Arytmil solution for injection 50 mg/ml, 3ml x 5 ampoules — Made in Ukraine — Free Delivery
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Description Arytmil solution for injection 50 mg/ml, 3ml x 5 ampoules — Made in Ukraine — Free Delivery
Pharmacological properties
Pharmacodynamics. Class III antiarrhythmic agent. the antiarrhythmic effect is due to an increase in phase III of the action potential, mainly due to the blockade of potassium channels of cardiomyocyte membranes, as well as calcium channels, a slowdown in conduction along the av-node and a decrease in the automatism of the sinus node. slightly blocks open and inactivated sodium channels and slows down the fast incoming sodium flow. the preparation noncompetitively blocks α- and β-adrenergic receptors, predominantly of the myocardium, which also helps to slow down sinoatrial, atrial and av-conduction, without affecting intraventricular conduction. amiodarone increases the refractory period and reduces myocardial excitability; slows down the conduction of excitation and lengthens the refractory period of the additional anterioventricular tracts. the antianginal effect of amiodarone is due to a decrease in oxygen consumption by the myocardium due to a decrease in heart rate and opsis. amiodarone does not cause a significant negative inotropic effect.
Pharmacokinetics. Amiodarone has a high volume of distribution. In the first days of administration, the preparation accumulates in almost all tissues, especially in fatty deposits, liver, spleen, lungs. After a few days, amiodarone is excreted from the body. Stable concentration is achieved within 1 to several months, depending on the individual characteristics of the patient. Amiodarone is excreted in bile and feces. Renal excretion is negligible. T½ is 20–100 days. After the termination of treatment with amiodarone, its elimination from the body occurs for several months. Amiodarone contains iodine, therefore, during metabolism in the liver, iodine is cleaved and excreted in the urine in the form of salts. The bulk of amiodarone and its metabolites are excreted through the intestines for more than 30 days.
After the preparation is discontinued, its effect lasts for several days or even weeks.
Indications
- tachyarrhythmia associated with WPW s-m;
- flutter and ventricular fibrillation when it is impossible to use other preparations;
- all types of paroxysmal tachycardia, including supraventricular, nodular and ventricular tachycardia, atrial fibrillation, when other preparations cannot be prescribed.
The tablet form of the preparation is used only for the treatment of severe rhythm disturbances, which pose a danger to the patient's life and are resistant to other medications, as well as if other preparations are contraindicated.
Treatment should be initiated and monitored only in a hospital setting or under the supervision of a specialist.
Application
Adults
Saturation dose
Treatment usually begins with 200 mg (1 tablet) 3 times a day for a week, reducing the dose to 200 mg 2 times a day for the next week.
Maintenance dose
The minimum effective dose should be used, depending on the patient's response to the use of the preparation. After the saturation period, the dose can be reduced to 200 or 100 mg / day. Rarely, a patient may need a higher maintenance dose. The maintenance dose must be regularly reviewed, especially if it exceeds 200 mg / day. Too high doses during maintenance therapy can cause side effects that are associated with high levels of amiodarone and its metabolites in body tissues.
Since Arrhythmil has a very long T½, it can be taken every other day (200 mg of the preparation can be taken every other day, and 100 mg is recommended to be taken every day). You can take breaks in taking the preparation - 2 days a week. The mode of taking the preparation is determined individually.
Elderly patients.
As with all patients, it is very important to use the lowest effective dose of the preparation. Elderly patients may be hypersensitive to the action of Arrhythmil, even with the appointment of usual doses. Particular attention should be paid to monitoring thyroid function.
Contraindications
hypersensitivity to iodine and / or to amiodarone or to other components of the preparation, sinus bradycardia, sinoatrial block, with the exception of patients with an artificial pacemaker (danger of stopping the sinus node); high degree of av-blockade, severe disturbances of intraventricular conduction (blockade of the 2nd and 3rd legs of the bundle of His), sick sinus syndrome in the absence of an artificial pacemaker; simultaneous use with preparations that can cause polymorphic ventricular tachycardia of the "torsade de pointes" type, dysfunction of the thyroid gland (hypothyroidism, hyperthyroidism). Before starting treatment, it is necessary to check the function of the thyroid gland in all patients; During pregnancy and breastfeeding.
