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SPC, UK: DESMOTABS Tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Ferring Pharmaceuticals Ltd
Διεύθυνση :
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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Περιεχόμενα

Name of the medicinal product

DESMOTABS 0.2mg.

Qualitative and quantitative composition

Each tablet contains 0.2mg desmopressin acetate. For excipients, see 6.1.

Pharmaceutical form

Tablet. Uncoated, white, round, convex tablets scored on one side and engraved 0.2 on the other side.

Therapeutic indications

Desmopressin tablets are indicated for the treatment of primary nocturnal enuresis.

Posology and method of administration

Children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability who have primary nocturnal enuresis should take 0.2mg at bedtime and only if needed should the ...

Contraindications

Desmopressin tablets are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Desmopressin tablets should only be used in patients with normal ...

Special warnings and precautions for use

Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis. In chronic renal disease the antidiuretic effect of desmopressin tablets would be less ...

Interaction with other medicinal products and other forms of interaction

Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading ...

Pregnancy and lactation

Pregnancy Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological ...

Effects on ability to drive and use machines

None.

Undesirable effects

Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including ...

Overdose

An overdose of desmopressin tablets leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Treatment Although the treatment of hyponatraemia should be individualised, ...

Pharmacodynamic properties

In its main biological effects, desmopressin does not differ qualitatively from vasopressin. However, desmopressin is characterised by a high antidiuretic activity whereas the uterotonic and vasopressor ...

Pharmacokinetic properties

The absolute bioavailability of orally administered desmopressin varies between 0.08% and 0.16%. Mean maximum plasma concentration is reached within 2 hours. The distribution volume is 0.2–0.32 l/kg. Desmopressin ...

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.

List of excipients

Lactose monohydrate Potato starch Povidone Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

36 months.

Special precautions for storage

Do not store above 25°C. Keep the container tightly closed.

Nature and contents of container

30ml High Density Polyethylene (HDPE) bottle with a tamper-proof, twist-off polypropylene (PP) closure with a silica gel desiccant insert. Each bottle contains 7, 30 or 90 tablets. Not all pack sizes may ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization number(s)

PL 03194/0046

Date of first authorization / renewal of the authorization

19th April 1999

Date of revision of the text

June 2011

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