Teva-Ramipril-HCTZ

Brand Name

Teva-Ramipril-HCTZ

Common Name

ramipril - hydrochlorothiazide

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

This combination product contains 2 active ingredients: ramipril and hydrochlorothiazide. Ramipril belongs to the class of medications called ACE inhibitors. It works by relaxing blood vessels and by making the heart pump more efficiently. Hydrochlorothiazide belongs to the class of medications known as diuretics or "water pills" and helps control blood pressure by getting rid of excess salt and water.

Ramipril - hydrochlorothiazide is used to treat high blood pressure. This combination medication is prescribed when your doctor feels it is appropriate for you to be taking both medications and you have taken ramipril and hydrochlorothiazide as separate medications without any problems.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Ramipril - hydrochlorothiazide is not intended to be used to start treatment of high blood pressure. Each medication should be taken as a separate tablet until the appropriate dose of each medication is determined. Once the dose of each medication (ramipril and hydrochlorothiazide) that best controls your blood pressure has been determined, the combination tablets can be started.

This combination medication is used to make taking the medication more convenient for people who are already taking both of the active ingredients (ramipril and hydrochlorothiazide).

The usual recommended dose of this medication is one tablet taken once a day, with or without food. The dose will depend on your response to the medication and on your kidney function. This medication should be taken at the same time each day, preferably in the morning. Swallow the medication whole. Do not crush or chew it.

Many things can affect the dose of a 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.

It is important that this medication be taken 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 this medication at room temperature 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.

What form(s) does this medication come in?

2.5 mg/12.5 mg
Each white-to-off-white, modified-capsule-shaped tablet, scored on both sides, on one side of the tablet debossed with "2.5" on one side of the score line and "12.5" on the other, and on the other side of the tablet debossed with "TV" on one side of the score line and "TV" on the other, contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

5 mg/12.5 mg
Each white-to-off-white, modified-capsule-shaped tablet, scored on both sides, on one side of the tablet debossed with "5" on one side of the score line and "12.5" on the other, and on the other side of the tablet debossed with "TV" on one side of the score line and "TV" on the other, contains 5 mg of ramipril and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

10 mg/12.5 mg
Each white-to-off-white, modified-capsule-shaped tablet, scored on both sides, on one side of the tablet debossed with "10" on one side of the score line and "12.5" on the other, and on the other side of the tablet debossed with "TV" on one side of the score line and "TV" on the other, contains 10 mg of ramipril and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

5 mg/25 mg
Each white-to-off-white, modified-capsule-shaped tablet, scored on both sides, on one side of the tablet debossed with "5" on one side of the score line and "25" on the other, and on the other side of the tablet debossed with "TV" on one side of the score line and "TV" on the other, contains 5 mg of ramipril and 25 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

10 mg/25 mg
Each white-to-off-white, modified-capsule-shaped tablet, scored on both sides, on one side of the tablet debossed with "10" on one side of the score line and "25" on the other, and on the other side of the tablet debossed with "TV" on one side of the score line and "TV" on the other, contains 10 mg of ramipril and 25 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

Who should NOT take this medication?

Do not take ramipril - hydrochlorothiazide if you:

• are allergic to ramipril, hydrochlorothiazide, or any ingredients of the medication
• are allergic to any other ACE inhibitor (e.g., enalapril, lisinopril, captopril)
• are allergic to sulfonamide medications (e.g., sulfamethoxazole)
• are pregnant or breast-feeding
• are not passing urine
• are taking the medication sacubitril - valsartan
• are taking the medication aliskiren or angiotensin II receptor antagonists and have
• diabetes
• kidney disease
• high levels of potassium in the blood
• congestive heart failure with low blood pressure
• have had angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell)
• have low blood pressure
• have narrowing of arteries to one or both kidneys
• are receiving dialysis
• have severely reduced liver function
• have severely reduced kidney function
• have uncorrected potassium, sodium, or calcium levels in the blood
• have diabetes and/or kidney disease and are taking the medication aliskiren or an angiotensin receptor blocker (ARB)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changes to sensory perception (e.g., vision, hearing, taste, smell)
• constipation
• cough (dry, persistent)
• drowsiness
• fatigue
• flushing
• headache
• hair loss
• muscle pain
• muscle stiffness
• nasal congestion
• sensitivity to sunlight
• sexual difficulties (for men)
• trouble sleeping
• unusual tiredness or weakness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• attention difficulties
• breast enlargement (men)
• dizziness, lightheadedness, or fainting when rising from a lying or sitting position
• fast heartbeat, irregular heartbeat, or palpitations
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of changed potassium levels (e.g., irregular heartbeat, muscle weakness, general feeling unwell)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, thirst, confusion, lack of coordination)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of legs, hands, fatigue)
• signs of liver damage (abdominal pain, fever, nausea, vomiting, loss of appetite, or yellowing of the skin or eyes)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• skin lesions that do not heal, new moles, or changes to existing moles
• skin rash (with or without itching), fever, or joint pain
• swelling of hands, ankles or feet
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abdominal pain (with or without nausea or vomiting)
• asthma flare-ups
• signs of an allergic reaction, including angioedema (shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of acute respiratory distress (ARDS; e.g., shortness of breath, chest tightness, cough, wheezing, fever weakness, confusion)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Angioedema: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated promptly. If you have difficulty breathing or notice hives or swelling of the face, lips, tongue, or throat, stop taking this medication and get emergency medical help at once. Other ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving this medication.

Blood disorders: In rare cases, a low white blood cell count has been reported by people taking this medication. Your doctor may occasionally monitor your level of white blood cells by performing blood tests. Low white blood cell levels may increase your risk for infection. If you notice any signs of infection (e.g., fever, sore throat), contact your doctor as soon as possible.

Cholesterol: Increases in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide.

Your doctor may monitor for this with blood tests.

Cough: People taking ramipril may develop a dry, persistent cough that usually disappears only after stopping ramipril. Inform your doctor of any cough that does not seem to be related to a usual cause.

Diabetes: Hydrochlorothiazide may make it more difficult for people with diabetes to control their blood sugar. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. An adjustment to doses of antidiabetic medications may be required.

Drowsiness/reduced alertness: This medication may reduce alertness, especially at the beginning of treatment. Exercise caution when driving or performing tasks that require alertness.

Electrolytes: The use of hydrochlorothiazide can reduce the levels of electrolytes such as potassium, sodium, magnesium, and chloride and increase the levels of calcium. Your doctor will periodically check to see if these levels are in balance, and a potassium supplement may be recommended. Warning signs or symptoms of fluid and electrolyte imbalance include:

• confusion
• drowsiness
• dryness of mouth
• lethargy
• low blood pressure
• muscle pains or cramps
• muscular fatigue
• nausea and vomiting
• racing heartbeat
• restlessness
• seizures
• thirst
• weakness

Gout: Hydrochlorothiazide may increase the level of uric acid in the body. If you have a history of gout, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you develop painful, warm and swollen joints, contact your doctor.

Glaucoma: Rarely, hydrochlorothiazide can cause an increase in the pressure in the eyes (glaucoma). If you experience decreased sharpness of vision or eye pain shortly after starting to take this medication, contact your doctor immediately. This may be more likely to happen to people who have previously had sulfonamide or penicillin allergies.

Kidney function: Decreased kidney function or kidney disease can cause this medication to build up in the body, causing side effects. Also, ramipril can cause decreases in kidney function. Certain people, such as those with narrowed blood vessels in their kidneys, or those with severe congestive heart failure may be more likely to experience this complication. The use of other diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren, may further increase risk of kidney problems. 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of decreased kidney function, such as puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Ramipril - hydrochlorothiazide may cause reduced liver function. If you experience any signs of liver problems such as yellowing of the skin or eyes, fever, generally feeling unwell, abdominal pain, nausea, vomiting, loss of appetite, itching, muscle pain, rash, or swollen glands, contact your doctor immediately. People who have preexisting liver problems will need to be closely monitored by their doctor while taking this medication.

