Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Amlodipine Oral Solution contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine Oral Solution is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal's or variant angina. In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine Oral Solution works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina. You must talk to a doctor if you do not feel better or if you feel worse.
listed in section 6, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing. If you have severe low blood pressure (hypotension). If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition
where your heart is unable to supply enough blood to the body). If you suffer from heart failure after a heart attack. Warnings and precautions Talk to your doctor or pharmacist before taking Amlodipine Oral Solution
Package Leaflet: Information for the User
Amlodipine 1 mg/ml Oral Solution
You should inform your doctor if you have or have had any of the following conditions: Recent heart attack Heart failure Severe increase in blood pressure (Hypertensive crisis) Liver disease You are elderly and your dose needs to be increased Children and adolescents Amlodipine Oral Solution has not been studied in children under the age of 6 years. Amlodipine Oral Solution should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3). For more information, talk to your doctor. Other medicines and Amlodipine oral solution Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Amlodipine Oral Solution may affect or be affected by other medicines, such as: ketoconazole, itraconazole (anti-fungal medicines) ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV) rifampicin, erythromycin, clarithromycin (antibiotics) hypericum perforatum (St. John's Wort) verapamil, diltiazem (heart medicines) dantrolene (infusion for severe body temperature abnormalities) tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the way your immune
system works) simvastatin (cholesterol lowering medicine) cyclosporine (an immunosuppressant) Amlodipine Oral Solution may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Amlodipine Oral Solution with food, drink and alcohol Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine Oral Solution. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine Oral Solution. Pregnancy and breast-feeding Pregnancy The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant or are planning to get pregnant, you must tell your doctor before you take Amlodipine Oral Solution. Breast-feeding Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding you must tell your doctor before taking Amlodipine Oral Solution. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Amlodipine Oral Solution may affect your ability to drive or use machines. If Amlodipine Oral Solution makes you feel sick, dizzy or tired or gives you a headache, do not drive or use machines and contact your doctor immediately. Amlodipine Oral Solution contains liquid maltitol (E965), glycerol (E422) and ethanol absolute Amlodipine contains liquid maltitol (a type of sugar). If your doctor has told you that you cannot
tolerate some sugars, talk to your doctor before taking this medicine.
3.16% w/v. The amount in ml of this medicine is equivalent to less than 0.8 ml beer or 0.32 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
Amlodipine contains glycerol. This may cause headaches, stomach upset and diarrhoea. This medicine contains 31.6 mg of alcohol (ethanol) in each ml of Oral Solution which is equivalent to
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic screw cap. • Empty the contents of the syringe into your mouth • After dosing, wash the syringe with water only (figure 7).
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
If you take more Amlodipine Oral Solution than you should Taking too much dose may cause your blood pressure to become low or even dangerously low. You may feel dizzy, light-headed, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too much dose. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake. If you forget to take Amlodipine Oral Solution
Do not worry. If you forget to take a dose, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose. If you stop taking Amlodipine oral solution Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Visit your doctor immediately if you experience any of the following side effects after taking this medicine.
