Co-Pritor 12,5 mg Tablets

CO - PRITOR 40/12,5 mg and 80/12,5 mg Treatment of mild to moderate essential hypertension. CO - PRITOR is indicated in adult patients whose blood pressure has been stabilised at the same dosage of the individual components given together.

Posology Adults CO - PRITOR should be taken once daily. Two dosage strengths are provided: 40/12,5 mg and 80/12,5 mg. The patient should be stabilised at the relevant dosage of the individual components given together and then changed to the appropriate combination dosage. Sodium and/ or volume depletion should be corrected before treatment commencement with CO - PRITOR.

When considering changing the patientu2019s therapy with CO - PRITOR it must be born in mind that treatment needs to be continued for at least 4 to 8 weeks before the maximum effect is obtained. When necessary, CO - PRITOR may be administered with another antihypertensive medicine.

Special populations Renal impairment Due to the hydrochlorothiazide component, CO - PRITOR must not be used for patients with severe renal dysfunction (creatinine clearance < 30 mL/min). Loop diuretics are preferred to thiazides in this population. Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary. Periodic monitoring of renal function is advised. Telmisartan is not removed from blood by haemofiltration and is not dialysable. Hepatic impairment In patients with mild (Child - Pugh Class A) to moderate (Child - Pugh Class B) hepatic impairment CO - PRITOR should be administered with caution. For telmisartan, the dosage should not exceed 40 mg once daily (see section 4.3). Thiazides should be used with caution in patients with impaired hepatic function. Geriatric patients No dosage adjustment is necessary. Paediatric patients There are no data on the safety and efficacy of CO - PRITOR in patients aged below 18 years. Use of CO - PRITOR is not recommended in children and adolescents.

Method of administration CO - PRITOR tablets are for once - daily oral administration and should be swallowed whole with liquid. CO - PRITOR can be taken with or without food. Handling instructions Due to the hygroscopic property of the tablets they should be taken out of the sealed blister shortly before administration.

• Hypersensitivity to any of the active substances of CO - PRITOR or to any of the excipients listed in section 6.1.
• Hypersensitivity to other sulphonamide - derived substances
• A history of angioedema related to previous therapy with ACE - inhibitors or angiotensin receptor blockers (ARBs): These patients must never again be given these medicines
• Hereditary or idiopathic angioedema
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Severe renal function impairment (creatinine clearance less than 30 mL/min) or serum creatinine > 1,8 mg/100 mL), anuria, or acute glomerulonephritis
• Bilateral renal artery stenosis
• Renal artery stenosis in patients with a single kidney
• Aortic stenosis
• Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride (see section 4.4 and 4.5)
• Porphyria
• Thiazide diuretics in (fixed dose) combination (CO - PRITOR) should not be given to patients with Addisonu2019s disease. This therapy is also contraindicated in patients with severe renal impairment or anuria, and in patients who show hypersensitivity to other sulphonamide - derived medicines
• Lithium therapy: Concomitant administration with CO - PRITOR may lead to toxic blood concentrations of lithium (see section 4.5)
• Pregnancy and lactation (see section 4.4 and 4.6)
• The concomitant use of CO - PRITOR with aliskiren - containing products is contraindicated (see section 4.4 and 4.5)
• Biliary obstructive disorders
• Severe hepatic impairment, biliary cirrhosis, cholestasis, coma heparicum, hepatic precoma
• Therapy - refractory hyponatraemia
• Hypovolaemia
• Symptomatic hyperuricaemia/gout
• Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia
• In case of rare hereditary conditions that may be incompatible with an excipient of the product, the use of CO - PRITOR is contraindicated. Patients with fructose intolerance should not take CO - PRITOR. Patients with galactosaemia should not take CO - PRITOR. (See section 4.4)
• Concomitant use of fluoroquinolones with ACE inhibitors/Angiotensin receptor blockers is contraindicated in patients with moderate to severe renal impairment (Creatinine Clearance u2264 30 mL/min) and in elderly patients.
• Patients with a history of previous and/or current basal cell carcinomas and/or squamous cell carcinomas of the skin and lip.

