Fosfato NM 3.56 g powder for oral solution
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Fosfato NM 3.56 g powder for oral solution
Monosodium phosphate monohydrate
Read the entire 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, 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Fosfato NM is and what it is used for
- What you need to know before taking Fosfato NM
- How to take Fosfato NM
- Possible adverse effects
- How to store Fosfato NM
- Contents of the pack and other information
1. What Fosfato NM is and what it is used for
Fosfato NM is used to increase the amount of phosphate in the body in cases of rickets and osteomalacia, where there is a deficiency of phosphate (hypophosphatemia) and which are resistant to vitamin D administration.
2. What you need to know before starting to take NM
Do not take Fosfato NM:
- If you are allergic to sodium phosphate
Warnings and precautions
Special care is needed when administering Fosfato NM to:
- Patients with renal insufficiency, as special care is required in these cases.
- Do not exceed the doses indicated by your doctor.
- Avoid consuming foods rich in calcium.
Consult your doctor or pharmacist before starting to take Fosfato NM.
Patients on low-sodium diets should be aware that this medicine contains 25.8 mmol (589.03 mg) of sodium per sachet.
Other medicines and Fosfato NM
Use of Fosfato NM with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
While using this medicine, avoid the use of antacids containing aluminium, as their use may prevent this medicine from working effectively.
Pregnancy, breastfeeding and fertility
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 problems regarding driving and using machines have been reported.
3. How to take Fosfato NM
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
Adults and children over 5 years of age
- In the treatment of vitamin D-resistant hypophosphatemic osteomalacia (a bone metabolism disorder characterized by impaired bone mineralization): 2-4 sachets daily.
It is necessary for the physician to adjust the dose according to blood phosphorus concentrations.
Children under 5 years of age
- In the treatment of vitamin D-resistant rickets: 1-2 sachets daily.
It is necessary for the physician to adjust the dose according to blood phosphorus concentrations.
Use in patients over 65 years of age:
- Do not exceed 4 sachets per day.
Use in patients with renal insufficiency:
- Should be used with caution in this patient group.
Method of administration
Fosfato NM must be dissolved in half a glass of water, stirred until completely dissolved, and then taken slowly.
If you take more Fosfato NM than you should
The main symptoms of overdose are hyperphosphatemia and hypernatremia.
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 Fosfato NM
Do not take a double dose to make up for missed doses.
If you stop using Fosfato NM
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Nausea and vomiting may occur in rare cases.
Other possible effects include:
- Nephrocalcinosis (calcium deposits in the kidney),
- diarrhea,
- abdominal pain,
- hyperphosphatemia (increased phosphate in the blood),
- hypocalcemia (decreased calcium in the blood),
- hypokalemia (decreased potassium in the blood), and
- hypernatremia (increased sodium in the blood).
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 may 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. Fosfato NM Storage
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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Package contents and additional information
Composition of Fosfato NM
- The active substance is Sodium Phosphate Monobasic Monohydrate. Each sachet contains 3.56 g of sodium phosphate monobasic monohydrate.
Appearance of the product and contents of the package
Packages containing 20 or 100 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
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
Date of the most recent review of this leaflet:
July 2016