UCEDANE 200 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Ucedane 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 Ucedane and what is it used for

1. What you need to know before you take Ucedane

1. How to take Ucedane

1. Possible side effects

1. Storage of Ucedane

1. Contents of the pack and other information

1. What is Ucedane and what is it used for

Ucedane can help eliminate excessive plasma levels of ammonia (high blood ammonia levels). Ammonia is especially 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 who suffer from one of these disorders need treatment during the hyperammonemia crisis.

2. What you need to know before you take Ucedane

Do not take Ucedane:

• Do not take Ucedane if you are allergic to carglumic acid or any of the other ingredients of Ucedane (listed in section 6).

• Do not take Ucedane during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting Ucedane.

Treatment with Ucedane should be initiated under the supervision of a doctor with experience 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 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 and Ucedane

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Using Ucedane with food and drinks

Ucedane 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.

Pregnancy and breastfeeding

The effects of Ucedane on pregnancy and the fetus are unknown. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not known whether carglumic acid passes into human breast milk. However, since it has been shown that carglumic acid is present in the milk of lactating rats, with possible toxic effects on the suckling pups, you should not breastfeed your child if you take Ucedane.

Driving and using machines

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

Ucedane contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per maximum daily dose; this is essentially 'sodium-free'.

3. How to take Ucedane

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Usual dose:

The initial daily dose is usually 100 mg per kg of body weight, up to a maximum of 250 mg per kg 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 kg of body weight.

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

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

When the patient is in hyperammonemic coma, Ucedane 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 Ucedane than you should

If you have any doubts, consult your doctor or pharmacist

If you forget to take Ucedane

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

If you stop taking Ucedane:

Do not stop taking Ucedane without informing your doctor.

If you have any other questions about the use of this medicine, 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 think any of the side effects you are experiencing are 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 experience 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 Ucedane

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 blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

Composition of Ucedane

• The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium stearyl fumarate (see section 2 "Ucedane contains sodium"), mannitol, copovidone K28, crospovidone type B.

Appearance and packaging of the product

Ucedane dispersible tablets are elongated, white, and biconvex, with three dividing scores on both sides and the inscription "L/L/L/L" on one side.

The approximate dimensions of the tablets are 17 mm in length and 6 mm in width.

The tablet can be divided into four equal doses.

The tablets are packaged in aluminum/aluminum blisters in a cardboard box.

Package sizes of 12 or 60 dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

Manufacturer

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

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

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

• Country of registration
  Spain
• Active substance
  carglumic acid
• Prescription required
  Yes
• Manufacturer
  Eurocept International B.V.
• Composition
  MANITOL SD 200 (E 421) (144.50 mg mg), FUMARATO DE ESTEARILO Y SODIO (5 mg mg)
• This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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