Coversyl tablets reviews | Uses, Dosage, Side Effects & Warnings

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coversyl tablets: Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril

When should Coversyl be taken?

the reduction of the risk of cardiac events, such as infarction, in patients with stable coronary artery disease (the blood supply to the heart is reduced or blocked) and having a history of infarction and / or intervention aimed at improve blood supply to the heart by dilating the blood vessels.

and other thing’s like:

• the treatment of arterial hypertension,
• the treatment of heart failure (the heart is unable to provide enough blood to meet the needs of the body)

what is coversyl tablets used for

coversyl 2.5 mg, 5 mg and 10 mg tablets:

what is coversyl tablets used for

Hypertension:

Treatment of high blood pressure.

Stable coronary disease:

Reduced risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.

2.5 mg and 5 mg tablets:

Heart failure :

Treatment of symptomatic heart failure.

coversyl dose :

It is recommended that COVERSYL 5 mg film-coated tablets be taken once daily in the morning before meals.

The dosage should be appropriate to the patient’s profile (see Warnings and Precautions section ) and his or her blood pressure response.

Hypertension

• COVERSYL 5 mg can be used alone or in combination with other antihypertensive drugs.
• The recommended starting dose is 5 mg daily in one morning dose.
• Patients whose renin-angiotensin-aldosterone system is highly stimulated (in particular, renovascular hypertension, water-soluble depletion, cardiac decompensation or severe hypertension) may experience a sudden fall in blood pressure after the first dose. An initial dose of 2.5 mg is recommended in these patients and initiation of treatment will be under medical supervision.
• The dosage may be increased to 10 mg once daily after one month of treatment.

Symptomatic hypotension may occur after treatment with COVERSYL 5 mg, particularly in patients treated with diuretics. Special attention is warranted in these patients who may experience water-soluble depletion.

If possible, diuretic therapy should be discontinued 2 to 3 days before initiation of treatment with COVERSYL 5 mg (see Warnings and Precautions ).

In hypertensive patients for whom the diuretic can not be stopped, treatment with COVERSYL should be initiated at a dose of 2.5 mg. Renal function and serum potassium should be monitored. The dosage of COVERSYL will then be adjusted according to the blood pressure response. If necessary, treatment with diuretics will be reintroduced.

In the elderly, treatment will be initiated at a dosage of 2.5 mg then it can be increased gradually to 5 mg after one month of treatment and then 10 mg if necessary, depending on the state of renal function (see table below).

Symptomatic heart failure

• It is recommended to initiate treatment with COVERSYL, generally used in combination with a non-potassium-sparing diuretic and / or digoxin and / or beta-blocker, under strict medical supervision, at an initial dosage of 2.5 mg in a morning catch. Depending on the tolerability, this dosage may be increased with a minimum interval of 2 weeks from 2.5 mg to 5 mg per day. The dosage will be adapted according to the patient’s response to the treatment.
• In patients with severe heart failure, and in those considered at high risk (patients with renal failure and a tendency to have electrolyte disturbances, patients receiving concomitant treatment with diuretics and / or vasodilators), treatment should be established under strict medical supervision (see Warnings and precautions for use ).
• Patients at high risk of symptomatic hypotension, such as patients with water-soluble depletion with or without hyponatremia, patients with hypovolemia or patients treated with high-dose diuretics should be equilibrated, if possible before initiation of treatment with COVERSYL. Blood pressure, renal function and serum potassium should be closely controlled, both before and during treatment with COVERSYL 5 mg (see Warnings and Precautions ).

Stable coronary disease

• Treatment with COVERSYL should be initiated at a dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and whether the 5 mg dose is well tolerated.
• Elderly patients will receive 2.5 mg once daily for one week, then 5 mg daily the following week, then the dose will be increased to 10 mg once daily depending on renal function (see Table 1 kidney failure “).

The dosage will be increased only if the previous dose is well tolerated.

Dosage adjustment in renal failure

The dosage in patients with renal impairment should be adjusted according to creatinine clearance as outlined in Table 1 below:

Table 1: Dosage Adjustment in Renal Failure

Creatinine clearance (ml / min)	Recommended dosage
ClCR ≥ 60	5 mg daily
30 <ClCR <60	2.5 mg daily
15 <ClCR <30	2.5 mg every other day
Hemodialysis patients *
ClCR <15	2.5 mg on days of dialysis

* The dialysis clearance of perindoprilat is 70 ml / min. For hemodialysis patients, the drug should be taken after dialysis.

