CARGLUMIC ACID WAYMADE 200 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Carglumic Acid Waymade 200 mg Dispersible Tablets EFG

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, as it may harm them, even if their symptoms are the same as yours.

• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

In this leaflet:

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

1. What you need to know before you take Carglumic Acid

1. How to take Carglumic Acid

1. Possible side effects

• Storage of Carglumic Acid

1. Further information

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

The name of this medicine is Carglumic Acid Waymade 200 mg Dispersible Tablets. In this leaflet, it will be called Carglumic Acid.

Carglumic Acid can help eliminate 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 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 start taking Carglumic Acid

Do not take Carglumic Acid:

• if you are allergic (hypersensitive) to carglumic acid or any of the other ingredients of this medicine (see section 6 for the complete list of ingredients).

• during breastfeeding.

Warnings and precautions

Treatment with carglumic acid should be initiated under the supervision of a doctor with experience in the treatment of metabolic disorders.

Your doctor will evaluate 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 you 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.

Use of other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Use of Carglumic Acid 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. Please consult your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

You should not breastfeed your child if you take Carglumic Acid. 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.

Driving and using machines

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

Carglumic Acid contains sodium.

The maximum recommended daily dose of this product contains 396 mg of sodium (main component of table salt/cooking salt). This is equivalent to 20% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need 132 or more tablets per day for a prolonged period, especially if you have been recommended a low-salt (sodium) diet.

3. How to take Carglumic Acid

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 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.

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 administration 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 Carglumic Acid than you should

If you accidentally take too many tablets, inform your doctor immediately or contact the nearest hospital. Bring the package and leaflet of the medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount ingested

If you forget to take Carglumic Acid

If you forget to take a dose, take the next one at the usual time. DO NOT TAKE a double dose to make up for the missed individual dose.

If you stop taking Carglumic Acid:

Do not stop taking carglumic acid without informing your doctor.

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

4. Possible side effects

Like all medicines, Carglumic Acid can cause side effects, although not everybody gets them.

The following side effects have been reported:

• Common (may affect up to 1 in 10 people):increased sweating
• Uncommon (may affect up to 1 in 100 people):decreased heart rate, diarrhea, fever, vomiting, increased aminotransferases (enzymes that may indicate liver damage)
• Frequency not known: skin rash.

If you experience any of the side effects, 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them through 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. Storage of Carglumic Acid

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP. The expiry date is the last day of the month shown.

Bottle

This medicine does not require any special storage conditions.

After opening the tablet container for the first time: do not refrigerate or freeze. Discard 1 month after first opening.

Keep the container tightly closed to protect it from moisture.

Blister

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Further information

Composition of Carglumic Acid

• The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.

• The other ingredients are microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, and sodium stearyl fumarate.

Appearance and packaging of the product

Carglumic Acid Waymade 200 mg Dispersible Tablets are white or almost white, bar-shaped tablets, 18 mm x 6 mm, with 3 break lines on both sides and engraved with "N" on one side.

The tablets can be divided into equal doses.

Carglumic Acid is available in plastic containers or blister packs of 5, 15, and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Waymade B.V.

Herikerbergweg 88,

1101 CM Amsterdam,

Netherlands

Manufacturer

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120 Wien

Austria

or

Waymade B.V.

Herikerbergweg 88,

1101 CM Amsterdam,

Netherlands

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorisation Holder.

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of last revision of this leaflet:August 2024

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/.