Coveram medicine 10mg/10mg Servier treat hypertension (30 tablets)

Too hypersensitivity to any excipients of the drug;

Be cautious when using

all warnings related to each component, as listed below, are applied to Coveram fixed -dose tablets.

involves Perindopril

Special warning:

Hypersensitivity/eagles:

Face angioema, limb, lips, mucosa, tongue, subjects and/or larynx are rarely recorded in patients treated with UCMC drugs, including perindopril.

This phenomenon may appear at any time during treatment. If this phenomenon occurs, stop immediately coveram and take appropriate and continuous monitoring measures until these symptoms are completely gone. In general, the phenomenon of local and lips swelling is usually cured without treatment, although antihistamine drugs may have the effect of reducing symptoms.

Evaluation related to laryngeal edema can be fatal.

When tongue edema, bar or larynx can cause respiratory obstruction, immediately use emergency measures. This measure includes the use of adrenalin with or not accompanied by airway ventilation measures. Patients should be closely monitored until the symptoms of complete retreat.

Patients with a history of angioedema are not related to the treatment of UCMC drugs that may increase the risk of angioedema when taking UCMCs.

Evaluation in the intestinal tract is rarely recorded in patients treated with UCM. These patients show signs of abdominal pain (with or without nausea or vomiting); In some cases, there is no previous edema and C-1 esterase level is normal.

Evaluation is diagnosed with abdominal CT scan, or ultrasound or during surgery and regression of symptoms after stopping the UCMC drug.

intestinal angioedema should be considered in distinguished diagnosis in patients using UCMC drugs with abdominal pain.

Combining Perindopril with Sacubitril/Valsartan is contraindicated due to increased risk of angioedema. Sacubitril/Valsartan is only started after 36 hours after the end of Perindopril's last dose.

If Sacubitril/Valsartan stops, Perindopril therapy is only started after 36 hours after the last dose of Sacubitril/Valsartan.

Simultaneous use of NEP inhibitors (such as racecadotril) and transferred enzyme inhibitors may also increase the risk of angioedema. Therefore, it is necessary to evaluate the benefit-mechanical benefits carefully before starting treatment with NEP inhibitors (such as racecadotril) in patients taking Perindopril.

Simultaneously used with MTor inhibitors (such as syrolimus, Everolimus, Temsirolimus):

Patients with simultaneous use with MTor inhibitors (such as syrolimus, Everolimus, temsirolimus) may increase the risk of angioedema (such as respiratory or tongue, with or without respiratory decline).

Hypersensitivity reactions in the process of filtering low density lipoprotein (LDL):

Rarely experienced life -threatening anaphylactic reactions in patients with UCMC drugs during filtering low density lipoprotein as dextran sulphat. Anaphylactic reactions can be avoided by temporarily stop taking UCMC before each filtering.

Anaphylactic reaction during sensitivity:

Patients taking UCM during the treatment of sensitivity (such as the venom of the winged insect) have encountered anaphylactic reactions that can avoid anaphylactic reactions on these patients when temporarily stopped the UCMC drugs but these reactions may reappear if inadvertently exposed to allergens.

leukopenia/grain leukemia/thrombocytopenia/anemia:

leukopenia/granulocytosis, thrombocytopenia and anemia have been recorded in patients with UCMCs.

Rarely appear leukopenia in patients with normal kidney function and no other complex factors. Should be especially cautious when taking Perindopril for patients with blood vessels to create glue, patients are treating immunosuppressive, treatment with Allopurinol or Procainamid, or combining these risk factors, especially if the patient has impaired renal function before. Some patients in these patients have severe infections, sometimes not responding to positive antibiotic treatments.

If using Perindopril for these patients, periodic monitoring should be monitored by the number of white blood cells and patients should be instructed to notify any signs of infection (such as sore throat, fever).

Aortic hypertension:

There is the ability to increase the risk of hypotension and renal failure when the patient has narrowed kidney stenosis on both sides or the kidney artery stenosis leads to the kidney function on the one side is treated with inhibition of enzyme.

