Each tablet of  Canartan® 16 contains: 

• Candesartan Cilexetil   16 mg

Each tablet of  Canartan® 8  contains:  

• Candesartan Cilexetil   8 mg  

Canartan® is indicated in : 

• Essential hypertension and in all grades of hypertension. 
• Treatment of patients with heart failure and impaired left ventricle systolic function as additional therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

• Canartan® is contraindicated in patients who are hypersensitive to any of its components.
• Since there  is no experience with the use of Canartan® in pregnant women, Canartan® should not be used in pregnancy. 

¤ No drug interactions of clinical significance have been found. Compounds which have been investigated in clinical studies include hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel), glibenclamide ,nifedipine and enalapril.

¤ The antihypertensive effect of Canartan® may be enhanced by other antihypertensives.

¤ Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium.

¤ Since lithium toxicity has been reported, careful monitoring of serum lithium  levels is recommended during concomitant administration of lithium and Canartan® tablets, since lithium reabsorption at renal tubule is increased.

• If pregnancy is detected during treatment, Canartan® should be discontinued immediately. The use of angiotensin converting enzyme inhibitors (ACEI) during the second or third trimesters of pregnancy has been associated with foetal and neonatal injury.
• It is not known whether candesartan is excreted in human milk. breast-feeding should be discontinued if the use of Canartan®  is considered essential.

• The safety and tolerability of Canartan® (Candesartan Cilexetil) was shown to be comparable to that if placebo in double-blinding clinical studies.
• Canartan®  was well tolerated and adverse events were mild and transient and showed no association with dose or age or gender.
• Withdrawals from treatment due to adverse events were similar with candesartan cilexetil and placebo.
• The adverse events reported were : dizziness/Vertigo, headache, back pain and respiratory tract infection.
• In general, there were no clinically important influences of Canartan on routine laboratory variables. In postmarketing surveillance, very rare cases (<1/ 10000), were reported slightly more often with Candesartan Cilexetil than with placebo including increase in liver enzymes, hepatitis, leucopenia,neutropenia, agranulocytosis, rash, urticaria, angioedema and hyponatremia, but no routine monitoring of laboratory variables is usually necessary for patients receiving Candesartan Cilexetil.

Overdose:

• Based on pharmacological considerations, the main result of an overdose is likely to be hypotension and dizziness.

Management of overdosage:

• If symptomatic hypotension occur, symptomatic treatment should be instituted and supervision of vital signs monitored. The patient should be placed supine in head-down position. If this is not sufficient, plasma volume should be increased by infusion of, e.g. isotonic saline solution.
• Sympathomimetic drugs may be administered if the above mentioned measures are not sufficient.
• Candesartan will probably not be removed by haemodialysis.

• The recommended initial and maintenance dose of Canartan®  is 8 mg or 16 mg once daily.
• In patients who require further blood pressure reduction, a dose increased to 16 mg once daily is recommended.
• The maximal antihypertensive effect is attained within 4 weeks of initiation of treatment.
• No initial dosage adjustment is necessary in elderly patients.
• No initial dosage adjustment is necessary in patients with mild renal impairment (i.e. creatinine clearance ≥ 30 ml/min/1.73m2 BSA). In patients with severe renal impairment (i.e. creatinine clearance < 30ml/ min/1.73m2 BSA), the clinical experience is limited and a lower initial dose of 4 mg should be considered.
• No initial dosage adjustment is necessary in patients with mild to moderate hepatic function.
• No experience available to date in patients with severe impairment hepatic function (e.g. cirrhoticpatients).
• Dosage in heart failure: The usual recommended initial dose of Canartan® is 4 mg once daily.
• Up-titration to the target dose of 32 mg once daily or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks.
• In patients with less than optimal blood pressure reduction on Candesartan, combination with a thiazide diuretic is recommended.
• Canartan® should be taken once dialy with or without food.
• The safety and efficacy of Canartan® have not been established in children.

• Concomitant use of Canartan® with potassium-sparing diuretics, may theoretically result in increased serum potassium levels. If co-administration is considered necessary, caution is adviced.
• Physician should know if patient is receiving Canartan®  because of possible hypotension during surgery in patients treated with angiotensin-II antagonists.

Warning: 

• Intravascular volume depletion: In patients with intravascular volume depletion (such as those  receiving high dose diuretics ), Symptomatic hypotension may occur, hence, this condition should be corrected before administration of Canartan®.
• Renal artery stenosis: Other drugs that affect the renin-angiotensin- aldosterone system, i.e. angiotensin converting enzyme (ACE) inhibitors, have been associated with increased blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Although not proved, probably this may occur also with angiotensin II receptor antagonists such as Candesartan Cilexetil.

• Canartan®16: Blister of 10 tablets, pack of 2 blisters. 
• Canartan® 8: Blister of 10 tablets, pack of 2 blisters.

• In dry place store below 30ºC.