Side effects
Side effects, information about which is given below, are classified by organs and systems, their frequency of occurrence: very often (≥10%); often (≥1% and 10%); infrequently (≥0.1% and 1%); rarely (≥0.01% and 0.1%); very rare (0.01%).
On the part of the blood and lymphatic system
very rarely - hemolytic anemia, aplastic anemia, thrombocytopenia.
On the part of the cardiovascular system
often - bradycardia, usually moderate and dose-dependent;
very rare: severe bradycardia and, in exceptional cases, stopping the sinus node, the treatment of which is different, especially in the elderly and / or in patients with sinus node dysfunction.
infrequently - the development or intensification of arrhythmias, sometimes to cardiac arrest; violation of conduction (sinoatrial blockade, AV blockade of varying degrees). Basically, these side reactions can occur when combined with preparations that lengthen the period of repolarization of the ventricles of the heart or in case of electrolyte imbalance.
Endocrine Disorders
often - hypothyroidism, hyperthyroidism, sometimes fatal;
very rare: syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
Ophthalmic Disorders
very often: microdeposits in the corneal epithelium, usually in the area under the pupil, which, as a rule, are noticeable only when examined with a slit lamp and are manifested by a colored halo in dazzling light or blurred vision. Microdeposits on the cornea consist of a complex of lipid layers, disappear after discontinuation of the preparation and do not require discontinuation of treatment;
very rare: neuropathy / optic neuritis, which can lead to blindness.
Gastrointestinal Disorders
very often: benign gastrointestinal disorders (nausea, vomiting, dysgeusia), which usually occur during saturation with the preparation and disappear when the dose is reduced.
From the hepatobiliary system
very often: an isolated increase in serum transaminase activity at the beginning of treatment, usually moderate (1.5–3 times higher than normal). The normalization of these indicators occurs with a decrease in the dose of the preparation or even spontaneously;
often: acute disorders of liver function (including liver failure), sometimes fatal, with high levels of transaminase activity in serum and / or with jaundice. With a significant increase in the level of transaminases, therapy should be discontinued. During treatment with amiodarone, periodic monitoring of liver function is recommended;
very rare: chronic liver disease (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal.
From the immune system
angioedema (there have been several reports, the exact frequency is unknown).
From the nervous system
often: extrapyramidal tremor (the appearance of which may dictate dose reduction or preparation withdrawal), disturbing dreams, sleep disturbance;
infrequently: peripheral sensorimotor neuropathies and / or myopathies, usually stop after discontinuation of the preparation;
very rare: cerebellar ataxia (regresses after dose reduction or preparation withdrawal), benign intracranial hypertension (pseudotumor of the brain), headache, dizziness.
From the reproductive system
very rare: epididymitis, orchitis, impotence.
From the respiratory system
often: toxic effect on lung tissue, sometimes fatal (hypersensitive pneumonitis, alveolar / interstitial pneumonitis or fibrosis, pleurisy, bronchiolitis obliterans associated with pneumonia). Pulmonary disorders, mostly reversible with early preparation withdrawal. Clinical symptoms usually disappear within 3-4 weeks, and then there is a slower recovery of the radiographic picture and lung function (over several months). Therefore, in such cases, the need to discontinue amiodarone and the advisability of prescribing glucocorticosteroids should be reviewed;
very rare: bronchospasm in patients with severe respiratory failure, especially in patients with asthma; acute respiratory distress syndrome, sometimes fatal, most often immediately after surgery (possibly after interaction with high doses of oxygen).
Cases of pulmonary bleeding have been reported (the exact frequency is unknown).