Treatment with diuretics can be a contribution. Kidney failure may even appear with a slight change of serum creatinine in patients with kidney stenosis on one side.

Double blockade of the renin-ankiotensin-aldosteron system (RAAS):

There is evidence that the simultaneous use of UCMC, Angiotensin II or Aliskiren receptor inhibitors increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure).

Dual blockade of RAAS systems using combination of UCMC drugs, Angiotensin II or Aliskiren receptor inhibitors are therefore not recommended. If the dual blockade therapy is certainly considered necessary, this use is only performed under the supervision of experts and should be closely monitored regularly for kidney, electrolyte and blood pressure.

Ancms and Angiotensin II receptor inhibitors should not be used simultaneously in patients with diabetes kidney disease.

Increase Aldosterone Tien Phat:

Patients with hypertrophy of primary aldosterone are generally not responding to anti-hypertension drugs that operate through inhibition of the renin-angiotensin system. Therefore, the use of this drug is not recommended.

Pregnant women:

Do not start using UCMC during pregnancy. Except for the continued use of UCM is considered necessary, patients are planning to get pregnant, so they should switch to another medication for hypertension, which has a safe data set in pregnant women. When the patient is diagnosed with pregnancy, it is necessary to stop treating immediately with UCM and if possible, another alternative treatment should be applied.

Be cautious when using:

Hypotension:

UCMC drugs can cause hypotension. Symptoms of hypotension are recognized as rare in patients with unnamed hypertension and is likely to appear more in patients with reduced circulatory volume such as diuretics treatment, salt -limiting diet, hemolysis, diarrhea or vomiting or on serious hypertension patients dependent on renin.

In patients with high risk of hypotension, symptoms should be closely monitored, kidney function and serum potassium concentration during Coveram treatment.

Similar considerations are applied to patients with myocardial oral disease, excessive hypotension can lead to myocardial infarction or stroke.

If the blood pressure appears, the patient should be on the back and if necessary, the veins of the sodium chloride solution should be inferior to 9 mg/ml (0.9%).

Hypotension is not contraindicated for the next dose, the next dose can usually be used without fear when blood pressure has increased after the collection of circulating mass.

Aortic stenosis and hypertrophic myocardial valve:

Should be cautious when taking UCMC medications for patients with mitral stenosis and congestion of left ventricular ventricle such as aortic stenosis or hypertrophic cardiomyopathy.

kidney failure:

In the case of renal failure (creatinine clearance

Potassium and creatinine control is regularly part of medical practice for patients with impaired renal function.

In some patients with narrowed kidney stenosis on both sides or one side stenosis has been treated with UCM, which has recorded serum hyper urea and creatinine, often recovered after stopping treatment. This is especially likely to occur in patients with renal failure.

The risk of severe hypotension and renal failure increases if there is signs of hypertension. Some patients with hypertension do not show signs of previous kidney disease, which have increased blood urea and creatinine, often mild and transient, especially when concurrent Perindopril and diuretics. This is more likely to happen in patients who have impaired renal function.

Hepatic failure:

The ICCs rarely associated with the syndrome begins with cholestatic jaundice and progresses into serious liver necrosis and (sometimes) death. The mechanism of this syndrome is not well known. Patients using jaundice and increased liver enzymes should stop using UCMC and appropriate medical monitoring.

Race:

UCMC drugs increase the rate of angioedema in black skin patients in other skin -colored patients.

The UCMC drugs may be less effective in lowering blood pressure on black people than other skin -colored people, which may be due to a more common low plasma renin activity in the population of hypertension patients with hypertension.

ho:

cough has been recorded when using ĐmC. Cough is characterized by dry, persistent and out of treatment. Coughing caused by UCMC drugs should be considered as part of cough diagnosis.

surgery/anesthesia:

In patients undergoing major surgery or during anesthesia, using drugs that can cause hypotension, coveram can inhibit the formation of secondary angiotensin II to compensate for released. Coveram should be stopped one day before surgery. If hypotension appears and hypotension is considered to be due to this mechanism, it is necessary to adjust by increasing the volume of circulation.

