Exforge HCT UAE

Regulatory Affairs

Exforge HCT^® 
(amlodipine besylate/valsartan/hydrochlorothiazide)

5 /160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg and 10/160/25 mg Film-coated tablets

National Succinct Statement 

Version 4.0.1

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without the consent of Novartis

Exforge HCT^®

Important note: Before prescribing, consult full prescribing information.

Presentation:

Film coated tablets containing 5 mg amlodipine as amlodipine besylate (a calcium antagonist), 160 mg valsartan (an angiotensin II antagonists) and 12.5 mg hydrochlorothiazide (a thiazide diuretic), or 10 mg amlodipine as amlodipine besylate, 160 mg valsartan and 12.5 mg hydrochlorothiazide or 5 mg amlodipine as amlodipine besylate, 160 mg valsartan and 25 mg hydrochlorothiazide or 10 mg amlodipine as amlodipine besylate, 160 mg valsartan and 25 mg hydrochlorothiazide.

Indications:

Treatment of essential hypertension.

Exforge HCT is indicated in patients whose blood pressure is not adequately controlled by dual therapy.

Exforge HCT is indicated as substitution therapy in patients already taking the same dosage strengths of valsartan, amlodipine and hydrochlorothiazide as separate tablets.

Dosage and administration:

1. Usual dosage

When switching from dual therapy to Exforge HCT, it is recommended that 1 Exforge HCT film-coated tablet be taken once daily at a dose of 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg or 10 mg/160 mg/25 mg.

Patients receiving valsartan, amlodipine and hydrochlorothiazide as separate tablets may be switched to the corresponding dose of Exforge HCT.

The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg (2 tablets of Exforge HCT 5 mg/160 mg/12.5 mg).

Exforge HCT should be taken with some water, with or without food.

See “Warnings and precautions” with regard to discontinuation of beta blockers.

1. Special dosage instructions

2. Patients with hepatic impairment

Due to the active substance components valsartan, hydrochlorothiazide and amlodipine, Exforge HCT should be used with particular caution in patients with hepatic impairment or biliary tract disorders. Consideration should be given to starting treatment with the lowest available dose of amlodipine. The lowest strength of Exforge HCT contains 5 mg amlodipine. (See “Warnings and precautions” and “Pharmacokinetics”).

1. Patients with renal impairment

No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ³30 ml/min).

Due to the active substance component hydrochlorothiazide, Exforge HCT is contraindicated in patients with anuria (see “Contraindications”) and should be used with caution in patients with severe renal impairment (GFR <30 ml/min) (see “Warnings and precautions” and “Pharmacokinetics”).

Thiazide diuretics are ineffective as monotherapy in severe renal impairment (GFR <30 ml/min), but may be useful even in patients with a GFR <30 ml/min when used with due caution in combination with a loop diuretic.

1. Elderly patients

Due to the amlodipine contained in Exforge HCT, consideration should be given to starting treatment with the lowest available dose of amlodipine.  The lowest strength of Exforge HCT contains 5 mg amlodipine (see “Properties/Effects” and “Pharmacokinetics”).

1. Children and adolescents

Exforge HCT is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.

Contraindications:

¨Known hypersensitivity to the components of this product or to sulfonamide derivatives ¨pregnancy, lactation ¨anuria ¨concomitant use with aliskiren in diabetic type II patients ¨Biliary cirrhosis or cholestasis ¨Hereditary angioedema or angioedema during previous treatment with an ACE inhibitor or angiotensin II receptor antagonist ¨Severe hypotension ¨Shock (including cardiogenic shock) ¨Obstruction of the left ventricular outflow tract (e.g. high-grade aortic stenosis) ¨Haemodynamically unstable heart failure after acute myocardial infarction.

Warnings/Precautions:

¨Use in women planning to become pregnant and while breast-feeding should be avoided. ¨Risk of hypotension in sodium- and/or volume-depleted patients. ¨Caution is advised when administering Exforge HCT to patients with renal impairment or systemic lupus erythematosus. ¨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 ¨No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation ¨Disturbance of serum electrolyte balance (monitoring recommended), glucose tolerance and serum levels of cholesterol, triglycerides and uric acid. ¨Not recommended in patients below 18 years of age.¨Caution in patients with hepatic impairment or biliary obstructive disorders. ¨Caution in patients experiencing angioedema with Exforge HCT or having history of angioedema with other drugs. Discontinue Exforge HCT immediately and do not re-administer ¨ Intestinal angioedema: Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including valsartan (see “Undesirable effects”). These patients experienced abdominal pain, nausea, vomiting and diarrhoea. The symptoms subsided after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, Exforge HCT should be discontinued and appropriate monitoring initiated until symptoms have completely resolved.¨Caution in patients with heart failure, severe chronic heart failure or other conditions with stimulation of the renin angiotensin-aldosterone-system. Impairment of renal function may occur. ¨Caution in patients with acute myocardial infarction. Worsening angina and acute myocardial infarction can develop after starting or increasing dose of amlodipine, particularly in patients with severe obstructive coronary artery disease ¨As with all other vasodilators, special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. ¨Acute angle-closure glaucoma. ¨Caution in patients with allergy or asthma. ¨Concomitant use with aliskiren in patients with severe renal impairment (GFR < 30 mL/min) should be avoided. ¨Caution is required while co-administering Exforge HCT with other agents blocking the RAS 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 Exforge HCT.

