Package Insert: Information for the User

Astonín 0.1 mg Tablets

Fludrocortisone

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Astonín and how is it used

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

3. How to take Astonín

4. Possible adverse effects

5. Storage of Astonín

6. Contents of the package and additional information

Astonínbelongs to a group of medications called “Mineralocorticoids”.They are a type of corticosteroid hormones that act by regulating the balance of salt, electrolytes, and water (liquids) in the body.

This medication is used to replace mineralocorticoidsproduced naturally by the body (by the adrenal cortex)in individuals with primary or secondary adrenal insufficiency.These conditions require the use of other medications, in addition to Astonín.

Do not take Astonín:

• if you are allergic to fludrocortisone or any of the other components of this medication (listed in section 6)
• in case of diseases that are characterized by edema (fluid accumulation), such as heart failure, chronic liver disease, or kidney disease
• in case of uncontrolled high blood pressure
• advanced cerebral arteriosclerosis (hardening of the brain's arteries)
• hypovolemic shock (circulatory collapse caused by a reduction in blood volume)
• organic heart disease-related hypotension (low blood pressure)
• hypokalemia (low potassium levels in the blood)

Warnings and precautions

This medication requires your doctor to regularly monitor your blood pressure and blood electrolyte levels. You may need to reduce your salt intake during meals and take potassium supplements while taking this medication.

Stopping treatment with this medication may cause acute adrenocortical insufficiency induced by corticosteroids. Do not abruptly discontinue taking this medication if your treatment is prolonged; consult your doctor before stopping it.

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

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

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

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

Taking Astonín with other medications

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

Inform your doctor if you are taking or have taken recently other medications, including those obtained without a prescription:

• Prostaglandin inhibitors (hormones that participate in a wide range of bodily functions): may increase the hypertensive effect (increase blood pressure) produced by this medication.
• Diuretics (to eliminate salts in the urine), digitalis glycosides (to treat heart problems), or laxatives, as this may worsen possible hypokalemia (low potassium levels in the blood).
• Antiulcer agents containing glycyrrhetinic acid, as this may increase some of the adverse effects of this medication, such as water and sodium retention, edema, hypokalemia, and hypertension.
• Some medications may increase the effects of Astonín, so your doctor will perform thorough controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

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

The excretion of fludrocortisone in breast milk is unknown. The decision to continue or discontinue breastfeeding or to continue or discontinue treatment should be made by a doctor.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

The influence of Astonín on the ability to drive and operate machinery is negligible or insignificant.

Astonin contains sodium (as croscarmelose sodium)

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will inform you of the duration of your treatment with Astonín. Do not discontinue treatment before.

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

Use in children

• First weeks and months of life: Your doctor will calculate the dose considering 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 groove is only for breaking the tablet if it is difficult to swallow 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Accidental intake of high doses of this medication may increase your adverse reactions, especially those related to the endocrine system (system that regulates hormones), metabolism, and electrolyte balance (balance between the different liquids and salts we take and eliminate through urine, feces, or sweat).

If you forgot to take Astonín

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Astonín

If you interrupt treatment with this medication, you may suffer from acute adrenocortical insufficiency induced by corticosteroids (disease characterized by weakness, constant feeling of fatigue, loss of appetite, and weight loss).

Do not abruptly discontinue administration of this medication if your treatment is prolonged. Consult with your doctor before stopping it.

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

Like all medications, this medication may produce adverse effects, although not all people will experience 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 resolves in most cases with continued treatment at lower doses)

Potassium loss.

• Vascular disorders:

Arterial hypertension (high blood pressure).

• Eye disorders:

Blurred vision.

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

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 prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Astonín

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

Appearance of the product and content of the packaging

Astonínis presented in the form of tablets. Each package contains 40 tablets in a PVC/PVDC/Aluminum blister.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

CYNDEA PHARMA, S.L.

Emiliano Revilla Sanz Industrial Estate

Ágreda Avenue, 31 - 42110 Ólvega (Soria)

Date of the last review of this leaflet:February 2023

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