Dosage adjustment in hepatic insufficiency

No dose adjustment is necessary in patients with hepatic impairment (see Warnings and Precautionsand Pharmacokinetic Properties sections ).

Children and adolescents (under 18 years old)

• Efficacy and safety of use have not been established in children and adolescents. As a result, use in children and adolescents is not recommended.

coversyl Contraindications

• Hypersensitivity perindopril
• IEC hypersensitivity
• History of angioedema linked to taking an ACE inhibitor
• Hereditary angioedema
• Idiopathic angioedema
• Second trimester pregnancy
• Third trimester pregnancy 

 Hypersensitivity to the active substance or to any of the excipients listed in section A composition or another angiotensin converting enzyme (ACE)

History of angioedema linked to taking an ACE inhibitor (see section Warnings and precautions for use),

 Hereditary or idiopathic Angioedema,

 2nd and 3rd trimesters of pregnancy (see sections warnings and precautions for use and fertility, pregnancy and lactation)

The combination of COVERSYL to medicines containing aliskiren is against-indicated in patients with diabetes or renal failure (GFR [glomerular filtration rate] <60 mL / min / 1.73m²) (see sections Interactions other drugs and other forms of interactions and Pharmacodynamic properties),

Concomitant use of valsartan / sacubitril (see sections warnings and precautions and interactions with other drugs and other forms of interaction),

Treatment flow cardiopulmonary causing contact of blood with negatively charged surfaces (see section Interaction with other medicinal products and other forms of interaction)

Important bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see Warnings and Precautions).

how coversyl works?

Pharmacotherapeutic Class: Non-Associated Conversion Enzyme Inhibitors (IEC), ATC Code: C09AA04

Action mechanism

• Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (Angiotensin Converting Enzyme ECA). This conversion enzyme, or kinase, is an exopeptidase that allows the conversion of angiotensin I to vasoconstrictor angiotensin II causing degradation of vasodilator bradykinin to an inactive heptapeptide.
• Inhibition of ACE induces a decrease in angiotensin II in plasma, leading to an increase in renin plasma activity (by inhibition of negative feedback control of renin release) and a decrease in secretion aldosterone. Since ECA inactivates bradykinin, inhibition of ACE also leads to an increase in the activity of local and circulating kallikrein-kinin systems (and consequently to activation of the prostaglandin system). This mechanism may contribute to the hypotensive action of ACE inhibitors and is partially responsible for some of their side effects (such as coughing).
• Perindopril works through its active metabolite, perindoprilat. The other metabolites do not show ACE inhibition in vitro .

Efficacy and clinical safety

Hypertension

• Perindopril is active at all stages of hypertension: mild, moderate, severe; there is a reduction in systolic and diastolic pressure, both supine and orthostatic.
• Perindopril reduces peripheral vascular resistance, leading to a decrease in blood pressure. As a result, peripheral blood flow increases, with no effect on heart rate.

In general, renal blood flow increases with a glomerular filtration rate (GFR) usually remaining unchanged.

The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is maintained for at least 24 hours: the valley / peak ratio is of the order of 87-100%.

The decrease in blood pressure occurs quickly. In responder patients, blood pressure normalization occurs during the first month of treatment, and is maintained without escape.

Stopping treatment is not accompanied by a rebound effect on blood pressure.

Perindopril reduces left ventricular hypertrophy.

In humans, the vasodilatory properties of perindopril have been confirmed. It improves the elasticity of large arterial trunks and decreases the media / lumen ratio  of small arteries.

The combination with a thiazide diuretic produces an additive synergy. The combination of ACE inhibitor and thiazide also decreases the risk of hypokalemia induced by diuretic therapy.

Heart failure

Perindopril reduces cardiac work by decreasing pre-load and post-load.

Studies in heart failure have demonstrated:

• · A decrease in left and right ventricular filling pressures,
• · A decrease in total peripheral vascular resistance,
• · An increase in cardiac output and an improvement in the cardiac index.

In comparative studies, the first 2.5 mg administration of perindopril arginine to patients with mild to moderate heart failure was not associated with a significant decrease in blood pressure compared with placebo.

Patients with stable coronary artery disease

• The EUROPA multicenter, international, randomized, double-blind, placebo-controlled clinical trial lasted 4 years.
• Twelve thousand two hundred and eighteen (12218) patients over 18 years of age were randomized to perindopril
  8 mg (equivalent to perindopril arginine 10 mg) (n = 6110) or placebo (n = 6108).
• The patients in the study had coronary artery disease with no clinical sign of heart failure. In total, 90% of patients had a history of myocardial infarction and / or a history of coronary revascularization. Most patients received the studied treatment in addition to their usual therapy including platelet aggregation inhibitors, lipid-lowering drugs and beta-blockers.
• The primary efficacy endpoint was a combined endpoint of cardiovascular mortality, nonfatal myocardial infarction, and / or recovered cardiac arrest. Treatment with perindopril 8 mg (equivalent to perindopril arginine 10 mg) once daily resulted in a significant absolute reduction of the primary endpoint of 1.9% (relative risk reduction of 20%, 95% CI [9.4, 28.6] – p < 0.001).
• Compared to placebo, an absolute reduction of 2.2% corresponding to a RRR of
  22.4% (95% CI [12.0, 31.6] – p < 0.001) of the primary endpoint was observed in patients with a history of myocardial infarction and / or revascularization.

Pediatric population

• The safety and efficacy of perindopril have not been established in children and adolescents under 18 years of age.
• In an open-label, non-comparative clinical study, 62 hypertensive children aged 2 to 15 years with a glomerular filtration rate> 30 ml / min / 1.73 m2 received perindopril at an average dose of 0.07 mg / kg.
• The dose was adapted for each patient according to his profile and his blood pressure response up to a maximum dose of 0.135 mg / kg / day.
• 59 patients completed the initial phase of 3 months of treatment and 36 patients completed the extension phase of the study, corresponding to a follow-up of at least 24 months (average duration of the study: 44 months).
• Systolic and diastolic blood pressure remained stable from baseline to last assessment in patients previously treated with other antihypertensive agents and decreased in patients who had never received antihypertensive therapy.
• More than 75% of children had a systolic and diastolic blood pressure lower than the 95th percentile in their last assessment.
• The safety of use was consistent with the known safety profile of perindopril.

Data from clinical trials related to double blockade of the renin-angiotensin-aldosterone system (RAAS):

• The use of a combination of a converting enzyme inhibitor (ACE) with an angiotensin II receptor antagonist (ARB II) was analyzed in two large randomized controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
• The ONTARGET study was conducted in patients with a history of cardiovascular disease or cerebrovascular disease, or type 2 diabetes with target organ involvement. The VA NEPHRON-D study was conducted in type 2 diabetic patients with diabetic nephropathy.
• In comparison with monotherapy, these studies did not show any significant beneficial effect on renal and / or cardiovascular outcomes and mortality, whereas an increased risk of hyperkalemia was observed. , acute renal failure and / or hypotension.
• These results are also applicable to other IEC and ARA II, given the similarity of their pharmacodynamic properties.
• ACE inhibitors and ARBs should not be used in patients with diabetic nephropathy.

The ALTITUDE study was conducted to evaluate the benefit of adding aliskiren to standard ACE inhibitors or AIIRAs in type 2 diabetes and chronic renal failure, with or without cardiovascular disorders. This study was stopped prematurely due to an increased risk of adverse events. Cardiovascular deaths and strokes were more common in the aliskiren group than in the placebo group; adverse events and some serious adverse events such as hyperkalemia, hypotension and

What are the side effects of taking Coversyl?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following potentially serious side effects, stop taking COVERSYL 5 mg film-coated tablets immediately and contact your doctor immediately:

• · Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema), (see section 2 “Warnings and Precautions” (uncommon – may affect up to 1 in 100 patients) )
• · Severe dizziness or fainting due to lhypotension (common – may affect up to 1 in 10),
• · Unusually fast or irregular heartbeat, chest pain (angina), or infarction (very rare – may affect up to 1 in 10,000 patients),
• · Weakness of the arms or legs, or delocution problems that may be signs of a possible stroke (very rare – may affect up to 1 in 10,000 patients),
• · Sudden wheezing, chest pain, shortness of breath or breathing difficulties (bronchospasm) (uncommon – may affect up to 1 in 100 patients),
• · Inflammation of the pancreas may result in severe abdominal and dorsal pain with very high discomfort (very rare – may affect up to 1 in 10,000 patients),
• · Yellowing of the skin or eyes (jaundice) may be a sign of hepatitis (very rare – may affect up to 1 in 10,000 patients),
• · Rashes often starting with red spots and itching on the face, arms or legs (erythema multiforme) (very rare – may affect up to 1 in 10,000 patients).

