Nordurine 0.1 mg Tablets

  • Name:

    Nordurine 0.1 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Desmopressin Acetate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Summary of Product Characteristics last updated on medicines.ie: 26/5/2015
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Ferring Ireland Limited

Ferring Ireland Limited

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Medicine Name DDAVP Desmopressin 100 micrograms/ml Nasal drops,solution Active Ingredients Desmopressin Acetate
Medicine Name DDAVP/Desmopressin 4 micrograms/ml Solution for Injection Active Ingredients Desmopressin Acetate
Medicine Name Desmospray, Desmopressin Nasal Spray Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 120 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 240 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 60 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name FIRMAGON 120 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name FIRMAGON 80 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name Glypressin 1 mg Powder and Solvent for Solution for Injection Active Ingredients Terlipressin acetate
Medicine Name Glypressin 1 mg/ 8.5 ml solution for injection Active Ingredients Terlipressin acetate
Medicine Name Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection Active Ingredients triptorelin acetate
Medicine Name Lutinus 100 mg Vaginal Tablets Active Ingredients Progesterone
Medicine Name Menopur 1200IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 600IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 75IU Powder and Solvent for Solution for Injection. Menotrophin (HMG) Active Ingredients Menotrophin
Medicine Name Noqturina 25 microgram oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Noqturina 50 microgram oral lyophilisate Active Ingredients Desmopressin
Medicine Name Nordurine 0.1 mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Nordurine 0.2mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Pabal 100 micrograms/ml solution for injection Active Ingredients Carbetocin
Medicine Name Pentasa 1 g Prolonged-release Tablets Active Ingredients Mesalazine
Medicine Name Pentasa 1 g Suppositories Active Ingredients Mesalazine
Medicine Name Pentasa 10 mg/ml Rectal Suspension Active Ingredients Mesalazine
Medicine Name Pentasa 500 mg Prolonged Release Tablets Active Ingredients Mesalazine
1 - 0 of 35 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26 May 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 26 May 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 9 December 2013 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 4.2:

New section:

General

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

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.  When restarting treatment strict fluid restriction should be enforced (see section 4.4).

If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.

 

Indication specific

 

Text deleted:

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:

Sentences updated as follows:

Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus as well as data on a limited number (n=54) of exposed pregnancies in women with von Willebrand disease indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/ newborn child.

There have been rare reports of malformations in children born to mothers treated for diabetes insipidus during pregnancy.

Caution should be exercised when prescribing Nordurine tablets to pregnant women.

Fertility studies have not been done.  In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentrations corresponding to recommended dose.

 

Section 4.7:

None. Nordurine Tablets have no or negligible influence on the ability to drive and use machines.

 

Section 4.8:

This section is fully updated.  Please see full SPC for the new, approved text.

 

Section 5.1:

This results in a considerably longer duration of action and a complete lack of pressor effect in the dosages clinically used.  Desmopressin is a potent compound with an EC50 value of 1.6 pg/ml, for the antidiuretic effect.  After oral administration, an effect lasting from 6 to 14 hours or more can be expected.  The uterotonic and vasopressor actions are extremely low in the dosages clinical used.

 

Section 5.2:

This section is fully updated.  Please see full SPC for the new, approved text.

 

Section 5.3:

This section is fully updated.  Please see full SPC for the new, approved text.

 

 

 

Updated on 9 December 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2:

New section:

General

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

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.  When restarting treatment strict fluid restriction should be enforced (see section 4.4).

If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.

 

Indication specific

 

Text deleted:

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:

Sentences updated as follows:

Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus as well as data on a limited number (n=54) of exposed pregnancies in women with von Willebrand disease indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/ newborn child.

There have been rare reports of malformations in children born to mothers treated for diabetes insipidus during pregnancy.

Caution should be exercised when prescribing Nordurine tablets to pregnant women.

Fertility studies have not been done.  In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentrations corresponding to recommended dose.

 

Section 4.7:

None. Nordurine Tablets have no or negligible influence on the ability to drive and use machines.

 

Section 4.8:

This section is fully updated.  Please see full SPC for the new, approved text.

 

Section 5.1:

This results in a considerably longer duration of action and a complete lack of pressor effect in the dosages clinically used.  Desmopressin is a potent compound with an EC50 value of 1.6 pg/ml, for the antidiuretic effect.  After oral administration, an effect lasting from 6 to 14 hours or more can be expected.  The uterotonic and vasopressor actions are extremely low in the dosages clinical used.

 

Section 5.2:

This section is fully updated.  Please see full SPC for the new, approved text.

 

Section 5.3:

This section is fully updated.  Please see full SPC for the new, approved text.

 

 

 

Updated on 12 July 2010 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.3: Added "Before prescribing Nordurine tablets the diagnoses of psychogenic polydopsia and alcohol abuse should be excluded".

Section 4.4: Added statement on lactose.  Added statement on the symptoms of hyponatraemia.

Section 4.8: Undesirable effects section updated to MedDra format.  Undesirable effects divided into two categories; (i) primary nocturnal enuresis and diabetes insipidus and (ii) nocturia.

Updated on 12 July 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3: Added "Before prescribing Nordurine tablets the diagnoses of psychogenic polydopsia and alcohol abuse should be excluded".

Section 4.4: Added statement on lactose.  Added statement on the symptoms of hyponatraemia.

Section 4.8: Undesirable effects section updated to MedDra format.  Undesirable effects divided into two categories; (i) primary nocturnal enuresis and diabetes insipidus and (ii) nocturia.

Updated on 8 January 2010 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Section 2:  Updated to include statement on lactose monohydrate
Section 3:  Updated to give directions that the scoreline is 'only to facilitate breaking for ease of swallowing and not to divide into equal halves'
Section 6.4: Storage conditions updated to include 'Store in the original package and keep the bottle tightly closed in order to protect from light and moisture'.

Updated on 8 January 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2:  Updated to include statement on lactose monohydrate
Section 3:  Updated to give directions that the scoreline is 'only to facilitate breaking for ease of swallowing and not to divide into equal halves'
Section 6.4: Storage conditions updated to include 'Store in the original package and keep the bottle tightly closed in order to protect from light and moisture'.

Updated on 15 October 2007 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to Section 3-changed from white, oval and convex to white, oval, convex.
Change to Section 4.8 Common listed as > i in 1000, changed to >1 in 100
Change to section 4.9-formatting
Change to section 5.1- typing correction-contains to contain.
Change to section 6.2- Not Applicable changd to None
Change to section 7- Typing correction in address.
Change to section 10- Date of revision updated to Sept 2005
 

Updated on 15 October 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 3-changed from white, oval and convex to white, oval, convex.
Change to Section 4.8 Common listed as > i in 1000, changed to >1 in 100
Change to section 4.9-formatting
Change to section 5.1- typing correction-contains to contain.
Change to section 6.2- Not Applicable changd to None
Change to section 7- Typing correction in address.
Change to section 10- Date of revision updated to Sept 2005
 

Updated on 16 August 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 August 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 June 2005 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 27 June 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 June 2005 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Updated on 7 June 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 October 2003 PIL

Reasons for updating

  • New SPC for new product

Updated on 29 October 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)