Blockadipine 10 mg 20 tablets

Blockadipine 10 mg 20 tablets

Composition:
Active ingredient:
Each film-coated tablet contains 10 mg of Lercanidipine hydrochloride, equivalent to 9.4 mg of Lercanidipine.
Excipients:
Tablet core: Lactose monohydrate, Microcrystalline cellulose (Avicel PH101), Sodium starch glycolate, Polyvinylpyrrolidone (PVP K30), Magnesium stearate, Purified water. Film coating (Opadry yellow II 85F32410): Polyvinyl alcohol, Titanium dioxide (C.I. 77891), Polyethylene glycol 4000, Iron oxide yellow (C.I. 77492), Talc.
Description:
Blockadipine 10 mg (Lercanidipine hydrochloride) is a calcium channel blocker of the dihydropyridine class used to treat essential hypertension.
It works by relaxing the smooth muscles of blood vessels, leading to vasodilation and a decrease in peripheral vascular resistance, thereby lowering blood pressure.
The drug provides a gradual onset and long-lasting antihypertensive effect with good tolerability.
Indications for Use:
Blockadipine is indicated in adults for the treatment of mild to moderate essential hypertension.
Dosage and Method of Administration:
- The recommended dose is 10 mg orally once daily, at least 15 minutes before meals. 
- Depending on the individual patient’s response, the dose may be increased to 20 mg once daily.
- Dose titration should be gradual, as the maximal antihypertensive effect may take up to 2 weeks to appear.
 - Patients not adequately controlled on monotherapy may benefit from combination therapy with a beta-blocker (atenolol), a diuretic (hydrochlorothiazide), or an ACE inhibitor (captopril, enalapril).
- Doses above 20 mg are unlikely to improve efficacy but may increase side effects.
Elderly:
No dose adjustment is generally required, but caution is advised when initiating therapy.
Children: Safety and efficacy in children under 18 years have not been established.
Renal/Hepatic impairment: Use with caution in mild to moderate impairment.
Do not use in severe renal (GFR < 30 ml/min) or hepatic impairment.
Method of administration:
Administer preferably in the morning, at least 15 minutes before breakfast.
Do not take with grapefruit juice.
Contraindications:
- Hypersensitivity to Lercanidipine or any excipient.
- Left ventricular outflow tract obstruction.
- Untreated congestive heart failure.
- Unstable angina pectoris or recent (<1 month) myocardial infarction.
- Severe hepatic impairment.
- Severe renal impairment (GFR < 30 ml/min), including dialysis patients.
- Co-administration with:
Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, erythromycin, clarithromycin).
Ciclosporin.
Grapefruit or grapefruit juice.
Precautions:
- Cardiac disorders: Use with caution in sick sinus syndrome (without pacemaker) and left ventricular dysfunction.
- Rarely may cause or worsen angina pectoris; isolated cases of myocardial infarction have been reported.
- Renal/hepatic impairment: Use with caution in mild/moderate impairment; contraindicated in severe impairment.
- Peritoneal dialysis: Lercanidipine has been associated with cloudy peritoneal effluent.
- Lactose intolerance: Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
- Sodium content: Contains less than 1 mmol sodium (23 mg) per tablet - essentially sodium-free.
- Driving and machine use: May cause dizziness, fatigue, or somnolence; use caution.
Side Effects:
- Common: Headache, dizziness, flushing, palpitations, tachycardia, peripheral edema, fatigue.
- Uncommon: Nausea, dyspepsia, abdominal pain, vomiting, rash, pruritus.
- Rare: Hypotension, gingival hypertrophy, increased liver enzymes, polyuria, myalgia, angina pectoris.
- Very rare: Syncope, urticaria, angioedema, chest pain, asthenia.
- Not known: Cloudy peritoneal effluent in peritoneal dialysis patients.
Pregnancy and Lactation:
- Pregnancy:
Not recommended. No human data; animal studies show no teratogenic effects, but similar drugs have.
Use only if clearly needed.
- Lactation: 
Unknown if excreted in human milk; avoid during breastfeeding.
Storage Conditions:
Store below 30°C, in a dry place, protected from light, in the original package.
Packaging:
Carton box containing 2 strips, each with 10 film-coated tablets, and a leaflet.