Low blood pressure: Occasionally, blood pressure drops too low after taking this medication. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur for those who take diuretics or the medication, aliskiren, have a salt-restricted diet, are on dialysis, or are suffering from diarrhea or vomiting. If any of these conditions apply to you, you should be monitored closely by their doctor for the first weeks of treatment and whenever the dose of the medication is increased. To reduce the risk of dizziness, get up slowly from a lying or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact a doctor. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Excessive sweating and lack of fluid intake may lead to an excessive fall in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a fall in blood pressure. Consult your doctor if you feel your blood pressure is too low.

Lupus: Hydrochlorothiazide can cause the symptoms of systemic lupus erythematosus (SLE) to worsen. If you have SLE, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 30 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Skin cancer: Recent reviews have connected long-term use of hydrochlorothiazide with an increased risk of developing non-melanoma skin cancer. Talk to your doctor about any concerns you may have.

Surgery: It is important that your physician and anesthesiologist know that you are taking this medication before you undergo any surgical procedures requiring general anesthesia.

Pregnancy: ACE inhibitors such as ramipril have the potential to cause harm or death to a developing fetus if taken by the mother during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: It is not known if ramipril passes into breast milk, but medications similar to ramipril pass into breast milk, and hydrochlorothiazide passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Its use by this age group is not recommended.

Seniors: Seniors may be more sensitive to the effects of this medication due to reduced kidney function.

What other drugs could interact with this medication?

There may be an interaction between ramipril - hydrochlorothiazide and any of the following:

• acetylsalicylic acid (ASA)
• aclidinium
• alcohol
• aldesleukin
• aliskiren
• allopurinol
• alpha-blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apomorphine
• atropine
• azathioprine
• barbiturates (e.g., phenobarbital, butalbital)
• benztropine
• beta-2 agonists (e.g., salbutamol, formoterol, terbutaline, salmeterol)
• bismuth subsalicylate
• bortezomib
• brimonidine
• bromocriptine
• buprenorphine
• butorphanol
• calcium supplements (e.g., calcium carbonate, calcium citrate)
• carbamazepine
• cholestyramine
• clidinium
• colesevelam
• colestipol
• conivaptan
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclobenzaprine
• cyclophosphamide
• darifenacin
• desmopressin
• diabetes medications (e.g., acarbose, canagliflozin, gliclazide, insulin, liraglutide, metformin, sitagliptin)
• diazoxide
• digoxin
• dimenhydrinate
• disopyramide
• diuretics (water pills; e.g., furosemide, amiloride, spironolactone, triamterene)
• drospirenone
• duloxetine
• eplerenone
• everolimus
• finerenone
• flunarizine
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• grass pollen allergen extract
• heparin
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• ipratropium
• iron dextran
• ivabradine
• ketotifen
• levodopa
• lithium
• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
• methadone
• methotrexate
• methylphenidate
• minoxidil
• multivitamins/minerals with ADE
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• nabilone
• narcotic medications (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, ibuprofen, indomethacin, ketorolac, naproxen)
• obinutuzumab
• oxybutynin
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• orphenadrine
• other angiotensin-converting enzyme inhibitors (ACEIs; e.g., captopril, lisinopril, ramipril)
• oxcarbazepine
• oxybutynin
• pentoxifylline
• pergolide
• phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• pizotifen
• polyethylene glycol
• pramipexole
• pregabalin
• propiverine
• ranolazine
• riociguat
• ropinirole
• rotigotine
• sacubitril
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
• sirolimus
• sodium phosphates
• solifenacin
• sotalol
• tacrolimus
• tiotropium
• tizanidine
• tolterodine
• tolvaptan
• topiramate
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• trihexyphenidyl
• trimethoprim
• trospium
• umeclidinium
• vilanterol
• vitamin D analogues (e.g., alfacalcidol, calcitriol, cholecalciferol)
• yohimbine

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 this medication. 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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Teva-Ramipril-HCTZ