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Leaflet Tarka Gastrointestinal disorders Very rare Nausea Instruction for use dry mouth /throat pancreatitis 1-NAME OF THE MEDICINAL PRODUCT vomiting Tarka 180 mg/2 mg, modified-release Hepatobiliary disorder tablet Very rare cholestasis 2- QUALITATIVE AND QUANTITATIVE COMPOSITION hepatitis Each tablet contains 180 mg of verapamil hydrochloride and 2 mg of increase in γGT trandolapril. increase in LDH 3-PHARMACEUTICAL FORM increase in lipase 4- CLINICAL PARTICULARS jaundice 4.1 Therapeutic indications Essential hypertension in patients whose blood pressure has been normalised with the individual Com- Skin and subcutaneous tissue ponents in the same proportion of doses. disorders Uncommon facial oedema 4.2 Posology and method of administration pruritus The usual dosage is one tablet once daily, taken in the morning half an hour before breakfast. rash The tablets should be swallowed whole. sweating increased Dosage in children: Tarka is contraindicated in children and adolescents )<18 years( rare alopecia Dosage in the elderly: As systemic availability is higher in elderly patients compared to younger hypertensives, some elderly patients might experience a more pronounced blood pressure lowering herpes simplex effect )see section 4.4( skin disorders, un- Dosage in renal failure: Tarka is contraindicated in severe renal impairment )see sections 4.3 and specified 4.4(. Very rare angioneurotic oedema Dosage in hepatic insufficiency: the use of Tarka is not recommended in patients with severe liver )see also section 4.4( hepatic impairment; Tarka is contraindicated in patients with liver cirrhosis with ascites )see sections erythema multiform 4.3 and 4.4(. exanthema or dermatitis 4.3 Contra-indications psoriasis known hypersensitivity to trandolapril or any other ACE inhibitor and/or verapamil or to any of the excipients. urticaria -History of angioneurotic oedema associated with previous ACE inhibitor therapy. Musculoskeletal -Hereditary/idiopathic angioneurotic oedema. Connective tissue and bone disorders -Cardiogenic shock. Very rare arthralgia -Recent myocardial infarction with complications. myalgia -Second- or third-degree AV block without a functioning pacemaker myasthenia -SA block -Sick sinus syndrome in patients without a functioning pacemaker Renal and urinary disorders -Congestive heart failure Uncommon polyuria -Atrial flutter/fibrillation in association with an accessory pathway )e.g. WPW-syndrome( Very rare acute renal failure )see -Severe renal impairment )creatinine clearance<10 ml/min( also section 4.4( -Dialysis Reproductive system and breast -Liver cirrhosis with ascites disorders Very rare gynecomastia -Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. impotence -Primary aldosteronism -Pregnancy General disorders and administration -Lactation site conditions common headache -Use in children and adolescents )< 18 years( uncommon chest pain 4.4 Special warnings and special precautions for use Very rare fatigue or asthenia Symptomatic hypotension: Investigations Under certain circumstances, Tarka may occasionally produce symptomatic hypotension. This risk is elevated in patients with a stimulated renin-angiotensin- aldosterone system )e.g., volume or salt uncommon liver function test, depletion, due to the use of diuretics, a low sodium diet dialysis, dehydration, diarrhea or vomiting; abnormal decreased left ventricular function, renovascular hypertension( rare hyperbilirubinemia Such patients should have their volume or salt depletion corrected beforehand and therapy should Very rare increase in alkaline preferably be Initiated in a hospital setting. Patients experiencing hypotension during titration should phosphatase lie down and may require volume expansion by oral fluid supply or intravenous administration of normal increase in serum saline. Tarka therapy can usually be continued once blood volume and pressure have been effectively potassium corrected increase in transam- Kidney function impairment )see also section 4.3( Patients with moderate renal impairment should have their kidney function monitored. inases Tarka may produce hyperkalemia in patients with renal dysfunction. The following adverse reactions have not yet been reported in relation to Tarka, but are generally Acute deterioration of kidney function )acute renal failure( may occur especially in patients with pre-ex- accepted as being attributable to ACE inhibitors: isting kidney function impairment, or congestive heart failure. - Blood and lymphatic system disorders: decreases in hemoglobin and hematocrit, There is insufficient experience with Tarka in secondary hypertension and particularly in renal vascular and in individual cases agranulocytosis. Isolated cases of hemolytic anemia have hypertension. Hence, Tarka should not be