Ammonaps 500 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
AMMONAPS 500 mg tablets
Sodium phenylbutyrate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if such adverse effects are not listed in this leaflet. See section 4.
Leaflet contents:
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What AMMONAPS is and what it is used for
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What you need to know before taking AMMONAPS
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How to take AMMONAPS
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Possible side effects
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How to store AMMONAPS
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Contents of the pack and other information
1. What AMMONAPS is and what it is used for
AMMONAPS is prescribed to patients with urea cycle disorders. Patients with these rare disorders lack certain liver enzymes and therefore cannot eliminate nitrogen waste. Since nitrogen is a component of proteins, it accumulates in the body after protein intake. Nitrogen waste, in the form of ammonia, is especially toxic to the brain and, in severe cases, may lead to 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 taking AMMONAPS
Do not take AMMONAPS:
- If you are pregnant.
- If you are breastfeeding.
- If you are allergic (hypersensitive) to sodium phenylbutyrate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take AMMONAPS
- If you have difficulty swallowing. AMMONAPS tablets may become lodged in the esophagus and cause ulcers. If you have trouble swallowing them, it is recommended that you use AMMONAPS granules instead.
- If you have heart failure, kidney failure, or any other condition that could worsen due to fluid retention caused by the sodium content of this medicine.
- If you have liver or kidney impairment, as AMMONAPS is eliminated from the body through the liver and kidneys.
- When administering to young children, as they may be unable to swallow the tablets and could choke. As an alternative, AMMONAPS granules are recommended.
AMMONAPS must be used in combination with a low-protein diet specifically designed for your condition by your doctor or dietitian. You must carefully follow this diet.
AMMONAPS does not completely prevent the buildup of ammonia in the blood and is not suitable for treating such a condition, which is considered a medical emergency.
If you need to have blood tests, it is important to remind your doctor that you are taking AMMONAPS, as sodium phenylbutyrate may alter the results of certain laboratory tests.
Taking AMMONAPS with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
It is especially important that you inform your doctor if you are taking medicines containing:
- valproic acid (an antiepileptic medicine)
- haloperidol (used to treat certain psychotic disorders)
- corticosteroids (cortisone-like medicines used to reduce inflammation in parts of the body)
- probenecid (used to treat hyperuricemia associated with gout)
These medicines may alter the effect of AMMONAPS, and you may need to have blood tests more frequently. If you are unsure whether your medicines contain these active substances, consult your doctor or pharmacist.
Pregnancy and breastfeeding
Do not take AMMONAPS if you are pregnant, as this medicine could harm the unborn baby. If you could become pregnant, you must use an effective method of contraception during treatment with AMMONAPS.
Do not use AMMONAPS if you are breastfeeding, as this medicine may pass into breast milk and harm your baby.
Driving and using machines
No studies have been conducted on the effects of AMMONAPS on the ability to drive or operate machinery.
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-salt (sodium) diet.
3. How to take AMMONAPS
Follow exactly the instructions for use of this medicine as given by your doctor.
If in doubt, consult your doctor or pharmacist again.
Dosage
The daily dose of AMMONAPS is calculated according to your tolerance to protein, diet, and body weight or body surface area. Regular blood tests should be performed to adjust the correct daily dose. Your doctor will tell you how many tablets you should take.
Method of administration
AMMONAPS should be taken orally in equal doses with each meal (for example, three times a day). AMMONAPS should be taken with plenty of water.
AMMONAPS must be taken while following a special low-protein diet.
AMMONAPS tablets must not be administered to children who are unable to swallow the tablets. As an alternative, AMMONAPS granules are recommended.
You will need to continue the diet and treatment for life, unless you undergo a successful liver transplant.
If you take more AMMONAPS than you should
Patients who have taken very high doses of AMMONAPS may experience:
- drowsiness, fatigue, dizziness, and less frequently, confusion
- headache
- taste disturbances (dysgeusia)
- decreased hearing capacity
- disorientation
- memory problems
- worsening of existing neurological conditions
If you experience any of these symptoms, you should contact your doctor or the nearest hospital emergency department immediately for symptomatic treatment.
If you forget to take AMMONAPS
Take a dose as soon as possible with the next meal. Make sure that at least 3 hours elapse between two doses. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following are the frequencies of possible adverse effects.
Very common: Affects more than 1 in 10 people
Common: Affects 1 to 10 in every 100 people
Uncommon: Affects 1 to 10 in every 1,000 people
Rare: Affects 1 to 10 in every 10,000 people
Very rare: Affects less than 1 in every 10,000 people
Unknown: Frequency cannot be estimated from the available data
Very common adverse effects: irregular menstruation and cessation of menstruation.
The absence of menstruation in sexually active women may not be caused by the use of AMMONAPS. If this occurs, consult your doctor, as you may be pregnant (see “Pregnancy and breastfeeding” in the previous section).
Common adverse effects: changes in the number of blood cells (red blood cells, white blood cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), abdominal pain, vomiting, nausea, constipation, body odour, rash, abnormal kidney function, weight gain, abnormal test results.
Uncommon adverse effects: low red blood cell count (anaemia) due to bone marrow suppression, bruising, changes in heart rhythm, rectal bleeding, gastric irritation, gastroduodenal ulcer, inflammation of the pancreas.
If you have persistent vomiting, you should consult your doctor immediately.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of AMMONAPS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the bottle after “EXP”. The expiry date refers to the last day of the month indicated.
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 and packaging you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of AMMONAPS
- The active substance is sodium phenylbutyrate.
Each AMMONAPS tablet contains 500 mg of sodium phenylbutyrate.
- The other components are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
Appearance of the product and package contents
AMMONAPS tablets are white to off-white, oval-shaped and engraved with “UCY 500”.
The tablets are packed in plastic bottles with child-resistant caps. Each bottle contains 250 or 500 tablets.
Marketing Authorization Holder
Immedica Pharma AB
SE-113 63 Stockholm
Sweden
Manufacturer
PATHEON France – BOURGOIN JALLIEU
40 boulevard de Champaret
BOURGOIN JALLIEU
38300
France
Date of the most recent revision of this summary:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/