ASTONIN 0.1 mg TABLETS

Introduction

Leaflet: information for the user

Astonin 0.1 mg tablets

Fludrocortisone

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Astonin and what is it used for
2. What you need to know before taking Astonin
3. How to take Astonin
4. Possible side effects
5. Storage of Astonin
6. Package contents and additional information

1. What is Astonin and what is it used for

Astonin belongs to a group of medicines called "Mineralocorticoids". They are a type of corticosteroid hormone that acts by regulating 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 diseases require the use of other medicines, in addition to Astonin.

2. What you need to know before taking Astonin

Do not take Astonin:

• if you are allergic to fludrocortisone or any of the other components of this medicine (listed in section 6)
• in case of diseases that involve edema (fluid accumulation), such as heart failure, liver cirrhosis (chronic liver disease), or nephrosis (kidney disease)
• in case of uncontrolled high blood pressure
• advanced cerebral sclerosis (hardening of the cerebral arteries)
• hypovolemic shock (circulatory collapse caused by a reduction in 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 electrolyte levels. You may need to reduce your salt intake and take potassium supplements while taking this medicine.

Stopping treatment with this medicine can cause acute adrenal insufficiency induced by corticosteroids. Do not suddenly stop taking this medicine if your treatment is prolonged; consult your doctor before stopping it.

This medicine, like other corticosteroids, reduces the inflammatory response and immune function. This can worsen the course of infections. The medicine can also mask some serious infections (such as septicemia or tuberculosis), allowing them to reach an advanced stage before being detected.

This medicine is not recommended for patients with severe psychiatric disorders (especially psychosis), latent or manifest tuberculosis, herpes simplex ophthalmicus, or certain viral diseases (e.g., chickenpox, herpes simplex, or herpes zoster during the viremic phase).

This medicine should be administered with caution in patients with diabetes, peptic ulcer, osteoporosis, thromboembolic diseases, or infectious states.

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

Taking Astonin with other medicines

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

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

• Prostaglandin inhibitors (hormones involved in various bodily functions): may increase the hypertensive effect (increase blood pressure) produced by this medicine.
• Diuretics (to eliminate salts in the urine), digitalis glycosides (to treat heart problems), or laxatives, as hypokalemia (low potassium levels in the blood) may worsen.
• Anti-ulcer agents containing glycyrrhizic acid, as some of the adverse effects of this medicine, such as water and sodium retention, edema, hypokalemia, and hypertension (high blood pressure), may increase.
• Some medicines may increase the effects of Astonin, so your doctor will closely monitor you if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or 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 breast milk. The decision to continue or stop breastfeeding or to continue or discontinue treatment should be made by a doctor.

Use in athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

Driving and using machines

Astonin has no significant effect on the ability to drive or use machines.

Astonin contains sodium (as sodium croscarmellose)

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

3. How to take Astonin

Follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor again.

Your doctor will indicate the duration of your treatment with Astonin. Do not stop treatment before.

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

Use in children

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

The score line is only for breaking the tablet if you find it difficult to swallow whole.

Tablets should be taken after meals with some liquid.

If you take more Astonin than you should

If you have taken more Astonin than you should, consult your doctor, pharmacist, or call the Toxicology Information Service (tel: 91 562 04 20) immediately, indicating the medicine and the amount used. It is recommended to take the package and leaflet of the medicine to the healthcare professional.

Taking high doses of this medicine accidentally may increase its adverse reactions, especially those related to the endocrine system (hormone-regulating system), metabolism, and electrolyte balance.

If you forget to take Astonin

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

If you stop taking Astonin

If you stop taking this medicine, you may experience acute adrenal insufficiency induced by corticosteroids (a disease characterized by weakness, constant fatigue, loss of appetite, and weight loss).

Do not suddenly stop taking this medicine if your treatment is prolonged. Consult your doctor before stopping it.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

• General disorders and administration site conditions:

Headache.

• Metabolism and nutrition disorders:

Weight gain.

Edema (fluid accumulation) due to sodium and water retention (which usually disappears when continuing treatment with lower doses)

Potassium loss.

• Vascular disorders:

Hypertension (high blood pressure).

• Ocular disorders:

Blurred vision.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Astonin

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

Do not store above 25°C.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Astonin

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

Appearance and package contents

Astonin is presented in tablet form. Each package 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.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31 - 42110 Ólvega (Soria)

Date of last revision of this leaflet:February 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/