Each film coated tablet of AMLOSAR® contains:

• Valsartan               160 mg
• Amlodipine             10 mg 

Each film coated tablet of AMLOSAR® contains:

• Valsartan                 160 mg
• Amlodipine                5 mg

• AMLOSAR® is indicated for Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy.
• AMLOSAR® is indicated for the initial treatment of hypertension. The choice of AMLOSAR® for initial treatment should be based on an assessment of the potential benefits and risks.

¤ AMLOSAR® must not be taken in:

• Known hypersensitivity to amlodopine, valsartan or to any of the excipients.
• Combination of AMLOSAR® with aliskiren in patients with diabetes mellitus ( type 1 and type 2) and patients with renal impairment (GFR < 60 ml/min ).
• Pregnancy and breastfeeding.

• Simvastatin: Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
• CYP3A4 Inhibitors: Coadministration with CYP3A4 inhibitors ((moderate e.g diltiazen) and((strong (e.g. ketoconazole, itraconazole, ritonavir )) in elderly patients increase systemic exposure to amlodipine and may require dose reduction.Caution should therefore be exercised when 
  co-administering amlodipine with CYP3A4 inhibitors.
• CYP3A4 inducers: No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Patients must be monitored to ensure the desired clinical effect when amlodipine is co-administered with CYP3A4 inducers (e.g. rifampicin, St. John’s Wort).
• Amlodipine may be concomitantly administered with thiazide diuretics, alpha blockers, beta blockers, ACE inhibitors, long-acting nitrates, sublingual glyceryl trinitrate (nitroglycerin),non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and oral anti-diabetics.
• Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine.
• Ciclosporin: may increase the systemic exposure of valsartan.
• Lithium: AMLOSAR® increases serum lithium concentrations and lithium toxicity.
• Potassium supplements: (e.g. potassium-sparing diuretics, potassium-containing preparations, heparin) may increase the risk of hyperkalaemia. In such cases, valsartan should be administered with caution and monitoring of potassium levels.
• Non-Steroidal Anti-Inflammatory Drug (NSAID):use of it with AMLOSAR® may lead to increase risk of renal impairment and loss of anti-hypertensive effect.
• Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with ACE inhibitor (ACEI), angiotensin Il receptor blocker (ARB) or aliskiren which  Increases risk of Hypotension, syncope, hyperkalaemia and renal impairment (including acute renal failure).
• Antibiotics (rifamycin group): may increase the effect of valsartan.
• Antiretrovirals (ritonavir): may increase the effect of valsartan.

• AMLOSAR® must not be used during pregnancy.
• It is not known whether valsartan and/or amlodipine are excreted in human milk. It is therefore not advisable for women who are breastfeeding to use AMLOSAR®.

¤ Amlosar can cause the following side effects:

• The most common are: Nasopharyngitis, influenza, headache, Oedema, pitting oedema, facial oedema, peripheral oedema, fatigue, flushing, asthenia, hot flushes.
• The uncommon adverse reactions are: dizziness, drowsness, postural dizziness, paraesthesia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, laryngeal pain, diarrhea, nausea, abdominal pain, constipation, rash, erythema, joint swelling, back pain, arthralgia.
• Rare adverse reactions are: Hypersensitivity, disturbed vision, anxiety, tinnitus, syncope, hypotension, hyperhidrosis, exanthema, pruritus, muscle spasm, sensation of heaviness, pollakiuria, polyuria, erectile dysfunction.

¤ Additional potentially serious rare adverse experiences reported with amlodipine monotherapy:

• Very rare: Thrombocytopenia, leucocytopenia, allergic reactions, Hyperglycemia, peripheral neuropathy, hypertonia, arrhythmia, bradycardia, atrial fibrillation, ventricular tachycardia, myocardial infarction, vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzyme increased (mostly consistent with cholestasis), angioedema, urticaria, erythema multiforme, Steven-Johnson-Syndrome, 
• Other uncommon adverse experiences reported with amlodipine monotherapy are: insomnia, mood changes, tremor, hypoesthesia, dysgeusia, diplopia, dyspnea, rhinitis, vomiting, dyspepsia, gastritis, alopecia, purpura, skin discoloration, photosensitivity, myalgia, micturition disorder,  nocturia, gynecomastia, pain, malaise, chest pain, weight decreased, weight increased.