Pregnancy CO - PRITOR should not be initiated during pregnancy. Should a woman become pregnant while receiving CO - PRITOR, the treatment should be stopped promptly and switched to a different class of antihypertensive medicine (see section 4.4 and 4.6). Should a woman contemplate pregnancy, the doctor should consider alternative medication. Patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with CO - PRITOR should be stopped immediately and, if appropriate, alternative therapy should be started. (See section 4.3.)

Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin - angiotensin - aldosterone system (See section 4.3.)

Renal impairment and kidney transplant CO - PRITOR must not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see section 4.3). Thiazide diuretic - associated uraemia may occur in patients with impaired renal function. In patients with mild to moderate renal impairment, periodic monitoring of potassium, creatinine and uric acid levels is mandatory. There is no experience regarding the administration of CO - PRITOR in patients with severe renal impairment or with a recent kidney transplant. (See section 4.3.) Telmisartan is not removed from blood by haemofiltration and is not dialyzable.

Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Volume and/or sodium depletion, should be corrected before the administration of CO - PRITOR.

Cases of hyponatraemia accompanied by neurological symptoms (nausea, progressive disorientation, apathy) have been observed with the use of HCTZ.

Dual blockade of the renin - angiotensin - aldosterone system (RAAS) There is evidence that the concomitant use of ACE - inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren may increase the risk of hypotension, hyperkalaemia and decreases renal function (including acute renal failure). Dual blockade of RAAS through the combined use of CO - PRITOR and aliskiren is therefore contraindicated (see section 4.3). CO - PRITOR should not be used concomitantly with aliskiren (see section 4.3).

Other conditions with stimulation of the renin - angiotensin - aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin - angiotensin - aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure.

Concomitant use of fluoroquinolones Concomitant use of fluoroquinolones and ACE inhibitors/Angiotensin receptor blockers may precipitate acute kidney injury in patients, especially those with moderate to severe renal impairment and elderly patients. (See section 4.3.) Renal function should be assessed before initiating treatment and monitored during treatment with fluoroquinolones or ACE inhibitors/Angiotensin receptor blockers whether used separately and/or concomitantly.

Primary aldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin - angiotensin system. Therefore, the use of CO - PRITOR is not recommended.

Mitral valve stenosis Special caution is indicated in patients suffering from mitral stenosis.

Hyperkalaemia During treatment with other medicinal products that affect the renin - angiotensin - aldosterone system hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure. While this is not documented with telmisartan (as in CO - PRITOR), adequate monitoring of serum potassium in patients at risk is recommended.

Based on experience with the use of other medicinal products that affect the renin - angiotensin system, concomitant use with potassium - sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase the potassium level (heparin, etc.) may lead to an increase in serum potassium and should therefore be co - administered cautiously with CO - PRITOR.

Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency can be expected to have reduced clearance. Therefore, telmisartan must not be given to these patients (see section 4.3). CO - PRITOR should be used only with caution in patients with mild to moderate hepatic impairment or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. There is no clinical experience with CO - PRITOR in patients with hepatic impairment.

Other metabolic disturbances Thiazide therapy, as in CO - PRITOR, may impair glucose tolerance. In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required. Latent diabetes mellitus may become manifest during CO - PRITOR therapy. An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy, as in CO - PRITOR. Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy, as in CO - PRITOR.

Electrolyte imbalance Periodic determination of serum electrolytes should be performed at appropriate intervals. Concomitant use with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other medicines that may increase potassium levels (heparin, etc.) should be undertaken with caution. Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic - induced hypokalaemia. The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH. Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of CO - PRITOR, hyperkalaemia might occur. Frequent monitoring of serum potassium is recommended.

Treatment with thiazide diuretics, as in CO - PRITOR, has been associated with hyponatraemia and hypochloroaemic alkalosis. Thiazides, as in CO - PRITOR, may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. CO - PRITOR should be discontinued before carrying out tests for parathyroid function. Thiazides, as in CO - PRITOR, increase the urinary excretion of magnesium, which may result in hypomagnesaemia. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.