Hemorrhage:

Serum hyperpass has been recorded in some patients treated with UCMCs, including perindopril.

Factors that increase blood potassium include renal failure, worsening kidney function, age (> 70 years old), diabetes, events that occur, especially dehydration, acute cardiovascular loss, metabolic acidosis and simultaneous use with potassium -keeping drugs (such as spironolacton, eplerenon, triamteren or amilorid, single or combined), container supplements or containing salts containing Kali; Or patients taking other drugs to increase serum potassium (such as heparin, other UCM drugs, Angiotensin II antagonists, acetylsalicyclic acid> 3G/day, COX-2 inhibitors and non-selective anti-inflammatory drugs, immunosuppressants such as ciclosporin or tacrolimus, trimethoprim), use of kolinos supplement Or replacement salts containing special potassium in patients with impaired renal function can significantly increase serum potassium.

Hyperboly hyperkalemia can cause serious arrhythmia, sometimes death. If the simultaneous use of Perindopril with any of the above drugs is really necessary, should be used carefully and regularly monitor blood potassium concentration.

Patients with diabetes:

In patients with diabetes treated with oral or insulin anti -diabetes, should strictly control blood glucose in the first month of treatment with UCMC.

related to amlodipine

Be cautious when using:

Safety and effectiveness of amlodipine in the hypertension has not been established.

heart failure:

Should be careful treatment for patients with heart failure.

In a long-term study, compared to the placebo, performed in patients with severe heart failure (NYHA III-IV), pulmonary edema events have been reported higher in the treatment group with amlodipine compared to the placebo group. Calcium channel blockers, including amlodipine, should be used carefully in patients with congestive heart failure because they can increase the risk of cardiovascular events and deaths later.

Hepatic failure:

In patients with impaired liver function, Amlodipine's exhaust time and prolonged area of ​​the curve (AUC) are higher; Recommendations for treatment are set. So start treatment as well as when increasing the dose. Requires a slow dosage increase and strict control in patients with severe liver failure.

Elderly:

Need to increase the dose with caution in older patients.

kidney failure:

Amlodipin may be used for patients with renal impairment at normal doses. Change plasma amlodipine concentration is not related to the level of renal failure. Amlodipine cannot be removed by dialysis.

involves coveram

All warnings related to each component, as listed above, are applied to Coveram fixed -dose tablets.

Be cautious when using:

excipients:

Due to the presence of lactose, patients with rare genetic diseases such as galactose intolerance, glucose -free -absorbing - galactose or Lapp Lactase deficiency should not use this drug.

Interactive:

Concomitant use of lithium cover, diuretics containing potassium or potassium supplements, or dantrolene are not recommended.

The ability to drive and operate machinery

There have been no studies conducted on the effect of Coveram 10/10 on driving and operating machinery. Amlodipine may have a slightly affected on average on the ability to drive and operate machinery. If the patient has a headache, fatigue, exhaustion, or nausea, the ability to react may be impaired.

Recommendation is careful when using Coveram 10/10, especially when starting treatment.

Pregnancy and lactation

Pregnancy

Related to Perindopril

Based on the influence of each ingredient in this combination preparation in pregnant and lactating women: It is not recommended to use coveram 10/10 in the first three months of pregnancy. Contraindicated use of coveram in the middle 3 months and the last 3 months of pregnancy.

It is not recommended to use UCMCs in the first three months of pregnancy. Contraindicated use of UCMC drugs in the middle and last three months of pregnancy.

Epidemiological evidence shows that there is no conclusion about the risk of fetal defects after taking UCM in the first three months of pregnancy; However, it is not excluded this risk increases. Unless the case is required to continue treating with UCMC, the patient is planning to become pregnant, so it should be transferred to other antihypertensive drugs that are considered to be safe during pregnancy. When the patient is diagnosed with pregnancy, it is advisable to stop treating with UCMCs immediately and if possible, the replacement therapy should start.