• Headache, dizziness, sleepiness (especially at the beginning of treatment) • Palpitations (awareness of your heartbeat), flushing • Abdominal pain, feeling sick (nausea) • Altered bowel habits, diarrhoea, constipation, indigestion • Tiredness, weakness • Visual disturbances, double vision • Muscle cramps • Ankle swelling Other side effects that have been reported include the following list. If any of these get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Uncommon: may affect up to 1 in 100 people
• Mood changes, anxiety, depression, sleeplessness • Trembling, taste abnormalities, fainting • Numbness or tingling sensation in your limbs, loss of pain sensation • Ringing in the ears • Low blood pressure • Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis) • Cough
• Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing • Swelling of eyelids, face or lips • Swelling of the tongue and throat which causes great difficulty in breathing • Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions • Heart attack, abnormal heart beat • Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell The following very common side effects have been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor. Very common: may affect more than 1 in 10 people
• Oedema (fluid retention) The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor. Common: may affect up to 1 in 10 people
• Confusion Very rare: may affect up to 1 in 10,000 people
• Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding • Excess sugar in blood (hyperglycaemia) • A disorder of the nerves which can cause muscular weakness, tingling or numbness • Swelling of the gums • Abdominal bloating (gastritis) • Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests • Increased muscle tension • Inflammation of blood vessels, often with skin rash • Sensitivity to light • Disorders combining rigidity, tremor, and/or movement • Disorders Not known: frequency cannot be estimated from the available data
• Dry mouth, vomiting (being sick) • Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration • Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine • Inability to obtain an erection, discomfort or enlargement of the breasts in men • Pain, feeling unwell • Joint or muscle pain, back pain • Weight increase or decrease Rare: may affect up to 1 in 1,000 people
• Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
The other ingredients are glycerol (E422), liquid maltitol (E965), Butylated hydroxyanisole (E320), ethanol absolute, and frozen peppermint flavour (containing menthofuran, pulegone and estragole). What Amlodipine Oral Solution looks like and contents of the pack Amlodipine Oral Solution is a clear pale straw colored, viscous liquid. Amlodipine 1mg/ml Oral Solution is packaged in amber colored glass bottle with white child resistant and tamper evident closure containing 150 ml of liquid product. The package contains 5 ml oral syringe with graduation marking at every 0.5 ml and printed at 1.0, 2.0, 3.0, 4.0 and 5.0 ml markings together with an adaptor. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Zydus Pharmaceuticals UK Ltd Sandretto Building Cavalry Hill Industrial Park Weedon Northampton NN7 4PP, UK Manufacturer LM Manufacturing Limited, Sandretto Building, Cavalry Hill Industrial Park, Weedon, Northampton, NN7 4PP, United Kingdom Amlodipine 1 mg/ml Oral Solution; PL 58839/0173 This leaflet was last revised in April 2026 To request a copy of this leaflet in Braille, large print or audio format then please contact the marketing authorisation holder at the address (or email) above.
Amlodipine 1 mg/ml Oral solution comes as solution containing 1 mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Amlodipine 1 mg/ml Oral solution is amlodipine besilate.
Medicines with the same active substance include: Amlodipine 1 mg/ml Oral Suspension (PL 00427/0277), Amlodipine 10 mg Tablets, Amlodipine 10mg tablets, Amlodipine 10mg tablet, Amlodipine 10mg tablets, Amlodipine 1mg/ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Amlodipine 1 mg/ml Oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal's) angina
Posology
Adults
For both hypertension and angina the usual initial dose is 5 mg Amlodipine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, Amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of Amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.
Special populations
Elderly patients
Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly but increase of the dosage should take place with care (see sections 4.4 and 5.2).
Patients with hepatic impairment
Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.
Patients with renal impairment
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Paediatric population
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 (see sections 5.1 and 5.2).
Children under 6 years old
No data are available.
Method of administration
This solution is for oral use only.
A 5 ml oral syringe with graduations of 0.5 ml equivalent to 0.5 mg of amlodipine with an adaptor are provided with the product.
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
Effects of other medicinal products on amlodipine
CYP3A4 inhibitors
Concomitant use of amlodipine 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
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored, and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
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 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 properties.
Tacrolimus
There is a risk of increased tacrolimus blood levels when co-administered 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.
Mechanistic Target of Rapamycin (mTOR) Inhibitors
mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates. Amlodipine is a weak CYP3A inhibitor. With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.
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
Co-administration 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.
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 lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.
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 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 amlodipine on infants is unknown. A decision on whether to continue/discontinue 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 amlodipine on fertility. In one rat study, adverse effects were found on male fertility (see section 5.3).
Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. Caution is recommended especially at the start of treatment.
In humans experience with intentional overdose is limited.
Symptoms
Available data suggest that gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
Treatment
Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Ask anything about Amlodipine 1 mg/ml Oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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