|The name of the preparation
||Character; dose; package
||Price after refund
||In which pharmacy?
12.5 mg + 2.5 mg (1 tablet contains: 2.5 mg ramipril, 12.5 mg hydrochlorothiazide);
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The drug is available on prescription
What is Ampril HL?
A medicine that reduces blood pressure. Combined preparation containing angiotensin converting enzyme inhibitor (ramipril) and moderate diuretic substance (hydrochlorothiazide).
What does Ampril HL contain and how does it work?
It is a combined preparation containing 2 active substances, ramipril and hydrochlorothiazide. Ramipril is an angiotensin-converting enzyme inhibitor. The common mechanism of action of drugs in this group consists in inhibiting the activity of the enzyme responsible for the formation of angiotensin II (this enzyme is an angiotensin convertase, often abbreviated as ACE, which is derived from the English nameAngiotensin Converting Enzyme
). Inhibition of this enzyme results in limiting the conversion (conversion) of inactive angiotensin I to active angiotensin II. Angiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The effect of drugs from the angiotensin-converting enzyme group leads to a decrease in the angiotensin II concentration, and thus to a decrease in blood pressure. In addition, ACE inhibitors exacerbate the effects of bradykinin (a substance that relaxes on blood vessels), exert a protective effect on vessels and have antiatherosclerotic activity. They are used as blood pressure lowering drugs and in the treatment and prophylaxis of cardiovascular diseases as well as in the treatment of kidney diseases (diabetic nephropathy and non-diabetic nephropathy). The other active substance is hydrochlorothiazide, a sulfonamide diuretic based thiazide diuretic. The effect of diuretics is to increase the volume of urine output. Hydrochlorothiazide inhibits the reversal of sodium ion transport in the kidney tubules, resulting in increased sodium excretion in the urine and increased volume of excreted water. Increased sodium excretion is accompanied by increased excretion of potassium, Magnesium
and chlorine, while Calcium
excretion decreases. The loss of potassium in the urine is less pronounced in the presence of lisinopril
. Hydrochlorothiazide also leads to vasodilatation and reduced vascular resistance.
The antihypertensive effect of the combined preparation is stronger than that of each of the active substances used independently (monotherapy).
When should I use Ampril HL?
It is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with either ramipril or hydrochlorothiazide monotherapy.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used.You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients of the preparation or to other ACE inhibitors, to thiazide diuretics or to other sulfonamides. You can not use the preparation if:
· You have ever had angioneurotic edema
or there is congenital (hereditary) angioneurotic edema
· Procedures of extracorporeal circulation (hemodialysis, hemofiltration, apheresis of low-density lipoproteins) are used, during which blood is exposed to electrically negatively charged surfaces (this may lead to severe anaphylactoid reactions)
· There is a significant bilateral renal artery stenosis or one-sided in the case of the only active kidney
· Severe renal impairment (creatinine clearance less than 30 ml / min)
· There are clinically significant electrolyte disturbances
· You have severe liver problems
· Hepatic encephalopathy.
Do not use in parallel with aliskiren in patients with diabetes mellitus or with renal impairment (creatinine clearance less than 60 ml / min).
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. The preparation should not be used during the first trimester of pregnancy.
Take special care with Ampril HL?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Special care should be taken because the preparation may cause a sudden and significant reduction in blood pressure, especially after the first dose. The increased risk of hypotension after the use of the preparation and the deterioration of renal function concerns in particular people with increased activation of the renin-angiotensin-aldosterone system (the so-called RAA system), which can be suspected in the case of:
· Severe hypertension
· Congestive heart failure
· Haemodynamically significant impairment of the inflow or outflow of blood from the left ventricle (eg aortic or mitral valve stenosis)
· Unilateral narrowing of the renal artery and the second active kidney
· People who are dehydrated or who are deficient in electrolytes (such as taking diuretics, using a low-salt diet, undergoing dialysis, diarrhea or vomiting who do not drink enough)
· People with liver cirrhosis and / or ascites
· People undergoing treatments or anesthetized.
In the above cases, treatment can only be started under close medical supervision. Because of the increased risk of hypotension, special medical supervision and monitoring of blood pressure is required, especially in the initial phase of treatment and during dose escalation. Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured.
Similar caution is required in people with an increased risk of myocardial or cerebral ischaemia in severe hypotension (eg, patients with ischemic heart disease or cerebrovascular narrowing, in whom hypotension could cause a heart attack, stroke).
