Exforge UAE

Regulatory Affairs

EXFORGE^® (amlodipine/valsartan)

5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg Film-coated tablets

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Version 4.0.1

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Exforge^® Film-coated tablets

Important note: Before prescribing, consult full prescribing information: https://www.swissmedicinfo.ch/.

Presentation: Exforge: Amlodipine (as amlodipine besylate) and valsartan 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg film-coated tablets.

Indications:

Treatment of essential hypertension.

Exforge is indicated in patients whose blood pressure is not adequately controlled by monotherapy with valsartan or amlodipine.

Exforge is indicated for the initial treatment of hypertension. The choice of Exforge as initial therapy for hypertension should be based on an assessment of the potential benefits and risks.

Dosage and administration:

Patients whose blood pressure is not adequately controlled by monotherapy may be switched to combination therapy with Exforge.

The recommended dose is one 5 mg/80 mg, 5 mg/160 mg or 10 mg/160 mg amlodipine/valsartan film-coated tablet per day up to a maximum of two 5 mg/160 mg amlodipine/valsartan film-coated tablets per day.

When clinically indicated, a direct switch from monotherapy to the combination therapy may be considered.

Patients receiving valsartan and amlodipine separately may be switched to the corresponding dose of Exforge.

For initial therapy, the usual starting dose of Exforge is 5/80 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of two 5 mg/160 mg Exforge tablets per day if this is needed to control blood pressure. Treatment with two 5 mg/160 mg Exforge film-coated tablets per day is restricted to patients not showing adequate blood pressure reduction on the lower-dose combinations. Exforge is not recommended as initial therapy in patients with intravascular volume depletion (see “Warnings and precautions”).

The maximum dose is 10/320 mg per day.

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

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

Special dosage instructions

Patients with hepatic impairment

Due to the active substances amlodipine and valsartan caution is required when administering Exforge to patients with hepatic impairment or biliary obstructive disorders. Consideration should be given to starting treatment with the lowest available dose of amlodipine. The lowest strength of Exforge contains 5 mg amlodipine (see “Warnings and precautions”, “Properties/Effects” and “Pharmacokinetics”).

Patients with renal impairment

No dose adjustment is required in patients with mild or moderate renal impairment. Caution is required if severe renal impairment occurs (see “Contraindications”). 

Elderly patients (65 years of age and over)

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

Children and adolescents (under 18 years of age)

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

Contraindications:¨Hypersensitivity to any component of Exforge. ¨Pregnancy, lactation. ¨Concomitant use with aliskiren in diabetic type II patients. ¨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: ¨Risk of hypotension in sodium- and/or volume-depleted patients. ¨Severe renal impairment (creatinine cleareance < 10 mL/min) and dialysis. ¨No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation.¨Caution in patients with hepatic impairment or biliary obstructive disorders. ¨Caution in patients experiencing angioedema with Exforge or having history of angioedema with other drugs. Discontinue Exforge immediately and do not re-administer ¨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. ¨ Not recommended in patients below 18 years of age. ¨Avoid concomitant use with aliskiren in patients with severe renal impairment (GFR < 30 mL/min). ¨Caution is required while co-administering Exforge with other agents blocking the RAS such as ACEIs or aliskiren.

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. ¨Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels (heparin etc.,). Monitoring of serum potassium advised ¨Concomitant treatment with NSAIDs including Cox-2 Inhibitors may decrease antihypertensive effects. In elderly, volume depleted or compromised renal function, monitoring of renal function recommended when concomitant use. ¨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. ¨Concomitant treatment with lithium may increase lithium concentrations and toxicity. Close monitoring of serum lithium levels is recommended.

Adverse reactions: ¨The most common and uncommon adverse reactions are: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, pitting oedema, facial oedema, hot flush, fatigue, flushing, asthenia, dizziness, somnolence, dizziness postural, paraesthesia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhoea, nausea, abdominal pain, constipation, dry mouth, rash, erythema, joint swelling, back pain, arthralgia. ¨Rare adverse reactions are: visual disturbance, anxiety, tinnitus, syncope, hypotension, hyperhidrosis, exanthema, pruritus, muscle spasm, sensation of heaviness, pollakiuria, polyuria, erectile dysfunction ¨Rare adverse reactions but potentially serious are: Hypersensitivity. ¨Very rare: intestinal angioedema.

¨Additional potentially serious adverse experiences reported with amlodipine monotherapy are: ♦Very Rare: Thrombocytopenia, leukopenia, allergic reactions, Hyperglycaemia, peripheral neuropathy, hypertension, myocardial infarction, vasculitis, pancreatitis, hepatitis, angioedema, erythema multiforme, Stevens-Johnson-Syndrome, exfoliative dermatitis, photosensitivity, hepatic enzyme increased (mostly consistent with cholestasis), icterus, gastritis, gingival hyperplasia. ♦Uncommon: arrhythmia, bradycardia, atrial fibrillation, ventricular tachycardia, depression, insomnia, mood changes, tremor, dysgeusia, syncope, hypoesthesia, paraesthesia, hypotension, rhinitis, cough, vomiting, dry mouth, alopecia, purpura, skin discoloration, photosensitivity, hyperhidrosis, pruritus, rash, exanthema, urticaria, myalgia, arthralgia, back pain, micturition disorder, nocturia, increased micturition frequency, gynecomastia, impotence, pain, malaise, chest pain, weight decreased, weight increased ♦Common: somnolence, dizziness, headache, visual impairment (including diplopia), palpitations, skin redness with feeling of warmth, dyspnoea, abdominal pain, nausea, dyspepsia, change in bowel habits (including diarrhoea and constipation), ankle swelling, muscle spasms, Fatigue, asthenia. ♦Very common: Oedema. ♦Not known: toxic epidermal necrolysis.

¨Additional potentially serious adverse experiences reported with valsartan monotherapy are: ♦Very Rare: rhinitis, thrombocytopenia, decreased haemoglobin and haematocrit, hypersensitivity, arrhythmias, vasculitis, abnormal liver function values, including increased blood bilirubin, vomiting, angioedema, myalgia, renal dysfunction, acute renal failure, renal impairment, increased blood creatinine, fetal complications. ♦Rare: light-headedness. ♦Uncommon: upper respiratory tract infection, pharyngitis, sinusitis, neutropenia, hyperkalaemia, insomnia, reduced libido, heart failure. ♦Common: viral infections, postural dizziness, increased blood creatinine. ♦Not known: hypersensitivity, including serum sickness, bullous dermatitis, increased liver function values, including increased blood bilirubin.

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NSS Version no.: 4.0.1

Leaflet Revision Date: May 2025

Leaflet Presentation Type: R02