iotensin system is not activated. Therefore, Exforge HCT is not recommended in this population.
Systemic lupus erythematosus
Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Other metabolic disturbances
Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides, and uric acid. In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Thiazides may reduce urinary calcium excretion and cause intermittant and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.
Photosensitivity
Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8). If photosensitivity reaction occurs during treatment with Exforge HCT, it is recommended to stop the treatment. If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
General
Caution should be exercised in patients who have shown prior hypersensitivity to other angiotensin II receptor antagonists. Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with allergy and asthma.
Elderly (age 65 years or over)
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
4.5 Interaction with other medicinal products and other forms of interaction
No formal interaction studies with other medicinal products were performed with Exforge HCT. Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
However, it is important to take into account that Exforge HCT may increase the hypotensive effect of other antihypertensive agents.
Concomitant use not recommended
Exforge HCT individual component
Known interactions with the following agents
Effect of the interaction with other medicinal products
Valsartan and HCT
Lithium
Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors and thiazides such as hydrochlorothiazide. Despite the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Valsartan
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Caution required with concomitant use
Exforge HCT individual component
Known interactions with the following agents
Effect of the interaction with other medicinal products
Amlodipine
CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir)
A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipin |
