Source: European Medicines Agency (EU)
Treatment of essential hypertension.
ADAPTUS/DELAMAN fixed dose combination (30 mg/10 mg) is indicated in patients whose blood pressure is not adequately controlled on delapril or manidipine alone (see section 4.3, 4.4, 4.5 and 5.1).
The usual posology is one tablet of ADAPTUS/DELAMAN once a day.
Individual dose titration with the components (delapril 30 mg and manidipine 10 mg) is recommended. If clinically acceptable, a direct switch from delapril or manidipine monotherapy to the fixed combination may be considered (see section 4.3, 4.4, 4.5 and 5.1).
Special care should be exercised when ADAPTUS/DELAMAN is used in elderly patients and patients with renal failure or hepatic insufficiency and dose titration should be performed using the single components delapril and manidipine according to the following approach:
Considering the possible impairment of renal function and the slowing down of metabolic processes in elderly patients; dose titration must be approached with caution. After appropriate dose titration with the components, the direct switch to half a tablet of the fixed combination may be considered.
Since in the presence of renal failure a reduced excretion of the component delapril occurs, dose adjustments are needed in patients with serum creatinine >3 mg/dl.
Due to the wide hepatic metabolization of the component manidipine, a dose reduction should be considered in patients with hepatic insufficiency, according to the severity of the concomitant disorder.
ADAPTUS/DELAMAN is contraindicated in children and adolescents (see section 4.3 and 4.4).
For oral use.
The tablet should be swallowed whole with sufficient water in the morning after breakfast.
Possible symptoms of an overdose include hypotension, shock, stupor, bradycardia, electrolyte disturbances, dehydration, and renal failure. Serum electrolytes and creatinine should be monitored frequently.
After intake of an overdose, the patient should be closely monitored preferably at an intensive care unit. If the tablets were taken recently, recommended measures include induction of vomiting, administration of activated charcoal and administration of a laxative and/or gastric lavage. Any dehydration, disturbances in the electrolyte balance and hypotension should be treated in an appropriate manner, e.g. plasma-substitution or – if the result is insufficient – with catecholamines. Due to the long pharmacological effect of manidipine, the cardiovascular function of patients who have taken an overdose should be monitored for 24 hours at least.
3 years.
After first opening:
2 months (14 and 28 tablets)
3.5 months (50 and 100 tablets)
Keep the bottle tightly closed.
(Only for 100 tablets pack sizes: Use completely the medicinal product contained in one bottle before opening the other bottle).
Primary container: bottle with child resistant closure. A silica gel tablet is included in the screw cap as dehydrating agent.
Final package: printed thin-cardboard box.
Pack sizes of 14, 28, 50 tablets of 30mg delapril and 10mg manidipine.
Pack sizes of 100 tablets (50x2 bottles) of 30mg delapril and 10mg manidipine.
Not all pack sizes may be marketed.
No special requirements.
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