0.1 mg and 0.2 mg tablets
Desmopressin acetate
What Nocutil is and what it is used for
Nocutil contains desmopressin acetate which is an antidiuretic that makes you produce less urine.
Nocutil is used to treat :
- bedwetting in children over five years after organic causes have been ruled out and other treatments have failed
- diabetes insipidus (a disease in which you produce a large amount of urine and become very thirsty, because the brain does not produce enough of the antidiuretic hormone that reduces the amount of water in the urine). Note! Diabetes insipidus is not the same as diabetes mellitus (diabetes)
- nocturnal urination in adults.
Desmopressin contained in Nocutil may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions and always follow their instructions
What you need to know before you take Nocutil
Do not take Nocutil
- if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6).
- if you have any neurological disease or dementia.
- if you drink unusually large amounts of water or other liquids (including alcohol) during the day or night.
- if you have a heart disease or other condition that requires treatment with diuretics.
- if you have low sodium in your blood.
- if you have kidney failure .
- if you have a syndrome that causes the body to produce the wrong amount of the antidiuretic hormone (SIADH).
- if the patient is under five years of age.
Warnings and cautions
| Fluid intake Before starting treatment with Nocutil, your doctor will talk to you about fluid intake. If you are being treated with Nocutil for bedwetting or nightmares, limit the amount you drink during the period 1 hour before to 8 hours after taking the tablets. Avoid unnecessary fluid intake during treatment with Nocutil and do not swallow water while swimming (especially for children). Excessive fluid intake can lead to the accumulation of water which dilutes the salt in the body ( electrolytes ). This can happen with or without warning symptoms that include: unusually severe or prolonged headache, nausea or vomiting, unexplained weight gain, and in severe cases seizures, swelling of the brain (cerebral edema ), or coma. If you (or your child) have any of these symptoms, stop treatment immediately and contact a doctor. In addition, you should stop taking Nocutil if you have a fever, an infection, diarrhea, and/or vomiting until you get better. This is especially important for very young and older patients. |
Before you start taking this medicine, you must tell your doctor if you have:
- cystic fibrosis (a disease in which you are more likely to suffer from lung infections and your body can not absorb fat and other nutrients)
- heart disease
- high blood pressure
- chronic kidney disease or
- preeclampsia (high blood pressure caused by pregnancy).
You must adhere to a dose that your doctor has prescribed for you and you should not take certain other medicines at the same time (see section “Other medicines and Nocutil”). This way you reduce the risk of seizures.
Other medicines and Nocutil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following drugs may potentiate the effect of desmopressin:
- indomethacin and possibly other non-steroidal anti-inflammatory drugs ( NSAIDs )
- oxytocin (stimulates pain)
- carbamazepine (for epilepsy )
- tricyclic antidepressants and selective serotonin reuptake inhibitors (for depression)
- chlorpromazine (for psychosis )
- loperamide (for diarrhea)
Concomitant use of the following drugs may reduce the effect of desmopressin:
- lithium (for depression)
- glibenclamide (for diabetes )
If you are taking any medicine for heart problems while taking desmopressin, your doctor should check your blood pressure, plasma sodium, and urine levels.
This may also apply to medicines you have taken before.
Nocutil with food and drink
Do not drink large amounts of water or other liquids. Ask your doctor for advice on your consumption of water and other fluids. Food can reduce your uptake of the drug. Therefore, do not take Nocutil with food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Desmopressin can be excreted in human milk in very small amounts. There is no evidence that the child is affected.
Driving and using machines
Desmopressin is unlikely to affect your ability to drive or use machines. However, some side effects (eg dizziness and headache, see section 4 “Possible side effects”) may affect your ability to concentrate and speed of reaction.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nocutil contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Nocutil
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
Desmopressin should always be taken at the same time as food intake, as food reduces absorption (see “Taking Nocutil with food and drink”).
Read the fluid intake information (see “Warnings and Precautions”).
The tablets can be divided into two halves to make them easier to swallow. Your doctor will decide how long you should take Nocutil.
Bedwetting (involuntary nocturnal bladder emptying, nocturnal enuresis ) (over 5 years):
A suitable starting dose is 0.2 mg at bedtime (2 Nocutil tablets of 0.1 mg or 1 Nocutil tablet of 0.2 mg). Your doctor may increase the dose by one up to 0.4 mg (4 Nocutil tablets of 0.1 mg or 2 Nocutil tablets of 0.2 mg) if the lower dose is not effective enough.
The doctor checks the need for continued treatment no later than after three months of treatment by interrupting the treatment for at least one week.
Diabetes insipidus:
The appropriate starting dose for children and adults is 0.1 mg three times daily. Dosage one is then adjusted according to your answer. Clinical experience has shown that the daily dose varies between 0.2 and 1.2 mg. For most patients, the maintenance dose is 0.1–0.2 mg three times daily.
Frequent bladder discharge during the night (nocturia):
The recommended starting dose is 0.1 mg at bedtime. If this dose is not effective enough after one week, your doctor may increase it weekly to 0.2 mg and then to 0.4 mg. Limited fluid intake should be observed.
If sufficient clinical effect is not achieved within 4 weeks, with a weekly dose increase, treatment should be discontinued. The duration of treatment should not exceed 12 months and the doctor regularly checks the need for further treatment.
The treatment of elderly patients must be monitored frequently due to the higher risk of hyponatremia (low blood sodium). If you belong to this patient group, your serum sodium value should be determined before starting treatment and also after 3 days of treatment and after each dose increase. Serum sodium should also be determined after 2 and 4 months of treatment.
If you take more Nocutil than you should
If you happen to take an overdose, stop taking the medicine and talk to your doctor immediately.
Overdose can lead to too much water in the body and cause symptoms such as increased blood pressure, higher heart rate, flushing, headache, nausea, and stomach cramps (see also section 4 “Possible side effects”).
All cases of suspected swelling of the brain (seizures, coma ) require immediate intensive care.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Nocutil:
If you miss a dose, simply take the next dose as usual.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed in the following categories:
Very common: occurs in more than one in 10 patients taking the medicine.
Common: occurs in more than one in 100 patients (but in less than one in 10).
Uncommon: occurs in more than one in 1,000 patients (but in less than one in 100).
Rare: occurs in less than one in 1,000 patients.
Very rare: affects less than one in 10,000 patients.
If you notice any of the following very rare reactions, contact your doctor immediately before taking another dose :
- Signs of water poisoning or low sodium in the blood (severe headache, nausea, severe seizures and coma ). This side effect is more common at the beginning of nocturia treatment and during dose adjustment.
- Common allergic reactions including skin rash (red spots, hives , itching ), feeling of tightness in the chest, swelling of the eyelids, face or lips (sometimes with difficulty breathing or swallowing).
Other possible side effects are:
- Common: Stomach pain, nausea, vomiting
- Common: Headache (very common after dose adjustment during treatment for nocturia)
- Very rare: Emotional disorders in children
When treating nocturia also:
Common: Swelling of the arms and legs, nausea, weight gain, dry mouth, increased frequency of urination.
How to store Nocutil
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store in the original package.
Close the package tightly.
Do not use this medicine after the expiry date which is stated on the carton and plastic container after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is desmopressin acetate. Each tablet contains 0.1 mg or 0.2 mg desmopressin acetate corresponding to 0.089 mg and 0.1780 mg desmopressin respectively.
- The other ingredients are 60 mg lactose monohydrate , potato starch, povidone, magnesium stearate and anhydrous colloidal silica.
What the medicine looks like and contents of the pack:
Nocutil is uncoated, white, round, and convex. Using a notch on one side, the tablet can be divided into two parts that are easier to swallow.
Each jar contains 15, 28, 30, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Gebro Pharma GmbH
6391 Fieberbrunn
Austria
Information provided by:
medac
Box 120
432 23 Varberg
Tel: 0340-645470
Fax: 0340-645479
This medicinal product is authorized under the European Economic Area under the names:
| Austria: | Nocutil 0.1 mg – The tabletsNocutil 0.2 mg – The tablets |
| Denmark: | Nocutil 0.1 mg tabletsNocutil 0.2 mg tablets |
| Sweden: | Nocutil 0.1 mg tabletsNocutil 0.2 mg tablets |