Prospect: information for the user

Actocortina 75 mg powder and solvent for injectable solution

hydrocortisone

1.What is Actocortina and for what it is used

2.What you need to know before starting touse Actocortina

3.How to use Actocortina

4.Possible adverse effects

5.Storage of Actocortina

6.Contents of the package and additional information

Actocortina belongs to a group of hormonal preparations called

systemic corticoesteroids that act as potent anti-inflammatory agents.

Actocortina is used for the treatment of:

• acute exacerbations of asthma
• anaphylactic shock and acute immediate hypersensitivity reactions that pose a life-threatening risk to the patient (e.g. angioedema, laryngeal edema)
• acute adrenal insufficiency
• treatment of acute rejection of organ transplants
• myxedema coma
• necrotizing vasculitis
• rheumatoid arthritis

tenosynovitis and bursitis

Do not use Actocortina

• if you are allergic to the active ingredient, other steroidsor to any of the other components ofthis medication (listed in section 6).

Except in emergency cases, this medication should not be used in the following cases as there is a risk of worsening. This decision should be made by your doctor:

• gastric or duodenal ulcers
• known psychiatric disorders, emotional instability, psychosis
• glaucoma
• herpetic keratitis
• lymphadenopathy following tuberculosis vaccination
• amoeba or fungal infections
• poliomyelitis
• viruses such as chickenpox, herpes simplex, herpes zoster
• latent or manifest tuberculosis
• during the pre- and post-vaccination period with live attenuated virus or bacterial vaccines (approximately 8 weeks before and 2 weeks after vaccination)

Warnings and precautions

Consult your doctor before starting to useActocortina.

You should inform your doctor if you suffer or have suffered from any of the following conditions:

• renal insufficiency
• heart failure
• diabetes mellitus
• osteoporosis
• hypertension
• glaucoma
• epilepsy
• severe psychiatric pathology
• muscle damage caused by steroid treatments
• gastrointestinal diseases such as digestive ulcers, ulcerative colitis, ileitis, diverticulitis
• myasthenia gravis
• poliomyelitis
• liver insufficiency
• serious fungal infections
• tuberculosis
• known or suspected infection (viral, bacterial or amoebic).
• pre-existing lymphoid tumors
• hyperparathyroidism
• hypothyroidism
• malaria cerebral

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

The rapid intravenous injection of high doses of Actocortina may sometimes cause acute cardiac problems, so injections should be administered slowly or by infusion.

This medication increases the risk of infections and increases the severity of the same. It is recommended to discard before starting treatment infections such as chickenpox or measles. It may also increase the risk of eye infections.

Vaccines with live strains should not be administered to patients undergoing corticosteroid treatment, and the response to other types of vaccines may be reduced.

Long-term systemic therapy with Actocortina may cause adrenal insufficiency, Cushing's syndrome, or unstable blood sugar levels in the body.

Actocortina may cause mental disorders that include euphoria, insomnia, mood changes, personality changes, depression, and psychotic tendencies. This can occur during the initiation of treatment and during dose adjustments. The risks may be greater when high doses are administered. Most reactions resolve after reducing the dose.

Treatment with high doses of Actocortina may cause "steroid diabetes" benign. This is reversible when treatment is stopped. In diabetics, treatment usually causes a disturbance, which can be compensated by adjusting the insulin dose.

Children and adolescents

It may cause growth retardation in childhood and adolescence that may be irreversible.

In premature infants, it may cause hypertrophic cardiomyopathy.If hydrocortisone is administered to a premature infant, it may be necessary to control heart function and structure.

Older patients

This medication may have greater consequences in this type of patient, such as osteoporosis, hypertension,hypokalemia, diabetes, increased risk of infections, skin thinning. Close medical supervision is required to avoid severe reactions.

Actocortina and other medications

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

The followingmedicationsreduce the therapeutic effect ofActocortina:

• rifampicin and rifabutin (medications used in the treatment of mycobacterial infections such as tuberculosis)
• carbamazepine (medication used in the treatment of manic-depressive disorders), barbiturates (phenobarbital, medication used in the treatment of epilepsy)
• phenytoin (medication used in the treatment of seizures and convulsions)
• ephedrine (medication with bronchodilator effect)
• aminoglutethimide (medication used in the treatment of adrenal cortex tumors)
• colestiramine and colestipol (medications used to treat hypercholesterolemia)
• CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, dexamethasone)

The following medications may increase the therapeutic effect of Actocortina:

• ciclosporin (immunosuppressive medication)
• oral contraceptives (e.g. estrogens)
• medications for the treatment of HIV (ritonavir, cobicistat)

Actocortina reduces the effects of the following medications:

• hypoglycemic agents (medications used in the treatment of diabetes,including insulin)
• anti-hypertensive medications (medications used to treat high blood pressure)
• diuretics (medications to increase urine production)
• cholinesterase inhibitors (medications used to treat muscle weakness and to diagnose gallstones)

Actocortina may increase the effects of the following medications:

• acetazolamide, diuretics, amphotericin B, and carbenoxolone (concomitant treatment may cause subsequent cardiac arrhythmias)
• coumarin anticoagulants (concomitant treatment requires monitoring to avoid spontaneous bleeding)
• ciclosporin (immunosuppressive medications)

Other interactions with medications

Actocortina may interact with other medications, so your doctor will make close controls if you are taking these medications.

