CO-DIOVAN® NSS - UAE
CO-DIOVAN® NSS - UAE
Regulatory Affairs
CO-DIOVAN® (valsartan / hydrochlorothiazide)
80/12.5 mg, 160/12.5 mg, 160/25 mg Film-coated tablets
National Succinct Statement
Version 3.1
CDS Effective date: 01-Feb-2021
Safety Label Change
(SLC) Not applicable
Tracking number:
Document status: Final
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without the consent of Novartis
Co-Diovan® Film-coated tablets
Important note: Before prescribing, consult full prescribing information: www.swissmedicinfo.ch
This link will contain the most updated product information approved by the reference country.
Presentation: Coated tablets containing 80 mg valsartan (an angiotensin II receptor antagonist) and 12.5 mg hydrochlorothiazide (a thiazide diuretic), or 160 mg valsartan and
12.5 mg hydrochlorothiazide or 160 mg valsartan and 25 mg hydrochlorothiazide.
Indications: Treatment of mild and moderate essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy.
Dosage: The recommended dose is one Co-Diovan 80/12.5 film-coated tablet per day. If blood pressure reduction is inadequate after 3 to 4 weeks of treatment, it may be necessary to continue treatment with one Co-Diovan 160/12.5 film-coated tablet per day. Use of one Co-Diovan 160/25 film-coated tablet per day is restricted to those patients in whom adequate reduction of blood pressure is not achieved with Co-Diovan 160/12.5. The maximum antihypertensive effect is seen within 2 to 4 weeks.
Co-Diovan may be taken with or without food. Co-Diovan should be taken with some liquid.
Patients with hepatic impairment
Dose reduction may be necessary in patients with hepatic impairment. Due to the active substance component hydrochlorothiazide Co-Diovan should be used with caution in patients with hepatic impairment (see “Warnings and precautions”). Due to the active substance component valsartan Co-Diovan is contraindicated in patients with biliary cirrhosis and cholestasis.
Patients with renal impairment
Dose reduction may be necessary in patients with renal impairment. Due to the active substance component hydrochlorothiazide Co-Diovan is contraindicated in patients with anuria (see “Contraindications”) and should be used with particular caution in patients with severe renal impairment (GFR <30 ml/min) (see “Warnings and precautions”).
There is no experience regarding the use of valsartan in patients with end-stage renal failure (GFR <10 ml/min) or patients undergoing dialysis.
Elderly patients
Co-Diovan may be taken by patients of any age.
Children and adolescents
The safety and efficacy of Co-Diovan have not been demonstrated in patients under 18 years of age.
Contraindications: ♦Known hypersensitivity to the components of this product or to sulfonamide derivatives♦pregnancy ♦anuria ♦concomitant use with aliskiren in diabetic type 1 or 2 patients ♦biliary cirrhosis or cholestasis
Warnings and Precautions: ♦ Risk of hypotension in volume-depleted patients. ♦Caution is advised when administering Co-Diovan to patients with renal artery stenosis, renal and liver disease or systemic lupus erythematosus. ♦Caution in patients experiencing angioedema with Co-Diovan or having history of angioedema with other drugs. Discontinue Co-Diovan immediately and do not re-administer. ♦Caution in patients with heart failure, severe heart failure or other conditions with stimulation of the renin angiotensin-aldosterone-system. Impairment of renal function may occur. ♦Like other thiazide diuretics, HCTZ can cause hypokalemia, which may favor the onset of digitalis-induced cardiac arrhythmias. Caution in patients with hypokalemia, hyponatremia, hypercalcemia or symptomatic hyperuricemia
♦ Disturbance of serum electrolyte balance, glucose tolerance and serum levels of cholesterol, tryglicerides and uric acid. ♦Acute angle-closure glaucoma. ♦Caution in patients with allergy or asthma. ♦Concomitant use with aliskiren in patients with severe renal impairment (GFR < 60 mL/min) should be avoided. ♦Caution is required while co-administering Co-Diovan with other agents blocking the RAAS such as ACEIs or aliskiren. ♦Increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide. Patients should protect their skin from excessive sun exposure, regularly check their skin for new lesions and promptly report any suspicious skin lesions while taking Co-Diovan.
Pregnancy, lactation, females and males of reproductive potential:
♦Contraindicated in pregnancy.♦Should not be used in women planning to become pregnant and while breast-feeding.
Interactions ♦Concomitant administration with other agents blocking the RAS such as ACEIs or aliskiren may increase incidence of hypotension, hyperkalemia and changes in renal function. Monitoring blood pressure, renal function and electrolytes is recommended when used concomitantly.♦Concomitant treatment with potassium-sparing diuretics or other drugs that may increase serum potassium levels (heparin, etc.) may increase potassium levels. Monitoring of serum potassium advised ♦Caution if combined with other antihypertensives, ♦Co- administration of inhibitors of the uptake transporter (rifampin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan ♦Concomitant treatment with lithium may increase lithium concentrations and toxicity. Close monitoring of serum lithium levels is recommended. ♦Caution with drugs causing hypokalemia (e.g. corticosteroids, ACTH, amphotericin, penicillin G, carbenoxolone, antiarrhythmics). ♦Monitoring of serum electrolyte balance with drugs causing hyponatremia (e.g. antidepressants, antipsychotics, antiepileptics). ♦Concomitant treatment with NSAIDs including Cox-2 Inhibitors may decrease antihypertensive effects. Monitoring of renal function with NSAIDs and Cox-2 selective inhibitors. ♦Electrolyte imbalance with digitalis glycosides. ♦Caution with insulin and oral antidiabetic agents. ♦Caution with anionic exchange resins, allopurinol, amantadine, diazoxide, cytotoxic drugs, anticholinergic agents, vitamin D, calcium salts, ciclosporin, methyldopa, pressor amines (e.g. noradrenaline), barbiturates, narcotics and alcohol.
Adverse reactions: Uncommon: Dehydration, paraesthesia, vision blurred, tinnitus, hypotension, myalgia, fatigue, dizziness. Common: Cough, diarrhea, arthralgia Very rare: impaired renal function. Frequency not known: Syncope, non-cardiogenic pulmonary oedema, hypokalaemia, hyponatraemia, neutropenia.
For the valsartan component, other reported adverse reaction during clinical trials irrespective of their causal association with the study drug: Arthralgia, asthenia, dizziness, insomnia, libido decrease, oedema.
For the hydrochlorothiazide component, other reported adverse reaction include: Very common and common adverse reactions: Hypokalaemia and rise in blood lipids, hypomagnesaemia, hyperuricaemia, hyponatraemia, urticaria and other forms of rash, decreased appetite, mild nausea and vomiting, orthostatic hypotension, erectile dysfunction.
♦Rare and very rare adverse reactions but potentially serious: cardiac arrhythmias, vasculitis, lupus erythematosus, toxic epidermal necrolysis, pancreatitis, pneumonitis, pulmonary oedema, hypersensitivity reactions, alkalosis hypochloremic, hypercalceamia, diarrhoea, thrombocytopenia with or without purpura, agranulocytosis, leucopenia, bone marrow depression, hemolytic anemia. ♦Not known: non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma).