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AstraZeneca

Ammonaps
sodium phenylbutyrate

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.


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.


Pregnancy and breast-feeding

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.


Driving and using machines

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


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.


  1. How to take AMMONAPS


    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


    Dosage

    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.


    Method of administration

    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.


    If you take more AMMONAPS than you should

    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.


      If you forget to take AMMONAPS

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


  2. 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 user in 10 Common: Affects 1 to 10 users in 100

    Uncommon: Affects 1 to 10 users in 1,000

    Rare: Affects 1 to 10 users in 10,000 Very rare: Affects less than 1 user in 10,000

    Not known: Frequency cannot be estimated from the available data


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

    If you are sexually active and your period stops altogether, do not assume that this is caused by AMMONAPS. If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above).


    Common side effects: changes in number of blood cells (red cells, white cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, weight gain, altered laboratory test values.


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


    If persistent vomiting occurs, you should contact your doctor immediately.


    Reporting of side effects

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


  3. 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 the bottle label after “EXP”. The expiry date refers to the last day of that month.


    Do not store above 30°C.


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


  4. Contents of the pack and other information What AMMONAPS contains


What AMMONAPS looks like and contents of the pack

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.


Marketing Authorisation Holder

Immedica Pharma AB SE-113 29 Stockholm Sweden


Manufacturer

PATHEON France – BOURGOIN JALLIEU

40 boulevard de Champaret BOURGOIN JALLIEU 38300

France


This leaflet was last revised in


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