Glanola® SR (GALNORA® SR)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGalantamineGalantamine
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    • Dosage form: & nbsptoprolonged action
    Composition:

    1 capsule prolonged action of 8 mg contains:

    Active substance:

    Galanthamine hydrobromide 10.25 mg (equivalent to galantamine 8 mg)

    Excipients:

    Gipromellose 50.02 mg, sodium lauryl sulfate 4.72 mg, carbomer 10.00 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.1: 1] 19.76 mg, giprolose 3.00 mg, magnesium stearate 0, 25 mg, talc 2.00 mg

    Gelatin capsule 61.00 mg

    Composition of empty gelatin capsules:

    Capsule body:

    Titanium dioxide (E 171) 0.7 mg, gelatin 35.9 mg

    Capsule cap:

    Titanium dioxide (E 171) 0.5 mg, gelatin 23.9 mg

    Composition of ink:

    Shellac 24-27%, anhydrous anhydrous * 23-26%, isopropanol * 1-3%, butanol * 1-3%, propylene glycol 3-7%, ammonia water ** 1-2%, iron dye oxide black (E172) 24-28%, potassium hydroxide 0.05-0.1%, water * 15-18%.

    1 capsule prolonged action of 16 mg contains:

    Active substance:

    Galanthamine hydrobromide 20.50 mg (equivalent to galantamine 16 mg)

    Excipients:

    Gipromellose 100.04 mg, sodium lauryl sulfate 9.44 mg, carbomer 20.00 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.1: 1] 39.52 mg, giprolase 6.00 mg, magnesium stearate 0, 50 mg, talc 4.00 mg

    Gelatin Capsule 76.00 mg

    Composition of empty gelatin capsules:

    Capsule body:

    Titanium dioxide (E 171) 0.91 mg, gelatin 44.62 mg, iron dye red oxide (E172) 0.05 mg, iron oxide dye yellow (E172) 0.02 mg

    Capsule cap:

    Iron dye red oxide (E172) 0.03 mg, iron dye oxide yellow (E172) 0.02 mg, titanium dioxide (E 171) 0.61 mg, gelatin 29.74 mg

    Composition of ink:

    Shellac 24-27%, anhydrous anhydrous * 23-26%, isopropanol * 1-3%, butanol * 1-3%, propylene glycol 3-7%, ammonia water ** 1-2%, iron dye oxide black (E172) 24-28%, potassium hydroxide 0.05-0.1%, water * 15-18%.

    1 capsule prolonged action of 24 mg contains:

    Active substance:

    Galanthamine hydrobromide 30.75 mg (equivalent to galantamine 24 mg)

    Excipients:

    Hypromellose 150.06 mg, sodium lauryl sulfate 14.16 mg, carbomer 30.00 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.1: 1] 59.28 mg, giprolase 9.00 mg, magnesium stearate 0, 75 mg, talc 6.00 mg

    Gelatin capsule 110.00 mg

    Composition of empty gelatin capsules:

    Capsule body:

    Titanium dioxide (E 171) 1.31 mg, gelatin 64.37 mg, ferric iron oxide red (E172) 0.18 mg, ferric iron oxide yellow (E172) 0.14 mg

    Capsule cap:

    Pig iron red oxide (E172) 0.12 mg, ferric iron oxide yellow (E172) 0.09 mg, titanium dioxide (E 171) 0.87 mg, gelatin 42.91 mg

    Composition of ink:

    Shellac 24-27%, anhydrous anhydrous * 23-26%, isopropanol * 1-3%, butanol * 1-3%, propylene glycol 3-7%, ammonia water ** 1-2%, iron dye oxide black (E172) 24-28%, potassium hydroxide 0.05-0.1%, water * 15-18%.

    * Ethanol anhydrous, isopropanol, butanol, water are volatile components and are not stored in the capsule.