Systemic lupus erythematosus Thiazide diuretics, as in CO - PRITOR, have been reported to exacerbate or activate systemic lupus erythematosus.

Diabetes mellitus In diabetic patients with an additional cardiovascular risk, i.e. patients with diabetes mellitus and coexistent coronary artery disease (CAD), the risk of fatal myocardial infarction and unexpected cardiovascular death may be increased when treated with blood pressure lowering agents such as ARBs or ACE - inhibitors. In patients with diabetes mellitus CAD may be asymptomatic and therefore undiagnosed. Patients with diabetes mellitus should undergo appropriate diagnostic evaluation, e.g. exercise stress testing, to detect and to treat CAD accordingly before initiating treatment with CO - PRITOR.

Choroidal effusion, acute myopia and secondary angle - closure glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle - closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicine initiation. Untreated acute angle - closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

Risk factors for developing acute angle - closure glaucoma may include a history of sulfonamide or penicillin allergy.

Non - melanoma skin cancer An increased risk of non - melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies. Photosensitising actions of HCTZ could act as a possible mechanism for NMSC. Patients taking CO - PRITOR should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. CO - PRITOR should not be used by patients who have had previous and/or current basal cell carcinomas and/or squamous cell carcinomas of the skin and/or lip (see section 4.3).

Ischaemic heart disease Excessive reduction in blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

General Hypersensitivity reactions to hydrochlorothiazide, as in CO - PRITOR, may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Cases of photosensitivity reactions have been reported with use of thiazide diuretics (see Adverse reactions). In the event of a photosensitivity reaction occurring during treatment, discontinuation of the treatment is recommended. If resumption of the treatment is essential, areas exposed to the sun or to artificial UVA rays should be protected.

Acute Respiratory Toxicity Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, CO - PRITOR should be withdrawn and appropriate treatment given. Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake.

Interactions linked to telmisartan Telmisartan, as in CO - PRITOR, may increase the hypotensive effect of other antihypertensive agents. Co - administration of telmisartan, as in CO - PRITOR, did not result in a clinically significant interaction with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine. For digoxin a 20 % increase in median plasma digoxin trough concentration has been observed (in a single case a 39 %); monitoring of plasma digoxin levels should be considered. In one study the co - administration of telmisartan and ramipril led to an increase of up to 2,5 fold in the AUC0 - 24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known.

Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Cases have also been reported with angiotensin II receptor antagonists, including telmisartan (as in CO - PRITOR). Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with CO - PRITOR. (See section 4.3).

Treatment with non - steroidal anti - inflammatory drugs (NSAIDS) Concomitant treatment with non - steroidal anti - inflammatory drugs (NSAIDs) including aspirin is associated with the potential for acute renal insufficiency, especially in patients who are dehydrated. Compounds acting on the renin - angiotensin system like CO - PRITOR may have synergistic effects. Patients receiving NSAIDs and CO - PRITOR should be adequately hydrated and be monitored for renal function at the beginning of, and during, combined treatment. A reduced effect of antihypertensive medicines like telmisartan by inhibition of vasodilating prostaglandins has been reported during combined treatment with NSAIDs. The co - administration of NSAIDs may reduce the diuretic, natriuretic and antihypertensive effects of CO - PRITOR.

Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data has shown that dual blockade of the renin - angiotensin - aldosterone - system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (see section 4.3 and 4.4).

Fluoroquinolones Concomitant use of fluoroquinolones and ACE inhibitors/Angiotensin receptor blockers may precipitate acute kidney injury. The mechanism of the possible interaction between the different classes of medicines, over and above different mechanisms of kidney damage, is unknown (see section 4.3). Additional information on CO - PRITOR interaction The pharmacokinetics of telmisartan are not affected by co - administration of hydrochlorothiazide.

