Nebilet plus pills p/o 5mg/12.5mg №14×2

Name:
Neticket Plus.
Description:
The active ingredients of Nebilet® Plus 5/12.5 are nebivolol and hydrochlorothiazide. Nebivolol belongs to the group of selective beta-blockers (i.e., it has a selective effect on the cardiovascular system) and is used to treat cardiovascular diseases. It prevents an increase in heart rate and controls the pumping function of the heart. Nebivolol also dilates blood vessels, which helps lower blood pressure. Hydrochlorothiazide is a diuretic and increases the amount of urine produced. Nebilet® Plus 5/12.5 tablets is a combination drug of nebivolol and hydrochlorothiazide and is used to treat arterial hypertension (high blood pressure). It is prescribed instead of two separate drugs, nebivolol and hydrochlorothiazide, to those patients who previously received them together. The main active ingredient is Nebivolol and hydrochlorothiazide. Release form Almost purple, round, slightly biconvex film-coated tablets with “5/25” embossed on one side. One original package contains: 1 blister containing 14 film-coated tablets and leaflet; 2 blisters containing 14 coated tablets each and a leaflet; Blister of white SOS polymer film and hard aluminum foil (PP/SOS/PP/aluminium). Indications for use Nebivolol belongs to the group of selective beta-blockers (i.e., it has a selective effect on the cardiovascular system) and is used to treat cardiovascular diseases. It prevents an increase in heart rate and controls the pumping function of the heart. Nebivolol also dilates blood vessels, which helps lower blood pressure. Hydrochlorothiazide is a diuretic and increases the amount of urine produced. Nebilet® Plus 5/12.5 tablets is a combination drug of nebivolol and hydrochlorothiazide and is used to treat arterial hypertension (high blood pressure). It is prescribed instead of two separate drugs, nebivolol and hydrochlorothiazide, to those patients who previously received them together. Dosage and administration Always take the medicine in accordance with the recommendations of your doctor. If you have any questions about treatment, please contact your doctor. The drug is taken one tablet a day, preferably at the same time. Nebilet® Plus 5/12.5 can be taken before, during or after meals, or between meals. Use in children and adolescents under 18 years of age. Do not give Nebilet® Plus 5/12.5 to children and adolescents under 18 years of age. The notch is intended solely to facilitate the breaking of the tablet in case of difficulty in swallowing the tablet whole. If you overdose If you accidentally overdose, tell your doctor or pharmacist immediately. The most common symptoms and signs of overdose are a very slow heart rate (bradycardia), low blood pressure with possible fainting, difficulty breathing (as in bronchial asthma), acute heart failure, frequent urination profusely followed by dehydration, nausea and drowsiness, muscle cramps, heart problems rhythm (especially when taking cardiac glycosides or drugs for the treatment of arrhythmias). If you forgot to take a medicine If you forgot to take Nebilet® Plus 5/12.5 on time and remembered it a little later, take the usual dose of the medicine. However, if you remember this late enough (for example, several hours after the scheduled time), when the next dose is due, then you need to skip the forgotten dose and take the next normal dose at the scheduled time. Do not take a double dose of medicine to make up for a missed one. Try to take the medicine at the appointed time, without gaps. In case of discontinuation Be sure to consult your doctor before stopping Nebilet® Plus 5/12.5. If you have any questions about your treatment, ask your doctor or pharmacist. Use during pregnancy and lactation Be sure to tell your doctor if you are pregnant or think you are pregnant. It is likely that the doctor will cancel Nebilet® Plus 5/12.5 and prescribe you another drug instead, since it is not recommended to take Nebilet® Plus 5/12.5 during pregnancy. The reason for this is that hydrochlorothiazide crosses the placental barrier. Taking Nebilet® Plus 5/12.5 during pregnancy may have adverse effects on the fetus and subsequently on the newborn. If you are breastfeeding or intend to breastfeed, tell your doctor. It is not recommended to take Nebilet® Plus 5/12.5 during breastfeeding. If you are pregnant or breastfeeding, or if you may or might be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Precautions In the following cases, before taking Nebilet® Plus 5/12.5, you should seek the advice of a doctor or pharmacist. In the presence or development