200 mg dispersible tablets 
Carglumic acid

Read all of this leaflet carefully before you start using this medicine.

  • Save this leaflet, you may need to read about it.
  • If you have any further questions, ask your doctor or pharmacist .
  • This medicine has been prescribed for you personally. You should not pass it on to others. It may harm them, even if they show symptoms similar to yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet you will find information about: 
1. WHAT CARBAGLU IS AND WHAT IT IS USED FOR 
2. BEFORE YOU TAKE CARBAGLU 
3. HOW TO TAKE CARBAGLU 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE CARBAGLU 
6. OTHER

1. WHAT CARBAGLU IS AND WHAT IT IS USED FOR

Carbaglu can help eliminate greatly elevated ammonia levels in the plasma(increased levels of ammonia in the blood). Ammonia is particularly toxic to the brain and can, in severe cases, lead to decreased levels of consciousness and coma. High ammonia levels (hyperammonemia) may be due to

  • deficiency of a specific liver enzyme, N-acetyl glutamate synthase. Patients with this rare disease are not able to eliminate nitrogen residues that are formed after consuming protein. The disease persists throughout the life of the affected patient and the need for this treatment is therefore lifelong.
  • isovaleric acidemia, methylmalonic acidemia, and propionic acidemia. Patients suffering from any of these diseases need treatment during the hyperammonemia crisis.

2. BEFORE YOU TAKE CARBAGLU

Do not take Carbaglu:

You must not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.

Do not use Carbaglu if you are breast-feeding.

Take special care with Carbaglu:

Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic diseases.

Your doctor will evaluate how you respond to treatment with carglumic acid before starting any long-term treatment.

Dose one should be adjusted individually to maintain normal ammonia plasma levels.

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

To monitor your condition and treatment, your doctor may need to examine you regularly for liver, kidneys, heart, and blood.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Use of Carbaglu with food and drink

Carbaglu should be taken by mouth before a meal or feeding.

The tablets should be dissolved in at least 5 to 10 ml of water and taken immediately. Suspension one has a slightly sour taste.

Pregnancy and breastfeeding

The effects of Carbaglu on pregnancy and the fetus are unknown. Ask your doctor if you are pregnant or planning to become pregnant.

The secretion of carglumic acid into breast milk has not been studied in women. However, as the presence of carglumic acid in the milk of lactating rats has been shown, with a risk of toxic effects on the fed pups, you should not breast-feed your baby if you are taking Carbaglu.

Driving and using machines

Effects on ability to drive and use machines are not known.

3. HOW TO TAKE CARBAGLA

Always take Carbaglu exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

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).

In the long term, the daily dose usually varies between 10 mg and 100 mg per kilogram body weight for patients who are deficient in N-acetyl glutamate synthase.

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

Carbaglu should ONLY be given by mouth or by gavage (with a syringe , if needed).

If the patient is in a hyperammonemia coma, Carbaglu is given by rapidly squeezing the dose one through a syringe through the tube inserted for nutrient delivery.

If you take more Carbaglu than you should

Consult your doctor or pharmacist.

If you forget to take Carbaglu

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

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, Carbaglu can cause side effects, although not everybody gets them.

The following adverse reactions have been reported as follows: very common (affects at least 1 in 10 patients), common (affects at least 1 in 100 patients), uncommon (affects at least 1 in 1,000 patients), rare (affects at least 1 patient) of 10,000 patients), very rare (occurs in at least 1 in 100,000 patients) and has been reported (occurs in an unknown number of users).

  • Common: increased sweating
  • Uncommon: bradycardia (decreased heart rate), diarrhea, fever, increased transaminases, and vomiting
  • Has been reported: rash

If any of the side effects gets serious, or 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. HOW TO STORE CARBAGLU

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tablet can.

Store in a refrigerator (2ºC-8ºC).

After opening the jar: Store in a cool place. Do not store above 30 ° C.

Close the package tightly. Moisture sensitive.

Write the date of opening on the tablet jar. Discard 3 months after opening the package.

6. FURTHER INFORMATION

Content declaration

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

What the medicine looks like and the contents of the pack

Carbaglu 200 mg tablet is an elongated tablet with four embossments on one side with three notches. Carbaglu is available in plastic packs of 5, 15, and 60 tablets that are closed with a childproof lid.

Marketing Authorisation Holder

Record Rare Diseases

Real Estate “Le Wilson”

70, Avenue du Général de Gaulle

F-92800 Puteaux

France

Tel: +33 1 4773 6458

Fax: +33 1 4900 1800

Manufacturer

Record Rare Diseases

Real Estate “Le Wilson”

70, Avenue du Général de Gaulle

F-92800 Puteaux

France

or

Record Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Belgique / België / BelgienRecordatiTel: +32 2 46101 36
BulgariaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France  Luxembourg / LuxemburgRecordatiTel: +32 2 46101 36Belgium / Belgium
Czech RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France HungaryRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58Franciaország
MaltaRecord Rare DiseasesTel: +33 1 47 73 64 58Franza
GermanyRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0 The NetherlandsRecordatiTel: +32 2 46101 36Belgium
EestiRecordati ABTel: + 46 8 545 80 230 Rootsi
GreeceRecordati Hellas:Ηλ: +30 210 6773822 AustriaRecord Rare DiseasesGermany GmbHTel: +49 731 140 554 0Germany
SpainRecordati Rare Diseases Spain SLUTel: + 34 91 659 28 90 PolandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
FranceRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58 PortugalJaba Recordati SATel: +351 21 432 95 00
CroatiaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58French RomaniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
IrelandRecord Rare DiseasesTel: +44 1491 414333United Kingdom SloveniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
Slovak RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
ItalyRecordati Rare Diseases Italy SrlTel: +39 02 487 87 173
ΚύπροςRecord Rare Diseases:Ηλ: +33 1 47 73 64 58.Αλλία
United KingdomRecord Rare Diseases(UK) Ltd.Tel: +44 (0) 1491 414333

Muhammad Nadeem

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