Kargluminic acid waymade

Package leaflet: information for the patient

Carglumic acid Waymade, 200 mg, tablets for oral suspension
Acidum carglumicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Carglumic acid Waymade is and what it is used for
2. Important information 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 Carglumic acid Waymade is and what it is used for

The name of this medicine is: Carglumic acid Waymade, 200 mg, tablets for oral suspension. In the remainder of this leaflet, the name Carglumic acid Waymade will be used.
Carglumic acid Waymade may help remove excess ammonia from the blood.
Ammonia is particularly toxic to the brain and, in severe cases, may cause disturbances of consciousness and coma.
High levels of ammonia in the blood may be caused by:

• deficiency of a specific liver enzyme, N-acetylglutamate synthase. Patients with this rare disorder are unable to excrete nitrogen waste products, which accumulate after protein intake. This condition persists throughout the patient's life, and therefore lifelong treatment is required;
• isovaleric acidemia, methylmalonic acidemia, and propionic acidemia. Patients affected by any of these disorders require treatment during episodes of hyperammonemia.

2. Important information before taking Kwas kargluminowy Waymade

When not to take Kwas kargluminowy Waymade

• if the patient has hypersensitivity (allergy) to Kwas kargluminowy Waymade or to any of the other ingredients of this medicine (list of ingredients is given in section 6);
• during breastfeeding.

Warnings and precautions
Treatment with Kwas kargluminowy Waymade should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Before starting long-term treatment, the treating physician will assess the individual patient's response to carglumic acid.
An individual dose adjustment is necessary to maintain normal plasma ammonia levels.
The treating physician may prescribe arginine as a supplementary medication or recommend limiting protein content in the diet.
The physician may periodically order liver, kidney, heart, and blood tests to monitor the patient's health and treatment progress.

Kwas kargluminowy Waymade with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Kwas kargluminowy Waymade with food and drink
Kwas kargluminowy Waymade should be taken (or administered) orally before meals.
At least 5–10 mL of water should be added to the tablets to form a suspension, which should be taken immediately. The suspension has a slightly sour taste.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
The effect of carglumic acid on pregnancy and the unborn child is unknown. If the patient is pregnant or planning to become pregnant, she should consult her doctor.

Breastfeeding
Breastfeeding should be avoided during treatment with Kwas kargluminowy Waymade.
It has not been studied whether carglumic acid passes into human breast milk. However, carglumic acid has been detected in the milk of lactating rats, with potential toxic effects on offspring fed with mother's milk.

Driving and operating machinery
The effect on the ability to drive and operate machinery is unknown.

Kwas kargluminowy 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 (present in table salt). This corresponds to 20% of the recommended maximum daily sodium intake for an adult.
Talk to your doctor or pharmacist if the patient requires 132 or more tablets per day over a prolonged period, especially if the patient has been advised to follow a low-salt (low-sodium) diet.

3. How to take Kwas kargluminowy Waymade

Kwas kargluminowy Waymade must always be taken as prescribed by the doctor.
If in doubt, consult a doctor or pharmacist.
Typically used dosage:
The usual initial daily dose is generally 100 mg per kilogram of body weight, up to a maximum of
250 mg per kilogram of body weight (for example, if the patient weighs 10 kg, they should take 1 g per day,
i.e. 5 tablets).
In patients with N-acetylglutamate synthase deficiency, during long-term treatment, the daily dose
usually ranges from 10 mg to 100 mg per kilogram of body weight.
The treating physician will determine the individual dose appropriate to maintain normal blood
ammonia levels in the given patient.
Kwas kargluminowy Waymade must be administered ORALLY ONLY or via a gastric feeding tube
(using a syringe if necessary).
If the patient is in a state of hyperammonemic coma, Kwas kargluminowy Waymade should be administered by rapid injection from a syringe through the feeding tube.
Patients with impaired kidney function must inform their doctor. The daily dose should be reduced.
Accidental overdose of Kwas kargluminowy Waymade
In case of accidental overdose, inform the doctor immediately or contact the nearest hospital emergency department without delay. Bring the medicine and this leaflet with you.
Missed dose of Kwas kargluminowy Waymade
If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping treatment with Kwas kargluminowy Waymade
Do not discontinue taking Kwas kargluminowy Waymade without informing your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported:

• Frequent (may occur in less than 1 in 10 people): increased sweating.
• Uncommon (may occur in less than 1 in 100 people): slowed heart rate, diarrhoea, fever, vomiting, increased aminotransferase activity (enzymes which may indicate liver damage).
• Frequency not known: rash.

If any of these side effects worsens, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Kwas kargluminowy Waymade

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle of tablets, carton, or blister pack following: EXP. The expiry date refers to the last day of the stated month.
Bottle
No special storage instructions apply for this medicine.
After first opening the bottle of tablets: Do not store in the refrigerator or freeze.
Discard after 1 month from the date of first opening the bottle.
Keep the bottle tightly closed to protect from moisture.
Blister
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Kwas kargluminowy Waymade contains

• The active substance is kargluminic acid. Each tablet contains 200 mg of kargluminic acid.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulphate, colloidal anhydrous silica, sodium stearyl fumarate.

What Kwas kargluminowy Waymade looks like and contents of the pack
Kwas kargluminowy Waymade 200 mg, tablets for oral suspension are white or almost white,
elongated tablets for suspension, measuring 18 mm x 6 mm, with three score lines on both sides and the letter "N" embossed on one side.
The tablet can be divided into equal doses.
Kwas kargluminowy Waymade is available in bottles or blisters containing 5, 15 or 60 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
The Netherlands
[email protected]

Importer
Drehm Pharma GmbH
Grünbergstraße 15/3/3
1120 Vienna
Austria

Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
The Netherlands