Desmopressin Acetate 0.2mg Tablets
Desmopressin Acetate 0.1mg Tablets Desmopressin Acetate 0.2mg Tablets
Desmopressin acetate
PATIENT INFORMATION
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet, you may need to use it again
If you have further questions, please ask your doctor or pharmacist This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Your medicine is called Desmopressin Acetate Tablets. They are tablets for oral use only.
• Desmopressin Acetate 0.1mg Tablets are presented in plastic bottles containing 90 tablets.
• Desmopressin Acetate 0.2mg 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 Desmopressin Acetate Tablets are lactose monohydrate, potato starch, povidone and magnesium stearate.
Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton UB7 7PS (UK)
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
1. What Destmopressin Acetate Tablets are and what they are used for
Desmopressin Acetate Tablets are for oral use only. Two strengths are available. Desmopressin Acetate 0.1mg Tablets are white, oval, convex tablets, scored on one side and engraved '0.1' on the other side. Desmopressin Acetate 0.2mg Tablets are white, round, convex tablets, scored on one side and engraved '0.2' on the other side. They contain desmopressin acetate, an antidiuretic (reduces urine production).
Desmopressin Acetate Tablets are used to treat:
• primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age)
• diabetes insipidus (extreme thirst and the continuous production of large volumes of dilute urine) IMPORTANT: Thisdiould not be confused with diabetesmellitus (sugar diabetes)
• 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 Desmopressin Acetate Tablets
There are general restrictions, precautions and warnings which apply to all patients taking Desmopressin Acetate Tablets and there are additional restrictions, precautions and warnings which apply depending on the use of the tablets.
General restrictions (all patients):
Do not take Desmopressin Acetate Tablets:
• if you have a serious heart or kidney disease
• if you are taking diuretics (water tablets)
• if you drink unusually large quantities of fluids, including alcohol
• if you are allergic to any of the ingredients listed.
General precautions and warnings (all patients):
All patients on Desmopressin Acetate Tablets should avoid excessive fluid intake as this may lead to a build up of water in the body.
Please consult your doctor before
taking Desmopressin Acetate Tablets:
• if you are on medication for depression or epilepsy
• if you are taking a medicine for pain and/or inflammation containing non-steroidal anti-inflammatory drugs (also known as NSAIDs) e.g indomethacin
• if you are taking a medicine containing loperamide, for diarrhoea
• if you have a medical condition causing fluid and/or electrolyte imbalance
• if you have a medical condition that could be made worse by fluid and/or electrolyte disturbance.
Additional restrictions, precautions and warnings for patients with primary nocturnal enuresis:
In addition to the general restrictions, precautions and warnings:
Do not take Desmopressin Acetate Tablets:
• if you are under 5 or over 65 years old
• if you are taking medication for high blood pressure or have been told that your blood pressure is abnormal.
Please consult your doctor before taking Desmopressin Acetate Tablets:
• if you have cystic fibrosis.
If you are on Desmopressin Acetate Tablets for primary nocturnal enuresis:
• fluid intake must be limited to a minimum from 1 hour before taking the dose at bedtime until the following morning (and, in any case, for at least 8 hours)
• avoid swallowing water while swimming to prevent a build up of water in the body.
• stop taking Desmopressin Acetate Tablets nsuffering from vomiting and/or diarrhoea until you are better.
Patients on Desmopressin Acetate Tablets for any of the conditions listed in this leaflet:
Pregnancy:
If you are pregnant or planning a pregnancy, please inform your doctor before you take Desmopressin Acetate Tablets, as blood pressure monitoring is recommended due to the increased risk of pre-eclampsia. 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 Desmopressin AcetateTablets.
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.
3. How to take Desmopressin Acetate Tablets
It is important that you do not take more than the prescribed dose in any 24 hour period.
If you have the impression that the effect of Desmopressin Acetate Tablets is too strong or too weak, talk to your doctor or pharmacist.
Bedwetting from the age of 5 years:
Your usual starting dose is one 0.2mg tablet at bedtime. Your doctor may increase the dose to two 0.2mg tablets at bedtime depending on how well the bedwetting is controlled. The need for continued treatment is normally checked every three months.
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.
Post-hypophysectomy polyuria/polydipsia:
Your doctor will prescribe the most suitable dose for you based on the concentration of your urine.
If you take more Desmopressin Acetate Tablets tath you should:
If you take more Desmopressin Acetate Tablets than you should, talk to your doctor or pharmacist immediately.
If you forget to take Desmopressin Acetate Tablets:
Do not take double doses to make up for forgotten doses.
If you are a patient with primary nocturnal enuresis, do not take Desmopressin Acetate Tablets until the usual time for your next dose.
If you are a patient with diabetes insipidus, please consult your doctor or pharmacist for advice.
4. Possible side effects
Like all medicines, Desmopressin Acetate Tablets can have side effects. Excessive fluid intake may lead to a build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions. If you experience an unusually bad or prologed headache, confusion, explained weight gain, nausea or vomiting, stop taking Desmopressin Acetate Tablets and tell your doctor immediately or go to your nearest casualty department.
Most people taking Desmopressin Acetate Tablets find it causes them no problems.
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 disturbances in children have 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 Desmopressin Acetate Tablets
Keep Desmopressin Acetate Tablets out of 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.
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.
Desmopressin Acetate 0.1mg Tablets PL 03194/0081
Desmopressin Acetate 0.2mg Tablets PL 03194/0082
This leaflet was revised in January 2012.