or both medicines.

• Aceclofenac
• Acemetacin
• Amprenavir
• Amtolmetin Guacil
• Aprepitant
• Boceprevir
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Clonixin
• Cobicistat
• Crizotinib
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyrone
• Dronedarone
• Droxicam
• Duvelisib
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Fosamprenavir
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Letermovir
• Lonafarnib
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mifepristone
• 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
• Ribociclib
• Rifapentine
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Schisandra sphenanthera
• Sodium Salicylate
• Sulindac
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Troleandomycin
• Tucatinib
• Valdecoxib
• Verapamil
• Voriconazole
• Voxelotor

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other issues, especially:

• Angina (severe chest pain) or
• Electrolyte imbalances (e.g., low sodium) or
• Fluid imbalances (due to dehydration, vomiting, or diarrhea) or
• Recent heart attack or
• Heart problems (e.g., aortic stenosis, heart failure) or
• Kidney problems—Use with caution. May worsen these conditions.

• Severe congestive heart failure—Using this may lead to kidney issues.

• Patients with diabetes or kidney problems 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 raise the risk of chest pain or heart attacks.

• Liver disease (including biliary obstructive disorders)—Use with caution. Effects may be stronger because the medicine is removed from the body more slowly.

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.

In the U.S.

• Twynsta

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

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.