ATENOLOL DENK 50 Tablet

This medicine belongs to a group of medications known as beta-receptor blockers.

Indications

- Functional cardiac-circulatory complaints (hyperkinetic heart syndrome, hypertonic regulation disorders);

- Cardio-vascular disease (chronic stable angina pectoris or unstable angina pectoris, in case of concomitant increase in heart rate or high blood pressure);

- Cardiac arrhythmias with increased heart beat:

- Supraventricular arrhythmias, additional therapeutic measure in case of sinus tachycardia due to thyrotoxicosis, paroxysmal supraventricular tachycardia, atrial fibrillation and flutter (when not effectively controlled by large dose therapy with cardiac glycosides)

- Ventricular arrhythmias, including ventricular extra systoles, when these result from increased activity of the sympathetic system (physical strain, induction phase in anaesthesia, halothane anaesthesia and the administration of exogenous sympathicomimetic agents), ventricular tachycardia and ventricular fibrillation (only prophylactic, especially when the ventricular arrhythmias result from increased activity of the sympathetic system).

- High blood pressure (arterial hypertonia).

Dosage

-Functional cardiac-circulatory complaints (hyperkinetic heart syndrome, hypertonic regulation disorders): Once daily 0.5 tablet.

- Cardio-vascular diseases (chronic stable angina pectoris or unstable angina pectoris): Once daily 1-2 tablets.

- Cardiac arrhythmias with increased heart beat (supraventricular and ventricular arrhythmias): 1 tablet 1-2 times a day or 2 tables once a day.

- High blood pressure: Start treatment with once daily 1 tablet. If required the dose can be increased after 1 week to once daily 2 tablets.

!! If the cardiac frequency and/or blood pressure falls to a level which requires treatment, or in case of other complications, stop treatment immediately.

Note: The dose must be adjusted in line with the renal clearance for patients suffering from inhibited kidney function: See the package insert for the details.

Mode of administration

The tablets should be swallowed whole with adequate liquid (e.g. 1 glass of water) before meals.

- hypersensitivity to atenolol or other beta-adrenoceptor blocking agents or to one of the excipients,

- weak heart muscle (manifest cardiac insufficiency),

- shock,

- conduction system disorders from the atrium to the ventricle (2nd and 3rd grade heart block),

- sick sins syndrome,

- conduction system disorders between the sinus node and atrium (sinu-artrial block),

- rest pulse of less than 50 beats per minute, before the start of therapy (bradycardia),

- very low blood pressure (hypotonia; systolic less than 90 mmHg),

- over-acidification of the blood (acidosis),

- tendency to bronchial cramps (bronchial hyper-reaction, e.g. with asthma bronchialis),

- late stages of peripheral circulatory disorders,

- concomitant administration of MAO inhibitors (except for MAO-B inhibitors).

The intravenous administration of verapamil and diltiazem type calcium antagonists or other anti-arrhythmatic agents (e.g. disopyramide) to patients under atenolol therapy is contraindicated (except in intensive medical care)

Particularly at the beginning of therapy, central nervous complaints including tiredness, dizziness, headache, visual disturbances, perspiration, lethargy, confusion, hallucinations, psychoses, nightmares or more intense dreams, insomnia and depressive states may occasionally result.

Occasionally excessive lowering of blood pressure (hypotonia), extreme lowering of heart rate (bradycardia), fit-like unconsciousness of a short duration (syncope), atrioventricular conduction disorders or intensification of a weakening of the heart muscle (cardiac insufficiency) may develop.

In individual cases for patients who have seizures of pain near the heart (angina pectoris) an intensification of these seizures cannot be ruled out.

Temporary gastro-intestinal side-effects may occasionally develop (nausea, vomiting, constipation, diarrhoea).

Occasionally a sensation of tickling, numbness or clod may develop in the extremities (paresthesia), rarely muscular weakness or muscle cramps occur. These effects have been observed to be more intensive in patients with peripheral circulatory disorders - including patients with cramps in the finger arteries (Raynaud syndrome).

Because of the possibility of increased respiratory resistance, patients with a tendency to bronchospastic reactions (particularly in case of obstructive respiratory tract disorders) may experience respiratory distress.

Rarely dryness of the mouth, inflammation of the iris (conjunctivitis) or reduced tear flow may develop.

In rare cases previously undiagnosed diabetes may be discovered (latent diabetes mellitus), or already diagnosed diabetes (manifest diabetes mellitus) may be exacerbated.

In case of intensive, longer periods of fasting or extreme physical strain and concomitant administration of this medicine conditions of reduced blood glucose (hypoglycaemic conditions) may develop. Warning signs for hypoglycaemia, including higher heart rate (tachycardia) and trembling of the fingers (tremor) may be masked.

Beta-adrenoceptor blocking agents such as this medicine can trigger in psoriasis vulgaris, or they may exacerbate the symptoms of this disease or result in psoriasis typical rashes.

