UREA NM 15 G ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the Patient

Urea NM 15 g Powder for Oral Solution

Urea

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Urea NM is and what it is used for
2. What you need to know before taking Urea NM
3. How to take Urea NM
4. Possible side effects
5. Storage of Urea NM
6. Package Contents and Additional Information

1. What Urea NM is and what it is used for

Urea NM is indicated for the treatment of hyponatremia (low sodium levels in the blood) in the Syndrome of Inadequate Secretion of Antidiuretic Hormone (SIADH).

2. What you need to know before taking Urea NM

Do not takeUrea NM

• If you are allergic to urea or any of the other components of this medication (listed in section 6).
• If you have severe kidney problems (renal insufficiency) or liver problems (hepatic insufficiency).
• If you have severe dehydration.
• If you have intracranial hemorrhage.
• If you have had membrane rupture, cervical stenosis, or uterine fibroma.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Urea NM.

You should consult your doctor if you have liver or kidney problems.

Children and Adolescents

The efficacy and safety of Urea NM have not been established in children.

Taking Urea NM with Other Medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

No problems are known with the use of urea with other medications.

Precautions with the use of diuretics (such as urea). The use of the following should be avoided:

• droperidol, a medication used to prevent nausea or vomiting,
• arsenic trioxide, a medication used in the treatment of leukemia,
• levacetilmetadol (levomethadyl), a medication for intense pain or control of dependence on drugs such as morphine or heroin.

Avoid consuming licorice.

Interference with Diagnostic Tests

If a diagnostic test is to be performed for the diagnosis of Helicobacter pyloriinfection, it should be taken into account to suspend the administration of Urea NM before the test, at least 2 days in advance.

Pregnancy, Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

No negative effects have been described on driving or using machines.

Urea NM Contains Glucose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Urea NM

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:The recommended doses of urea are 1 to 2 sachets of 15 grams each, in periods of 24 hours (15 - 30 grams/day).

In cases of moderate or severe hyponatremia, use doses of 0.25 - 0.50 grams/kilogram of body weight.

Patient with Renal or Hepatic Insufficiency (Kidney or Liver Dysfunction):It should be used with caution in these patients.

Method of administration:

Dissolve previously in a glass of water. Shake until completely dissolved.

If necessary, it can be administered through a nasogastric tube.

Do not exceed 45 grams (3 sachets) in 24 hours.

If You Take More Urea NM Than You Should

There are no data on overdose with urea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Urea NM

Do not take a double dose to make up for forgotten doses.

If You Interrupt Treatment with Urea NM

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects have been described with an unknown frequency (cannot be estimated from the available data):

• Gastrointestinal disorders: feeling of fullness (abdominal distension), diarrhea, nausea, vomiting.
• Cardiac disorders: loss of consciousness (syncope).
• Nervous system disorders: headache (cephalalgia).
• Psychiatric disorders: disorientation.
• Renal and urinary disorders: decreased urine production (oliguria).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications (website: www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Urea NM

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Urea NM

• The active ingredient is Urea. Each sachet contains 15 grams of Urea.
• The other components are: orange flavor, sodium cyclamate, citric acid, glucose monohydrate, sodium saccharin.

Appearance of the Product and Package Contents

Package with 30 sachets. Sachets of Paper/LDPE/Aluminum/RT (copolymer of ethylene and acrylic acid).

Marketing Authorization Holder

Nutrición Médica, S.L

C/ Arequipa, 1

28043- Madrid. Spain.

Manufacturer

Industrial Farmacéutica Cantabria S.A

Pirita, 9.

28850.- Torrejón de Ardoz. Spain

Date of the Last Revision of this Package Leaflet:

March 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/