Interactions linked to hydrochlorothiazide (HCTZ) The antihypertensive effect of HCTZ can be potentiated by other diuretics, antihypertensive medicines, guanethidine, methyldopa, calcium antagonists, ACE inhibitors, ARBs, DRIs, beta - receptor blockers, nitrates, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators or by alcohol consumption. Salicylates and other non - steroidal anti - inflammatory drugs (e.g. indomethacin) may reduce the antihypertensive and diuretic effect of HCTZ. In patients taking high - dose salicylates, the toxic effect of salicylates on the central nervous system may be potentiated. In patients developing hypovolaemia during treatment with HCTZ, concomitant administration of non - steroidal anti - inflammatory drugs may trigger acute renal failure. Co - administration of thiazides (including hydrochlorothiazide) and allopurinol may possibly increase the frequency of hypersensitivity reactions to allopurinol. Co - administration of thiazides and amantadine may possibly increase the risk of amantadine - related adverse reactions. There is an increased risk for the onset of hyperglycaemia with concomitant administration of HCTZ and beta - receptor blockers. The effect of insulin or oral antidiabetics, uric acid - lowering medicines, as well as norepinephrine and epinephrine, may be attenuated with concomitant use of HCTZ. An adjustment of the insulin or oral antidiabetic dosage may therefore be required. In concomitant treatment with cardiac glycosides, it must be remembered that myocardial sensitivity to cardiac glycosides will be increased by any hypokalaemia and/or hypomagnesaemia that develops during HCTZ therapy, thereby potentiating the effects and adverse effects of these cardiac glycosides. Concomitant use of HCTZ and kaliuretic diuretics (e.g. furosemide), glucocorticoids, ACTH, carbenoxolone, penicillin G, salicylates, amphotericin B, antiarrhythmics or laxatives may lead to increased potassium loss. In the event of dehydration caused by diuretics, there is an increased risk of acute functional renal failure, particularly during use of high doses of iodinated contrast products. Rehydration before administration of the iodinated product is required. Concomitant use of natriuretic diuretics and antidepressants, antipsychotics or antiepileptics may lead to increased sodium loss. Concomitant use of thiazide diuretics and cytotoxic medicines (e.g. cyclophosphamide, fluorouracil, methotrexate) may lead to a reduction in the renal excretion of cytotoxic medicines. Increased bone marrow toxicity (especially granulocytopenia) can be expected. The bioavailability of thiazide diuretics may be increased by anticholinergic medicines (e.g. atropine, biperiden). This is probably due to a decrease in gastrointestinal motility and the gastric emptying rate. In contrast, prokinetic medicinal products such as cisapride may reduce the bioavailability of thiazide diuretics. Diuretics increase plasma lithium levels. As concomitant administration of HCTZ and lithium leads to potentiation of the cardio - and neurotoxic effects of lithium due to decreased lithium excretion, the lithium level must be monitored in patients receiving HCTZ and lithium. In patients in whom lithium has induced polyuria, diuretics can have a paradoxical antidiuretic effect. The effect of curare - like muscle relaxants may be potentiated or prolonged by HCTZ. In cases where HCTZ cannot be discontinued before the use of curare - like muscle relaxants, the anaesthetist must be informed of the treatment with HCTZ. Concomitant use of cholestyramine or colestipol reduces the absorption of HCTZ. However, the interaction may possibly be minimized by staggered dosing of hydrochlorothiazide and the resinate, so that hydrochlorothiazide is taken at least 4 hours before or 4 - 6 hours after administration of the resinate. Concomitant use with vitamin D may reduce the excretion of calcium via the urine and potentiate the increase of calcium in serum. When co - administered with calcium salts, hypercalcaemia may occur due to the increase in tubular calcium reuptake. Concomitant use with ciclosporin may increase the risk of hyperuricaemia and gout - like complications. Thiazides can increase the hyperglycaemic effect of diazoxide. During concomitant use of methyldopa, there have been uncommon reports of haemolysis, caused by the formation of antibodies against hydrochlorothiazide. Hydrochlorothiazide may reduce the response to adrenergic amines, such as norepinephrine.

