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Package Leaflet: Information for the Patient

Waymade Carbamoyl Glutamate, 200 mg, Tablets for Oral Suspension

Acidum carbamoylglutamicum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Another Person, Even if Their Symptoms are the Same.
• If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Waymade Carbamoyl Glutamate and What is it Used For
• 2. Important Information Before Taking Waymade Carbamoyl Glutamate
• 3. How to Take Waymade Carbamoyl Glutamate
• 4. Possible Side Effects
• 5. How to Store Waymade Carbamoyl Glutamate
• 6. Package Contents and Other Information

1. What is Waymade Carbamoyl Glutamate and What is it Used For

The Name of this Medication is: Waymade Carbamoyl Glutamate, 200 mg, Tablets for Oral Suspension. In this Package Leaflet, the Name Waymade Carbamoyl Glutamate will be Used. Waymade Carbamoyl Glutamate can Help Remove Excess Ammonia from the Blood. Ammonia is Particularly Toxic to the Brain and in Severe Cases can Cause Changes in Consciousness and Coma. High Blood Ammonia Levels can be Caused by:

• Lack of a Specific Enzyme in the Liver, N-Acetylglutamate Synthase. Patients with this Rare Disorder are Unable to Excrete the Product of Nitrogen Metabolism, which Accumulates after Protein Intake. The Disease Persists Throughout the Patient's Life, and Therefore, Treatment is Needed Throughout Life;
• Isobutyric Aciduria, Methylmalonic Aciduria, and Propionic Aciduria. Patients with one of these Diseases Require Treatment During Episodes of Hyperammonemia.

2. Important Information Before Taking Waymade Carbamoyl Glutamate

When Not to Take Waymade Carbamoyl Glutamate

• If the Patient has a Known Hypersensitivity (Allergy) to Waymade Carbamoyl Glutamate or Any of the Other Ingredients of this Medication (List of Ingredients can be Found in Section 6);
• During Breastfeeding.

Warnings and Precautions

Treatment with Waymade Carbamoyl Glutamate should be Initiated Under the Supervision of a Doctor Experienced in the Treatment of Metabolic Disorders. Before Starting Long-Term Treatment, the Doctor will Assess the Individual Patient's Response to the Action of Carbamoyl Glutamate. It is Necessary to Individually Adjust the Dose of the Medication to Maintain Normal Blood Ammonia Levels. The Doctor may Prescribe the Use of Arginine as a Supplement or Recommend a Low-Protein Diet. The Doctor may Regularly Order Liver, Kidney, Heart, and Blood Tests to Monitor the Patient's Health and Treatment Progress.

Waymade Carbamoyl Glutamate and Other Medications

Tell the Doctor or Pharmacist About All Medications the Patient is Currently Taking or Has Recently Taken, as Well as Any Medications the Patient Plans to Take.

Waymade Carbamoyl Glutamate with Food and Drink

Waymade Carbamoyl Glutamate should be Taken (or Administered) Orally Before Meals. At Least 5-10 ml of Water should be Added to the Tablets to Create a Suspension, which should be Taken Immediately. The Suspension has a Slightly Acidic Taste.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant, or Plans to Have a Child, She should Consult a Doctor Before Taking this Medication.

Pregnancy

The Effect of Carbamoyl Glutamate on Pregnancy and the Fetus is Not Known. If the Patient is Pregnant or Plans to Become Pregnant, She should Consult a Doctor.

Breastfeeding

Do Not Breastfeed While Taking Waymade Carbamoyl Glutamate. It has Not been Studied in Nursing Mothers. However, Carbamoyl Glutamate has been Shown to be Present in the Milk of Lactating Rats, with Potential Toxic Effects on the Offspring.

Driving and Operating Machinery

The Effect on the Ability to Drive and Operate Machinery is Not Known.

