· High blood pressure.

· Renal, cardiac and hepatic edema

High blood pressure

1/2 to 1 tablet per day Treatment is initiated at a dose of one half tablet per day in case of ineffectiveness after 6 to 8 weeks of treatment the dosage is increased to 1 tablet / Day.

Cardiac and renal edema

· Attack treatment: 3 to 4 tablets per day. These doses will then be lowered according to the patient's response.
· Maintenance treatment: 1 to 2 tablets per day.

· High blood pressure · Renal, cardiac and liver edema

Hepatic edema

· Attack treatment: 4 to 6 tablets per day.

· Maintenance treatment: 1 to 2 tablets per day.

In the case of edema, these doses will be adapted to the response obtained (diuresis, weight) and the electrolyte balance of the patient

Absence of information in the AMM

DIURETIC THIAZID AND DIURETIC POTASSY SAVINGER IN ASSOCIATION

(C03EA04: Cardiovascular system).

The altizide combination (diuretic, thiazide-related) and spironolactone (potassium-sparing diuretic, anti-hormone) provides low natriuresis with a potassium-sparing effect thereby decreasing the potassium-induced loss of potassium The altizide.

Altizide acts by inhibiting the reabsorption of sodium at the cortical segment of dilution. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing diuresis and exerting an antihypertensive action. >

Spironolactone is a competitive antagonist of aldosterone in the receptors of the mineralocorticoid hormone.



This medicinal product MUST NEVER BE USED in case of

· Severe or acute renal failure, including: anuria, renal dysfunction, rapid change

· Hyperkalemia

· Terminal stage of hepatic impairment

· Hypersensitivity to sulfonamides

· Hypersensitivity to spironolactone

· Association with other diuretics, hyperkalaemia, potassium salts (except in cases of hypokalemia) (see section Interactions with other medicines and other forms of interactions)
< Br>

This medicinal product is generally not recommended for cirrhotic patients, when the serum sodium levels are lower, at 125 mmol / l and in subjects susceptible to acidosis. >
Special warnings

The combination of a diuretic, a potassium-sparing agent and a natriuretic does not exclude the occurrence of hyperkalaemia or hypokalaemia.



Hypokalemia

The risk of occurrence of hypokalemia (
Hyperkalemia

Any prescription of a drug acting on the renin-angiotensin-aldosterone system is liable to cause hyperkalaemia. This risk, potentially fatal, is increased in the elderly, renal and diabetic patients, and / or in the case of combination of several drugs, hyperkalaemic agents, and / or on the occurrence of intercurrent events See also Interactions with other medicinal products and other forms of interactions)

Before considering a combination of several drugs blocking the renin-angiotensin-aldosterone system, the ratio should be evaluated carefully, benefit / risk and possible alternatives.

The main risk factors for hyperkalemia to be taken into consideration are

· Diabetes, impairment of renal function, age (> 70 years)

· Combination with one or more other blocking drugs, the renin-angiotensin-aldosterone system, and / or other hyperkalaemic drugs and / or potassium supplements. Certain drugs or therapeutic classes are likely to promote the occurrence of hyperkalaemia: potassium salts, hyperkalaemic diuretics, inhibitors, angiotensin II antagonists (ARI II) ), Non-steroidal anti-inflammatory drugs (including selective COX 2 inhibitors), heparins (low molecular weight or non-fractionated), immunosuppressants such as ciclosporin or tacrolimus, trimethoprim. Br>

Intercurrent events, in particular, dehydration, acute cardiac decompensation, metabolic acidosis, impairment of function, renal, severe and sudden alteration of the general condition (for example in diseases, infectious), suffering and cell lysis Eg, acute ischemia of a limb, rhabdomyolysis, trauma, extensive).
The follow-up of patients, and in particular patients at risk, should include a blood ionogram, in particular a control of serum potassium, serum sodium and renal function

· Before the initiation of treatment and then a week to 15 days after

(Before and after) each increase in dose, or change in treatment, and then in maintenance treatment, checks must be performed regularly OR, when an intercurrent event occurs. Br>

Risk of encephalopathy and liver disease in patients with hepatic impairment, especially when the serum sodium content is less than 125 mmol / l and in subjects susceptible to acidosis. In this case, the administration of this diuretic combination should be immediately interrupted.

Reactions of photosensitivity have been reported in the use of thiazide diuretics. (See section 4.4).

In the event of a photosensitivity reaction under treatment, it is recommended to discontinue the treatment. If re-administration of the treatment is essential it is recommended to protect areas exposed to the sun or artificial UVA

The attention of athletes is drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction of the tests carried out during the antidoping tests. Code>
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Precautions for use

· Hydroelectrolytic balance

It should be monitored prior to initiation of treatment, and thereafter at regular intervals thereafter, particularly in elderly and cirrhotic patients in whom the administration is discouraged when the serum sodium levels are below 125 mmol / l.

Calcium: Thiazide and related diuretics may decrease the urinary excretion of calcium and result in a mild and transient increase in serum calcium. A frank hypercalcaemia may be related to unrecognized hyperparathyroidism (discontinue treatment before exploring the function, parathyroid).


Renal function Spironolactone and altizide are only fully effective when renal function is normal or poorly altered (serum creatinine, less than values ​​on the order of 25 mg / l, ie 220 μmol / l The value of serum creatinine may be falsely reassuring for renal function, which may be better evaluated by an ionogram or a formula such as Cockroft's which takes into account age, Weight and sex: C cr '= (140 - age) x weight / 0.814 x creatinine
O with age in years

O weight in kg

O creatinine in micromol / l.

