Section 1

Change of Trade Name:

Tenormin 5 mg/ml Syrup

Section 10

Section 4.5, 5^th paragraph

Following sentence deleted:

Caution must be exercised when prescribing a beta-blocker with Class I antiarrhythmic agents such as disopyramide and quinidine.

And replaced by following new sentence:

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.

Section 10

Section 4.4

In Paragraph 10 epinephrine was added (in bold):

Such patients may be unresponsive to the usual doses of adrenaline (epinephrine) used to treat the allergic reactions.

In Paragraph 13 the figure 1.7 was replaced with 1.73.

Section 4.5

In Paragraph 6 epinephrine was added (in bold):

Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.

Section 4.8

Undesired events are now listed by body system and frequencies. Text is as follows:

The following undesired events, listed by body system, have been reported with the following frequencies: very common (³10%), common (1–9.9%), uncommon

(0.1–0.9%), rare (0.01–0.09%), very rare (<0.01%) including isolated reports., not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Rare:                Purpura, thrombocytopenia.

Psychiatric disorders:

Uncommon:            Sleep disturbances of the type noted with other beta-blockers.

Rare:    Mood changes, nightmares, confusion, psychoses and   hallucinations.

Nervous system disorders:

Rare:                Dizziness, headache, paraesthesia.

Eye disorders:

Rare:                Dry eyes, visual disturbances.

Cardiac disorders:

Common:          Bradycardia.

Rare:                Heart failure deterioration, precipitation of heart block.

Vascular disorders:

Common:          Cold extremities.

Rare:        Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud's phenomenon.

Respiratory, thoracic and mediastinal disorders:

Rare:            Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common:                     Gastrointestinal disturbances.

Rare:                Dry mouth.

Hepato-biliary disorders:

Uncommon:        Elevations of transaminase levels.

Rare:                Hepatic toxicity including intrahepatic cholestasis.

Skin and subcutaneous tissue disorders:

Rare:            Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.

Not known:            Hypersensitivity reactions, including angioedema and urticaria.

Reproductive system and breast disorders:

Rare:                Impotence.

General disorders and administration site conditions:

Common:                     Fatigue.

Investigations:

Very rare: An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.

Section 10