Arifam tabs 10mg + 1.5mg #30

Instruction for Arifam

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Composition

1 tablet 5 mg + 1.5 mg with modified release, film-coated, contains: active ingredients: amlodipine besylate 6.935 mg, which corresponds to 5,000 mg of amlodipine, and indapamide 1,500 mg.
1 tablet 10 mg + 1.5 mg with modified release, film-coated, contains: active ingredients: amlodipine besylate 13.870 mg, which corresponds to 10,000 mg of amlodipine, and indapamide 1,500 mg.
Excipients:
Core: hypromellose-4 thousand 84,000 / 84,000 mg, lactose monohydrate 104.500 / 104.500 mg, magnesium stearate 2.050 / 2.050 mg, povidone K-30 8.600 / 8.600 mg, colloidal silicon dioxide 0.820 / 0.820 mg, calcium hydrogen phosphate dihydrate 56.700 / 56.700 mg , microcrystalline cellulose 128,095 / 121,160 mg, croscarmellose sodium 10,500 / 10,500 mg, pregelatinized corn starch 6,300 / 6,300 mg.
Film casing: glycerol 0.61992 / 0.61992 mg, hypromellose-6 thousand 10.30445 / 10.30445 mg, macrogol-6000 0.65797 / 0.65797 mg, magnesium stearate 0.61992 / 0.61992 mg, titanium dioxide (E171) 1.98375 / 1.75162 mg. The tablet shell 10 mg + 1.5 mg additionally contains iron dye red oxide (E172) 0.23213 mg.

Description

5 mg +1.5 mg: white round, biconvex tablets with the company logo engraved on one side;
10 mg + 1.5 mg: pink, round, biconvex tablets with company logo engraved on one side.

Pharmacodynamics

Amlodipine is a calcium ion influx inhibitor, a dihydropyridine derivative (slow calcium channel blocker, or calcium ion antagonist) that inhibits the transmembrane influx of calcium ions into cardiomyocytes and vascular smooth muscle cells.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxing effect on vascular smooth muscle.
Indapamide is a sulfonamide derivative with an indole ring, belonging to the pharmacological group of thiazide-like diuretics, which acts by reducing sodium reabsorption in the cortical segment of the nephron loop. Indapamide increases the excretion of sodium and chloride in the urine and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing diuresis and exerting an antihypertensive effect.

Pharmacodynamic effects

In patients with arterial hypertension, taking amlodipine once a day provides a clinically significant decrease in blood pressure in the supine and standing position for 24 hours. Due to the slow development of the effect, amlodipine usually does not cause acute hypotension.
Amlodipine does not have an undesirable effect on lipid metabolism and does not cause changes in the lipid profile of blood plasma, therefore it is suitable for use in patients with bronchial asthma, diabetes mellitus and gout.
The antihypertensive activity of indapamide is associated with an improvement in the elastic properties of arteries and a decrease in arteriolar and total peripheral vascular resistance.
In clinical studies of phases II and III, with the use of indapamide in monotherapy at doses that do not have a pronounced diuretic effect, a 24-hour hypotensive effect was demonstrated.
Indapamide reduces left ventricular hypertrophy.
An increase in the dose of thiazide diuretics above certain ones is accompanied by the achievement of a plateau of the therapeutic effect, but is accompanied by the occurrence of adverse reactions. If therapy does not lead to the desired therapeutic effect, the dose of Arifam should not be increased.
It has also been shown that with short-term, medium-term and long-term use in patients with arterial hypertension, indapamide:
- does not affect the indicators of lipid metabolism, including the level of triglycerides, cholesterol, low density lipoproteins and high density lipoproteins;
- does not affect the indicators of carbohydrate metabolism, including in patients with diabetes mellitus.

Pharmacokinetics

The simultaneous use of amlodipine and indapamide does not change their pharmacokinetic properties in comparison with the separate use of these agents.

Amlodipine

Amlodipine is presented in Arifam in an immediate-release form.
Absorption, distribution, binding to plasma proteins
Amlodipine is well absorbed when taken orally in therapeutic doses, while the maximum concentration in the blood plasma is reached 6-12 hours after taking Arifam orally. Absolute bioavailability ranges from 64 to 80%. The volume of distribution is about 21 l / kg. In vitro studies have shown that approximately 97.5% of circulating amlodipine binds to blood plasma proteins.
Concomitant food intake does not affect the bioavailability of amlodipine.

