Carbaglu – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Carbaglu, 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.
What is i n this leaflet :
1. What Carbaglu is and what it is used for 2. What you need to know before you take Carb aglu 3. How to take Carbaglu 4. Possible side effects 5 How to store Carbaglu 6. Contents of the pack and other information
ℹ️ 1. What Carbaglu is and what it is used for
Carbaglu can help eliminating excessive ammonia plasma levels (elevated ammonia level in the blood) . Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Hyperammonaemia may be due to
- the lack of a specific liver enzyme N – acetylglutamate synthase. Patients with this rare di sorder are not able to eliminate nitrogen waste, which b uilds up after eating protein.
This disorder persist s during the entire life of the affected patient and therefore the need for this treatment is lifelong.
- isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia . Patients suffering from one of the se disorder s need treatment during the hyperammonaemia crisis.
⚠️ 2. What you need to know before you take Carbaglu
Do not take Carbaglu
if you are allergic to carglumic acid or any of the other ingredients of Carbaglu (listed in section 6) .
Do not take Carbaglu during breast -feeding
Warnings and precautions
Talk to your doctor or pharmacist before taking Carbaglu. Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Your doctor will evaluate your individual responsiveness to carglumic acid before initiating any long term treatment.
The dose should be individually adjusted in order to maintain normal ammonia plasma le vels.
Your doctor may prescribe supplemental arginine or restrict your protein intake.
In order to follow -up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis.
Other medicin es and Carbaglu Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines. Carbaglu with food and drink Carbaglu must be taken orally before meals or feedings.
The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately. The suspension has a slightly acidic taste.
Pregnancy and Breast -feeding The effects of Carbaglu on pregnancy and the unborn child are not known. 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.
The excretion of carglumic acid into breast milk has not been studied in women. Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you should not breast feed your baby if you are taking Carbaglu.
Driving and using machines
Effects on the ability to drive and use machines are not known.
💊 3. How to take Carbaglu
Always take this medicine exactly as your doctor has told you. C heck with your doctor or pharmacist if you are not sure .
The usual dose:
The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight ( for example, if you weight 10kg, you should take 1g per day, or 5 tablets), For patients suffering from N -acetylglutamate synthase deficiency, in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight. Your doctor w ill determine the dose suitable to you in order to maintain normal ammonia levels in your blood. Carbaglu should ONLY be administered by mouth or via a feeding tube into the stomach (using a syringe, if necessary).
When the patient is in hyperammonaemic coma, Carbaglu is administered by fast push through a syringe via the tube set up and used to feed you.
Tell your doctor in case you are suffering from renal impairement. Your daily dose should be reduced.
If you take more Carbaglu than you should
Ask yo ur doctor or pharmacist for advice.
If you forget to take Carbaglu
Do not take a double dose to make up for forgotten doses.
If you stop taking Carbaglu
Do not stop Carbaglu without informing your doctor. If you have any further questions on the use of t his product, ask your doctor or pharmacist.
❗ 4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them .
The following side effects were reported as follows: very common ( may affect more than 1 in 10 people ), common ( may affect up to 1 in 10 people ), uncommon ( may affect up to 1 in 100 people ), rare ( may affect up to 1 in 1,000 people ), very rare (may affect up to 1 in 10,000 people ) and not known (frequency cannot be estimated from the availab le data).
- Common: increased sweating
- Uncommon : bradycardia (decreased frequency of the heart), diarrhoea, fever, increased transaminases, vomiting
- Not known: rash If any of the side effects gets serious, or if you notice any side effects not listed in th is leaflet, please tell your doctor or pharmacist.
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 medicin e.
🌡️ 5. How to store Carbaglu
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 tablet container after EXP.
The expiry date refers to the last day of that month .
Store in a r efrigerator (2 °C – 8° C).
After first opening of the container: do not refrigerate, do not store above 30° C.
Keep the container tightly closed in order to protect from moisture.
Write the date of opening on the tablet container. Discard 3 months after firs t opening.
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 .
📦 6. Contents of the pack and other information
What Carbaglu contains
- The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
- The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose, croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate.
What Carbaglu looks like and contents of the pack
Carb aglu 200mg tablet is a bar -shaped tablet, with 4 punches on one side with 3 break -mark sides.
Carbaglu is presented in a plastic container of 5, 15 and 60 t ablets which is closed with a child resistant cap.
23 Marketing Authorisation Holder Recordati Rare Diseases Tour Hekla 52 avenue du Général de Gaulle 92800 Puteaux France Tel: + 33 1 4773 6458 Fax: + 33 1 4900 1800
Manufacturer
Recordati Rare Diseases Tour Hekla 52 avenue du Général de Gaulle 92800 Puteaux France or Recordati Rare Diseases Eco River Parc 30, rue des Peupliers 92000 Nanterre France For any information about this medicine , please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgi en Recordati Tél/Tel: +32 2 46101 36 Lietuva Recordati AB.
Tel: + 46 8 545 80 230 Švedija България Recordati Rare Diseases Teл.: +33 (0)1 47 73 64 58 Франция Luxembourg/Luxemburg Recordati Tél/Tel: +32 2 46101 36 Belgique/Belgien Česká republika Reco rdati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francie Magyarország Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franciaország Danmark Recordati AB.
Tlf : +46 8 545 80 230 Sverige Malta Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Nederland Recordati Tel: +32 2 46101 36 België Eesti Recordati AB.
Tel: + 46 8 545 80 230 Rootsi Norge Recordati AB.
Tlf : +46 8 545 80 230 Sverige Ελλάδα Recordati Hellas Τηλ: +30 210 6773822 Österreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland España Recordati Rare Diseases Spain S.L. U.
Tel: + 34 91 659 28 90 Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francja France Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Portugal Recordati Rare Diseases SARL Tel: +351 21 432 95 00 Hrvatska Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francuska România Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franţa Ireland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France Slovenija Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francija Ísland Recordati AB.
Simi :+46 8 545 80 230 Svíþjóð Slovenská republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francúzsko Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173 Suomi/Finland Recordati AB.
Puh/Tel : +46 8 545 80 230 Sverige Κύπρος Recordati Rare Diseases Τηλ : +33 1 47 73 64 58 Γαλλία Sverige Recordati AB.
Tel : +46 8 545 80 230 Latvija Recordati AB.
Tel: + 46 8 545 80 230 Zviedrija
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.em a.europa.eu. There are also links to other websites about rare diseases and treatments.
📄 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 Carbaglu (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/02/246).
⚠️ 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.