Tell your doctor if you notice any of the following side effects:

Frequent (may affect up to 1 in 10 patients):

1. · Headache,
2. · Discomfort,
3. · Vertigo,
4. · Tingling and tingling sensations,
5. · Visual disturbances,
6. · Hissing (feeling of noise in the ears) and ringing of the ear,
7. · Cough,
8. · Difficulty breathing (dyspnea),
9. · Gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficult digestion, diarrhea, constipation),
10. · Allergic reactions (such as rash, itching),
11. · Muscle cramps,
12. · Tiredness

Uncommon (may affect up to 1 in 100 patients):

1. · Mood disorders,
2. · Sleep disorders,
3. · Dry mouth,
4. · Severe itching or severe rash,
5. · Blistering on the skin,
6. · Kidney problems,
7. · Impotence,
8. · Perspiration,
9. · Deosinophilic excess (category of white blood cells),
10. · Sleepiness,
11. · Fainting,
12. · Palpitations,
13. · Tachycardia,
14. · Vasculitis (inflammation of the blood vessels),
15. · Photosensitivity reaction (increased sensitivity of the skin to the sun),
16. · Arthralgia (joint pain),
17. · Myalgia (muscle pain),
18. · Chest pain,
19. · Malaise,
20. · Peripheral edema,
21. · Fever,
22. · Fall,
23. · Modification of biological parameters: increase of reversible potassium at the end of treatment, decrease of sodium level, hypoglycaemia (very low blood sugar level) in diabetic patients, elevation of blood creatinine level, elevation of blood levels duration.

Rare (may affect up to 1 in 1000 patients):

• · Worsening of psoriasis,
• · Changes in biological parameters: increased levels of liver enzymes, elevated serum bilirubin.

Very rare (may affect up to 1 in 10,000 patients):

• · Confusion,
• · Eosinophilic pneumonia (a rare type of pneumonia),
• · Rhinitis (stuffy nose or runny nose),
• · Renal insufficiency,
• · Changes in blood constants such as a decrease in the number of white and red blood cells, a decrease in hemoglobin, a decrease in the number of blood platelets. 

coversyl drug interactions

Data from clinical trials have shown that renin-angiotensin-aldosterone system double-blocking (RAAS) by the concomitant use of angiotensin II receptor antagonists, angiotensin II aliskiren is associated with a higher incidence of adverse events such as hypotension, hyperkalemia, and impaired renal function (including acute renal failure) compared with the use of a single drug acting on the RAAS (see sections Contraindications , Warnings and Precautions for Use and Pharmacodynamic Properties ).

coversyl interactions other drugs

Drugs causing hyperkalemia

Certain drugs or therapeutic classes may increase the appearance of hyperkalemia such as:

• aliskiren.
• potassium salts.
• potassium-sparing diuretics.
• ACE inhibitors.
• ARBs II.
• nonsteroidal anti-inflammatory drugs (NSAIDs).
• heparins immunosuppressants such as ciclosporin or tacrolimus and trimethoprim. 

The combination of these drugs increases the risk of hyperkalemia.

Contraindicated combinations (see Contraindications section )

Aliskiren

• The risk of hyperkalemia, deterioration of renal function and cardiovascular morbidity and mortality increases in patients with diabetes or renal insufficiency,
• Associations not recommended (see section Warnings and precautions for use )

Aliskiren

The risk of hyperkalaemia, deterioration of renal function and cardiovascular morbidity and mortality increases in patients other than diabetic patients or patients with renal insufficiency.

Treatment associating an IEC with an ARA II

It has been reported in the literature that in patients with diagnosed atherosclerosis, heart failure or in diabetic patients with organic lesions, concomitant treatment with ACEI and ARB II is associated with a higher frequency of hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) compared to monotherapy with a molecule acting on the renin-angiotensin-aldosterone system. Double blockage (eg combination of an ACEI with an ARB II) should be limited to individual and defined cases, with increased monitoring of renal function, potassium level and blood pressure.

 Estramustine

• Risk of increased side effects such as angioneurotic edema (angioedema).

Racecadotril

• ACE inhibitors (eg perindopril) are known to cause angioedema. This risk may be increased when used concomitantly with racecadotril (a drug used for acute diarrhea).

MTOR inhibitors (eg sirolimus, everolimus, temsirolimus)

• Patients treated concomitantly with an mTOR inhibitor may have a higher risk of angioedema (see Warnings and Precautions section ).

Potassium sparing diuretics (eg triamterene, amiloride …), potassium (salts)

• Hyperkalemia (potentially fatal), especially in a context of renal failure (cumulative hyperkalemic effects).
• The combination of perindopril with the medicines mentioned above is not recommended (see Warnings and Precautions ). If concomitant use is indicated, however, these medicinal products should be used with caution and periodic serum potassium control should be performed. For the use of spironolactone in heart failure see below.

Lithium

Reversible increases in serum lithium concentrations and therefore toxicity have been reported during concomitant administration of lithium with ACE inhibitors. The use of perindopril with lithium is not recommended, but if the association proves necessary, careful monitoring of lithium levels should be performed (see section Warnings and precautions for use ).

Associations advised against

Antidiabetic drugs (insulins, oral hypoglycemic agents)

Epidemiological studies have suggested that the combination of ACE inhibitors and antidiabetic drugs (insulins, oral hypoglycaemic agents) may cause an increase in the hypoglycemic effect with a risk of hypoglycaemia. This phenomenon seems to occur more particularly during the first weeks of the combination of these treatments and in patients with renal insufficiency.

Baclofen

Increased antihypertensive effect. If necessary, monitor the blood pressure and adjust the dosage of the antihypertensive drug.

Non-potassium sparing diuretics

• Patients treated with diuretics, particularly those with hypovolemia and / or water-soluble depletion, may be subject to a severe decrease in blood pressure after initiation of treatment with an ACE inhibitor. The hypotensive effect may be decreased by discontinuing the diuretic, increasing the volume or salt intake before initiating treatment with low and progressive doses of perindopril.
• In arterial hypertension , when previous diuretic therapy may have caused hypovolemia and / or water-soluble depletion, the diuretic must be discontinued before initiating an ACE; in this case, a non-potassium-sparing diuretic may then be reintroduced or the IEC should be initiated at a low dose gradually increased.
• In the diuretic treatment of congestive heart failure, the ACE inhibitor should be initiated at a very low dose and after reducing the dose of the associated potassium-sparing diuretic.
• In all cases, renal function (creatinine level) should be monitored during the first few weeks of treatment with IEC.

Potassium-sparing diuretics (eplerenone, spironolactone)

• With eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily and with low doses of IEC:
• In the treatment of NYHA class II-IV heart failure with an ejection fraction <40%, and previously treated with an ACE inhibitor and loop diuretic, there is a risk of hyperkalemia, potentially life-threatening especially in case of non-compliance with the prescription recommendations of this association. Before initiating the combination, check for the absence of hyperkalemia and renal failure. Strict control of serum potassium and serum creatinine is recommended once a week in the first month of treatment and once a month in subsequent months.

Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin ³ 3 g / day

• When ACE inhibitors are administered concurrently with NSAIDs (such as acetylsalicylic used as an anti-inflammatory, COX-2 inhibitors, and non-selective NSAIDs), an attenuation of the antihypertensive effect may occur.
• Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of worsening renal function, including a risk of acute renal failure, and an increase in serum potassium, particularly in patients with pre-existing impairment. existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be properly hydrated and measures should be taken to control renal function at the start of treatment and periodically thereafter.

Associations subject to precautions for use

Antihypertensives and vasodilators

• Concomitant use of these agents may increase the hypotensive effects of perindopril. Concomitant use of nitroglycerin and other nitrates, or other vasodilators, may decrease blood pressure.

Gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin)

• Increased risk of angioedema due to decreased activity of dipeptidylpeptidase IV (DPP-IV) caused by gliptin in patients co-treated with ACE.

Tricyclic Antidepressants / Antipsychotics / Anesthetics

• Concomitant use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to an increase in blood pressure reduction (see Warnings and Precautions section ).

 Sympathomimetics

• Sympathomimetics may reduce the antihypertensive effects of ACE.

Golden Salts

Nitritoid reactions (symptoms including facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients receiving gold injections (sodium aurothiomalate) and an ACE inhibitor (including perindopril) concomitantly.

Warnings and Precautions

Stable coronary disease

• If an unstable dangor episode (major or non-major) occurs during the first month of treatment with perindopril, a thorough benefit-risk assessment should be performed before continuing treatment.

hypotension

• ACE inhibitors can cause a drop in blood pressure. Symptomatic hypotension is rarely observed in uncomplicated hypertensive patients, but occurs preferentially in patients with volume depletion ie treated with a diuretic, under a salt-restricted diet, on dialysis, with diarrhea or vomiting, or in those with severe renin-dependent hypertension.
• Symptomatic hypotension has been observed in patients with heart failure, with or without associated renal failure.
• It occurs preferentially in these patients who have a severe degree of cardiac insufficiency, related to the use of high doses of diuretics of lanse, hyponatremia or functional renal failure.
• Linitiation of treatment and dosage adjustment should be performed under strict medical supervision in patients at high risk of symptomatic hypotension.
• The same precautions apply to patients with cardiac dischemia or cerebrovascular disease in whom excessive blood pressure drop can lead to myocardial infarction or stroke.
• If hypotension occurs, the patient should be placed supine and, if necessary, receive an intravenous infusion of 9 mg / ml (0.9%) sodium chloride solution.
•  Transient hypotension is not a contraindication to continued treatment, which can usually be continued without problems once the blood pressure increases after the increase in volume.
• A further decrease in blood pressure may occur with COVERSYL 5 mg in some heart failure patients with normal or low blood pressure. 
• This expected effect does not generally require the cessation of treatment.
•  If hypotension becomes symptomatic, a dose reduction or discontinuation of COVERSYL 5 mg may be necessary.

Stenosis of the aortic and mitral valves / hypertrophic cardiomyopathy

• As with other ACE inhibitors, COVERSYL 5 mg should be given with caution in patients with mitral valve stenosis and left ventricular flow obstruction such as aortic stenosis or hypertrophic cardiomyopathy.

Renal failure

• In case of renal insufficiency, (creatinine clearance <60 ml / min) the initial dose of perindopril should be adjusted according to the patient’s creatinine clearance and then depending on the patient’s response to treatment . Periodic monitoring of potassium and creatinine is a routine part of these patients.
• Hypotension secondary to initiation of ACE inhibitor therapy may lead to impaired renal function in heart failure patients. In such cases, acute renal failure, usually reversible, has been observed.
• Increases in blood urea and serum creatinine, usually reversible at the end of treatment, have been observed in some patients with bilateral renal artery stenosis or single kidney stenosis treated with ACE inhibitors.
• This has been observed in particular in patients with renal insufficiency.
• There is an increased risk of severe hypotension and renal insufficiency if renovascular hypertension is also present.
• In these patients, treatment should be initiated under strict medical supervision with a low dosage and a gradual increase thereof. Since diuretic therapy is an additional risk factor, it should be discontinued and renal function should be monitored during the first few weeks of treatment with COVERSYL 5 mg.
• Often small and transient increases in blood-serum creatinine levels, especially when COVERSYL 5 mg was associated with a diuretic, have been observed in some hypertensive patients with no history of renovascular disease. This particularly concerns patients with pre-existing renal insufficiency. Dose reduction and / or discontinuation of diuretic and / or COVERSYL 5 mg may be necessary.

Hemodialysis patients

Anaphylactoid reactions have been reported in dialysis patients with high permeability membranes and concomitantly treated with an IEC. Another type of dialysis membrane or antihypertensive agent of different class should be used in these patients.

Kidney transplantation

• There are no data on the administration of COVERSYL 5 mg in patients with recent kidney transplantation.

Hypersensitivity / angioneurotic edema

• Angio-edema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx has been reported rarely in patients treated with ACE, COVERSYL 5 mg included.
• This can happen at any time during treatment. In such cases, COVERSYL 5 mg should be discontinued immediately and the patient should be monitored until symptoms are completely resolved.
• When the edema is only interested in the face and the lips, the evolution is generally regressive without treatment, although antihistamines have been used to relieve the symptoms.
• Langio-edema associated with laryngeal edema can be fatal. When the tongue, glottis or larynx is affected, which can cause airway obstruction, emergency treatment should be given promptly. This may include adrenaline administration and / or airway clearance. The patient must be kept under strict medical supervision until the complete disappearance of symptoms.
• Patients with a history of angioedema not associated with an ACE inhibitor are at an increased risk of angioedema under ACE.
• An intestinal angio-edema has been reported rarely in patients treated with a conversion enzyme inhibitor. These patients had abdominal pain (with or without nausea or vomiting); in some cases it was not preceded by facial angioedema and C-1 esterase levels were normal. The diagnosis was made by an abdominal CT scan, an ultrasound, or during surgery and the symptoms disappeared at the end of the ECI. 
• Intestinal Langio-edema should be part of the differential diagnosis in case of abdominal pain in a patient under IEC.

Concomitant use of mTOR inhibitors (eg sirolimus, everolimus, temsirolimus)

• Patients treated concomitantly with an mTOR inhibitor (eg sirolimus, everolimus, temsirolimus) may have a higher risk of angioedema (eg, airway or tongue edema, with or without respiratory failure).