    ** Ammonia water is used only for pH adjustment - present in amounts below the detection limit.

    Description:

    Capsules 8 mg:

    Hard gelatin capsules № 2. Body and capsule capsules are white. On the lid is marked with black ink inscription G8. Contents of the capsule: oval tablet - the core of white color.

    Capsules 16 mg:

    Hard gelatin capsules №1. The capsule body and capsule are pink. On the lid is marked with black ink inscription G16. Contents of the capsule: two oval tablets - white cores.

    Capsules 24 mg:

    Hard gelatin capsules №0. The body and cap of the capsule are orange-pink in color. On the lid is marked with black ink inscription G24. Contents of the capsule: three oval tablets - kernels of white color.

    Pharmacotherapeutic group:Dementia remedy
    ATX: & nbsp

    N.06.D.A.04   Galantamine

    Pharmacodynamics:

    Galantamine (tertiary alkaloid) is a selective, competitive and reversible inhibitor of acetylcholinesterase. Besides, galantamine enhances the effect of acetylcholine on nicotinic receptors, probably due to binding to the allosteric portion of the receptor. By increasing the activity of the cholinergic system, cognitive function may improve in patients with Alzheimer's dementia.

    Pharmacokinetics:

    Galantamine is the basic compound with a single dissociation constant (pKa 8.2). It has a weak lipophilicity with a distribution coefficient (LogP) between n-octanol and a buffer solution (pH 12) of 1.09. The solubility in water (pH 6) is 31 mg / ml. Galantamine has 3 chiral centers. S, R, S-Configuration is natural (natural). Galantamine partially metabolized by various cytochromes, mainly isoenzymes CYP2D6 and CYP3A4. Some of the metabolites formed during the degradation of galantamine are active in conditions in vitro, but do not have a significant value in the conditions in vivo.

    Suction

    Absolute bioavailability of galantamine when ingested is high - 88.5 ± 5.4%. The area under the "concentration-time" curve (AUC24h) and the minimum concentration (Cmin) in the blood plasma are similar to those when taking galantamine immediate release twice a day. The maximum concentration (Cmax) in the blood plasma is achieved through 4.4 h. Withmax galantamine prolonged action is 24% lower than after taking galantamine immediate release. Eating does not have a significant effect on the AUC, while it causes an increase in Cmax by about 12% and the extension of the time to reach Cmax (TCmax) - for about 30 minutes. However, these changes have no clinical significance.

    Distribution

    Average volume of distribution (Vd) is 175 liters. The degree of binding to plasma proteins is low and is 18%.

    Metabolism

    Research in vitro showed that the main isoenzymes of the cytochrome P450 system participating in the biotransformation of galantamine are - CYP2D6 and CYP3A4. Isozyme CYP2D6 is involved in the formation of O-desmethylgalanthamine, and isoenzyme CYP3A4 - N-Galanthamine oxide. Excretion of radioactive dose by the kidneys and through the intestine does not differ in patients with "slow" and "fast" metabolism (low and high isoenzyme activity CYP2D6 respectively). In the blood plasma of patients with "fast" and "slow" metabolism, most of the radioactive substances are unchanged galantamine and its glucuronide. After a single administration of galantamine, none of the active metabolites of galantamine (norgalanthamn, O-desmethylgalanthamine and O-desmethylnoghalanthamine) were detected in unconjugated form in the blood plasma of patients with "fast" and "slow" metabolism. Norgalantamine was detected in the blood plasma of patients after prolonged use of the drug, while its concentration was no more than 10% of the concentration of galantamine. Research in conditions in vitro indicate a very low ability of the main isoenzymes of the human cytochrome P450 system to inhibit galantamine.

    Excretion

    The excretion of galantamine is of a bi-exponential nature.The final half-life (T1/2) in healthy volunteers is 8-10 hours. Based on the results of the study of immediate release galantamine in population studies, the clearance with oral galantamine intake in the target population is usually about 200 ml / min with an interindividual variability of 30%.

