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Sandoz Perindopril Erbutamine/Indapamide

(perindopril - indapamide)

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

This combination product contains 2 medications: perindopril and indapamide. It is used to treat adults with mild-to-moderate high blood pressure.

Perindopril belongs to the class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by relaxing blood vessels and helping the heart to pump blood that carries oxygen to the different parts of the body more efficiently.

Indapamide belongs to the class of medications called 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.

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?

This combination medication is used to make dosing more convenient for people who need to take both of these medications (perindopril and indapamide). The dose of the combination medication depends on the doses of the individual medications the person needs.

The usual recommended dose of this medication is one tablet taken once a day, preferably in the morning before a meal.

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 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 mg/0.625 mg
Each white, rod-shaped, scored tablet contains 2 mg of perindopril erbumine and 0.625 mg of indapamide. Nonmedicinal ingredients: hydrophobic colloidal silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

4 mg/1.25 mg
Each white, rod-shaped tablet contains 4 mg of perindopril erbumine and 1.25 mg of indapamide. Nonmedicinal ingredients: hydrophobic colloidal silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

8 mg/2.5 mg
Each white, round tablet contains 8 mg of perindopril erbumine and 2.5 mg of indapamide. Nonmedicinal ingredients: hydrophobic colloidal silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Who should NOT take this medication?

Do not use perindopril - indapamide if you:

  • are allergic to perindopril, indapamide, or any ingredients of the medication
  • are allergic to sulfa (sulfonamide) medications (e.g., sulfamethoxazole)
  • are pregnant or are planning to become pregnant or are not using effective birth control
  • are breast-feeding
  • are taking the medication sacubitril/valsartan, or have taken sacubitril/valsartan in the past 36 hours
  • have decreased kidney function or are unable to pass urine
  • have untreated high or low potassium
  • have had angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) after taking any ACE inhibitors (e.g., captopril, ramipril)
  • have diabetes or kidney disease and are taking aliskiren
  • have galactose intolerance (a rare hereditary disease) or lactose intolerance
  • have hereditary angioedema (a serious allergic reaction which causes swelling of the hands, feet, ankles, face, lips, tongue, or throat) or have angioedema with no known cause
  • have severely decreased liver function or have hepatic encephalopathy
  • are taking other medications that affect heart rhythm
  • have bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
  • are receiving dialysis or any other type of blood filtration

This medication should not be given to anyone who is in a coma due to reduced liver function.

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.

  • abdominal pain
  • constipation
  • cough (dry, persistent)
  • decreased sexual ability
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • falls
  • flushing
  • headache
  • loss of appetite
  • nausea
  • pins and needles sensation
  • spinning sensation
  • sensitivity to sunlight
  • sweating
  • taste changes (e.g., metallic taste)
  • tiredness
  • 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 check seek medical attention.

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

  • chest pain
  • discolouration, numbness, and pain in fingers or toes
  • dizziness, lightheadedness, or fainting (signs of low blood pressure)
  • joint pain (e.g., toe pain may be a sign of gout)
  • mood swings
  • muscle cramps or unexplained muscle 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 dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • 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, lack of coordination, thirst, confusion, tremor)
  • 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 problems (e.g., abdominal pain, nausea or vomiting, itching of skin, yellow eyes or skin)
  • signs of too much or too little potassium in the body (e.g., 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)
  • signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
  • skin rash, with or without itching, fever, or joint pain
  • stomach pain (severe) with nausea and vomiting
  • 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 inappropriate anti-diuretic hormone secretion (SIADH; dark-coloured urine, nausea, vomiting, muscle cramps, confusion, seizures)
  • symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
  • worsening psoriasis
  • worsening symptoms of lupus
  • vision changes

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

  • chest pain
  • difficulty breathing
  • formation of clusters of blisters over the skin
  • 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)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes)
  • symptoms of a serious allergic reaction, including angioedema (e.g., hives; swelling of the face, mouth, hands, or feet; and difficulty breathing)
  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • 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 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.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, tacrolimus) can increase the risk of a type of abnormal heart rhythm called torsades de pointes and should be used with caution with indapamide.

If you are taking medication for abnormal heart rhythms, 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.

Allergic reaction: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated promptly. People who are also taking sirolimus, tacrolimus, or diabetes medications ending in “-gliptin” may be more likely to experience this type of reaction. If you have difficulty breathing, 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 counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Cough: People taking perindopril may develop a dry, persistent cough that usually disappears only after stopping this medication.

Decreased blood pressure: Occasionally, blood pressure drops too low after taking this medication, especially when getting up from a sitting or lying position. This may lead to fainting. It is more common after the first or second dose, when the dose is increased, or when a person is dehydrated. People who are taking aliskiren, have a salt-restricted diet, are on dialysis, or are suffering from diarrhea or vomiting are also more likely to experience this effect. If any of these conditions apply to you, you should be monitored closely by your 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 down or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Diabetes: Indapamide may make it more difficult for people with diabetes to control their blood sugar. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing 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.

Drowsiness/reduced alertness: Perindopril – indapamide may cause drowsiness or dizziness, affecting your ability to drive or operate machinery, particularly when you start taking the medication or increase the dose. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Your levels of electrolytes, such as potassium, sodium, calcium, magnesium, and chloride, may change due to this medication. Your doctor may periodically ask for tests to check that these are in balance. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Salt substitutes containing potassium should be avoided.