Anaphylactoid Reactions During Apheresis of Low-Density Lipoprotein (LDL)

• Rarely, life-threatening anaphylactoid reactions have been reported in those receiving ACE inhibitors during low density lipoprotein apheresis with adsorption on dextran sulfate. These reactions can be avoided by transiently interrupting IEC treatment before each apheresis.

Anaphylactoid reactions during desensitization

• Some patients on ACE during desensitization therapy (eg with hymenoptera venom) have had anaphylactoid reactions. These reactions could be avoided in these patients by transiently interrupting the ACE inhibitors during desensitization, but they reappeared when the treatment was inadvertently resumed.

Hepatic insufficiency

ACE inhibitors have been rarely associated with a syndrome that begins with cholestatic jaundice and may lead to fulminant necrotizing hepatitis and (sometimes) death. The mechanism of this syndrome is unclear. Patients taking ACE inhibitors who develop jaundice or have marked hepatic enzyme elevations should discontinue IEC therapy and receive appropriate medical supervision (see section 4.8).

Neutropenia / Agranulocytosis / Thrombocytopenia / Anemia

Neutropenia / agranulocytosis, thrombocytopenia and anemia have been reported in some patients on ACE. In patients with normal renal function and no other risk factors, neutropenia is rarely observed. Perindopril should be used with extreme caution in patients with vascular collagen diseases, in immunosuppressed patients, in patients treated with allopurinol or procainamide, or in patients with a combination of these risk factors, particularly in patients with case of pre-existing renal failure. Some of these patients developed serious infections, which in a few cases did not respond to intensive antibiotic treatment. If perindopril is used in these patients,

Ethnic particularities

• ACE inhibitors cause greater angioedema in black patients.
• As with other ACE inhibitors, perindopril may be less effective in lowering blood pressure in black patients, because of the possibility of a higher prevalence of low renin levels in this type of population.

Cough

• A cough has been reported with the use of IEC. Characteristically, the cough is non-productive, persistent and disappears after treatment. IEC-induced cough should be part of the differential diagnosis of cough.

Surgery / Anesthesia

• In patients undergoing major surgery or anesthesia with agents causing hypotension, COVERSYL 5 mg may block the production of langiotensin II secondary to renin release. 
• Treatment should be discontinued one day before surgery. 
• If hypotension occurs and is attributed to this mechanism, it can be corrected by an increase in the volume.

hyperkalemia

• Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril. The risk factors for hyperkalemia are renal failure, deterioration of renal function, age (> 70 years), diabetes, intercurrent events such as dehydration, acute cardiac decompensation, metabolic acidosis, concomitant use of potassium-sparing diuretics (eg for example: spironolactone, eplerenone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium or other treatments that increase serum potassium (eg heparin). The use of potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium, especially in patients with impaired renal function, can cause a significant rise in serum potassium. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias. If concomitant use of the agents mentioned above is deemed necessary, they should be used with caution and frequent monitoring of serum potassium should be performed.

Diabetic patients

• In diabetic patients treated with oral antidiabetic drugs or insulin, blood glucose control should be closely monitored during the first month of ICI treatment.

Lithium

• The combination of lithium and perindopril is generally not recommended.
• Potassium-sparing diuretics, potassium supplements or substitutes containing potassium salts
• Combination of perindopril with potassium-sparing diuretics, potassium supplements or potassium-containing substitutes is generally not recommended.

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

It has been established that the combination of conversion enzyme (ACE) inhibitors, langiotensin-II receptor antagonists (ARA II) or daliskiren increases the risk of hypotension, hyperkalemia and impaired renal function (including the risk of acute renal failure). As a consequence, the double blockade of the RAIS by the association of ECI, DARA II or daliskiren is not recommended (see sections 4.5 and 5.1).

Nevertheless, if such an association is considered absolutely necessary, it can be done only under the supervision of a specialist and with a close and frequent control of the renal function, blood lionogram and arterial pressure. ACE inhibitors and ARBs should not be used in patients with diabetic nephropathy.

Pregnancy

ACE inhibitors should not be started during pregnancy. Unless IEC therapy is considered essential, it is recommended that patients considering pregnancy change their antihypertensive therapy for a drug with a well-established safety profile during pregnancy. If pregnancy is diagnosed, treatment with IEC should be stopped immediately and if necessary, alternative treatment should be started (see sections 4.3 and 4.6).

excipients

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

 INTERACTIONS WITH OTHER DRUGS AND OTHER FORMS OF INTERACTION

Data from clinical trials have shown that double blockade of the renin-angiotensin-aldosterone system (RAAS) by concomitant use of conversion enzyme inhibitors, langiotensin II receptor antagonists or daliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalemia, and renal function impairment (including acute renal failure) compared to the use of a single drug acting on the RAAS.