    7 days after a single oral administration of 4 mg 3N-galantamine 90-97% of the radioactive dose is excreted by the kidneys in the form of unchanged galantamine and 2.2-6.3% through the intestine. After intravenous administration and oral administration, 18-22% of the dose was excreted as unchanged galantamine by the kidneys for 24 hours. The kidney clearance was 65 ml / min (20-25% of the total plasma clearance).

    Pharmacokinetics is linear in the dose range from 8 mg to 24 mg once a day in elderly patients and young patients.

    Pharmacokinetics of special groups of patients

    The results of clinical studies have shown that in patients with Alzheimer's disease the concentration of galantamine in blood plasma is 30-40% higher than in young healthy individuals. Based on the analysis of population pharmacokinetics data, the clearance in women is 20% lower compared to men.Galantamine clearance in patients with a "slow" isozyme metabolism CYP2D6 is 25% lower in comparison with patients with "fast" metabolism, while bimodality in the population is not observed. Thus, the patient's metabolic status is not considered clinically significant in the total population.

    Impaired liver function: in patients with mild violations of liver function (5-6 points on the Child-Pugh scale), the pharmacokinetic parameters of galantamine were similar to those of healthy people. In patients with moderate impaired liver function (7-9 on the Child-Pugh scale) AUC and T1/2 galantamine were increased by about 30%.

    Impaired renal function: in patients with Alzheimer's disease and renal dysfunction (creatinine clearance (CC) ≥ 9 mL / min) no dose adjustment is required.

    Pharmacokinetic-pharmacodynamic relationship

    In large phase III studies with a regimen of galantamine dosage of 12 mg and 16 mg twice daily, there was no apparent correlation between mean plasma concentrations and efficacy (changes in the cognitive function score for Alzheimer's disease (ADAS-cog/ 11) and the scale of assessing the patient's condition on the basis of impressions of the doctor and carers of patients (CIBIC-plus) at the 6th month of therapy).

    Concentrations in blood plasma in patients with syncope were in the same range as in other patients taking the same dose. The occurrence of nausea is correlated with a higher peak in plasma concentration.

    Indications:Symptomatic treatment of dementia of Alzheimer's type of mild and moderate severity.
    Contraindications:

    Hypersensitivity to galantamine hydrobromide and other components of the drug, severe liver dysfunction (more than 9 points by wkale Child-Pugh), severe renal dysfunction (QC less than 9 mL / min), children under 18 years of age (insufficient data on efficacy and safety).

    Carefully:

    Syndrome of weakness of the sinus node (SSSU), including bradycardia, violations of supraventricular conduction, period after acute myocardial infarction, hyperkalemia, hypokalemia, atrioventricular blockade of II-III degree, unstable angina, chronic heart failure of III-IV functional class according to NYNA classification , for the first time detected atrial fibrillation, concomitant use with drugs contributing to a decrease in the heart rate (heart rate) (digoxin, beta-adrenoblockers), sedatives, ethanol; hypertension, epilepsy, peptic ulcer and duodenal ulcer in the anamnesis, simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs), obstruction of the gastrointestinal tract (GI tract), condition after surgery on the gastrointestinal tract and bladder, obstruction of the urinary tract, bronchial asthma (BA), chronic obstructive pulmonary disease (COPD), acute infectious lung diseases, general anesthesia.

    Pregnancy and lactation:
    There are no clinical data on the use of galantamine in pregnant women. Studies in animals have revealed reproductive toxicity. Care should be taken when using the drug Galnor® SR in pregnant women.

    There is no data on the isolation of galantamine with breast milk. There have been no clinical studies on breastfeeding women, so the use of the drug Galnor® SR during breastfeeding is not recommended.

    Dosing and Administration:
    Inside, 1 time per day (in the morning), preferably during meals. Capsule to swallow whole, squeezed a small amount of liquid.Capsules should not be chewed or broken.

    Patients who have difficulty swallowing can take the contents out of the capsule and swallow whole and drink with water. The contents of the capsule should not be chewed or broken.

    Initial dose is 8 mg / day for 4 weeks.

    Maintenance dose is 16 mg / day for at least 4 weeks.

    - It is necessary to regularly monitor the patient's condition within 3 months from the start of therapy. In the future, the effectiveness of the drug and the patient's condition are regularly assessed in accordance with clinical recommendations. Supportive therapy can be continued as long as the therapeutic effect remains and with good tolerability of therapy. If there is no therapeutic effect or poor tolerability of therapy, the drug should be discarded.

    - The initial maintenance dose is 16 mg / day. Patients should take this dose for at least 4 weeks.

    - The question of increasing the maintenance dose to the maximum recommended 24 mg / day should be decided based on the analysis of the clinical situation, therapeutic effectiveness and tolerability of the therapy.

    - If increasing the dose to 24 mg / day does not lead to an increase in the effectiveness of treatment or is accompanied by a deterioration in tolerability, it is possible to reduce the dose to 16 mg per day.

    - With the sudden cessation of treatment (for example, before surgery), the "cancellation" syndrome does not develop.

    Transition from the therapy of galantamine in immediate-release tablets to long-acting capsules of Galnor® SR

    When switching from galantamine to immediate-release tablets, taken 2 times a day, for therapy with prolonged-action capsules, Galnor® CP, taken once a day, the daily dose should remain unchanged. The patient should take the last tablet with immediate release in the evening and the next day, in the morning, start taking the drug Galnor® CP once a day.

    In case of a break in taking the drug for several days, you should take the initial dose of the drug Galnor® SR and then increase the dose according to the above scheme to the previous maintenance dose.

    Impaired liver function

    In patients with moderate and severe impairment of liver and / or kidney function, the concentration of galantamine in the blood plasma may increase.

    In patients with moderate impairment of liver function, the recommended initial dose is 8 mg once a day every other day, preferably in the morning, for one week. In the future, the dose is increased to 8 mg / day for 4 weeks. In such patients, the daily dose should not exceed 16 mg.

    In patients with mild violations of the liver, dose adjustment is not required.

    Impaired renal function

    In patients with QC greater than 9 ml / min, dose adjustment is not required.

    Combination Therapy

    With the simultaneous use of potent inhibitors of isoenzymes CYP2D6 or CYP3A4, it may be necessary to reduce the dose of the drug Galnor ® SR (see the section "Interaction with other drugs").

    Side effects:

    The most frequent undesirable effects were nausea and vomiting. In general, the adverse events were episodic, were observed with the selection of a dose of galantamine and lasted, in most cases, less than a week. In these cases, it is advisable to use antiemetics and provide adequate fluid intake.

    The frequency and nature of adverse events with galantamine in the form of prolonged-action capsules are comparable to those obtained with immediate-release tablets once daily.

    Classification of the frequency of development of side effects of the World Health Organization (WHO):

    Often

    ≥ 1/10

    often

    from ≥ 1/100 to <1/10

    infrequently

    from ≥ 1/1000 to <1/100

    rarely

    from ≥ 1/10000 to <1/1000

    rarely

    < 1/10000

    frequency unknown

    can not be estimated from the available data.
    Table

    Classification by Med-DRA

    Frequency

    Often

    Often

    Infrequently

    Rarely

    Rarely

    Immune system disorders:

    Hypersensitivity

    Disorders from the metabolism and nutrition:

    Decreased appetite, anorexia

    Dehydration (in rare cases leading to the development of renal failure)

    Disorders of the psyche:

    Hallucinations, depression (very rarely with suicide)

    Visual hallucinations, auditory hallucinations, aggression, agitation

    Impaired nervous system:

    Fainting, dizziness, tremor, headache, drowsiness, retardation, insomnia, fever

    Paresthesia, taste perversion, hypersomnia, convulsions *, cerebrovascular disease, transient ischemic heart disease

    Exacerbation of Parkinson's disease, seizures

    Disorders from the side of the organ of vision:

    Blurred vision

    Hearing disorders and labyrinthine disturbances:

    Noise in ears

    Heart Disease:

    Bradycardia

    Supraventricular extrasystole, atrioventricular blockade of I degree, sinus bradycardia, palpitations, arrhythmia, acute myocardial infarction, coronary heart disease, tachycardia

    Vascular disorders:

    Arterial hypertension,

    Arterial hypotension, sensation of "hot flashes"

    Disorders from the gastrointestinal tract:

    Vomiting, nausea

    Abdominal pain, upper abdominal pain, diarrhea, dyspepsia, a feeling of discomfort in the stomach, a feeling of discomfort in the abdomen

    Desires for vomiting

    Dysphagia, gastrointestinal bleeding

    Disorders from the liver of the izhelchevyvodayuschih ways:


    Hepatitis

    Disturbances from the skin and subcutaneous tissues:

    Hyperhidrosis

    Skin rash

    Musculoskeletal and connective tissue disorders:

    Muscle Cramps

    Muscle weakness

    General disorders and disorders at the site of administration:

    Increased fatigue, asthenia, malaise, weakness


    Laboratory and instrumental data:

    Weight loss

    Increased activity of "liver" enzymes

    Trauma, intoxication and complications of manipulation:

    Falling, injuries


    * Potentially cholinomimetic drugs can cause seizures.
    Overdose:

    Symptoms: perhaps the symptoms of galantamine overdose are similar to the symptoms of an overdose by other cholinomimetics. Usually, there are changes in the central nervous system, parasympathetic nervous system and neuromuscular synapses. There may be muscle weakness or fasciculation, as well as some or all of the symptoms of the cholinergic crisis: severe nausea, vomiting, abdominal cramping, increased salivation, lacrimation, urinary and fecal incontinence, increased sweating, bradycardia, lowering blood pressure, collapse and convulsions. The expressed muscular weakness in a combination to a hypersecretion of a mucosa of a trachea and a bronchospasm can lead to life threatening a disturbance of patency of respiratory ways.

    In post-marketing surveillance, reports of a bi-directional-fusiform (polymorphic) ventricular tachycardia such as pirouette, lengthening of the interval QT, Bradycardia, ventricular tachycardia with transient loss of consciousness with an inadvertent overdose of galantamine.In one of these cases, the patient ingested 32 mg galantamine within one day.

    In addition, two cases of accidental use of galanthamine at a dose of 32 mg (nausea, vomiting and dryness of the oral mucosa, nausea, vomiting and retrosternal pain) and one case in a dose of 40 mg (vomiting) with complete recovery. One patient with a history of hallucinations within the previous two years (who was prescribed 24 mg / day) with unintentional use of galantamine at a dose of 24 mg twice a day for 34 days developed hallucinations requiring hospitalization. Another patient (who was prescribed 16 mg / day of galantamine, a solution for oral administration) developed an excessive sweating, vomiting, bradycardia and a condition close to fainting an hour after the accidental application of galantamine at a dose of 160 mg (40 ml of oral solution) that required hospitalization of the patient. Symptoms of an overdose disappeared within 24 hours.

    Treatment: symptomatic therapy. In severe cases, as an antidote, intravenously atropine in a dose of 0.5-1.0 mg, then the dose is selected taking into account the patient's condition.

    Interaction:

    Pharmacodynamic interaction

    Simultaneous application from other cholinomimetic preparations (ambenonium chloride, donepezil, neostigmine methylsulfate, pyridostigmine bromide, rivastigmine or pilocarpine system action) it is contraindicated.

    Galantamine is an antagonist of anticholinergic drugs. With a sudden reversal of the anticholinergic drug, for example, atropine it is possible to enhance the effect of galantamine.

    As with other cholinomimetic agents, pharmacodynamic interaction with drugs that help to reduce heart rate (digoxin, beta-blockers), some blockers of "slow" calcium channels (BCC) and amiodarone. Care should be taken when applying simultaneously drugs that have the potential to cause a polymorphic ventricular tachycardia of the type "pirouette". In such cases it is necessary to undergo ECG-controlled treatment.

