Desmotabs 0.2mg
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet, you may need to read it again
• If you have further questions, please ask your doctor or pharmacist
• This medicine has been precribed 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Important things that you need to know:
• Desmotabs are used to treat primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age).
• You should avoid drinking large amounts of fluid while you are being treated with Desmotabs, 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.
• If you experience unusually bad or prolonged headache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting, STOP USING Desmotabs. You should tell your doctor immediately or go to the casualty department at your nearest hospital.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine
There are general restrictions, precautions and warnings which apply to all patients using Desmotabs.
General restrictions:
Do not take Desmotabs 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
• are under 5 or over 65 years old
• are taking medication for high blood pressure or have been told that your blood pressure is abnormal
You should avoid drinking large amounts of fluid while you are being treated with Desmotabs, 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:
Please consult your doctor before
taking Desmotabs 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 your body
• have cystic fibrosis
In this leaflet:
1. What Desmotabs are and what they are used for
2. Before you take Desmotabs
3. How to take Desmotabs
4. Possible side effects
5. How to store Desmotabs
6. Further information
While taking Desmotabs:
• 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)
• stop taking Desmotabs when suffering from vomiting and/or diarrhoea until you are better
• avoid swallowing water while swimming to prevent a build up of water in the body.
Desmotabs are tablets for oral use only. They are available in 0.2mg strength. They contain Desmopressin acetate, an antidiuretic (reduces urine production).
Desmotabs are used:
• to treat primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age).
Taking/using other medicines:
Please inform your doctor or
pharmacist if you:
• are taking or having recently taken or used any other medicines, even those not prescribed
• if you are on medication for depression or epilepsy
• if you are taking a medicine for pain and/or inflammation
containing non-steroidal antiinflammatory drugs (also known as NSAIDs) e.g. indometacin
• if you are taking a medicine containing loperamide for diarrhoea
Pregnancy:
If you are pregnant or planning a pregnancy, please inform your doctor before you take Desmotabs 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 Desmotabs.
Desmotabs contain Lactose monohydrate:
Desmotabs contains the ingredient, lactose monohydrate. 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.
3. How to take Desmotabs
Desmotabs 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 Desmotabs is too strong or too weak, talk to your doctor or pharmacist.
The usual dose is:
Your usual starting dose is one tablet 0.2mg taken 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.
If you take more Desmotabs than you should:
If you take more Desmotabs than you should, talk to your doctor or pharmacist immediately.
If you forget to take Desmotabs:
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
4. Possible side effects
Like all medicines, Desmotabs can have side effects.
You should avoid drinking large amounts of fluid while you are being treated with Desmotabs, 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.
STOP USING Desmotabs 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 (sighs of allergic reactions)
If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.
Most people taking Desmotabs 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 Desmotabs
Keep Desmotabs 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 Desmotabs 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
• Desmotabs are presented in plastic bottles containing 30 or 90 tablets
• each tablet contains 0.2mg of the active ingredient, Desmopressin acetate
• other ingredients in Desmotabs are lactose monohydrate, potato starch, povidone and magnesium stearate
• they are white, round tablets, scored on one side and engraved ‘0.2’ on the other side.
Marketing Authorisation Holder:
PL 03194/0046
Ferring Pharmaceuticals Ltd.,
The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ (UK).
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
This leaflet was last revised in June 2010. Desmotabs is a registered trademark.