Drugs causing hyperkalemia

Certain drugs or therapeutic classes may increase the appearance of hyperkalemia such as: laliskiren, potassium salts, potassium-sparing diuretics, ACE inhibitors, ARBs II, nonsteroidal anti-inflammatory drugs (NSAIDs), heparins, immunosuppressants such as ciclosporin or tacrolimus and trimethoprim. The association of these drugs increases the risk of hyperkalemia.

Contraindicated combinations .

Golden salts

Nitritoid reactions (symptoms including facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients receiving dor injection (sodium aurothiomalate) and an ACE inhibitor (including perindopril) concomitantly.

Drive and use machines

• COVERSYL does not directly affect alertness, but feelings of vertigo or fatigue in relation to a drop in blood pressure may occur in some patients.
• Therefore, the ability to drive or use machines can be reduced.

PREGNANCY / BREAST FEEDING / FERTILITY:

coversyl and pregnancy

• The use of ACE inhibitors is not recommended during the 1 ^st  trimester of pregnancy ( see Warnings and Precautions ). The use of ACE inhibitors is against-indicated to 2 ^e and 3 ^e  trimesters of pregnancy ( see Contraindications , Warnings and Precautions ).
• Available epidemiological data on the risk of malformation after exposure to ACE in the 1 ^st trimester of pregnancy are inconclusive. However, a small increase in the risk of congenital malformations can not be ruled out. Unless IEC therapy is considered essential, it is recommended that patients considering pregnancy change their antihypertensive therapy for a drug with a well-established safety profile during pregnancy. If pregnancy is diagnosed, treatment with IEC should be stopped immediately and, if necessary, alternative treatment should be started.
• The exposure to ACE inhibitors during the 2 ^e and 3 ^e  trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull) and toxicity in the newborn ( renal insufficiency, hypotension, hyperkalemia): see Preclinical safety . If ACE inhibitor exposure from 2 ^th trimester of pregnancy, it is recommended to perform a fetal ultrasound check of renal function and the bones of the skull. Infants born to mothers treated with IEC should be monitored for blood pressure ( see Contraindications , Warnings and Precautions ).

Breastfeeding

• Due to the lack of information available on the use of Coversyl during breastfeeding, Coversyl is not recommended. It is best to use other treatments with a well-established safety profile during breastfeeding, especially in the newborn or preterm infant.

Fertility

• There is no effect on reproductive function or fertility.

What should I do if I miss a dose?

It is important to take your medicine every day as regular treatment is more effective. However, if you have forgotten to take COVERSYL 5 mg film-coated tablets, the next day simply resume your treatment as usual.

Do not take a double dose to make up for the dose you forgot to take.

What happens if I overdose from Coversyl ?

If you have taken too many tablets, contact your nearest hospital or doctor immediately. The most likely event, in case of overdose, is hypotension which may result in dizziness or lightheadedness. If this happens, lie down with your legs up.

What is  Forms and Composition ?

FORMS and PRESENTATIONS

2.5 mg film-coated tablet (round and convex, white) and 10 mg (round, biconvex, one heart engraved on one side and the Servier logo on the other, green):   30 tablets pillboxes, packs of 1 and 3 pillboxes. 5 mg film-coated tablet (stick-shaped, scored on both sides, Servier logo engraved on one side, light green):   30 tablets pill boxes, 1 and 3 pill boxes.

COMPOSITION

	p cp
Perindopril (INN) arginine	2.5 mg
or	5 mg
or	10 mg
(Perindopril: 1.66975 mg / tablet 2.5 mg, 3.395 mg / tablet 5 mg, 6.790 mg / tablet 10 mg)

Excipients (common): Core: lactose monohydrate, magnesium stearate, maltodextrin, hydrophobic colloidal silica, sodium carboxymethyl starch (type A). Film coating: macrogol 6000, glycerol, hypromellose, magnesium stearate, titanium dioxide, cupric chlorophyllin (cp 5 mg and 10 mg).

Excipients with known effect: lactose monohydrate (36.29 mg / cw 2.5 mg, 72.58 mg / cd 5 mg, 145.16 mg / cp 10 mg).

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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