of the following conditions, immediately notify your doctor: – pain behind the sternum due to a sudden spasm of the heart vessels (Prinzmetal’s angina); – cardiac (atrioventricular) blockade of the 1st degree (a slight violation of the conduction of impulses in the heart muscle, affecting the rhythm of the heart); – pronounced decrease in heart rate; – untreated chronic heart failure; – systemic lupus erythematosus (a disease of the immune system that protects the body); – psoriasis (skin disease, manifested by the formation of scaly pink plaques) now or in the past; – increased activity of the thyroid gland: in this case, the drug may mask an increase in heart rate; – violation of blood circulation in the vessels of the arms or legs, for example, Raynaud’s disease or syndrome, pain when walking due to narrowing of the vessels of the legs; – allergies: this medicine may increase allergic reactions to pollen or other allergens; – prolonged difficulty breathing; – diabetes mellitus: this drug may mask the symptoms of a decrease in blood glucose concentration (for example, increased or rapid heartbeat) or require an increase in the dose of antidiabetic drugs, you may need to check your blood sugar more often; – impaired renal function: during treatment, kidney function is checked to prevent deterioration; in case of severe impairment of kidney function, Nebilet® Plus 5/12.5 is contraindicated (see paragraph “In the following cases, the drug is contraindicated”); – with a low level of potassium in the blood and, especially, with long QT syndrome (ECG deviation), or during treatment with cardiac glycosides (drugs to improve the pumping function of the heart); the risk of a decrease in the concentration of potassium in the blood increases with cirrhosis of the liver, rapid loss of water during treatment with diuretics, or with insufficient intake of potassium from food; – when performing a surgical operation before anesthesia, be sure to inform the anesthesiologist that you are taking Nebilet® Plus 5/12.5; Nebilet® Plus 5/12.5 can increase the level of lipids and uric acid in the blood, as well as change the concentration of electrolytes, and therefore control blood tests are performed during treatment. Hydrochlorothiazide, which is part of the drug Nebilet® Plus 5 / 12.5, may increase the sensitivity of the skin to sunlight or artificial UV radiation. If you experience a rash, itching, or skin sensitivity during treatment with Nebilet® Plus 5/12.5, stop taking it and contact your doctor (see also section Possible side effects). Anti-doping test: Nebilet® Plus 5/12.5 may cause a positive anti-doping test. In children and adolescents under 18 years of age Due to the lack of sufficient data on the use of the drug Nebilet® Plus 5 / 12.5 in children and adolescents under 18 years of age, it is not recommended to use the drug for the treatment of this group of patients. Nebilet® Plus 5/12.5 contains lactose This medicine contains lactose. If you have an intolerance to any sugars, talk to your doctor before taking this medicine. Interaction with other drugs If you are currently or have recently taken other drugs, be sure to tell your doctor or pharmacist. Be sure to tell your doctor if you are taking the following medicines in addition to Nebilet® Plus 5/12.5: – Medicines that, like Nebilet® Plus 5/12.5, may affect blood pressure and/or heart function: Medicines to control blood pressure or to treat heart disease (eg, amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecanide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine , nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil). Sedative and psychotic medicines (mental disorders) e.g. amylsulpiride, barbiturates (also used to treat epilepsy), chlorpromazine, cyamemazine, droperidol, haloperidol, levomepromazine, narcotic medicines, phenothiazine (also used to treat vomiting and nausea), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoroperazine. Medicines to treat depression, eg amitriptyline, fluoxetine, paroxetine. Drugs used for anesthesia in surgical operations. Medicines to treat bronchial asthma, relieve nasal congestion, and medicines to treat certain eye conditions such as glaucoma (increased intraocular pressure) or pupil dilation. Baclofen (an antispastic drug). Amifostine (a protective agent used during cancer treatment). – Means, the effect or toxicity of which may increase when combined with Nebilet® Plus 5 / 12.5: Lithium preparations (used to normalize mood). Cisapride (used to treat digestive disorders). Bepridil (used to treat angina). Difemanil (used for excessive