Enalapril Maleate/HCTZ

The recommended dose ranges from 1 to 2 tablets once daily of enalapril 10 mg - hydrochlorothiazide 25 mg. Before starting the combination product, your doctor should start you on the individual components of this medication. Once the desired dose of each medication is determined to achieve optimal effect on blood pressure, the combination product can be substituted if possible. Enalapril - hydrochlorothiazide may be taken with or without food. Try to take it at the same time each day.

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, protect it from 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.

**5 mg/12.5 mg **
Each green, squared-capsule-shaped, biconvex, unscored tablet, engraved with "5/12.5" on one side and plain on the other, contains 5 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: anhydrous lactose and zinc stearate. Each 5 mg/12.5 mg tablet also contains FD&C Blue No. 2 and iron oxide yellow.

Do not take this medication if you:

• are allergic to enalapril, hydrochlorothiazide, or any ingredients of this medication

• are allergic to sulfa medications

• are pregnant

• cannot pass urine (also known as anuria)

• have had angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) after taking any other medication from the class of medications known as ACE inhibitors (e.g., lisinopril, ramipril, captopril)

• have been diagnosed with hereditary angioedema

• have diabetes or kidney disease and are taking aliskiren

• are taking the medication sacubitril

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.

• abdominal pain

• abnormal dreams

• back or joint pain

• changed sense of taste

• cough (dry, persistent)

• constipation

• decreased appetite

• decreased interest in sexual activity

• decreased sense of smell

• dizziness

• drowsiness

• dry or watery eyes

• dry mouth

• erectile dysfunction (impotence)

• fast heartbeat

• flushing

• gas

• hair loss

• headache

• heartburn

• increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin or severe sunburn after exposure to sunlight)

• itching

• loss of appetite

• nausea

• nervousness

• pink eye

• ringing in the ears

• skin rash

• spinning sensation

• trouble sleeping

• unusual tiredness or fatigue

• vomiting

• weakness

Although most of the 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:

• breathing difficulty, shortness of breath

• chest pain

• confusion

• dizziness, lightheadedness, or fainting (signs of low blood pressure)

• enlarged breasts (men)

• eye pain or vision changes

• fever

• hearing loss

• muscle cramps or pain

• 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 gout (e.g., joint pain, swelling and warmth of joints)

• 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 or hands, fatigue)

• signs of liver problems such as abdominal pain, nausea or vomiting, itching of skin, yellow eyes or skin

• signs of non-melanoma skin cancer (e.g., lump or discolored patch on skin that changes slowly; red or pink firm lumps; flat, scaly patches on the skin)

• signs of Raynaud's phenomenon (decreased blood flow to the fingers and toes; e.g., prickly or stinging feeling, waxy or cold fingers or toes, change in colour – white to blue)

• 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)

• signs of too much or too little potassium in the body

  • dry mouth

  • increased thirst

  • irregular heartbeat

  • mood or mental changes

  • muscle cramps or pain

  • numbness or tingling in hands, feet, or lips

  • weak pulse

  • weakness or heaviness of legs

• skin rash (with or without itching), fever, or joint pain

• symptoms of decreased muscle coordination (i.e., difficulty with tasks such as eating, buttoning shirt, or writing)

• symptoms of electrolyte imbalance (e.g., weakness, drowsiness, muscle pain or cramps, irregular heartbeat)

• 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 shingles (e.g., painful rash of fluid-filled blisters, itching)

• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

• tingling or burning sensation

• trouble swallowing

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

• severe difficulty breathing, including fever, shortness of breath, weakness, or confusion

• severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)

• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

• symptoms of a blood clot in the lungs (e.g., chest pain that increases with deep breathing, coughing up bloody sputum, shortness of breath)

• symptoms of a serious allergic reaction, including angioedema (e.g., hives; swelling of the face, mouth, hands, or feet; and difficulty breathing)

• symptoms of fluid in the lungs (e.g., difficulty breathing that worsens with activity or lying down, extreme shortness of breath, wheezing, cold clammy skin, irregular heartbeat, cough with frothy sputum, blue-tinged lips)

• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)

• symptoms of SIADH (syndrome of inappropriate anti-diuretic hormone secretion; e.g., dark coloured urine, feeling unwell, muscle cramps, confusion, seizures)

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.

