Hydrocortisone Pharmis 100 mg powder and solvent for solution for injection and infusion EFG: detailed information

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Hydrocortisone Pharmis 100 mg Powder and solvent for solution for injection

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, as you may need to read it again.

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

This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

What Hydrocortisone Pharmis is and what it is used for
What you need to know before using Hydrocortisone Pharmis
How to use Hydrocortisone Pharmis
Possible side effects
How to store Hydrocortisone Pharmis
Contents of the pack and other information

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

This medicine contains hydrocortisone as sodium succinate.

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

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

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

Corticosteroids can also help treat hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inflammatory or allergic conditions affecting:

lungs, e.g. bronchial asthma or inflammation caused by inhalation (aspiration) of vomit or stomach contents,
skin, e.g. Stevens-Johnson syndrome (an autoimmune disorder in which the immune system causes the skin to blister and peel) or systemic lupus erythematosus (lupus).

This medicine may be prescribed to treat conditions other than those listed above, such as adrenal insufficiency and other medical emergencies such as 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 this medicine has been given to you.

2. What you need to know before using Hidrocortisona Pharmis

Do not 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 containing corticosteroids, or any of the components of this medicine (a list of excipients is included in section 6). An allergic reaction may cause a rash or skin redness, swelling of the face or lips, or difficulty breathing.
if you have a fungal infection that is not being treated.
if you have recently received or are about to receive any vaccine.

This medicine must not be injected:

into the spinal cord (intrathecal) [except as part of certain chemotherapy regimens], or epidurally. This medicine is not recommended for intrathecal administration.

Children and adolescents

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

If hydrocortisone is administered to premature newborns, monitoring of heart function and structure may be necessary.

Contact your doctor immediately in any of the above cases.

Warnings and precautions

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

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, adjust your dose, or prescribe another medicine.

Chickenpox, shingles, or a herpes eye infection. If you think you have been in contact with someone who has chickenpox or shingles and you have not had these diseases, or if you are unsure whether you have had them.
Severe depression or manic depression (bipolar disorder). This includes having depression before or while taking steroid medicines such as this, or if any of your close relatives have had these conditions.
If you experience mood changes, insomnia, or personality changes.
If you are under unusual stress.
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 pressure in the eye) or if there is a family history of glaucoma.
Cataracts.
Contact your doctor if you experience blurred 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).
If you have overactivity of the thyroid gland (hyperthyroidism).
Pancreatitis (inflammation of the pancreas causing severe abdominal and back pain).
Peritonitis (inflammation of the thin lining (peritoneum) around the intestines and stomach).
Joint infection.
Kidney or liver disease.
If you have previously had muscle problems (pain or weakness) while taking steroids.
Myasthenia gravis (a condition causing tired and weak muscles).
Osteoporosis (brittle bones – bones that break easily).
Pheochromocytoma (a rare tumor of the adrenal gland tissue. The adrenal glands are located above the kidneys).
Skin abscess.
Stomach ulcer, diverticulitis (inflammation of the intestinal wall) or other serious stomach or intestinal problems.
Thrombophlebitis: vein problems due to thrombosis (blood clots in veins) resulting in phlebitis (red, swollen, and tender veins).
Traumatic brain injury.
Tuberculosis (TB) or if you have had tuberculosis in the past.

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using hydrocortisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with overactivity of the thyroid gland (hyperthyroidism) treated with hydrocortisone. You may need additional treatment to relieve this condition.

Caution should be exercised with corticosteroids, as they may cause an eye condition (central serous chorioretinopathy), in which fluid accumulates beneath the light-sensitive tissue layer at the back of the inner eye (retina), causing visual impairment and potentially leading to retinal detachment.

Long-term, high-dose corticosteroid therapy may cause abnormal fat deposition inside or outside the spinal lining (epidural lipomatosis).

Use in athletes:

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping control tests.

