Amlodipine 1 mg/ml Oral solution
- Revised
- 13/04/2026
- Source updated
- 20 Jul 2026
- MA number
- PL 58839/0173
- ATC
- C08CA01
- Legal status
- Prescription only medicine
Indications
Concepts (25)
+Heart conditionsContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+Obstructed blood flow from the heartContraindicated
patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+Allergy to the medicineContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+Low blood pressureContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+BlockageContraindicated
patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+ShockContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • 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
Source SmPC ↗+UnclassifiedContraindicated
Amlodipine is contraindicated in patients with: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1. • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of
Source SmPC ↗+Taken with other medicinesWarning
The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). 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. Aml
Source SmPC ↗+Older peopleWarning
sing 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. Elderly patients In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2). Patients with renal impairment Amlodipine may be used in such patients at normal doses. Changes in
Source SmPC ↗+Intolerance to an ingredientWarning
d in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. Ingredients in the formulation • The product contains liquid maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Source SmPC ↗+Liver conditionsWarning
. 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. Amlodipine should therefore be initiat
Source SmPC ↗+Sugar alcoholsWarning
d in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. Ingredients in the formulation • The product contains liquid maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Source SmPC ↗+Kidney conditionsWarning
and careful monitoring may be required in patients with severe hepatic impairment. Elderly patients In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2). Patients with renal impairment Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. Ingredients
Source SmPC ↗+Breathing conditionsWarning
The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). 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. Aml
Source SmPC ↗+AlcoholInteraction
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. A dose of 5 mg of Amlodipine oral solution administered to (a child 7 years of age and weighing approximately 23 kg or a dose of 10 mg of Amlodipine oral solution administered to an adult weighing 70 kg) would result in exposure to 4.51 mg/kg (adults an adult weighing 70 kg) and 6.87 mg (a child 7 years of age and weighing) of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.7 mg/100 ml (adults an adult weighing 70 kg) or .009 mg/100 ml (a child 7 years of age and weighing). For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may
Source SmPC ↗+Salt and mineral balanceInteraction
mlodipine 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 co-administration 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 blood pressure- lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+Heart rhythm blockInteraction
mlodipine 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 co-administration 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 blood pressure- lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+CancerInteraction
mlodipine 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 co-administration 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 blood pressure- lowering effects of other medicinal products with antihypertensive
Source SmPC ↗+ChildrenInteraction
n adult weighing 70 kg) or .009 mg/100 ml (a child 7 years of age and weighing). For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.
Source SmPC ↗+Propylene glycolInteraction
n adult weighing 70 kg) or .009 mg/100 ml (a child 7 years of age and weighing). For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.
Source SmPC ↗+BreastfeedingPregnancy
ty was observed at high doses (see section 5.3). Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus. Breast-feeding Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3–7%, with a maximum of 15%. The effect of amlodip
Source SmPC ↗+FertilityPregnancy
breast-feeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breast-feeding to the child and the benefit of amlodipine therapy to the mother. Fertility Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of a
Source SmPC ↗+PregnancyPregnancy
Pregnancy The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Use in pregnancy is only recommended w
Source SmPC ↗+Stomach and gutNot in scanned sections
+Sodium and potassium contentNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
36 months
After first opening: 60 days
§6.4 — Special precautions for storage
No special storage condition required, Store in a tightly closed container protected from light. Do not store above 25oC after opening of the bottle.