Combination of various drugs acting on the renin-angiotensin-aldosterone system is not recommended. Therefore, the parallel use of the angiotensin receptor or aliskiren receptor formulation and antagonists is not recommended due to the increased risk of adverse reactions, including hypotension, renal dysfunction, hyperkalemia, syncope and stroke.
Inform the doctor about the use of the preparation if you are planning an operation or other procedure requiring anesthesia. Use of the preparation in parallel with medicines used for anesthesia may lead to significant hypotension. If necessary, the doctor may recommend discontinuation of the preparation the day before the planned treatment.
The preparation is not recommended in patients with primary hyperaldosteronism. However, if the doctor considers the use of the preparation to be necessary, then the potassium level should be monitored.
Patients with hepatic impairment should be cautious. The use of thiazide diuretics may favor disturbances of water and electrolyte balance, which may lead to encephalopathy and hepatic coma.Patients in this group should remain under special medical supervision and regularly carry out the prescribed examinations.
Before and during the treatment, your doctor will advise you to check your kidneys regularly. Particularly careful controls are required for people with impaired renal function. Depending on kidney function, the doctor will adjust the dosage of the preparation. The use of ACE inhibitors may cause renal dysfunction in some people. The risk of renal dysfunction is particularly high in patients with congestive heart failure, pre-existing kidney disease or kidney transplantation.
In patients with impaired renal function, care should be taken because the effect of the preparation may be exacerbated. Thiazide diuretics used in people with kidney disease can cause uremia (a complex set of severe multi-organ disorders). After applying the preparation, the concentration of urea and creatinine in the blood may increase. If you have progressive kidney problems, your doctor will consider discontinuing the combination.
Due to the content of thiazide diuretic, the preparation may affect the water-electrolyte balance and cause sodium deficiency (hyponatraemia), potassium (hypokalaemia), magnesium and chlorine. During the period of application, the doctor will recommend regular monitoring of the concentration of these ions.
Ramipril contained in the preparation prevents hypokalemia caused by a thiazide diuretic. The risk of hypokalemia is higher in patients with liver cirrhosis, with increased diuresis, receiving insufficient amounts of electrolytes, and in patients receiving corticosteroid
s or ACTH. Your doctor will recommend regular monitoring of potassium in the blood (the first measurement should be done in the first week of treatment). Disorders of potassium in the blood (both hypokalemia and hyperkalemia) can cause serious arrhythmias. Hypokalemia intensifies the toxic effects of digitalis used in parallel.
Ramipril may cause hyperkalaemia (increased potassium in the blood), especially in people at increased risk of hyperkalemia (people with kidney failure, over 70 years of age, people with diabetes who take medicines that increase the amount of potassium in the blood, including potassium salts or potassium-depleted diuretics, dehydrated persons, people with heart failure or metabolic acidosis). Avoid using medicines that may increase the level of potassium in the blood, such as, for example, potassium supplements, potassium chloride replacers, potassium sparing diuretics or Heparin
. If your doctor considers these medicines to be necessary, he will advise you to exercise caution and monitor your blood potassium levels.
The use of the preparation may cause the syndrome of abnormal secretion of antidiuretic hormone and subsequent hyponatraemia. Elderly people or those particularly at risk for hyponatraemia may recommend monitoring blood sodium levels.
The product reduces the excretion of calcium in the urine and may cause a slight increase in blood calcium (hypercalcemia). Significant hypercalcemia may be the result of unrecognized hyperparathyroidism. In the case of significant hypercalcemia, tests to assess parathyroid function should be performed. Before performing parathyroid function tests, the preparation should be discontinued (only after consultation with a doctor and on his recommendation).
The preparation may cause angioneurotic edema (swelling of the face, lips, tongue, throat, larynx that may impede breathing and may be life-threatening). Angioedema may occur at any time during treatment. In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. Hospitalization is necessary, observation of the patient for at least 12-24 hours and sometimes appropriate treatment. After the occurrence of angioneurotic edema, the preparation or other ACE inhibitors may not be used again. The risk of angioneurotic edema is increased in people who have had angioedema in the past and in black people. Angioneurotic edema can also affect the intestines (symptoms are abdominal pain with or without nausea and vomiting), which should be taken into account in case of abdominal pain.