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

Other medicines and Hidrocortisona Pharmis

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

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

Acetazolamide – used to treat glaucoma and epilepsy.
Anticoagulants – used to "thin" the blood, such as acenocoumarol, phenindione, and warfarin.
Anticholinergics – neuromuscular blocking medicines used in some surgical procedures.
Anticholinesterases – used to treat myasthenia gravis (a muscle condition), such as distigmine and neostigmine.
Antibacterials – such as isoniazid, erythromycin, clarithromycin, troleandomycin.
Antidiabetics – medicines used to treat high blood sugar levels.
Antiemetics – such as aprepitant and fosaprepitant to prevent nausea and vomiting.
Antifungals – ketoconazole or itraconazole.
Antituberculosis agents – rifampicin and rifabutin: antibiotics used to treat tuberculosis (TB).
Antivirals – used to treat HIV infections.
Aromatase inhibitors – aminoglutethimide – used to treat cancer.
NSAIDs – aspirin (high dose) and non-steroidal 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 for stomach acidity.
Cyclosporine – used to treat conditions such as severe rheumatoid arthritis, severe psoriasis, or after organ or bone marrow transplantation.
Calcium channel blockers – diltiazem.
Cardiac glycosides – digoxin – used for heart failure and/or irregular heartbeats.
Immunosuppressants – tacrolimus and cyclophosphamide: used after organ transplantation to prevent organ rejection.
Neuromuscular blocking agents – 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. You must not receive "live" vaccines while using this medicine. Other vaccines may be less effective.
Grapefruit 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 the doses of medicines used to treat these conditions may need to be adjusted.

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

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as it may delay the baby's growth.

Corticosteroids can cross the placenta, which is associated with the risk of low birth weight in the baby.

Cataracts have been observed in babies born to mothers treated with corticosteroids over the long term during pregnancy.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

The effect of this class of medicines on the ability to drive or use machines has not been studied. Since adverse effects such as seizures may occur with corticosteroid use, you should not drive or use machines if you experience these symptoms.

Hidrocortisona Pharmis contains sodium.

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

3. How to use Hidrocortisona Pharmis

Follow exactly the instructions for administering this medicine as given by your doctor. Consult your doctor or nurse if you are unsure.

Dosage information

Your doctor will decide the injection site, the amount of medicine, and how many injections you will receive, depending on the condition being treated and its severity. Your doctor will prescribe the lowest possible dose for the shortest possible time needed 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 medicine by injection, either into a vein (intravenous) or into a muscle (intramuscular). The first dose is usually given intravenously, especially in emergency situations.

It will be administered slowly over a period of 1 to 10 minutes. Depending on your condition, repeated doses may be given at intervals of 2 to 6 hours. High doses are typically used for only two or three days.

This medicine is first dissolved in sterile water for injectable preparations. If the medicine is to be administered by infusion (via pump or drip), it is also mixed with another suitable liquid. No other medicines should be mixed with it.

Elderly population

Treatment will normally be the same as for younger adults. However, your doctor may wish to see you more regularly to monitor how you are responding to this medicine.

Use in children and adolescents

Corticosteroids may affect children's growth, 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 too many injections of this medicine, speak to your doctor immediately.

If you forget to use Hidrocortisona Pharmis

Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, you should inform your doctor if you believe a dose has not been administered.

If you stop treatment with Hidrocortisona Pharmis

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

you have been taking corticosteroids, such as this medicine, for a long time,
you have received high doses of corticosteroids, such as this medicine,
you have previously received treatment with corticosteroid tablets or injections within the past year,
you already have adrenal gland problems (adrenocortical insufficiency) before starting this treatment.

You must stop taking this medicine gradually to avoid withdrawal symptoms. These symptoms may include skin itching, fever, muscle and joint pain, runny nose, sticky eyes, sweating, and weight loss.

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

Mental health problems while taking this medicine

Mental health problems may occur while taking steroids such as this medicine (see also section 4, Possible side effects).

These conditions can be serious.
They usually begin within a few days or weeks after starting the medicine.
They are more likely to occur with high doses.
Most of these problems resolve if the dose is reduced or the medicine is stopped. However, if they occur, treatment may be required.

Talk to a doctor if you (or someone who takes this medicine) show signs of mental health problems. This is particularly important if you are depressed or may be thinking about suicide. In some cases, mental health problems have occurred when doses were reduced or discontinued.

If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Your doctor may have prescribed this medicine because your condition is not being adequately controlled and could worsen.

