Hydrocortisone Lorién 100 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

B.PACKAGE LEAFLET

Package leaflet: information for the user

Hydrocortisone Lorien 100 mg powder for injectable solution and for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Hidrocortisona Lorien is and what it is used for

The active substance in Hidrocortisona Lorien is hydrocortisone, a glucocorticoid (a natural hormone) produced in humans by the adrenal cortex. The main effect of hydrocortisone is the suppression of inflammatory and immune reactions (the immune system's responses to foreign substances). In addition, it has an effect on carbohydrate and protein metabolism.

When the adrenal cortex does not function properly, for example in Addison's disease or adrenogenital syndrome, this medicine may be used in combination with other adrenal cortex hormones. It may also be used when adrenal cortex function is impaired due to another condition.

Additionally, this medicine may be used for short periods when other treatments do not help or are not sufficiently effective:

• in cases of severe exacerbations of asthma, chronic bronchitis, or emphysema;
• in status asthmaticus (a persistent asthma attack);
• in combination with other agents for severe hypersensitivity reactions.

2. What you need to know before using Hidrocortisona Lorien

Do not use Hidrocortisona Lorien

• if you are allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6);
• if you have an acute viral, fungal, or tropical worm infection. Bacterial infections must be treated first before starting treatment with this medicine;
• if you have gastric or duodenal ulcer;
• if you have received or need to receive vaccines with live or attenuated viruses, do not use this medicine at a dose that would weaken your immune system.

This medicine must not be injected:

• into the spinal cord (intrathecal) or via the epidural route.

General conditions for not using adrenal cortex hormones (glucocorticosteroids) and precautions applicable to systemic glucocorticosteroid therapy also apply to this medicine.

Warnings and precautions

Because the risk of side effects with glucocorticosteroid use increases as the dose and duration of treatment increase, the benefits and risks of treatment will be carefully weighed against each other when determining the dose and duration of therapy.

The use of this medicine must not be stopped suddenly, but should be gradually withdrawn.

Consult your doctor or pharmacist before starting to use this medicine.

• Patients undergoing surgery, experiencing an accident, or contracting an infection during or after hydrocortisone treatment may occasionally require treatment with fast-acting glucocorticoids.
• Glucocorticoids may suppress the symptoms of infection, and new infections may occur during their use because your resistance may decrease. In case of bacterial infection, your doctor will first identify the type of bacteria and treat the infection before you receive glucocorticoid treatment.
• If you are taking medicines that suppress the immune system, you may be more susceptible to infections than healthy individuals.
• If you have a pre-existing cardiovascular risk factor, high doses and prolonged use of this medicine may increase the risk of cardiovascular disease. Examples include increased blood pressure and increased and/or decreased levels of one or more blood fats (lipids, cholesterol, triglycerides).
• If you have reduced heart pumping strength (congestive heart failure).
• Hydrocortisone may cause elevated blood pressure, water and salt retention, and increased potassium excretion. Your doctor may prescribe a low-salt diet with potassium supplements. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
• If you have septic shock—a condition caused by infection characterized by a sudden drop in blood pressure, pallor, restlessness, rapid and weak pulse, moist skin, and reduced consciousness. In such cases, routine use of this medicine is not recommended.
• You should not be vaccinated with a live virus vaccine during treatment with high-dose hydrocortisone.
• If you have active tuberculosis or are being treated for tuberculosis, your doctor will monitor you closely during treatment with this medicine.
• If you have ever had an allergic reaction to a medicine, your doctor will take necessary precautions before starting treatment.
• If you have an eye infection caused by herpes, an ophthalmologist should monitor you regularly during treatment.
• Corticosteroid treatment may cause retinal detachment and cataracts. Contact your doctor if you experience blurred vision or other visual disturbances.
• Therapy with corticosteroids may cause retinal detachment and cataracts.
• During treatment, psychiatric changes may occur, such as euphoria, insomnia, irritability, personality changes, and depression.
• Cases of fat accumulation in the spinal canal have been reported with prolonged use of high-dose corticosteroids.
• If you have inflammation of the stomach or intestines, high blood pressure, active or latent gastric ulcer, kidney failure, adrenal medulla tumor, Kaposi's sarcoma (a specific type of skin cancer), osteoporosis, myasthenia gravis (a muscle disease), or if you have or are at increased risk of thrombosis, your doctor will exercise great caution when prescribing this medicine.
• If you have liver disease, your doctor may prescribe a lower dose, as the effect of hydrocortisone may be enhanced.
• If you have Cushing's disease (a condition caused by excessive levels of cortisol hormone in the blood).
• If you have reduced thyroid function (hypothyroidism).
• If you have diabetes.
• If you have a condition associated with seizures/convulsions (e.g., epilepsy).
• If you are taking certain anti-inflammatory and antipyretic analgesics (NSAIDs).
• If you have pancreatitis, with severe upper abdominal pain radiating to the back, nausea, and vomiting.
• If hydrocortisone is administered to a premature newborn, monitoring of heart function and structure may be necessary.

