Carglumic acid Waymade 200 mg dispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
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.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
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If you think any of the side effects you experience is severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
In this leaflet:
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What Carglumic Acid is and what it is used for
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What you need to know before taking Carglumic Acid
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How to take Carglumic Acid
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Possible side effects
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How to store Carglumic Acid
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Further information
1. What is Carbaglu acid and what is it used for
The name of this medicine is Carbaglu acid Waymade 200 mg dispersible tablets. In this leaflet, it will be referred to as Carbaglu acid.
Carbaglu acid can help remove elevated levels of ammonia in the blood. Ammonia is particularly toxic to the brain and, in severe cases, may lead to decreased level of consciousness and coma.
Hyperammonemia may be due to:
- deficiency of a specific liver enzyme (N-acetylglutamate synthase). Patients with this rare disorder are unable to eliminate nitrogenous waste, which increases after eating protein.
This disorder persists throughout the patient's life; therefore, lifelong treatment is necessary.
- isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients affected by any of these disorders require treatment during episodes of hyperammonemia.
2. What you need to know before taking Carglumic acid
Do not take Carglumic acid:
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if you are allergic (hypersensitive) to carglumic acid or to any of the other ingredients of this medicine (see section 6 for the full list of ingredients).
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during breastfeeding.
Warnings and precautions
Treatment with carglumic acid should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Your doctor will assess your individual response to carglumic acid before starting any long-term treatment. The dose must be individually adjusted in order to maintain normal plasma ammonia levels.
Your doctor may prescribe arginine supplements or restrict your protein intake.
To monitor your disease and treatment, your doctor may periodically examine your liver, kidneys, heart, and blood.
Use of other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Use of Carglumic acid with food and drink
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 are planning 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 planning to become pregnant.
Breastfeeding
You should not breastfeed while taking Carglumic acid. Passage of carglumic acid into human breast milk has not been studied. However, carglumic acid has been shown to be present in the milk of lactating rats, with potential toxic effects on nursing offspring.
Driving and using machines
The effects on the ability to drive and use machines are unknown.
Carglumic acid contains sodium.
The recommended maximum daily dose of this product contains 396 mg of sodium (main component of table/cooking salt). This corresponds to 20% of the maximum recommended daily sodium intake for an adult.
Consult your doctor or pharmacist if you need to take 132 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
3. How to take Carbaglu
Follow exactly the instructions for administration of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
The usual initial daily dose is generally 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 long-term N-acetylglutamate synthase deficiency, the usual daily dose typically ranges between 10 mg and 100 mg per kg of body weight.
Your doctor will determine the appropriate dose for you to maintain normal ammonia levels in your blood.
Carbaglu must be administered ORALLY or through a nasogastric tube (using a syringe if necessary).
When the patient is in hyperammonemic coma, Carbaglu is administered rapidly using a syringe through the feeding tube.
Inform your doctor if you have impaired kidney function. Your daily dose should be reduced.
If you take more Carbaglu than you should
If you accidentally take too many tablets, inform your doctor immediately or contact the nearest hospital. Take the medicine packaging and leaflet with you.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.
If you forget to take Carbaglu
If you miss a dose, take the next dose at the usual time. DO NOT take a double dose to make up for the missed dose.
If you stop taking Carbaglu:
Do not stop taking Carbaglu without informing your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Carglumic acid may cause adverse effects, although not everyone experiences them.
The following adverse 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, diarrhoea, fever, vomiting, increased aminotransferases (enzymes that may indicate liver damage)
- Frequency not known: skin rash
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Carglumic Acid:
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tablet container, carton, or blister pack, following EXP. The expiry date refers to the last day of the month indicated.
Bottle
This medicine does not require special storage conditions.
After first opening the tablet container: do not refrigerate or freeze. Discard 1 month after first opening.
Keep the container tightly closed to protect it from moisture.
Blister Pack
This medicine does not require special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and their packaging properly. This will help protect the environment.
6. Additional information
Composition of Carglumic acid
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The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
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The other components are microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal anhydrous silica, and stearoyl fumarate sodium.
Appearance of the product and contents of the container
Carglumic acid Waymade 200 mg dispersible tablets are white or almost white, bar-shaped, dispersible tablets, 18 mm x 6 mm, with 3 break lines on both sides and engraved with "N" on one side.
The tablets may be divided into equal doses.
Carglumic acid is available in plastic containers or blisters containing 5, 15, or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Waymade B.V.
Herikerbergweg 88,
1101 CM Amsterdam,
The Netherlands
Manufacturer
Drehm Pharma GmbH
Grünbergstraße 15/3/3,
1120 Vienna
Austria
or
Waymade B.V.
Herikerbergweg 88,
1101 CM Amsterdam,
The Netherlands
Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder.
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Date of the most recent revision of this leaflet: August 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.