Consumer Information for: PMS-DESMOPRESSIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

pms-DESMOPRESSIN is a drug that is prescribed for children 5 years of age and older who wet their bed at night. This condition is called Primary Nocturnal Enuresis (PNE).

pms-DESMOPRESSIN - Diabetes Insipidus

pms-DESMOPRESSIN tablets are used to prevent or control the frequent urination, increased thirst, and loss of water associated with Diabetes Insipidus (water diabetes).

What is Diabetes Insipidus (DI):
Diabetes Insipidus is a medical condition in which your kidneys are unable to retain water. This results in the production of large volumes of urine which in turn makes you feel dry and very thirsty.

What it does

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

pms-DESMOPRESSIN tablets reduces the amount of urine (pee) that your child makes at night. The result is your child’s bladder will not fill up as much and your child will be less likely to wet the bed at night.

pms-DESMOPRESSIN - Diabetes Insipidus

pms-DESMOPRESSIN tablets reduce the amount of urine that you make. The result is that your bladder (where urine is stored) does not fill as quickly, so a person taking this medicine does not need to pass urine so often.

When it should not be used

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

There are people who should not take pmsDESMOPRESSIN tablets. Tell your child’s doctor or pharmacist if your child has:

  • Diarrhea
  • Vomiting
  • Any heart, liver or kidney problems
  • Hyponatremia (low blood sodium levels)
  • Bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease
  • Constant thirst
  • Eating disorders such as bulimia (over-eating followed by purging or anorexia nervosa (self-starvation)
  • Adrenal problems (e.g. Addison’s disease)
  • An allergy to desmopressin acetate or to any of the ingredients listed under “What the nonmedicinal ingredients are”
  • Lactose intolerance

pms-DESMOPRESSIN - Diabetes Insipidus

There are people who should not take pms-DESMOPRESSIN tablets. Tell your doctor or pharmacist if you have:

  • Diarrhea
  • Vomiting
  • Any heart, liver or kidney problems
  • Hyponatremia (low blood sodium levels)
  • Bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease
  • Eating disorders such as bulimia (over-eating followed by purging) or anorexia nervosa (self-starvation)
  • Adrenal problems (e.g. Addison’s disease)
  • An allergy to desmopressin acetate or to any of the ingredients in pms-DESMOPRESSIN tablets (see What the non-medicinal ingredients are)
  • Lactose intolerance
What the medicinal ingredient is

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

Desmopressin acetate (as desmopressin acetate trihydrate)

pms-DESMOPRESSIN - Diabetes Insipidus

Desmopressin acetate (as desmopressin acetate trihydrate)

What the non-medicinal ingredients are

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

Lactose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

pms-DESMOPRESSIN - Diabetes Insipidus

Lactose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

What dosage form it comes in

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

pms-DESMOPRESSIN 0.1 mg tablets are available as white, oval-shaped tablet with “0.1” debossed on one side and scored on the other side.

pms-DESMOPRESSIN 0.2 mg tablets are available as white, round tablet with “0.2” debossed on one side and scored on the other side.

pms-DESMOPRESSIN are available are supplied in bottles of 100 tablets.

pms-DESMOPRESSIN - Diabetes Insipidus

pms-DESMOPRESSIN 0.1 mg tablets are available as white, oval-shaped tablet with “0.1” debossed on one side and scored on the other side.

pms-DESMOPRESSIN 0.2 mg tablets are available as white, round tablet with “0.2” debossed on one side and scored on the other side.

pms-DESMOPRESSIN are available are supplied in bottles of 100 tablets.

Warnings and precautions

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

BEFORE your child uses pms-DESMOPRESSIN, talk to your child’s doctor or pharmacist if your child has:

  • hyponatremia (low blood sodium level)
  • heart problems
  • liver disease
  • kidney problems
  • bleeding problems
  • fever
  • cystic fibrosis
  • any allergies to desmopressin acetate or any of the ingredients listed in “What the nonmedicinal ingredients are”

It is important to limit the number of drinks of any kind that your child has after supper, especially one hour before bedtime, until the next morning (at least 8 hours) in order to decrease the potential occurrence of water intoxication and hyponatremia.This can become a serious problem and may lead to convulsions.

pms-DESMOPRESSIN should not be given to dehydrated patients until water balance is adequately restored.

pms-DESMOPRESSIN - Diabetes Insipidus

BEFORE you use pms-DESMOPRESSIN tablets, talk to your doctor or pharmacist if you are:

  • Breast-feeding
  • Pregnant or think you might be pregnant

And/or if you have:

  • Hyponatremia (low blood sodium level)
  • Heart problems
  • Liver disease
  • Kidney problems
  • Bleeding problems
  • Fever
  • Cystic fibrosis
  • Any allergies to desmopressin acetate or any of the ingredients listed in “What the non-medicinal ingredients are”.

Before you commence treatment with this medicine, you should receive appropriate advice concerning fluid intake from your doctor. Excessive fluid intake may lead to a build-up of water in the body resulting in water intoxication and hyponatremia.

pms-DESMOPRESSIN tablets should not be given to dehydrated patients until water balance is adequately restored.

Talk to your doctor before stopping or interrupting treatment with pms-DESMOPRESSIN.

