Package Insert: Information for the Patient

Hidrocortisona Pharmis 100 mgPowder and Solvent for Injectable Solution

and for EFG Infusion

Read this entire package insert carefully before starting to use this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or nurse.

• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.

Package Insert Content

1. What is Hidrocortisona Pharmisand how it is used

2. What you need to know before starting to use Hidrocortisona Pharmis

3. How to use Hidrocortisona Pharmis

4. Possible adverse effects

5. Storage of Hidrocortisona Pharmis

6. Contents of the package and additional information

This medication contains hydrocortisone as sodium succinate.

Hydrocortisone belongs to a group of medications called corticosteroids or steroids.

Corticosteroids are produced naturally in our body and are important for many of our body's functions.

The use of extra corticosteroids, such as hydrocortisone, is an effective way to treat various diseases that involve inflammatory processes in the body. This medication reduces this inflammation, which would otherwise worsen. You should take this medication regularly to get the maximum benefit.

Corticosteroids can also help treat anaphylactic reactions or other stressful conditions. These include inflammatory or allergic conditions that affect:

•lungs, for example, bronchial asthma or inflammation caused by inhalation (aspiration) of vomit or stomach contents,

•skin, for example, Stevens-Johnson syndrome (an autoimmune disorder in which the immune system causes the skin to form blisters and peel) or systemic lupus erythematosus (lupus).

This medication may be prescribed to treat conditions other than those listed above, such as adrenal insufficiency and other medical emergencies, including treatment of shock associated with this.

You should consult a doctor if you do not feel better or if you feel worse or if you are unsure why you have been given this medication.

No use Hidrocortisona Pharmis

• If you think you have ever had an allergic reaction, or any other type of reaction after receiving this medicine, or any other medicine that contains corticosteroids, or any of the components of this medicine (a list of excipients is included in section 6). An allergic reaction can cause a rash or redness of the skin, swelling of the face or lips, or difficulty breathing.
• If you have an untreated fungal infection.
• If you have recently received or are about to receive a vaccine.

This medicine should not be injected:

• Into the spinal cord (intratecal) [except as part of certain chemotherapy regimens], or by epidural route. This medicine is not recommended for use in the intratecal administration route

Children and adolescents

This medicine should be used with caution in children as prolonged use interferes with the child's growth and development and may cause cataracts.

Hydrocortisone administered to premature newborns may require monitoring of heart function and structure.

Consult your doctor immediately in any of the above cases.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Hydrocortisone.

Inform your doctor before taking this medicine if you are in any of the following situations. Your doctor may need to monitor your treatment more closely, modify your dose, or administer another medicine.

• Chickenpox, shingles, or herpes eye infection. If you think you have been in contact with someone with chickenpox or shingles and have not yet had these diseases, or if you are unsure if you have had them.
• Severe depression or manic depression (bipolar disorder)(including having depression before or while taking steroid medicines like this, orif any of your close relativeshave had these diseases).
• If you experience mood swings, insomnia, and changes in personality.
• If you are under unusualstress.
• If you develop adrenal insufficiency.

• Cushing's syndrome(a hormonal disorder caused by high levels of cortisol in the blood).
• Diabetes(or if there is a family history of diabetes).
• Epilepsy, seizures, or convulsions.
• Glaucoma(increased eye pressure) or if there is a family history of glaucoma.
• Cataracts.
• Contact your doctor if you experience blurry vision or other visual disturbances.
• Heart problems, including heart failure or infections.
• Hypertension(high blood pressure).
• Fluid retention in the body.
• Hypothyroidism(an underactive thyroid).
• Pancreatitis(inflammation of the pancreas that causes severe abdominal and back pain).
• Peritonitis(inflammation of the thin layer of tissue (peritoneum) surrounding the intestines and stomach).
• Joint infection.
• Renal or hepatic disease.
• You have hadmuscle problems(pain or weakness) while taking steroids in the past.
• Myasthenia gravis(a condition that causes tired and weak muscles).
• Osteoporosis(fragile bones – bones that break easily).
• Phaeochromocytoma(a rare tumor of the adrenal gland tissue. The adrenal glands are located above the kidneys).
• Skin abscess.
• Peptic ulcer, diverticulitis(inflammation of the intestinal wall) or other severe stomach or intestinal problems.
• Thrombophlebitis: problems with veins due to thrombosis (blood clots in the veins) that result in phlebitis (red, swollen, and sensitive veins).
• Head trauma.
• Tuberculosis(TB) or if you have had tuberculosis in the past.

Corticosteroids should be used with caution as they can cause a condition known as central serous chorioretinopathy, where a collection of fluid forms under the light-sensitive layer in the back of the eye (retina), causing visual impairment and potentially leading to retinal detachment.

Prolonged high-dose corticosteroid therapy can cause an abnormal amount of fat deposition in or outside the spinal cord covering (epidural lipomatosis).

Use in athletes:

Warning to athletes: this medicine contains a component that may result in a positive analytical result for doping control.

Inform your doctor if you suspect an infection, as corticosteroids are known to increase susceptibility to infections and may mask their signs.

Other medicines and Hydrocortisone Pharmis

Inform your doctor or pharmacist if you are taking or have recently taken other medicines.

You should inform your doctor if you are using any of the following medicines, which may affect how Hydrocortisone works or any other medicine:

• Acetazolamide- used to treat glaucoma and epilepsy.
• Anticoagulants- used to "thin" the blood, such as acenocoumarol, phenindione, and warfarin.
• Anticholinergics- medicines called neuromuscular blockers that are used in some surgical procedures.
• Anticholinesterases- used to treat myasthenia gravis (a muscle disorder), such as distigmina and neostigmina.
• Antibiotics- such as isoniazid, erythromycin, clarithromycin, and troleandomycin.
• Antidiabetics- medicines used to treat high blood sugar.
• Antiemetics- such as Aprepitant and Fosaprepitant to prevent nausea and vomiting.
• Antimycotics- ketoconazole or itraconazole.
• Antituberculosos- rifampicin and rifabutin: antibiotics used to treat tuberculosis (TB).

• Antivirals- used to treat HIV infections.
• Inhibitors of aromatase- aminoglutethimide- used to treat cancer.
• NSAIDs- aspirin (high dose) and nonsteroidal anti-inflammatory drugs, such as ibuprofen, used to treat mild to moderate pain.
• Antiepileptics/anticonvulsants- barbiturates, carbamazepine, and phenytoin, used to treat epilepsy.
• Carbenoxolone- used to treat stomach acid.
• Ciclosporina- used to treat conditions such as severe rheumatoid arthritis, severe psoriasis, or after an organ or bone marrow transplant.
• Calcium channel blockers – Diltiazem.
• Cardiac glycosides- Digoxin - used to treat heart failure and/or irregular heartbeats.
• Immunosuppressants- tacrolimus and cyclophosphamide: used after an organ transplant to prevent organ rejection.
• Neuromuscular blockers - pancuronium, used in some surgical procedures.
• Oral contraceptives- products containing estrogen.
• Pharmacokinetic enhancers: products containing cobicistat
• Agents that reduce potassium, such as diuretics, amphotericin B, xanthines, or beta2 agonists (e.g., medicines used to treat asthma).
• Vaccines- inform your doctor or nurse if you have recently been vaccinated or are about to be vaccinated.Do notget "live" vaccines while using this medicine. Other vaccines may be less effective.
• Grape juice.

If you are taking medication continuously

If you are being treated for diabetes, high blood pressure, or fluid retention (edema), inform your doctor, as it may be necessary to adjust the dose of the medicines used to treat these conditions.

Before undergoing surgery, inform your doctor, dentist, or anesthesiologist to indicate that you are taking this medicine.

If you need your doctor to perform a test or in the hospital, it is essential to inform your doctor or nurse that you are taking this medicine. This medicine may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medicine, as it may delay fetal growth.

Corticosteroids can cross the placenta, which is a risk associated with low birth weight.

Cataracts have been observed in babies born to mothers treated with corticosteroids for a long time during pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding, as small amounts of corticosteroids may be found in breast milk. If you continue breastfeeding while on treatment, your baby may need additional tests to ensure they are not affected by this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

No studies have been conducted on the effect of this class of medicines on the ability to drive or operate machinery. Since corticosteroids may cause adverse effects such as seizures, do not drive or operate machinery if you experience these symptoms.

Hydrocortisone Pharmis contains sodium

This medicine contains 9.36 mg of sodium (main component of table salt) in each vial. This is equivalent to 0.5% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult with your doctor or nurse if you are unsure.

Dosage Information

Your doctor will decide the injection site, the amount of medication, and how many injections you will receive, depending on the condition being treated and its severity. Your doctor will administer the lowest dose for the shortest time possible to achieve effective relief of your symptoms. Your doctor may also want you to take a second type of steroid or a salt supplement to help balance your salt levels.

Adults

Your doctor or nurse will administer this medication as an injection, either into a vein (intravenous) or into a muscle (intramuscular). The first dose is usually administered into a vein, especially in emergency cases.

