Patient leaflet - Ddavp tablets 0.1 mg

1. What DDAVP Tablets are and what they are used for

DDAVP Tablets are for oral use only. They are available in two strengths, 0.1mg and 0.2mg. They contain Desmopressin acetate, an antidiuretic (reduces urine production). They are used:

to treat diabetes insipidus (a condition that causes extreme thirst and the continuous production of large volumes of dilute urine) IMPORTANT: This should not be confused with diabetes mellitus (sugar diabetes)
to treat post-hypophysectomy polyuria/polydipsia (extreme thirst and the continuous production of large volumes of dilute urine following surgical removal of the pituitary gland).

2. Before you take DDAVP Tablets

There are general restrictions, precautions and warnings which apply to all patients using DDAVP Tablets.

General restrictions (all patients):

Do not take DDAVP Tablets if you:

have a serious heart or kidney disease
are taking diuretics (water tablets)
are allergic to any of the ingredients listed in section 6 of this leaﬂet
drink unusually large quantities of ﬂuids, including alcohol.

You should avoid drinking large amounts of ﬂuid while you are being treated with DDAVP Tablets, as this could lead to a build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions.

General precautions and warnings (all patients):

Please consult your doctor before taking DDAVP Tablets if you:

have an illness causing ﬂuid and/or salt imbalance e.g. vomiting, diarrhoea, systemic infections, fever or gastroenteritis
have a medical condition that could be made worse by ﬂuid and/or electrolyte disturbance. Condition where your blood sodium levels are too low or you are likely to build up too much water in the body

Taking/using other medicines:

Please inform your doctor or pharmacist if you:

are taking or have recently taken or used any other medicines - even those not prescribed
are on medication for depression or epilepsy
are taking a medicine for pain and/or inﬂammation containing non-steroidal anti-inﬂammatory drugs (also known as NSAIDs) e.g. indometacin
are taking a medicine containing loperamide for diarrhoea

Pregnancy:

If you are pregnant or planning a pregnancy, please inform your doctor before you take DDAVP Tablets, as blood pressure monitoring is recommended due to the increased risk of

pre-eclampsia (a condition in pregnant women that can cause serious complications). Symptoms of

pre-eclampsia include high blood pressure, oedema (swelling due to the build up of ﬂuid) and proteinuria (protein in the urine).

Breast-feeding:

If you are breast-feeding ask your doctor or pharmacist for advice before taking DDAVP Tablets.

DDAVP Tablets contain Lactose monohydrate:

DDAVP Tablets contain the ingredient, lactose monohyodrate. Therefore, if you have been told by your doctor that you have an intolerance to some sugars (including lactose), contact your doctor before taking this medicinal product.

8 mm

3. How to take DDAVP Tablets

DDAVP Tablets are for oral use only.

Do NOT take more than the prescribed dose in any 24 hour period.

If you have the impression that the effect of DDAVP Tablets is too strong or too weak, talk to your doctor or pharmacist.

The usual doses are:

Treatment of diabetes insipidus:

Your doctor will prescribe the dose most suitable for you. The most common dose in adults and children is one 0.1mg tablet or one 0.2mg tablet taken three times a day.

Treatment of extreme thirst and the continuous production of large volumes of dilute urine following surgical removal of the pituitary gland:

Your doctor will prescribe the most suitable dose for you based on the concentration of your urine.

If you take more DDAVP Tablets than you should:

If you take more DDAVP Tablets than you should, talk to your doctor or pharmacist immediately.

If you forget to take DDAVP Tablets:

Do not take a double dose to make up for a forgotten dose. If you are a patient with diabetes insipidus, please consult your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, DDAVP Tablets can have side effcts.

You should avoid drinking large amounts of ﬂuid while you are being treated with DDAVP Tablets, as this could lead to a build up of water which dilutes the salt in the body. Ths is a serious problem and may lead to convulsions.

STOP USING DDAVP Tablets if you experience:

unusually bad or prolonged headache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting
itching, skin rashes, swelling of the face, lips or throat, difﬁculty in breathing, wheeziness, chest tightness or coughing (signs of allergic reaction)

If you experience any of the above side effects, you should contact your doctor or go to the nearest casualty department immediately.

Most people taking DDAVP Tablets ﬁnd it causes them no problems. However, common side effects can include:

headache
stomach pain

Very rare cases of emotional disorders including

aggression in children have also been reported.

If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.

5. Storing DDAVP Tablets

Keep DDAVP Tablets out of the reach and sight of children.

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

Do not remove the silica gel insert from the bottle top.

Do not take past the expiry date on the packaging. The expiry date refers to the last day of that month.

If you are unsure about the storage, ask your pharmacist. It is best to return all old and unused medicines to your pharmacist for safe disposal.

6. Further Information

DDAVP Tablets are presented in plastic bottles containing either 30 or 90 tablets
each tablet contains either 0.1mg or 0.2mg of the active ingredient, Desmopressin acetate other ingredients in DDAVP Tablets are lactose monohydrate, potato starch, povidone and magnesium stearate
The 0.1mg tablets are white, oval tablets, scored on one side and engraved ‘0.1’ on the other side. The 0.2mg tablets are white, round tablets, scored on one side and engraved ‘0.2’ on the other side.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd.,

Drayton Hall, Church Road,

West Drayton, UB7 7PS (UK).

Manufacturer:

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany

DDAVP Tablets 0.1mg

PL 03194/0040

DDAVP Tablets 0.2mg

PL 03194/0041

This leaﬂet was last revised in October 2011.

DDAVP is a registered trademark. This leaflet was last revised in November 2018.

Keep DDAVP Tablets out of the sight and reach of children.

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Desmopressin
Strength	0.1 mg
Pharmaceutical form	Oral tablet Uncoated, white, oval, convex tablets scored on one side and engraved '0.1' on the other side.
How is it taken	Oral
Excipients	Lactose monohydrate, Potato starch, Povidone, Magnesium stearate
Pack sizes	90 tablet
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	36 months.
Storage	Do not store above 25°C. Keep the container tightly closed.
Drug group (ATC)	H Systemic hormonal preparations, excl. sex hormones and insulins H01 Pituitary and hypothalamic hormones and analogues H01B Posterior pituitary lobe hormones H01BA Vasopressin and analogues H01BA02 desmopressin
Marketing authorisation	PL 03194/0040 (first authorised 13 January 1993)
Marketing authorisation holder	Ferring Pharmaceuticals Ltd
Codes	GTIN 5015919153223 · BNF 06050200

Ddavp tablets 0.1 mg – patient leaflet, side effects, dosage