The use of ACE inhibitors is associated with an increased risk of Anaphylactic reactions
to insect venom and other allergens, also during desensitization (if desensitization is planned, a doctor should be consulted who, if possible, will recommend temporary discontinuation of the preparation).
Procedures for extracorporeal circulation (hemodialysis, hemofiltration, apheresis of low density LDL lipoproteins), during which blood is exposed to electrically negatively charged surfaces may cause severe anaphylactoid reactions, manifested by facial edema, hypotension, dyspnea, sudden feeling of heat, sometimes a direct threat to life. Before this type of surgery it is necessary to consult a doctor who will recommend other antihypertensive agents or other types of dialysis membranes.
Drugs from the angiotensin-converting enzyme inhibitors may cause haematological disorders (decreased neutrophil count [neutropenia / agranulocytosis], decreased white blood cell count, thrombocytopenia, anemia). Your doctor will advise you to regularly check your blood counts, especially at the beginning of treatment, and if you have kidney problems, people with connective tissue disease (such as lupus erythematosus or scleroderma), or other medicines that may cause changes in blood counts (allopurinol, immunosuppressants) , corticosteroids, procainamide, cytostatics). In the event of any symptoms of infection (eg fever, enlargement of the lymph nodes, sore throat) it is necessary to consult a doctor and make sure that the body's immunity has not been reduced.
Hydrochlorothiazide, like other sulfonamides, may cause hypersensitivity reactions including sudden deterioration of visual acuity, eye pain, transient myopia, and angle-closure glaucoma. These symptoms may occur within a few hours or a few weeks after starting the preparation. Increased risk occurs in people who are allergic to sulphonamides or penicillin.
In black people, the preparation may be less effective in lowering blood pressure.
Your doctor will advise you to carefully monitor your blood Glucose
, especially during the initial period of use. There is a risk of disturbed blood glucose control, hypo- and hyperglycemia may occur. The preparation may affect the effectiveness of oral antidiabetic agents and insulin
and may need to be adjusted by the doctor. Hydrochlorothiazide reduces glucose tolerance. During the period of application, latent diabetes may appear.
Hydrochlorothiazide may cause an increase in blood lipids (cholesterol and triglycerides).
Thiazide diuretics may cause raised levels of uric acid in the blood (hyperuricaemia) and in rare cases cause gout attacks.
ACE inhibitors can also cause persistent cough (due to the severity of bradykinin), without coughing, which disappears after discontinuation of the preparation.
Hydrochlorothiazide may induce lupus erythematosus or exacerbate its symptoms.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose, should not use this preparation
· The preparation may give rise to positive anti-doping tests.
Does this preparation affect the ability to drive vehicles?
The preparation may occasionally cause dizziness, fatigue, drowsiness or other symptoms that may impair psychophysical fitness and the ability to drive vehicles and operate machinery and equipment. This effect occurs particularly at the beginning of treatment, during dose or preparation changes and when alcohol is consumed in parallel. It is not recommended to drive or operate machines / machines after the first dose and also after increasing the dose.
Dosage of Ampril HL
The preparation is in the form of tablets for oral use. The preparation should be taken once a day, at the same time every day, preferably in the morning. Can be taken with or without food. The tablet should be swallowed with water. Do not chew or crush tablets.Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
The doctor will individually adjust the dosage. Normally, before prescribing a combined preparation, your doctor will gradually adjust your individual active ingredients (ie ramipril and hydrochlorothiazide) to achieve the desired blood pressure control. Treatment should be started with the lowest available dose. The maximum daily dose is 10 mg ramipril and 25 mg hydrochlorothiazide.
Parallel use of a diuretic increases the risk of hypotension after starting treatment. Whenever possible, your doctor will advise you to reduce your dose or stop taking your diuretic before taking a combination.
In people with mild or moderate kidney problems, care should be taken. The doctor will individually adjust the dosage. The maximum daily dose in this group of patients is 5 mg ramipril and 25 mg hydrochlorothiazide. In patients with severe renal impairment (creatinine clearance less than 30 ml / min), the use of the preparation is contraindicated.
In patients with mild or moderate hepatic impairment, caution should be exercised and treatment can only be started under close medical supervision. The doctor will adjust the dosage. The daily maximum dose in this group of patients is 2.5 mg ramipril and 12.5 mg hydrochlorothiazide. In patients with severe hepatic impairment, the use of the preparation is contraindicated.