Use in sports

This medicine contains substances that may lead to a positive analytical finding in doping control tests.

Children and adolescents

Long-term treatment with glucocorticoids may cause growth retardation in children and adolescents. Therefore, doctors usually treat children with alternate-day dosing.

Infants and children treated with corticosteroids long-term have an increased risk of developing increased intracranial pressure.

High doses of corticosteroids may cause pancreatitis in children.

Other medicines and Hidrocortisona Lorien

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

You must inform your doctor about any other medicines, such as:

• Isoniazid: used to treat bacterial infections.
• Rifampicin: an antibiotic used to treat tuberculosis.
• Substances that counteract blood clotting (oral anticoagulants).
• Barbiturates, carbamazepine, and phenytoin used to treat epilepsy.
• Substances used to treat certain nervous system disorders (anticholinergics).
• Substances used for the muscle disease myasthenia gravis (anticholinesterases).
• Substances used to treat diabetes (antidiabetics).
• Aprepitant and fosaprepitant: used to prevent nausea and vomiting.
• Itraconazole and ketoconazole: used to treat fungal infections.
• Some medicines may increase the effects of hydrocortisone, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: indinavir, ritonavir, cobicistat).
• Aminoglutethimide and cyclophosphamide: used to treat cancer.
• Tacrolimus: used after organ transplantation to prevent organ rejection.
• Diltiazem: used to treat heart problems or high blood pressure.
• Digoxin: a heart medicine belonging to a group of medicines called cardiac glycosides.
• Estrogens (including oral contraceptives containing estrogens).
• Cyclosporine: used to treat conditions such as severe joint inflammation (rheumatoid arthritis), severe skin conditions associated with dry, scaly rashes (psoriasis), and to prevent rejection of a transplanted organ.
• Clarithromycin, erythromycin, and/or troleandomycin: substances used to prevent/combat certain infections.
• Aspirin (acetylsalicylic acid) and a certain group of analgesics that also have anti-inflammatory and antipyretic action (NSAIDs).
• Potassium-depleting substances, such as diuretics.

Hidrocortisona Lorien with food and drinks

Grapefruit juice may alter the effects of this medicine. Always consult your doctor or pharmacist about drinking grapefruit juice with this medicine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medicine may be used according to approved indications. Chronic use of higher doses should be avoided as much as possible.

Breastfeeding

Corticosteroids pass into breast milk. Therefore, breastfeeding is not recommended during corticosteroid treatment unless advised by your doctor.

Fertility

There is no evidence that corticosteroids interfere with fertility.

Driving and using machines

Various possible side effects of this medicine, such as blurred vision, mood changes, muscle weakness, and involuntary muscle contractions, may negatively affect the ability to drive and use machines.

Hidrocortisona Lorien contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial (9.46 mg per dose), i.e., essentially "sodium-free." This should be taken into account in patients on sodium-controlled diets.

3. How to use Hydrocortisone Lorien

Your doctor or nurse will inject this medicine. It can be administered into a vein (by injection or infusion) or into a muscle (by injection).

Your doctor will determine the appropriate dose for you based on your illness and condition.

If you use more Hydrocortisone Lorien than you should

There is no information available on acute overdose with this medicine. Hydrocortisone is dialyzable. This means that, in case of overdose, excess hydrocortisone can be removed from the blood with the help of an artificial kidney. With repeated long-term use (daily or several times a week), Cushing's syndrome (including moon face) may occur.

If you forget to use Hydrocortisone Lorien

Usually, your doctor will ensure you receive the next dose on time. Do not take a double dose to make up for missed doses.

If you stop treatment with Hydrocortisone Lorien

If treatment with this medicine is stopped suddenly, or if you undergo surgery, experience an accident, or develop a serious infection during treatment, your adrenal cortex may not function as well. This could cause the symptoms of the condition for which you are being treated to reappear. Epileptic seizures, dizziness, and headache may occur, especially in children, if treatment is stopped too early. Therefore, your doctor will usually gradually reduce treatment with this medicine.

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 following side effects have been reported with unknown frequency, meaning that the frequency cannot be estimated from the available data:

• Hydrocortisone suppresses the symptoms of an inflammatory response, so infections may be difficult to detect, latent infections may be activated, and new infections may occur.
• Infections that are normally rare may occur (opportunistic infection).
• A type of skin cancer (Kaposi's sarcoma).
• Severe increase in blood pressure due to inflammation of the adrenal medulla (pheochromocytoma).
• Higher than normal number of white blood cells in the blood (leukocytosis).
• Severe allergic reaction to certain substances, involving a sudden drop in blood pressure, paleness, restlessness, rapid and weak pulse, moist skin, and reduced consciousness following significant and sudden vasodilation (anaphylactic reaction).
• Sudden drop in blood pressure, paleness, restlessness, rapid weak pulse, moist skin, and reduced consciousness due to significant and sudden vasodilation without pre-existing allergy (anaphylactoid reaction).
• Hypersensitivity to medicines.
• Development of obesity (in head and trunk), moon-shaped face, and high blood pressure (Cushing's syndrome).
• Deficiency of one or more hormones secreted by the pituitary gland (suppression of the hypothalamic-pituitary-adrenal axis).
• Syndrome associated with withdrawal symptoms that may appear after stopping corticosteroid treatment (steroid withdrawal syndrome).
• Acidification of the blood (metabolic acidosis).
• Sodium retention by the kidneys (sodium retention).
• Retention of excess fluid in the body (fluid retention).
• Disruption of fat metabolism (dyslipidemia).
• Altered acid-base balance in the blood due to excessive loss of potassium (hypokalemic alkalosis).
• Reduced ability to tolerate glucose (reduced glucose tolerance).
• Dysregulation of blood sugar leading to the detection of latent diabetes or increased need for insulin or other medications to lower blood sugar.
• Increased appetite.
• Accumulation of fatty tissue in different parts of the body (lipomatosis).
• Psychotic disorders, such as excessive lightheartedness associated with high energy (mania), delusions, seeing things that are not there (hallucinations), and severe mental illness (schizophrenia) characterized by gradual personality change.
• Mood disorders such as depressed mood, extreme feeling of happiness (euphoria), emotional lability, drug dependence, suicidal thoughts.
• Mental disorder.
• Confusion.
• Fear.
• Personality change.
• Mood changes.
• Abnormal behavior.
• Insomnia.
• Irritability.
• Worsening of pre-existing psychotic behavior.
• Accumulation of fat in the spinal canal (epidural lipomatosis).
• Increased intracranial pressure.
• Increased pressure in the brain with inflammation of the mucous membranes (benign intracranial hypertension).
• Seizure with loss of consciousness and muscle spasms (convulsions).
• Memory loss (amnesia).