Pregnancy Safety in pregnancy and lactation has not been established (see section 4.3). When pregnancy is planned or confirmed CO - PRITOR should be discontinued. Refer to section 4.3 and 4.4. Non - clinical studies with telmisartan, as in CO - PRITOR, do not indicate teratogenic effect, but have shown fetotoxicity. Medicines affecting the renin - angiotensin system, such as CO - PRITOR, can cause embryonal toxicity, foetal and neonatal morbidity and mortality when administered to pregnant women. Women of childbearing age should ensure effective contraception. Should exposure to CO - PRITOR have occurred during pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken CO - PRITOR should be closely observed for hypotension. Thiazides, as in CO - PRITOR, cross the placental barrier and appear in cord blood. They may cause foetal electrolyte disturbances and possibly other reactions that have occurred in the adults. Cases of neonatal thrombocytopaenia and foetal, or neonatal, jaundice have been reported with maternal thiazide therapy.

Breastfeeding CO - PRITOR is contraindicated during lactation, since it is not known whether telmisartan is excreted in human milk. Animal studies have shown excretion of telmisartan in breast milk. Thiazides appear in human milk and may inhibit lactation.

Fertility No studies on fertility in humans with the fixed dose combination or with the individual components have been performed. In non - clinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility were observed.

No studies on the effect on the ability to drive and use machines have been performed. However, it should be taken into account that dizziness, syncope or vertigo may occur when taking antihypertensive therapy. If patients experience these adverse events, they should avoid potentially hazardous tasks such as driving or operating machinery.

Tabulated list of adverse reactions The following side effects derived from the use of the CO - PRITOR (telmisartan and hydrochlorothiazide combination) or the use of the monocomponents (telmisartan or hydrochlorothiazide) in clinical trials or from post - marketing experience are shown in the table below classified by MedDRA System organ class and MedDRA Preferred terms. The following frequency classification is used: very common u2265 1/10; common u2265 1/100 and < 1/10; uncommon u2265 1/1 000 and < 1/100; rare u2265 1/10 000 and < 1/1 000; very rare < 1/10 000; not known: cannot be estimated from the available data.

