Leaflet:Information for the user

Carbaglu 200 mg dispersible tablets

carbamazepine

Read this leaflet carefully before you start taking the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Carbaglu and what it is used for

2.What you need to know before starting to take Carbaglu

3.How to take Carbaglu

4.Possible side effects

5Storage of Carbaglu

6.Contents of the pack and additional information

Carbaglu can help eliminate excessive plasma levels of ammonia (elevated ammonia in the blood). Ammonia is especially toxic to the brain and, in severe cases, can cause decreased levels of consciousness and coma.

The hyperammonemia may be due to

• the lack of a specific liver enzyme,N-acetylglutamate synthase. Patients with this rare disorder are unable to eliminate nitrogenous waste, which increases after consuming protein.

This disorder persists throughout the patient's lifetime, so this treatment is necessary for life.

• isovaleric acidemia, methylmalonic acidemia, or propionic acidemia.Patients suffering from one of these disorders require treatment during episodes of hyperammonemia.

Do not take Carbaglu:

Do not take Carbaglu if you are allergic (hypersensitive) to valine or to any of the other components of Carbaglu (listed in section 6).

Do not take Carbaglu during breastfeeding.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Carbaglu.

The treatment with Carbaglu should be initiated under the supervision of a doctor with experience in the treatment of metabolic disorders.

Your doctor will evaluate your individual response to valine before initiating any long-term treatment.

Your dose should be adjusted individually to maintain normal plasma ammonia levels.

Your doctor may prescribe arginine supplements or limit your protein intake.

To monitor your disease and treatment, your doctor may examine your liver, kidneys, heart, and blood periodically.

Other medicines and Carbaglu:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Use of Carbaglu with food and drinks:

Carbaglu should be taken orally before main meals or food intake.

The tablets should be dispersed in a minimum of 5 to 10 ml of water and should be 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 or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines:

The effects on the ability to drive and operate machines are unknown.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual dose:

The initial daily dose is usually 100mg per kg of body weight, up to a maximum of 250mg per kg of body weight (for example, if you weigh10kg, you shouldtake1gper day, or 5 tablets). For patients with N-acetylglutamate synthase deficiency, the usual daily dose over the long term typically ranges from 10mg to 100mg per kg of body weight.

Your doctor will determine the suitable dose for you to maintain normal levels of ammonia in your blood.

Carbaglu should be administered ONLY orally or through a nasogastric tube (using a syringe, if necessary).

When the patient is in hyperammonemic coma, Carbaglu is administered via rapid bolus with a syringe through the feeding tube used.

Inform your doctor if you experience renal deterioration. Your daily dose should be reduced.

If you take more Carbaglu than you should

Consult your doctor or pharmacist.

If you forgotto take Carbaglu

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Carbaglu:

Do not stop taking Carbaglu without informing your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (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 unknown frequency (cannot be estimated from available data).

• Frequent:Increased sweating
• Infrequent:Bradycardia (decreased heart rate), diarrhea, fever, increased aminotransferases, vomiting.
• Unknown frequency:Urticaria

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Report any adverse effects to your doctor or pharmacist.

Reporting 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 prospectus.You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging of the tablets after CAD.

The expiration date is the last day of the month indicated.

Store in the refrigerator (between2°Cand8°C)

After opening the tablet packaging for the first time: do not refrigerate. Do not store at a temperature above 30° C.

Keep the packaging perfectly closed to protect it from moisture.

Write the opening date on the tablet packaging. Dispose of it 3 months after the first opening.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the medications you no longer need. This way, you will help protect the environment.

Carbaglu Composition

• The active ingredient is carglumic acid. Each tablet contains 200mg of carglumic acid.
• The other components are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, anhydrous colloidal silica, sodium stearoylfumarate.

Appearance of the product and contents of the pack

Carbaglu 200 mg tablets are a bar-shaped tablet, with 4 divisions on one side with 3 breaking marks. Carbaglu is presented in plastic containers of 5, 15 and 60 tablets that are closed with a child-resistant cap.

Marketing Authorization Holder

Recordati Rare Diseases

Immeuble “Le Wilson”

70 avenue du Général de Gaulle

F-92800 Puteaux

France

Tel.: +33 1 4773 6458

Fax: + 33 1 4900 1800

Responsible for manufacturing

Recordati Rare Diseases

Immeuble “Le Wilson”

70, 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 more information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.