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What AMMONAPS is and what it is used for
AMMONAPS is prescribed to patients with disorders in the urea cycle. In the body of patients with these rare diseases there is a shortage of certain liver enzymes and therefore they can not eliminate the waste nitrogen. Nitrogen is a building block of proteins and therefore has a nitrogen build-up in the body after eating proteins. The waste nitrogen is in the form of ammonia, which is particularly toxic to the brain, and in severe cases leads to disturbances of consciousness and coma.
AMMONAPS helps the body to eliminate waste nitrogen by reducing the amount of ammonia in your 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 to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking it
- if you have difficulty swallowing because AMMONAPS tablets could get stuck in the esophagus and cause ulcers. If you have difficulty in swallowing, it is recommended to use AMMONAPS in granules.
- if you suffer from heart failure, impaired kidney function, or other conditions where the inhibition of sodium salts contained in this medicine may worsen your condition.
- if you have reduced liver or kidney function, as AMMONAPS is eliminated from the body through the liver and kidneys.
When given to young children because they may not be able to swallow the tablets and choke. Instead, it is recommended to use AMMONAPS granules.
AMMONAPS should be combined with a protein-poor diet, specifically for you by a doctor and a nutritionist. You have to follow this diet thoroughly.
AMMONAPS does not completely prevent the occurrence of a sharp increase in ammonia concentration in the blood and is not suitable for the treatment of this condition requiring urgent intensive care.
If you need laboratory tests, it is important to remind your doctor that you are taking AMMONAPS because sodium phenylbutyrate may affect the results of certain laboratory tests.
Other medicines and AMMONAPS
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 (antiepileptic drug),
-haloperidol (used for some psychiatric disorders),
- corticosteroids (cortisone-like medicines used to relieve inflammation of the body)
-probenecid (for the treatment of gout-related hyperuricaemia).
These medicines can alter the effects of AMONAPS and you will need more frequent blood tests. If you are not sure if your medicines contain these ingredients, ask your doctor or pharmacist for advice.
Pregnancy and breastfeeding
Do not use AMMONAPS if you are pregnant because this medicine can harm your baby. If you are a woman who could become pregnant, use reliable contraception during treatment with AMMONAPS.
Do not use AMMONAPS if you are breast-feeding because this medicine can pass into breast milk and affect 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. Consider patients on a controlled sodium diet.
3.How to take AMMONAPS
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The daily dose of AMMONAPS is calculated according to your tolerance to protein, diet and body weight or body surface area. You will need regular blood tests to determine the correct daily dose. Your doctor will tell you how many tablets you should take.
Mode of application
You should take AMMONAPS orally in divided doses during each meal (for example, three times a day). You should take AMMONAPS with plenty of water.
AMMONAPS should be taken with a special, low-protein diet.
AMMONAPS tablets should not be given to children who are unable to swallow them. In these cases it is recommended to use AMMONAPS granules instead of tablets.
You need to be on a diet and diet throughout your life unless you are subjected to a successful liver transplant.
If you take more AMMONAPS than you should
Patients who received very high doses of AMMONAPS experienced:
- constipation, tiredness, dizziness and less often - confusion,
- taste changes (taste disturbances),
- low hearing,
- weak memory,
- worsening of existing neurological conditions.
If you experience any of these symptoms, you should immediately contact your doctor or nearest hospital emergency department for maintenance treatment.
If you forget to take AMMONAPS
You should take the dose as soon as possible at your next meal. Observe the requirement that at least three (3) hours have passed between two doses. Do not take a double dose to make up for a missed dose.
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 everyone gets them.
Possible side effects are listed below depending on their frequency.
Very common side effects: irregular menstrual cycle and discontinuation of the menstrual cycle. If you are a woman who has sex and your cycle stops, do not take it unreservedly because this is due to the intake of AMMONAPS. If this happens, discuss it with your doctor because the lack of menstruation may be the result of a pregnancy (see section "Pregnancy and Breastfeeding" above).
Common side effects: changes in the number of blood cells (red blood cells, white blood cells and platelets), decreased appetite, depression, irritability, headache,
Loss of appetite (abnormal taste), abdominal pain, vomiting, nausea, constipation, skin odor, rash, impaired kidney function, weight gain, altered laboratory tests.
Uncommon side effects: reduced red blood cell count due to bone marrow depression, bruising, changes in 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
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5.How to store AMMONAPS
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle label after "EXP". The expiry date refers to the last day of that month.
Store below 30 ° C.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What AMMONAPS contains
The active ingredient is sodium phenylbutyrate.
Each AMMONAPS tablet contains 500 mg of sodium phenylbutyrate.
- The other ingredients are microcrystalline cellulose, magnesium stearate, and colloidal anhydrous silica.
What AMMONAPS looks like and contents of the pack
AMMONAPS tablets are almost white, oval with a convex embossment "UCY 500".
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