What is Nevilol H and what is it used for:

Nevilol H contains the active ingredients:
•Nebivololbelongs to the group of selective beta-blockers (i.e. it acts selectively on the cardiovascular system). It reduces heart rate. It also dilates blood vessels, which helps to lower blood pressure.
•Hydrochlorothiazidebelongs to the group of diuretics and increases the amount of urine produced.

Nevilol H is used for the treatment of high blood pressure (hypertension). The medicine is prescribed to patients who were previously taking two separate medicines at the same time: nebivolol and hydrochlorothiazide.

What you need to know before taking Nevilol H:

Do not take Nevilol H:
• if you are allergic to nebivolol, hydrochlorothiazide, or any of the other ingredients of this medicine.
• if you are allergic to sulfonamide-derived substances (such as hydrochlorothiazide, which belongs to the sulfonamide group).
• if you have one or more of the following conditions:

• very slow heart rate (less than 60 beats per minute);

• other serious heart rhythm disorders (e.g. sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block);

• newly diagnosed or worsening heart failure, or treatment of circulatory failure in acute heart failure with intravenous medicines that improve heart function;

• low blood pressure;

• severe disturbances of blood circulation in the limbs;

• untreated pheochromocytoma – a tumor located near the upper pole of the kidney (adrenal gland tumor);

• severe kidney function impairment, complete cessation of urine output (anuria);

• metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis;

• asthma or breathing difficulties (current or past);

• liver function impairment;

• high blood calcium level, low blood potassium level, or long-lasting low blood sodium level that does not respond to treatment;

• high uric acid levels and symptoms of gout.

  
  

Special warnings and precautions:
Consult your doctor before taking Nevilol H.
Tell your doctor if you have or develop any of the following:
• chest pain caused by sudden spasm of the heart blood vessels (Prinzmetal’s angina);
• first-degree heart block (minor impairment of impulse conduction in the heart muscle affecting heart rhythm);
• marked slowing of heart rate;
• untreated chronic heart failure;
• systemic lupus erythematosus (a disease of the immune system);
• psoriasis (a skin disease characterized by scaly pink patches), current or past;
• increased thyroid activity: the medicine may mask symptoms of increased heart rate;
• circulation disorders in the blood vessels of the limbs, e.g. Raynaud’s disease or syndrome, pain when walking caused by narrowing of blood vessels in the lower limbs;
• allergy: the medicine may intensify allergic reactions to pollen or other allergens;
• long-term breathing difficulties;
• diabetes mellitus: the medicine may mask symptoms of low blood glucose (e.g. increased or rapid heartbeat); your doctor may ask you to check your blood sugar more often while taking Nevilol H, as adjustment of antidiabetic medicines may be required;
• kidney function impairment: monitoring of kidney function is recommended during treatment to prevent deterioration; Nevilol H is contraindicated in severe kidney impairment (see “Do not take Nevilol H”);
• low blood potassium levels, especially in prolonged QT interval syndrome (a type of ECG abnormality), or during treatment with cardiac glycosides; the risk of low potassium increases in liver cirrhosis, during diuretic treatment with rapid fluid loss, or with insufficient dietary potassium intake;
• before surgery and anesthesia, inform the anesthesiologist that you are taking Nevilol H;
• if you have skin cancer or if unexpected abnormal skin lesions appear during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sunlight and UV radiation during treatment;
• if you have had breathing or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing problems develop after taking Nevilol H, seek medical attention immediately.

During treatment:

• Nevilol H may increase blood lipid and uric acid levels.

• Nevilol H may alter electrolyte concentrations (magnesium, potassium, sodium, chloride); your doctor may order regular blood tests. This may cause symptoms such as dry mouth, thirst, weakness, fatigue, muscle weakness, pain or spasms, palpitations, dizziness, low blood pressure, anxiety, nausea, and reduced urine output. Inform your doctor if these occur.

• Hydrochlorothiazide in Nevilol H may increase skin sensitivity to sunlight or UV radiation. If rash, itching, or increased skin sensitivity occurs, stop taking Nevilol H and consult your doctor.

• If visual disturbances or eye pain occur during treatment, inform your doctor. These may be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma. Stop taking Nevilol H and seek medical help.

  
  

Laboratory tests:

• Doping tests: Nevilol H may cause a false positive result.

• Nevilol H may affect parathyroid gland function test results. Inform your doctor before such tests.

  
  

Children and adolescents:
Due to insufficient data, Nevilol H is not recommended for use in children and adolescents.

Taking Nevilol H with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Be sure to inform your doctor if you take the following with Nevilol H:

Medicines that, like Nevilol H, affect blood pressure and/or heart function:
• medicines for blood pressure control or heart disease (e.g. amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil).
• sedatives and medicines for psychoses (mental disorders), e.g. amisulpride, barbiturates (also used for epilepsy), chlorpromazine, cyamemazine, droperidol, haloperidol, levomepromazine, narcotics, phenothiazines (also used to treat nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine.
• medicines for depression (e.g. amitriptyline, fluoxetine, paroxetine).
• anesthetics used during surgery.
• medicines for bronchial asthma, nasal congestion, and certain eye conditions such as glaucoma, or pupil-dilating agents.
• baclofen (muscle relaxant).
• amifostine (protective agent used in cancer treatment).
• cholestyramine and colestipol (lower cholesterol).