On the part of the skin and subcutaneous tissues
very often: photosensitivity;
often: grayish or bluish pigmentation of open skin areas, especially of the face, in cases of prolonged treatment with high doses of the preparation; after cessation of treatment, this pigmentation slowly disappears (over 10-12 months).
very rare: erythema during radiotherapy; rash, usually nonspecific; exfoliative dermatitis; alopecia; urticaria (frequency unknown).
Vascular disorders
very rare: vasculitis.
Side effects of the preparation are usually dose dependent, so care should be taken to determine the minimum effective maintenance dose to prevent or minimize the risk of unwanted effects.
Special instructions
Special security measures. In patients with impaired carbohydrate tolerance, such as congenital galactosemia, glucose-galactose malabsorption syndrome, lactase deficiency, the use of the preparation is contraindicated due to its lactose content.
Amiodarone can cause serious adverse reactions from the organs of sight, heart, lungs, liver, thyroid gland, skin, and peripheral nervous system. Since the onset of these reactions can be delayed in time, the condition of patients with prolonged treatment must be carefully monitored. Considering that undesirable manifestations are dose-dependent, therefore, with maintenance therapy, the minimum effective dose should be used.
Before surgery, it is imperative to warn the anesthesiologist that the patient has received / is receiving amiodarone (the threat of respiratory distress syndrome).
To prevent undesirable effects, concomitant therapy should be carefully prescribed, taking into account the clinically significant interactions of amiodarone.
Features of the application. The preparation should be used with caution in the elderly, patients who take cardiac glycosides, due to the risk of severe bradycardia, severe conduction disturbances with the possible occurrence of idioventricular rhythm, especially when used in high doses. If such conditions occur, treatment with Arrhythmil must be discontinued, beta-adrenomimetics or glucagon can be used, if necessary, cardiac stimulation.
Due to the prolonged T½ of amiodarone, if bradycardia is severe, an artificial pacemaker should be considered.
The use of a tablet form of amiodarone is not contraindicated in latent or overt heart failure, however, caution is required, since existing heart failure may worsen. In such cases, Arrhythmil should be used in combination with appropriate preparations.
During treatment with amiodarone, ECG changes are possible: lengthening of the Q – T interval (due to prolongation of repolarization), the appearance of the U wave, deformation of the T wave. These changes are not a manifestation of the preparations toxicity.
In elderly patients, a significant decrease in heart rate is possible.
Treatment with the preparation must be discontinued in case of AV blockade of II or III degree, sinoatrial block or bifascicular block.
Amiodarone exhibits a low proarrhythmic effect, which manifests itself mainly when combined with preparations that prolong the period of ventricular repolarization or in case of electrolyte imbalance (especially in hypokalemia). It is advisable to correct the electrolyte imbalance before starting treatment with Arrhythmil. The occurrence of new arrhythmias or an increase in pre-existing arrhythmias, sometimes fatal, have been reported.
Before starting treatment, each patient needs to do an ECG, to determine the level of potassium in the blood plasma. ECG monitoring is recommended throughout the entire treatment with the preparation.
Amiodarone can increase the defibrillation threshold and / or the pacing threshold in patients with implanted cardioverter-defibrillators or pacemakers, which can adversely affect the effectiveness of the device. It is recommended that regular tests be performed to ensure proper functioning of the device after starting treatment or changing the dose of the preparation.
Amiodarone can cause dysfunction of the thyroid gland (hypothyroidism, hyperthyroidism), especially in patients with a history of thyroid dysfunction (including family), in elderly patients. Therefore, by the beginning and during treatment (every 6 months), as well as for several months after its completion, it is necessary to conduct a thorough clinical and laboratory monitoring of the thyroid gland function.
If thyroid dysfunction is suspected, serum TSH should be measured.
In life-threatening situations, if hypothyroidism occurs, treatment with amiodarone can be continued in combination with levothyroxine, the doses of which are adjusted according to thyroid hormone levels. The euthyroid state usually recovers 3 months after discontinuation of amiodarone treatment.
