HIDROALTESONA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Hydrocortisone 20 mg Tablets

Hydrocortisone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Hydrocortisone and what is it used for

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

Hydrocortisone is used to treat a disease 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 need replacement therapy to survive.

Hydrocortisone replaces the missing natural cortisol in adrenal insufficiency.

2. What you need to know before you take Hydrocortisone

Do not take Hydrocortisone

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hydrocortisone.

• When you have any illness that prevents you from taking the medicine or it is not absorbed correctly in your stomach. This situation may occur in case of digestive problems with vomiting or diarrhea. In such situations, you should immediately consult your doctor to receive treatment with hydrocortisone injections and fluid administration.
• If you have any short-term or temporary condition, such as an infection, fever, or any situation that causes significant physical stress, such as surgery: your dose of hydrocortisone should be temporarily increased. Ask your doctor without delay to inform you about the best way to handle these situations. If you are going to undergo 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 such a case, consult your doctor immediately.
• If your thyroid does not function normally; tell your doctor, as you may need to adjust your dose of Hydrocortisone.
• If hydrocortisone is administered to a premature newborn, it may be necessary to monitor heart function and structure.
• If you have hyperthyroidism (an overactive thyroid gland).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using hydrocortisone. They may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with hyperthyroidism treated with hydrocortisone. You may need additional treatment to alleviate this condition.

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

Taking Hydrocortisone with other medicines

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

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

During long-term treatment with medicines for the treatment of infections (antibiotics), your doctor may need to adjust your dose of Hydrocortisone. If used with mifepristone, a medicine used to interrupt pregnancy, the effect of Hydrocortisone may be reduced.

Also, consult your doctor or pharmacist if you are taking any of the following medicines, as you may need to have your dose of Hydrocortisone changed:

• 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 or Hypericum: used to treat depression and other diseases.
• Ketoconazole, itraconazole, posaconazole, and voriconazole: used to treat fungal infections.
• Erythromycin, telithromycin, and clarithromycin: used to treat bacterial infections.
• Growth stimulants such as somatropin.
• 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 digitalis.

Taking Hydrocortisone with food and drinks

Do not take the medicine with grapefruit juice, as it will interfere with its action.

Pregnancy, breastfeeding, and fertility

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

It is essential to continue treatment with Hydrocortisone during pregnancy. It is unlikely that treatment in pregnant women with adrenal insufficiency will produce harmful effects in the mother or the child. If you become pregnant, you should inform your doctor, as your dose of Hydrocortisone may need to be adjusted.

You can breastfeed while taking Hydrocortisone tablets. Hydrocortisone is excreted in breast milk. The doses of hydrocortisone used as replacement therapy are unlikely to have any effect on the child. 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 to indicate that Hydrocortisone, at the doses used in replacement therapy, affects fertility.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is small. Extreme fatigue and brief episodes of dizziness (vertigo) have been reported. Untreated or poorly treated adrenal insufficiency reduces the ability to concentrate and affects the ability to drive and use machines. Therefore, it is essential to take this medicine as your doctor has indicated when driving or using machines. If you feel affected, do not drive or operate machines until you have discussed the problem with your doctor.

Hydrocortisone contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Information for athletes

This medicine contains hydrocortisone, a component that can produce a positive result in doping tests.

3. How to take Hydrocortisone

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The dose is specific for you and has been decided by your doctor.

The usual maintenance dose in adults is 20-30 mg per day, administered once a day 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 should not be chewed or crushed. If more than one administration is needed per day, the morning dose should be taken as indicated; additional doses can be taken with or without food.

Need for additional doses of Hydrocortisone

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

The following signs and symptoms may indicate that you need to take additional doses of Hydrocortisone or other medicines containing hydrocortisone: fatigue, weight loss, stomach upset, feeling dizzy when standing up from sitting or standing, darkening of the skin, especially in skin folds and exposed areas. Contact your doctor as soon as possible if you notice any of these signs or symptoms.

Seek medical attention immediatelyif 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 great mental confusion).

If you take more Hydrocortisone than you should

Taking too high a dose of this medicine for more than a few days can be harmful to your health. It can cause high blood pressure, weight gain, and excessive blood sugar. Sometimes it is necessary to increase the dose so that the body can handle certain stressful situations, such as fever. If you need extra doses frequently and periodically, you should consult your doctor to reconsider your maintenance dose.

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

It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Hydrocortisone

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

If you stop taking Hydrocortisone

Stopping the intake of Hydrocortisone can be life-threatening. Therefore, it is essential to continue taking this medicine as your doctor has indicated. Do not stop treatment without consulting your doctor.

Do not stop treatment abruptly. The reduction of the dose should always be gradual, to avoid possible effects on the corticosteroids produced by our body.

If you have any other 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 everybody gets them.

The side effects observed may be associated with the prolonged use of corticosteroids and occur with greater probability at the start of treatment or when increasing the dose.

The frequency of these possible side effects is not known (cannot be estimated from the available data). Consult your doctor if you experience any of them:

• Moderate or severe allergic reactions (anaphylaxis).

• Greater predisposition to infections, activation of viral or fungal infections (including herpes).
• Diabetes or problems with blood sugar levels (checked with blood tests).
• Retention of salts and water that produces edema and arterial hypertension (checked in the clinical examination), and low potassium levels in the blood, increased appetite, and weight gain.
• Dizziness, discomfort, fatigue, difficulty sleeping.
• Increased eye pressure (glaucoma), opacity of the eye lens (cataract), dry eye, blurred vision.
• Burning, worsening of existing stomach ulcers, stomach pain, nausea, diarrhea, esophageal or pancreatic inflammation, tooth erosion.
• Weakening of bones: may cause bone fractures, joint inflammation.
• Stretch marks, bruising, acne-like rash, excessive growth of facial hair, slow wound healing.
• Irregular menstruation or interruption of menstruation.
• Worsening of epilepsy, convulsions, sedation.
• Delayed growth in childhood, adolescence, and youth.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature newborns.

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

• If you feel depressed, even thinking about suicide.
• If you feel euphoric or have mood changes.
• If you have anxiety, sleep problems, difficulty thinking, feel confused, or notice that you are losing your memory.
• If you see, hear, or feel things that do not exist.
• If you have strange and frightening thoughts, change your behavior.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Hydrocortisone

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Hydrocortisone

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

Appearance of the product and pack contents

Round, biconvex tablets, white in color, scored on one face and smooth on the other.

The tablet can be divided into equal doses.

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

Not all 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 last revision of this leaflet:August 2025

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