25 micrograms lyophilized tablet, 50 micrograms lyophilized tablet
desmopressin
What Nocdurna is and what it is used for
Nocdurna contains desmopressin, an antidiuretic that reduces urine output.
Nocdurna is used to treat nocturia (need to get up frequently to urinate at night) due to nocturnal polyuria (overproduction of urine during the night) in adults.
What you need to know before using Nocdurna
Do not take Nocdurna
- if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from polydipsia (you feel increased thirst and have an abnormally large fluid intake) or psychogenic polydipsia (mentally caused increased thirst and increased fluid intake)
- if you have known or suspected impaired heart function (the heart is not able to pump enough blood throughout the body)
- if you have any disease that requires treatment with diuretics
- if you have moderate or severe renal impairment
- if you have or have had hyponatremia (low blood sodium)
- if you have a disturbed secretion of antidiuretic hormone (SIADH)
Warnings and cautions
Talk to your doctor or pharmacist before taking Nocdurna.
You must talk to your doctor before taking Nocdurna if you:
- have severe bladder function and difficulty urinating
- is 65 years of age or older, as your doctor should check the level of sodium in your blood (see section 3 “How to take Nocdurna” below)
- have low levels of sodium in the blood
- have a medical condition that causes disturbed fluid and / or electrolyte balance
- have any medical condition that may be aggravated by fluid and / or electrolyte imbalance
- get an acute condition (such as systemic infection , fever and stomach flu) as it may be necessary for the doctor to discontinue / reconsider treatment with Nocdurna
- have cystic fibrosis , coronary heart disease, high blood pressure , chronic kidney disease or pre- eclampsia
You must limit your fluid intake to a minimum during the period 1 hour before to 8 hours after taking Nocdurna. Treatment without concomitant reduction of fluid intake can lead to fluid retention and/or electrolyte disturbance with or without signs of illness such as headache, nausea/vomiting, weight gain, and in severe cases seizures.
Other medicines and Nocdurna
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are using:
- tricyclic antidepressants , antidepressants (eg clomipramine, imipramine, desipramine)
- selective serotonin reuptake inhibitors ( SSRIs ) to treat depression and anxiety (such as citalopram , paroxetine , sertraline )
- chlorpromazine, an anti-psychotic drug used to treat schizophrenia
- diuretics (diuretics such as thiazides or other types of diuretics )
- carbamazepine, which is used to treat bipolar disorder and epilepsy
- antidiabetic drugs used to treat type II diabetes (drugs in the sulphonylurea group), in particular chloropropamide
- non-steroidal anti-inflammatory drugs ( NSAIDs ), which are medicines to treat pain and inflammation (eg aspirin and ibuprofen )
- oxytocin , which is a medicine used in connection with childbirth
- lithium, which is used to treat bipolar disorder
- loperamide, which is a drug used to treat diarrhea
Nocdurna with food, drink and alcohol
Nocdurna should not be taken with food, as the effect may be reduced.
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.
Your doctor will decide if you can use this medicine during pregnancy or breastfeeding.
Driving and using machines
Nocdurna has no or negligible effect on the ability to drive and use machines.
You are always 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.
How to take Nocdurna
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
- Women: 25 micrograms daily under the tongue without water one hour before bedtime.
- Men: 50 micrograms daily under the tongue without water one hour before bedtime.
The lyophilized tablet is placed under the tongue where it dissolves without water.
Instructions for use
- Tear off the entire tab on the short side of a blister card by tearing along the perforation, from the corner with the hand symbol.
- Detach a blister from the strip by tearing along the perforation.
- Remove the foil on the blister, starting at the corner with the printed arrow, by pulling the foil away in the direction of the arrow. Do not push the tablet through the foil .
- Carefully take one tablet out of the blister. Place the tablet under the tongue and allow it to dissolve. Do not chew or swallow the tablet.
- If a tablet breaks into more than two parts while removing it from the blister, do not remove the broken parts. Take one tablet from another blister.
You must limit your fluid intake to a minimum during the period 1 hour before to 8 hours after taking Nocdurna. Discontinue treatment and consult a physician if you experience any of the following symptoms: headache, nausea/vomiting, weight gain, and in severe cases seizures (see section “Warnings and precautions” above). The doctor may decide to continue treatment. If treatment is continued, you must limit your fluid intake properly. In addition, your doctor will closely monitor the levels of sodium in your blood.
Use in the elderly (65 years or older)
If you are 65 years of age or older, your doctor may need to check your blood sodium level before starting treatment, during the first week of treatment (4-8 days after starting treatment), and again about a month after starting treatment.
Impaired renal function
Do not take Nocdurna if you have moderate to severe renal impairment. Talk to your doctor.
Hepatic impairment
Talk to your doctor before taking Nocdurna if you have impaired liver function.
Use for children and adolescents
This medicine is for adults only.
If you take more Nocdurna than you should
You mustn’t take more than the prescribed dose during 24 hours. Pay special attention to signs of fluid retention, that the fluid remains in the body, such as weight gain, headaches, nausea, and in severe cases seizures.
Talk to your doctor if you have taken more Nocdurna than you should.
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 Nocdurna
Do not take a double dose to make up for a forgotten tablet. Take the tablet, as usual, the next day.
If you stop taking Nocdurna
Treatment should only be discontinued on the advice of a physician.
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.
Drinking too much fluid can in severe cases lead to an accumulation of water that dilutes the salt in the body. This can be a serious problem and can lead to seizures.
Stop taking this medicine and talk to a doctor immediately or see your nearest emergency department if you experience any of these symptoms.
- unusually severe or prolonged headache
- confusion
- unexplained weight gain
- nausea or vomiting
Side effects include:
Very common (may affect more than 1 user in 10)
- dry mouth
Common (may affect up to 1 in 10 people)
- nausea, malaise, muscle weakness and confusion due to decreased levels of sodium in the blood ( hyponatremia )
- headache
- dizziness
- nausea
- diarrhea
Uncommon (may affect up to 1 in 100 people)
- constipation
- stomach upset
- weakness (fatigue)
- swelling of the legs and feet (peripheral edema )
How to store Nocdurna
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage instructions regarding temperature.
Store in the original package (sensitive to moisture, light-sensitive).
Use immediately after opening the respective blister.
Do not use this medicine after the expiry date which is stated on the carton and blister 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 (as desmopressin acetate)
Each lyophilised tablet contains 25 micrograms desmopressin
Each lyophilised tablet contains 50 micrograms desmopressin - The other ingredients are gelatin, mannitol (E 421) and anhydrous citric acid
What the medicine looks like and contents of the pack
Nocdurna 25 micrograms:
White, round lyophilized tablet, diameter about 12 mm, embossed with 25 on one side.
Nocdurna 50 micrograms:
White, round freeze-dried tablet, diameter about 12 mm, embossed with 50 on one side.
Laminated aluminum blisters in an outer carton. Each blister card contains 10 lyophilized tablets.
Pack sizes
10×1, 30×1, 90×1 or 100×1 freeze-dried tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer
Ferring GmbH
Westland 11
24109 Kiel
Germany