940 mg / g granules 
Sodium phenylbutyrate

500 mg tablets 
Sodium phenylbutyrate

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What AMMONAPS is and what it is used for

AMMONAPS is prescribed to patients with urea metabolic disorders. Patients suffering from these unusual disorders are deficient in certain liver enzymes and therefore cannot excrete nitrogen residues. Nitrogen is a building block in protein and therefore nitrogen accumulates in the body when you have eaten protein. Nitrogen residues in the form of ammonia are especially toxic to the brain and in severe cases lead to decreased consciousness and coma.

AMMONAPS helps the body excrete nitrogen residues, and reduces the amount of ammonia in your body.

2. What you need to know before taking AMMONAPS

Do not take AMMONAPS

  • 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).

Warnings and cautions

Talk to your doctor before taking AMMONAPS

  • if you suffer from heart failure, a decrease in your kidney function, or any other disease then the retention of the sodium salts contained in this medicine may worsen your condition
  • if you have impaired kidney or liver function, as AMMONAPS is excreted from the body through the kidneys and liver.

AMMONAPS should be combined with a diet, which is protein-reduced and which is individually adapted for you by the doctor or dietitian. This diet must be followed carefully.

AMMONAPS does not completely prevent an acute excess of ammonia in the blood

arises and is not suitable for the treatment of such a condition, which is considered an acute medical condition.

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

Other medicines and AMMONAPS

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

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

  • valproate (a medicine used to treat epilepsy ),
  • haloperidol (used in certain psychotic disorders),
  • corticosteroids ( cortisone-like drugs used to relieve inflamed areas of the body),
  • probenecid (for the treatment of elevated levels of uric acid in the blood associated with gout )

These medicines may affect the way AMMONAPS works and you may need to do more frequent blood tests. If you are not sure if your medicines contain these substances, ask your doctor or pharmacist.

Pregnancy and breastfeeding

Do not use AMMONAPS if you are pregnant, as this medicine may harm the fetus. If you are a woman who may become pregnant, you must use a reliable contraceptive 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 on the effects on the ability to drive and use machines have been performed.

AMMONAPS contains sodium

A small white spoon of AMMONAPS granules contains 149 mg of sodium.

A medium-sized yellow spoon of AMMONAPS granules contains 408 mg of sodium.

A large blue spoon of AMMONAPS granules contains 1200 mg of sodium.

Talk to your doctor or pharmacist if you need to take 2 or more of the small white spoon or 1 or more medium yellow or large blue spoon daily for an extended period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

3. How to take AMMONAPS

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

The daily dose of one of AMMONAPS is calculated based on your ability to tolerate protein, diet, and body weight or body surface area. You will need regular blood tests to determine the correct daily dosage. Your doctor will tell you how much granules take.

Method of administration

AMMONAPS should be taken in equal doses by mouth, through a gastrostomy (gastric fistula, a tube that passes through the abdominal wall to the stomach), or through a gastric tube (a tube that passes through the nose to the stomach).

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

You should take AMMONAPS at every meal or feeding. In young children, this can be 4 to 6 times a day.

To measure the dose:

  • Lightly shake the bottle before opening it
  • Use the correct spoon when measuring the following amount of AMMONAPS: 1.2 g = small white spoon, 3.3 g = medium-sized yellow spoon, and 9.7 g = large blue spoon
  • Take a spoonful of granules from the bottle
  • Apply a smooth surface, e.g. a knife, over granules et in the spoon to remove the excess granules
  • Granules that remain on the spoon are counted as one spoon
  • Take the correct number of spoons of granules from the bottle

Ingestion by mouth

Mix the measured dose with solid food (such as mashed potatoes or apple puree) or liquid food (such as water, apple juice, orange juice, or protein-free infant drink) to be taken immediately after mixing.

Patients with gastrostomy (gastric fistula) or gastric tube

Mix the granules with water until there are no dry granules left (by stirring in the solution, the granules can be more easily dissolved). When the granules have been dissolved in water, a milky white solution is obtained. Take the solution immediately after mixing.

You need to receive treatment and diet for the rest of your life if you do not undergo a successful liver transplant.

If you take more AMMONAPS than you should

Patients who have taken very high doses of AMMONAPS experienced:

  • drowsiness, fatigue, dizziness, and on more rare occasions confusion,
  • headache,
  • changed taste perception,
  • impaired hearing,
  • disorientation,
  • impaired memory,
  • deterioration of existing neurological conditions.

If you experience any of these symptoms, contact your doctor or nearest emergency department immediately for supportive care.

If you forget to take AMMONAPS

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The frequency of possible side effects is listed below.

Very common: Affects more than 1 in 10 users
Usual: Affects 1 to 10 users out of 100
Uncommon: Affects 1 to 10 users out of 1000
Rare: Affects 1 to 10 users out of 10,000
Very rare: Affects less than 1 in 10,000 users
No known frequency: The frequency cannot be calculated from the available data

Very common side effects: irregular periods or missed periods. If you are sexually active and your period stops completely, do not take it for granted that this has been caused by AMMONAPS. If this happens, you should discuss it with your doctor, as missed periods can also be due to pregnancy (see the section on pregnancy and breastfeeding above).

Common side effects: altered blood cell count ( red blood cells, white blood cells, and platelets ), decreased appetite, depression, irritability, headache, fainting, fluid retention (swelling), taste changes, abdominal pain, vomiting, nausea, constipation, skin odor, rash, abnormal kidney function weight gain, altered laboratory test values.

Uncommon side effects: lack of red blood cells due to bone marrow depression, bruising, altered heart rhythm, rectal bleeding, stomach irritation, stomach ulcer, inflammation of the pancreas.

If repeated vomiting occurs, contact your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.

5. How to store 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 carton and bottle label after “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is sodium phenylbutyrate. One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
  • The other ingredients are calcium stearate and colloidal anhydrous silica.

What the medicine looks like and the contents of the pack

AMMONAPS granules are off-white.

Granules are packed in plastic bottles with childproof lids. Each bottle contains 266 g or 532 g of granules. Three spoons (a small white spoon, a medium-sized yellow spoon, and a large blue spoon) are included for measuring the daily dose.

Marketing Authorisation Holder

Immedica Pharma AB

SE-113 29 Stockholm


Manufacturer

PATHEON France – BOURGOIN JALLIEU

40 Boulevard de Champaret

BOURGOIN JALLIEU

38300

France

Muhammad Nadeem

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