Leaflet: information for the user

Waymade Calcium Gluconate 200 mg dispersible tablets EFG

calcium gluconate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

In this leaflet:

1. What is Calcium Gluconate and for what it is used

1. What you need to know before taking Calcium Gluconate

1. How to take Calcium Gluconate

1. Possible side effects

• Storage of Calcium Gluconate

1. Additional information

The name of this medication is Calcium Gluconate Waymade 200 mg Dispersible Tablets. In this leaflet, it will be referred to as Calcium Gluconate.

Calcium Gluconate may help eliminate elevated levels of ammonia in the blood. Ammonia is especially toxic to the brain and can cause, in severe cases, decreased levels of consciousness and coma.

Hyperammonemia may be due to

• the lack of a specific liver enzyme (N-acetylglutamate synthase). Patients with this rare disorder are unable to eliminate nitrogenous waste, which increases after consuming protein.

This disorder persists throughout the patient's lifetime, so this treatment is necessary for life.

• isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients suffering from one of these disorders require treatment during episodes of hyperammonemia.

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Do not take Carglumic Acid:

• if you are allergic (hypersensitive) to carglumic acid or to any of the other components of this medication (see section 6 for the complete list of components).

• while breastfeeding.

Warnings and Precautions

Carglumic acid treatment should be initiated under the supervision of a doctor with experience in the treatment of metabolic disorders.

Your doctor will evaluate your individual response to carglumic acid before initiating any long-term treatment. The dose should be adjusted individually to maintain normal plasma ammonia levels.

Your doctor may prescribe arginine supplements or limit your protein intake.

To monitor your disease and treatment, your doctor may periodically examine your liver, kidneys, heart, and blood.

Use of other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Use of Carglumic Acid with food and beverages

Carglumic acidshould be taken orally before main meals or food intake.

Tablets should be dispersed in a minimum of 5 to 10 ml of water and should be taken immediately. The suspension has a slightly acidic taste.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.

Pregnancy

The effects of carglumic acid on pregnancy and the fetus are unknown. Please consult your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

You should not breastfeed your child if you are taking Carglumic Acid. Carglumic acid has not been studied in human breast milk. However, it has been shown that carglumic acid is present in the milk of lactating rats, with possible toxic effects on suckling offspring.

Driving and operating machinery

The effects on driving and operating machinery are unknown.

Carglumic Acid contains sodium.

The maximum daily recommended dose of this product contains 396 mg of sodium (main component of table salt/for cooking). This is equivalent to 20% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 132 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose:

The initial daily dose is usually 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 N-acetylglutamate synthase deficiency, the usual daily dose is typically between 10 mg and 100 mg per kg of body weight over a long period.

Your doctor will determine the suitable dose for you to maintain normal levels of ammonia in your blood.

Carglumic acid should be administered ONLY orally or through a nasogastric tube (using a syringe, if necessary).

When the patient is in hyperammonemic coma, carglumic acid is administered through a rapid administration with a syringe through the tube used to feed them.

Inform your doctor if you experience renal deterioration. Your daily dose should be reduced.

If you take more Carglumic Acid than you should:

If you accidentally take too many tablets, immediately inform your doctor or contact the nearest hospital. Bring the packaging and medication leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Carglumic Acid:

If you forget to take a dose, take the next one at the usual time. DO NOT TAKE a double dose to compensate for the missed individual dose.

If you interrupt treatment with Carglumic Acid:

Do not stop taking carglumic acid without informing your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Calcium Gluconate may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

• Frequent (may affect up to 1 in 10 people):Increased sweating
• Rare (may affect up to 1 in 100 people):Decreased heart rate, diarrhea, fever, vomiting, increased aminotransferases (enzymes that may indicate liver damage)
• Unknown frequency: Skin rash.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging of the tablets, box or blisterafter EXP. The expiration date is the last day of the month indicated.

Container

This medication does not require special conservation conditions.

After opening the tablet packaging for the first time: do not refrigerate or freeze. Dispose of it 1 month after the first opening.

Keep the container perfectly closed to protect it from moisture.

Blister

This medication does not require special conservation conditions.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Calcium Carbonate

• The active ingredient is calcium carbonate. Each tablet contains 200 mg of calcium carbonate.

• The other components are microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, and sodium stearate and fumarate.

Appearance of the product and contents of the package

Calcium Carbonate Waymade 200 mg dispersible tablets are white or off-white, bar-shaped tablets, 18 mm x 6 mm, with 3 breaking marks on both sides and engraved with “N” on one side.

The tablets can be divided into equal doses.

Calcium Carbonate is presented in plastic containers or blisters of 5, 15, and 60 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Waymade B.V.

Herikerbergweg 88,

1101 CM Amsterdam,

Netherlands

Responsible for Manufacturing

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120 Wien

Austria

or

Waymade B.V.

Herikerbergweg 88,

1101 CM Amsterdam,

Netherlands

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder.

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Last review date of this leaflet:August 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.