Hyperthyroidism may occur during treatment with amiodarone or several months after treatment is stopped. Cases of fatal hyperthyroidism have been reported, so if it occurs, amiodarone should be discontinued. Clinical recovery usually occurs over several months.
In cases of severe thyroid hyperactivity, consideration should be given to the use of antithyroid preparations, possibly in combination with corticosteroids.
Arrhythmil contains iodine, so it can affect the results of tests for the accumulation of radioactive iodine in the thyroid gland, but does not affect the level of hormones T3, T4, TSH.
If visual clarity or visual acuity deteriorates, a complete ophthalmologic examination, including fundus examination, should be performed immediately. It is necessary to stop taking amiodarone in case of neuropathy and / or optic neuritis caused by amiodarone, since there is a risk of their progression to complete blindness. In the future, an annual ophthalmological examination of such patients is recommended.
Taking amiodarone can cause various side effects from the liver, including cirrhosis, hepatitis, jaundice and severe hepatocellular insufficiency, sometimes fatal (mainly with long-term therapy, especially after intravenous administration of amiodarone in the first 24 hours). Therefore, at the beginning and during treatment with Arrhythmil, it is recommended to regularly (every 6 months) check the liver function (transaminase activity) for early detection of its damage. With a significant increase in the level of transaminases, treatment should be discontinued.
At the beginning of treatment, an isolated increase in the activity of transaminases in the blood serum is possible, as a rule, moderate (1.5-3 times higher than normal). The normalization of these indicators occurs when the dose is reduced or even spontaneously.
Chronic liver diseases have been reported during treatment with the preparation for more than 6 months (pseudo-alcoholic hepatitis, cirrhosis). Clinical symptoms and laboratory changes may be minimal (hepatomegaly is possible, the level of transaminases is 1.5–5 times higher than normal). Therefore, regular monitoring of liver function is recommended during treatment. Clinical and laboratory abnormalities, as a rule, decrease after discontinuation of the preparation, however, there have been isolated cases with a fatal outcome.
It is undesirable to consume alcohol during treatment with Arrhythmil, although there have been no reports of potentiation of a negative effect on the liver.
Amiodarone can cause the appearance of peripheral sensorimotor neuropathy and / or myopathy with prolonged use, usually after discontinuation of the preparation, everything returns to normal. However, recovery may be incomplete, very slow, and manifest only a few months after preparation withdrawal.
The occurrence of shortness of breath and unproductive cough may be associated with the manifestation of the toxic effect of amiodarone on the respiratory system (hypersensitive pneumonitis, alveolar / interstitial pneumonitis or fibrosis, pleurisy, bronchiolitis obliterans with pneumonia).
Patients who develop dyspnea or a productive cough, both in isolation and with a worsening of the general condition (fatigue, weight loss, increased body temperature), should undergo a chest X-ray and, if necessary, discontinue the preparation.
Such cases of pneumopathy can lead to pulmonary fibrosis, but they are generally reversible with early withdrawal of amiodarone, both with and without corticosteroids. Clinical symptoms, as a rule, disappear within 3-4 weeks, and then there is a slower recovery of the radiographic picture and lung function (over several months).
In some cases, pleurisy associated with interstitial pneumonia may develop.
In patients with severe respiratory disorders, and especially in patients with asthma, in some cases, bronchospasm may occur.
In some cases, patients receiving amiodarone experienced acute distress syndrome immediately after surgery (possibly incompatibility with high oxygen concentrations). When using mechanical ventilation, careful monitoring of such patients is recommended.
It is not recommended to use Arrhythmil with beta-blockers (except for sotalol and esmolol), some calcium channel blockers (verapamil, an injectable form of diltiazem), laxatives that stimulate intestinal motility and can cause hypokalemia. Also, with the combined use of Arrhythmil and flecainide, it is necessary, given the increase in the plasma level of the latter, to accordingly reduce the dose of flecainide and carefully monitor the patient's condition.
During treatment with amiodarone, it is not recommended to consume grapefruit juice due to the risk of an increase in the concentration of amiodarone in the blood.
