DEMOVO

25 ml) three times daily. 5 ml) to 1080 micrograms (3 ml) of desmopressin. Thereafter, this dosage regimen should then be adjusted in accordance with the patient’s response. 5 ml) three times daily. If symptoms of fluid retention and/or hyponatremia appear (headache, nausea, vomiting, weight gain, and, in severe cases, seizures), the treatment should be discontinued and the dose of desmopressin should be readjusted.

5 ml) of desmopressin at bedtime. The dose may be increased up to 360 micrograms (1 ml) if the lower dose is not effective enough. Demovo 360 micrograms/ml oral solution is recommended for treatment periods of 3 months. In connection with long-term treatment, a treatment free period of at least one week should be introduced every three months to assess whether spontaneous healing has occurred.

Fluid intake should be controlled. If symptoms or signs of fluid retention and/or hyponatremia appear (headache, nausea, vomiting, weight gain, and, in severe cases, seizures), the treatment should be discontinued until the patient has recovered.

4). If the desired clinical effect is not achieved after 4 weeks of dose titration, treatment should be discontinued Treatment of elderly patients (≥65 years of age) should be followed closely due to the increased risk of hyponatremia.

Serum sodium should be measured at baseline, three days after onset of treatment or at any dose increase and regularly during prolonged therapy. Method of administration Demovo 360 micrograms/ml oral solution is for oral use.

8. It is therefore recommended that this danger be pointed out to patients, in particular elderly patients and the parents of young children. Cerebral oedema has repeatedly been reported in children and young adults treated with desmopressin for nocturnal enuresis.

During treatment with desmopressin, body weight, serum sodium and/or blood pressure may have to be monitored. Care should be taken in patients with reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Demovo 360 micrograms/ml oral solution would be less than usual.

Precautions for use:

Precautions to prevent hyponatremia shall be taken in: - conditions characterised by fluid and/or electrolyte imbalance, such as systemic infections, fever, gastroenteritis, and SIADH (syndrome of inappropriate secretion of ADH), - concomitant treatment with drugs known to induce SIADH, such as tricyclic antidepressants, selective inhibitors of serotonin reuptake, clorpromaxina and carbamazepine, - concomitant treatment with non steroidal anti-inflammatory drugs (NSAIDs).

- Desmopressin should be used with caution and the dose should be adjusted on the basis of the plasma osmolality in patients with cystic fibrosis - Serious bladder dysfunction and outlet obstruction should be considered before onset of treatment.

g. benign prostatic hyperplasia (BPH), urinary tract infection, bladder stones/tumours, bladder sphincter disorders), polydipsia and inadequately controlled diabetes mellitus, the specific cause of the problems should primarily be treated resp.

excluded. - Older people and patients with low serum sodium may have an increased risk of hyponatraemia.

Warnings of excipients:

This product contains sodium methyl (E-219) and sodium propyl (E-217) parahydroxybenzoate. It may cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’.

g. 4). 4). Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. 3)It is unlikely that desmopressin interacts with other drugs which affect liver metabolism, because no significative hepatic metabolism has been observed in in vitro studies in human microsomes.

However, no formal studies have been conducted in vivo. Concomitant treatment with dimeticone may reduce the absorption of desmopressin. A standardised 27% greasy meal decreased the absorption of desmopressin (rate and extent). It has not been observed any significant effect on the pharmacodynamics (urine production and osmolality), there is the potential for this to occur at lower doses.

If a diminution of effect is noted, then the effect of food should be considered before increasing the dose. 6 Fertility, pregnancy and lactation Pregnancy: There is a limited amount of data from the use of desmopressin in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Reproductive studies performed in rats and rabbits at doses 100 higher than that recommended in humans did not reveal harmful evidence of desmopressin on foetuses.

Data on a limited number of exposed pregnancies in women treated with desmopressin during pregnancy indicate rare cases of malformations in children. Nonetheless, a review of available data did not suggest an increase of malformations in children exposed to desmopressin during pregnancy.

To date, no other relevant epidemiological data are available. Caution should be exercised when prescribing to pregnant women. 4). The physician should weigh the possible therapeutic advantages against the possible risk in each case.

Breastfeeding:

Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin which may be transferred to the infant are considerably lower than the amounts required to influence diuresis.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Demovo 360 micrograms/ml oral solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility No fertility data available. 7 Effects on ability to drive and use machines Demovo 360 micrograms/ml oral solution has no or negligible influence on the ability to drive and use machines. 8 Undesirable effects Treatment without concomitant restriction of fluid intake may result in fluid restriction /hyponatraemia with or without concurrent warning signs or symptoms.

4) The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

The most common include headache and gastrointestinal disorders.

Immune system disorders:

Not known: Allergic reactions.

Metabolism and nutrition disorders:

Very rare : […]

Special warnings:

In the case of primary nocturnal enuresis, fluid intake shall be limited from 1 hour before administration until the next morning (at least 8 hours). Treatment without concomitant reduction in water intake may result in fluid retention and/or hyponatraemia with or without warning symptoms and signs (headache, nausea / vomiting, weight gain, and, in severe cases, seizures).

8. It is therefore recommended that this danger be pointed out to patients, in particular elderly patients and the parents of young children. Cerebral oedema has repeatedly been reported in children and young adults treated with desmopressin for nocturnal enuresis.

During treatment with desmopressin, body weight, serum sodium and/or blood pressure may have to be monitored. Care should be taken in patients with reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Demovo 360 micrograms/ml oral solution would be less than usual.

Precautions for use:

Precautions to prevent hyponatremia shall be taken in: - conditions characterised by fluid and/or electrolyte imbalance, such as systemic infections, fever, gastroenteritis, and SIADH (syndrome of inappropriate secretion of ADH), - concomitant treatment with drugs known to induce SIADH, such as tricyclic antidepressants, selective inhibitors of serotonin reuptake, clorpromaxina and carbamazepine, - concomitant treatment with non steroidal anti-inflammatory drugs (NSAIDs).

- Desmopressin should be used with caution and the dose should be adjusted on the basis of the plasma osmolality in patients with cystic fibrosis - Serious bladder dysfunction and outlet obstruction should be considered before onset of treatment.

g. benign prostatic hyperplasia (BPH), urinary tract infection, bladder stones/tumours, bladder sphincter disorders), polydipsia and inadequately controlled diabetes mellitus, the specific cause of the problems should primarily be treated resp.

excluded. - Older people and patients with low serum sodium may have an increased risk of hyponatraemia.

Warnings of excipients:

This product contains sodium methyl (E-219) and sodium propyl (E-217) parahydroxybenzoate. It may cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’.

1. - Psychogenic or habitual polydipsia. - Known or suspected history of cardiac insufficiency. - Hyponatraemia or predisposition to hyponatraemia. 5). - Moderate or severe renal failure (creatinine clearance < 50 ml/min). - Uncontrolled blood pressure.

- Syndrome of inadequate ADH Production (SIADH) – a condition involving inappropriately high ADH production.