DILATREND is indicated for treatment of mild to moderate essential hypertension. DILATREND is indicated for the treatment of mild, moderate, and severe stable, symptomatic heart failure of ischaemic or cardiomyopathic origin. DILATREND may be used as adjunct to standard therapy. DILATREND has been used in patients unable to tolerate an ACE-inhibitor and patients who are, or are not, taking digoxin. DILATREND is indicated for long term treatment following otherwise uncomplicated myocardial infarction, but with left ventricular dysfunction (left ventricular ejection fraction (LVEF) ≤ 40 % or wall motion index ≤ 1,3), in combination with ACE -inhibitors and other treatments recommended in the management of patients after myocardial infarction.
1. What DILATREND is and what it is used for.
2. What you need to know before you take/use DILATREND.
Contraindications
DILATREND must not be used in patients with:
- Hypersensitivity to carvedilol or any component of the product.
- Severe heart disease.
- 2nd and 3rd degree atrioventricular (AV) block.
- Sick sinus syndrome (including sino-atrial block).
- Cardiogenic shock.
- Severe bradycardia (< 50 bpm).
- Asthma.
- Chronic obstructive pulmonary disease (COPD) with a bronchospastic component.
- Clinically manifest liver dysfunction.
- Safety in children has not been established.
- Severe hypotension (systolic blood pressure < 85 mmHg).
Special warnings and precautions for use
DILATREND should not be given to patients with bronchospasm or obstructive airways disease, allergic conditions involving the airways (e.g. allergic rhinitis, glottis oedema), metabolic acidosis, sinus bradycardia, or partial heart block. It should be given to patients with congestive heart failure only after having achieved adequate clinical control, and then only with great caution.
3. How to take/use DILATREND.
Method of Administration
The tablets are to be swallowed with sufficient fluid. In hypertensive patients it is not necessary to time the dose in relation to meals.
Duration of Treatment
Treatment with DILATREND is a long-term therapy. Treatment should not be stopped abruptly but rather gradually reduced at weekly intervals for one to two weeks. This is particularly important in the case of patients with concomitant coronary heart disease.
4. Possible side effects.
Undesirable effects
Adverse Drug Reactions (ADRs) are listed according to MedDRA system organ class and CIOMS frequency category: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (< 1/10 000); unknown (frequency cannot be established from the available data).
Table 1 below summarises undesirable effects that have been reported in association with the use of DILATREND in pivotal clinical trials with following indications: symptomatic congestive heart failure, left ventricular dysfunction following acute myocardial infarction, hypertension and the long-term management of coronary heart disease.
| System Organ Class | Adverse Reaction | Frequency |
|---|---|---|
| Blood and lymphatic system disorders | Anaemia | Common |
| Cardiac disorders | Cardiac failure | Very common |
| Gastrointestinal disorders | Nausea | Common |
| General disorders and administration site conditions | Asthenia (fatigue) | Very common |
| Vascular disorders | Hypotension | Very common |
5. How to store DILATREND.
Special precautions for storage
Store at or below 30 °C in the original package to protect from light. Keep out of reach of children.