Leaflet: information for the user

Ucedane 200 mg dispersible tablets

calcium gluconate

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Ucedane

1. How to take Ucedane

1. Possible side effects

1. Storage of Ucedane

1. Contents of the pack and additional information

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

The condition of high ammonia levels in the blood may be due to

• the lack of a specific liver enzyme, N-acetylglutamate synthase. Patients with this rare disorder are unable to eliminate nitrogen waste products, which increase after consuming protein.

This disorder persists throughout the patient's lifetime, so this treatment is necessary for life.

• isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients suffering from one of these disorders require treatment during episodes of high ammonia levels.

Do not take Ucedane:

• Do not take Ucedane if you are allergic to calcium gluconate or to any of the other components of Ucedane (listed in section 6).

• Do not take Ucedane during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ucedane.

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

Your doctor will evaluate your individual response to calcium gluconate before initiating any long-term treatment.

Your dose should be adjusted individually to maintain normal plasma ammonia levels.

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

To monitor your disease and treatment, your doctor may periodically examine your liver, kidneys, heart, and blood.

Other medicines and Ucedane

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Use of 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 should be 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Calcium gluconate has not been studied in human breast milk. However, since it has been shown that calcium gluconate is present in the milk of lactating rats, with possible toxic effects on suckling offspring, do not breastfeed your child if you take Ucedane.

Driving and operating machines

The effects on driving and operating 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».

Follow exactly the administration instructions for this medication as indicated 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 usual daily dose over the long term typically ranges from 10 mg to 100 mg per kg of body weight.

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

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

When the patient is in hyperammonemic coma, Ucedane is administered by rapid bolus with a syringe through the feeding tube used.

Inform your doctor if you experience renal deterioration. 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 forgot to take Ucedane

Do not take a double dose to compensate for the missed individual dose.

If you interrupt treatment with Ucedane:

Do not stop taking Ucedane without informing your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (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 unknown frequency (cannot be estimated from available data).

• Frequent:Increased sweating
• Infrequent:Bradycardia (decreased heart rate), diarrhea, fever, increased aminotransferases, vomiting.
• Unknown frequency:Urticaria

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Ucedane

• The active ingredient is calcium gluconate. Each tablet contains 200 mg of calcium gluconate.
• The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium fumarate, mannitol, copovidone K28, and crospovidone type B.

Appearance of the product and contents of the pack

Ucedane dispersible tablets are elongated, white, and biconvex, with three dividing grooves on both faces and the inscription "L/L/L/L" on one face.

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 aluminium/aluminium blisters packaged in a cardboard box.

Package size of 12 or 60 dispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

Responsible for manufacturing

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

The Netherlands

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Last update of the summary of product characteristics:

Other sources of information

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