Ucedane 200 mg dispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ucedane 200 mg dispersible tablets

carglumic acid

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

• Keep this leaflet as 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 they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ucedane is and what it is used for

2. What you need to know before taking Ucedane

3. How to take Ucedane

4. Possible side effects

5. How to store Ucedane

6. Contents of the pack and other information

1. What Ucedane is and what it is used for

Ucedane can help remove excessive plasma levels of ammonia (elevated blood ammonia levels). Ammonia is especially toxic to the brain and, in severe cases, may lead to reduced consciousness and coma.

Hyperammonemia may be due to:

• deficiency 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 life, so lifelong treatment is necessary.

• isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients affected by any of these disorders require treatment during episodes of hyperammonemia.

2. What you need to know before taking Ucedane

Do not take Ucedane:

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

• Do not take Ucedane during breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ucedane.

Treatment with Ucedane should be initiated under the supervision of a physician experienced in the management of metabolic disorders.

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

The dose must be individually adjusted in order to maintain normal plasma ammonia levels.

Your doctor may prescribe arginine supplements or recommend restriction of protein intake.

To monitor your disease and treatment, your doctor may periodically perform examinations of your liver, kidneys, heart, and blood.

Other medicines and Ucedane

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

Use of Ucedane with food and drink

Ucedane should be taken orally before main meals or food intake. The tablets should be dispersed in at least 5 to 10 ml of water and taken immediately. The resulting 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 are planning 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 carglumic acid has been shown to be present in the milk of lactating rats, with potential toxic effects on suckling offspring, breastfeeding must be avoided while taking Ucedane.

Driving and use of machinery

The effects of Ucedane 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; hence, it is essentially "sodium-free".

3. How to take Ucedane

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

If in doubt, consult your doctor or pharmacist again.

The 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 usual daily dose in the long term typically ranges between 10 mg and 100 mg per kg of body weight.

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

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

When the patient is in hyperammonemic coma, Ucedane is administered rapidly via a syringe through the feeding tube.

Inform your doctor if you have renal 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 missed individual dose.

If you stop taking Ucedane:

Do not stop taking Ucedane without informing your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

The following adverse 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 frequency not known (cannot be estimated from the available data).

• Common: increased sweating
• Uncommon: bradycardia (reduced heart rate), diarrhoea, fever, increased aminotransferases, vomiting
• Frequency not known: rash

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

Reporting of 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 leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the blister and the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

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 properly dispose of medicines and packaging you no longer need. 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 components are microcrystalline cellulose, anhydrous colloidal silica, sodium stearyl fumarate (see section 2 “Ucedane contains sodium”), mannitol, copovidone K28, crospovidone type B.

Nature and contents of the container

Ucedane dispersible tablets are elongated, white, biconvex tablets with three dividing notches on both sides and the imprint «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 presented in aluminum/aluminum blisters packed in cardboard boxes.

Pack sizes of 12 or 60 dispersible tablets.

Some pack sizes may not 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

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.eu游戏副本.