Carbaglu
Italy
Table of Contents
Package leaflet: Information for the user
Carbaglu 200 mg dispersible tablets
carglumic acid
Please 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Contents of this leaflet
- What Carbaglu is and what it is used for
- What you need to know before taking Carbaglu
- How to take Carbaglu
- Possible side effects
- How to store Carbaglu
- Contents of the pack and other information
1. What Carbaglu is and what it is used for
Carbaglu can help remove excessive levels of ammonia in the plasma (elevated blood ammonia levels). Ammonia is particularly toxic to the brain and, in severe cases, may lead to reduced levels of consciousness and coma.
Hyperammonemia (elevated blood ammonia levels) may be caused by:
- deficiency of a specific liver enzyme, N-acetylglutamate synthase. Patients affected by this rare disorder are unable to eliminate nitrogen-containing metabolic waste products formed after protein intake. This condition persists throughout the patient's entire life and therefore requires lifelong treatment.
- isovaleric, methylmalonic, or propionic acidemia. Patients affected by one of these disorders require treatment during episodes of hyperammonemia.
2. What you need to know before taking Carbaglu
Do not take Carbaglu
- if you are allergic to carglumic acid or to any of the other ingredients of this medicine (listed in section 6). Do not take Carbaglu during breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Carbaglu.
Treatment with Carbaglu must be initiated under the supervision of a physician experienced in the management of metabolic disorders.
Your doctor will need to assess your individual response to carglumic acid before starting long-term treatment.
The dose must be individually adjusted to maintain normal plasma ammonia levels.
Your doctor may prescribe additional arginine or restrict protein intake.
To monitor the disorder and response to treatment, your doctor may periodically perform liver, kidney, and heart function tests, as well as blood analyses.
Other medicines and Carbaglu
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Carbaglu with food and drink
Carbaglu should be taken orally before meals or food intake.
The tablets must be dispersed in at least 5–10 ml of water and taken immediately. The suspension has a slightly acidic taste.
Pregnancy and breastfeeding
The effects of Carbaglu on pregnancy and the fetus are unknown.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Excretion of carglumic acid in human breast milk has not been studied. However, since carglumic acid has been shown to be present in the milk of lactating rats, with potential toxic effects on breastfed infants, you must not breastfeed while taking Carbaglu.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.
3. How to take Carbaglu
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Normal dosage:
The usual initial daily dose is 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if the patient weighs 10 kg, the daily dose is 1 g, i.e. 5 tablets).
For patients with long-term N-acetylglutamate synthase deficiency, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Your doctor will determine the appropriate dose to maintain normal blood ammonia levels.
Carbaglu must be administered ORALLY ONLY or via a feeding tube inserted into the stomach (using a syringe if necessary).
If the patient is in hyperammonemic coma, Carbaglu should be administered rapidly by syringe through the feeding tube used for nutrition.
Inform your doctor if you have impaired kidney function, as in this case the daily dose should be reduced.
If you take more Carbaglu than you should
Contact your doctor or pharmacist for advice.
If you forget to take Carbaglu
Do not take a double dose to make up for the missed dose.
If you stop taking Carbaglu
Do not stop taking Carbaglu without informing your doctor.
If you have any questions about the use of this medicine, consult 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 have been reported with the following frequencies: 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 available data).
- Common: increased sweating
- Uncommon: bradycardia (reduced heart rate), diarrhoea, fever, increased transaminases (liver enzymes), vomiting
- Not known: skin rash
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
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 stated on the tablet container after "Exp".
The expiry date refers to the last day of that month.
Store in the refrigerator (2°C – 8°C).
After opening the tablet container: do not refrigerate. Do not store at temperatures above 30°C.
Keep the container tightly closed in order to protect the product from moisture.
Write the date of opening on the tablet container. Discard the product 3 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Carbaglu contains
- The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
- The other components are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.
Description of the appearance of Carbaglu and package contents
Carbaglu 200 mg tablets are elongated-shaped tablets with four dots imprinted and three score lines on one side.
Carbaglu is supplied in plastic containers containing 5, 15 or 60 tablets with child-resistant closure.
Marketing Authorization Holder
Recordati Rare Diseases
Tour Hekla
52 avenue du Général de Gaulle
F- 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
F- 92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F- 92000 Nanterre
France
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.
Belgique/België/Belgien Lietuva
Recordati Recordati AB.
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България
Recordati Rare Diseases
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Recordati
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Recordati AB. Recordati Rare Diseases
Tlf: +46 8 545 80 230 Tel: +33 1 47 73 64 58
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Recordati Rare Diseases Germany GmbH Recordati
Tel: +49 731 140 554 0 Tel: +32 2 46101 36
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Zviedrija
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.