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. ¨Monitoring when used concomitantly with lithium ¨Caution when used concomitantly with potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (heparin etc.,). Monitoring of serum potassium advised. ¨Monitoring of serum potassium levels with skeletal muscle relaxants (e.g. curare derivatives). ¨Caution if combined with other antihypertensives. ¨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. ¨Limit dose of simvastatin to 20 mg when co-administered with amlodipine. ¨Caution when concomitant use of amlodipine with CYP34A inhibitors (e.g. ketoconazole, itraconazole, ritonavir) as amlodipine plasma concentration may increase. ¨Caution when concomitant use of amlodipine with CYP3A4 inducers (e.g. rifampicin, hypericum perforatum). Monitoring of clinical effect advised. ¨Co-administration of inhibitors of the uptake transporter (rifampin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan ¨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:

Exforge HCT: 

Common: hypokalaemia, dizziness, headache, hypotension, dyspepsia, pollakiuria, fatigue, oedema. 

Uncommon: Anorexia, hypercalcaemia, hyperlipidaemia, hyperuricaemia, hyponatraemia, weight gain, Insomnia, sleep disorders, abnormal coordination, postural dizziness, exertional dizziness, dysgeusia, lethargy, paraesthesia, peripheral neuropathy, neuropathy, somnolence, syncope, visual disturbances, vertigo, tachycardia, orthostatic hypotension, phlebitis, thrombophlebitis, cough, dyspnoea, throat irritation, abdominal discomfort, upper abdominal pain, breath odour, diarrhoea, dry mouth, nausea, vomiting, rash, erythema, back pain, joint swelling, muscle spasm, muscle weakness, myalgia, pain in the extremities. increased serum creatinine, acute renal failure, erectile dysfunction, abasia, gait disturbance, asthenia, discomfort, malaise, non-cardiac chest pain, increased blood urea nitrogen (BUN), increased blood uric acid.

Rare: hyperhidrosis, exanthema, pruritus. 

Very rare: Acute respiratory distress syndrome, intestinal angioedema.

Additional information on the individual active substances 

The following adverse effects, which were not observed in the study with Exforge HCT, have occurred during treatment with the individual active substances:

Amlodipine

Common and uncommon adverse reactions: Headache, somnolence, dizziness, palpitations, flushing, abdominal pain, nausea, edema, fatigue, insomnia, mood changes including anxiety, tremor, hypoaesthesia, dysgeusia, paresthesia, syncope, visual impairment, diplopia, tinnitus, hypotension, dyspnea, rhinitis, vomiting, dyspepsia, dry mouth, constipation, diarrhoea, alopecia, hyperhidrosis, pruritus, rash, purpura, skin discoloration,  back pain, muscle spasm, myalgia, arthralgia, micturion disorders, nocturia, gynecomastia, erectile dysfunction, asthenia, pain, malaise, chest pain, weight decreased, weight increased, depression, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), cough, exanthema, ankle swelling, increased micturition frequency, urticaria. 

Very rare adverse reactions: hyperglycaemia,gastritis, gingival hyperplasia, jaundice,. 

Very rare adverse reactions but potentially serious: thrombocytopenia, leucocytopenia, allergic reactions, peripheral neuropathy,myocardial infarction, vasculitis, pancreatic, hepatitis, angioedema, erythema multiforme, Stevens-Johnson-Syndrome, Hepatic enzyme increased including increased serum bilirubin (mostly consistent with cholestasis), intrahepatic cholestasis, hypertension, exfoliative dermatitis, photosensitivity. 

Rare: confusion.

.

Valsartan

Common: viral infections, postural dizziness.

Uncommon adverse reactions: upper respiratory tract infection, pharyngitis, sinusitis, neutropenia, decreased libido, hyperkalaemia, heart failure. 

Rare: light-headedness

Very rare: rhinitis, thrombocytopenia, decreased haemoglobin and haematocrit, hypersensitivity, arrhythmias, vasculitis, abnormal liver function values, including increased blood bilirubin, angioedema, rash, exanthema, arthralgia, renal dysfunction, acute renal failure, renal impairment, increased blood creatinine, fetal complications.

Frequency not known: dermatitis bullous.

Hydrochlorothiazide

Very common and common adverse reactions: hypokalaemia and blood lipids increased, hypomagnesemia, hyponatremia, urticaria and other forms of rash, decreased appetite, mild nausea and vomiting, orthostatic hypotension , erectile dysfunction. 

Rare: thrombocytopenia, sometimes with purpura, hypercalcaemia, hyperglycaemia, glycosuria, worsening of diabetic metabolic state, sleep disorders, headache, dizziness and depression, visual impairment, particularly in the first few weeks of treatment, arrhythmias, abdominal discomfort, constipation and diarrhoea, cholestasis or icterus, photosensitivity reactions. 

Very rare: Leukopenia, agranulocytosis, bone marrow failure, haemolytic anaemia. necrotising vasculitis, hypersensitivity reactions, hypochloraemic alkalosis, respiratory symptoms, including pneumonitis and pulmonary oedema, pancreatitis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus and toxic epidermal necrolysis

Frequency not known: non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), choroidal effusion, acute renal failure, renal impairment, aplastic anaemia, erythema multiforme, pyrexia, muscle spasms, asthenia, acute myopia and acute angle-closure glaucoma

Packs and prices: Country specific.

Legal classification: Country specific.

NSS Version no.: 4.0.1

Leaflet Revision Date: May 2025

Leaflet Presentation Type: R02