Patient Leaflet Updated 22-Aug-2024 | Sovereign Medical
Carglumic acid 200 mg Dispersible tablets (100178)
Carglumic Acid 200 mg Dispersible Tablets
carglumic acid
1. What Carglumic Acid is and what it is used for
2. What you need to know before you take Carglumic Acid
3. How to take Carglumic Acid
4. Possible side effects
5. How to store Carglumic Acid
6. Contents of the pack and other information
Your medicine is called Carglumic Acid 200 mg Dispersible Tablets. In this leaflet it will be called Carglumic Acid.
Carglumic Acid can help to eliminate high ammonia levels in the blood. Ammonia is especially toxic for the brain and can lead, in severe cases, to reduced levels of consciousness and to coma.
High levels of ammonia in the blood may be due to:
Carglumic Acid treatment should be initiated under the supervision of a doctor experienced in treating metabolic disorders.
Your doctor will evaluate your individual response to carglumic acid before starting any long term treatment. The dose should be individually adjusted in order to maintain normal ammonia plasma levels.
Your doctor may prescribe a supplement called arginine, or restrict your protein intake.
In order to follow up your condition and your treatment, your doctor may examine your liver, kidneys, heart and blood on a regular basis.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines.
Take carglumic acid before meals or feeds.
Disperse the tablets in at least 5 to 10 ml of water and take it immediately. The suspension will have a slightly acidic taste.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
The effects of Carglumic Acid on pregnancy and the unborn child are not known. Please consult your doctor for advice if you are pregnant or planning to become pregnant.
Breast-feeding
Do not breast-feed your baby if you are taking Carglumic Acid. The excretion of carglumic acid into breast milk has not been studied in women.
Nevertheless, carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups.
Effects on the ability to drive and use machines are not known.
This medicinal product contains up to 3 mg of sodium per tablet.
The maximum recommended daily dose of this medicinal product contains 396 mg sodium (found in table salt). This is equivalent to 20% of the adult recommended maximum daily dietary intake for sodium.
Talk to your doctor or pharmacist if you need 132 or more tablets daily for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.
Always take Carglumic Acid exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
The usual dose:
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 you weigh 10 kg, you should take 1 g per day, or 5 tablets).
For patients suffering from N-acetylglutamate synthase deficiency, in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood.
Carglumic Acid should ONLY be given by mouth, or through a feeding tube into the stomach (using a syringe, if necessary).
When the patient is in hyperammonaemic coma, Carglumic Acid is administered by fast push through a syringe via the tube set up to feed them.
Tell your doctor in case you are suffering from renal impairment. Your daily dose should be reduced.
If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department immediately. Take your medicine and this leaflet with you.
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 a forgotten dose.
Do not stop taking Carglumic Acid without informing your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Carglumic Acid can have side effects, although not everybody gets them.
The following side effects were reported as follows:
If any of these side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tablet container, carton or blister after EXP. The expiry date refers to the last day of that month.
Bottle:
This medicinal product does not require any special storage conditions.
After first opening of the tablet container: do not refrigerate, do not freeze. Discard 1 month after first opening.
Keep the container tightly closed in order to protect from moisture.
Blister:
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid. The other ingredients are microcrystalline cellulose, croscarmellose sodium, sodium laurilsulfate, colloidal anhydrous silica, sodium stearyl fumarate.
Carglumic Acid 200 mg Dispersible Tablets are white to off-white elongated dispersible tablets, 18 mm x 6 mm, with three score marks on both side and engraved with 'N's on one side.
The tablet can be divided into equal doses.
Carglumic Acid is presented in containers or blisters of 5, 15 and 60 tablets. Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2024.
PL 06464/3072 Carglumic Acid 200 mg Dispersible Tablets
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
UK 675-8700-PIL
Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR
+44 (0)1268 535 299
+44 (0)1268 535 200
+44 (0) 1748 827 299
+44 (0)1268 535 299