    Galantamine, which is holinomimetic, can enhance the blockade of neuromuscular transmission of the depolarizing type (miorelaxation) caused by general anesthesia (when used as a peripheral muscle relaxant suksametoniya), especially with pseudocholinesterase deficiency.

    With simultaneous application galantamine strengthens the action depolarizing muscle relaxants, weakens - nondepolarizing muscle relaxants, is a weak antagonist morphine and its structural analogues with respect to the inhibitory effect on the respiratory center.

    Strengthens the action ethanol and sedative drugs.

    Restores neuromuscular conduction, blocked nondepolarizing muscle relaxants (tubocurarine bromide, etc.).

    M-holinoblokatory (atropine and etc.) eliminate peripheral muscarine-like effects of galantamine, Nondepolarizing muscle relaxants and ganglion blockers - nicotine-like effects of galatamine.

    Pharmacokinetic interaction

    Elimination of galantamine occurs by metabolic reactions and excretion by the kidneys. The risk of clinically significant pharmacokinetic interaction is low. However, in some cases clinically significant interaction is possible. The ingestion of food slows the absorption of galantamine, while not affecting the degree of absorption.Galnor® CP capsules should be taken with meals to reduce possible cholinergic side effects.

    Other drugs that affect the metabolism of galantamine

    With simultaneous application from paroxetine (a potent inhibitor of the isoenzyme CYP2D6) or with ketoconazole and erythromycin (isoenzyme inhibitors CYP3A4) increases the bioavailability of galantamine (magnitude AUC) by about 40% or 30% and 12%, respectively. Therefore, at the beginning of treatment powerful inhibitors of isoenzyme CYP2D6 (eg, quinidine, paroxetine or fluoxetine) or isoenzyme inhibitors CYP3A4 (e.g., ketoconazole or ritonavir) it is possible to increase the incidence of cholinergic unwanted reactions, mainly nausea and vomiting. In these cases, it is advisable to reduce the maintenance dose of the drug Galnor® SR (see the section "Method of administration and dose").

    Simultaneous application a receptor antagonist N-methyl-D-aspartate (NMDA) memantine in a dose of 10 mg once a day for 2 days, and then 10 mg twice a day for 12 days did not affect the pharmacokinetics of galantamine in the equilibrium state after taking 16 mg galantamine in the form of sustained-release capsules once a day.

    The influence of galantamine on the metabolism of other drugs (LS)

    Galantamine in therapeutic doses (24 mg / day) did not affect the pharmacokinetics digoxin, the pharmacodynamic interaction is not excluded.

    Galantamine in therapeutic doses (24 mg / day) also did not affect the pharmacokinetics warfarin and prolongation of prothrombin time.

    Research in conditions in vitro showed that galantamine has a weak inhibitory ability in respect of basic isoenzymes of cytochrome P450.

    Special instructions:

    The drug Galnor ® SR is indicated for the treatment of dementia of the Alzheimer's type of mild and moderate severity. Efficacy of galantamine in patients with other types of dementia and other memory disorders has not been established. There is also no positive effect of the use of galantamine (for 2 years) on the delay of cognitive impairment and the slowing of the transition to clinically pronounced dementia in patients with the syndrome of "soft" cognitive decline ("soft" types of memory impairment that do not meet the criteria of Alzheimer's dementia ). Mortality galantamine group was significantly higher than in the placebo group, 14/1026 (1.4%) patients treated with galantamine, and 3/1022 (0.3%) of patients receiving placebo.

    The causes of deaths were different. About half of the cases of deaths in the galantamine group was a result of various vascular causes (myocardial infarction, stroke, and sudden death). The significance of the data obtained for the treatment of patients with Alzheimer's dementia is unknown. Placebo-controlled studies of patients with Alzheimer's dementia were performed only for 6 months. In these studies, mortality in the galantamine group did not increase.

    Treatment with the drug Galnor® SR should be carried out only under the supervision of a doctor and under the supervision of a person providing care for the patient.