It will be administered slowly over a period of 1 - 10 minutes. Depending on your situation, a repeated dose may be injected at intervals of between 2 to 6 hours. Normally, large doses can be used for only two or three days.

This medication is first dissolved in sterile water for injectable preparations. If the medication is to be administered through infusion (using a pump or drip), it is also mixed with another suitable liquid. Do not mix other medications.

Geriatric Population

The treatment will usually be the same as for younger adults. However, your doctor may want to see you more regularly to check how you are doing with this medication.

Use in Children and Adolescents

Corticosteroids can affect the growth of children, so your doctor will prescribe the lowest effective dose (not less than 25 mg per day).

If you use more Hidrocortisona Pharmis than you should

If you think you have received more injections of this medication, talk to your doctor immediately.

If you forgot to use Hidrocortisona Pharmis

Since this medication will be administered under close medical supervision, it is unlikely that you will miss a dose. However, you should inform your doctor if you think you have not received a dose.

If you interrupt treatment with Hidrocortisona Pharmis

Your doctor will decide when it is time to stop your treatment. You should stop this treatment gradually if:

You should stop this medication gradually to avoid withdrawal symptoms. These symptoms may include itching skin, fever, muscle and joint pain, nasal discharge, sticky eyes, sweating, and weight loss.

If your symptoms seem to return or worsen as the dose of this medication is reduced, inform your doctor immediately.

Mental Health Problems while taking this medication

Mental health problems can occur while taking steroids like this medication (see also section 4, Possible side effects).

Talk to a doctor if you (or someone taking this medication) shows signs of mental health problems. This is particularly important if you are depressed or could be thinking about suicide. In some cases, mental health problems have occurred when doses were reduced or stopped.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor may have prescribed this medicine because your condition is not being treated adequately and could worsen.

In certain medical conditions, medicines like Hydrocortisone (steroids) should not be stopped abruptly. If you experience any of the following symptoms, seek immediate attention.

Your doctor will then decide whether you should continue taking your medicine.

If you experience any of the following side effects, or if you notice any other unusual effect not mentioned in this leaflet, inform your doctor immediately.

The frequency of side effects is unknown. The frequency cannot be estimated from the available data.

Blood, heart, and circulation.

Body fluids and electrolytes.

Digestive system.

Eyes.

Eyes.

General disorders.

• Feeling tired or unwell.
• Reactions at the injection site.

Hormones and metabolic system.

Muscles and bones.

Nervous system and mood disorders.

Steroids, including this medicine, may cause serious mental health problems.

These are common in both adults and children. They may affect approximately 5 out of every 100 people who take medicines like this.

• Feeling depressed, even with suicidal thoughts.
• Feeling euphoric (manic) or experiencing mood swings.
• Feeling anxious, having trouble sleeping, difficulty thinking, or being confused and losing memory.

Seeing, hearing, or feeling things that do not exist. Having strange and terrifying thoughts, changing your behavior, or feeling lonely. If you notice any of these problems,talk to a doctor immediately..

Other nervous system side effects may include:

• Seizures (convulsions), dizziness, drowsiness, difficulty breathing, irritability, feeling cold, hot, or numb, tinnitus, or loss of consciousness.
• Headache.
• Back pain, decreased strength or sensation in the legs, or loss of balance, caused by a buildup of fat within the spinal canal (lipomatosis epidural).

Skin.

• Abscess, especially near injection sites.
• Acne.
• Poor wound healing.
• Thinning of the skin with striae.
• Striae (stripes on the skin).
• Ecchymoses.
• Small purple or red spots on the skin.
• Unusual pale or dark patches on your skin, or increased patches of unusual color.
• Excessive growth of body and facial hair.
• Hives, itching, urticaria.
• Increased sweating.

Reporting side effects.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of 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.

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

Store below 25°C.

Store in the original packaging to protect it from light.

Solution after reconstitution and dilution:

Do not refrigerate.

The chemical and physical stability of the solution has been demonstrated for 24 hours if stored at 2-8°C.

From a microbiological point of view, unless the reconstitution method excludes the risk of microbial contamination, the product must be used immediately.

If not used immediately, storage times and conditions in use are the responsibility of the user.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. These measures will help protect the environment.

Environmental risk assessment studies demonstrated that dexamethasone showed endocrine secondary effects in fish species.

Composition of Hydrocortisone Pharmis

• The active principle is sodium succinate of hydrocortisone.

Each vial contains 100 mg of hydrocortisone (equivalent to 133.7 mg of sodium succinate of hydrocortisone).

• The other components are sodium dihydrogen phosphate monohydrate and sodium hydrogen phosphate.

Each ampoule of solvent contains 2 ml of water for injectables.

The solvent does not contain excipients.

