CARGLUMIC ACID TILLOMED 200 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Carglumic Acid Tillomed 200 mg Dispersible Tablets EFG

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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.

Your medicine will be referred to as “carglumic acid” throughout this leaflet.

Contents of the pack

1. What is Carglumic Acid Tillomed and what is it used for
2. What you need to know before you take Carglumic Acid Tillomed
3. How to take Carglumic Acid Tillomed
4. Possible side effects
5. Storing Carglumic Acid Tillomed
6. Contents of the pack and other information

1. What is Carglumic Acid Tillomed and what is it used for

Carglumic acid can help eliminate excessive plasma levels of ammonia (high levels of ammonia in the blood). 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 accumulates after ingesting 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 Carglumic Acid Tillomed

Do not take Carglumic Acid Tillomed:

• if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in section 6).
• while breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor or pharmacist before taking carglumic acid.

Treatment with carglumic acid 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 plasma 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 Carglumic Acid Tillomed

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Using Carglumic Acid Tillomed with food and drinks

Carglumic acid 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Pregnancy

The effects of carglumic acid on pregnancy and the fetus are unknown.

Breastfeeding

It has not been studied whether carglumic acid passes into human breast milk. However, it has been shown that carglumic acid is present in the milk of lactating rats, with possible toxic effects on the suckling pups. Therefore, you should not breastfeed your child if you are taking Carglumic Acid Tillomed.

Driving and using machines

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

Carglumic Acid Tillomed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Carglumic Acid Tillomed

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The tablet can be divided into two equal halves.

The usual dose:

The initial daily dose is usually 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 or 5 tablets).

For patients with N-acetylglutamate synthase deficiency, the long-term daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.

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

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

When the patient is in hyperammonemic coma, carglumic acid is administered by rapid infusion with a syringe through the tube used for feeding.

Tell your doctor if you have kidney failure. Your daily dose should be reduced.

If you take more Carglumic Acid Tillomed than you should

If you accidentally take too many tablets, contact your doctor or the nearest hospital emergency department immediately for advice. Remember to bring this leaflet or the remaining tablets with you.

You can also consult your pharmacist or call the Toxicological Pharmacovigilance Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Carglumic Acid Tillomed

Take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Carglumic Acid Tillomed

Do not stop taking carglumic acid without first consulting your doctor.

If you have any further questions on 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.

Seek medical attention immediately if you develop the following symptoms:

• Allergic reactions: Swelling of the face, throat, or tongue, difficulty breathing, dizziness.

Common (may affect up to 1 in 10 people):

• increased sweating

Uncommon (may affect up to 1 in 100 people):

• slower heartbeats (bradycardia)
• diarrhea
• fever
• increased transaminases
• feeling sick (vomiting)

Frequency not known (cannot be estimated from the available data)

• skin rash

If any of the side effects get 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 get 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Carglumic Acid Tillomed

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. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carglumic Acid Tillomed

• The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
• The other ingredients are microcrystalline cellulose (E460), hypromellose (E464), sodium lauryl sulfate, croscarmellose sodium (E468), colloidal anhydrous silica (E551), and sodium stearyl fumarate (E485).

Appearance and packaging

Carglumic Acid Tillomed is available in smooth aluminum/PAP/PET lidding material and aluminum-aluminum blister packaging, with 5, 15, and 60 dispersible tablets per pack.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Tillomed Spain, S.L.U.

c/ Cardenal Marcelo Spinola, 8

28016 Madrid (Spain)

Manufacturer

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/