NM PHOSPHATE 3.56 g POWDER FOR ORAL SOLUTION

Introduction

Patient Information Leaflet

Sodium Phosphate 3.56 g Powder for Oral Solution

Sodium Phosphate Monohydrate

Read the entire leaflet carefully before starting to take 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 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 leaflet. See section 4.

Contents of the Leaflet

1. What is Sodium Phosphate and what is it used for
2. What you need to know before taking Sodium Phosphate
3. How to take Sodium Phosphate
4. Possible side effects
5. Storage of Sodium Phosphate
6. Package contents and additional information

1. What is Sodium Phosphate and what is it used for

Sodium Phosphate is used to increase the amount of phosphate in the body in cases of rickets and osteomalacia, where there is a lack of phosphate (hypophosphatemia) and which are resistant to vitamin D.

2. What you need to know before taking Sodium Phosphate

Do not take Sodium Phosphate:

• If you are allergic to sodium phosphate.

Warnings and precautions

Special attention should be paid when administering Sodium Phosphate to:

• Patient with renal insufficiency, as these cases require special care.
• Do not exceed the doses indicated by your doctor.
• Avoid consuming foods rich in calcium.

Consult your doctor or pharmacist before starting to take Sodium Phosphate.

Patient with low-sodium diets should note that this medicine contains 25.8 mmol (589.03 mg) of sodium per sachet.

Other medicines and Sodium Phosphate

Use of Sodium Phosphate with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

While using this medicine, avoid using antacids that contain aluminum, as their use may make this medicine less effective.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

No problems have been reported regarding driving and using machines.

3. How to take Sodium Phosphate

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 5 years

• In the treatment of hypophosphatemic osteomalacia (bone metabolism disease characterized by an alteration of bone mineralization) resistant to vitamin D: 2-4 sachets daily.

It is necessary for the doctor to adjust the dose according to the phosphorus concentrations in the blood.

Children under 5 years

• In the treatment of rickets resistant to vitamin D: 1-2 sachets daily.

It is necessary for the doctor to adjust the dose according to the phosphorus concentrations in the blood.

Use in patients over 65 years:

• Do not exceed 4 sachets per day.

Use in patients with renal insufficiency:

• It should be used with caution in this group of patients.

Method of administration

Sodium Phosphate should be dissolved in half a glass of water, shaking until complete dissolution, and drunk slowly.

If you take more Sodium Phosphate 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 or go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sodium Phosphate

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

If you stop treatment with Sodium Phosphate

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Rarely, nausea and vomiting may occur.

Other effects may also appear, such as:

• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System (website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Phosphate

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Sodium Phosphate

• The active ingredient is Sodium Phosphate Monohydrate. Each sachet contains 3.56 g of sodium phosphate monohydrate.

Appearance of the product and package contents

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

Date of the last revision of this leaflet:

July 2016