UCEDANE 200 mg Dispersible Tablets
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How to use UCEDANE 200 mg DISPERSIBLE TABLETS
Contents of the leaflet
- Introduction
- What is Ucedane and what is it used for
- What you need to know before you take Ucedane
- How to take Ucedane
- Possible side effects
- Storage of Ucedane
- Contents of the pack and other information
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:
- What is Ucedane and what is it used for
- What you need to know before you take Ucedane
- How to take Ucedane
- Possible side effects
- Storage of Ucedane
- 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.
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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.
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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.
Belgium/Belgique/Belgien | Lithuania | |
Lucane Pharma | FrostPharma AB | |
Phone: +33 153 868 750 | Phone: +46 824 36 60 | |
Bulgaria | Luxembourg/Luxemburg | ||
Lucane Pharma | Lucane Pharma | ||
Phone: +33 153 868 750 | Phone: +33 153 868 750 | ||
Czech Republic | Hungary | |
Lucane Pharma | Lucane Pharma | |
Phone: +33 153 868 750 | Phone: +33 153 868 750 | |
Denmark | Malta | |
FrostPharma AB | Lucane Pharma | |
Phone: +46 824 36 60 | Phone: +33 153 868 750 | |
Germany | Netherlands |
Lucane Pharma | Eurocept International BV |
Phone: +33 153 868 750 | Phone: +31 35 528 39 57 |
Estonia | Norway | ||||||
FrostPharma AB | FrostPharma AB | ||||||
Phone: +46 824 36 60 | Phone: +46 824 36 60 | ||||||
Greece Lucane Pharma Phone: +33 153 868 750 | Austria Lucane Pharma Phone: +33 153 868 750 | ||||||
Spain | Poland | ||||||
Lucane Pharma | Lucane Pharma | ||||||
Phone: +33 153 868 750 | Phone: +33 153 868 750 | ||||||
France | Portugal | ||||||
Lucane Pharma | Lucane Pharma | ||||||
Phone: +33 153 868 750 | Phone: +33 153 868 750 | ||||||
Croatia | Romania | ||||||
Lucane Pharma | Lucane Pharma | ||||||
Phone: +33 153 868 750 | Phone: +33 153 868 750 | ||||||
Ireland | Slovenia | ||||||
Lucane Pharma | Lucane Pharma | ||||||
Phone: +33 153 868 750 | Phone: +33 153 868 750 | ||||||
Iceland | Slovakia | ||||||
Lucane Pharma | Lucane Pharma | ||||||
Phone: +46 824 36 60 | Phone: +33 153 868 750 | ||||||
Italy | Finland | ||||||
Lucane Pharma | FrostPharma AB | ||||||
Phone: +33 153 868 750 | Phone: +46 824 36 60 | ||||||
Cyprus | Sweden | ||||||
Lucane Pharma | FrostPharma AB | ||||||
Phone: +33 153 868 750 | Phone: +46 824 36 60 | ||||||
Latvia | |||||||
FrostPharma AB | |||||||
Phone: +46 824 36 60 | |||||||