The use of UCMC in the middle and the last three months of pregnancy is known to be toxic to the fetus (reducing the kidney function, amniotic fluid, skull slowly) and toxicity in infants (kidney failure, hypotension, hyperkalemia).

If the patient takes the UCMC for three months in the middle of the pregnancy, it is recommended that the ultrasound should be taken to check the kidney function and the fetal skull.

Babies with mothers use UCMC drugs should be closely monitored by the risk of hypotension.

Related to amlodipine

The safety of amlodipine in pregnant women has not been established.

In animal studies, reproductive toxicity has been recorded in high doses. Only recommendation on pregnant women when there is no safer alternative measure and when the risk is due to the disease is greater than the mother and the fetus.

Breastfeeding period

Related to Perindopril

Due to the lack of information related to the use of Perindopril during breastfeeding, it is not recommended to use Perindopril and should be replaced by other treatments that have been known more about safety during breastfeeding, especially when raising infants or premature babies.

Related to amlodipine

Amlodipin is excreted through breast milk. The ratio of the child's dosage received from the mother is estimated in the four - 7%quartet, with a maximum of 15%. It is currently unknown the effect of amlodipin on breastfeeding. The decision to continue/stop breastfeeding or continue/stop treatment with amlodipin should be considered based on the benefits of breastfed babies and amlodipine treatment benefits on the mother.

Reproduction

Related to Perindopril

There is no influence on reproduction or fertility.

Related to amlodipine

The biochemical change in the tip of the sperm has been recorded in some patients treated with calcium channel blockers. There are no clinical data on the ability of amlodipine to fertility. In a study on rats, the adverse effects on the fertility of the male rat.

Drug interaction

related to Perindopril

Clinical research data has shown double-anpiotensin-aldosteron (RAAS) lens by using a combination of UCMC drugs, Angiotensin II or Aliskiren receptor inhibitors that are related to higher frequency of adverse events such as lowering blood pressure, hyperboly blood and kidney function reduction (including acute renal failure) when compared with the use of anti-medications on the system of drugs Raas.

Hemorrhage -causing potassium -causing drugs

Some drugs or therapy may increase the likelihood of hyperkalemia: Aliskiren, potassium salts of potassium diuretic, enzyme inhibitors, angiotensin-II receptor antagonists, nsaid drugs, heparin drugs, immunosuppressants such as cyclosporin, tacrolimus, trimethoprim and the combination of dosage in combination with a combination of the combination of the combination of the combination of the combination of the combination of the combination of the combination of the combination of the union sulfamethoxazol (co-trimoxazol). The combination of these drugs increases the risk of hyperkalemia.

Coordination is contraindicated

Aliskiren:

Patients with diabetes or renal failure, the risk of hyperkalemia, worsens the kidney function and the rate of disease and death due to cardiovascular disease.

Extra body treatment:

The body treatment leads to blood exposure to negative charged surfaces such as a juris or dialysis with certain high -speed filters (such as polyacrylonitril film) and removing low density lipoprotein with dextran sulphate due to increased risk of sensitivity. If this treatment is required, it is necessary to consider using another type of filter or another anti -hypertension drug.

sacubitril/valsartan:

Concomitance Perindopril's use with Sacubitril/Valsartan is contraindicated due to the coordination of neprilysin inhibitors and transferred enzyme inhibitors that can increase the risk of angioedema. Sacubitril/Valsartan is only used after 36 hours after the last dose of Perindopril. Perindopril therapy only starts 36 hours after the last dose of Sacubitril/Valsartan.

Uncountable coordination:

Aliskiren:

Patients with diabetes or renal impairment, the risk of hyperkalemia, worsens the kidney function and the rate of disease and death due to cardiovascular disease.

Agent enzyme inhibitors and Angiotensin receptor blockers:

There has been a report in literature showing that patients with atherosclerosis, heart failure or diabetes with internal organs damage, enzyme inhibitors and angiotensin receptor blockers are associated with the frequency of hypotension, fainting, hyperkalemia, and worsening renal function (including acute renal failure) higher than using only one effect on one system. Renin-Anotensin-Aldosterone.