This formula is valid for male subjects and should be corrected for women by multiplying the result by 0.85 Hypovolemia, secondary to loss of water and sodium induced by the diuretic in the beginning Of treatment, results in a reduction in glomerular filtration. This may result in an increase in blood urea and serum creatinine. This transient functional renal failure is without consequence in the subject with renal function normal but may aggravate a pre-existing renal insufficiency

Anesthesia: Prudence during anesthesia: sensitivity to norephedrine may be decreased, that to tubocurarine can be increased

Related to spironolactone

Certain drugs or classes of therapeutics are likely to promote the onset of hyperkalaemia: potassium salts, hyperkalaemic diuretics, angiotensin II antagonists, angiotensin II antagonists, anti- Non-steroidal inflammatory drugs, heparins (low molecular weight or non-fractionated), immunosuppressants such as ciclosporin, or tacrolimus, trimethoprim. The combination of these drugs increases the risk of hyperkalaemia. This risk is particularly important with potassium-sparing diuretics, especially when they are combined with one another or with potassium salts, while the combination of an ACE inhibitor and an NSAID, for example, Is at a lower risk from the moment that the recommended precautions are implemented.

For drug-specific risks and stress levels, hyperkalaemia, refer to the interactions specific to each substance.

However, certain substances, such as trimethoprim, are not subject to specific interactions with respect to this risk. However, they may act as promoting factors when they are associated with other medicines already mentioned in this cap.

Associations, contraindicated

(Unless there is hypokalemia)

+ Other diuretics, potassium-sparing (alone or in combination) (amiloride, potassium canonate, triamterene)
Hyperkalemia potentially lethal especially in the renal insufficiency (addition, hyperkalaemic effects).

+ Potassium salts

Hyperkalemia potentially lethal especially in renal insufficiency (addition of hyperkalaemic effects)

Associations deprecated

+ Ciclosporin, tacrolimus

Hyperkalemia potentially lethal, especially in renal insufficiency (addition, hyperkaleemic effects)

+ ACE inhibitors (unless there is hypokalemia)

Except for spironolactone at doses between 12.5 mg and 50 mg / day in the treatment of heart failure.
Risk of hyperkalaemia (potentially lethal), especially in patients with impaired renal function (addition of hyperkalaemic effects)
Associations subject to precautions for use

+ ACE inhibitors, in the case of heart failure (treated with low-dose IEC combination + diuretic, low-dose hypokalaemic)

With spironolactone at 12.5 to 50 mg per day and with doses of ACE inhibitors
In particular, the treatment of edema, hydrosodic retention or gravitational hypertension is not an indication for treatment, as diuretics during pregnancy, as these may lead to fetoplacental ischemia with a risk; Fetal hypotrophy.

Related to altizide

In general, the administration of thiazide and related diuretics should be avoided in pregnant women and should never be prescribed during physiological (and therefore untreatable) edema of pregnancy. Diuretics may cause foetoplacental ischemia with a risk of fetal hypotrophy.


Diuretics remain an essential part of the treatment, cardiac, hepatic and renal edema in pregnant women

Breastfeeding

Related to spironolactone

Spironolactone is excreted in low amounts in breast milk. Nevertheless, it should not be used during breastfeeding, because

· A decrease or even suppression of the milk secretion

Of its undesirable effects, in particular biological effects (serum potassium).

Linked to the altizide

Thiazides are excreted in low amounts in breast milk. However, they should not be used during periods of breastfeeding because of
· A decrease or even suppression of the milk secretion

Of their adverse effects, in particular biological effects (serum potassium)

· Their belonging to sulphonamides with risk of allergy and of jaundice.

Related to spironolactone

These adverse effects have been observed in adults

Gynecomastia may appear during the use of spironolactone: its development appears to be related to both the dosage used and the duration of the therapy, it is usually reversible, Administration of spironolactone, however, in rare cases it may persist.


· Impotence in humans

· Disorders of menstruation in women

· Intestinal digestive

· Skin rash

· Sleepiness

· Cramps of the lower limbs.

Biologically speaking

Under spironolactone, serum potassium may increase moderately. More severe hyperkalaemias are reported in patients with renal insufficiency and in patients under potassium or IEC supplementation: although the vast majority of these hyperkalemias are asymptomatic, they should be promptly corrected. In case of hyperkalaemia, treatment with spironolactone will be discontinued.
These disorders are usually reversible upon discontinuation of treatment.

Related to altizide

The biological or clinical adverse effects are most dose-dependent and can be reduced by the search for the minimum dose, effective, especially in hypertension. >
Thiazide and related diuretics may cause

Biologically speaking

· Potassium depletion with hypokalaemia, particularly in cases of severe diuresis, and particularly severe in certain populations at risk (section Mises, custody and precautions for use).

· Hyponatremia with hypovolemia at the origin, dehydration and orthostatic hypotension. The concomitant loss of chlorine ions can lead to secondary metabolic alkalosis, and the incidence and amplitude of this effect are low.

· An increase in uricemia and blood glucose during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects. >
· Haematological disorders, much more rare, thrombocytopenia, leukopenia, agranulocytosis, aplasia, medullary, haemolytic anemia.
· Exceptional Hypercalcemia

At the clinical level

· In case of liver failure, possibility of occurrence of hepatic encephalopathy (section, Contraindications and section Warnings and precautions for use)

· Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic manifestations

· Cases of photosensitivity reaction (very rare) have been reported (see Warnings and Precautions for Use).

· Maculopapular eruptions, purpura, possibility of aggravation of acute lupus erythematosus, disseminated preexisting

Nausea, constipation, dizziness, asthenia, paraesthesia, headache, rarely observed and most often giving rise to a reduction in dosage.
· Exceptionally: pancreatitis.