Side effects of stopping micardis

Micardis

SIDE EFFECTS

The following adverse reaction is described elsewhere in labeling:

  • Renal dysfunction upon use with ramipril

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

MICARDIS has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of MICARDIS (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with MICARDIS and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with MICARDIS and at a Greater Rate Than Patients Treated with Placebo

Telmisartan
n=1455
%
Placebo
n=380
%
Upper respiratory tract infection 7 6
Back pain 3 1
Sinusitis 3 2
Diarrhea 3 2
Pharyngitis 1 0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with MICARDIS tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with telmisartan in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with MICARDIS monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to MICARDIS tablets:

Autonomic Nervous System: impotence, increased sweating, flushing;

Body as a Whole: allergy, fever, leg pain, malaise;

Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG;

CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia;

Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, nonspecific gastrointestinal disorders;

Metabolic: gout, hypercholesterolemia, diabetes mellitus;

Musculoskeletal: arthritis, arthralgia, leg cramps;

Psychiatric: anxiety, depression, nervousness;

Resistance Mechanism: infection, fungal infection, abscess, otitis media;

Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis;

Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis;

Vascular: cerebrovascular disorder;

Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of MICARDIS tablets.

Hemoglobin

A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine

A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes

Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of telmisartan in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of telmisartan for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on telmisartan and 7.6% on placebo. The only serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MICARDIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to MICARDIS.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including MICARDIS.

Read the entire FDA prescribing information for Micardis (Telmisartan)

Micardis HCT

Micardis HCT is the brand name of a prescription medicine that contains the drugs telmisartan and hydrochlorothiazide. It’s used to treat high blood pressure.

Lowering your blood pressure can reduce your risk of having a heart attack, a stroke, or another cardiovascular complication.

Micardis HCT is sometimes also used to treat heart failure.

Telmisartan is an angiotensin II receptor antagonist that works by relaxing the blood vessels.

Hydrochlorothiazide is a thiazide diuretic that prevents your body from absorbing too much salt.

The U.S. Food and Drug Administration (FDA) approved Micardis HCT in 2000. It’s marketed by Boehringer Ingelheim Pharmaceuticals, Inc.

Micardis HCT Warnings

Before taking Micardis HCT, tell your doctor if you have, or have ever had, any of the following conditions:

  • Asthma
  • Gout (a form of arthritis)
  • Heart problems
  • Liver or kidney disease
  • Gallbladder problems
  • Diabetes
  • Lupus (an autoimmune disease characterized by inflammation and a variety of symptoms)
  • Trouble urinating
  • High or low blood electrolyte levels
  • High cholesterol or triglyceride levels
  • Glaucoma, secondary angle closure, or myopia (eye conditions)
  • Allergies to medications (especially to penicillin, sulfa drugs, or any of the ingredients in Micardis HCT)

Also, let your doctor know if you’re dehydrated, are on a low-salt diet, or have severe or persistent diarrhea before taking and while using Micardis HCT.

This medicine may cause drowsiness, dizziness, fainting, or lightheadedness. Hot weather, exercise, and alcohol consumption can worsen these effects.

To prevent dizziness, try to sit or stand up slowly, especially in the morning when getting out of bed.

Older adults may be more sensitive to the side effects of Micardis HCT.

This medicine may cause you to become sunburned more easily. Avoid exposure to the sun and sunlamps until you know how Micardis HCT affects you. Wear sunscreen and protective clothing while outdoors.

In rare cases, Micardis HCT may cause certain eye problems that could lead to permanent vision loss if untreated. Tell your doctor immediately if you experience any of the following symptoms:

  • Eye pain
  • Blurry vision
  • Vision changes

Your doctor may recommend that you follow a specific diet and exercise program while taking this medicine. You may also be told to drink extra fluids. Follow your doctor’s instructions carefully.

Don’t use a salt substitute, or any product that has potassium in it, while taking Micardis HCT without first talking to your doctor.

Tell your healthcare provider you’re taking this medicine before having any type of test or surgery, including a dental procedure.

Let your doctor know if you’ve recently had a type of nerve surgery called sympathectomy.

If you have diabetes, you should know that Micardis HCT may affect your blood sugar levels. Monitor your condition carefully while using this medicine.

Before starting on this drug, tell your doctor if you’re also taking a medication that contains aliskiren (such as Amturnide, Tekturna, or Tekamlo).

In rare cases, this medicine can cause a condition that leads to kidney failure. Tell your doctor right away if you experience the following symptoms while taking Micardis HCT:

  • Muscle pain, tenderness, or weakness (especially if you also have fever, nausea, and dark-colored urine)

Keep all appointments with your doctor and laboratory while taking this medicine. Your doctor provider will probably want to perform frequent tests to check your body’s response to this drug.

Pregnancy and Micardis HCT

Micardis HCT contains a black box warning because it may cause birth defects or death in a fetus if taken during pregnancy.

Use an effective method of birth control to prevent pregnancy while you’re taking Micardis HCT.

Call your doctor right away if you think you might be pregnant during your treatment.

Micardis HCT passes into breast milk. Don’t breastfeed a baby while using this drug.

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

Telmisartan belongs to a class of medications known as angiotensin II receptor antagonists. These medications reduce blood pressure by blocking the actions of a chemical (angiotensin II) that causes blood vessels to constrict or tighten. It is used to treat mild to moderate high blood pressure.

When blood pressure is allowed to remain high for a long time, the blood vessels of the heart, kidneys, and brain may become damaged. This puts a person at increased risk for heart attack and stroke as well as kidney failure and blindness. Keeping blood pressure in the normal range can reduce the risk for these conditions.

Telmisartan is also used to reduce the risk of death after a heart attack in people who cannot use another type of medication called angiotensin-converting enzyme inhibitor.

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?

40 mg
Each white, oblong-shaped, uncoated tablet, marked with the Boehringer Ingelheim logo on one side, and on the other side, with “51H”, contains telmisartan 40 mg. Nonmedicinal ingredients: magnesium stearate, meglumine, povidone, sodium hydroxide, and sorbitol.

80 mg
Each white, oblong-shaped, uncoated tablet, marked with the Boehringer Ingelheim logo on one side, and on the other side, with “52H”, contains telmisartan 80 mg. Nonmedicinal ingredients: magnesium stearate, meglumine, povidone, sodium hydroxide, and sorbitol.

How should I use this medication?

The recommended adult dose of telmisartan is 80 mg once a day at approximately the same time each day, with or without food. It will take about 2 weeks for reductions in blood pressure to become noticeable and another 2 weeks until the full effects of the medication are realized. People with reduced liver function are usually given 40 mg once daily to start.

It is important to take this medication regularly and to follow your doctor’s instructions regarding blood pressure monitoring to ensure that you are getting the maximum benefit from the medication.

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.

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.

Store telmisartan at normal room temperature in a dry place (not in the bathroom) and keep it out of the reach of children. Do not remove tablets from their blister-pack until you are ready to take them.

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 take telmisartan if you:

  • are allergic to telmisartan or to any of the ingredients of the medication
  • have experienced angioedema as a reaction to any angiotensin receptor blocker (ARB)
  • are pregnant or plan to become pregnant
  • are breast-feeding
  • have diabetes or kidney disease and are taking the medication aliskiren
  • are allergic to certain sugars (fructose and/or sorbitol intolerant)

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.

  • anxiety
  • back or leg pain
  • constipation
  • diarrhea
  • difficulty sleeping
  • dizziness
  • dry mouth
  • eczema or skin rash
  • headache
  • heartburn
  • joint pain
  • muscle cramps or spasms
  • nausea
  • nervousness
  • rash
  • tiredness
  • upper respiratory tract infection (such as colds or sinus infections)
  • upset stomach

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

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

  • chest pain
  • dizziness, fainting or lightheadedness
  • palpitations
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
  • shortness of breath
  • signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of too much potassium in the body (e.g., irregular heartbeat, muscle weakness, generally feeling unwell)
  • swelling of ankles, feet, or hands
  • unexplained muscle pain, tenderness or weakness
  • vision changes

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

  • signs of a serious allergic reaction (e.g., swelling of face, lips, tongue, or throat; hives; difficulty breathing)

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?

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of telmisartan. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

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.

Drowsiness/reduced alertness: Telmisartan may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Kidney disease: Telmisartan may affect kidney function, especially for people who already have kidney problems. If you have reduced kidney function or kidney 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.

Liver disease: Telmisartan is removed from the body by the liver. On rare occasions, it may cause liver problems. If you have liver disease or decreased liver function, 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 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: If you have orthostatic hypotension (a sudden drop in blood pressure caused by standing up, which may lead to fainting), you should be cautious while taking telmisartan, as it can worsen the condition. The first time this medication is taken, it may cause dizziness, lightheadedness, or fainting. This may be reduced by taking the medication in a sitting position and being careful to rise slowly to a standing position. The dizziness usually improves after the first dose, but if the medication is stopped and then started again, it may reappear. Your doctor may also adjust the dose.

Potassium levels: This medication may affect potassium levels in the blood, especially when used for heart failure, or when taken with other medications called ACE inhibitors or diuretics such as spironolactone. Your doctor will monitor your potassium levels while on this medication. Avoid using salt substitutes that contain potassium while you are taking telmisartan.

Pregnancy: Telmisartan may cause severe harm to an unborn fetus and should not be taken during pregnancy. If you discover you are pregnant while taking this medication, stop taking the medication and tell your doctor at once.

