Ammonaps 500 mg tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What AMMONAPS is and what it is used for
2. What you need to know before you take AMMONAPS
3. How to take AMMONAPS
4. Possible side effects
5. How to store AMMONAPS
6. Contents of the pack and other information

• if you are pregnant.
• if you are breast-feeding.
• if you are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before taking AMMONAPS

• if you have difficulty swallowing. AMMONAPS tablets can get stuck in the oesophagus and cause ulcers. If you have difficulty swallowing it is recommended to use AMMONAPS granules instead.
• if you suffer from heart failure, a decrease in your kidney function or other diseases, where the retention of the sodium salt contained in this medicine, may make your condition worse.
• if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body through the kidney and liver.
• when given to small children, since they may not be able to swallow the tablets and may choke. It is recommended to use AMMONAPS granules instead.

AMMONAPS must be combined with a diet reduced in proteins designed especially for you by the doctor and the dietician. You must follow this diet carefully.

AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.

If you require laboratory tests, it is important to remind your doctor that you are taking AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to tell your doctor if you are taking medicines containing:

• valproic acid (an antiepileptic drug),
• haloperidol (used in certain psychotic disorders),
• corticosteroids (cortisone-like medicines that are used to provide relief for inflamed areas of the body),
• probenecid (for treatment of hyperuricemia associated with gout).

These medicines may change the effect of AMMONAPS and you will need more frequent blood controls. If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.

Do not use AMMONAPS if you are pregnant, because this medicine can harm your unborn baby. If you are a woman who could get pregnant, you must use reliable contraception, during treatment with AMMONAPS.

Do not use AMMONAPS if you are breast-feeding, because this medicine can pass into the breast-milk and harm your baby.

No studies on the effects on the ability to drive and use machines have been performed.

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.

The daily dose of AMMONAPS will be calculated from your protein tolerance, diet and body weight or body surface. You will need regular blood tests to determine the correct daily dose. Your doctor will tell you how many tablets you should take.

You should take AMMONAPS by mouth in equally divided doses with each meal (for example three times per day). You should take AMMONAPS with a large volume of water.

AMMONAPS must be taken with a special diet reduced in protein.

AMMONAPS tablets should not be given to children who are not able to swallow tablets. It is recommended that AMMONAPS granules are used instead.

You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.

Patients who have taken very high doses of AMMONAPS experienced:

• sleepiness, tiredness, light-headedness and less frequently confusion,
• headache,
• changes in taste (taste disturbances),
• decrease in hearing,
• disorientation,
• impaired memory,
• worsening of existing neurological conditions.

If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.

You should take a dose as soon as possible with your next meal. Make sure that there are at least 3 hours between two doses. Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sodium phenylbutyrate.
  Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
• The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.

AMMONAPS tablets are off-white, oval and embossed with “UCY 500”.

The tablets are packaged in plastic bottles with child-resistant caps. Each bottle contains 250 or 500 tablets.