4.7 Effects on ability to drive and use machines
No studies on the effect of Co-Diovan, on the ability to drive and use machines have been performed. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.

4.8 Undesirable effects
Adverse reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual postmarketing reports are presented below according to system organ class. Adverse reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan/ hydrochlorothiazide.

Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Table 1. Frequency of adverse reactions with valsartan/hydrochlorothiazide

Metabolism and nutrition disorders
 
Uncommon
 Dehydration
 
Nervous system disorders
 
Very rare
 Dizziness
 
Uncommon
 Paraesthesia
 
Not known
 Syncope
 
Eye disorders
 
Uncommon
 Vision blurred
 
Ear and labyrinth disorders
 
 
Uncommon
 Tinnitus
 
Vascular disorders
 
Uncommon
 Hypotension
 
Respiratory, thoracic and mediastinal disorders
 
Uncommon
 Cough
 
Not known
 Non cardiogenic pulmonary oedema
 
Gastrointestinal disorders
 
Very rare
 Diarrhoea
 
Musculoskeletal and connective tissue disorders
 
Uncommon
 Myalgia
 
Very rare
 Arthralgia
 
Renal and urinary disorders
 
Not known
 Impaired renal function
 
General disorders and administration site conditions
 
Uncommon
 Fatigue
 
Investigations
 
Not known
 Serum uric acid increased, Serum bilirubin and Serum creatinine increased, Hypokalaemia, Hyponatraemia, Elevation of Blood Urea Nitrogen, Neutropenia
 

Additional information on the individual components

Adverse reactions previously reported with one of the individual components may be potential undesirable effects with Co-Diovan as well, even if not observed in clinical trials or during postmarketing period.

Table 2. Frequency of adverse reactions with valsartan

Blood and lymphatic system disorders
 
Not known
 Decrease in haemoglobin, decrease in haematocrit, thrombocytopenia
 
Immune system disorders
 
Not known
 Other hypersensitivity/allergic reactions inc