Medicines whose effect or toxicity may be increased when combined with Nevilol H:
• lithium.
• cisapride.
• bepridil.
• diphemanil.
• anti-infective medicines: erythromycin (IV/IM), pentamidine, sparfloxacin, amphotericin, penicillin G (sodium salt), halofantrine.
• vincamine.
• mizolastine and terfenadine.
• diuretics and laxatives.
• anti-inflammatory medicines: steroids (e.g. cortisone, prednisone), ACTH, and salicylates (e.g. acetylsalicylic acid/aspirin).
• carbenoxolone.
• calcium salts (dietary supplements).
• muscle relaxants (e.g. tubocurarine).
• diazoxide.
• amantadine.
• cyclosporine.
• iodine-containing contrast agents.
• anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).

Medicines whose effect may be reduced when used with Nevilol H:
• medicines that lower blood glucose (insulin and oral antidiabetics, metformin).
• medicines for gout (e.g. allopurinol, probenecid, sulfinpyrazone).
• noradrenaline-like medicines.
• pain-relieving and anti-inflammatory medicines (NSAIDs), which may reduce the blood-pressure-lowering effect of Nevilol H.
• medicines for hyperacidity and ulcers (antacids), e.g. cimetidine, omeprazole: use with Nevilol H is not recommended due to possible interactions.

Taking Nevilol H with drinks:
Caution is advised when drinking alcohol during treatment, as dizziness or fainting may occur. If such effects develop, avoid alcohol (including wine, beer, or alcopops) during treatment.

Pregnancy and breastfeeding:
If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
As a rule, your doctor will prescribe another medicine instead of Nevilol H, as Nevilol H is not recommended during pregnancy. It crosses the placenta and may harm the fetus.
Nevilol H is not recommended during breastfeeding.

Driving and using machines:
This medicine may cause dizziness or fatigue. If affected, do not drive or use machines or tools.
Nevilol H contains lactose. If you have been told you have intolerance to certain sugars, consult your doctor before taking this medicine.

How to take Nevilol H
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor.

Recommended dose:1 tablet once daily, preferably at the same time each day, with water.
Nevilol H should be taken on an empty stomach, at least 30 minutes before meals.

If you have difficulty swallowing the whole tablet, it may be divided.

Children and adolescents:
Use is not recommended.

Overdose:
In case of overdose, contact your doctor or pharmacist immediately. Common symptoms include slow heart rate (bradycardia), low blood pressure, fainting, shortness of breath, acute heart failure, excessive urination with subsequent dehydration, nausea, drowsiness, muscle spasms, and heart rhythm disturbances.

Missed dose:

If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, wait and take it at the scheduled time. Do not take a double dose.

Consult your doctor before stopping Nevilol H.

Possible side effects:
Like all medicines, this medicine may cause side effects, although not everybody gets them.

Stop taking Nevilol H and seek medical attention immediately if you experience:
• systemic allergic reactions with generalized rash; sudden swelling, especially of the lips, eyes, or tongue, with breathing difficulty (angioedema). Frequency unknown.
• acute respiratory distress (severe shortness of breath, fever, weakness, confusion). Very rare.

Side effects reported with nebivolol:
Common:headache, dizziness, fatigue, unusual burning/tingling/itching/numbness, diarrhea, constipation, nausea, shortness of breath, swelling of hands or feet.
Uncommon:slow pulse, low blood pressure, leg pain when walking, visual disturbances, impotence, depression, digestive disorders, vomiting, rash, itching, bronchospasm, nightmares.
Very rare:fainting, worsening of psoriasis.
Frequency unknown:itching, rash, hives, hallucinations, psychosis, Raynaud’s syndrome, dry eyes, thickening of eyelids or sclera.

Side effects reported with hydrochlorothiazide:
(benign and malignant tumors, allergic reactions, cardiovascular, blood, metabolic, gastrointestinal, respiratory, nervous system, skin, eye, musculoskeletal, urinary, reproductive, and general disorders as listed in the original text).

Reporting side effects:
If you notice any side effects, including those not listed, tell your doctor or pharmacist. You can also report side effects through the national reporting system of Georgia.

How to store Nevilol H:
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use after the expiry date stated on the carton and blister.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of them.

Contents of Nevilol H:

• Active substances: nebivolol and hydrochlorothiazide.
  Each film-coated tablet contains 5 mg nebivolol (as nebivolol hydrochloride) and 12.5 mg hydrochlorothiazide.

• Other ingredients:
  Tablet core: lactose monohydrate, polysorbate 80, hypromellose (13.6 mPas), corn starch, microcrystalline cellulose, citric acid monohydrate, colloidal anhydrous silica, magnesium stearate.
  Coating: Opadry white 03A580004 [5/12.5 mg only], Opadry yellow 03A520012 [5/25 mg only], hypromellose (6 mPas), titanium dioxide (E171), polyoxyl (macrogol) stearate, microcrystalline cellulose, iron oxide yellow (E172) [5/25 mg only].

  
  

Dispensing conditions:
Pharmaceutical product group II, dispensed with prescription form No. 3

LLC New Pharma
Address: Georgia, Tbilisi 0154, Evdoshvili St. #18

Manufacturer:
Fine Foods & Pharmaceuticals N.T.M. S.P.A.
Italy, Brembate (BG), Grignano St. 43 – 24041