Fosfato nm 3,56 g polvo para solucion oral

Package Insert: Information for the Patient

Phosphate NM 3.56 g Powder for Oral Solution

Sodium Monohydrate Phosphate

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

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

NM 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 that are resistant to vitamin D intake.

Do not take NM Phosphate:

• If you are allergic to sodium phosphate

Warnings and precautions

Special attention should be given when administering NM Phosphate 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 NM Phosphate.

Patients with low-sodium diets should note that this medication contains 25.8 mmol (589.03 mg) of sodium per packet.

Other medications and NM Phosphate

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

While using this medication, avoid the use of antacids containing aluminum, as their use may make this medication ineffective.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

No problems have been described regarding driving and operating machines.

Follow exactly the administration instructions for this medication as 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 old

• For the treatment of osteomalacia (a bone metabolism disorder characterized by altered bone mineralization) resistant to vitamin D: 2-4 sachets per day.

The doctor must adjust the dose according to the blood phosphorus concentrations.

Children under 5 years old

• For the treatment of vitamin D-resistant rickets: 1-2 sachets per day.

The doctor must adjust the dose according to the blood phosphorus concentrations.

Use in patients over 65 years old:

• Do not exceed 4 sachets per day.

Use in patients with renal insufficiency:

• Use with caution in this group of patients.

Administration form

Phosphate NM must be dissolved in a half glass of water, shaking until complete dissolution and drinking slowly.

If you take more Phosphate 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 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 Phosphate NM

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

If you interrupt the treatment with Phosphate NM

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

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

In rare cases, it may cause nausea and vomiting.

Other effects may also appear, including:

• Nephrocalcinosis (calcium deposits in the kidney),
• diarrhea,
• abdominal pain,
• hyperphosphatemia (elevated phosphate in the blood),
• hypocalcemia (decreased calcium in the blood),
• hypokalemia (decreased potassium in the blood), and
• hypernatremia (elevated sodium in the blood).

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 about 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 Phosphate NM

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

Appearance of the product and content of the packaging

Packaging containing 20 or 100 sachets.

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

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/

Date of the last review of this leaflet:

July 2016