VISKEN

VISKEN®
Pindolol
COMPOSITION
1 tablet contains:
Active substance:
pindolol 5 mg
Excipients:
precipitated silica, magnesium stearate, corn starch, microcrystalline cellulose.
PHARMACEUTICAL FORM AND PACKAGE
VISKEN 5 mg tablets: 30 tablets
PHARMACOTHERAPEUTIC CATEGORY

• beta-blocker.

MARKETING AUTHORISATION HOLDER
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
MANUFACTURER
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia
THERAPEUTIC INDICATIONS
Angina pectoris (prevention of attacks).
Haemodynamic and cardiac rhythm disorders responsive to treatment with beta-adrenergic blocking agents.
CONTRAINDICATIONS
Atrioventricular block, marked bradycardia, heart failure refractory to digitalis, bronchial asthma, cor pulmonale, metabolic acidosis, ether anaesthesia, treatment with calcium transport inhibitors (e.g.: verapamil).
PRECAUTIONS FOR USE
Although clinical experience has shown that VISKEN may have a modest negative inotropic effect, digitalization is recommended in cases of manifest or latent heart failure.
When VISKEN is administered to control arrhythmias following recent myocardial infarction, the patient must be continuously monitored with essential ECG examinations.
In patients with a tendency to bronchospasm (e.g.: bronchial asthma between attacks, obstructive pulmonary diseases), VISKEN generally does not cause significant changes in pulmonary ventilation. However, like cardioselective beta-blockers, VISKEN may occasionally increase bronchoconstriction and provoke an asthmatic attack.
If administration of VISKEN must be discontinued prior to surgery or general anaesthesia, the dosage should, whenever possible, be gradually reduced.
When general anaesthesia is used in a patient under beta-blockade, it is important to carefully monitor cardiovascular function.
In phaeochromocytoma, a beta-blocker and an -blocker must always be administered together.
Pre-existing peripheral vascular disorders may be worsened by beta-blocking therapy.
In severe renal insufficiency, a further deterioration of renal function due to beta-blockade has been reported in a few cases. In diabetic patients, VISKEN should be administered with caution, as well as during prolonged fasting; hypoglycaemia may be increased or its symptoms masked.

SPECIAL WARNINGS
For athletes: the use of this drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Pregnancy and lactation
Animal studies have not revealed any adverse effects during pregnancy; however, the effects of beta-blockade on the fetus and pregnant uterus have not yet been fully elucidated.
Like other beta-blockers, VISKEN should therefore be administered only if strictly necessary during pregnancy and breastfeeding.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Oral use (before meals)

• Angina pectoris: 1 tablet three times daily. Milder cases respond to ½ tablet three times daily.
• Cardiac rhythm disorders: 1 tablet three times daily. Certain cases may require up to 4 tablets daily.

Children
Experience with the use of VISKEN in children is still limited.
OVERDOSAGE
In cases of overdose or idiosyncrasy (very rare), administer 0.5 – 1.0 mg or more of atropine sulphate intravenously. If stimulation of beta-receptors is required, isoprenaline hydrochloride may be given by slow intravenous infusion (5 g/min) up to 25 g or until the desired effect is achieved, with continuous patient monitoring.
ADVERSE EFFECTS
Rarely, the following may occur: fatigue, dizziness, mild and transient gastrointestinal disturbances, headache, sleep disturbances, which are generally mild and transient.
Allergic skin reactions and psychic symptoms (depression, hallucinations) have been observed rarely and require discontinuation of therapy.
If undesired effects not described in this leaflet occur after taking the medicine, they should be reported to the attending physician.

WARNING: Do not use the medicine after the expiry date stated on the
packaging.