Twynsta

The usual dose of Twynsta depends on the doses of amlodipine and telmisartan taken separately before starting Twynsta. The dose is taken once daily, at the same time of day, preferably in the morning.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Amlodipine - telmisartan may be taken with or without food.

It is important to take Twynsta exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Twynsta at room temperature in the original package, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause leg swelling or water retention. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

40 mg/5 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white-to-off-white and the other layer blue, marked with the company logo and "A1" contains 40 mg telmisartan and 5 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminum Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).

40 mg/10 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white-to-off-white and the other layer blue, marked with the company logo and "A2" contains 40 mg telmisartan and 10 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminum Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).

80 mg/5 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white-to-off-white and the other layer blue, marked with the company logo and "A3" contains 80 mg telmisartan and 5 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminum Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).

80 mg/10 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white-to-off-white and the other layer blue, marked with the company logo and "A4" contains 80 mg telmisartan and 10 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminum Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).

Do not take Twynsta if you:

• are allergic to amlodipine, telmisartan, or any ingredients of the medication
• are allergic to similar medications (e.g., calcium channel blockers, ARBs)
• are breast-feeding
• are pregnant
• have Diabetes or Kidney Disease and are taking the medication Aliskiren
• have had angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell) after taking any other ARBs (e.g., Candesartan, Losartan) or angiotensin-converting-enzyme inhibitors (ACEIs)
• have a rare hereditary condition of fructose intolerance (Twynsta contains sorbitol)
• have biliary obstruction (problems with the draining of bile from the liver and gall bladder)
• have severely decreased liver function
• have severely reduced blood pressure
• have low heart output because of a serious heart problem
• have unstable heart failure as a result of a Heart Attack

There may be an interaction between amlodipine - telmisartan and any of the following:

• alcohol
• Aldesleukin
• aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• amifostine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• angiotensin-converting-enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• other angiotensin receptor blockers (ARBs; e.g., candesartan, Irbesartan, losartan)
• Apalutamide
• Apomorphine
• Aprepitant
• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bosentan
• brimonidine
• Bromocriptine
• other calcium channel blockers (e.g., Diltiazem, Nifedipine, Verapamil)
• calcium supplements (e.g., calcium carbonate, calcium citrate)
• certain anti-psychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Clopidogrel
• Cobicistat
• conivaptan
• Cyclosporine
• Dantrolene
• Deferasirox
• dexmethylphenidate
• Digoxin
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Dronedarone
• drospirenone
• Duloxetine
• Enzalutamide
• Eplerenone
• Everolimus
• Flibanserin
• grapefruit juice
• Guanfacine
• Heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• levodopa
• lithium
• Lomitapide
• Lovastatin
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
• magnesium supplements
• medications that increase the level of potassium in the blood (e.g., Spironolactone, Amiloride, triamterene, or salt substitutes that contain potassium)
• melatonin
• Methylphenidate
• mifepristone
• Minoxidil
• Mitotane
• Modafinil
• Morphine
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., Asa, Naproxen, Diclofenac)
• Obinutuzumab
• opioid pain medications (e.g., Codeine, morphine, Oxycodone)
• Paclitaxel
• Pentoxifylline
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimozide
• potassium supplements
• Pramipexole
• protein kinase inhibitors (e.g., Ceritinib, Crizotinib, Dabrafenib, Dasatinib, imatinib, Nilotinib, Ribociclib)
• quinidine
• Rasagiline
• rifabutin
• rifampin
• Riociguat
• Ropinirole
• Rotigotine
• sacubitril
• St. John's wort
• Sarilumab
• seizure medications (e.g., Carbamazepine, Eslicarbazepine, phenobarbital, Phenytoin, primidone)
• Selegiline
• siltuximab
• Simvastatin
• Sirolimus
• sodium phosphate
• Tacrolimus
• Temsirolimus
• Tizanidine
• Tocilizumab
• Tolvaptan
• Triazolam
• Trimethoprim
• Yohimbine
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Twynsta. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Twynsta.

Angioedema: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with ARBs, such as telmisartan, although rarely. If you experience swelling of the face, tongue, or throat, you should stop taking Twynsta at once and get immediate medical attention.

Dizziness, fainting, spinning sensations: Twynsta can cause dizziness, fainting, or spinning sensations.

Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how Twynsta affects you.

Heart attack and Stroke: If you have a history of heart problems, discuss with your doctor how Twynsta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Twynsta, and whether any special monitoring is needed.

If you have heart disease, problems with blood supply to the brain, low blood pressure, or have had a recent heart attack, there is a risk that Twynsta may cause a heart attack or a stroke.

If you develop symptoms of a heart attack (e.g., chest pain, pressure, or heaviness; nausea; shortness of breath; anxiety; cool, clammy skin) or a stroke (e.g., sudden dizziness, difficulty speaking, headache, difficulty walking, confusion, blurred vision), get immediate medical attention.

Kidney function: Telmisartan can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe Congestive Heart Failure). The use of diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase risk of kidney problems for people already at risk of this problem. If you have reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, discuss with your doctor how Twynsta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Twynsta, and whether any special monitoring is needed. If you have reduced kidney function, you may require lower doses of Twynsta.

Taking aliskiren may further increase the risk of kidney problems. If you have kidney disease, discuss with your doctor how Twynsta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Twynsta, and whether any special monitoring is needed.

Twynsta should not be taken by people with severely decreased kidney function.

People who have kidney problems and take Twynsta are more likely to experience increased levels of potassium in the blood. If you experience an irregular or slow heartbeat or nausea, contact your doctor as soon as possible.

Liver function: Amlodipine - telmisartan is removed from the body by the liver. People with reduced liver function are more likely to experience side effects related to Twynsta.

If you have mild-to-moderate liver problems, discuss with your doctor how Twynsta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Twynsta, and whether any special monitoring is needed. If you have severe liver problems or have biliary obstruction, you should not use Twynsta.

Low blood pressure: Twynsta may cause low blood pressure. Low blood pressure is more likely to occur if you are dehydrated, are taking aliskiren, other diuretics ("water pills"), are on a low-salt diet, or have diarrhea or vomiting. If you experience dizziness or lightheadedness, lie down until the symptoms go away and contact your doctor.

Potassium levels: Twynsta can increase potassium levels in the blood. Your doctor may monitor your potassium levels with blood tests. Do not use potassium supplements or salt substitutes with potassium unless recommended by your doctor.

Pregnancy: As with other medications related to telmisartan, Twynsta can cause serious harm or even death to the developing baby if taken during pregnancy. Twynsta should not be used during pregnancy. If you become pregnant while taking Twynsta, contact your doctor immediately.

Breast-feeding: It is not known if telmisartan passes into breast milk. Amlodipine passes into breast milk. If you are a breast-feeding mother and taking Twynsta, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Twynsta have not been established for adolescents and children under the age of 18.

Seniors: Seniors may be more sensitive to the side effects of Twynsta.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. Consult your pharmacist before consuming grapefruit or grapefruit juice during treatment. Grapefruit may change the effect of this drug in some people.