Dual inhibition (for example, a combination of enzyme inhibitors and Angiotensin II receptor blockers) should be limited in specific cases with closely monitoring kidney function, potassium and blood pressure levels.

estramustine:

The risk of increasing unwanted effects such as nerveema (angioedema).

co-trimoxazole (trimethoprim/sulfamethoxazole):

Patients with simultaneous use of co-trimoxazole (trimethoprim/sulfamethoxazole) may cause risk of hyperkalemia.

Potassium diuretics (such as triamterene, amiloride ...), potassium salts:

Hemorrhage hyperka (may cause death) especially in the case of kidney failure (the effect of hyperkalemia in the same syllable).

Perindopril combination with the above drugs is not recommended. If this combination is indicated, be careful and regularly check serum potassium. To use Spironolactone in case of heart failure, see below.

Lithi:

Increased lithe and toxic lithium recovery has been recorded when used simultaneously with lithium with UCMC drugs. It is not recommended to use Perindopril with Lithi. If necessary, it is necessary to coordinate, recommend should closely monitor serum lithium concentration.

Caution should be particularly cautious:

anti -diabetic drugs (insulin, oral hypoglycemic drugs):

Epidemiological studies have shown simultaneous use of enzyme inhibitors and anti -diabetes drugs (insulin, oral hypoglycemic drugs) may increase the effect of hypoglycemia, causing this phenomenon that seems to occur more in the first weeks of combined treatment and in patients with renal insufficiency.

Diuretics do not keep potassium:

Patients who use diuretics, and especially in patients with volume and/or salt, may be excessive blood pressure after starting treatment with enzyme inhibitors, the possibility of lowering blood pressure can be reduced by taking diuretics, increasing volume or salt intake before starting treatment in low amounts and increasing perindopril doses from.

In arterial hypertension, when the previous diuretic use may cause a reduction in salt volume, or to stop diuretics before starting treatment with enzyme inhibitors, in this case, a potassium -free diuretic can be used later or must start the enzyme inhibitors in low doses and increase the dose slowly.

In congestive heart failure, diuretics treatment, enzyme inhibitors should be started with a very low dose, maybe after reducing the diuretic dose does not hold potassium.

In all cases, renal function (creatinine concentration) in the first few weeks of using enzyme inhibitors.

Potassium diuretics (Eplerenon, Spironolactone):

With Epleron or Spironolactone dose from 12.5 mg to 50 mg daily and with low dose of the transferred enzyme inhibitors:

In the treatment of heart failure II-IV (NYHA) with blood emulsion rates

Before starting combining treatment, checking no hyperkalemia and kidney failure.

Advice to closely monitor blood potassium and blood creatinine at once a week in the first month of treatment and monthly treatment.

racecadotril:

Enzyme inhibitors (such as perindopril) have been known to cause angioedema. This risk may increase when used simultaneously with racecadotril (a drug used to prevent acute diarrhea).

MTor inhibitors (such as syrolimus, Everolimus, temsirolimus):

Treated patients in combination with MTOR inhibitors may increase the risk of angioed.

Non -steroid anti -inflammatory drugs (NSAID) include aspirin doses> 3G/day:

When concurrent use of non-steroid anti-inflammatory drugs (such as acetylsalicylic acid at an anti-inflammatory dosage, COX-2 inhibitors and non-selective steroid anti-inflammatory drugs), hypotension effects can be impaired, simultaneous use of UCMCs and non-steroid anti-inflammatory drugs that can increase the risk of renal and renal absorption, including the ability to increase the impulsion and increase the capacity Especially in patients with poor kidney function before.

Should be cautious when combined, especially in elderly patients. Patients should be fully rehydrated and consider monitoring of kidney function after starting treatment and periodic treatment.

Careful coordination:

Gliptine (linagliptine, saxagliptine, sitagliptine, Villagliptine):

Increased risk of angioedema, due to Dipeptidyl peptidase IV (DPP-IV), which is reduced activity by Gliptine, in patients treated simultaneously with an enzyme inhibitor.