Elderly patients will prescribe lower starting doses due to the increased risk of side effects.
Do not use the preparation in children and adolescents up to 18 years of age, due to the lack of data on the safety and efficacy of the preparation in this age group.
Can Ampril HL be used during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Angiotensin converting enzyme and hydrochlorothiazide may have adverse effects on pregnancy, fetus and newborn development. The use of the preparation in the second and third trimester of pregnancy is contraindicated. The preparation should not be used during the first trimester of pregnancy.
The preparation should not be initiated during pregnancy. If a woman plans to become pregnant she should consult a doctor because it is recommended to change the way of antihypertensive treatment. If you suspect or confirm pregnancy during the period of taking the preparation, you should consult a doctor as soon as possible because immediate discontinuation of the preparation is required. Your doctor may prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Contraindications for extracorporeal circulation (hemodialysis, hemofiltration, apheresis of low-density lipoprotein LDL) are contraindicated, during which blood is exposed to electrically negatively charged surfaces may cause severe anaphylactoid reactions, which are sometimes directly life-threatening. Before this type of surgery it is necessary to consult a doctor who may recommend other antihypertensive agents or other types of dialysis membranes.
Combination of various drugs acting on the renin-angiotensin-aldosterone system is not recommended. Therefore, the parallel use of the angiotensin receptor or aliskiren receptor formulation and antagonists is not recommended due to the increased risk of adverse reactions, including hypotension, renal dysfunction, hyperkalemia, syncope and stroke. If your doctor recommends such combination treatment, your blood pressure, kidney function and electrolyte levels should be monitored.
The use of the parallel formulation with aliskiren in patients with diabetes mellitus or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
Parallel administration with potassium supplements (potassium salts, some diuretics and antihypertensive agents, eg spironolactone, triamterene, amiloride, eplerenone, potassium supplements, trimethoprim, tacrolimus, cyclosporine, heparin) and potassium substitutes of table salt is not recommended. This may lead to hyperkalemia (increased potassium in the blood). If it is necessary to use the above preparations the doctor will recommend regular monitoring of potassium in the blood.
The preparation may increase the effect of other antihypertensive agents, vasodilators or other medicines that may lower blood pressure (eg some antidepressants, antipsychotics, hypnotics, sedatives, barbiturates, opioids, nitrates, baclofen, alfuzosin, Doxazosin
, prazosin, Tamsulosin
, terazosin). Intensification of hypotension and hypotension may occur.
Drugs that increase blood pressure (eg, sympathomimetics, Dopamine
, epinephrine) can reduce the antihypertensive effect of the preparation. Blood pressure should be monitored regularly.
Drugs that can affect blood counts (allopurinol, immunosuppressive drugs, corticosteroids, procainamide, cytostatics) increase the risk of hematological disorders.
The preparation may increase the concentration of lithium and exacerbate its toxic effects. It is not recommended to use lithium concurrently, and if necessary such combination therapy should be used with caution and often control the concentration of lithium in the blood.
The preparation may affect the effectiveness of oral antidiabetic agents and insulin and may need to be adjusted by the doctor. Blood glucose should be closely monitored.
Non-steroidal anti-inflammatory drugs (e.g. Acetylsalicylic acid
, indometacin, selective COX-2 inhibitors) may reduce the antihypertensive effect of the preparation and may cause renal dysfunction and increase in potassium in the blood. Adequate hydration and regular renal function should be ensured. Caution should be exercised, especially in elderly patients.
The effect of anticoagulants may be reduced when co-administered with hydrochlorothiazide.
Parallel use of the preparation with drugs that cause potassium loss (eg corticosteroids, tetracosactis, amphotericin B, carbenoxolone, ACTH, penicillin G, salicylic acid and its derivatives, laxatives, some diuretics, Licorice root
preparations) may increase the risk of hypokalaemia (decreases in potassium in the blood). If it is necessary to use these substances, the level of potassium in the blood should be monitored.
The preparation may cause hypokalaemia, which intensifies the toxicity of cardiac glycosides and other anti-arrhythmic drugs and extending the QT interval on the ECG. Patients using the above preparations should be cautious and control potassium levels and perform regular ECG examinations.
The use of the preparation with methyldopa may contribute to the development of haemolytic anemia.
