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PERINDOPRIL/AMLODIPINE is a brand name for Amlodipine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Perindopril/Amlodipine is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The fixed dose combination is not suitable for initial therapy. If the change of the dosage is needed, it should be carried out by individual titration of the free combination’s ingredients. 2) Elimination of perindoprilat is decreased in the elderly and in patients with renal failure.
Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium. Perindopril/Amlodipine can be administered in patients with Clcr ≥ 60 ml/min, and is not suitable for patients with Clcr < 60 ml/min.
In these patients, an individual dose titration with the monocomponents is recommended. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. 2 A dosage regimen for patients with hepatic impairment has not been established.
Therefore, Perindopril/Amlodipine should be administered with caution. 2). To find the optimal starting dose and maintenance dose of patients with hepatic impairment, the patients should be individually titrated using the free combination of amlodipine and perindopril.
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. Paediatric population Perindopril/Amlodipine should not be used in children and adolescents as the efficacy and tolerability of perindopril alone or in combination with amlodipine, have not been established in children and adolescents.
Method of administration Oral route. One tablet per day as a single dose, preferably to be taken in the morning and before a meal.
a. Summary of safety profile The most commonly reported adverse reactions with perindopril and amlodipine given separately are: oedema, somnolence, dizziness, headache (especially at the beginning of the treatment), dysgeusia, paraesthesia, visual impairment (including diplopia), tinnitus, vertigo, palpitations, flushing, hypotension (and effects related to hypotension), dyspnoea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrheoa, constipation, prurit, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.
b.
Tabulated list of adverse reactions:
The following undesirable effects have been observed during treatment with perindopril or amlodipine given separately and ranked under the MedDRA classification by body system and under the following frequency: - 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, undesirable effects are presented in order of decreasing seriousness.
4) Uncommon Uncommon Photosentivity reactions Very rare Uncommon* Pemphigoid - Uncommon* Psoriasis aggravation - Rare Stevens-Johnson Syndrome Very rare - Exfoliative dermatitis Very rare - Skin and subcutaneous tissue disorders Toxic epidermal necrolysis Not known - Joint swelling (ankle swelling) Common - Arthralgia Uncommon Uncommon* Myalgia Uncommon Uncommon* Muscle cramps Common Common Musculoskeletal and connective tissue disorders Back pain Uncommon - Micturition disorder, nocturia, pollakiuria Uncommon - Renal impairment - Uncommon Renal failure acute - Rare Renal and urinary disorders Anuria/Oliguria - Rare Erectile dysfunction Uncommon UncommonReproductive system and breast disorders Gynaecomastia Uncommon - Oedema Very common - Oedema peripheral - Uncommon* Fatigue Common - Chest pain Uncommon Uncommon* General disorders and administration site conditions Asthenia Common Common Pain Uncommon - Malaise Uncommon Uncommon* Pyrexia - Uncommon* Weight increase, weight decrease Uncommon - Blood urea increased - Uncommon* Blood creatinine increased - Uncommon* Blood bilirubin increase - Rare Hepatic enzyme increase - Rare Investigations Haemoglobin decreased and haematocrit decreased - Very rare Injury, poisoning and procedural complications Fall - Uncommon* * Frequency calculated from clinical trials for adverse events detected from spontaneous report Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
8). This may occur at any time during therapy. In such cases, Perindopril/Amlodipine should promptly be discontinued and appropriate monitoring should be initiated and continued until complete resolution of symptoms has occurred. In those instances where swelling was confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, emergency therapy should be administered promptly. This may include the administration of adrenaline and/or the maintenance of a patient airway.
The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred. 3). Intestinal angioedema has been reported rarely in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal.
The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema.
Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of perindopril. 5). g. g. g. 5). g. sirolimus, everolimus, temsirolimus) and vildagliptin in a patient already taking an ACE inhibitor. 8).
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis:
Rarely, patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Linked to perindopril - Hypersensitivity to perindopril or to any other ACE inhibitor. - History of angioedema associated with previous ACE inhibitor therapy. - Hereditary or idiopathic angioedema. 6). - Concomitant use with sacubitril/valsartan therapy.
5). 5). 4). g. high grade aortic stenosis), - Haemodynamically unstable heart failure after acute myocardial infarction. Linked to Perindopril/Amlodipine All contraindications related to each monocomponent, as listed above, should apply also to the fixed combination of Perindopril/Amlodipine.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. hymenoptera venom) have experienced anaphylactoid reactions. In the same patients, these reactions have been avoided when the ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia:
Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre- existing impaired renal function.
Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy. g. sore throat, fever).
Pregnancy:
ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
6). 3). Treatment with diuretics may be a contributory factor. Loss of renal function may occur with only minor changes in serum creatinine even in patients with unilateral renal artery stenosis. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Primary aldosteronism:
Patients with primary hyperaldosteronism generally will not respond to […]