Metabolism and excretion

The terminal half-life of amlodipine from blood plasma is approximately 35-50 hours, which is consistent with taking Arifam once a day. Amlodipine is actively metabolized in the liver with the formation of inactive metabolites, while 10% of the original compound in unchanged form and 60% of metabolites are excreted in the urine.
Application for severe liver dysfunction.
There are very limited clinical data on the use of amlodipine in patients with severe hepatic impairment. In patients with hepatic insufficiency, the clearance of amlodipine decreases, which leads to an increase in the half-life and an increase in the area under the concentration-time curve (AUC) by approximately 40-60%.
Use in the elderly.
The time to reach maximum plasma concentrations of amlodipine does not differ in the elderly and young people. The clearance of amlodipine in elderly patients tends to decrease, resulting in an increase in AUC and half-life. The increase in AUC and elimination half-life in patients with congestive heart failure was in line with the expected values ​​for these age groups of patients.

Indapamide

Indapamide 1.5 mg in Arifam modified release, distributed in a special carrier matrix, which allows the gradual release of indapamide.

Suction

The released share of indapamide is rapidly and completely absorbed in the gastrointestinal tract.
Food intake slightly increases the rate of absorption, but does not affect the completeness of absorption.
The maximum concentration of Arifam in the blood plasma is achieved approximately 12 hours after oral administration of a single dose; with repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between 2 doses of Arifam are smoothed out. There is an intra-individual variability in the absorption of the drug.

Distribution

The binding of indapamide to blood plasma proteins is 79%. The half-life is (T½) 14-24 hours (average 18 hours). Equilibrium concentration is reached after 7 days. Repeated intake does not lead to accumulation.

Withdrawal

Arifam is excreted mainly in the urine (70% of the dose) and in the feces (22%) in the form of inactive metabolites.

High-risk patients

In patients with renal insufficiency, pharmacokinetic parameters do not change.

Indications

Arterial hypertension in patients requiring therapy with amlodipine and indapamide.

Contraindications

- Hypersensitivity to active ingredients, other sulfonamides, dihydropyridine derivatives or any of the excipients;
- severe renal failure (creatinine clearance <30 ml / min);
- severe hepatic failure or hepatic encephalopathy;
- hypokalemia;
- the period of breastfeeding;
- severe hypotension;
- shock (including cardiogenic shock);
- obstruction of the outflow tract of the left ventricle (for example, high-grade aortic stenosis);
- heart failure after acute myocardial infarction with unstable hemodynamics;
- galactose intolerance, lactase deficiency or glucose-galactose malabsorption (since Arifam contains lactose);
- children under 18 years of age.

Carefully

Decreased circulating blood volume (BCC) (taking diuretics, salt-free diet, vomiting, diarrhea), old age, patients with mild to moderate liver dysfunction, patients with peripheral edema and ascites, coronary heart disease, chronic heart failure, patients with an extended interval QT, bradycardia, chronic heart failure III-IV functional class according to NYHA classification, diabetes mellitus, renal artery stenosis (including bilateral), the only functioning kidney, renal failure, gout.

Application during pregnancy and lactation

Given the effect of the individual components of this combination during pregnancy and lactation:
Arifam is not recommended for use during pregnancy.
Arifam is contraindicated for use during breastfeeding.

Pregnancy

Amlodipine:
The safety of using amlodipine in pregnant women has not been established. In experimental studies on animals, the toxic effect on the reproductive system was established when using the drug in high doses.
Indapamide:
At the moment, there is not enough data on the use of indapamide during pregnancy (less than 300 cases have been described). Prolonged exposure to thiazides during the third trimester of pregnancy can cause hypovolemia in the mother, as well as reduce uteroplacental blood flow, which can lead to placental ischemia and fetal growth retardation. In addition, rare cases of hypoglycemia and thrombocytopenia have been reported in newborns while taking diuretics shortly before delivery. Animal studies have not revealed direct or indirect toxic effects on reproductive function.

Breastfeeding period

Amlodipine:
The ability of amlodipine to pass into breast milk has not been studied.
Indapamide:
It is not known whether indapamide or its metabolites are excreted in breast milk. Taking thiazide diuretics causes a decrease in the amount of breast milk or suppression of lactation. In this case, the newborn may develop hypersensitivity to sulfonamide derivatives and hypokalemia.
The risk to the newborn / infant cannot be excluded.

Fertility

Amlodipine:
In some patients treated with slow calcium channel blockers, reversible biochemical changes in the sperm heads were observed. There is not enough clinical data regarding the potential effect of amlodipine on reproductive function. In a study in rats, undesirable effects on fertility were found in males.
Indapamide:
Reproductive toxicity studies have shown no effect on reproductive function in rats of either sex. It can be assumed that there is no effect on fertility in humans.

Method of administration and dosage

Inside, 1 tablet 1 time per day, preferably in the morning. The tablet must be swallowed without chewing and drinking water.

Special patient groups

Patients with impaired renal function (see sections "Contraindications" and "Special instructions")
With severe kidney damage (creatinine clearance less than 30 ml / min), Arifam is contraindicated.
No dose adjustment is required in patients with mild to moderate renal impairment.
Use in elderly patients (see sections "Special instructions" and "Pharmacokinetics")
Arifam may be prescribed to elderly patients taking into account renal function.
Patients with impaired liver function (see sections "Contraindications" and "Special instructions")
In case of severe liver damage, therapy with Arifam is contraindicated.
Recommendations for dosing amlodipine have not been established for patients with mild to moderate hepatic impairment, therefore the dose should be selected with caution, and treatment should be started with the lowest dose (see sections "Special instructions" and "Pharmacokinetics").

Children and adolescents

There are currently no data on the safety and efficacy of Arifam in children and adolescents.

Side effects

Allergic reactions to the components of Arifam, increased uric acid and blood glucose levels during therapy, thrombocytopenia, agranulocytosis, aplastic anemia, malaise, asthenia, hyperglycemia, increased fatigue, hyponatremia with hypovolemia, gynecomastia, mood changes (including anxiety), renal failure , confusion, nocturia, dizziness, back pain, tremor, myalgia, fainting, leg edema, paresthesia, photosensitivity, hypertonicity, exfoliative dermatitis, visual impairment (including diplopia), Stevens-Johnson syndrome, blurred vision, urticaria, tinnitus , exanthema, myocardial infarction, pruritus, tachycardia of the "pirouette" type (potentially fatal), discoloration of the skin, arterial hypotension, purpura, shortness of breath, possible development of hepatic encephalopathy in case of liver failure, cough, increased activity of "liver" enzymes, nausea , hepatitis, dyspepsia, gingival hyperplasia, dry mouth, pancreatitis, gastric it, changes in bowel function (including diarrhea and constipation), constipation, vomiting, jaundice, abdominal pain, liver dysfunction, rhinitis, maculopapular rash, vasculitis, alopecia, flushing of the facial skin, hyperhidrosis, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), skin rash, palpitations, angioedema, decreased visual acuity, toxic epidermal necrolysis, myopia, erythema multiforme, peripheral neuropathy, Quincke's edema, vertigo, exacerbation of arthralgia, exacerbation of volition, acute changes in taste, prolongation of the QT interval on the electrocardiogram (ECG), muscle spasms, headache, urinary disturbances, drowsiness, increased urination, depression, impotence, insomnia, edema, hypercalcemia, chest pain, hypokalemia, pain, hemolytic anemia, weight loss body, weight gain.

Overdose

There is no information on an overdose of Arifam.

Amlodipine

Information on intentional overdose in humans is limited.
The available data indicate that significant overdose can lead to excessive peripheral vasodilation and possibly reflex tachycardia. There have been cases of severe and probably prolonged systemic hypotension up to the development of shock with a fatal outcome.
In case of clinically significant hypotension due to an overdose of amlodipine, active support for the functioning of the cardiovascular system is necessary, including frequent monitoring of cardiac and respiratory functions, elevation of the limbs, and control of circulating blood volume and urine output.
To restore vascular tone and blood pressure, the use of vasoconstrictors can be effective in the absence of contraindications to their use. Intravenous administration of calcium gluconate can help eliminate calcium channel blockade.
In some cases, gastric lavage may be appropriate. In healthy volunteers, the use of activated charcoal for a period up to 2 hours after taking 10 mg of amlodipine led to a decrease in the rate of absorption of amlodipine.
Since amlodipine is highly protein bound, dialysis is unlikely to be effective.

