Ammonaps – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Ammonaps, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet careful ly be fore 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 ques tions, ask your doctor or pharmacist.
- This medicine has been prescribed for yo u only . Do not pass it on to o thers. 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.
ℹ️ 1. What AMMONAPS is and what it is used for
AMMONAPS is prescribed to patients with urea cycle disorders . Patients with these rare d isorders have a deficiency of certain liver enzymes and are therefore unable to elimina te nitrogen waste.
Nitrogen is a building block of proteins, because of this there is a build up of nitrogen in the body after eating protein . Nitrogen waste, in the for m of ammonia, is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
AMMONAPS helps the body to eliminat e nitrogen waste, reducing the amount of ammonia in your body.
⚠️ 2. What you need to know befo re you take AMMONAPS
Do not take AMMONAPS
- if you are pregnant.
- if you are breast -feeding.
- if you are allergic to sodi um phenyl butyrate or any of the other in gredients of this medicine (listed in section 6) .
Warnings and preca utions Talk to your doctor be fore taking AMMONAPS
- if you suffer from heart failure, a decrease in your kidney f unction or other diseases where the retention of the sodium salt contain ed in this medicine may make your condition worse.
- if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body through the kidney and liver.
AMMONAPS mu st be combined with a diet reduced in pr oteins, designed especially for you by the doctor and the dietician. You must follow this diet carefu lly.
AMMONAPS does not comp letely prevent the occurrence of an acute excess of ammonia in the blood and is not app ropriate for treating such a condition, w hich is a medical emergency.
30 If you require laboratory tests, it is important to remind y our doctor that you are taking AMMONAP S, since sodium phenylbutyrate may influence certain laboratory test results.
Other me dicines and AMMONAPS Tell your doctor or pharmacist if you are taking, hav e recently taken or might take any other medicines.
It is especial ly important to tell your do ctor if you are taking medicines containing:
- valproic acid (an antiepileptic drug),
- haloperidol (used in certain psych otic dis orders) ,
- corticosteroids (corti sone-like medicines that are used to provide relief for inf lamed area s of the body),
- probenecid ( for treatment of hyperuricemia associated with gout) .
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 shoul d check with your doctor or p harmacist.
Pregnancy and breast -feeding Do not use AMMONAPS if you are pregnant, because this medicine can harm your unborn ba by. If you are a woman who coul d get pregnant, you must use reliable contraception, during treatment with AMMONAPS.
Do not use A MMONAPS if you are breast -feeding, because this medicine can pass into the breast – milk and harm your baby.
Driving and using m achines No studies on the effec ts on the ability to drive and use machines have been performed.
AMM ONAPS contains sodium
One small white spoon of AMMONAPS granules contains 149 mg of sodium .
One medium sized yellow spoon of AMMONAPS granules cont ains 408 mg of sodium .
One large blue s poon o f AMMONAPS granules contains 1200 mg of sodium .
Talk to your pharmacist or doctor if you ne ed 2 or more small white spoons or 1 or more medi um yellow or large blue spoons daily for a prolonged period, e specially if you have been advised to follow a low salt (sodium ) diet.
💊 3. How to take AMMONAPS
Always take this medicine exactly as your doc tor has told you . Check with your doctor or pharmacist if you are not sure.
Dosage The daily dose of AMMONA PS will be calculated from your protein toleran ce, diet and body weight or body surface. You will need regul ar blood t ests to determine the correct daily dose. You r doctor will tell you the amount of granules you should take.
Meth od of admi nistration You should take AMMONAPS in equally divided doses by mouth, through a gastrostomy (tube that goes through the abdomen to the stomach) or through a na sogastric tub e (tube that goes through the nose to the stomach).
AMMONAPS must be ta ken with a special diet red uced in protein.
31 You should take AMMONAPS w ith each meal or feeding. In small children this can be 4 to 6 times per day.
To measure the dose:
- Shake the bo ttle lightly before opening
- Use the correct spoon to dispense the follow ing am ount of AMMONAPS : 1.2 g = small white spoon, 3.3 g = medium sized yellow spoon and 9.7 g = large blue spoon
- Take a heaped spoo nful of gr anules out of the bottle
- Pass a flat surface, e.g. the back of a knife blade, over the top of the spoon to r emove the ex cess of granules
- The granules left in the spoon are one spoonful
- Take the correct number of spoonfuls of granules from the bot tle.