Waymade Carbamoyl Glutamate Contains Sodium

This Medication Contains up to 3 mg of Sodium per Tablet. The Maximum Recommended Daily Dose of this Medication Contains 396 mg of Sodium (as Sodium Salt). This Corresponds to 20% of the Recommended Maximum Daily Sodium Intake for an Adult. Consult a Doctor or Pharmacist if the Patient Needs to Take 132 or More Tablets per Day for a Long Time, Especially if the Patient has been Advised to Follow a Low-Sodium Diet.

3. How to Take Waymade Carbamoyl Glutamate

Waymade Carbamoyl Glutamate should Always be Taken as Directed by the Doctor. In Case of Doubt, Consult a Doctor or Pharmacist. The Usual Dose of the Medication is: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 the Patient Weighs 10 kg, they should Take 1 g per Day, or 5 Tablets). In Patients with N-Acetylglutamate Synthase Deficiency, the Daily Dose During Long-Term Treatment is Usually Between 10 mg and 100 mg per Kilogram of Body Weight. The Doctor will Determine the Individual Dose Necessary to Maintain Normal Blood Ammonia Levels in the Patient. Waymade Carbamoyl Glutamate should be Administered Orally or Through a Gastric Tube (Using a Syringe if Necessary). If the Patient is in a Hyperammonemic Coma, Waymade Carbamoyl Glutamate is Administered by Rapidly Injecting with a Syringe Through a Feeding Tube. Patients with Renal Impairment should Inform their Doctor. The Daily Dose should be Reduced.

Taking More than the Recommended Dose of Waymade Carbamoyl Glutamate

In Case of Accidental Overdose, Tell the Doctor or Immediately Contact the Nearest Hospital Emergency Department. Bring the Medication and this Package Leaflet.

Missing a Dose of Waymade Carbamoyl Glutamate

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 Waymade Carbamoyl Glutamate Treatment

Do Not Stop Taking Waymade Carbamoyl Glutamate Without Informing the Doctor. If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Waymade Carbamoyl Glutamate 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): Slow Heart Rate, Diarrhea, Fever, Vomiting, Increased Activity of Aminotransferases (Enzymes that May Indicate Liver Damage).
• Frequency Not Known: Rash

If Any of these Side Effects Worsen or if You Experience Any Side Effects Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication. Side Effects can also be Reported to the Marketing Authorization Holder.

5. How to Store Waymade Carbamoyl Glutamate

Keep the Medication Out of Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Bottle, Carton, or Blister Pack: EXP. The Expiration Date Refers to the Last Day of the Month Stated. Bottle: No Special Precautions for Storage. After First Opening the Bottle: Do Not Store in the Refrigerator or Freeze. Discard After 1 Month from First Opening the Bottle. Keep the Bottle Tightly Closed to Protect from Moisture. Blister: No Special Precautions for Storage. Medications should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Waymade Carbamoyl Glutamate Contains

• The Active Substance is Carbamoyl Glutamate. Each Tablet Contains 200 mg of Carbamoyl Glutamate.
• The Other Ingredients are: Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Sodium Lauryl Sulfate, Colloidal Silica, Sodium Stearyl Fumarate.

What Waymade Carbamoyl Glutamate Looks Like and Contents of the Package

Waymade Carbamoyl Glutamate, 200 mg, Tablets for Oral Suspension are White or Almost White, Prolonged-Release Tablets, 18 mm x 6 mm in Size, with Three Score Lines on Both Sides and the Letter "N" Embossed on One Side. The Tablet can be Divided into Equal Doses. Waymade Carbamoyl Glutamate is Available in Bottles or Blisters Containing 5, 15, and 60 Tablets, in a Carton. Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

Waymade B.V. Herikerbergweg 88 1101CM Amsterdam Netherlands. [email protected]

Importer

Drehm Pharma GmbH Grünbergstraße 15/3/3 1120 Vienna Austria. Waymade B.V. Herikerbergweg 88 1101CM Amsterdam Netherlands.

Date of Last Revision of the Package Leaflet: