CARBAGLU 200 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet:Information for the User

Carbaglu 200 mg dispersible tablets

carglumic acid

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.

Contents of the pack and other information:

1. What is Carbaglu and what is it used for
2. What you need to know before you take Carbaglu
3. How to take Carbaglu
4. Possible side effects

5 Storage of Carbaglu

1. Contents of the pack and further information

1. What is Carbaglu and what is it used for

Carbaglu can help eliminate excessive plasma levels of ammonia (high blood ammonia levels). Ammonia is particularly toxic to the brain and can cause, in severe cases, a decrease in the level of consciousness and coma.

Hyperammonemia can be due to

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

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

• isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients suffering from one of these disorders need treatment during the hyperammonemia crisis.

2. What you need to know before you take Carbaglu

DonottakeCarbaglu:

Do not take Carbaglu if you are allergic (hypersensitive) 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

Consult your doctor or pharmacist before starting to take Carbaglu.

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

Your doctor will assess your individual response to carglumic acid before starting any long-term treatment.

The dose should be adjusted individually to maintain normal blood ammonia levels.

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

In order to monitor your disease and treatment, your doctor may periodically examine your liver, kidneys, heart, and blood.

Other medicines andCarbaglu

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Using 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 taken immediately. The suspension has a slightly acidic taste.

Pregnancyand breast-feeding

The effects of Carbaglu on pregnancy and the fetus are unknown.

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.

Driving and using machines

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

3. How to take Carbaglu

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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 weigh 10 kg, you should take 1 g per day, or 5 tablets). For patients with N-acetylglutamate synthase deficiency, the long-term daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.

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

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

When the patient is in hyperammonemic coma, Carbaglu is administered by rapid push with a syringe through the tube used for feeding.

Tell your doctor if you have kidney impairment. Your daily dose should be reduced.

If you take more Carbaglu than you should

Consult your doctor or pharmacist.

If you forgetto take Carbaglu

Do not take a double dose to make up for forgotten doses.

If you stop taking Carbaglu:

Do not stop taking Carbaglu without informing your doctor.

If you have any further questions on the use of this 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 have been reported: 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 (cannot be estimated from the available data).

• Common:increased sweating
• Uncommon:bradycardia (decreased heart rate), diarrhea, fever, increased aminotransferases, vomiting.
• Not known:rash

If you notice any side effects not listed in this 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 medicine.

5. Storage of 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 carton after EXP.

The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

After first opening of the tablet container: do not refrigerate. Do not store above 30°C.

Keep the container tightly closed to protect from moisture.

Write the date of opening on the tablet container. Discard 3 months after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Carbaglu

• The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
• The other ingredients are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.

Appearance and packaging

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

Marketing Authorisation 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

Manufacturer

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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other web sites about rare diseases and treatments.