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Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.
Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.
Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.
Aliskiren, amlodipine, and hydrochlorothiazide is a combination medicine used to treat high blood pressure (hypertension). This medicine is usually given after other blood pressure medications have been tried without successful treatment of symptoms.
Aliskiren, amlodipine, and hydrochlorothiazide may also be used for purposes not listed in this medication guide.
You should not use this medicine if you are unable to urinate, or if you are allergic to sulfa drugs.
Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant.
If you have diabetes, you should not use this medicine together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).
You should not take this medicine if you are allergic to aliskiren, amlodipine, or hydrochlorothiazide, or if:

• you are unable to urinate; or
• you are allergic to sulfa drugs.

If you have diabetes, you should not use this medicine together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with aliskiren, amlodipine, and hydrochlorothiazide if you have kidney disease.
To make sure aliskiren, amlodipine, and hydrochlorothiazide is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• liver disease;
• heart disease or prior heart attack;
• coronary artery disease (hardened arteries);
• glaucoma;
• asthma or allergies;
• gout;
• systemic lupus erythematosus (SLE);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• if you are on a low-salt diet; or
• if you have ever had an allergic reaction to penicillin or a blood pressure medication.

FDA pregnancy category D. Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Aliskiren, amlodipine, and hydrochlorothiazide can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.
It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medicine to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; vomiting, severe stomach pain; dizziness, difficulty breathing; swelling of your face, lips, tongue, or throat.
Your chest pain may become worse when you first start taking the medicine or when your dose is increased. Tell your doctor if your chest pain is severe or ongoing.
Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urinating;
• eye pain, vision problems;
• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling);
• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;
• lupus-like symptoms--joint pain with fever, skin sores, butterfly-shaped skin rash on your cheeks and nose, numbness or pale appearance of your fingers or toes;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• swelling in your hands, ankles, or feet;
• headache, dizziness, tired feeling;
• cough;
• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.
Avoid taking with foods that are high in fat, which can make it harder for your body to absorb aliskiren.
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of this medicine.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aliskiren, amlodpine, and hydrochlorothiazide, especially:

• antifungal medicine;
• any heart or blood pressure medicines;
• a barbiturate--amobarbital, phenobarbital, secobarbital and others;
• cholesterol medicine--atorvastatin (Lipitor), simvastatin (Zocor), cholestyramine or colestipol;
• cyclosporine;
• a diuretic or "water pill";
• HIV or AIDS medicine (indinavir, ritonavir, and others);
• insulin or oral diabetes medicine;
• lithium;
• narcotic pain medicine (OxyContin, Vicodin, fentanyl, and many others);
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with aliskiren, amlodipine, and hydrochlorothiazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
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 feel very dizzy.
Your blood pressure will need to be checked often.
If you need surgery or medical tests, tell the surgeon ahead of time that you are using aliskiren, amlodipine, and hydrochlorothiazide. You may need to stop using the medicine for a short time.
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 in the original container at room temperature, away from moisture and heat.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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.

Methyldopa lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels (veins and arteries) to relax (widen) and your heart to beat more slowly and easily.
Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.
The combination of hydrochlorothiazide and methyldopa is used to treat high blood pressure (hypertension).
Hydrochlorothiazide and methyldopa may also be used for purposes not listed in this medication guide.
You should not use this medication if you are allergic to methyldopa (Apresoline) or hydrochlorothiazide, if you are unable to urinate, or if you have liver disease (including cirrhosis or hepatitis), or a history of liver problems caused by taking methyldopa.
Do not use hydrochlorothiazide and methyldopa if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Before using hydrochlorothiazide and methyldopa, tell your doctor if you have kidney disease (or are on dialysis), angina pectoris (chest pain), glaucoma, asthma, gout, lupus, diabetes, an allergy to sulfa drugs or penicillin, or if you have ever had a stroke.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctors instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
There are many other drugs that can interact with hydrochlorothiazide and methyldopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
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 medication for the rest of your life.
Do not use hydrochlorothiazide and methyldopa if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
You should not use this medication if you are allergic to methyldopa (Apresoline) or hydrochlorothiazide, or if you have:

• liver disease (including cirrhosis or hepatitis);
• a history of liver problems caused by taking methyldopa; or
• if you are unable to urinate.

To make sure you can safely take hydrochlorothiazide and methyldopa, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• angina pectoris (chest pain);
• glaucoma;
• asthma;
• gout;
• lupus;
• diabetes;
• an allergy to sulfa drugs or penicillin; or
• if you have ever had a stroke.

FDA pregnancy category C. It is not known whether hydrochlorothiazide and methyldopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Hydrochlorothiazide and methyldopa can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using hydrochlorothiazide and methyldopa and call your doctor at once if you have a serious side effect such as:

• eye pain, vision problems;
• feeling like you might pass out;
• chest pain, slow heart rate, feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions);
• numbness, drooping, or loss of movement in one side of your face;
• jerky or rolling muscle movements you cannot control;
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
• urinating less than usual or not at all;
• fever, skin rash, bruising, severe tingling, numbness; or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling;severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

• stomach cramps, diarrhea, constipation;
• depressed mood, trouble concentrating;
• joint pain;
• muscle pain or weakness;
• restless feeling;
• dizziness, drowsiness, headache;
• soreness or black discoloration of your tongue;
• blurred vision; or
• impotence, or loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and methyldopa.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctors instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
Avoid exposure to sunlight or tanning beds. Hydrochlorothiazide and methyldopa can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Tell your doctor about all other medicines you use, especially:

• cholestyramine (Prevalite, Questran);
• colestipol (Colestid);
• digoxin (Lanoxin);
• insulin or oral diabetes medication;
• lithium (Eskalith, LithoBid);
• a barbiturate such as phenobarbital (Solfoton);
• medicines that contain iron, such as ferrous gluconate (Fergon, Ferralet, Simron), or ferrous sulfate (Chem-Sol, Feosol, Slow Fe, and others);
• muscle relaxers or narcotic pain medicine;
• steroids (prednisone and others);
• other blood pressure medications; or
• a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and methyldopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Your blood pressure will need to be checked often. Your liver function may also need to be tested. Visit your doctor regularly.
Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctors instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and methyldopa. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.
Your blood and urine may both be tested if you have been vomiting or are dehydrated.
If you need surgery or medical tests, tell the doctor ahead of time that you are taking medication that contains hydrochlorothiazide. You may need to stop using the medicine for a short time.
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 medication for the rest of your life.
Store at room temperature away from moisture, heat, and light.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.
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.