Nevilob Plus 5/12.5 mg 20 tablets

Nevilob Plus 5/12.5 mg 20 tablets

Composition:
Each tablet contains:
- Nebivolol hydrochloride 5.45 mg (equivalent to 5 mg nebivolol), 
- Hydrochlorothiazide 12.5 mg.
Excipients:
Polysorbate 80, hydroxypropyl methylcellulose 5 cps, lactose monohydrate, corn starch, croscarmellose sodium, microcrystalline cellulose PH102, colloidal silicon dioxide (Aerosil 200), magnesium stearate.
Product Description:
Nevilob Plus is a fixed-dose combination antihypertensive medicinal product containing the selective beta‑blocker nebivolol and the thiazide diuretic hydrochlorothiazide.
The two active substances reduce blood pressure through complementary mechanisms of action.
Indications for Use:
Treatment of hypertension in adult patients who have previously received nebivolol and hydrochlorothiazide as separate tablets.
Method of Administration and Dosage:
The usual dose is one tablet once daily.
The tablet should be taken at the same time each day, with or without food, swallowed whole with water.
Not recommended in children and adolescents under 18 years of age.
Contraindications:
- Hypersensitivity to nebivolol, hydrochlorothiazide, sulfonamide derivatives or any excipients.
- Hepatic impairment.
- Cardiogenic shock, acute or decompensated heart failure.
- Severe bradycardia (<60 bpm), marked hypotension.
- Severe peripheral circulatory disorders.
- Severe renal impairment, anuria.
- History of bronchospasm or asthma.
- Untreated pheochromocytoma.
- Metabolic acidosis.
- Electrolyte disturbances (hypokalaemia, hyponatraemia, hypercalcaemia), gout or history of urinary stones.
- Pregnancy and breastfeeding.
Precautions:
Use with caution in patients with:
- heart failure;
- cardiac conduction disorders;
- angina pectoris;
- peripheral vascular diseases;
- thyroid disorders;
- chronic respiratory diseases;
- psoriasis;
- systemic lupus erythematosus;
- allergic conditions.
During treatment, monitoring of blood electrolytes, glucose, lipid, and uric acid levels is necessary.
The medication may mask symptoms of hypoglycemia in patients with diabetes mellitus.
Visual disturbances and increased intraocular pressure (choroidal effusion, acute angle-closure glaucoma) are possible.
If eye pain or vision deterioration occurs, consult a physician immediately.
Long-term use of hydrochlorothiazide may increase the risk of non-melanoma skin cancer.
Protection from UV radiation and regular skin examinations are recommended.
The product contains lactose.
Adverse Reactions (Side Effects):
Nebivolol-related:
- headache, dizziness, fatigue, paraesthesia, diarrhoea, constipation, nausea, dyspnoea, peripheral oedema.
Less common
- bradycardia, hypotension, heart failure, visual disturbances, depression, nightmares, bronchospasm, skin reactions, erectile dysfunction.
Hydrochlorothiazide-related:
- Electrolyte disturbances, hyperglycaemia, hyperuricaemia, photosensitivity reactions, skin reactions.
Rare and very rare:
- thrombocytopenia, leukopenia, pancreatitis, hepatitis, severe skin reactions, non‑melanoma skin cancer, acute respiratory distress.
Pregnancy and lactation:
Nevilob Plus is contraindicated during pregnancy and breastfeeding.
Storage conditions:
Store at a temperature not exceeding 30 °C, in a dry place.
Keep out of reach of children
Packaging:
A carton box containing 2 blisters of 10 tablets each and a leaflet.