sweating). Medicines to treat infections: erythromycin (intravenous or intramuscular), pentamidine and sparfloxacin, amphotericin and penicillin G (sodium salt), halofantrine (used for malaria). Vincamine (used for disorders of cerebral circulation). Mizolastine and terfenadine (used to treat allergies). Diuretics and laxatives. Agents for the treatment of acute inflammatory processes: steroids (eg cortisone and prednisone), ACTH (adrenocorticotropic hormone) and salicylic acid derivatives (eg acetylsalicylic acid/aspirin and other salicylates). Carbenoxolone (used to treat heartburn and stomach ulcers). Calcium salts (used as nutritional supplements to strengthen bones). Muscle relaxers (eg tubocurarine). Diaxoside (used for low blood sugar and high blood pressure). Amantadine (an antiviral drug). Cyclosporine (used to suppress the immune system). Iodine-containing contrast agents (used for contrast radiography). Medicines for the treatment of malignant neoplasms (eg, cyclophosphamide, fluorouracil, methotrexate). – Medicines that may be less effective when combined with Nebilet® Plus 5/12.5: Medicines that lower blood sugar levels (insulin and oral antidiabetic medicines, metformin). Medicines to treat gout (eg, probenicide, sulfinpyrazone, and allopurinol). Medicines similar to norepinephrine are used for low blood pressure or slow heart rate. – Medicines used to eliminate pain and inflammation (nonsteroidal anti-inflammatory drugs), which can reduce the hypotensive effect of Nebilet® Plus 5/12.5: – Medicines used for hyperacidity and peptic ulcer disease (antacids): Nebilet® Plus 5/ 12.5 should be taken with meals, antacid – in between meals. Nebilet® Plus 5/12.5 and alcohol Alcohol should be consumed with caution during treatment with Nebilet® Plus 5/12.5, as dizziness or fainting may occur. With the development of these phenomena, you should stop drinking any alcohol, including wine, beer or low-alcohol cocktails, while taking the drug. Contraindications for allergy to nebivolol or hydrochlorothiazide, or other components of Nebilet® Plus 5 / 12.5 (listed in the Composition section); if you are allergic (hypersensitive) to other sulfonamide derivatives (such as hydrochlorothiazide, which belongs to the class of sulfonamide derivatives); in the presence of one or more of the following disorders: – very rare pulse (less than 60 beats per minute); – other serious heart rhythm disturbances (for example, sick sinus syndrome, sinoatrial block, atrioventricular block 2 and 3 degrees); – recent or worsening heart failure, treatment of vascular insufficiency against the background of acute heart failure with intravenous drugs that improve heart function; – low blood pressure; – severe circulatory disorders in the vessels of the arms or legs; – untreated pheochromocytoma – a tumor located in the region of the upper pole of the kidney (tumor of the adrenal glands); – severe impairment of kidney function, complete cessation of urine output (anuria); – metabolic disorders (metabolic acidosis), for example, diabetic ketoacidosis; – asthma or difficulty breathing (currently or in the past); – impaired liver function; – high blood calcium levels, low blood potassium levels, low blood sodium levels for a long time, not amenable to treatment; – high uric acid levels and symptoms of gout. The active ingredients of the drug are nebivolol and hydrochlorothiazide. One tablet contains 5 mg of nebivolol (as nebivolol hydrochloride: 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 12.5 mg of hydrochlorothiazide. – The other ingredients are: tablet core: lactose monohydrate; polysorbate 80 (E433); hypromellose (E464); corn starch; croscarmellose sodium salt (E468); microcrystalline cellulose (E460); silicon dioxide colloidal anhydrous (E551); magnesium stearate (E572); film coat: macrogol-40 stearate, type I; titanium dioxide (E171); carmine (aluminum varnish of carminic acid, E120); hypromellose (E464); microcrystalline cellulose (E460). Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported for nebivolol: Common side effects (may affect up to 1 in 10 patients): – headache; – dizziness; – increased fatigue; – sensation of burning, tingling or “crawling” on the skin; – diarrhea; – constipation; – nausea; – shortness of breath; swelling of the hands or feet. Uncommon side effects (may affect up to 1 in 100 people): – slow heart rate or other changes in the heart; – lowering blood pressure; – pain in the legs when walking; – visual impairment; – impotence; – depression; – indigestion, accumulation of gases in the stomach or intestines, vomiting; – skin rash, itching; – difficulty breathing (as in bronchial asthma) due to a sudden spasm of the muscles of the respiratory tract (bronchospasm); – Nightmarish dreams. Very rare side effects (may affect up to 1 in 10,000 patients): – fainting; – exacerbation of psoriasis (skin disease with the appearance of scaly pink plaques). The following side effects were observed only in a few patients: – systemic allergic reactions with extensive skin rashes (hypersensitivity reactions); – sudden swelling, especially in the lips and eyes, swelling of the tongue with possible sudden difficulty in breathing (angioneurotic edema); – skin rash, which is a pale red, itchy, raised above the skin level pimples of an allergic or non-allergic nature (urticaria). For hydrochlorothiazide, the following side effects are noted: Allergic reactions – a systemic allergic reaction (anaphylactic reaction). Cardiovascular system – heart rhythm disturbance, palpitations; – changes in the electrocardiogram; – sudden fainting when standing up, the formation of blood clots in the veins (thrombosis) and embolism, vascular collapse (shock). Blood – a change in the concentration of blood cells, for example, a decrease in the level of leukocytes, platelets, erythrocytes, impaired hematopoiesis in the bone marrow; – changes in the fluid content (dehydration) and electrolytes in the body, in particular a decrease in the level of potassium, sodium, magnesium, chlorine and an increase in the level of calcium; – increased uric acid levels, gout, increased blood glucose levels, diabetes mellitus, metabolic alkalosis (metabolic disorders), increased cholesterol and (or) triglycerides. Gastrointestinal tract – loss of appetite, dry mouth, nausea, vomiting, stomach discomfort, abdominal pain, diarrhea, decreased intestinal motility (constipation), cessation of intestinal motility (intestinal obstruction), flatulence; – inflammation of the salivary glands, inflammation of the pancreas, increased levels of amylase (pancreatic enzyme) in the blood; – yellowing of the skin (jaundice), inflammation of the gallbladder. Chest organs – respiratory depression, inflammation of lung tissue (pneumonitis), fibrous tissue in the lungs (interstitial lung disease), accumulation of fluid in the lungs (pulmonary edema). Nervous system – vestibular vertigo (sense of rotation); – convulsions, clouding of consciousness, coma, headache, dizziness; – apathy, confusion, depression, irritability, anxiety, sleep disturbance; – an unusual sensation of burning, stinging or “goosebumps” on the skin; – muscle weakness (paresis). Skin and hair – itching, red patches/rash on the skin (hemorrhagic purpura), hives (urticaria), skin sensitivity to sunlight, rash, facial rash and/or patchy rash with scarring (cutaneous form of systemic lupus erythematosus) ), inflammation of blood vessels with subsequent necrosis of their walls (necrotizing vasculitis), peeling, redness of the skin, blistering, peeling of skin flaps (toxic epidermal necrolysis). Organs of vision and organs of hearing – the perception of the environment in yellow, blurred vision, aggravation of myopia, a decrease in tearing. Joints and muscles – muscle cramps, muscle pain. Urinary system – impaired renal function, acute renal failure (with a decrease in urine production and accumulation of fluid and toxins in the body), inflammation of the connective tissue of the kidneys (interstitial nephritis), the appearance of glucose in the urine. Reproductive system – erectile dysfunction. Systemic phenomena / other – general weakness, fatigue, fever, thirst. Reporting side effects If you experience any side effects, talk to your doctor, pharmacist or nurse. This applies to any possible side effects, including those not described in this leaflet. You can also report side effects directly through the national alert system. By reporting side effects, you can help gather more information about the safety of this medicine. Storage conditionsKeep out of the reach of children. This medicinal product does not require special storage conditions. This medicinal product must not be used after the expiry date which is stated on the carton and on the blister pack (after “Best before”). The expiry date is the last day of the specified month. Any medicines should not be thrown into the sewer or with household waste. Talk to your pharmacist about how to dispose of unused medicine. These measures contribute to the protection of the environment. By reporting side effects, you can help gather more information about the safety of this medicine. plus tablets p / o 5mg / 12.5mg No. 14×2