Ammonaps 500 mg tablets

2.         What you need to know before you take AMMONAPS

AMMONAPS contains sodium

Each AMMONAPS tablet contains 62 mg of sodium.

Talk to your doctor or pharmacist if you need 6 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

6.         Contents of the pack and other information

This leaflet was last revised in 10/2020

2.         What you need to know before you take AMMONAPS

AMMONAPS contains sodium

Each AMMONAPS tablet contains 62 mg of sodium.

Talk to your doctor or pharmacist if you need 6 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

6.         Contents of the pack and other information

This leaflet was last revised in 10/2020

 

 

New text highlighted in blue

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Note: sections only provided where amendments have been made

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500 mg sodium phenylbutyrate.

Excipient(s) with known effect

Each AMMONAPS tablet contains 2.7 mmol (62 mg) of sodium.

For the full list of excipients, see section 6.1.

4.4         Special warnings and precautions for use

AMMONAPS tablets should not be used in patients with dysphagia due to the potential risk of oesophageal ulceration if tablets are not promptly delivered to the stomach.

This medicinal product contains 62 mg sodium per tablet, equivalent to 3% of the WHO recommended maximum daily intake for sodium.

The maximum recommended daily dose of this product contains 2.5 g sodium which is equivalent to 124% of the WHO recommended maximum daily intake for sodium.

AMMONAPS is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

Each AMMONAPS tablet contains 62 mg (2.7 mmol) of sodium, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose. AMMONAPS should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.

Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, AMMONAPS should be used with caution in patients with hepatic or renal insufficiency.

Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.

Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.

AMMONAPS is not recommended for the management of acute hyperammonaemia, which is a medical emergency.

In children unable to swallow tablets, it is recommended to use AMMONAPS granules instead.

10.       DATE OF REVISION OF THE TEXT

06/06/201914/10/2020