Seeds like sympathetic:

Sympathetic medications can reduce the hypotension effect of enzyme inhibitors.

Gold:

Nitritoid reactions (symptoms including flushing, nausea, vomiting and hypotension) are rarely recorded in the patient being treated with gold) injected (sodium aurothiomalate) and simultaneous use with an enzyme inhibitor including Perindopril.

related to amlodipine

Uncountable coordination:

dantrolen (intravenous):

In animals, ventricular vibration and cardiovascular collapse lead to death has been recorded related to hyperkalemia when combining Verapamil and intravenous dantrolen. Due to the risk of hyperkalemia, it is recommended not to simultaneously use a calcium channel blockers such as amlodipine with dantrolen in patients who have the ability to increase malignant body temperature and in the treatment of malignant body temperature.

Caution should be particularly cautious:

CYP3A4 induction drugs:

When combined with the known CYP3A4 induction drugs, the amlodipine concentration in plasma may change. Therefore, it is necessary to control blood pressure and consider adjusting the dose during and after the combination of drugs, especially with strong induction drugs CYP3A4 (for example, Rifampicin, Hypericum Perforatum).

CYP3A4 inhibitors:

Simultaneous use of amlodipine with strong and medium inhibitors CYP3A4 (Protease inhibitors, Azol derivatives, macrolids such as erythromycin and clarithromycin, verapamil or diltiazem) can significantly increase amlodipine levels. Clinical manifestations corresponding to this pharmacokinetic change of the drug can be more clear in elderly patients. Therefore, clinical monitoring and dose adjustment.

There is an increase in the risk of hypotension in patients using clarithromycin with amlodipine. It is recommended to closely monitor patients when using simultaneously amlodipine with clarithromycin.

Coordination needs to consider:

Amlodipine's hypotension effect plus the hypotension effect of other anti -hypertension drugs.

tacrolimus:

There is a risk of increased blood tacrolimus concentration when combined with amlodipine. To avoid the toxicity of Tacrolimus, blood concentration should be monitored and adjust the appropriate tacrolimus dose when taking amlodipine in patients treated with tacrolimus.

MTor inhibitors

MTor inhibitors such as syrolimus, temsirols and everolimus are the substrates of CYP3A. Amlodipine is a weak CYP3A inhibitor.

When combined with mtor inhibitors, Amlodipine can increase the concentration of MTOR inhibitors.

ciclosporine

There are no drug interactive studies between ciclosporine and amlodipin controlled in healthy volunteers or other populations except for kidney transplant patients, when they notice that the bottom level changes (average of 0%-40%) of Ciclosporine. Ciclosporine concentration should be considered in kidney transplant patients using amlodipine, and reducing ciclosporine dose if necessary.

simvastatin:

Amlodipin 10 mg multi -dose combination treatment with simvastatin 80 mg increases 77% of simvastatin concentration compared to simvastatin treatment. Limit the dose of simvastatin in patients using Amlodipin 20 mg daily.

Other combinations

In clinical interactive studies, Amlodipin does not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin.

Use amlodipine with grapefruit or grapefruit juice is not recommended due to amlodipine bioavailability may increase above some patients leading to increased hypotension effect of the drug.

involves coveram

Caution should be particularly cautious:

baclofen:

Increased hypotension effect. Control blood pressure and kidney function, adjust the dose of anti -hypertension if necessary.

Coordination should be considered

Antid for hypertension (such as beta blockers) and vasodilators:

Timeless use of these drugs may increase the hypotension effect of Perindopril and Amlodipin. Using the drug simultaneously with nitroglycerin and other nitrates or other vasodilators may cause more severe hypotension, so it is advisable to be carefully considered.

corticosteroids, tetracosactid:

Reduce the effect of lowering blood pressure (due to the effect of holding water and salt of corticosteroids).

Alpha blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin):

Increased hypotension and increased the risk of hypotension.

Amifostin

can increase anti -hypertension efficiency of amlodipine.

Three -round antidepressants/anti -psychosis/anesthesia:

Increased hypotension and increased the risk of hypotension.