Dilapress

Carvedilol
Tablet

1. What is and what it is used for?
Dilapress® (Carvedilol) is a cardiovascular drug whose main pharmacological action is neuro hormonal antagonist consisting of non-selective beta-blocker, alpha 1-blocker and antioxidant properties.
Dilapress® (Carvedilol) is indicated for the treatment of essential hypertension. It can be used alone or in combination with other antihypertensive agents, especially thiazide type diuretics.
Dilapress® (Carvedilol) is also indicated for the treatment of mild to moderate heart failure, to reduce the progression of disease, to reduce mortality and cardiovascular hospitalization.
Dilapress® (Carvedilol) may be used in-patients unable to tolerate an ACE inhibitor.
Dilapress® (Carvedilol) may be used in-patients who are not receiving digitalis, hydralazine or nitrate therapy.

2. Before you take Dilapress
Do not take this medicine and tell your doctor if:

Dilapress® (Carvedilol) must not be used in patients with NYHA class IV (New York Heart Association Class IV) decompensated heart failure requiring intravenous inotropic support, Asthma, Chronic obstructive pulmonary disease (COPD) with a bronchospastic component, 2nd or 3rd degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia. Therapy is not to be initiated in severe heart failure.Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor before taking Dilapress.

Take special care with Dilapress
Take precaution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating.

Taking other medicines
As with other anti-hypertensives, there is a potential for pronounced hypotension during general anaesthesia. As with other agents with beta-blocking activity. Carvedilol may potentiate the effect of other concomitant administered drugs that are anti-hypertensive in action or have hypotension as part of their adverse effect profile. As with other drugs with beta-blocking activity, caution should be exercised when administered Class I anti-arrthythmic drugs or calcium antagonists such as verapamil. These drugs should be administered intravenously.
Trough plasma digoxin levels may be increased in patient’s co-administered carvedilol and digoxin. Increased monitoring of digoxin levels is recommended when initiating, adjusting or discontinuing carvedilol.
Care should be required in those receiving inducers of mixed function oxidase e.g. rifampicin, as serum levels of Carvedilol may be reduced.

Pregnancy and breast-feeding
Carvedilol should not be used during pregnancy as no studies have been performed in this group. Carvedilol and its metabolites are excreted in breast milk. Therefore, breast-feeding is not recommended during administration of carvedilol.

3. How to take Dilapress?
In essential hypertension initially 12.5 mg once daily for 2 days. Thereafter the recommended dose is 25 mg once daily. If necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients the initial dose of 12.5 mg daily may provide satisfactory control.
In heart failure, initially 3.125 mg twice daily may be given for 2 weeks, dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body weight and 50 mg twice daily in patients over 85 kg.
In angina pectoris the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dose is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

If you take more Dilapress than you should
In humans, experience with intentional overdosage of Dilapress is limited. If massive overdosage occurs, active cardiac and respiratory monitoring should be instituted.

If you forget to take Dilapress
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dilapress
Do not stop taking this medicine without talking to your doctor. You should not stop taking Dilapress just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Dilapress can cause side effects, although not everybody gets them.

Dizziness, headache, fatigue, gastrointestinal disturbances, postural hypotension, peripheral oedema, bradycardia, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza - like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud′s phenomenon, allergic skin reactions, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5. How to store Dilapress?
Store at temperature between 15° C to 30° C


Dilapress Prescribing Information

Located in: Cardiovascular