Breast-feeding: It is not known if telmisartan passes into breast milk. If you are a breast-feeding mother and are 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.

What other drugs could interact with this medication?

There may be an interaction between telmisartan and any of the following:

  • alfuzosin
  • aliskiren
  • amifostine
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • barbiturates (e.g., secobarbital, phenobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • brimonidine
  • canagliflozin
  • celecoxib
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • clonidine
  • cyclosporine
  • digoxin
  • dipyridamole
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • drospirenone
  • guanfacine
  • heparin
  • hydralazine
  • isosorbide dinitrate or isosorbide mononitrate
  • levodopa
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • methyldopa
  • methylphenidate
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • nitroglycerin
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium supplements or medications that increase potassium in the blood
  • rituximab
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • sodium phosphates
  • tolvaptan
  • trimethoprim

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 – 2020. 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/Micardis

Micardis Plus

This is a combination product that contains two medications used to lower hypertension (high blood pressure): telmisartan and hydrochlorothiazide. It is used to treat high blood pressure for people who require treatment with both telmisartan and hydrochlorothiazide.

Telmisartan belongs to a class of medications called angiotensin II blockers, which help to lower blood pressure by relaxing blood vessels. Hydrochlorothiazide is a diuretic (water pill) that helps control blood pressure by getting rid of excess salt and water.

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.

80 mg/12.5 mg
Each bilayered, oblong, uncoated tablet, the telmisartan layer being white and the hydrochlorothiazide layer being red, marked “BOEHRINGER INGELHEIM” and “H8” on the white layer, contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: iron oxide (red), lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sorbitol.

80 mg/25 mg
Each bilayered, oblong, uncoated tablet, the telmisartan layer being white and the hydrochlorothiazide layer being yellow, marked “BOEHRINGER INGELHEIM” and “H9” on the white layer, contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide. Nonmedicinal ingredients: iron oxide yellow, lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sorbitol.

The recommended dose is 1 tablet once daily. This medication is intended to be used by people who have not had their blood pressure well-controlled with just telmisartan, or by people who have had doses of telmisartan and hydrochlorothiazide already established.

The medication can be taken with or without food, but it should be taken consistently with respect to food intake.

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 light 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.

Do not take telmisartan – hydrochlorothiazide if you:

  • are allergic to telmisartan, hydrochlorothiazide, or any ingredients of the medication
  • are allergic to sulfa (sulfonamide) medications (e.g., sulfamethoxazole)
  • are pregnant or breast-feeding
  • have anuria (is able to pass little or no urine)
  • have diabetes or kidney disease and are taking aliskiren
  • have fructose intolerance (a rare hereditary condition)
  • have galactose intolerance (a rare hereditary condition)

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
  • anxiety
  • back or leg pain
  • constipation
  • decreased appetite
  • diarrhea
  • dizziness or lightheadedness when rising from a lying or sitting position
  • dry mouth
  • flu-like symptoms
  • headache
  • increased sweating
  • nausea
  • pins and needles sensation
  • sexual difficulties
  • tiredness
  • vomiting

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

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

  • pounding, rapid heartbeat
  • 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 potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
  • 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)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • unexplained muscle tenderness or weakness

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

  • chest pain
  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)signs of a serious allergic reaction (swelling of face or throat, hives, 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.

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.

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of telmisartan. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

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.

Cholesterol: Cholesterol and triglyceride levels may increase when taking hydrochlorothiazide. 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: 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

Hereditary fructose or galactose intolerance: Due to the sorbitol and lactose content in the medication, this medication is not suitable for people with hereditary fructose or galactose intolerance.

Gout: An acute gout attack may occur in some patients taking telmisartan – hydrochlorothiazide as a result of high levels of uric acid in the blood. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, follow your doctor’s instructions for dealing with the attack.

Kidney function: Telmisartan – hydrochlorothiazide can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase risk of kidney problems 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.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. 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 greater-than-expected drop in blood pressure occurs after taking this medication. It is more likely to occur if you are taking additional diuretics (water pills) or the medication aliskiren, have 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 extreme drop in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a drop 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. People with lupus or a history of lupus should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision changes: Hydrochlorothiazide occasionally causes vision changes, including increased eye pressure and myopia (nearsightedness). If you experience any eye symptoms, such as pain or change in vision, contact your doctor as soon as possible.

Pregnancy: Telmisartan can cause injury or death to the developing fetus if taken by a woman who is pregnant. This medication should not be taken by pregnant women. If you become pregnant while taking telmisartan – hydrochlorothiazide, consult your doctor immediately as the medication should be stopped as soon as possible.

Breast-feeding: It is not known if telmisartan passes into breast milk. Hydrochlorothiazide does pass into breast milk. If you are a breast-feeding mother and are 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 and is not recommended for children.