When taken by mouth Mix the measured dose with so lid foods (such as mashed potatoes or apple sauce) or liquid foods (such as wa ter, apple juice, ora nge juice or protein -free infant formulas) a nd take it immediately after mixing.
Patients with a gas trostomy o r nasogastric tube Mix the gr anules with water until there are no dry granules left (stirring the solution helps to dissolve the granules). Wh en the granules are dissolved in water you get a milky white liquid. Take the solution immediately after mixing.
You will need to have treatme nt and to follow a diet throughout your life, unless you have a successful liver transplantatio n.
If you take more AMMONAPS than you should
Patients who have t aken very high doses of AMMONAPS experienced:
- sleepiness, tiredness, light -headedness and less f requently confusi on,
- headache,
- changes in taste (taste disturbances),
- decrease in hearing,
- disorientation,
- impaired memory,
- worsening of existing neurolog ical conditions.
If you experience any of these symptoms , you should immediately contact your d octor or the near est hospital emergency department for supportive treatment.
If you forget to take AMMONAPS
You should take a dose as soon as possible with you r next meal. Make sure that there are at least 3 hours be tween two doses. Do not take a double dose to make up fo r a forgotten dose.
If you have any further questions on th e use of this medi cine, ask your doc tor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of pos sible side effects is listed below.
Very common: Affects m ore than 1 user in 10
Common: Affects 1 to 10 users in 100
Uncommon: Affects 1 t o 10 users in 1,000
Rare: Affects 1 to 10 users in 10,000
Very ra re: Affects less than 1 use r in 10,000 32 Not k nown: Frequency cannot be estimated from the available dat a Very common side effects: irregular menstrual periods and cessation of menstrual periods.
If you are sexually active and your period sto ps altoget her, do not assume that this is caused by AMMO NAP S. If this occurs, please discuss it with your doctor, be cause the absence of your period may be caused by pregnancy (see Pregnancy and brea st-feeding section above).
Common side effects : changes in number of blood cells (red cells, wh ite cells and pla telets), reduced appetite, depression, irritability, headache, fainting, fluid ret ention (swelling) , changes in taste (taste disturbances), pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, we ight gain, altered laboratory test values.
Uncommon side effects : deficiency in red blood cells due to bone marrow d epression, bruising, altered heart rhythm, r ectal bleeding, stomach irritation, stomach ulcer, inflammation of the pancreas.
If persistent vomiting occurs, you should contact your doctor immediately.
Reporting of s ide effects If you get any side effects, talk to your doctor or pharmacist. This inc ludes any possible side effects not listed in this leafl et. You ca n also report side effects di rectly via the nation al reporting system listed in Appendix V . By reporting side effects you can help provide more inf ormation on the safety of this medicine.
🌡️ 5. H ow to store AMMONAPS
Keep this medicine out of the sight and reach of childre n.
Do not use thi s medicine after the expiry date which is stated on the carton and the bottle label after “EXP”. The ex piry date refers to the last day of that month.
Do not stor e above 25°C.
Do not throw away any medicines via wast ewater or household wast e. Ask your pharm acist how to throw away medicines you no longer use. These measures will help protect the environment .
📦 6. C ontents of the pack and other information
What AMM ONAPS contains
- The active substance is sodium phenylbuty rate.
One gram of AMM ONAPS granules contains 940 mg of sodium phenylbutyrate.
- The other ingredients are calcium stearate and colloidal anhydrous s ilica.
What AMMONAPS looks like and contents o f the pack AMMONAPS granules are off -white.
The granules ar e packaged in plas tic bottles with c hild-resistant caps. Each bottle contains 2 66 g or 532 g of granules. Three spoons (one small white sp oon, one m edium siz ed yellow spoon and one large blue spoon) are included to measure your daily dose.
Marketing Authorisation Holder
Immed ica Pharma AB SE-113 63 Stockholm Sweden 33 Manufacturer PATHEON France – BOURGOIN JALLIEU 40 boulevard de Champaret BOURGOIN JALLIEU 38300 France This leaflet was last revise d in Detailed information on this m edicine is available on the Euro pean Medicines Agen cy web site: http://www.ema.europa.eu /.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Ammonaps (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/99/120).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.