ASTONIN 0.1 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Astonín 0.1 mg tablets

Fludrocortisone

Read the entire leaflet carefully before you start taking this medicine, as 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Astonín is and what it is used for

Astonín belongs to a group of medicines called "Mineralocorticoids". These are a type of corticosteroid hormone that regulate the balance of salt, electrolytes, and water (fluids) in the body.

This medicine is used to replace the mineralocorticoids naturally produced by the body (by the adrenal cortex) in people with primary or secondary adrenal insufficiency. These conditions require the use of other medicines in addition to Astonín.

2. What you need to know before starting to take Astonín

Do not take Astonín:

• if you are allergic to fludrocortisone or to any of the other ingredients of this medicine (listed in section 6)
• if you have conditions associated with edema (fluid accumulation), such as heart failure, hepatic cirrhosis (chronic liver disease), or nephrosis (a kidney disorder)
• if you have uncontrolled high blood pressure
• advanced cerebral sclerosis (hardening of the cerebral arteries)
• hypovolemic shock (circulatory collapse caused by reduced blood volume)
• hypotension (low blood pressure) due to organic heart disease
• hypokalemia (low potassium levels in the blood).

Warnings and precautions

Treatment with this medicine requires your doctor to regularly monitor your blood pressure and blood electrolyte levels. You may need to reduce your dietary salt intake and take potassium supplements while taking this medicine.

Stopping treatment with this medicine may cause acute corticosteroid-induced adrenal insufficiency. Do not abruptly discontinue this medicine if your treatment has been prolonged; consult your doctor before stopping.

Like other corticosteroids, this medicine reduces the inflammatory response and immune function. This may worsen the course of infections. The medicine may also mask serious infections (such as sepsis or tuberculosis), allowing them to progress to an advanced stage before detection.

Administration of this medicine is not recommended in patients with severe psychiatric disorders (especially psychosis), latent or active tuberculosis, ocular herpes simplex, or certain viral diseases (e.g., chickenpox, herpes simplex, or herpes zoster during the viremic phase).

This medicine should be used with caution in patients with diabetes, peptic ulcer, osteoporosis, thromboembolic disorders, or infectious conditions.

Contact your doctor if you experience blurred vision or other visual disturbances.

Taking Astonín with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription:

• Prostaglandin inhibitors (hormones involved in a wide range of bodily functions): may increase the hypertensive effect (raise blood pressure) of this medicine.
• Diuretics (to eliminate salts in urine), digitalis glycosides (used to treat heart problems), or laxatives, as these may worsen potential hypokalemia (low potassium levels in the blood).
• Anti-ulcer agents containing glycyrrhizic acid, as they may increase some of the adverse effects of this medicine, such as water and sodium retention, edema, hypokalemia, and hypertension (elevated blood pressure).
• Some medicines may increase the effects of Astonín; your doctor will perform careful monitoring if you are taking these medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you become pregnant, your doctor may need to adjust the dose of this medicine.

It is unknown whether fludrocortisone is excreted in human breast milk. The decision whether to continue or discontinue breastfeeding or to continue or stop treatment should be made by a physician.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Driving and using machines

The effect of Astonín on the ability to drive and use machines is negligible or none.

Astonín contains sodium (as sodium croscarmellose)

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Astonín

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

Your doctor will determine the duration of your treatment with Astonín. Do not stop treatment earlier than advised.

The usual recommended dose is 1 to 3 tablets per day.

Use in children

• First weeks and months of life: Your doctor will calculate the dose based on body surface area (1 to 3 tablets per m² per day).
• Second year of life: Half the initial dose.
• Third year of life: One-third or one-quarter of the initial dose.

The tablet score line is intended only to divide the tablet if you have difficulty swallowing it whole.

The tablets should be taken after meals with some liquid.

If you take more Astonín than you should

If you have taken more Astonín than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Accidental ingestion of high doses of this medicine may increase its adverse reactions, especially those related to the endocrine system (the system that regulates hormones), metabolism, and electrolyte balance (the balance between the various fluids and salts we take in and eliminate through urine, feces, or sweat).

If you forget to take Astonín

Do not take a double dose to make up for forgotten doses.

If you stop taking Astonín

If you stop treatment with this medicine, you may develop acute corticosteroid-induced adrenal insufficiency (a condition characterized by weakness, constant fatigue, loss of appetite, and weight loss).

Do not abruptly stop taking this medicine if your treatment has been prolonged. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

• General disorders and administration site conditions:

Headache.

• Metabolism and nutrition disorders:

Weight gain.

Oedema (fluid accumulation) due to sodium and water retention (which in most cases disappear when continuing treatment with lower doses).

Potassium loss.

• Vascular disorders:

High blood pressure.

• Eye disorders:

Blurred vision.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Astonín

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Astonín

• The active substance is fludrocortisone 0.1 mg.
• The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

Appearance of the medicinal product and contents of the container

Astonín is presented as tablets. Each pack contains 40 tablets in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

CYNDEA PHARMA, S.L.

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31 - 42110 Ólvega (Soria)

Date of the most recent revision of this leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/