Nordurine 0.2mg Tablets

In the event of signs of water retention/hyponatraemia treatment should be interrupted until the patient has recovered.

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. The supervising specialist should decide whether or not to restart treatment in such a patient. If restarting treatment strict fluid restriction should be enforced (see 4.4).

Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see section 4.5).

Text inserted:

Special Populations

Elderly:

Older patients:

The initiation of treatment in older patients (patients over 65 years) is contraindicated in patients being treated for nocturia and primary nocturnal enuresis.

Dosage recommendation for older patients suffering from central diabetes insipidus is the same as for other age groups.

Renal Impairment

Nordurine Tablets are contraindicated in cases of moderate and severe renal insufficiency (creatinine clearance below 50 ml/min (see section 4.3

Hepatic Impairment

In vitro human liver microsome metabolism studies of desmopressin have shown that no significant amount is metabolized in the liver by the cytochrome P450 system. Thus human liver metabolism in vivo by the cytochrome P450 system is unlikely to occur. The effect of desmopressin on the PK of other drugs is likely to be minimal due to its lack of inhibition of the cytochrome P450 drug metabolizing system (see section 4.5).

Paediatric Population

Nordurine Tablets are indicated in Central Diabetes Insipidus and Primary Nocturnal Enuresis (see section 5.1 and indication specific information in 4.2 above).  Dose recommendations are the same as in adults.

Section 4.4:

Note: some text has been relocated within the section. Only new text and deleted text is indicated below.

New section:

Special warnings:

All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.

Updated text (in bold):

Precautions:

- Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.

- Older Elderly patients and patients with low serum sodium levels may have an increased risk of hyponatraemia therefore Nordurine Tablets are contraindicated in patients being treated for primary nocturnal enuresis and nocturia.

- Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis).

- Precautions must be taken in patients at risk for increased intracranial pressure.

- Desmopressin should be used with caution in patients with conditions characterized by fluid and/or electrolyte imbalance.

Section 4.5:

Substances, which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonine reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the sulfonylurea group particularly Chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of water retention/hyponatraemia

The concomitant use of food decreases the rate and extent of absorption of Nordurine tablets by 40%. A standardized 27% fat meal significantly decreased absorption (rate and extent) of oral desmopressin.

Section 4.6:

In the event of signs of water retention/hyponatraemia treatment should be interrupted until the patient has recovered.

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. The supervising specialist should decide whether or not to restart treatment in such a patient. If restarting treatment strict fluid restriction should be enforced (see 4.4).

Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see section 4.5).

Text inserted:

Special Populations

Elderly:

Older patients:

The initiation of treatment in older patients (patients over 65 years) is contraindicated in patients being treated for nocturia and primary nocturnal enuresis.

Dosage recommendation for older patients suffering from central diabetes insipidus is the same as for other age groups.

Renal Impairment

Nordurine Tablets are contraindicated in cases of moderate and severe renal insufficiency (creatinine clearance below 50 ml/min (see section 4.3

Hepatic Impairment

In vitro human liver microsome metabolism studies of desmopressin have shown that no significant amount is metabolized in the liver by the cytochrome P450 system. Thus human liver metabolism in vivo by the cytochrome P450 system is unlikely to occur. The effect of desmopressin on the PK of other drugs is likely to be minimal due to its lack of inhibition of the cytochrome P450 drug metabolizing system (see section 4.5).

Paediatric Population

Nordurine Tablets are indicated in Central Diabetes Insipidus and Primary Nocturnal Enuresis (see section 5.1 and indication specific information in 4.2 above).  Dose recommendations are the same as in adults.

Section 4.4:

Note: some text has been relocated within the section. Only new text and deleted text is indicated below.

New section:

Special warnings:

All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.

Updated text (in bold):

Precautions:

- Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.

- Older Elderly patients and patients with low serum sodium levels may have an increased risk of hyponatraemia therefore Nordurine Tablets are contraindicated in patients being treated for primary nocturnal enuresis and nocturia.

- Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis).

- Precautions must be taken in patients at risk for increased intracranial pressure.

- Desmopressin should be used with caution in patients with conditions characterized by fluid and/or electrolyte imbalance.

Section 4.5:

Substances, which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonine reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the sulfonylurea group particularly Chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of water retention/hyponatraemia

The concomitant use of food decreases the rate and extent of absorption of Nordurine tablets by 40%. A standardized 27% fat meal significantly decreased absorption (rate and extent) of oral desmopressin.

Section 4.6: