Product Information for the Patient

Hidroaltesona 20 mg Tablets

Hydrocortisone

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

• Keep this product information, 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 who may 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 product information. See section 4.

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

Hydrocortisone 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 need a replacement treatment to survive.

Hydrocortisone replaces the missing natural cortisol in adrenal insufficiency.

Do not take Hidroaltesona

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroaltesona.

• When you have any disease that prevents you from taking the medication or it does not absorb correctly in your stomach. This situation may occur in case of digestive problems that occur with vomiting or diarrhea. In such situations, you must immediately go to the doctor to receive treatment with hydrocortisone injections and administration of liquids.
• If you have any short-term or temporary process, such as an infection, fever, or any situation that causes a lot of physical stress, such as a surgical intervention: your hydrocortisone dose must be temporarily increased. Ask your doctor without delay to inform you about the best way to handle these situations. If you are to undergo a surgical intervention, inform your doctor or dentist that you are taking this medication.
• If, for any other reason, your general health worsens despite taking the medication as prescribed; in such a case, go to the doctor immediately.
• If your thyroid does not function normally; tell your doctor, as they may need to adjust your Hidroaltesona dose.
• If hydrocortisone is administered to a premature newborn, it may be necessary to monitor the heart's function and structure.

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

Taking Hidroaltesona with other medications

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

Some medications may increase the effects of Hidroaltesona, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

During long-term treatment with medications for infection treatment (antibiotics), it may be necessary for your doctor to adjust your Hidroaltesona dose. If used with mifepristone, a medication used to terminate pregnancy, the effect of Hidroaltesona may decrease.

Also, consult your doctor or pharmacist if you are taking any of the following medications, as it may be necessary to change your Hidroaltesona dose:

• 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 promoters such as somatotropin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) and salicylates.
• Medications used to treat certain types of cancer, such as methotrexate.
• Estrogens and other oral contraceptives, anticoagulants, antidiabetics, antihypertensives, diuretics, and digitalis.

Taking Hidroaltesona with food and drinks

Do not take the medication 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 medication.

It is essential to continue treatment with Hidroaltesona during pregnancy. It is unlikely that treatment in pregnant women with adrenal insufficiency will cause adverse effects in the mother or child. If you become pregnant, you must inform your doctor, as they may need to adjust your Hidroaltesona dose.

You can breastfeed while taking Hidroaltesona 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 is no evidence that Hidroaltesona, at the doses used in replacement therapy, affects fertility.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is small. Extreme fatigue and brief episodes of dizziness (vertigo) have been reported. Untreated or poorly treated adrenal insufficiency reduces concentration ability and affects the ability to drive and operate machinery. Therefore, it is essential to take this medication as directed by your doctor while driving or operating machinery. If you feel affected, do not drive or operate machinery until you have discussed the problem with your doctor.

Hidroaltesona contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult them before taking this medication.

Information for athletes

This medication contains hydrocortisone, a component that may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication as 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 per day is needed, the morning dose should be taken as indicated; additional doses can be taken with or without food.

Need for additional doses of Hydrocortisone

During brief or temporary episodes, such as infections, fever, or physical stress of the type of a surgical intervention, you will need more hydrocortisone, as the 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 other hydrocortisone tablets instead of or in addition to Hydroaltesona. Consult your doctor and follow their instructions on the best course of action in these situations.

The following signs and symptoms may indicate that you need to take additional doses of Hydroaltesona or other medications containing hydrocortisone: fatigue, weight loss, stomach discomfort, dizziness when standing up or standing, darkening of the skin, especially in skin folds and exposed areas. Contact your doctor as soon as possible if you observe any of these signs or symptoms.

Seek immediate medical attentionif you experience any of the following signs or symptoms: intense weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, decreased level of consciousness, delirium (extreme mental confusion).

If you take more Hydroaltesona than you should

A dose that is too high for an extended period can be harmful to your health. It may cause elevated blood pressure, weight gain, and excessive blood sugar levels. In some cases, it may be necessary to increase the dose to help the body cope with stressful situations, such as fever. If you need additional 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 at 915 62 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Hydroaltesona

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

If you interrupt the treatment with Hydroaltesona

Stopping the treatment with Hydroaltesona can be life-threatening. Therefore, it is essential to continue taking this medication as prescribed by your doctor. Do not stop treatment without consulting your doctor.

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

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

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

The observed side effects may be associated with the prolonged use of corticosteroids and occur more frequently at the beginning of treatment or when increasing the dose.

The frequency of these possible side effects is unknown (cannot be estimated from 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 (checked with blood tests).
• Retention of salts and water that produces edema and high blood pressure (checked in clinical examination), and low potassium levels in the blood, increased appetite and weight.
• Dizziness, discomfort, fatigue, difficulty sleeping.
• Increased eye pressure (glaucoma), opacity of the cornea (cataract), dry eye, blurred vision.
• Pain, worsening of existing stomach ulcers, stomach pain, nausea, diarrhea, esophageal or pancreatic inflammation, dental erosion.
• Weakening of bones: may cause bone fractures, joint inflammation.
• Stretch marks, bruises, acne-like rash, excessive facial hair growth, slow wound healing.
• Irregular menstruation or cessation of menstruation.
• Worsening of epilepsy, seizures, sedation.
• Retardation of growth in childhood, adolescence, and youth.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature newborns.

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

• Feeling depressed, even thinking about suicide.
• Feeling euphoric, or experiencing mood changes.
• Experiencing anxiety, difficulty sleeping, difficulty thinking, feeling confused, or noticing memory loss.
• Seeing, hearing, or feeling things that do not exist.
• Having strange and terrifying thoughts, changing behavior.

Reporting side effects

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

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

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Hydroaltesona

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

Appearance of the product and contents of the packaging

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 blisters in packs containing 10 and 30 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last review of this leaflet:November 2020.

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