Ucedane
Italy
Table of Contents
Patient Information Leaflet: Instructions for the User
Ucedane 200 mg dispersible tablets
Carglumic acid
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Ucedane is and what it is used for
- What you need to know before taking Ucedane
- How to take Ucedane
- Possible side effects
- How to store Ucedane
- Contents of the pack and other information
1. What Ucedane is and what it is used for
Ucedane can help remove excessive levels of ammonia in the plasma (elevated blood ammonia levels). Ammonia is particularly toxic to the brain and, in severe cases, may lead to decreased levels of consciousness and coma.
Hyperammonemia (elevated blood ammonia levels) may be caused by:
- deficiency of a specific liver enzyme, N-acetylglutamate synthase. Patients affected by this rare condition are unable to eliminate nitrogenous metabolic waste products formed after protein intake. This disorder persists throughout the patient's life and therefore requires lifelong treatment with this medicine.
- isovaleric, methylmalonic, or propionic acidemia. Patients affected by one of these forms of the disease require treatment during episodes of hyperammonemia.
2. What you need to know before taking Ucedane
Do not take Ucedane
- If you are allergic to carglumic acid or to any of the other ingredients of Ucedane (listed in section 6). Do not take Ucedane during breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ucedane.
Treatment with Ucedane must be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Your doctor will need to assess your individual response to carglumic acid before starting long-term treatment.
The dose must be individually adjusted to maintain normal plasma ammonia levels.
Your doctor may prescribe additional arginine or restrict protein intake.
To monitor the disorder and response to treatment, your doctor may periodically perform tests to assess liver, kidney, and heart function, as well as blood analyses.
Other medicines and Ucedane
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Ucedane with food and drink
Ucedane should be taken orally before meals or food intake.
The tablets must be dispersed in at least 5–10 ml of water and taken immediately.
The suspension has a slightly sour taste.
Pregnancy and breastfeeding
The effects of Ucedane on pregnancy and the unborn child are unknown.
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Excretion of carglumic acid in human breast milk has not been studied. However, since carglumic acid has been shown to be excreted in the milk of lactating rats, with potential toxic effects on breastfed infants, you must not breastfeed while taking Ucedane.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Ucedane contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum daily dose, i.e. it is essentially "sodium-free".
3. How to take Ucedane
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Normal dosage:
The usual daily dose is normally 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, i.e. 5 tablets).
For patients with long-term N-acetylglutamate synthase deficiency, the daily dose normally ranges from 10 mg to 100 mg per kilogram of body weight.
Your doctor will determine the appropriate dose to maintain normal blood ammonia levels.
Ucedane must be administered ORALLY ONLY or through a feeding tube inserted into the stomach (using a syringe if necessary).
If the patient is in hyperammonemic coma, Ucedane should be administered rapidly via syringe through the feeding tube.
Inform your doctor if you have renal impairment, as in this case the daily dose should be reduced.
If you take more Ucedane than you should
Consult your doctor or pharmacist for advice.
If you forget to take Ucedane
Do not take a double dose to make up for the missed dose.
If you stop taking Ucedane
Do not stop taking Ucedane without informing your doctor.
If you have any questions about how to use this medicine, consult 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 with the following frequency: 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 (frequency cannot be estimated from the available data).
- Common: increased sweating
- Uncommon: bradycardia (reduced heart rate), diarrhoea, fever, increased transaminases (liver enzymes), vomiting
- Not known: rash
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Ucedane contains
- 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.
Description of the appearance of Ucedane and contents of the pack
Ucedane dispersible tablets are white, oval-shaped, biconvex tablets with three notches on both sides and the imprint “L/L/L/L” printed 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 supplied in aluminum/aluminum blisters packed in cardboard boxes. The pack contains 12 or 60 dispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
The Netherlands
Manufacturer
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Lucane Pharma FrostPharma AB
Tel/Tél: +33 153 868 750 Tel: +46 824 36 60
[email protected] [email protected]
България Luxembourg/Luxemburg
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tél/Tel: +33 153 868 750
[email protected] [email protected]
Česká republika Magyarország
Lucane Pharma Lucane Pharma
Tel/Tél: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
Danmark Malta
FrostPharma AB Lucane Pharma
Tlf: +46 824 36 60 Tel: +33 153 868 750
[email protected] [email protected]
Deutschland Nederland
Lucane Pharma Eurocept International BV
Tel: +33 153 868 750 Tel: +31 35 528 39 57
[email protected] [email protected]
Eesti Norge
FrostPharma AB FrostPharma AB
Tel: +46 824 36 60 Tlf: +46 824 36 60
[email protected] [email protected]
Ελλάδα Österreich
Lucane Pharma Lucane Pharma
Τηλ: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
España Polska
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
France Portugal
Lucane Pharma Lucane Pharma
Tél: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
Hrvatska România
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
Ireland Slovenija
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]
Ísland Slovenská republika
FrostPharma AB Lucane Pharma
Sími: +46 824 36 60 Tel: +33 153 868 750
[email protected] [email protected]
Italia Suomi/Finland
Lucane Pharma FrostPharma AB
Tel: +33 153 868 750 Puh/Tel: +46 824 36 60
[email protected] [email protected]
Κύπρος Sverige
Lucane Pharma FrostPharma AB
Tel: +33 153 868 750 Tel: +46 824 36 60
[email protected] [email protected]
Latvija
FrostPharma AB
Tel: +46 824 36 60
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.