• Impairment of cognitive functions such as perception, attention, concentration, memory, orientation, language use, and skills (cognitive decline).
• Dizziness.
• Headache.
• Retinal and choroidal disease (chorioretinopathy).
• Blurred vision.
• Clouding of the lens (cataracts).
• Increased eye pressure (glaucoma).
• Abnormal protrusion of the eye (exophthalmia).
• Vertigo.
• The heart's pumping strength may decrease in at-risk patients (congestive heart failure).
• Increased blood clotting (thrombosis).
• Reduced blood pressure (hypotension).
• Increased blood pressure (hypertension).
• Pulmonary embolism.
• Persistent hiccups.
• Gastric/duodenal ulcers with possible perforation and bleeding.
• Bleeding and injury to the intestinal wall (intestinal perforation).
• Gastric bleeding.
• Inflammation of the pancreas with severe upper abdominal pain radiating to the back, nausea, and vomiting (pancreatitis).
• Inflammation of the esophagus with or without ulcers (esophagitis).
• Abdominal pain.
• Swollen stomach (abdominal distension).
• Diarrhea.
• Impaired digestion with a feeling of fullness in the upper stomach, stomach pain, belching, nausea, vomiting, and heartburn (dyspepsia).
• Nausea.
• Sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema).
• Excessive hair growth in women (hirsutism).
• Small spots of bruising under the skin (petechiae).
• Small spots of bruising on a mucous membrane (ecchymosis).
• Thin, fragile, and wrinkled skin (cutaneous atrophy).
• Redness of the skin (erythema).
• Excessive sweating (hyperhidrosis).
• Stretch marks on the skin (striae).
• Skin rash.
• Itching (pruritus).
• Skin rash with intense itching and formation of bumps (urticaria).
• (Adolescents) Acne.
• Muscle weakness.
• Muscle pain (myalgia).
• Muscle disease (myopathy).
• Reduction of muscle tissue due to disuse or inability to use a muscle because of a nervous system disorder (muscle atrophy).
• Bone death (osteonecrosis).
• Loss of bone density (osteoporosis).
• Bone fracture (pathological fracture).
• Joint disease due to a nervous disorder (neuropathic arthropathy).
• Joint pain (arthralgia).
• Growth delay.
• Collapsed vertebrae (spinal compression fracture).
• Tendon ruptures.
• Irregular menstruation.
• Impaired wound healing.
• Accumulation of fluid in arms and legs (peripheral edema).
• Fatigue.
• General feeling of discomfort.
• Skin reactions at the injection site.
• Increased intraocular pressure.
• Decreased ability to process sugars (carbohydrates), which may lead to increased need for insulin or other substances to reduce blood sugar levels.
• Decreased potassium levels in the blood, severe cases recognizable by muscle cramps or muscle weakness and fatigue (hypokalemia).
• Increased calcium levels in the urine.
• Abnormal blood test results (increased alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase in blood).
• Increased levels of waste products in the blood due to protein breakdown (increased blood urea).
• Suppression of reactions in skin allergy tests.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature newborns.
• Weight gain.

Other adverse effects in children and adolescents

Growth suppression may occur in children.

Reporting of adverse effects

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

5. Storage of Hydrocortisone Lorien

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

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

Do not store above 25°C. Keep the vials in the original packaging to protect them from light.

Once the medicine has been mixed with sterile water for injectable preparations, the solution should be used immediately. Any unused liquid should be safely discarded.

Your doctor will check that the solution contains no particles and has not changed colour before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hydrocortisone Lorien

• The active substance is hydrocortisone. Each vial contains 100 mg of hydrocortisone (as sodium hydrocortisone succinate).
• The other components are: sodium dihydrogen phosphate dihydrate, anhydrous disodium hydrogen phosphate, and sodium hydroxide.

Appearance of Hydrocortisone Lorien and contents of the pack

Hydrocortisone Lorien is a white or almost white powder for injectable solution/perfusion. It is supplied in a colourless glass vial containing 100 mg of hydrocortisone, closed with a rubber stopper and sealed with an aluminium cap.

