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 contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine 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 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.
• Severe increase in blood pressure (Hypertensive crisis) • Liver disease • You are elderly and your dose needs to be increased Children and adolescents Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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 Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Amlodipine 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 may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Amlodipine with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. 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. 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. Breast-feeding Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Amlodipine may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.
Amlodipine 10 mg once daily. This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipine with grapefruit juice. Use in children and adolescents For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. . It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor. If you take more Amlodipine than you should Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, 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 many Amlodipine tablets. 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 Do not worry. If you forget to take a tablet, 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 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. • 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 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 effect has 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 • Headache, dizziness, sleepiness (especially at the beginning of treatment) • Palpitations (awareness of your heart beat), 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 • 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 • 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 • 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate. What Amlodipine looks like and contents of the pack Tablet White to off white round shaped, biconvex tablets debossed with 'J' on one side and '21'on the other side. Diameter: 8.0 ± 0.2 mm (7.8 mm – 8.2 mm) Amlodipine tablets are available in Alu-PVC-PVdC blister packs containing 14 and 28 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Amarox Limited Congress House, 14 Lyon Road Harrow, Middlesex HA1 2EN United Kingdom Manufacturer Amarox Limited Congress House, 14 Lyon Road Harrow, Middlesex HA1 2EN United Kingdom or Pharmadox Healthcare Ltd KW20A Kordin Industrial Park Paola, PLA 3000 Malta This leaflet was last revised in 07/2022.
Amlodipine 10mg tablets comes as tablet containing 10mg. 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 10mg tablets is amlodipine besilate.
Medicines with the same active substance, strength and form include: ISTIN 10 mg tablets, Amlodipine 10 mg Tablets, Amlodipine 10mg tablets. In total there are 7 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Amlodipine 10mg tablets, 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
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).
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.
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
Tablet for oral administration
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.
The safety and efficacy of amlodipine in hypertensive crisis has not been established.
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.
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 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.
Elderly
In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2).
Use in renal failure
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.
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.
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin or warfarin.
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.
Summary of the safety profile
The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
Tabulated list of adverse reactions
The following adverse reactions have been observed and reported during treatment with amlodipine with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class
Frequency
Adverse reactions
Blood and lymphatic system disorders
Very rare
Leukocytopenia, thrombocytopenia
Immune system disorders
Very rare
Allergic reactions
Metabolism and nutrition disorders
Very rare
Hyperglycaemial
Psychiatric disorders
Uncommon
Depression, mood changes (including anxiety), Insomnia
Rare
Confusion
Nervous system disorders
Common
Somnolence, dizziness, headache (especially at the beginning of the treatment)
Uncommon
Tremor, dysgeusia, syncope, hypoesthesia, paraesthesia
Very rare
Hypertonia,
peripheral neuropathy
Eye disorders
Common
Visual disturbance (including diplopia)
Ear and labyrinth disorders
Uncommon
Tinnitus
Cardiac disorders
Common
Palpitations
Uncommon
Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)
Very rare
Myocardial infarction
Vascular disorders
Common
Flushing
Uncommon
Hypotension
Very rare
Vasculitis
Respiratory, thoracic and mediastinal disorders
Common
Dyspnoea
Uncommon
Cough, rhinitis
Gastrointestinal disorders
Common
Abdominal pain, nausea dyspepsia, altered bowel habits (including diarrhoea and constipation)
Uncommon
Vomiting, dry mouth
Very rare
Pancreatitis, gastritis, gingival hyperplasia
Hepatobiliary disorders
Very rare
Hepatitis, jaundice, hepatic enzymes increased*
Skin and subcutaneous tissue disorders
Uncommon
Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria
Very rare
Angioedema, erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, Quincke oedema, photosensitivity
Not known
Toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders
Common
Ankle swelling, muscle cramps
Uncommon
Arthralgia, myalgia, back pain
Renal and urinary disorders
Uncommon
Micturition disorder, nocturia, increased urinary frequency
Reproductive system and breast disorders
Uncommon
Impotence, gynecomastia
General disorders and administration site conditions
Very common
Oedema,
Common
Fatigue, asthenia
Uncommon
Chest pain, pain, malaise
Investigations
Uncommon
Weight increase, weight decreased
*mostly consistent with cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In humans experience with intentional overdose 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 10mg tablets. 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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