Patient Information Leaflet: Package Insert

Urea NM 15 g powder for oral solution

Urea

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

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 a severe kidney problem (renal insufficiency) or liver problem (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 in children have not been established.

Taking Urea NM with other medications

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

No interactions with other medications are known.

Precautions with the use of diuretics (such as urea). Avoid using:

- droperidol, a medication used to prevent nausea or vomiting,

- arsenic trioxide, a medication used in the treatment of leukemia,

- levacetilmetadol (levometadil), a medication for intense pain or control of dependence on drugs like morphine or heroin.

Avoid consuming licorice.

Interference with diagnostic tests

If you are to undergo a diagnostic test for the diagnosis of Helicobacter pylori infection, you will need to take this into account to suspend the administration of Urea NM at least 2 days before the test.

Pregnancy, breastfeeding

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

Driving and operating machinery

No adverse effects on driving or operating machinery have been described.

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.

Follow exactly the administration instructions for this medication 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 packets of 15 grams each, in 24-hour periods (15 - 30 grams/day).

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

Patients with renal or hepatic insufficiency (alteration of the function of their kidney or liver):Use with caution in these patients.

Administration form:

Dissolve previously in a glass with water. Agitate until complete dissolution.

It may be administered via nasogastric tube if necessary.

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

If you take more Urea NM than you should

There are no data on overdoses 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Urea NM

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Urea NM

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Urea NM

-The active ingredient is Urea. Each sachet contains 15 grams of Urea.

- The other components are: orange aroma, sodium cyclamate, citric acid, monohydrate glucose, sodium saccharin.

Appearance of the product and contents of the packaging

Packaging with 30 sachets. Sachets of Paper/LDPE/Aluminum/RT (ethylene-vinyl acetate copolymer).

Holder of the marketing authorization

Nutrición Médica, S.L

C/ Arequipa, 1

28043- Madrid. Spain.

Responsible for manufacturing

Industrial Farmacéutica Cantabria S.A

Pirita, 9.

28850.- Torrejón de Ardoz. Spain

Date of the last review of this leaflet:

March2017

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/