Interactions with this medication

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

Tell your child’s doctor or pharmacist if your child is taking any of the following medications:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs such as etodolac, ibuprofen, naproxen, celecoxib)
  • Tricyclic antidepressants (amitriptyline, nortriptyline)
  • Serotonin reuptake inhibitors (for example, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram)
  • Diuretics (water pills)
  • Loperamide
  • Chlorpromazine
  • Carbamazepine
  • Clofibrate
  • Chlorpropamide
  • Demeclocyclin
  • Lithium
  • Norepinephrine

pms-DESMOPRESSIN - Diabetes Insipidus

Drugs that may interact with pms-DESMOPRESSIN tablets include:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs such as etodolac, ibuprofen, naproxen, celecoxib)
  • Tricyclic antidepressants (amitriptyline, nortriptyline)
  • Serotonin reuptake inhibitors (for example, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram)
  • Diuretics (water pills)
  • Loperamide
  • Chlorpromazine
  • Carbamazepine
  • Clofibrate
  • Chlorpropamide
  • Demeclocyclin
  • Lithium
  • Norepinephrine

If you are taking any of these drugs, please talk to your doctor or pharmacist before taking pms-DESMOPRESSIN tablets.

Proper use of this medication

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

Usual dose

Take the medication at the dose prescribed by your physician 1 hour before bedtime. Use the following dosage plan or one that has been recommended by your physician.

Step 1 - For the first 3 nights.

Take 1 tablet (1 x 0.2 mg) 1 hour before bedtime.
If the child is dry for 3 nights taking 1 tablet each night, continue this way. Do NOT increase the dose.

If the child is NOT dry for these 3 nights, move to Step 2.

Step 2 - Nights 4, 5 & 6.

Take 2 tablets (2 x 0.2 mg) 1 hour before bedtime.
If the child is dry for 3 nights taking 2 tablets each night, continue this way. Do NOT increase the dose.

If the child is NOT dry for these 3 nights, move to Step 3.

Step 3 - Nights 7, 8 & 9.

Take 3 tablets (3 x 0.2 mg) 1 hour before bedtime.
If the child is dry for 3 nights taking 3 tablets each night, continue this way. Do NOT increase the dose.

If your child is not dry every night after taking 3 tablets each night for 3 nights, see the “What should I do if...?” section below or visit your doctor to find out why the medicine has not worked.

What should I do if the child is still wetting the bed?

  • Make sure the child is taking the correct number of tablets each night.
  • Limit the number of drinks the child has after supper.
  • If it’s still not working, call your doctor.

Overdose

If you think your child has taken too much pms-DESMOPRESSIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Your child should not to take any extra pms-DESMOPRESSIN tablets. Take the same number of pms-DESMOPRESSIN tablets as before the child forgot. For example, Mary took one pms-DESMOPRESSIN tablet on Monday but she forgot to take it on Tuesday. On Wednesday, Mary should take just one of pms-DESMOPRESSIN tablet.

pms-DESMOPRESSIN - Diabetes Insipidus

How many pms-DESMOPRESSIN tablets should I take?

Usual dose

Follow your doctor’s direction on how much medicine you should take. The recommended treatment range for diabetes insipidus is 0.2 mg to 1.2 mg per day divided equally into 2 or 3 doses a day.

Overdose

If you think you have taken too much pms-DESMOPRESSIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose of pms-DESMOPRESSIN tablets, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

Side effects and what to do about them

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

As with all medicines, side effects may be experienced. With pms-DESMOPRESSIN tablets, these may include:

  • headache
  • nausea
  • nasal congestion
  • rhinitis
  • flushing
  • mild abdominal cramps

These have occurred usually when the medication is being adjusted. Once you are taking the right amount of medicine for your condition, these side effects will usually go away. Tell your doctor about any side effects you experience.

Unusually bad or prolonged headache
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
Rare
Convulsions    
   
Confusion    
Unexplained weight gai    
Nausea    
Vomiting    

This is not a complete list of side effects. For any unexpected effects while taking pms-DESMOPRESSIN tablets, contact your doctor or pharmacist.

pms-DESMOPRESSIN - Diabetes Insipidus

As with all medicines, side effects may be experienced. With pms-DESMOPRESSIN tablets, these may include:

  • Headache
  • Nausea
  • Nasal congestion
  • Rhinitis
  • flushing
  • mild abdominal cramps

These have occurred usually when the medication is being adjusted. Once you are taking the right amount of medicine for your condition, these side effects will usually go away. Tell your doctor about any side effects you experience.

Unusually bad or prolonged headache
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
Rare
Convulsions    
   
Confusion    
Unexplained weight gai    
Nausea    
Vomiting    

This is not a complete list of side effects. For any unexpected effects while taking pms-DESMOPRESSIN tablets, contact your doctor or pharmacist.
How to store

pms-DESMOPRESSIN - Primary Nocturnal Enuresis

Store in a dry place between 15°C and 30°C. Avoid humidity and light exposure.

Keep out of reach and sight of children.

pms-DESMOPRESSIN - Diabetes Insipidus

Store in a dry place between 15°C and 30°C. Avoid humidity and light exposure.

Keep out of reach and sight of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
                    Health Canada
                    Postal Locator 0701E
                    Ottawa, ON
                    K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmascience Inc., at 1-888-550-6060.

This leaflet was prepared by
        Pharmascience Inc.
        Montréal, Canada
        H4P 2T4

www.pharmascience.com

Last revised: February 8, 2016