Seniors: Seniors may be more sensitive to the effects of this medication.

There may be an interaction between telmisartan – hydrochlorothiazide and any of the following:

  • aclidinium
  • alcohol
  • aldesleukin
  • aliskiren
  • allopurinol
  • alpha-adrenergic blocking agents (e.g., clonidine, doxazosin, prazosin, terazosin)
  • amifostine
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • anticholinergics (e.g., benztropine, disopyramide, ipratropium, oxybutynin)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • barbiturates (e.g., butalbital, pentobarbital phenobarbital)
  • beta-blockers (e.g., atenolol, carvedilol, propranolol)
  • beta-2 agonists (e.g., salbutamol, formoterol, terbutaline)
  • brimonidine
  • calcitriol
  • calcium carbonate, calcium citrate
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • cholestyramine
  • ciprofloxacin
  • colestipol resins
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclophosphamide
  • cyclosporine
  • dalteparin
  • darifenacin
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • drospirenone
  • flavoxate
  • ginger
  • ginseng
  • heparin
  • hydralazine
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • lithium
  • licorice
  • low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
  • methylphenidate
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • multivitamins/minerals
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine)
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen)
  • oxcarbazepine
  • pentoxifylline
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • porfimer
  • pramipexole
  • quinidine
  • quinine
  • rituximab
  • scopolamine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • sodium phosphates
  • solifenacin
  • tolcapone
  • tolvaptan
  • topiramate
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • vitamin D analogues (e.g., alfacalcidiol, calcitriol, cholecalciferol)
  • warfarin
  • 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 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.

What Medications Can Cause Hair Loss, and What Can You Do About It?

Here are some of the types of medications that can cause hair loss as a side effect.

Vitamin A

High doses of vitamin A and medications derived from it can cause hair loss.

Acne medications

One type acne of vitamin A-derived medication, isotretinoin (Accutane) and tretinoin (Retin-A) can cause hair loss. Because there can be other serious side effects as well, you may want to discuss other options with your dermatologist.

Antibiotics

Prescription antibiotics can cause temporary hair thinning. Antibiotics can deplete your vitamin B and hemoglobin, which disrupts hair growth.

When hemoglobin is too low, you can become anemic and lose hair as a result. Normal levels of vitamin B are also critical to maintaining healthy hair.

Antifungals

Antifungal medications are indicated for fungal infections and have been linked to hair loss in some people. The antifungal medication voriconazole is one such treatment that has been associated with alopecia in the past.

Anti-clotting drugs

Anticoagulants like heparin and warfarin are used to thin the blood and prevent blood clots and certain health concerns in some people (like those with heart conditions).

These medications can cause hair loss that begins after taking these medications for about three months.

Cholesterol-lowering drugs

Some statin drugs like simvastatin (Zocor) and (atorvastatin) Lipitor have been reported to cause hair loss.

Immunosuppressants

Some immune-suppressing drugs used to treat autoimmune conditions like lupus and rheumatoid arthritis can cause hair loss. A few of these include methotrexate, leflunomide (Arava), cyclophosphamide (Cytoxan), and etanercept (Enbrel).

Anticonvulsants

Medications that prevent seizures, like valproic acid (Depakote) and trimethadione (Tridione), can lead to hair loss in some people.

Blood pressure medications

Beta blockers, including the following, can cause hair loss:

  • metoprolol (Lopressor)
  • timolol (Blocadren)
  • propranolol (Inderal and Inderal LA)
  • atenolol (Tenormin)
  • nadolol (Corgard)

ACE inhibitors can also lead to thinning hair. These include:

  • enalapril (Vasotec)
  • lisinopril (Prinivil, Zestril)
  • captopril (Capoten)

Antidepressants and mood stabilizers

Some people who take medications for depression and mood stabilization may experience hair loss. Drugs that may cause this include:

  • paroxetine hydrochloride (Paxil)
  • sertraline (Zoloft)
  • protriptyline (Vivactil)
  • amitriptyline (Elavil)
  • fluoxetine (Prozac)

Weight loss drugs

Weight loss medications like phentermine can cause hair loss, but the side effect isn’t often listed. This is because dieters who lose their hair are often also nutrient-deficient or may have underlying health conditions contributing to their hair loss.

So, while some people taking weight loss drugs have reported hair loss, that loss could be due to malnutrition.

Medications for gout

Gout medications like allopurinol (Zyloprim and Lopurin) have been reported to cause hair loss.

Chemotherapy

Chemotherapy drugs used to treat certain types of cancer and autoimmune illness can cause anagen effluvium. This hair loss includes eyelashes, eyebrows, and body hair.

These drugs are designed to destroy the fast-growing cancer cells in your body, but they also attack and destroy other cells that grow quickly, like the roots of your hair. Regrowth will occur after treatments have ended.

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