Aqneursa – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Aqneursa, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. 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 Aqneursa is and what it is used for
Aqneursa contains the active substance l evacetylleucine, a modified amino acid.
Aqneursa is used in adults and children aged 6 years and older and weighing at least 20 kg to treat neurological symptoms of Niemann -Pick type C disease
- in combination w ith miglustat: another Niemann -Pick type C disease medicine, or
- on its own if miglustat is not tolerated.
In patients with this hereditary disease, specific changes in certain genes disrupt the function of lysosomes (small sacs inside the body’s cells that digest large molecules, such as fats). Th e disruption causes increased amount of lipids, cholesterol and other fats stored in cells, which the body cannot break down. This leads to progressive loss of nerve cells with symptoms that includ e movement coordination problems, slurred speech, difficulty swallowing and uncontrollable shaking.
Levacetylleucine improv es function of lysosomes , thereby reduc ing the amount of fats and cholesterol in cells .
⚠️ 2. What you need to know before you take Aqneursa
Do not take Aqneursa
- if you are allergic to levacetylleucine or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
This medicine may cause allergic reaction s, including sudden and severe allergic reactions. Stop taking Aqneursa and immediately talk to a doctor if you have allergic reaction s after taking Aqneursa.
Symptoms of include:
- breathing difficulties
- swelling of the face, lips, throat or tongue
- itchy rash on one part or the whole body 24 Other medicines and Aqneursa Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Aqneursa may affect how other medicines work or may make their side effects more likely. In particular, tell your doctor especially if you take any of the following medicines :
- digoxin: to treat heart weakness and irregular heartbeat
- dabigatran : to inhibit blood clotting
- loperamide : to treat diarrhoea
- irinotecan , doxorubicin, vinblastine, paclitaxel, seliciclib: to treat cancer
- fexofenadine : to treat symptoms of an allergy
- quinidine : to treat heart rhythm disorders
- talinolol: to lower blood pressure
- sulfasalazine: to treat severe bowel and rheumatic joint inflammation
- rosuvastatin : to lower elevated cholesterol levels Other medicines may affect how Aqneursa works. In particular, tell your doctor if you are taking the following medicine s:
- N-acetyl -DL-leucine, N-acetyl -D-leucine: to treat acute vertigo Children and adolescents Aqneursa is not recommended for children aged less than 6 years or weighing less than 20 kg.
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Pregnan cy Aqneursa is not recommended during pregnancy.
- Women of childbearing potential Women who are able to have a baby are recommended to use effective contraception during treatment with Aqneursa.
- Breast-feeding It is not known if levacetylleucine passes into breast milk. This medicine may harm your nursing baby.
If you are breast -feeding, you and your doctor will need to decide whether to continue breast – feeding or Aqneursa therapy . This will take into account the benefits of breast -feeding for the baby and the benefits of Aqneursa for the nursing mother .
Driving and using machines
Aqneursa has no or negligible influence on the ability to drive and use machines.
Aqneursa contains isomalt and propylene glycol
Each sachet contains 642.2 mg isomalt. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicin e contains 0.153 mg propylene glycol in each sachet.
💊 3. H ow to take Aqneursa
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
25 The recommended dose is based on patient’s body weight in kilo grams and taken as follows:
Patient’s b ody weight Morning dose Afternoon dose Evening dose 20 to 24 kg 1 sachet No dose 1 sachet 25 to 34 kg 1 sachet 1 sachet 1 sachet 35 kg or more 2 sachets 1 sachet 1 sachet Method of use Avoid food and drink 30 minutes before and 2 hours after administration.
- Oral use with liquid
- Pour the content of one sachet into 40 mL (3 tablespoons) of water. Stir until fully mixed .
Do not use hot liquid.
- Drink all of the mixture immediately after preparation (within 30 minutes).
- If the medicine is not taken within 30 minutes of preparation, stir it again before drinking.
- A small amount of mixture may remain after drinking; no additional rinsing should be done in this case.
- Repeat all steps if a second sachet is required.
- Use via gastrostomy tube Aqneursa may also be given via a tube through the abdomen into the stomach (French size 18 or larger) :
- Stop the feeding via tube (if on continuous feeding).
- Draw up at least 20 mL of water into a catheter tip syringe and flush the tube to prevent interactions between feed and Aqneursa.
- Empty the content of one sachet into 40 mL of water.
- Mix until all granules are evenly distributed in the liquid.
- Draw up the entire mixture into the catheter tip syringe.
- Administer the mixture into the gastrostomy tube immediately (within 30 minutes) by applying steady pressure. Do not keep the mixture for later use.
- Repeat the steps listed above starting with emptying the sachet if a second sachet is required.
- Refill the catheter tip syringe with at least 20 mL of water and flush the gastrostomy tube.
- Restart the feed when appropriate.
If you take more Aqneursa than you should
Inform your doctor or pharmacist if this occurs.
Symptomatic treatment is recommended.
If you forget to take Aqneursa
Do not take a double dose to make up for a forgotten dose . Continue the next dose as scheduled.
If you stop taking Aqneursa
Do not stop treatment without approval of your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist .
❗ 4. P ossible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
26 Side effects may occur with following frequency:
Common , may affect up to 1 in 10 people
- wind (flatulence)
Reporting of side effects
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.
🌡️ 5. H ow to store Aqneursa
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 sachet, carton and/or label after EXP . The expiry date refers to the last day of that month.
This medicin e does not require any special storage conditions.
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 wil l help protect the environment.
📦 6. Contents of the pack and other information
What Aqneursa contains
- The active substance is levacetylleucine. One single-dose sachet contains 1 g levacetylleucine.
- The other excipients are isomalt (E953) , hypromellose , strawberry flavour ( contains propylene
glycol (E1520)) . See section 2 “Aqneursa contains isomalt and propylene glycol”.
What Aqneursa looks like and contents of the pack
Aqneursa granules for oral suspension are white to off -white, strawberry -flavoured granules.
Aqneursa is supplied in single -dose paper -backed aluminium/polyethylene sachets and packed in a carton.
Pack sizes:
- 28 single -dose sachets
- Multipack containing 112 (4 packs of 28) single -dose sachets Not all pack sizes may be marketed.
Marketing Authorisation Holder
IntraBio Ireland Ltd 10 Earlsfort Terrace Dublin 2 Ireland
Manufacturer
Patheon France 40 Boulevard De Champaret 38300 Bourgoin-Jallieu France
This leaflet was last revised i n
Detailed information on this medicine is available on the European Medicines Agency web site: https://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 Aqneursa (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1928).
⚠️ 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.