Desmopressin Acetate 200 Microgram Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Desmopressin acetate 100 microgram and 200 microgram tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you have any of the side effects, or if you notice any side effects not listed, please tell your doctor or pharmacist.
In this leaflet:
1. What Desmopressin is and what it is used for
2. Before you take Desmopressin acetate tablets
3. How to take Desmopressin acetate tablets
4. Possible side effects
5. How to store Desmopressin acetate tablets
6. Further information
1. WHAT DESMOPRESSIN IS AND WHAT IT IS USED FOR
The ingredient that makes the tablet work (the active substance) is called desmopressin. Desmopressin is an antidiuretic, which reduces the amount of urine produced by the kidneys.
Desmopressin acetate tablets are used to treat:
• a chronic disease called diabetes insipidus which causes extreme thirst and continuous production of large volumes of dilute urine Important: Not to be confused with diabetes mellitus (sugar diabetes)
• bedwetting in children (involuntary nightly urination)
• excessive thirst or frequent urination when caused by certain medical procedures (hypophysectomy)
2. BEFORE YOU TAKE DESMOPRESSIN ACETATE TABLETS Do not take Desmopressin acetate tablets if you:
• are allergic (hypersensitive) to desmopressin or any of the other ingredients in Desmopressin acetate tablets (see section 6)
• drink unusually large amounts of fluid
• suffer from alcoholism
• suffer from heart problems or other diseases needing treatment with diuretics (water tablets)
• suffer from reduced kidney function, cardiovascular disease or cystic fibrosis.
• know you have a low level of sodium in your blood (hyponatraemia)
• suffer from “syndrome of inappropriate high secretion of antidiuretic hormone” (SIADH).
• are being treated for primary nocturnal enuresis and have high blood pressure.
Check with your doctor or pharmacist before taking Desmopressin acetate tablets if you:
• are elderly (over 65)
• have a medical condition causing fluid and/or electrolyte imbalance in the body such as an infection, fever or stomach upset
• suffer from a serious bladder problem or impaired urine outflow.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• tricyclic or SSRI antidepressants (used to treat depression)
• carbamazepine (used to treat epilepsy)
• chlorpromazine (used to treat psychosis or schizophrenia)
• loperamide (used to treat diarrhoea)
• medicines for pain and/or inflammation called non-steroidal anti-inflammatory drugs (NSAIDs) e.g. indometacin, ibuprofen.
Fluid intake
• Before you start treatment with this medicine, your doctor should give you advice about fluid intake.
• When using this medicine for bedwetting or nocturia, keep your fluid intake to a minimum from 1 hour before you take a tablet until 8 hours after a dose.
• Too much fluid intake may lead to a build up of water, which dilutes the salt in the body. This can occur with or without warnings or symptoms, which include unusually bad or prolonged headache, feeling or being sick, unexplained weight gain and in serious cases, fits. If you have any of these symptoms, stop the treatment and contact your doctor at once.
Pregnancy and breastfeeding
Desmopressin acetate tablets can be used during breastfeeding but should only be used in pregnancy as directed by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no evidence to suggest that Desmopressin acetate tablets affect the ability to drive or use machines.
Sugar Intolerance
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine product, as it contains lactose.
3. HOW TO TAKE DESMOPRESSIN ACETATE TABLETS
Always take Desmopressin acetate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
• Divide the tablets in half or swallow whole.
• Do not take Desmopressin acetate tablets with food, as the effect of the tablets may be reduced.
Usual doses
• Diabetes insipidus
Adults and children - 100 micrograms three times a day.
• Bedwetting (Involuntary nightly urination)
Children (over 5 years) and adults (up to 65 years of age) 200 micrograms at bedtime. This may be increased to 400 micrograms at bedtime depending on how well the bedwetting is controlled. The need for continued treatment is normally checked every three months by introducing a treatment-free week.
• Excessive thirst or frequent urination when caused by certain medical procedures
The dose will be decided by your doctor depending on the strength of your urine.
When using this medicine for bedwetting keep your fluid intake to a minimum from 1 hour before you take a tablet until 8 hours after a dose. Avoid swallowing water while swimming to prevent a build up of water in the body.
If you take more Desmopressin acetate tablets than you should
An overdose may lengthen the effect of desmopressin and increase the risk of water build up in the body and low blood salt. Symptoms include fits and unconsciousness. If you take more Desmopressin acetate tablets than prescribed, contact your doctor, pharmacist or the nearest hospital at once.
If you forget to take Desmopressin acetate tablets
Do not take a double dose to make up for a forgotten dose.
If you stop taking Desmopressin acetate tablets
You should only change or stop your treatment if advised by your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Desmopressin acetate tablets can cause side effects, although not everybody gets them.
Stop the treatment and contact your doctor at once if the following occur
• symptoms of a build up of water in the body: unusually bad or prolonged headache, feeling or being sick, unexplained weight gain and in serious cases, fits.
• allergic reaction: rash, itching, fever, swelling of the mouth, tongue or airways causing difficulties in swallowing or breathing.
Tell your doctor or pharmacist if you notice any of the following other side effects, or if you notice any not listed:
• Headache.
• Abdominal pain, feeling sick, dizziness, swelling of arms and legs, weight gain, frequent urination.
• Emotional disturbances in children.
5. HOW TO STORE DESMOPRESSIN ACETATE TABLETS
Keep out of the reach and sight of children.
Do not store Desmopressin acetate tablets above 30°C.
Keep the container tightly closed in order to protect from moisture.
Do not use Desmopressin acetate tablets after the expiry date, stated on the pack.
Always return any left over medicine to your pharmacist.
6. FURTHER INFORMATION
What Desmopressin acetate tablets contain
• the active substance (the ingredient that makes the tablet work) is desmopressin acetate. Each tablet contains either 100 micrograms or 200 micrograms of the active substance.
• the other ingredients of the tablets are lactose monohydrate, potato starch, povidone and magnesium stearate.
What Desmopressin acetate tablets look like and contents of the pack
Desmopressin acetate tablets are white, round, and marked with a break line on one side.
The tablets are in plastic containers containing 7, 10, 15, 20, 30, 90, 100 or 250 tablets. Not all pack sizes may be available.
Marketing Authorisation Holder
Aptil Pharma Limited, 9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL Manufacturer
Inpac AS, Gjellebekkstubben 10, 3420 Lierskogen, Norway
The leaflet was last revised in 11/2011
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