Each tablet of Amlotense® 5 contains: .

• Amlodipine  5 mg  (As Amlodipine besylate ).

Each tablet of Amlotense® 10 contains: 

• Amlodipine  10 mg  (As Amlodipine besylate ).

Amlotense® is indicated in the treatment of: 

• Hypertension.
• Prevention of angina :stable angina and spontaneous angina.(Prinzmetal's) angina.

Amlotense® is contraindicated in patients with:

• Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients.
• Severe hypotension.
• Shock (including cardiogenic shock).
• Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis).
• Haemodynamically unstable heart failure after acute myocardial infarction.
• Have unstable angina

¤ Effects of other medicinal products on amlodipine:
CYP3A4 inhibitors:

• Concomitant use of Amlotense® with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin,verapamil or diltiazem) may give rise to significant increase in amlodipine exposure resulting in an increased risk of hypotension. The clinical translation of these PK variations may be more pronounced in the elderly. Clinical monitoring and dose adjustment may thus be required.

CYP3A4 inducers:

• There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
• The concomitant use of CYP3A4 inducers (e.g., rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers. Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects

Dantrolene (infusion):

• In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene. Due to risk of hyperkalemia, it is recommended that the coadministration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.

¤ Effects of amlodipine on other medicinal products:
The blood pressure lowering effects of amlodipine adds to the bloo pressure-lowering effects of other medicinal products with antihypertensiveproperties.

Tacrolimus:

• There is a risk of increased tacrolimus blood levels when coadministered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.

Cyclosporine:

• No drug interaction studies have been conducted with cyclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% 40%) of cyclosporine were observed. Consideration should be given for monitoring cyclosporine levels in renal transplant patients on amlodipine, and cyclosporine dose reductions should be made as necessary.

Simvastatin:

• Coadministration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

¤ In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,digoxin or warfarin.

• No information available in pregnant women. Amlotense® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Amlotense® should not be used during lactation, no information available. 

Common:

• Somnolence, dizziness, headache (especially at the beginning of the treatment),visual disturbance (including diplopia), palpitations, flushing, dyspnoea, abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation), ankle swelling, muscle cramps, fatigue, asthenia.

Uncommon:

• Depression, mood changes (including anxiety), insomnia, tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia, tinnitus, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), hypotension, cough, rhinitis, vomiting, dry mouth, alopecia, purpura, skin discolouration, hyperhidrosis, rash, exanthema, urticaria, pruritus, arthralgia, myalgia, back pain, micturition disorder, nocturia, increased urinary frequency, impotence, gynaecomastia, chest pain, pain, malaise, weight increased, weight decreased.

¤ Effects on ability to drive and use machines:

• If patients taking amlodipine suffer from dizziness, fatigue.
• Caution is recommended especially at the start of treatment.

¤ For both hypertension and angina:

• the usual initial dose is 5 mg of Amlotense® once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response.

¤ Use in elderly patients:

• Amlotense® used at similar doses in elderly or younger patients is equally well tolerated.

¤ Use in patiens with renal impairment:

• Changes in Amlotense® plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlotense® is not dialysable.

¤ Use in children and adolescents with hypertension from 6 years to 17  years of age:

• The recommended antihypertensive oral dose in paediatric patients ages 6 - 17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks.
• Doses in excess of 5 mg daily have not been studied in paediatric patients.
• Amlotense® is not recommended for use in children less than 6 years of age.

¤ Patients with cardiac failure:

• Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.

¤ Patients with hepatic impairment:

• The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.Amlotense® should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.

• Amlotense® 5 tablets :Blister of 10 tablets, pack of two blisters.
• Amlotense® 10 tablets :Blister of 10 tablets, pack of two blisters.

• Store at temperature below 25ºC.