¤ Additional potentially serious adverse effects experiences reported with valsartan monotherapy are:

• Common: viral infections, postural dizziness
• Uncommon: upper respiratory tract infection, pharyngitis, sinusitis, Neurtropenia, hyperkalaemia,blood potassium increased, insomnia, heart failure.
• Very Rare and rare: Rhinitis, thrombocytopenia, haemoglobin and heamatocrit decreased, hypersensitivity, arrhythmia, vasculitis, abnormal liver function tests including  increased blood bilirubin, vomiting, angiooedema, myalgia, altered renal function, acute renal failure and renal impairment, increased blood creatinine, fetal complication.

Overdose:

• There is no experience of overdosage with AMLOSAR®.
• The major symptom of overdosage with valsartan is possibly pronounced hypotension with dizziness.
• Overdosage with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and potentially prolonged systemic hypotension up to include shock with fatal outcome.

Management of overdosage:

• If the ingestion is recent, induction of vomiting or gastric lavage may be considered.
• Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
• Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
• Both valsartan and amlodipine are unlikely to be removed by haemodialysis.

• The recommended dose is one tablet per day of AMLOSAR® (10/ 160 mg).
• For initial therapy: the usual starting dose is AMLOSAR® (5 /80 mg ) once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of (10 /320 mg) per day as needed to control blood pressure. 
• AMLOSAR® is not recommended as initial therapy in patients with intravascular volume depletion.
• The maximum dose of AMLOSAR® is 10 /320mg per day.
• Special population Elderly (aged 65 years or above): Consideration should be given to Start treatment with the lowest available dose of amlodipine. The lowest strength of AMLOSAR® contains 5 mg of amlodipine.
• Children and adolescents under 18 years of ages: AMLOSAR® is not recommended for use due to a lack of data on safety and efficacy.
• Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment.
• Hepatic impairment: caution should be exercised when administering AMLOSAR® to patients with hepatic impairment or biliary obstructive disorders. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of AMLOSAR® contains 5 mg of amlodipine

¤ The following section describes when AMLOSAR® must be used with special caution:

• Risk of hypotension in patients with sodium and/or volume-depleted . If hypotension occurs with AMLOSAR®, the patient should be placed in the supine position and, if necessary, given an i.v. infusion of normal saline.
• Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be
  undertaken with caution and with frequent monitoring of potassium levels.
• AMLOSAR® should be used with caution in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney (or after recent  kidney transplantation).
• AMLOSAR® should be used with caution in severe renal impairment (creatinine clearance < 10 mL/min).
• Particular caution should be exercised when administering AMLOSAR® to patients with hepatic impairment or biliary obstructive disorders .
• AMLOSAR® should be immediately discontinued in patients who develop angioedema and AMLOSAR® should not be re-administered for them. 
• AMLOSAR® should be used with particular caution in patients with severe heart failure/post-myocardial infarction, Because has been associated with oliguria and/or progressive azotaemia, and in rare cases with acute renal failure and/or death. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
• Risk of myocardial infarction or exacerbation of angina pectoris in patients with severe obstructive coronary artery disease after starting or increasing the dose of amlodipine.
• AMLOSAR® should be used with particular caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy As with all vasodilators.

• AMLOSAR® 10 / 160: Blister of 10 tablets, pack of 2 blisters.
• AMLOSAR® 5 / 160: Blister of 10 tablets, pack of 2 blisters.

• Store in a dry place at a temperature not exceeding 25 ºC.