Use during pregnancy and lactation. Since the preparation acts on the fetal thyroid gland, the use of the preparation during pregnancy is contraindicated, except in special situations.
Amiodarone is excreted in breast milk in significant quantities, therefore, if it is necessary to take the preparation by women who are breastfeeding, breastfeeding should be stopped during treatment.
Children. Controlled clinical studies to study the safety and efficacy of the preparation for the treatment of children have not been conducted.
The ability to influence the reaction rate when driving or working with other mechanisms. The preparation can adversely affect the reaction rate when driving or operating other mechanisms, especially in patients with amiodarone-induced visual disorders.
Interactions
Tablets and injection solution. combined use with preparations that can cause polymorphic paroxysmal ventricular tachycardia of the pirouette type ("torsade de pointes") due to prolongation of the q – t interval is contraindicated:
- antiarrhythmic preparations, including class IA preparations (quinidine, hydroquinidine, procainamide, disopyramide), class III (dofetilide, ibutilide), sotalol, bepridil;
- preparations that do not have antiarrhythmic activity, including vincamine, cisapride, erythromycin (i.v.), spiramycin (i.v.), vincamine (i.v.), co-trimazole, parenteral pentamidine, as there is a risk of developing paroxysmal tachycardia fatal;
- antipsychotics: some phenothiazine antipsychotics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine); benzamides (amisulpride, sultopride, sulpiride, tiapride), butyrophenones (droperidol, galaperidol), pimozide, sertindole;
- lithium preparations and tricyclic antidepressants (doxepin, maprotiline, amitriptyline, trazodone);
- some antihistamines (loratadine, terfenadine, astemizole, mizolastine);
- antimalarial preparations (quinine, mefloquine, chloroquine, halofantrine);
- moxifloxacin, sparfloxacin.
Combination therapy with the following preparations is not recommended:
- beta-blockers (except for sotalol and esmolol) and some calcium channel blockers (verapamil, an injectable form of diltiazem), since there may be a violation of automatism (severe bradycardia), conduction (AV blockade) and contractility of the heart due to suppression of sympathetic compensatory mechanisms. If such a combination is necessary, careful preliminary monitoring of the Q – T interval and continuous ECG monitoring during treatment is required;
- fluoroquinolones (except for moxifloxacin, sparfloxacin, the combination with which is contraindicated) - the occurrence of paroxysmal tachycardia of the "torsade de pointes" type is possible. If such a combination is necessary, then careful preliminary monitoring of the Q – T interval and continuous ECG monitoring is required.
The following preparations are prescribed with caution in combination with Arrhythmil.
Preparations that cause hypokalemia and thus increase the risk of developing paroxysmal tachycardia of the "torsade de pointes" type:
- diuretics that cause hypokalemia (alone or in combination with other preparations);
- corticosteroids (glucocorticoids, mineralocorticoids);
- tetracosactide;
- amphotericin B (i.v.);
- laxatives that stimulate intestinal motility.
It is necessary to prevent the occurrence of hypokalemia and, if necessary, correct it; control the Q – T interval and the appearance of U waves on the ECG. It is permissible to increase the Q – TS interval up to 450 ms or not more than 25% of the initial value.
In the event of a paroxysmal tachycardia of the "torsade de pointes" type, do not use antiarrhythmic preparations, but use intravenous administration of magnesium sulfate solution or cardiac stimulation aimed at lowering the heart rate.
Oral anticoagulants
Strengthening the effect of oral anticoagulants and an increased risk of bleeding dictate the need for more frequent monitoring of the level of prothrombin in the blood and correction of doses of anticoagulants during treatment with amiodarone and after discontinuation of the preparation.
Oral diltiazem
The risk of developing bradycardia and AV block, especially in the elderly. Clinical monitoring and ECG monitoring of the patient's condition is required.
Cardiac glycosides
Violation of automatism (pronounced bradycardia) and AV conduction (synergism of action) may occur; in addition, an increase in the concentration of digoxin in the blood plasma is possible (as a result of a decrease in the clearance of digoxin).