MedDRA preferred term: Frequency for CO - PRITOR (telmisartan and hydrochlorothiazide fixed dose combination) Frequency for telmisartan as monotherapy Frequency for hydrochlorothiazide as monotherapy Infections and infestations Sepsis (including fatal outcome) - Rare - Bronchitis Rare - - Pharyngitis Rare - - Sinusitis Rare - - Upper respiratory tract infection - Uncommon - Urinary tract infection - Uncommon - Cystitis - Uncommon - Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non - melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma of skin or lip) - - Not known Blood and lymphatic system disorders Anaemia - Uncommon - Thrombocytopenia - Rare Rare Thrombocytopenic purpura - - Rare Eosinophilia - Rare - Aplastic anaemia - - Not known Haemolytic anaemia - - Very rare Bone marrow failure - - Very rare Leukopenia - - Very rare Agranulocytosis - - Very rare Immune system disorders MedDRA preferred term: Frequency for CO - PRITOR (telmisartan and hydrochlorothiazide fixed dose combination) Frequency for telmisartan as monotherapy Frequency for hydrochlorothiazide as monotherapy Anaphylactic reaction - Rare - Hypersensitivity - Rare Very rare Metabolism and nutrition disorders Hypokalaemia Uncommon - Very common Hyponatraemia Rare Rare Common Hyperuricaemia Rare - Common Hyperkalaemia - Uncommon - Hypoglycaemia (in diabetic patients) - Rare - Decreased appetite - - Common Hyperglycaemia - - Rare Hypomagnesaemia - - Common Hypercalcaemia - - Rare Hypochloraemic alkalosis - - Very rare Hyperlipidaemia - - Very common Diabetes mellitus - inadequate control - - Rare Psychiatric disorders Anxiety Uncommon Rare - Depression Rare Uncommon Rare Insomnia Rare Uncommon - Nervous system disorders Dizziness Common - Rare Syncope (fainting) Uncommon Uncommon - Paraesthesia Uncommon - Rare Sleep disorder Rare - Rare Headache - - Rare Eye disorders Visual impairment Rare Rare Rare Blurred vision Rare - - Angle - closure glaucoma - - Not known Choroidal effusion - - Not known Ear and labyrinth disorders Vertigo Uncommon Uncommon - Cardiac disorders Dysrhythmia Uncommon - Rare Tachycardia Uncommon Rare - Bradycardia - Uncommon - Vascular disorders Hypotension Uncommon Uncommon - MedDRA preferred term: Frequency for CO - PRITOR (telmisartan and hydrochlorothiazide fixed dose combination) Frequency for telmisartan as monotherapy Frequency for hydrochlorothiazide as monotherapy Orthostatic hypotension Uncommon Uncommon Common Necrotising vasculitis - - Very rare Respiratory, thoracic and mediastinal disorders Dyspnoea Uncommon Uncommon - Respiratory distress Rare - Very rare Pneumonitis Rare - Very rare Pulmonary oedema Rare - Very rare Acute respiratory distress syndrome - - Very rare Gastrointestinal disorders Diarrhoea Uncommon Uncommon Common Dry mouth Uncommon Rare - Flatulence Uncommon Uncommon - Abdominal pain Rare Uncommon - Constipation Rare - Rare Dyspepsia Rare Uncommon - Vomiting Rare Uncommon Common Gastritis Rare - - Abdominal discomfort - Rare Rare Pancreatitis - - Very rare Nausea - - Common Hepatobiliary disorders Abnormal hepatic function / liver disorder Rare Rare - Jaundice - - Rare Cholestasis - - Rare Skin and subcutaneous tissue disorders Angioedema (with fatal outcome) Rare Rare - Erythema Rare Rare - Pruritus Rare Uncommon - Rash Rare Uncommon Common Hyperhidrosis Rare Uncommon - Urticaria Rare Rare Common Eczema - Rare - Drug eruption - Rare - Toxic skin eruption - Rare - Toxic epidermal necrolysis - - Very rare Lupus - like syndrome - - Very rare Cutaneous lupus erythematosus - - Very rare Photosensitivity reaction - - Rare Erythema multiforme - - Not known Musculoskeletal and connective tissue disorders Back pain Uncommon Uncommon - Muscle spasm (cramps in legs) Uncommon Uncommon Not known Myalgia Uncommon Uncommon - Arthralgia Rare Rare - Pain in extremity (leg pain) Rare Rare - Tendon pain (tendonitis like symptoms) - Rare - Systemic lupus erythematosus Rare - - Renal and urinary disorders Renal impairment (including acute kidney injury) - Uncommon Not known (renal impairment), Uncommon (acute kidney injury) Glycosuria - - Rare Reproductive system and breast disorders Erectile dysfunction Uncommon - Common General disorders and administration site conditions Chest pain Uncommon Uncommon - Influenza like illness Rare Rare - Pain Rare - - Asthenia (weakness) - Uncommon Not known Pyrexia - - Not known Investigations Blood uric acid increased Uncommon Rare - Blood creatinine increased Rare Uncommon - Hepatic enzyme increased Rare Rare - Blood creatine Phosphokinase increased Rare Rare - Haemoglobin decreased Rare Rare -

Limited information is available for CO - PRITOR with regard to overdose in humans. Symptoms The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia also occurred. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasm and/or accentuate cardiac dysrhythmias associated with the concomitant use of digoxin or certain anti - dysrhythmic medicines.

Therapy No specific information is available on the treatment of overdosage with CO - PRITOR. The patient should be closely monitored, and the treatment should be symptomatic and supportive depending on the time since ingestion and the severity of the symptoms. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly. Telmisartan is not removed by haemofiltration and is not dialyzable. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.