Amdocal Plus

Amlodipine and Atenolol
Tablet

1. What Amdocal Plus is and what it is used for?
Amdocal Plus® is a fixed dose combination of Amlodipine Besilate and Atenolol. Amlodipine Besilate is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Atenolol is (2-Hydroxy-3-isopropyl- aminopropoxy) phenylacetamide, a selective b1 blocker. Amdocal Plus used in the treatment of Hypertension not controlled by monotherapy, Angina pectoris & hypertension co-existing diseases, Post M.I patients. Refractory angina pectoris where nitrate therapy has failed.

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

Amlodipine is contraindicated in patients with a known sensitivity to dihydropyridines. It should not be used in cardiogenic shock, clinically significant aortic stenosis, unstable angina (excluding Prinzmetal’s angina). Atenolol is contraindicated with a known hypersensitivity to Atenolol, severe bradycardia, second degree or the third degree heart block, uncontrolled heart failure, hypotension, severe peripheral vascular disease (including intermittent claudication), sick sinus syndrome, cardiogenic shock, phaeocromocytoma (without a concommitant alpha blocker), metabolic acidosis. Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor before taking Amdocal Plus.

Take special care with Amdocal Plus
Atenolol may mask the symptoms of hyperthyroidism. It may also mask the symptoms of hypoglycaemia, as well as enhancing the effects of hypoglycemic agents in patients with diabetes mellitus.

Taking other medicines
Atenolol: The effects of other myocardial depressant agents, including anti-arrhythmics such as Quinidine, Procainamide, or Lignocaine, Phenytoin, and medicines which interfere with calcium transport, such as Verapamil, may also be enhanced by Atenolol.
The effects of Atenolol are diminished by beta-adrenoceptor stimulating agents such as Isoprenaline; the hypotensive effects of Atenolol may be dangerously reversed and the peripheral vasoconstrictor effects enhanced by alpha-adrenoceptor stimulating agents such as noradrenaline or those with mixed alpha- and beta-adrenoceptor stimulating properties such as adrenaline; bradycardia may also occur.
The effects of Atenolol may be enhanced by adrenergic neuron blocking agents such as Guanethidine or Bethanidine, or Catecholamine-depleting agents such as Reserpine and the hypotensive effects by diuretics. Atenolol may enhance some of the cardiac effects of digitalis and diminish others. It has been suggested that clonidine withdrawal symptoms may be exacerbated in patients who are concurrently taking a beta blocker.

Pregnancy and breast-feeding
Atenolol crosses the placenta. So it is contraindicated in pregnancy and lactation.

3. How to take Amdocal Plus?
The recommended dosage is one tablet of Amdocal Plus® 50 (Amlodipine 5mg and Atenolol 50mg) or Amdocal Plus® 25 (Amlodipine 5mg and Atenolol 25 mg). Depending upon the therapeutic response, titration of the dosage is recommended. In elderly patients, it is advisable to initiate the therapy with 1/2 tablet of fixed dose combination of Amlodipine & Atenolol i.e. 2.5 mg Amlodipine & 25 mg Atenolol.

If you take more Amdocal Plus than you should
In humans, experience with intentional overdosage of Amlodipine is limited. If massive overdosage occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential.

If you forget to take Amdocal Plus
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 Amdocal Plus
Do not stop taking this medicine without talking to your doctor. You should not stop taking Amdocal Plus 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, Amdocal Plus can cause side effects, although not everybody gets them.

Amlodipine: Peripheral edema may occasionally be present but is fully reversible. As with other calcium channel blockers peripheral edema and skin erythema occur in a proportion of patients and facial flushing occurs in 2-5% of patients. Complaints of fatigue were also reported more frequently than in placebo-treated patients. There is evidence that these effects are more common in patients treated with doses greater than 10 mg daily.
Atenolol: Pronounced fatigue and cold extremities have been observed in 10 to 20% of the treated subjects. Complaints about bradycardia, dizziness and gastrointestinal symptoms are less frequent. Despite its relative selectivity, Atenolol can cause bronchospasms in asthma patients.

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 Amdocal Plus?
Store below 25°C. Protect from light. Keep out of reach of children.


Amdocal Plus Prescribing Information

Located in: Cardiovascular