How does this medication work? What will it do for me?
Eprosartan - hydrochlorothiazide is a combination product that contains two medications to treat mild-to-moderate high blood pressure.
Eprosartan belongs to the class of medications called angiotensin II receptor blockers. These medications work by relaxing blood vessels. Angiotensin II is a chemical the body releases to cause the tightening of blood vessels. Eprosartan blocks angiotensin II, causing the blood vessels to relax. This relaxation causes the blood pressure to drop.
Hydrochlorothiazide belongs to the class of medications called thiazide diuretics or "water pills," which help control blood pressure by getting rid of excess salt and water.
This combination medication is prescribed when your doctor feels it is appropriate for you to be taking both medications. You should already be taking each medication individually before starting this combination medication. The full effects of eprosartan - hydrochlorothiazide are usually seen in about 2 to 3 weeks.
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.
What form(s) does this medication come in?
Each butterscotch-coloured, film-coated, capsule-shaped tablet, marked with "SOLVAY" on one side and "5147" on the other, contains 600 mg of eprosartan and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, crospovidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide, iron oxide black, and iron oxide yellow.
How should I use this medication?
This combination medication is used to make dosing more convenient for people who are already taking both active ingredients (eprosartan and hydrochlorothiazide).
The recommended dose is one tablet taken once daily, with or without food. It is best to establish a routine with this medication with respect to time of day you take it and whether you take it with or without food. For example, if you take the medication with food in the morning, continue to take it with food 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.
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 and moisture, and keep it out of the reach of children. It should be left in the protective blisters until immediately before it is to be taken.
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.
Who should NOT take this medication?
Do not use eprosartan - hydrochlorothiazide if you:
- are allergic to eprosartan, hydrochlorothiazide, or any ingredients of the medication
- are allergic to thiazides or sulfa medications (e.g., sulfamethoxazole)
- are breast-feeding
- are pregnant
- have anuria (unable to urinate) or severe kidney dysfunction
- have diabetes or kidney disease and are taking aliskiren
- have severe liver dysfunction
- have symptoms of gout or unusually high uric acid levels
- have untreated or treatment resistant electrolyte abnormalities
- have fructose intolerance (a rare hereditary condition)
- have galactose intolerance (a rare hereditary condition)
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.
- back or leg pain
- decreased appetite
- dry mouth
- flu-like symptoms
- joint pain
- pins and needles sensation
- sexual difficulties
- stomach pain
- trouble sleeping
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:
- pounding rapid heartbeat
- shortness of breath with exertion
- 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 depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of gout (e.g., joint pain, swelling and warmth of joints)
- signs of infections (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 the feet and ankles)
- signs of liver damage (yellowing of skin or whites of eyes, abdominal pain, loss of appetite, brown urine, light-coloured stools, tiredness, or weakness)
- signs of low blood pressure such as dizziness, lightheadedness, or fainting
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- swelling legs, ankles, or hands
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- skin rash (especially if you also have joint pain)
- unexplained muscle pain or weakness
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
- symptoms of a serious allergic reaction (such as hives; swelling of the face, eyes, and throat; and difficulty breathing)
- symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
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 taking 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 take this medication.
HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of eprosartan. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reactions: 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.
Cholesterol: Cholesterol and triglyceride levels may increase when taking hydrochlorothiazide. Talk to your doctor about whether you will need to have your cholesterol levels tested while you are taking this medication. If you have increased cholesterol or triglyceride levels, 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.
Diabetes: Hydrochlorothiazide may make it more difficult for people with diabetes to control their blood sugar levels. High blood sugar may occur, glucose tolerance may change, and diabetes may worsen. A dose adjustment of diabetes medications, including insulin, may be required. 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.
Electrolytes: Your levels of electrolytes such as potassium, sodium, magnesium, and chloride may change with the use of this medication. Your doctor will periodically check that these are in balance and a potassium supplement may be necessary when taking this medication. If you experience symptoms such as muscle pains or cramps; dryness of mouth; numbness in hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible
Gout: Some people taking hydrochlorothiazide may experience an episode of gout (symptoms include sudden swelling, redness, and pain in a joint, usually the big toe). If this occurs while you are taking this medication, contact your doctor.
Kidney function: Eprosartan - hydrochlorothiazide may affect the function of the kidneys, especially in people who already have kidney problems. If you have kidney 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. This medication should not be taken by people with severely impaired kidney function.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. People with reduced liver function may need a lower-than-normal dose of eprosartan; therefore, it may be necessary to use the components of the combination product separately. If you have reduced liver function or liver disease, 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. This medication is not recommended for people with severe liver impairment.
This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Low blood pressure: Occasionally, a larger-than-expected decrease in blood pressure occurs after taking eprosartan - hydrochlorothiazide. In some cases, this happens after the first dose. It is more likely to occur if you have a reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting.
Blood pressure should be monitored more often in these situations. To reduce the risk of dizziness, those with low blood pressure or those just starting to take this medication should stand or sit up slowly when getting up from a lying down or sitting position.
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: There have been reports of a worsening or activation of lupus in people taking hydrochlorothiazide. If you have lupus, 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.
Pregnancy: Pregnant women should not take this medication. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.
Breast-feeding: It is not known if eprosartan passes into breast milk. Hydrochlorothiazide passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Do not breast-feed while you are taking this medication.
Children: The safety and effectiveness of using this medication have not been established for children. This medication is not recommended for children.
What other drugs could interact with this medication?
There may be an interaction between eprosartan - hydrochlorothiazide and any of the following:
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 that 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.
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