Products information : ADEX

ADEX 2,5 mg Indapamide
 
Products technical sheet

Pharmaceutical form and presentation

 Pharmaceutical form
Tablet
Presentation
Box of 30 tablets
M.A number: 923 326 1

Pharmacological class

 This drug is a diuretic antihypertensive

Composition

Indapamide………............................……...2.5 mg
Excipients: sodium carboxymethyl starch (A type), magnesium stearate s.q.f one tablet
Lactose monohydrated………..............…………s.q

Therapeutic indications

 Adex is indicated in the treatment of essential hypertension.

Contraindications

 -Hypersensitivity to sulfonamides.
-Severe renal insufficiency (creatinin clearance < 30ml/min.).
-Hepatic encephalopathy.
-Hypokaliemia.
-Lactase deficiency.
-Glucose and galactose malabsorption syndrome.

Warnings and precautions of use

 Warnings
In a case of hepatic impairment, the thiazidic diuretics and related products can induce a hepatic encephalopathy. The occurrence of such disorder requires the immediate discontinuation of the treatment and the management of eventual hypokaliemia.
Precautions of use
A regular control, especially in risky patients, is required for:
-Natremia:  to be controlled before treatment initiation.
-Kaliemia: the first control is to be done during the first week of treatment.
-Thiazidic diuretics can induce a slight and transient increase of calcemia. The treatment should be discontinued before any exploration of parathyroidal function.

Pregnancy and breastfeeding

 Pregnancy
Thiazidic diuretics and related products are contraindicated in pregnant women and are not indicated in the treatment of the pregnancy physiological oedema (risk of foetal hypotrophy).
Breastfeeding
Breastfeeding is not recommended.

Sportsmen and sportswomen

 Sportsmen and sportswomen should take care because this drug contains an active substance which can induce a positive reaction in the anti-doping tests.

Effects on the ability to drive or to operate on machines

 Individual reactions due to the lowering of blood pressure can occur in some patients. The ability to drive or to operate on machines can, thus, be reduced.

Drugs interactions

 You should inform your doctor or your pharmacist if you take or have taken recently any other drug, even drugs obtained without medical prescription.

Undesirable effects

 Like all drugs, adex 2.5mg is susceptible to induce undesirable effects:
-Risk of hyponatremia with hypovolemia which can cause dehydration and orthostatic hypotension and even a mental confusion syndrome.
-Risk of potassium depletion with hypokaliemia, especially in cirrhotic, elderly, not well fed, under multiple drugs, with coronary heart disease and with heart failure patients. This drug can induce severe rhythm disorders, especially torsades de pointes (which can be fatal), especially in case of heart failure.
-Other biological disorders: hyperuricemia, hyperglycemia, and exceptionally hypercalcemia.
-Neurological disorders (rare):  dizziness, asthenia, paresthesia and headaches.
-Digestive disorders (rare): nausea, constipation and exceptionally pancreatitis.
-Haematological disorders (exceptionally): thrombocytopenia, leucopenia, agranulocytosis, bone marrow aplasia and haemolytic anemia.
-Others: hypersensitive reactions, essentially dermatologic reactions: maculo-papulous eruptions, purpura, risk of worsening of a pre-existing systemic lupus erythematous and mouth dryness.

Dosage and mode of administration

 Oral route.
1 tablet a day, preferably in the morning before meals.

Storage

 To be stored in a temperature less than 25°C, away from light and heat.

Delivery conditions

 LIST II