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4.3 Contra-indications SOTACOR should not be used where there is evidence of sick sinus syndrome; second and third degree AV heart block unless a functioning pacemaker is present; congenital or acquired long QT syndromes; torsades de pointes; symptomatic sinus bradycardia; uncontrolled congestive heart failure; cardiogenic shock; anaesthesia that produces myocardial depression; untreated phaeochromocytoma; hypotension (except due to arrhythmia); Raynaud's phenomenon and severe peripheral circulatory disturbances; history of chronic obstructive airway disease or bronchial asthma (a warning will appear on the label) hypersensitivity to any of the components of the formulation; metabolic acidosis; renal failure (creatinine clearance < 10 ml/min).
4.3 Contra-indications
SOTACOR should not be used where there is evidence of sick sinus syndrome; second and third degree AV heart block unless a functioning pacemaker is present; congenital or acquired long QT syndromes; torsades de pointes; symptomatic sinus bradycardia; uncontrolled congestive heart failure; cardiogenic shock; anaesthesia that produces myocardial depression; untreated phaeochromocytoma; hypotension (except due to arrhythmia); Raynaud's phenomenon and severe peripheral circulatory disturbances; history of chronic obstructive airway disease or bronchial asthma (a warning will appear on the label) hypersensitivity to any of the components of the formulation; metabolic acidosis; renal failure (creatinine clearance < 10 ml/min).
1. NAME OF THE MEDICINAL PRODUCT
SOTACOR 80 MG TABLETS
3. PHARMACEUTICAL FORM
Tablets
Round, biconvex, white tablets with a break bar on each side..
The tablet can be divided into equal halves.
6.5 Nature and contents of container
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80mg sotalol hydrochloride.
Each tablet contains 53.8mg of lactose (as lactose monohydrate).
For a full list of excipients, see section 6.1.
For excipients, see 6.1
4.4 Special wWarnings and Special Pprecautions for Uuse
This product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4.5 Interactions with oOther medicinal products Medicaments and Oother Fforms of Iinteraction
Not recommended associations:
Antiarrhythmics: Class 1a antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide and flecainide and other antiarrhythmic drugs such as amiodarone and bepridil are not recommended as concomitant therapy with SOTACOR, because of their potential to prolong refractoriness (see § 4.4 Special Warnings and Precautions). The concomitant use of other beta-blocking agents with SOTACOR may result in additive Class II effects.
Other drugs prolonging the QT-interval: SOTACOR should be given with extreme caution in conjunction with other drugs known to prolong the QT-interval such as phenothiazines, tricyclic antidepressants, terfenadine and astemizole. Other drugs that have been associated with an increased risk for torsades de pointes include erythromycin IV, halofantrine, pentamidine, and certain quinolone antibiotics such as grepafloxacin.
4.8 Undesirable Eeffects
Sotacor is well tolerated in the majority with the most frequent adverse effects arising from beta-blockade properties. Adverse effects are usually transient in nature and rarely necessitate interruption of, or withdrawal from treatment. If they do occur, they usually disappear when the dosage is reduced. The most significant adverse effects, however, are those due to proarrhythmia, including torsades de pointes (see 4.4 Special wWarnings and precautions).
Frequency is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000) including isolated reports.
The following are adverse events considered related to therapy with SOTACOR:
. , occurring in 1% or more of patients treated with SOTACOR.
Cardiovascular:
Common: Bradycardia, dyspnoea, chest pain, palpitations, oedema, ECG abnormalities, hypotension, proarrhythmia, syncope, heart failure, presyncope.
Dermatological:
Common: Rash.
Gastro-intestinal:
Common: Nausea/vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence.
Musculoskeletal:
Common: Cramps.
Nervous/psychiatric:
Common: Fatigue, dizziness, asthenia, lightheadedness, headache, sleep disturbances, depression, paraesthesia, mood changes, anxiety.
Urogenital:
Common: Sexual dysfunction.
Special Senses:
Common: Visual disturbances, taste abnormalities, hearing disturbances.
Body as a whole:
Common: Fever.
In trials of patients with cardiac arrhythmia, the most common adverse events leading to discontinuation of SOTACOR are listed in the table below.:
were fatigue 4%, bradycardia (<50 bpm) 3%, dyspnoea 3%, proarrhythmia 2%, asthenia 2% and dizziness 2%.
- fatigue
4%
- bradycardia(<50 bpm)
3%
- dyspnoea
- proarrythmia
2%
- asthenia
- dizziness
6.6 Special precautions for disposal of a used medicinal product and other handlingInstructions for Use/handling
7. MARKETING AUTHORISATION HOLDER
t/a Bristol-Myers Pharmaceuticals
Swords,
Co. Dublin
Ireland
10. DATE OF (PARTIAL) REVISION OF THE TEXT
March 2006 January 2009February 2010