Appearance of the product and contents of the package

This medication is presented in vials containing a white lyophilized powder of hydrocortisone (as sodium succinate) and ampoules containing a solvent, water for injectable preparations.

The lyophilized powder is presented in colourless type I glass vials of 4 ml and the solvent in colourless type I glass ampoules of 2 ml.

This medication is available in clinical packs containing 50 vials and 50 ampoules of solvent.

Holder of the Marketing Authorization

Pharmis Biofarmacêutica, Lda.

Praceta do Farol, 77

2750-610 Cascais

Portugal

Tel.: +351 214823850

Fax: +351 214823859

e-mail: [email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder in Spain:

Local Representative:

Pharmis Biofarmacéutica, S.L.

C/ San Germán, nº 52, piso 1º D,

28020 - Madrid.

Tel.: 91 640 22 88

Fax: 91 640 08 45

Email:[email protected]

Responsible for manufacturing

Infosaúde – Instituto de Formação e Inovação em Saúde, S.A.

Rua das Ferrarias Del Rei, nº6,

Urbanização da Fábrica da Pólvora,

2730-269 Barcarena

Portugal

This medication is authorized in the Member States of the European Economic Area with the following names:

French:Hydrocortisone Pharmis

Polish:Hydrocortisone Pharmis

Portuguese:Hidrocortisona Pharmis

Spanish:Hidrocortisona Pharmis 100 mg powder and solvent for injectable solution and for infusion EFG

Last review date of this leaflet:{MM/YYYY}

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The following information is intended only for healthcare professionals.

For more information, see the Summary of Product Characteristics.

Dosage and administration.

This medication can be administered by intravenous injection, by intravenous infusion, or by intramuscular injection. The preferred method for initial emergency use is intravenous injection. After the initial emergency period, consideration should be given to the use of a prolonged-acting injectable preparation or an oral preparation.

The general dose varies from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of 1 to 10 minutes. The dose may be repeated at intervals of 2, 4, or 6 hours as indicated by the response and clinical status of the patient.

The dose requirements are variable and should be individualized based on the disease being treated, its severity, and the patient's response during the entire duration of treatment. A decision on the risk/benefit ratio should be made in each individual case on a continuous basis.

The appropriate maintenance dose should be determined by gradually reducing the initial dose of the drug in small decrements at appropriate intervals until the lowest dose is reached, which will maintain an adequate clinical response.

Generally, treatment with high doses of corticosteroids should only be continued until the patient's condition has stabilized, which is usually not more than 48 to 72 hours. When treatment with high doses of hydrocortisone must be continued beyond 72 hours, hyponatremia may occur. In such circumstances, it may be necessary to replace this medication with another corticosteroid such as sodium succinate of methylprednisolone, which causes little or no sodium retention.

If after long-term treatment the drug must be discontinued, it should be withdrawn gradually rather than abruptly (see section 4.4 of the technical dossier).

Adverse effects can be minimized by using the lowest effective dose for the shortest period (see section 4.4 of the technical dossier).

Treatment with corticosteroids is a complement and not a replacement for conventional treatment.

In patients with liver disease, there may be an increase in effect (see section 4.4 of the technical dossier), so consideration should be given to reducing the dose.

Geriatric population:Hydrocortisone is mainly used for acute short-term conditions. When used as instructed, there is no information to justify a change in dose in these individuals. However, treatment of elderly patients should be planned taking into account the more severe consequences of common corticosteroid adverse effects in this age group and also closer clinical monitoring should be performed (see section 4.4 of the technical dossier).

Pediatric population:While the dose may be reduced for infants and children, it is more governed by the severity of the condition and the patient's response than by age or body weight, but it should not be less than 25 mg per day (see Section 4.4 of the technical dossier).

This medication should not be used by the intrathecal route.

Method of administration

Preparation of solutions:

For intravenous or intramuscular administration, prepare the solution aseptically by adding up to 2 ml of sterile water for injectables to the vial containing the lyophilized powder, agitate, and withdraw the amount to be used.

The reconstituted solution is isotonic or nearly isotonic.

For intravenous infusion, first prepare the solution by adding up to 2 ml of sterile water for injectables to the vial. This solution can be added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution if the patient has no sodium restriction).

This medication should not be mixed with other medications, except those mentioned in section 6.6 of the Technical Dossier.

When reconstituted, the pH of the solution will vary from 7.0 to 8.0.

Parenteral pharmaceutical products should be visually inspected to detect particles and discoloration before administration. The reconstituted solution should be clear without visible particles.

Elimination:

Any unused medication or waste material should be disposed of in accordance with local requirements.