Hidroaltesona 20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hidroaltesona 20 mg tablets

Hydrocortisone

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Hidroaltesona is and what it is used for

Hidroaltesona contains a substance called hydrocortisone (sometimes also called cortisol). Hydrocortisone is a glucocorticoid. It belongs to a group of medicines known as corticosteroids. Glucocorticoids are naturally produced in the body and help maintain overall health and well-being.

Hidroaltesona is used to treat a condition known as adrenal insufficiency or cortisol deficiency. This occurs when the adrenal glands (located just above the kidneys) do not produce enough cortisol. Patients with long-term (chronic) adrenal insufficiency require replacement therapy to survive.

Hidroaltesona replaces the natural cortisol that is lacking in adrenal insufficiency.

2. What you need to know before taking Hidroaltesona

Do not take Hidroaltesona

• if you are allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting Hidroaltesona.

• If you have any illness that prevents you from taking the medicine or prevents its proper absorption in your stomach. This may occur in cases of gastrointestinal problems accompanied by vomiting or diarrhoea. In such situations, you must immediately see a doctor to receive treatment with hydrocortisone injections and fluid replacement.
• If you experience any short-term or temporary condition, such as an infection, fever, or any situation causing significant physical stress, such as surgery: your hydrocortisone dose should be temporarily increased. Promptly ask your doctor for advice on how best to manage these situations. If you are scheduled for surgery, inform your doctor or dentist that you are taking this medicine.
• If, for any other reason, your general health worsens despite taking the medicine as prescribed; in this case, contact your doctor immediately.
• If your thyroid gland is not functioning normally; inform your doctor, as your Hidroaltesona dose may need adjustment.
• If hydrocortisone is administered to a premature newborn, monitoring of heart function and structure may be necessary.
• If you have overactivity of the thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness while using hydrocortisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with overactivity of the thyroid gland (hyperthyroidism) treated with hydrocortisone. You may require additional treatment to relieve this condition.

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

Taking Hidroaltesona with other medicines

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

Some medicines may increase the effects of Hidroaltesona, so your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

During long-term treatment with medicines used to treat infections (antibiotics), your doctor may need to adjust your Hidroaltesona dose. If used together with mifepristone, a medicine used to terminate pregnancy, the effect of Hidroaltesona could be reduced.

Additionally, consult your doctor or pharmacist if you are taking any of the following medicines, as your Hidroaltesona dose may need to be adjusted:

• Phenytoin, carbamazepine, and barbiturates: used to treat epilepsy.
• Rifampicin or rifabutin: used to treat tuberculosis.
• Ritonavir, efavirenz, and nevirapine: used to treat HIV infection.
• St. John’s wort (Hypericum perforatum): used to treat depression and other conditions.
• Ketoconazole, itraconazole, posaconazole, and voriconazole: used to treat fungal infections.
• Erythromycin, telithromycin, and clarithromycin: used to treat bacterial infections.
• Growth stimulants such as somatotropin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) and salicylates.
• Medicines used to treat certain types of cancer, such as methotrexate.
• Estrogens and other oral contraceptives, anticoagulants, antidiabetics, antihypertensives, diuretics, and cardiac glycosides.

Taking Hidroaltesona with food and drinks

Do not take this medicine with grapefruit juice, as it may interfere with its action.

Pregnancy, breastfeeding, and fertility

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

It is important that you continue Hidroaltesona treatment during pregnancy. Treatment in pregnant women with adrenal insufficiency is unlikely to have harmful effects on the mother or the child. If you become pregnant, inform your doctor, as your Hidroaltesona dose may need adjustment.

You may breastfeed while taking Hidroaltesona tablets. Hydrocortisone is excreted in breast milk. The doses of hydrocortisone used in replacement therapy are unlikely to have any effect on the infant. However, inform your doctor if you plan to breastfeed.

Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced. There are no data indicating that Hidroaltesona, at the doses used in replacement therapy, affects fertility.

Driving and using machines

The influence of this medicine on the ability to drive and operate machinery is minor. Extreme fatigue and brief episodes of dizziness (vertigo) have been reported. Poorly treated or untreated adrenal insufficiency reduces concentration ability and affects the capacity to drive and use machines. Therefore, it is important to take this medicine as directed by your doctor when driving or operating machinery. If you feel affected, do not drive or operate machinery until you have discussed the issue with your doctor.

Hidroaltesona contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Information for athletes

This medicine contains hydrocortisone, a substance which may result in a positive doping test.

3. How to take Hidroaltesona

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The dose is specific to you and has been determined by your doctor.

