When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. NAME OF THE MEDICINAL PRODUCT
Sotoger Tablets 80mg 80mg Tablets Sotoger Tablets 160mg 160mg Tablets 2. QUALITATIVE AND QUANTITIVE COMPOSITION Sotalol Hydrochloride BP 80.0mg Each tablets contains Sotalol Hydrochloride 80mg Sotalol Hydrochloride BP 160.0mg Each tablets contains Sotalol Hydrochloride 160mg For list of excipients, see section 6.1 For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets White flat bevel-edged tablet with “SL” breakline “80” on one side and blank on the reverse, approximately 7mm in diameter. White flat bevel-edged tablet with “SL” breakline “160” on one side and blank on the reverse, approximately 9.5mm in diameter. The breakline allows the tablet to be divided into two equal halves. 4.3 Contra-indications Ccardiogenic shock; uncontrolled heart failure; hypersensitivity to Sotalol or excipients; sick sinus syndrome or sinu-atrial block; chronic obstructive pulmonary disease; pulmonary hypotension; second and third degree heart block; Prinzmetal’s angina; severe bradycardia; hypotension; severe peripheral circulatory disturbances; metabolic acidosis, diabetic ketoacidosis; untreated phaeochromocytoma; history of bronchospasm, bronchial asthma; allergy, including seasonal rhinitis; severe renal insufficiency or renal failure; Ccongenital or acquired prolonged QT-syndromes 5.1 Pharmacodynamic Properties Therapeutic classification C 07 AA 07. Group of Beta blocking agents, non-selective Sotoger belongs to the group of non-selective beta receptor blocking agents. It counteracts the sympathetic neurotransmitters by competitive dislocation around the sympathetic nerve endings. This causes a decrease in the contractile strength of the heart muscle and the heart rate. Sotoger does not have any Intrinsic Sympathomimetic Activity (ISA) or local anaesthetic effect but it does have Class III anti-arrhythmic activity. 6.4 Special precautions for Storage Polypropylene Containers Store in the original container in order to protect from light. Blister Packs Keep the container in the outer carton in order to protect from light. 6.6 Special precautions for disposal and other handling None. No special requirements.
Sotalol Hydrochloride BP 80.0mg Each tablets contains Sotalol Hydrochloride 80mg Sotalol Hydrochloride BP 160.0mg Each tablets contains Sotalol Hydrochloride 160mg
For list of excipients, see section 6.1 For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets White flat bevel-edged tablet with “SL” breakline “80” on one side and blank on the reverse, approximately 7mm in diameter. White flat bevel-edged tablet with “SL” breakline “160” on one side and blank on the reverse, approximately 9.5mm in diameter. The breakline allows the tablet to be divided into two equal halves. 4.3 Contra-indications Ccardiogenic shock; uncontrolled heart failure; hypersensitivity to Sotalol or excipients; sick sinus syndrome or sinu-atrial block; chronic obstructive pulmonary disease; pulmonary hypotension; second and third degree heart block; Prinzmetal’s angina; severe bradycardia; hypotension; severe peripheral circulatory disturbances; metabolic acidosis, diabetic ketoacidosis; untreated phaeochromocytoma; history of bronchospasm, bronchial asthma; allergy, including seasonal rhinitis; severe renal insufficiency or renal failure; Ccongenital or acquired prolonged QT-syndromes 5.1 Pharmacodynamic Properties Therapeutic classification C 07 AA 07. Group of Beta blocking agents, non-selective Sotoger belongs to the group of non-selective beta receptor blocking agents. It counteracts the sympathetic neurotransmitters by competitive dislocation around the sympathetic nerve endings. This causes a decrease in the contractile strength of the heart muscle and the heart rate. Sotoger does not have any Intrinsic Sympathomimetic Activity (ISA) or local anaesthetic effect but it does have Class III anti-arrhythmic activity. 6.4 Special precautions for Storage Polypropylene Containers Store in the original container in order to protect from light. Blister Packs Keep the container in the outer carton in order to protect from light. 6.6 Special precautions for disposal and other handling None. No special requirements.
Tablets
White flat bevel-edged tablet with “SL” breakline “80” on one side and blank on the reverse, approximately 7mm in diameter. White flat bevel-edged tablet with “SL” breakline “160” on one side and blank on the reverse, approximately 9.5mm in diameter. The breakline allows the tablet to be divided into two equal halves. 4.3 Contra-indications Ccardiogenic shock; uncontrolled heart failure; hypersensitivity to Sotalol or excipients; sick sinus syndrome or sinu-atrial block; chronic obstructive pulmonary disease; pulmonary hypotension; second and third degree heart block; Prinzmetal’s angina; severe bradycardia; hypotension; severe peripheral circulatory disturbances; metabolic acidosis, diabetic ketoacidosis; untreated phaeochromocytoma; history of bronchospasm, bronchial asthma; allergy, including seasonal rhinitis; severe renal insufficiency or renal failure; Ccongenital or acquired prolonged QT-syndromes 5.1 Pharmacodynamic Properties Therapeutic classification C 07 AA 07. Group of Beta blocking agents, non-selective Sotoger belongs to the group of non-selective beta receptor blocking agents. It counteracts the sympathetic neurotransmitters by competitive dislocation around the sympathetic nerve endings. This causes a decrease in the contractile strength of the heart muscle and the heart rate. Sotoger does not have any Intrinsic Sympathomimetic Activity (ISA) or local anaesthetic effect but it does have Class III anti-arrhythmic activity. 6.4 Special precautions for Storage Polypropylene Containers Store in the original container in order to protect from light. Blister Packs Keep the container in the outer carton in order to protect from light. 6.6 Special precautions for disposal and other handling None. No special requirements.
The breakline allows the tablet to be divided into two equal halves.
4.3 Contra-indications
5.1 Pharmacodynamic Properties Therapeutic classification C 07 AA 07. Group of Beta blocking agents, non-selective Sotoger belongs to the group of non-selective beta receptor blocking agents. It counteracts the sympathetic neurotransmitters by competitive dislocation around the sympathetic nerve endings. This causes a decrease in the contractile strength of the heart muscle and the heart rate. Sotoger does not have any Intrinsic Sympathomimetic Activity (ISA) or local anaesthetic effect but it does have Class III anti-arrhythmic activity. 6.4 Special precautions for Storage Polypropylene Containers Store in the original container in order to protect from light. Blister Packs Keep the container in the outer carton in order to protect from light. 6.6 Special precautions for disposal and other handling None. No special requirements.