Urea NM 15 g powder for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Urea NM 15 g powder for oral solution
Urea
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Urea NM is and what it is used for
- What you need to know before taking Urea NM
- How to take Urea NM
- Possible side effects
- How to store Urea NM
- Contents of the pack and other information
1. What Urea NM is and what it is used for
Urea NM is indicated for the treatment of hyponatremia (low blood sodium) in the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
2. What you need to know before starting to take Urea NM
Do not take Urea NM
- If you are allergic to urea or to any of the other components of this medicine (listed in section 6).
- If you have severe kidney problems (renal failure) or liver problems (hepatic failure).
- If you have severe dehydration.
- If you have intracranial hemorrhage.
- If you have experienced membrane rupture, cervical stenosis, or uterine fibroids.
Warnings and precautions
Talk to 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 has not been established.
Taking Urea NM with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
There are no known problems associated with using urea together with other medicines.
Precautions regarding the use of diuretics (such as urea). The use of the following should be avoided:
- droperidol, a medicine used to prevent nausea or vomiting,
- arsenic trioxide, a medicine used in the treatment of leukemia,
- levacetylmethadol (levomethadyl), a medicine for severe pain or management of drug dependence such as to morphine or heroin.
Avoid consumption of liquorice.
Interference with diagnostic tests
If you are scheduled to undergo a diagnostic test for Helicobacter pylori infection, this should be taken into account and Urea NM administration must be discontinued at least 2 days prior to the test.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No negative effects on driving or operating machinery have been reported.
Urea NM contains glucose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Urea NM
Follow exactly the instructions for use of this medicine as given 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, within 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 impairment (impaired kidney or liver function): This medicine should be used with caution in these patients.
Method of administration:
Dissolve first in a glass of water. Shake until completely dissolved.
If necessary, it may be administered via 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, go to a medical center immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Urea NM
Do not take a double dose to make up for missed doses.
If you stop taking Urea NM
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
The following adverse effects have been reported with 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 of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products (website: www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Urea NM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Urea NM
- The active substance is Urea. Each sachet contains 15 grams of Urea.
- The other components are: orange flavour, sodium cyclamate, citric acid, glucose monohydrate, sodium saccharin.
Nature of the product and contents of the pack
Pack containing 30 sachets. Paper/LDPE/Aluminum/RT (ethylene-acrylic acid copolymer) sachets.
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 most recent review of this leaflet:
March 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/