Nebilet Plus 5/12.5, 3p x 28 pills— Made in Germany — Free Delivery

Product description

Nebilet® Plus 5 / 12.5 tablets are used to treat essential hypertension. The preparation with a fixed combination "Nebilet® Plus 5 / 12.5" is indicated for patients whose blood pressure is properly controlled by the combined use of 5 mg of nebivolol and 12.5 mg of hydrochlorothiazide.

Composition

One film-coated tablet contains active ingredients):

nebivolol (as nebivolol hydrochloride) 5 mg

hydrochlorothiazide - 12.5 mg.

Excipients: polysorbate 80, hypromellose, lactose monohydrate, corn starch, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silicon dioxide, magnesium stearate; shell: hypromellose, microcrystalline cellulose, macrogol stearate, titanium dioxide (E 171), carminic acid (E 120).

Contraindications

• hypersensitivity to active ingredients or to any of the excipients listed in the "Composition" section;
• hypersensitivity to other substances - sulfonamide derivatives (since hydrochlorothiazide is a sulfonamide derivative);
• liver failure or liver dysfunction;
• anuria, severe renal failure (creatinine clearance less than 30 ml / minute);
• acute heart failure, cardiogenic shock or episodes of decompensated heart failure requiring the administration of preparations with a positive inotropic effect;
• sick sinus syndrome, including sinoatrial block;
• blockade of the second and third degree (without an implanted pacemaker);
• bradycardia (before starting treatment, the heart rate is less than 60 beats / minute);
• arterial hypotension (systolic blood pressure less than 90 mm Hg);
• severe disorders of peripheral circulation;
• a history of bronchospasm and bronchial asthma;
• untreated pheochromocytoma;
• metabolic acidosis;
• resistant hypokalemia, hypercalcemia, hyponatremia, and symptomatic hyperuricemia.

Mode of application

Adults. Nebilet® Plus 5 / 12.5 is indicated for patients in whom blood pressure is adequately controlled by the combined use of 5 mg of nebivolol and 12.5 mg of hydrochlorothiazide.

The dosage is one tablet (5 mg / 12.5 mg) per day, preferably at the same time of the day.

Method of use: oral administration. The tablets can be taken with meals.

Application features

Pregnant

There is no sufficient data on the use of Nebilet® Plus 5 / 12.5 by pregnant women. Animal studies of the two separate components are insufficient to establish the reproductive effect of a combination of nebivolol and hydrochlorothiazide.

The use of the preparation "Nebilet® Plus 5 / 12.5" during breastfeeding is not recommended. If Nebilet® Plus 5 / 12.5 is used during breastfeeding, the dose should be the smallest.

Children

The efficacy and safety of the preparation "Nebilet® Plus 5 / 12.5" in children and adolescents (under 18 years of age) have not been studied. No data available. Thus, the use of children and adolescents is not recommended.

Drivers

The study of the effect on the ability to drive vehicles and work with other mechanisms has not been conducted. However, when driving vehicles and working with mechanisms, it should be borne in mind that dizziness and fatigue may sometimes occur with antihypertensive therapy.

Overdose

Symptoms

There is no evidence of an overdose of nebivolol. Beta-blocker overdose symptoms: bradycardia, arterial hypotension, bronchospasm, and acute heart failure. An overdose of hydrochlorothiazide is associated with electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis. The most common signs and symptoms of a hydrochlorothiazide overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasms and / or cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic preparations .

Treatment

In case of overdose or hypersensitivity, the patient should be closely monitored in an intensive care setting.

Side effects

Nebivolol

Reported adverse reactions following nebivolol monotherapy were mild to moderate in most cases.

From the nervous system: headache, dizziness, paresthesia.

From the respiratory tract, chest and mediastinum: shortness of breath.

From the gastrointestinal tract: constipation, nausea, diarrhea.

Hydrochlorothiazide

Benign, malignant and unidentified neoplasms (including cysts and polyps): frequency unknown: non-melanoma skin cancer (NMSC) (basal cell carcinoma and squamous cell carcinoma).

NMSSH: Based on the available epidemiological data, an association was found between the cumulative dose of hydrochlorothiazide and NMSSH.

Blood and lymphatic system disorders: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow suppression.

Immune system disorders: anaphylactic reactions.

Disorders of metabolism and digestion: anorexia, dehydration, gout, diabetes mellitus, metabolic alkalosis, hyperuricemia, electrolyte imbalance (including hyponatremia, hypokalemia, hypomagnesemia, hypochloremia, hypercalcemia), hyperglycemia, hyperamilasemia.

Mental disorders: apathy, disorientation, depression, nervousness, agitation, sleep disturbance.

Disorders of the nervous system: convulsions, decreased level of consciousness, coma, headache, dizziness, paresthesia, paresis.

From the side of the organ of vision: xanthopsia, blurred vision, myopia (exacerbation), decreased lacrimation.

On the part of the hearing organs and the labyrinth: vertigo.

Cardiac disorders: arrhythmia, palpitations.

Vascular disorders: orthostatic hypotension, thrombosis, embolism, shock.

Respiratory, thoracic and mediastinal disorders: respiratory distress syndrome, pneumonia, interstitial lung disease, pulmonary edema.

Gastrointestinal disorders: dry mouth, nausea, vomiting, stomach discomfort, diarrhea, constipation, abdominal pain, paralytic intestinal obstruction, flatulence, sialadenitis, pancreatitis.

Hepatobiliary disorders: cholestatic jaundice, cholecystitis.

Skin and subcutaneous tissue disorders: itching, purpura, urticaria, photosensitivity reactions, rash, cutaneous lupus erythematosus, necrotic vasculitis, toxic epidermal necrolysis.

Musculoskeletal disorders, connective tissue and bone disorders: muscle spasms, myalgia.

From the side of the kidneys and urinary system: renal impairment, acute renal failure, interstitial nephritis, glycosuria.

On the part of the reproductive system and mammary glands: erectile dysfunction.

Storage conditions

No special storage conditions are required. Do not use after the expiration date. Keep out of the reach of children.

The shelf life is 3 years.