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, tell 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: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with ACE inhibitors, including this medication, although it is not common. If you experience swelling of the face, tongue, or throat, stop taking this medication at once and get immediate medical attention.

People taking certain diabetes medications, such as alogliptin, linagliptin, saxagliptin, and sitagliptin may be at an increased risk of experiencing angioedema.

People who have had angioedema caused by other substances may be at increased risk of angioedema while taking an ACE inhibitor like the one contained in 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: An increase in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide. Your doctor will monitor you for these changes while you are taking this medication.

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

Diabetes: This medication may make it more difficult for people who have 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/dizziness: Enalapril - hydrochlorothiazide can cause dizziness and fatigue, particularly when starting the medication. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: The levels of electrolytes such as potassium, sodium, magnesium, and chloride can be reduced by the use of hydrochlorothiazide. Your doctor will periodically check to see whether these are in balance, and a potassium supplement may be necessary. Warning signs or symptoms of fluid and electrolyte imbalance include:

• confusion

• drowsiness

• dry mouth

• lethargy

• low blood pressure

• muscle pains or cramps

• muscle fatigue

• nausea and vomiting

• racing heartbeat

• restlessness

• seizures

• thirst

• weakness

**Galactose intolerance/glucose malabsorption: **Enalapril - hydrochlorothiazide tablets are prepared with lactose. If you have lactose or galactose intolerance you should not take these medications.

Gout: Hydrochlorothiazide may increase the level of uric acid in the body, causing symptoms of gout. 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.

This medication may also affect kidney function for certain people. Let your doctor know if you notice any decrease in urine output or increased swelling of the lower limbs, which suggests an accumulation of fluid due to decreased urination.

Certain people taking this medication have experienced changes in kidney function. The use of other diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase risk of kidney problems for those at risk for this problem. If you have kidney disease, 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.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. This medication can also worsen liver function. 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. If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking enalapril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur if you take water pills, such as aliskiren, have a salt-restricted diet, are on dialysis, are sweating excessively and not drinking enough fluids, or are suffering from diarrhea or vomiting. If low blood pressure causes you to faint or feel lightheaded, contact a doctor.

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 your doctor.

**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.

Potassium levels: Increases in blood levels of potassium occur for some people who take this medication or other ACE inhibitors. This rarely causes problems, but your doctor will likely want to monitor your potassium levels through blood tests. Avoid using salt substitutes that contain potassium while you are taking enalapril.

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 higher. If you notice any unusual skin rash or peeling, contact your doctor immediately.

**Skin cancer: **Long-term use of hydrochlorothiazide may increase the risk of developing certain types of skin cancer. Hydrochlorothiazide is also known to increase sensitivity of the skin to the sun and increase the risk of severe sunburn. While you are taking this medication, protect your skin from the sun by using sunscreen with at least 30 SPF and covering exposed skin during peak hours of sunlight. Notify your doctor as soon as possible if you notice any new skin lesions or moles, or changes to existing skin lesions.

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 enalapril may cause severe harm or death to the developing baby if taken during pregnancy and should not be taken by pregnant people. If you become pregnant while taking this medication, stop taking this medication at once and contact your doctor immediately.

Breast-feeding: These medications pass into breast milk. If you are breast-feeding and taking enalapril and hydrochlorothiazide, 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. Children should not take this medication.

**Seniors: **People over the age of 65 may be more at risk of experiencing side effects from taking enalapril - hydrochlorothiazide.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other 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.

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/Enalapril-MaleateHCTZ