Bile acid medications (cholestyramine, colestipol) can significantly reduce the absorption of hydrochlorothiazide from the gastrointestinal tract. Thiazides should be taken at least 1 hour before or 4-6 hours after taking these preparations.
The preparation may increase and prolong the effect of skeletal muscle relaxants (eg tubocurarines).
The concurrent use of calcium salts or vitamin D may increase the level of calcium in the blood (hypercalcaemia). If it is necessary to use calcium supplements, the concentration of calcium in the blood should be closely monitored.
Hydrochlorothiazide may influence the results of parathyroid function tests due to its effect on calcium metabolism.
The concomitant use of carbamazepine may result in hyponatremia (reduction of sodium in the blood). The amount of sodium in the blood should be monitored.
Hydrochlorothiazide reduces the excretion of penicillin and quinine.
Parallel use of vildagliptin and ACE inhibitors may increase the incidence of angioedema.
What side effects can occur?
Like all medicines, Ampril HL, -HD may cause side effects, although they will not occur in all patients using this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common side effects include: headache and dizziness, fatigue, weakness, increased blood lipids, increased blood glucose, insufficient diabetes control, increased uric acid in the blood, worsening of gout, cough without expectoration, bronchitis. Uncommonly possible: myocardial ischaemia (including angina pectoris), increased heart rate (tachycardia), arrhythmias, palpitations, peripheral edema, hematological disorders (decrease in the number of white blood cells or red blood cells, decrease in the number of platelets [thrombocytopenia], decrease hemoglobin, haemolytic anemia), nervousness, apathy, anxiety, depressed mood, sleep disorders (including daytime sleepiness), tingling and numbness (paresthesia), tremors, balance disorders, taste disorders, visual disturbances (blurred vision, conjunctivitis), tinnitus, sinusitis, dyspnea, nasal congestion, loss of appetite, nausea, constipation, discomfort in the gastrointestinal tract, gastroenteritis, digestive disorders, gingivitis, renal dysfunction (including acute renal failure
) ), increase in creatinine and urea in the blood, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and life-threatening), psoriasis-like skin inflammation, rash, pruritus, excessive sweating, baldness, pains joints and muscles, decrease in potassium in the blood (hypokalaemia), increased thirst, symptoms caused by hypotension in this orthostatic hypotension (e.g. dizziness, fainting, balance disorders), flushing, chest pain, fever, hepatitis (cholestatic or cytolytic) in rare cases leading to death, increased liver enzymes, increased bilirubin, cholecystitis, impotence. Very rarely possible: aphthae, inflammation of the tongue, diarrhea, vomiting, epigastric pain, dry mouth, increase in potassium in the blood (hyperkalemia). In addition, possible side effects for which their incidence has not been determined, including: myocardial infarction or ischemic stroke
(secondary to excessive hypotension), transient ischemic attacks, haematological disorders (neutrophil neutrophilia / neutropenia / agranulocytosis), myelosuppression , eosinophilia, blood thickening due to hypovolaemia), disturbances in psychomotor performance, olfactory hallucinations, yellow vision, reduction of tear secretion, glaucoma with occluding angulation, impaired hearing, bronchospasm, asthma exacerbation, allergic alveolitis, eosinophilic pneumonia, pulmonary edema, pancreatitis, sometimes fatal, angioedema of the intestines, salivary gland inflammation, interstitial nephritis, severity of proteinuria, severe skin reactions (Stevens-Johnson syndrome, necrosis toxic diffusion) on epidermis, erythema multiforme), pemphigus, exacerbation of psoriasis, exfoliative dermatitis, hypersensitivity to light, rash, systemic lupus erythematosis, urticaria, rash, muscle weakness, joint pain, muscle spasms, tężyczka, syndrome of abnormal secretion of antidiuretic hormone, increase in calcium in the blood (hypercalcemia), decrease in blood sodium (hyponatremia), excretion of glucose in the urine, metabolic alkalosis, dehydration, decreased intravascular volume sometimes associated with thrombosis, Raynaud's syndrome, vasculitis, anaphylactic reactions, acute liver failure, cholestatic jaundice , liver cell damage, sexual dysfunction, gynecomastia, confusion, anxiety, concentration disorders.
Other preparations on the Polish market containing hydrochlorothiazide + ramipril
Ampril HD (tablets)
Ramicor Comb (coated tablets)
Ramizek HCT (tablets)
Tritace 2,5 comb (tablets)
Tritace 5 comb (tablets)