Hydrocortisone Lorien is available in the following pack sizes:

Carton box containing 1 vial or carton box containing 2 PVC protective trays, each covered with a PET/PE foil and containing 5 vials, with a package leaflet.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Lorien, S.L.

Av. Josep Tarradellas, 8, Ático 1ª 08029 Barcelona, Spain

Manufacturer:

S.C. Rompharm Company S.R.L.

Eroilor Street, no. 1A, Otopeni, Ilfov County, 075100, Romania

This medicinal product is authorized in the European Economic Area countries with the following names:

Hungary: Hydrocortison Rompharm 100 mg por oldatos injekcióhoz/ infúzióhoz
Romania: Hidrocortizon Rompharm 100 mg pulbere pentru soluție injectabila/perfuzabila
Bulgaria: Хидрокортизон Ромфарм 100 mg прах за инжекционен/инфузионен разтвор
Spain: Hidrocortisona Lorien 100 mg powder for injectable solution and for perfusion EFG

Date of the most recent review of this leaflet: May 2023

This information is intended for healthcare professionals only:

Posology and method of administration:

This medicinal product may be administered by intravenous or intramuscular injection, or by intravenous infusion. Intravenous injection is the preferred method for emergency use.

After the initial emergency period, consideration should be given to using a long-acting injectable preparation or an oral formulation. The duration of intravenous administration depends on the dose; it may range from 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more).

In general, high-dose corticosteroid therapy should only be administered until the patient's condition has stabilized (usually within 48 to 72 hours).

Although adverse effects associated with short-term, high-dose corticosteroid therapy are uncommon, peptic ulceration may occur. Prophylactic therapy with antacids is indicated.

If hydrocortisone therapy needs to be continued for periods exceeding 48–72 hours, hypernatraemia may occur; therefore, it may be preferable to switch to another corticosteroid such as sodium methylprednisolone succinate, which causes little or no sodium retention.

The initial dose of this medicinal product is 100 mg to 500 mg or more, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4, or 6 hours, according to the patient's clinical condition. Corticosteroid therapy is an adjunctive treatment and not a substitute for conventional therapy.

In patients with hepatic disease, an increased effect may occur, and a dose reduction should be considered.

Paediatric population

The dose of this medicinal product in paediatrics is determined more by the severity of the condition and the patient's response than by age or body weight. The dose may be reduced for these patients, but should not be less than 25 mg per day.

Preparation of solutions:

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

After reconstitution, the solution is clear, without visible particles or precipitates. The formulation contains no preservatives and is for single use only. Once opened, the contents of a vial should normally be used immediately.

Instructions:

Do not add more than 2 ml of sterile water for injections to the contents of a vial containing sterile powder, under aseptic conditions.

For intravenous or intramuscular injection:

Prepare the solution as described above. No further dilution is required for intravenous or intramuscular injection; shake, withdraw, and use.

For intravenous infusion:

First prepare the solution as described above, adding no more than 2 ml of sterile water for injections to the vial. This solution containing 100 mg of hydrocortisone may be added to 100–1000 ml (but not less than 100 ml) of one of the following solutions:

• 5% aqueous glucose solution
• 0.9% sodium chloride solution

If the patient is on a low-sodium diet, the 5% glucose solution may be used.

When reconstituted as directed, the pH of the solution will range from 7.0 to 8.0.

Shelf life

Unopened vial:

2 years.

In-use stability of the solution after reconstitution with 2 ml of sterile water for injections has not been investigated. Therefore, the reconstituted solution must be used immediately.

After reconstitution and dilution:

After reconstitution and dilution with 100 ml and 1000 ml of 0.9% sodium chloride injection solution, chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.

After reconstitution and dilution with 100 ml and 1000 ml of 5% glucose injection solution, chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for in-use storage conditions and duration lies with the user.

Special precautions for storage:

Do not store above 25°C.

Keep the vial in the outer packaging to protect from light.

For further information, refer to the Summary of Product Characteristics.