It is necessary to carry out clinical, ECG and laboratory control (including, if possible, the determination of the level of digoxin in the blood plasma); it may be necessary to change the dose of cardiac glycosides.
Esmolol
Perhaps a violation of automatism, conduction and contractile properties of the heart due to the suppression of sympathetic compensatory mechanisms. Clinical and ECG monitoring of the patient's condition is required.
Phenytoin
An increase in the level of phenytoin in the blood plasma with symptoms of an overdose (in particular of a neurological nature) is possible. Clinical monitoring and dose reduction of phenytoin is required with the appearance of signs of overdose; if possible - determination of the level of phenytoin in blood plasma.
Clopidogrel
Amiodarone is a CYP 3A4 inhibitor, increasing plasma levels of other preparations that are metabolized by this enzyme. Since clopidogrel metabolizes to its active form CYP 3A4, the combined use of amiodarone may lead to ineffectiveness in inhibiting platelet aggregation.
Preparations metabolized by the cytochrome P450 3A4 system
Their simultaneous use with amiodarone, which is an inhibitor of this enzyme, increases the concentration of these preparations in the blood plasma, and, as a consequence, their toxicity may increase:
cyclosporine: it is possible to increase the level of cyclosporine in the blood plasma by 2 times; dose adjustment is necessary to maintain the therapeutic concentration of the preparation in the blood plasma;
lidocaine, tacrolimus, sildenafil, fentanyl, midazolam, ergotamine: dose adjustment required;
simvastatin, atorvastatin, lovastatin: dose-dependent increase in the risk of developing side effects such as rhabdomyolysis (due to a decrease in the metabolism of statins in the liver). For example, the dose of simvastatin should not exceed 20 mg / day. If, when using the preparation in such a dose, it is not possible to achieve a therapeutic effect, it is necessary to prescribe another statin that does not interact with amiodarone.
Flecainide
An increase in the level of flecainide in the blood plasma is possible; dose adjustment is necessary.
Preparations that cause bradycardia
In addition to the above beta-blockers (except for sotalol), calcium channel blockers, cardiac glycosides, amiodarone interacts with clonidine, guanfacine, cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, ambemonium, pyridostigmine, neostigmine) with an increased risk of developing gastric arrhythmias especially paroxysmal tachycardia of the "torsade de pointes" type. Clinical and ECG monitoring of the patient's condition is recommended.
General anesthesia
Cases of severe complications in patients undergoing general anesthesia have been described: bradycardia, which is not corrected by atropine, arterial hypotension, conduction disturbances, and decreased cardiac output.
Rare cases of severe respiratory complications, which sometimes ended in death (acute respiratory distress syndrome in adults), were more often observed in the early postoperative period during oxygen therapy.
Grapefruit juice inhibits cytochrome P450 3A4, which can lead to an increase in the concentration of amiodarone in the blood plasma.
Overdose
Tablets and injection solution. information on acute overdose of amiodarone when using the tablet form is not enough. several cases of sinus bradycardia, cardiac arrest, attacks of ventricular tachycardia, paroxysmal tachycardia "torsade de pointes", vascular insufficiency, liver damage have been described.
Treatment. Symptomatic therapy, gastric lavage to reduce the absorption of the preparation. In the case of bradycardia, beta-adrenergic agonists, atropine or glucagon preparations can be used, if necessary, cardiac stimulation. In the case of paroxysmal tachycardia "torsade de pointes" - intravenous administration of magnesium salts, cardiac stimulation aimed at lowering the heart rate.
Taking into account the pharmacokinetic profile of amiodarone, it is recommended to monitor the patient's condition (especially cardiac activity) for a long time.
Amiodarone and its metabolites are not excreted during dialysis.
There is no information regarding an overdose of amiodarone with intravenous administration.
Storage conditions
store in its original packaging at a temperature not exceeding 25 ° C.
Tags: Arytmil
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