    In patients with Alzheimer's disease, body weight decreases. Treatment with cholinomimetic agents, including galantamine, accompanied by a decrease in body weight, so during therapy should monitor this figure.

    Like other cholinomimetic drugs, the preparation Galnor ® SR should be used cautiously in the following diseases:

    Diseases of the cardiovascular system

    Due to pharmacological action holinomimeticheskie funds can cause vagotonic effects (for example, bradycardia).It should be used with caution in patients with SSSU and other disorders of supraventricular conduction, with simultaneous therapy with drugs that lower heart rate (digoxin and beta-adrenoblockers) and in patients with electrolyte metabolism disorders (hyperkalemia, hypokalemia), in the period after acute myocardial infarction; with newly diagnosed atrial fibrillation; in patients with atrioventricular blockade of grade II-III, unstable angina or chronic heart failure, especially III-IV functional class by classification NYHA.

    Against the background of therapy with the drug Galnor ® SD dementia Alzheimer's type, the risk of unwanted reactions from the cardiovascular system increases.

    Diseases of the digestive system

    In patients with an increased risk of developing erosive-ulcerative gastrointestinal lesions (for example, peptic ulcer and 12 duodenal ulcer in the anamnesis, therapy with NSAIDs), it is necessary to monitor the condition for the purpose of early detection of the corresponding pathological symptoms. The drug Galnor ® SR is not recommended for patients with gastrointestinal obstruction or after a recent surgicalinterference with the gastrointestinal tract.

    Diseases of the nervous system

    The use of cholinomimetic agents can cause seizures. It should be remembered that convulsive activity may be a manifestation of Alzheimer's disease itself. In rare cases, the strengthening of cholinergic tone may cause a worsening of Parkinson's disease.

    In patients with dementia of the Alzheimer's type, galantamine, rarely noted the development of cerebrovascular events. This should be considered in the appointment of galantamine to patients with cerebrovascular disease.

    Diseases of the respiratory system

    The drug Galnor® SR should be administered with caution to patients with severe asthma, COPD, acute infectious lung diseases (eg pneumonia).

    Diseases of the kidneys and urinary tract

    The drug Galnor ® SR is not recommended for patients with obstruction of the urinary tract who have recently undergone a surgical procedure on the bladder.

    General anesthesia

    Galantamine, which is holinomimetic, can enhance the blockade of neuromuscular transmission of the depolarizing type (miorelaxation) caused by general anesthesia (when used as a peripheral muscle relaxant suksametoniya), especially with pseudocholinesterase deficiency.

    With sudden discontinuation of treatment (for example, before surgery), the "cancellation" syndrome does not develop.

    Influence on the ability to manage transport and other technical devices: the preparation Galnor ® SR, like other cholinomimetic agents, can cause drowsiness and dizziness, which adversely affect the management of transport and other mechanisms, especially in the first weeks after the start of treatment.

    Effect on the ability to drive transp. cf. and fur:PGalanol ® SR, like other cholinomimetic drugs, can cause drowsiness and dizziness, which adversely affect the management of transport and other mechanisms, especially in the first weeks after the start of treatment.

    Form release / dosage:

    Capsules of prolonged action, 8 mg, 16 mg and 24 mg.

    Packaging:

    For 7 capsules, 10 capsules or 14 capsules in a blister of the combined material OPA / Al / PVC and aluminum foil (OPA/Al /PVC foil and aluminium foil) or from the composite material PVC / PE / PVDC and aluminum foil.

    For 1, 4, 8 and 12 blisters (a blister for 7 capsules) or 3, 6 and 9 blisters (a blister for 10 capsules), or 2, 4 and 6 blisters (14 capsules blister) are placed in a cardboard box together with instructions for use.

    Storage conditions:

    In a place protected from moisture, at a temperature of no higher than 25 ° C, in the original packaging.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002417
    Date of registration:03.04.2014
    Expiration Date:03.04.2019
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp15.03.2017
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