Carglumic acid Waymade

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carglumic Acid Waymade 200 mg dispersible tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet

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

1. What Acido Carglumico Waymade is and what it is used for

Your medicine is called Acido Carglumico Waymade 200 mg dispersible tablets.
In this leaflet, it will be referred to as Acido Carglumico Waymade.
Acido Carglumico Waymade can help remove elevated levels of ammonia
in the blood. Ammonia is particularly toxic to the brain and, in severe cases,
can lead to reduced levels of consciousness and coma.
Hyperammonaemia (high level of ammonia in the blood) may be caused by:

• deficiency of a specific liver enzyme, N-acetylglutamate synthase. Patients affected by this rare disorder are unable to eliminate nitrogen-containing metabolic waste products that build up after protein intake. This disorder persists throughout the patient's life and therefore requires lifelong treatment.
• isovaleric, methylmalonic or propionic acidaemia. Patients affected by one of these conditions require treatment during episodes of hyperammonaemia.

2. What you need to know before taking Acido Carglumico Waymade

Do not take Acido Carglumico Waymade:

• if you are hypersensitive (allergic) to acido carglumico Waymade or to any of the other ingredients of this medicine (listed in section 6).
• during breastfeeding.

Warnings and precautions
Treatment with Acido Carglumico Waymade must be initiated under the supervision of a physician experienced in the management of metabolic disorders.
The physician should assess the individual response to acido carglumico before starting long-term treatment.
The dose must be individually adjusted to maintain normal plasma ammonia levels.
Your doctor may prescribe a supplement called arginine or recommend restricting protein intake.
To monitor the disorder and treatment, your doctor may periodically perform tests to assess liver, kidney, and heart function, as well as blood analyses.

Other medicines and Acido Carglumico Waymade
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Acido Carglumico Waymade with food and drink
Acido Carglumico should be taken before meals or food intake.
The tablets must be dispersed in at least 5–10 ml of water and taken immediately. The suspension will have a slightly acidic taste.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy
The effects of Acido Carglumico Waymade on pregnancy and the fetus are unknown. Consult your doctor if you are pregnant or planning a pregnancy.

Breastfeeding
If you are taking Acido Carglumico Waymade, you must not breastfeed. Excretion of acido carglumico Waymade in human breast milk has not been studied. However, acido carglumico has been detected in the milk of breastfeeding rats, with potential toxic effects on suckling infants.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

Acido Carglumico Waymade contains sodium.
This medicine contains up to 3 mg of sodium per tablet.
The maximum recommended daily dose of this medicine contains 396 mg of sodium (the main component of table salt). This corresponds to 20% of the maximum daily intake recommended in an adult's diet.
Talk to your doctor or pharmacist if you need to take 132 or more tablets per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to take Acido Carglumico Waymade

Take Acido Carglumico Waymade exactly as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dosage:
The usual initial daily dose is normally 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, i.e. 5 tablets).
For long-term treatment of patients with N-acetylglutamate synthase deficiency, the
daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Your doctor will determine the appropriate dose to maintain normal blood ammonia levels.
Acido Carglumico Waymade must be administered ORALLY ONLY or
through a feeding tube inserted into the stomach (using a syringe if
necessary).
If the patient is in hyperammonemic coma, Acido Carglumico Waymade should be
administered via rapid injection using a syringe through the feeding tube.
If you take more Acido Carglumico Waymade than you should
If you accidentally take too much medicine, inform your doctor immediately or go
immediately to the nearest hospital department. Take your medicine and this leaflet
with you.
If you forget to take Acido Carglumico Waymade
If you forget to take 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 Acido Carglumico Waymade
Do not stop treatment with Acido Carglumico Waymade without informing your
doctor.
If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Acido Carglumico Waymade can cause side effects, although not everybody experiences them.
The following side effects have been reported as follows:

• Common (may affect up to 1 in 10 people): increased sweating
• Uncommon (may affect up to 1 in 100 people): reduced heart rate, diarrhoea, fever, vomiting, increased transaminases (enzymes that may indicate liver damage)
• Not known: rash

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acido Carglumico Waymade

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tablet container.
This medicine does not require any special storage conditions.
After opening the tablet container: do not refrigerate or freeze.
Dispose of the product 1 month after first opening.
Keep the container tightly closed in order to protect the product from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Acido Carglumico Waymade contains

• The active substance is acido carglumico. Each tablet contains 200 mg of acido carglumico.
• The other components are microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, anhydrous colloidal silica, sodium stearyl fumarate.

What Acido Carglumico Waymade looks like and contents of the pack
Acido Carglumico Waymade 200 mg dispersible tablets are white/whitish in colour, elongated in shape, 18 mm x 6 mm, with three dots on each side and engraved with "N" on one side. The tablet may be divided into two equal parts.
Acido Carglumico Waymade is supplied in containers containing 5, 15 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Waymade B.V.
Herikerbergweg 88, 1101CM,
Amsterdam, The Netherlands

Manufacturer
AcertiPharma B.V.
Boschstraat 51,
4811GC Breda,
The Netherlands
Drehm Pharma GmbH,
Hietzinger Hauptstraße 37/2,
Wien, 1130,
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
Waymade B.V.
Herikerbergweg 88,
1101CM Amsterdam,
The Netherlands