Nocdurna: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NOCDURNA is used in the treatment of adults who have to wake up during the night, up to four times, to urinate (pee).

What it does:

NOCDURNA contains desmopressin (dez-moe-PRESS-in). It works by making the kidneys reabsorb more water, thereby producing less urine.

When it should not be used:

DO NOT take NOCDURNA, if you:

• are allergic to desmopressin acetate or any of the other ingredients in NOCDURNA tablets
• have or have had low blood sodium levels (hyponatremia)
• have a moderate or severe decrease of kidney function have heart problems such as heart failure (cardiac insufficiency) and other conditions requiring treatment with water pills (diuretics)
• have a condition known as habitual or psychogenic polydipsia (excessive water drinking)
• have known or suspected syndrome of inappropriate antidiuretic hormone secretion (SIADH) where your body makes too much antidiuretic hormone that may cause too much water to remain in the body resulting in low sodium levels.
• have bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease.
• have conditions which may affect blood sodium such as nausea, vomiting, eating disorders (bulimia or anorexia nervosa), diarrhea, adrenal problems (e.g. Addison’s disease), or kidney problems (salt losing nephropathies)

What the medicinal ingredient is:

The medicinal ingredient is desmopressin acetate.

What the nonmedicinal ingredients are:

The non-medicinal ingredients are gelatin, mannitol and citric acid.

What dosage forms it comes in:

NOCDURNA 25 µg is a white, round, orally disintegrating tablet with “25”on one side.

NOCDURNA 50 µg is a white, round, orally disintegrating tablet with “ 50”on one side.

NOCDURNA comes in a blister pack with each box containing 30 tablets.

The NOCDURNA initiation pack for men over 65 years comes in a blister pack containing 4 tablets.

WARNINGS AND PRECAUTIONS

NOCDURNA can cause too much water to remain in the body resulting in low sodium levels (hyponatremia). Hyponatremia is a serious condition which in severe cases and if not treated can result in death. If you experience symptoms such as unusual headache, dark urine or little amount of urine passed, nausea, vomiting, feeling weak or tired, sleepiness, unexplained weight gain, muscle cramps, contact your doctor immediately.

Fluid intake must be reduced to a minimum from 1 hour before taking NOCDURNA until at least 8 hours after taking NOCDURNA to prevent hyponatremia.

BEFORE you use NOCDURNA talk to your doctor or pharmacist if you:

• have or have had hyponatremia (low blood sodium levels)
• have constant thirst or the habit of drinking large amounts of water or liquids
• have a fever, the flu, an infection, or diarrhea that may affect your body fluid and salts (electrolytes)
• have any heart disease or high blood pressure
• have kidney problems
• have cystic fibrosis
• have a bladder problem or outlet obstruction

• are pregnant or planning to become pregnant

• are breast-feeding
• have condition that needs to take water pill (diuretic)

Your doctor will ask you to get your blood checked for sodium before starting NOCDURNA, and men aged 65 years and older on NOCDURNA 50 µg should have their serum sodium checked within 4-8 days and after one month after taking NOCDURNA.These blood tests are for your safety.

NOCDURNA tablets have not been studied in children.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about your other medication, including the ones that you bought without prescription, natural health products. Especially if you are taking any medicines that may increase risk of increased fluid and decreased salt levels such as nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen, celecoxib (Celebrex).

PROPER USE OF THIS MEDICATION

You should take NOCDURNA as prescribed by your doctor.

Usual adult dose:

Women: 25 µg once daily at bedtime.

Men: 50 µg once daily at bedtime

Water or liquid intake must be limited, especially 1 hour before taking NOCDURNA and until at least 8 hours after taking NOCDURNA.

How to take NOCDURNA?

NOCDURNA should be placed under the tongue one hour before bedtime. The tablet disintegrates instantaneously in the mouth without the need for water.

1. 1. Be sure your hands are dry.
2. 2. Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
3. 3. Now remove one blister from the strip by tearing along the perforations.
4. 4.

   Remove the foil on each blister, starting at the corner with the printed arrow, by peeling off the foil in the direction of the arrow. Do not push the tablet through the foil.

   1. 5.

      Carefully take one NOCDURNA tablet out of its blister.

      Place the NOCDURNA tablet under the tongue and allow it to dissolve. Do not chew or swallow the tablet.

Missed Dose:

If you miss a dose, skip the missed dose and take the next dose at your regular time. Do not take two (2) doses at the same time. Do not make up for a missed dose.

Overdose:

Do not take more than prescribed for you. In case of drug overdose, contact your doctor, or a poison control centre, or go to emergency room of the hospital near you immediately, even if there are no symptoms

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects with NOCDURNA include:

Common side effects: hyponatremia, dry mouth, diarrhea and headache..

Hyponatremia is a serious side effects with early symptoms include an unusually bad or prolonged headache, confusion, unexplained weight gain, nausea and vomiting, loss of appetite, feeling restless or irritable, feeling weak or tired, sleepiness and muscle cramps. This can become a serious problem and may lead to convulsions and death. If you experience one or more of these symptoms, stop taking this medicine. Tell your doctor immediately or go to the nearest emergency hospital.

This is not a complete list of side effects. For any unexpected effects while taking Nocdurna contact your doctor or pharmacist.

HOW TO STORE IT

Store at 25^oC; excursions permitted to 15 – 30^oC. Keep in original package to protect from moisture and light.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Ferring Inc., at: 1-800-263-4057.

Last revised: September 3, 2014