Gout: Indapamide may cause an increased level of uric acid in the body. This can cause symptoms of gout (a type of arthritis that causes sudden, severe attacks of joint pain with redness, warmth, and swelling in the affected area). If you develop painful, warm and swollen joints or difficulty with urination, contact your doctor as soon as possible.

Kidney function: Decreased kidney function or kidney disease can cause this medication to build up in the body, causing side effects. Also, perindopril can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. 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.

Perindopril - indapamide may cause abnormally low amounts of urine or none at all to be passed. The use of other diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase the risk of kidney trouble for people already at risk for 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 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 have reduced kidney function, you may require lower doses of this medication.

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.

Lactose intolerance: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency), you should not take this medication.

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, or yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.

Lupus: Indapamide can cause symptoms of systemic lupus erythematosus (SLE) to flare up. 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.

Sun sensitivity: Indapamide may cause increased sensitivity to the sun. Avoid exposure to excessive sunlight, including sunlamps and tanning beds. If you must spend time in the sun, use sunblock with minimum SPF 30. Talk to your doctor if severe sun sensitivity occurs.

Surgery: Tell your doctor and anesthesiologist that you are taking this medication before you undergo any surgical procedures requiring general anesthesia.

Vision changes: Indapamide can cause an abnormal build-up of fluid in the eye, causing eye pain and decreased vision. This usually happens within the first weeks of starting the medication. Get immediate medical attention if you experience any changes in your vision or eye pain, to ensure your eyes do not become permanently damaged.

Pregnancy: ACE inhibitors such as perindopril have the potential to cause severe harm to the developing baby if taken during pregnancy. Do not take this medication if you are pregnant. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: Perindopril passes into breast milk. It is not known if indapamide passes into breast milk. Do not breast-feed if you are taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children. It is not recommended for children.

Seniors: Seniors may be more sensitive to the effects of this medication due to reduced kidney function. Lower doses may be necessary to minimize side effects.

What other drugs could interact with this medication?

There may be an interaction between perindopril - indapamide and any of the following:

  • acetylsalicylic acid (ASA)
  • aclidinium
  • alcohol
  • aldesleukin
  • aliskiren
  • allopurinol
  • alpha-blockers (e.g., alfuzosin, silodosin, tamsulosin)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • other angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, lisinopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • antihistamines (e.g., cetirizine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
  • antipsychotics (e.g., aripiprazole, cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone, thioridazine, ziprasidone)
  • apomorphine
  • atropine
  • azathioprine
  • barbiturates (e.g., phenobarbital, butalbital)
  • benztropine
  • beta-2 agonists (e.g., formoterol, salbutamol, salmeterol)
  • bisacodyl
  • bismuth subsalicylate
  • brigatinib
  • brimonidine
  • bromocriptine
  • buprenorphine
  • calcium supplements (e.g., calcium carbonate, calcium citrate)
  • cholestyramine
  • clidinium
  • colesevelam
  • colestipol
  • cyclobenzaprine
  • cyclophosphamide
  • darifenacin
  • desmopressin
  • diabetes medications (e.g., acarbose, dapagliflozin, insulin, glyburide, linagliptin, liraglutide, metformin, rosiglitazone)
  • diazoxide
  • digoxin
  • dimenhydrinate
  • disopyramide
  • diuretics (water pills; e.g., furosemide, amiloride, spironolactone, triamterene)
  • drospirenone
  • duloxetine
  • eplerenone
  • everolimus
  • fesoterodine
  • finerenone
  • general anesthetics (medications used to put people to sleep before surgery)
  • gold salts (e.g., sodium aurothiomalate)
  • ginger
  • grass pollen allergen extract
  • glycopyrrolate
  • heparin
  • icatibant
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • iodinated contrast media
  • ipratropium
  • ivabradine
  • iron dextran
  • iron supplements
  • ketotifen
  • levodopa
  • licorice
  • lithium
  • low-molecular-weight heparins (LMWH) (e.g., dalteparin, enoxaparin, tinzaparin)
  • medications that increase blood levels of potassium (e.g., potassium supplements, salt replacements containing potassium, spironolactone, triamterene, amiloride)
  • methadone
  • methylphenidate
  • multivitamins/minerals with ADE
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., cyclobenzaprine, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, hydromorphone, morphine, tramadol)
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., celecoxib, ibuprofen, indomethacin, naproxen)
  • obinutuzumab
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • oxybutynin
  • paclitaxel
  • pentoxifylline
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • pizotifen
  • polyethylene glycol electrolyte solution
  • pramipexole
  • pregabalin
  • primidone
  • propiverine
  • riociguat
  • ropinirole
  • rotigotine
  • sacubitril
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
  • senna
  • sirolimus
  • sodium phosphate
  • solifenacin
  • sotalol
  • tacrolimus
  • temsirolimus
  • tiotropium
  • tizanidine
  • tolterodine
  • tolvaptan
  • topiramate
  • tretinoin
  • tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline)
  • trihexyphenidyl
  • trimethoprim
  • trospium
  • vilazodone
  • 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.<ul type="disc"> 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.

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/Sandoz-Perindopril-ErbutamineIndapamide

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