Soprol

Soprol

Antihypertensive

Composition

Each film coated tablet contains: 5 or 10 mg bisoprolol hemifumarate.

Indications

High blood pressure (hypertension), Coronary heart disease (angina pectoris).

Contra-indication

Asthma or history of obstructive airways disease

Uncontrolled heart failure, Prinzmetal’s angina, marked bradycardia, hypotension, sick sinus syndrome, second or third degree AV block, cardiogenic shock.

Metabolic acidosis, severe peripheral arterial disease & phaeochromocytoma.

Pregnancy.

Side effects

Particularly at the start of treatment tiredness, dizziness, mild headaches, perspiration, sleep disturbances, vivid dreams and depressive moods may occur. These symptoms are usually of a less severe nature and generally reduced within 1-2 weeks after the start of treatment. In rare cases, gastrointestinal disturbances (diarrhea, constipation, nausea, and abdominal pain) and skin reactions (e.g. erythema, pruritus) may occur.

Occasionally a marked decrease in blood pressure, slow pulse rate or a disturbance of AV conduction are observed.

Treatment can occasionally lead to tingling and a sensation of coldness in the limbs and in rare case to muscle weakness, muscle cramp and reduced lacrimation (to be taken into account if contact lenses are worn).

In patients suffering from intermitted claudication and Raynaud's phenomenon at the start of therapy complaints might become aggravated, and myocardial insufficiency might intensify. An increase in airway resistance (difficulties in breathing in patients tending towards bronchospastic reactions. e.g. with asthmatic bronchitis) may occur in rare cases.

Arthralgia, dizziness, headache, hypotension, diarrhea, nausea, depression, hypoaesthesia, dyspnea, pharyngitis, rhinitis, sinusitis, URI & peripheral oedema.

In elderly patients concurrently suffering from diabetes (impaired glucose tolerance) the signs of low blood-glucose levels (e.g. rapid heart rate) may be masked.

Dosage

According to the doctor's prescription. One film coated tablet of SOPROL 5 or one film coated tablet of SOPROL 10 once daily.

In milder forms of the disease as well as at the start of treatment: 1 tablet of SOPROL 5 once daily is sufficient in most cases. If necessary this dosage may be increased to 2 tablets of SOPROL 5 or 1 tablet of SOPROL 10 once daily. A dosage increase to 20 mg (2 tablets of SOPROL 10 once daily) may be necessary only in isolated cases.

The film-coated tablets should be swallowed whole with some liquid. It is recommended to take SOPROL in the morning on an empty stomach or with the breakfast.

Patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 ml/min) the initial daily dose should be 2.5 mg and caution should be used in dose titration.

Drug interactions

SOPROL may potentiates the effect of other anti-hypertensive drugs concurrently administered. Concomitant therapy of SOPROL and reserpine a methyldopa, clonidine or guanfacine may cause a considerable decrease in heart rate. In concomitant treatment with clonidine, clonidine should not be discontinued unless administration of SOPROL has been terminated for a few days.

The concurrent use of nifedipine may potentiates the anti-hypertensive effect of SOPROL in concurrent use of SOPROL and calcium antagonists of the verapamil or deltiazem type or other antiarrhythmic agents careful monitoring of the patient is indicated as this can cause hypotension, bradycardia and other arrhythmias. The intravenous administration of calcium antagonists and antiarrhythmic agents is therefore not recommended  during treatment with SOPROL.

The concurrent use of SOPROL and rifampicin can slightly reduce the half-life of SOPROL. An increase in dose is generally not necessary.

The concurrent use of SOPROL and insulin or oral antihyperglycaemic agents may potentiate the effect of the later. The symptoms of hypoglycaemia (in particular tachycardia) are masked or mitigated, blood-glucose levels should be monitored regularly. As cardic output may be impaired under anaesthesia, prior to an operation the anaesthetist should be informed if the patient is being treated with SOPROL. B-blocker may mask clinical signs of hyperthyrodism.

Precaution

Due to the anti-hypertensive effect of SOPROL the ability to drive or to operate machinery may be impaired as a result of reactions to the drug varying from individual to individual. This is particularly the case at the start of treatment and with a change of medication as well as upon interaction with alcohol specific investigations have shown, however, that there is no fear of reactivity being directly impaired by SOPROL.

If by way of exception SOPROL has been used during pregnancy, therapy should be terminated 72 hours to the expected date of birth due to the possibility of bradycardia, hypotension and hypoglycaemia occruing in the neonate. If this is not possible the neonate should be carefully monitored for 48-72 hours after delivery.

It may be advisable to take therapy with SOPROL over approximately one week with the patient under careful observation.

Caution should be exercised in patients with peripheral vascular disease whose arterial insufficiency may be aggravated by use of B-blocker.

SOPROL may be used with caution in patients with bronchospastic disease who do not respond to or can not tolerate other antihypertensive treatment, lowest possible dose use in such patient 2.5 mg as a starting dose and bronchodilation should be made available.

Storage

Store below 30°C.

Keep out of reach of children.

Package

SOPROL 5 : carton box containing 1 or 2 strips each of 10 tablets.

SOPROL 10 : carton box containing 1 or 2 strips each of 10 tablets.