Telstran Plus Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely.
Tabulated list of adverse reactions: Adverse reactions reported in all clinical trials and occurring more frequently with telmisartan plus hydrochlorothiazide than with placebo are shown as follows according to system organ class. Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Telmisartan/Hydrochlorothiazide.
Adverse reactions have been ranked under headings of frequency using the following convention: very common; common; uncommon; rare; very rare, not known.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations: Rare: Bronchitis, pharyngitis, sinusitis.
Immune system disorders: Rare: Exacerbation or activation of systemic lupus erythematosus.
Metabolism and nutrition disorders: Uncommon: Hypokalaemia.
Rare: Hyperuricaemia, hyponatraemia.
Psychiatric disorders: Uncommon: Anxiety.
Rare: Depression.
Nervous system disorders: Common: Dizziness.
Uncommon: Syncope, paraesthesia.
Rare: Insomnia, sleep disorders.
Eye disorders: Rare: Visual disturbance, vision blurred.
Ear and labyrinth disorders: Uncommon: Vertigo.
Cardiac disorders: Uncommon: Tachycardia, arrhythmias.
Vascular disorders: Uncommon: Hypotension, orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea.
Rare: Respiratory distress (including pneumonitis and pulmonary oedema).
Gastrointestinal disorders: Uncommon: Diarrhoea, dry mouth, flatulence.
Rare: Abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Hepatobiliary disorders: Rare: Abnormal hepatic function/liver disorder.
Skin and subcutaneous tissue disorders: Rare: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria.
Muscoloskeletal, connective tissue and bone disorders: Uncommon: Back pain, muscle spasms, myalgia.
Rare: Arthralgia, muscle cramps, pain in limb.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction.
General disorders and administration site conditions: Uncommon: Chest pain.
Rare: Influenza-like illness, pain.
Investigations: Uncommon: Blood uric acid increased.
Rare: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased.
For further description, please see Description of selected adverse reactions as follows.
Additional information on individual components: Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Telmisartan/Hydrochlorothiazide, even if not observed in clinical trials with this product.
Telmisartan: Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo in placebo controlled trials. The following adverse reactions listed as follows have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Infections and infestations: Uncommon: Upper respiratory tract infection, urinary tract infection including cystitis.
Rare: Sepsis including fatal outcome.
Blood and lymphatic system disorders: Uncommon: Anaemia.
Rare: Eosinophilia, thrombocytopenia.
Immune system disorders: Rare: Hypersensitivity, anaphylactic reactions.
Metabolism and nutrition disorders: Uncommon: Hyperkalaemia.
Rare: Hypoglycaemia (in diabetic patients).
Cardiac disorders: Uncommon: Bradycardia.
Nervous system disorders: Rare: Somnolence.
Respiratory, thoracic and mediastinal disorders: Uncommon: Cough.
Very rare: Interstitial lung disease.
Gastrointestinal disorders: Rare: Stomach discomfort.
Skin and subcutaneous tissue disorders: Rare: Eczema, drug eruption, toxic skin eruption.
Musculoskeletal, connective tissue and bone disorders: Rare: Arthrosis, tendon pain.
Renal and urinary disorders: Uncommon: Renal impairment (including acute renal failure).
General disorders and administration site conditions: Uncommon: Asthenia.
Investigations: Rare: Haemoglobin decreased.
For further description, please see Description of selected adverse reactions as follows.
Hydrochlorothiazide: Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance.
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: Infections and infestations: Not known: Sialadenitis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Not known: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Blood and lymphatic system disorders: Rare: Thrombocytopenia (sometimes with purpura).
Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis.
Immune system disorders: Not known: Anaphylactic reactions, hypersensitivity.
Endocrine disorders: Not known: Diabetes mellitus inadequate control.
Metabolism and nutrition disorders: Common: Hypomagnesaemia.
Rare: Hypercalcaemia.
Very rare: Hypochloraemic alkalosis.
Not known: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia.
Psychiatric disorders: Not known: Restlessness.
Nervous system disorders: Rare: Headache.
Not known: Light-headedness.
Eye disorders: Not known Xanthopsia, acute myopia, acute angle-closure glaucoma.
Vascular disorders: Not known: Vasculitis necrotizing.
Gastrointestinal disorders: Common: Nausea.
Not known: Pancreatitis, stomach discomfort.
Hepatobiliary disorders: Not known: Jaundice hepatocellular, jaundice cholestatic.
Skin and subcutaneous tissue disorders: Not known: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme.
Musculoskeletal, connective tissue and bone disorders: Not known: Weakness.
Renal and urinary disorders: Not known: Nephritis interstitial, renal dysfunction, glycosuria.
General disorders and administration site conditions: Not known: Pyrexia.
Investigations: Not known: Triglycerides increased.
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Not known: Skin and lip cancer (Non-melanoma skin cancer).
Description of selected adverse reactions: Hepatic function abnormal/liver disorder: Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
Sepsis: An increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known.
Interstitial lung disease: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established.
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Frequency not known: non melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependant association between HCTZ and NMSC has been observed.