The usual maintenance dose in adults is 20–30 mg per day, administered once daily in the morning. In patients with some residual cortisol production, a lower dose may be sufficient. The highest maintenance dose studied is 40 mg. The lowest possible maintenance dose should be used.

The recommended dose in children and adolescents is 10–30 mg in divided doses.

The tablets should be taken orally with a glass of water upon waking, preferably in an upright position, and on an empty stomach. The tablets must not be chewed or crushed. If more than one dose per day is required, the morning dose should be taken as indicated; additional doses may be taken with or without food.

Need for additional doses of Hidroaltesona

During short-term or temporary conditions such as infections, fever, or physical stress such as surgery, you will need more hydrocortisone, since your body cannot produce the additional amount of cortisol required in these situations. Therefore, the dose should be temporarily increased, and your doctor may advise you to take additional hydrocortisone tablets instead of or in addition to Hidroaltesona. Consult your doctor and follow their instructions on the best way to manage these situations.

The following signs and symptoms may indicate that you need additional doses of Hidroaltesona or other hydrocortisone-containing medicines: fatigue, weight loss, stomach discomfort, dizziness when moving from sitting to standing or upon standing, and darkening of the skin, especially in skin folds and exposed areas. Contact your doctor as soon as possible if you experience any of these signs or symptoms.

Seek immediate medical attention if you experience any of the following signs or symptoms: severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, decreased level of consciousness, delirium (a state of marked mental confusion).

If you take more Hidroaltesona than you should

A dose of this medicine that is too high for more than a few days may be harmful to your health. It may cause high blood pressure, weight gain, and excessive increase in blood sugar levels. Sometimes it is necessary to increase the dose so the body can cope with certain stressful situations, such as fever. If extra doses are frequently and regularly needed, you should see your doctor so they can reconsider your maintenance dose.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 915 62 04 20, indicating the medicine and the amount taken.

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Hidroaltesona

If you forget to take the morning tablet, take it as soon as possible. Do not take a double dose to make up for missed doses. If you experience any of the signs or symptoms mentioned in the section “Need for additional doses of Hidroaltesona”, contact your doctor immediately.

If you stop taking Hidroaltesona

Stopping treatment with Hidroaltesona may be life-threatening. Therefore, it is important that you continue taking this medicine exactly as prescribed by your doctor. Do not stop treatment without consulting your doctor.

Do not stop treatment abruptly. Dose reduction should always be gradual to avoid potential effects on the corticosteroids produced by your body.

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 can cause adverse effects, although not everyone will experience them.

The adverse effects observed may be associated with prolonged use of corticosteroids and are more likely to occur at the beginning of treatment or when the dose is increased.

The frequency of these possible adverse effects is unknown (cannot be estimated from the available data). Consult your doctor if you experience any of the following:

• Moderate or severe allergic reactions (anaphylaxis).

• Increased susceptibility to infections, activation of viral or fungal infections (including herpes).

• Diabetes or problems with blood sugar concentration (detected by blood tests).

• Retention of salts and water leading to edema and arterial hypertension (detected during clinical examination), and low potassium levels in the blood, increased appetite, and weight gain.

• Dizziness, malaise, fatigue, difficulty sleeping.

• Increased intraocular pressure (glaucoma), clouding of the eye's lens (cataract), dry eye, blurred vision.

• Burning sensation, worsening of existing stomach ulcers, stomach pain, nausea, diarrhea, esophageal or pancreatic inflammation, dental erosion.

• Weakening of the bones: may lead to bone fractures, joint inflammation.

• Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.

• Irregular menstruation or cessation of menstruation.

• Worsening of epilepsy, seizures, sedation.

• Growth delay in childhood, youth, and adolescence.

• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature newborns.

Steroids, including hydrocortisone, can cause serious mental health problems. These adverse effects are common (may affect up to 1 in 10 people). Inform your doctor:

• If you feel depressed, including thoughts of suicide.
• If you feel euphoric, or experience mood changes.
• If you have anxiety, trouble sleeping, difficulty thinking, feel confused, or notice memory loss.
• If you feel, see, or hear things that do not exist.
• If you have strange and frightening thoughts, or changes in your behavior.

Reporting of adverse effects

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

5. Storage of Hydroaltesone

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroaltesona

• The active substance is hydrocortisone. Each tablet contains 20 milligrams of hydrocortisone.
• The other components are: lactose, pregelatinized corn starch, talc and magnesium stearate.

Description of the product and contents of the pack

Round, biconvex white tablets, scored on one side and smooth on the other.

The tablet can be divided into equal doses.

The tablets are available in blister packs containing 10 and 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent revision of this leaflet: August 2025

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