Actocortina increases the toxicity of digitalis glycosides (e.g. digoxin) and the risk of gastrointestinal bleeding and ulceration when used concomitantly with medications such as aspirinand non-steroidal anti-inflammatory drugs (NSAIDs).

The concomitant use of Actocortina withfluoroquinolones (medications for treating bacterial infections) may increase the risk of tendon rupture.

Corticosteroids may reduce the effects of certain types of vaccines.

Use of Actocortina with food

Ginseng may increase the risk of side effects of Actocortina.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

It is not recommended to use Actocortina during pregnancy, or in women of childbearing age who are not using contraceptive methods.

Breastfeeding

Actocortina is excreted in breast milk. It cannot be ruled out that there is a risk to the newborn or infant.

Your doctor must decide whether to interrupt breastfeeding or interrupt treatment.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

Drug analysis/control doping

Inform athletes that this medication contains a component that may establish a positive analytical result for doping control.

Actocortina contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

Your doctor will decide the location of the injection, the amount of medication, and the number of injections you will receivedepending on the disease being treated and its severity. Your doctor will administer the lowest dose for the shortest time necessary to relieve symptoms.

Your doctor or another healthcare professional will administer the treatment. The contents of the vial must be dissolved with injection water, and it will be administeredthrough intramuscular injection, slow intravenous injection, drop by drop, or continuous infusion.

The recommended dose is as follows:

Adults

• Intravenous or intramuscular:

Generally, the recommended dose range for a single dose, although not limited, varies from a fraction of the vial contents (less than 74.53 mg of hydrocortisone) to approximately 372.65 mg of hydrocortisoneadministered by slow intravenous injection over a period of 1 to 10 minutes (for doses of 372.65 mg or higher). This dose can be repeated at intervals of 2, 4, or 6 hours, depending on the disease being treated and the patient's response. Alternatively, this medication can be administered as an intravenous infusion. Clinical effect is observed in two to four hours and persists for up to eight hours after intravenous injection. The same dose can be administered byintramuscular injection, but the response is likely to be slower, especially in shock.Do not exceed 6 g/day.

• Intra-articular and soft tissues (infiltration when limited to one or two locations):

The amount administered depends on the site of application (large joints: 19 mg; small joints: 7.5 mg; serous bursae, including hallux valgus: 19-28 mg; tendon sheaths: 4-9 mg; soft tissue infiltration: 19-37.5 mg; ganglia: 9-19 mg).

Use in children

Although the dose of Actocortina can be reduced for infants and children, it is guided more by the severity of the condition and the response than by age or body weight, but it should not be less than 25 mg per day.

Geriatric patients

If you use Actocortina for a prolonged period, you will havean increased risk of diabetes, hypertension, congestive heart failure, osteoporosis, and depression.

Clinical monitoring is required to avoid life-threatening reactions.

Patients with altered renal function

If you have severe kidney problems, your doctor may monitor you and may need to adjust the dose.

Patients with altered liver function

You are more prone to severe unwanted effects.Dosage adjustments may be necessary.

If you use more Actocortina than you should

In prolonged treatments, an increase in blood cortisol levels may occur, which subsides in some days with medication cessation.

No cases of overdose have been described. In case of overdose or accidental ingestion, consult your doctor and/or hospital.

If you forgot to use Actocortina

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

If you interrupt treatment with Actocortina

Your doctor will indicate the duration of your treatment with Actocortina.

The treatment should not be stopped abruptly. Your doctor will indicate how to do it, as therapid withdrawal of Actocortina after prolonged treatment can lead to serious complications such as acute adrenal insufficiency, hypotension,hormonal imbalances, or death.

You may also experience a "withdrawal syndrome," including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful/pruritic skin nodules, and weight loss.

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

The side effects of Actocortina depend on the dose, the time of administration, and the duration of treatment. Adverse reactions can be minimized by using the lowest effective dose for the shortest possible time.

The following drug reactions with hydrocortisone have been reported at high doses or in indications other than adrenal insufficiency replacement therapy, although the frequency is unknown.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, even if it is a possible adverse reaction that does not appear 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

Store below 25°C.Store in the original packaging to protect it from light.

Once the solution is reconstituted, it must be stored in the refrigerator (between 2°C and 8°C) and cannot be used after 24 hours from reconstitution.

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

Composition of Actocortina

• The active principle is sodium phosphate hydrocortisone.Each vial contains 74.53 mg of hydrocortisone (equivalent to 100 mg of sodium phosphate hydrocortisone).
• The other component is injection water.

Appearance of Actocortinaand content of the container

White to bone-colored powder.

The sterile powder is packaged in a 5 ml type I colorless glass vial.

The transparent and colorless solvent is packaged in ampoules.

Each container contains 10 vials with sodium phosphate hydrocortisone powder and 10 ampoules of solvent.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

B.BRAUN MEDICAL, S.A.

Ronda de los Olivares

Polígono Industrial Los Olivares

Parcela 11. 23009; Jaén

Spain

Local Representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet:November 2022

Other sources of information

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

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This information is intended solely for healthcare professionals:

Dissolve the contents of the vial with injection water and administer by intramuscular injection, slow intravenous drip, drop by drop, or continuous infusion:

• Actocortina 75 mg with 1 ml of injection water

In the absence of compatibility studies, this medication should not be mixed with others.