SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Octim® Nasal Spray

2.    Qualitative and Quantitative Composition

Desmopressin acetate 150 micrograms per actuation For excipients, see 6.1

3.    Pharmaceutical Form

Nasal Spray, Solution Clear, colourless solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Octim Nasal Spray is indicated as follows:

1)    To increase Factor VIIIC and Factor VIII:Ag (vWf) in patients with mild to moderate haemophilia or von Willebrand's disease undergoing surgery, following trauma or with other bleeding episodes such as menorrhagia and epistaxis.

2)    To test for fibrinolytic response.

4.2    Posology and method of administration

Mild to moderate haemophilia and von Willebrand's disease:

Adults (including the elderly) should take 300 micrograms (one spray into each nostril) half an hour before surgery or at bleeding.

Under direct medical supervision, further doses may be administered at 12 hourly intervals so long as cover is required. As some patients have shown a diminishing response to successive doses, Factor VIII levels should continue to be monitored.

Unless specifically directed by the doctor, when Octim Nasal Spray is self-administered by the patient, there should be an interval of at least three days between doses.

Increase of Factor VIII levels are dependent on basal levels and are normally between 2 and 5 times the pre-treatment levels. If results from a previous administration of Desmopressin are not available then blood should be taken pre-dose and 60 minutes post-dose for assay of Factor VIII levels in order to monitor response.

Fibrinolytic response testing:

Adults (including the elderly) should take 300 micrograms (one spray into each nostril). A sample of venous blood should be taken 60 minutes later.

In patients with a normal response the sample should show fibrinolytic activity

2

of euglobulin clot precipitate on fibrin plates of at least 240mm

4.3 Contra-indications

Octim Nasal Spray is contraindicated in cases of:

-    habitual and psychogenic polydipsia

-    unstable angina pectoris

-    decompensated cardiac insufficiency

-    von Willebrand's Disease Type IIB where the administration of

Desmopressin may result in pseudothrombocytopenia due to the release of abnormal clotting facors which cause platelet aggregation.

Fibrinolytic response testing should not be carried out in patients with hypertension, heart disease, cardiac insufficiency and other conditions requiring treatment with diuretic agents.

4.4 Special Warnings and Precautions for Use

Precautions to prevent fluid overload must be taken in:

-    conditions characterised by fluid and/or electrolyte imbalance

-    patients at risk for increased intracranial pressure

Care should be taken with patients who have reduced renal function and or cardiovascular disease or cystic fibrosis.

When repeated doses are used to control bleeding in haemophilia or von Willebrand's disease, care should be taken to prevent fluid overload. Patients should only take as much fluid as they require to satisfy thirst. Intravenous infusions should not be left up as a routine after surgery. Fluid accumulation can be readily monitored by weighing the patient or by determining plasma sodium or osmolality.

Measures to prevent fluid overload must be taken in patients with conditions requiring treatment with diuretic agents.

Special attention must be paid to the risk of water retention. The fluid intake should be restricted to the least possible and the body weight should be checked regularly.

If there is a gradual increase of the body weight, decrease of serum sodium to 130mmol/l or plasma osmolality to below 270mOsm/kg, the fluid intake must be reduced drastically and the administration of Octim Nasal Spray interrupted.

Octim Nasal Spray does not reduce prolonged bleeding time in thrombocytopenia.

4.5 Interaction with other Medicaments and other forms of Interaction

Indomethacin may augment the magnitude but not the duration of response to Desmopressin.

Substances which are known to release antidiuretic hormone e.g. tricyclic antidepressants, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect and increase the risk of water retention.

4.6 Pregnancy and Lactation

Pregnancy:

Octim Nasal Spray should be given with caution to pregnant patients, although the oxytocic effect of Desmopressin is very low.

Reproduction studies performed in rats and rabbits with doses of more than 100 times the human dose have revealed no evidence of a harmful action of Desmopressin on the fetus. There have been rare reports of malformations in children born to mothers treated for diabetes insipidus during pregnancy. However, a review of available data suggests no increase in the rate of malformations in children exposed to Desmopressin throughout pregnancy.

Lactation:

Results from analyses of milk from nursing mothers receiving 300 micrograms Desmopressin intranasally indicate that the amount of Desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis or haemostasis.

4.7 Effects on Ability to Drive and Use Machines

None

4.8    Undesirable effects

Side-effects include headache, stomach pain, nausea, nasal congestion, rhinitis and epistaxis. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

4.9    Overdose

Overdose of Octim Nasal Spray can lead to hyponatraemia and convulsions. Treatment:

Overdosage increases the risk of fluid retention and hyponatraemia. If hyponatraemia occurs, Desmopressin treatment should immediately be discontinued and fluid intake restricted until serum sodium is normalised.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Desmopressin is an analogue of the hormone vasopressin in which the antidiuretic activity has been enhanced by the order of 10, whilst the vasopressor effect has been reduced by the order of 1500. The duration of activity has also been extended.

Like vasopressin, Desmopressin also increases concentrations of Factor VIII:C, Factor VIII:Ag (vWf ) and plasminogen activator (t-PA)

5.2    Pharmacokinetic Properties

ATC code H01A02

Following intranasal administration, the bioavialability of Desmopressin is of the order of 6-10%. Peak plasma levels are achieved in approximately 50 minutes and the mean plasma half-life is about three hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC

6.    PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Sodium Chloride Citric acid monohydrate Disodium phosphate dihydrate Benzalkonium chloride soln 50%

Purified Water Ph. Eur.

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

36 months.

6.4 Special Precautions for Storage

Do not store above 25 °C . Keep vial in the outer carton. Do not freeze

6.5 Nature and Contents of Container

Multidose container, Type I glass vial with a pre-compression pump set comprising of a spray pump with a metering valve, nasal applicator and protection cap.

Pack size: 2.5ml (25 sprays)

6.6 Instructions for Use, Handling and Disposal

None

7 MARKETING AUTHORISATION HOLDER

Ferring Pharmaceuticals Ltd

Drayton Hall

Church Road

West Drayton

UB7 7PS

UK

8.    MARKETING AUTHORISATION NUMBER(S)

PL 3194/0056

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/03/2009

10 DATE OF REVISION OF THE TEXT

04/11/2015