Indapamide

Indapamide showed no toxicity when used in doses up to 40 mg, that is, 27 times higher than the therapeutic dose.
Signs of acute poisoning are mainly water-electrolyte disturbances (hyponatremia, hypokalemia). The clinical picture may include nausea, vomiting, hypotension, muscle spasms, vertigo, drowsiness, confusion, polyuria or oliguria, possibly up to anuria (due to hypovolemia).
Initial measures of emergency care include the rapid elimination of the taken substances (s) by gastric lavage and / or the administration of activated charcoal, followed by restoration of the water-electrolyte balance to normal in a specialized department.

Interaction

Amlodipine

Dantrolene (i.v.): animals experienced ventricular fibrillation and fatal cardiovascular collapse with hyperkalemia after taking verapamil and intravenous dantrolene. Due to the risk of hyperkalemia, it is recommended to avoid the combined use of slow calcium channel blockers, such as amlodipine, in patients with a predisposition to malignant hyperthermia, as well as in the treatment of malignant hyperthermia.
Taking amlodipine with grapefruit or grapefruit juice is not recommended, because in some patients the bioavailability of amlodipine may increase, which leads to increased blood pressure lowering effects.
Inhibitors of cytochrome CYP3A4: The simultaneous use of amlodipine with strong or moderate inhibitors of CYP3A4 (protease inhibitors, antifungal agents from the azole group, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) can lead to a significant increase in the concentration of amlodipine. The clinical manifestations of these pharmacokinetic abnormalities may be more pronounced in elderly patients. Clinical monitoring and dose adjustment may be required.
CYP3A4 inducers: There is no information on the effect of CYP3A4 inducers on amlodipine. The simultaneous use of inducers of CYP3A4 (for example, rifampicin, St. John's wort) can lead to a decrease in the concentration of amlodipine in the blood plasma. Amlodipine should be used with caution in conjunction with CYP3A4 inducers.

The effect of amlodipine on other drugs

Amlodipine has an additional hypotensive effect when taken simultaneously with other drugs that have an antihypertensive effect.
In clinical studies of drug interactions, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin, or cyclosporin.
Simvastatin: The simultaneous use of multiple doses of amlodipine 10 mg and simvastatin 80 mg resulted in a 77% increase in the concentration of simvastatin compared with simvastatin monotherapy. In patients receiving amlodipine, the dose of simvastatin should not exceed 20 mg per day.

Indapamide

Drug combinations that are not recommended
Lithium preparations:
With the simultaneous use of indapamide and lithium preparations, an increase in the level of lithium in the blood plasma with signs of an overdose may be observed, as with a salt-free diet (reduced urinary lithium excretion). However, if the use of diuretics is necessary, careful monitoring of plasma lithium and dosage adjustment is required.
Combinations requiring safety precautions
Drugs causing pirouette-type tachycardia:
- class Ia antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide),
- Class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide);
- some antipsychotic drugs:
phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoroperazine);
benzamides (amisulpride, sulpiride, sultopride, tiapride); butyrophenones (droperidol, haloperidol);
- others: bepridil, cisapride, diphemanil, erythromycin for intravenous administration, halofantrine, mizolastine, pentamidine. sparfloxacin, moxifloxacin, vincamycin for intravenous administration.
Increased risk of ventricular arrhythmias, especially pirouette tachycardia (hypokalemia as a risk factor)
Before prescribing drugs that cause tachycardia of the "pirouette" type, while taking Arifam, a study should be carried out in order to detect hypokalemia and correction, if necessary. Monitoring of the clinical condition, plasma electrolytes and ECG is required.
In the presence of hypokalemia, drugs that do not cause pirouette-type tachycardia should be used.
Non-steroidal anti-inflammatory drugs (systemic use), including selective cyclooxygenase-2 inhibitors, high doses of salicylic acid (≥ 3 g / day):
Possible decrease in the antihypertensive effect of indapamide.
The risk of developing acute renal failure in patients with dehydration (decreased glomerular filtration). At the beginning of treatment, hydration and monitoring of renal function should be performed.
Angiotensin-converting enzyme (ACE) inhibitors:
The risk of sudden hypotension and / or acute renal failure at the beginning of treatment with an ACE inhibitor against the background of an already existing decrease in sodium levels (especially in patients with renal artery stenosis).
With arterial hypertension, if previous diuretic treatment could cause a decrease in sodium levels, it is necessary:
- stop taking diuretics 3 days before starting treatment with an ACE inhibitor. In the future, if necessary, diuretics can be resumed;
- or prescribe an ACE inhibitor at a low initial dose and gradually increase the dose.
In chronic heart failure, treatment with ACE inhibitors should be started at low doses, with a possible preliminary reduction in the dose of diuretics.
In all cases, kidney function (plasma creatinine level) should be monitored during the first weeks of treatment with an ACE inhibitor.
Other drugs that cause hypokalemia: amphotericin B (IV), gluco- and mineralocorticoids (systemic use), tetracosactide, laxatives that stimulate intestinal motility:
Increased risk of hypokalemia (additive effect).
The concentration of potassium in the blood plasma should be monitored and, if necessary, corrected. This is especially true with concomitant treatment with cardiac glycosides. Use laxatives that do not stimulate intestinal motility.
Cardiac glycosides:
Hypokalemia enhances the toxic effects of cardiac glycosides.
It is necessary to monitor the concentration of potassium in the blood plasma and ECG parameters, as well as adjust the treatment if necessary.
Baclofen:
Strengthening the antihypertensive effect.
At the beginning of treatment, hydration and monitoring of renal function should be performed.
Allopurinol:
Concomitant use with indapamide may increase the risk of hypersensitivity reactions to allopurinol.
Combinations of drugs requiring attention
Potassium-sparing diuretics (amiloride, spironolactone, triamterene):
Although in some patients the use of combinations is advisable, hypokalemia or hyperkalemia may occur (especially in patients with renal failure and diabetes mellitus). Plasma potassium concentration and ECG readings should be monitored, and, if necessary, treatment should be reviewed.
Metformin:
Functional renal failure, which can occur on the background of diuretics, especially loop diuretics, with the simultaneous administration of metformin, increases the risk of developing lactic acidosis. Do not use metformin if plasma creatinine levels exceed 15 mg / L (135 μmol / L) in men and 12 mg / L (110 μmol / L) in women.
Iodine contrast agents:
With diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine-containing contrast media.
Before the administration of an iodine-containing drug, fluid loss should be compensated.
Tricyclic antidepressants, antipsychotics:
There is an increased risk of orthostatic hypotension and increased antihypertensive effect (additive effect).
Calcium salts:
Due to a decrease in the excretion of calcium in the urine, there is a risk of hypercalcemia.
Cyclosporine, tacrolimus:
There is a risk of an increase in plasma creatinine levels without any change in the concentration of circulating cyclosporine, even in the absence of water / sodium loss.
Corticosteroids, tetracosactide (systemic use):
Decreased antihypertensive effect (water / sodium retention due to corticosteroids).

Special instructions

Hepatic encephalopathy:
If liver function is impaired, thiazide-like diuretics can cause hepatic encephalopathy, especially in the case of electrolyte imbalance. Due to the presence of indapamide, with the development of this phenomenon, the use of the drug Arifam should be stopped immediately.
Photosensitivity:
Cases of photosensitivity reactions when taking thiazide and thiazide-like diuretics are described (see the section "Side effects"). If a photosensitivity reaction occurs during treatment, it is recommended to discontinue treatment.
If re-administration of a diuretic is deemed necessary, it is recommended to protect exposed parts of the body from exposure to the sun or artificial ultraviolet rays.
Hypertensive crisis
The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Water and electrolyte balance:
- Content of sodium ions in blood plasma:
Before starting treatment, it is necessary to determine the content of sodium ions in the blood plasma.
While taking the drug, this indicator should be regularly monitored. All diuretics can cause hyponatremia, which sometimes leads to serious complications. Hyponatremia at the initial stage may not be accompanied by clinical symptoms, therefore, regular laboratory monitoring is necessary. More frequent monitoring of the sodium ion content is indicated for elderly patients and patients with liver cirrhosis (see sections "Side Effects" and "Overdose").
- Content of potassium ions in blood plasma:
Potassium depletion with the development of hypokalemia is the main risk associated with the use of thiazide and thiazide-like diuretics. It is necessary to prevent the development of hypokalemia (<3.4 mmol / L), in patients at high risk, namely, the elderly, weakened and / or receiving combined drug therapy, patients with cirrhosis of the liver, peripheral edema and ascites, patients with coronary heart disease, heart failure. In these patients, hypokalemia increases the cardiotoxicity of cardiac gliclazides and the risk of arrhythmias.
Persons with a prolonged QT interval are also at risk, regardless of the origin of this disorder - congenital or iatrogenic. Hypokalemia, as well as bradycardia, are contributing factors to severe arrhythmias, in particular the potentially fatal pirouette-type tachycardia.
In all of the above situations, it is necessary to measure the concentration of potassium in the blood plasma more often. The first measurement of the level of potassium ions in blood plasma should be carried out within the first week from the start of treatment.
If hypokalemia occurs, appropriate treatment should be prescribed.
- Plasma calcium content:
Thiazide and thiazide-like diuretics can reduce urinary calcium excretion and cause a slight and temporary increase in plasma calcium levels. True hypercalcemia may be associated with previously undiagnosed hyperparathyroidism.
Before examining the function of the parathyroid gland, treatment should be discontinued.
Plasma glucose:
Due to the presence of indapamide, it is necessary to control the blood glucose level in patients with diabetes mellitus, especially in the presence of hypokalemia.
Heart 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 incidence of pulmonary edema was higher in the amlodipine group than in the placebo group. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure as they may increase the risk of cardiovascular events and death.
Kidney function:
Thiazide and thiazide-like diuretics are fully effective only in case of normal or slightly impaired renal function (plasma creatinine level is below 25 mg / l, that is, 220 μmol / l in adult patients). In elderly patients, normal plasma creatinine levels should be calculated based on age, body weight and sex.
At the beginning of treatment, patients may experience a decrease in the glomerular filtration rate due to hypovolemia, which, in turn, is caused by the loss of water and sodium ions while taking diuretic drugs. This can lead to an increase in the concentration of urea and creatinine in the blood plasma. This transient functional renal failure is not clinically significant in normal renal function, but may exacerbate pre-existing renal failure.
In patients with renal impairment, amlodipine can be used in normal doses. Changes in the concentration of amlodipine in blood plasma do not correlate with the degree of renal dysfunction. Amlodipine is not eliminated from the body through dialysis.
The effects of the combined drug Arifam in renal impairment have not been studied. In case of impaired renal function, the dose of the drug should be selected taking into account the content of individual components.
Uric acid:
Due to the presence of indapamide, patients with hyperuricemia may have an increased risk of developing gout attacks.
Liver function:
In patients with impaired liver function, T1 / 2 and AUC of amlodipine increase. Dosing recommendations for these patients have not been established. Reception of amlodipine should be started with the lowest doses and precautions should be taken, both at the beginning of treatment and when increasing the dose.
The effects of combined intake of amlodipine + indapamide in liver dysfunction have not been studied. Taking into account the effects of separate administration of indapamide and amlodipine, Arifam is contraindicated for use in patients with severe hepatic impairment, and caution should be exercised when treating patients with mild to moderate hepatic impairment.
Elderly patients
Elderly patients can take the drug Arifam taking into account renal function (see sections "Dosage and Administration" and "Pharmacodynamics").
Excipients:
Arifam should not be used to treat patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Influence on the ability to drive vehicles or operate machinery

Arifam has a small or moderate effect on the ability to drive vehicles and work with mechanisms.
Amlodipine has little or moderate effect on the ability to drive vehicles and work with mechanisms. If dizziness, headache, fatigue, or nausea occur in patients receiving amlodipine, the ability to respond may be impaired. Caution is advised, especially at the beginning of treatment.
Indapamide does not affect alertness, but in some cases, various reactions associated with a decrease in blood pressure may occur, especially at the beginning of treatment or when another antihypertensive drug is added.
As a result, the ability to drive vehicles and work with mechanisms may be impaired.

Storage conditions

At a temperature not exceeding 30 ° C.
Keep out of the reach of children.
Shelf life is 2 years.
Do not use after the expiration date.

Terms of sell

You can buy Arifam without a prescription.