In individual cases libido and potency disturbances have been observed.

Therapy with this medicine can result in disturbances of metabolism. In cases where total cholesterin levels were generally normal, a reduction of HDL-cholesterin and an increase in triglycerides were observed in plasma.

Treatment with this medicine may mask the clinical symptoms of thyrotoxicosis (e.g. tachycardia, tremor) in patients suffering from hyperthyroidism.

(See the package insert about the details below.)

The following interactions with this medicine have been described under concomitant administration of:

- Blood pressure reducing agents, diuretics, vasodilators, tricyclic anti-depressive agents, barbiturates, phenothiazine

- Medications for treating arrhythmias

- Verapamil and diltiazem type calcium antagonists, other medications for treating arrhythmia (e.g. disopyramide)

- Calcium antagonists belonging to the nifedipine type

- Cardiac glycosides, reserpine, alpha-methyldopa, guanfacin, clonidine

If treatment with clonidine is abruptly stopped, under concomitant administration with this medicine, blood pressure may increase excessively. Therapy with clonidine may therefore only be stopped, if the administration of this medicine was halted several days previously. Thereafter clonidine therapy can be ended in steps.

- Oral hypoglycaemic drugs, insulin

- Norepinephrine, epinephrine

- Medicines for treating inflammations (e.g. indomethacin)

- Anaesthetics and narcotics

- Peripheral muscle relaxants (e.g. suxamethonium halogenide, tubocurarine)

Atenolol should only be used during pregnancy after careful consideration of the potential benefits and risks. Neonates must be monitored for signs of beta blockade for at least 48 hours after being delivered. Atenolol accumulates in breast mild and reaches higher concentrations there than in the mother’s blood. The infant must therefore be monitored very closely for signs of beta blockade effects during the nursing period.

This medicine may only be administered, after carefully weighing up the benefits against the risks in case of;

- slight conduction system disorders from the atriums to the ventricles(1st grade heart block),

- diabetic patients (patients with diabetes mellitus) with strong fluctuations in blood glucose levels (conditions in which severely reduced levels of blood glucose are possible),

- lengthy fasting and much physical strain (conditions in which severely reduced levels of blood glucose are possible),

- patients suffering from hormone producing tumors of the adrenal medulla (pheochromocytoma; previous treatment required with alpha-receptor blockers),

- patients with impaired kidney function.

Beta receptor blocking agents should only be used in patients suffering from, or who have a history of, or whose family has a history of psoriasis after very careful consideration of the benefits against the possible risks.

Beta receptor blocking agents can increase sensitivity to allergies and the severity of anaphylactic reactions. Indications have to be observed strongly in patients with a history of severe hypersensitivity reactions and in patients receiving therapy to reduce or eliminate allergic reaction ability (desensibilisation therapy) (attention: anaphylactic reaction may be amplified).

As warning signs of hypoglycaemia may be masked in diabetic patients, increased heart rate (tachycardia) and trembling fingers (tremor) in particular, regular blood sugar testing is required.

Contact lens wears should bear in mind that there may be reduced lacrimation.

In patients with severe kidney dysfunction the kidney function should be monitored when receiving atenolol. since a worsening of kidney function has been observed under therapy with other beta-adrenoceptor blocking agents for this group of patients.

The liver values should be checked regularly if taking this medicine, since therapy with other beta-adrenoceptor blocking agents have resulted in liver dysfunctions.

Therapy with other beta-adrenoceptor blocking agents has resulted in small bloody patches on the skin or mucous membrane, with or without simultaneous reduction of blood platelets (thrombocytopenic and non-thrombocytopenic purpura), so that attention should be paid to signs of such a manifestation when taking this medicine.

Careful monitoring of patients is indicated during concomitant use of this medicine and calcium antagonists of the verapamil or diltiazem type or other antiarrhythmics (e.g. disopyramide), as there may be a severe drop in blood pressure (hypotension), severely reduced heart rate (bradycardia) or other arrhythmias.

If clonidine is discontinued abruptly in patients receiving concomitant treatment with this medicine, there may be an excessive rise in blood pressure. Clonidine should therefore only be discontinued a few days after treatment with this medicine has ended. Clonidine can subsequently be discontinued gradually.

This drug contains lactose monohydrate. Please consult with physician before taking this medicine if you suffer from sugar intolerance.

Pharmacotherapeutic group: Beta-receptor blocker.

Atenolol is a hydrophile beta-receptor blocking agent with relative beta1-selectivity (cardio-selectivity), without intrinsic sympathomimetic activity (ISA) and without a membrane stabilising action.

The substance sinks the frequency and the contraction strength of the heart, in dependence on the degree of sympathomimetic tonus. It also reduces the AV transmission speed and the plasma renin activity. Atenolol can result in increased tonus of the smooth muscle by inhibiting beta2-receptors.