Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Adjunctive therapy for the treatment of symptomatic congestive heart failure to reduce morbidity and increase patient well-being.
Treatment of hypertension.
Long-term management of stable angina pectoris.
The dosage must be titrated to individual requirements and monitored during up-titration.
For those patients receiving diuretics and/or digoxin and/or ACE inhibitors, dosing of these other medicinal products should be stabilised prior to initiation of Eucardic treatment.
The recommended dose for the initiation of therapy is 3.125 mg (half a 6.25 mg tablet) twice a day for two weeks. If this dose is tolerated, the dosage should be increased subsequently, at intervals of not less than two weeks, to 6.25 mg twice daily, followed by 12.5 mg twice daily and thereafter 25 mg twice daily. Dosing should be increased to the highest level tolerated by the patient.
The maximum recommended dose is 25 mg twice daily for all patients with severe CHF and for patients with mild to moderate CHF weighing less than 85 kg (187 lbs). In patients with mild or moderate CHF weighing more than 85 kg, the maximum recommended dose is 50 mg twice daily.
Before each dose increase the patient should be evaluated by the physician for symptoms of worsening heart failure or vasodilation. Transient worsening of heart failure, vasodilation or fluid retention may be treated with increased doses of diuretics or ACE inhibitors or by modifying or temporarily discontinuing Eucardic treatment. Under these circumstances, the dose of Eucardic should not be increased until symptoms of worsening heart failure or vasodilation have been stabilised.
If carvedilol treatment is discontinued for more than one week, therapy should be recommenced at a lower dose level (twice daily) and up-titrated in line with the above dosing recommendation.
If Eucardic is discontinued for more than two weeks, therapy should be recommenced at 3.125 mg (half a 6.25 mg tablet) twice daily and up-titrated in line with the above dosing recommendation.
As for adults.
Once daily dosing is recommended.
The recommended dose for initiation of therapy is 12.5 mg once a day for the first two days. Thereafter the recommended dosage is 25 mg once a day. Although this is an adequate dose in most patients, if necessary the dose may be titrated up to a recommended daily maximum dose of 50 mg given once a day or in divided doses.
Dose titration should occur at intervals of at least two weeks.
An initial dose of 12.5 mg daily is recommended. This has provided satisfactory control in some cases. If the response is inadequate the dose may be titrated up to the recommended daily maximum dose of 50 mg given once a day or in divided doses.
The recommended dose for initiation of therapy is 12.5 mg twice a day for the first two days. Thereafter, the recommended dosage is 25 mg twice a day. If necessary, the dose may be titrated up to 50 mg twice a day.
Dose titration should occur at intervals of at least two weeks.
The recommended maximum daily dose is 50 mg given in divided doses.
As with all beta-blockers, treatment should not be stopped abruptly but rather gradually reduced at weekly intervals. This is particularly important in the case of patients with concomitant coronary heart disease.
Pharmacokinetic data and clinical studies in patients with renal impairment (including renal failure) suggest no dose adjustment is needed in moderate to severe renal impairment (see section 4.4 and 5.2).
The safety and efficacy of Eucardic in children and adolescents aged under 18 years has not been established (see section 5.1).
Eucardic tablets are for oral use only. The tablets should be taken with fluid.
For Congestive Heart Failure (CHF) patients Eucardic should be given with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
In the event of overdose, there may be severe hypotension, bradycardia, heart failure, cardiogenic shock, sinus arrest and cardiac arrest. There may also be respiratory problems, bronchospasm, vomiting, disturbed consciousness and generalised seizures.
The patients should be monitored for the above-mentioned signs and symptoms and managed according to the best judgment of the treating physicians and according to standard practice for patients with beta-blocker overdose (e.g. atropine, transvenous pacing, glucagon, phosphodiesterase inhibitor such as amrinone or milrinone, beta-sympathomimetics).
Gastric lavage or induced emesis may be useful in the first few hours after ingestion.
In cases of severe overdose with symptoms of shock, supportive treatment as described should be continued for a sufficiently long period of time, i.e. until the patient stabilises, since prolonged elimination half-life and redistribution of carvedilol from deeper compartments can be expected.
4 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture and light.
Oriented Polyamide/Aluminium/PVC blister.
Blisters are packed in cartons containing 14, 28, 30 or 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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