administered to these patients, especially since patients with been reported in patients with congenital G-6-PDH deficiency. bilateral renal artery stenosis or unilateral renal artery stenosis in individuals with a single functioning - Psychiatric disorders: occasionally confusion. kidney )e.g.,renal transplant patients( are endangered to suffer an acute loss of kidney function. - Nervous system disorders: rarely, sleep disorders. Proteinuria: - Ear and labyrinth disorders: rarely, problems with balance, tinnitus. Proteinuria may occur particularly in patients with existing renal function impairment or on relatively - Cardiac disorders/vascular disorders: Individual cases of arrhythmia, myocardial high doses of ACE inhibitors. infarction and transient ischemic attacks have been reported for ACE inhibitors in Severe hepatic impairment: association with hypotension. Since there is insufficient therapeutic experience in patients with severe hepatic Impairment as such, - Respiratory, thoracic and mediastinal disorders: Rarely, sinusitis, rhinitis, glossitis and bronchospasm. the use of Tarka cannot be recommended. Tarka is contraindicated in patients with liver cirrhosis with - Gastrointestinal disorders: occasionally indigestion. Individual cases of ileus. ascites )see also section 4.3(. - Hepatobiliary disorders: individual cases of cholestatic icterus. Angioneurotic oedema: - Skin and subcutaneous tissue disorders: occasionally allergic and hypersensitivity reactions such as Rarely ACE inhibitors )such as trandolapril( may cause angioneurotic oedema that includes swelling of Stevens-Johnson syndrome, toxic epidemic necrolysis. This can be accompanied by fever, myalgia, the face, extremities, tongue, glottis, and/or larynx. Patients experiencing angioneurotic oedema must arthralgia, eosinophilia and / or increased ANA – titers. immediately discontinue trandolapril therapy and be monitored until oedema resolution. -Investigations: increases in blood urea and plasma creatinine may occur especially in the presence of Angioneurotic oedema confined to the face will usually resolve spontaneously. renal insufficiency, severe heart failure and renovascular hypertension. These increases are however Oedema involving not only the face but also the glottis may be life-threatening because of the risk of reversible on discontinuation. airway obstruction. Symptomatic or severe hypotension has occasionally occurred after initiation of therapy with ACE Compared to non-black patients a higher incidence of angioedema has been reported in black patients inhibitors. This occurs especially in certain risk groups, such as patients with a stimulated renin- angi- treated with ACE inhibitors. otensin-aldosterone system. Angioneurotic oedema involving the tongue, glottis or larynx requires immediate subcutaneous ad- The following adverse reactions have not yet been reported in relation to Tarka, but are generally ministration of 0.3-0.5 ml of epinephrine solution )1:1000( along with other therapeutic measures as accepted as being attributable to phenylalkylamine calcium-channel blockers: appropriate. -Nervous system disorders: in some cases, there may be extrapyramidal symptoms )Parkinson’s dis- Caution must be exercised in patients with a history of idiopathic angioneurotic oedema, and Tarka ease, choreoathetosis, dystonic syndrome(. Experience so far has shown that these symptoms resolve is contraindicated If angioneurotic oedema was an adverse reaction to an ACE inhibitor )see also once the medicinal product is discontinued .There have been isolated reports of exacerbation of my- section 4.3( asthenia gravis, Lambert Eaton syndrome and advanced cases of Duchenne’s muscular dystrophy. Neutropenia/agranulocytosis: - Gastrointestinal disorders: gingival hyperplasia following long-term treatment is The risk of neutropenia appears to be dose-and type-related and is dependent on the patients clinical extremely rare and reversible after discontinuation of therapy. status. It is rarely seen in uncomplicated patients but may occur in patients with some degree of renal - Skin and subcutaneous tissue disorders: Stevens- Johnson syndrome and impairment especially when it is associated with collagen vascular disease e.g. systemic lupus eryth- erythromelalgia have been described. In isolated cases allergic skin reactions like ematosus, scleroderma and therapy with immunosuppressive medicinal products. It is reversible after erythema. discontinuation of the ACE inhibitors. - Reproductive system and breast disorders: Hyperprolactinemia and galactorrhea have been Cough: described. During treatment with an ACE inhibitor a dry and non-productive cough may occur which disappears Excessive hypotension in patients with angina pectoris or cerebrovascular disease
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