AMMONAPS 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

AMMONAPS 500 mg tablets

Sodium phenylbutyrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack and other information:

1. What is AMMONAPS and what is it used for
2. What you need to know before you take AMMONAPS
3. How to take AMMONAPS

1. Possible side effects
2. Storing AMMONAPS

1. Contents of the pack and further information

1. What is AMMONAPS and what is it used for

AMMONAPS is prescribed to patients with urea cycle disorders. Patients with these rare disorders have a deficiency of certain liver enzymes, so they cannot eliminate nitrogen waste. Since nitrogen is a component of proteins, it accumulates in the body after protein consumption. Nitrogen waste, in the form of ammonia, is especially toxic to the brain and, in severe cases, can cause loss of consciousness and coma.

AMMONAPS helps the body eliminate excess nitrogen and reduces the amount of ammonia in the body.

2. What you need to know before you take AMMONAPS

Do not take AMMONAPS:

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

Warnings and precautions

Consult your doctor or pharmacist before taking AMMONAPS

• If you have difficulty swallowing. AMMONAPS tablets may get stuck in the esophagus and cause ulcers. If you have difficulty swallowing them, it is recommended to use AMMONAPS granules as an alternative.
• If you have heart failure, kidney failure, or other conditions that may worsen due to sodium retention caused by this medicine.
• If you have liver or kidney failure, as AMMONAPS is eliminated from the body through the kidneys and liver.
• When administering to small children, as they may be unable to swallow the tablets and choke. As an alternative, it is recommended to administer AMMONAPS granules.

AMMONAPS must be combined with a low-protein diet that your doctor or dietitian has specifically designed for your case. You must follow this diet carefully.

AMMONAPS does not completely prevent excess ammonia from occurring in the blood and is not suitable for treating this condition, which is considered a medical emergency.

If you need to have tests, it is important to remind your doctor that you are taking AMMONAPS, as sodium phenylbutyrate may alter the results of some tests.

Using AMMONAPS with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important to inform your doctor if you are taking medicines that contain:

• valproic acid (an antiepileptic medicine)
• haloperidol (used to treat certain psychotic disorders)
• corticosteroids (medicines similar to cortisone used to relieve inflamed areas of the body)
• probenecid (for the treatment of hyperuricemia associated with gout)

These medicines may modify the effect of AMMONAPS, and you may need to have blood tests more frequently. If you are not sure if the medicines you are using contain these active ingredients, consult your doctor or pharmacist.

Pregnancy and breast-feeding

Do not take AMMONAPS if you are pregnant, as this medicine may harm the fetus. If you could become pregnant, you must use an effective contraceptive method during treatment with AMMONAPS.

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

Driving and using machines

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

AMMONAPS contains sodium

Each AMMONAPS tablet contains 62 mg of sodium.

Consult your doctor or pharmacist if you need to take 6 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take AMMONAPS

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Dosage

The daily dose of AMMONAPS is calculated according to your tolerance to proteins, diet, and body weight or body surface area. You will need to have regular blood tests to adjust the correct daily dose. Your doctor will tell you how many tablets to take.

Method of administration

AMMONAPS should be taken orally in equal doses with each meal (e.g., three times a day). You should take AMMONAPS with plenty of water.

AMMONAPS should be taken while following a special low-protein diet.

AMMONAPS tablets should not be administered to children who are unable to swallow the tablets. As an alternative, it is recommended to administer AMMONAPS granules.

You will need to follow the diet and treatment for life, unless you undergo a successful liver transplant.

If you take more AMMONAPS than you should

Patient who have taken very high doses of AMMONAPS experience:

• drowsiness, fatigue, dizziness, and, less frequently, confusion
• headache
• changes in taste (taste disorders)
• decreased hearing
• disorientation
• memory problems
• worsening of existing neurological conditions

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

If you forget to take AMMONAPS

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

If you have any further questions on 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 everybody gets them.

The following frequencies are used to describe the occurrence of side effects:

Very common: affects more than 1 in 10 people

Common: affects 1 to 10 in 100 people

Uncommon: affects 1 to 10 in 1,000 people

Rare: affects 1 to 10 in 10,000 people

Very rare: affects less than 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Very common side effects: irregular menstrual periods and cessation of menstruation.

It is possible that the absence of menstruation in sexually active women is not caused by the use of AMMONAPS. If this occurs, consult your doctor, as you may be pregnant (see "Pregnancy and breast-feeding" in the previous section).

Common side effects: changes in blood cell count (red blood cells, white blood cells, and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disorders), abdominal pain, vomiting, nausea, constipation, body odor, rash, abnormal kidney function, weight gain, alteration of test results.

Uncommon side effects: low red blood cell count (anemia) due to bone marrow depression, bruising, irregular heartbeat, rectal bleeding, stomach irritation, gastroduodenal ulcer, pancreatitis.

If you have persistent vomiting, you should consult your doctor immediately.

Reporting of side effects

If you experience 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 the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing AMMONAPS

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

Do not use this medicine after the expiry date which is stated on the packaging and the label on the bottle after "EXP". The expiry date is the last day of the month stated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of AMMONAPS

• The active substance is sodium phenylbutyrate

Each AMMONAPS tablet contains 500 mg of sodium phenylbutyrate.

• The other ingredients are microcrystalline cellulose, magnesium stearate, and anhydrous colloidal silica.

Appearance and packaging

AMMONAPS tablets are white, oval, and engraved with "UCY 500".

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

Marketing authorisation holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

PATHEON France – BOURGOIN JALLIEU

40 boulevard de Champaret

BOURGOIN JALLIEU

38300

France

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/