With certain medical conditions, medicines such as hydrocortisone (steroids) should not be stopped abruptly. If you experience any of the following symptoms, seek immediate medical attention.

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

Allergic reactions, such as skin rash, swelling of the face, or wheezing and difficulty breathing. This type of side effect is rare, but can be serious.
Acute pancreatitis, stomach pain that may spread to the back, possibly accompanied by vomiting, shock, and loss of consciousness.
Ulcers or bleeding ulcers, whose symptoms include severe stomach pain that may extend to the back and may be associated with bleeding from the anus, black or blood-stained stools, and/or vomiting blood.
Infections. This medicine may mask or alter the signs and symptoms of certain infections, or reduce your resistance to infection, making early diagnosis difficult. Symptoms may include high temperature and feeling unwell. Symptoms of a flare-up of a previous TB infection may include coughing up blood or chest pain. This medicine may also make you more likely to develop a serious infection. It may also increase your susceptibility to infections that can mask or alter the usual reactions of skin tests, such as the tuberculosis test.
Symptoms of pulmonary embolism (blood clot in the lung) include sudden, sharp chest pain, difficulty breathing, and coughing up blood.
Increased pressure in the skull in children (pseudotumor cerebri), whose symptoms include headaches with vomiting, lack of energy, and drowsiness. This side effect usually occurs after treatment has been stopped.
Thrombophlebitis (blood clots or thrombosis in a leg vein), whose symptoms include painful, swollen, red, and tender veins.

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

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

Blood, heart, and circulation

Problems with your heart's pumping function (heart failure), whose symptoms include swollen ankles and difficulty breathing.
High blood pressure (hypertension), whose symptoms include headaches or general malaise.
Increased number of white blood cells (leukocytosis).
Low blood pressure.
Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants.

Body fluids and salts

Swelling and high blood pressure caused by elevated levels of water and salt in the body.
Swelling of body extremities, e.g., ankles.
Cramps and spasms due to loss of potassium from the body. In rare cases, this may lead to congestive heart failure (when the heart cannot pump properly).

Digestive system

Nausea (feeling sick) or vomiting (being sick).
Ulcers or sores in the throat (pain when swallowing).
Indigestion.
Bloating of the stomach.
Abdominal pain.
Diarrhea.

Ears

Feeling dizzy or a sensation of spinning (vertigo).

Eyes

Glaucoma (increased pressure inside the eye, causing eye pain and headaches).
Inflammation of the optic nerve (causing a condition called papilledema, which may lead to visual disturbances).
Damage to the optic nerve or cataracts (indicated by vision failure).
Thinning of the clear front part of the eye (cornea) or the white part of the eye (sclera).
Worsening of viral or fungal eye infections.
Protrusion of the eyeballs (exophthalmos).
Visual impairment, such as blind spots, reduced or blurred vision, and distortion of shapes, caused by fluid accumulation beneath the tissue lining the back of the eye (retina).
Blurred vision.

General disorders

Feeling tired or unwell.
Skin reactions at the injection site.

Hormones and metabolic system

Slowed normal growth in babies, children, and adolescents, which may be permanent.
Irregular or absent menstrual periods in women.
Round or moon-shaped face (Cushingoid facies).
Increased appetite and weight gain.
Diabetes or worsening of existing diabetes.
Prolonged therapy may lead to lower levels of certain hormones, which in turn can cause low blood pressure and dizziness. This effect may persist for months.
Increased blood urea levels.
Increased levels of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase, and alkaline phosphatase, which help the body metabolize medicines and other substances. These levels may rise after corticosteroid treatment. The change is usually minor, and enzyme levels return to normal once the medicine has been naturally eliminated from your system. You will not notice any symptoms, but this may show up in a blood test.
Drug withdrawal syndrome, including symptoms such as runny nose, fever, headache, loss of appetite, fatigue, joint pain, skin peeling, weight loss, and low blood pressure.
Abnormal levels of fats, e.g., cholesterol in the blood.
Abnormal fat deposition in the body.

Muscles and bones

Muscle pain.
Muscle weakness or wasting.
Brittle bones (bones that break easily).
Broken bones or fractures.
Bone and joint collapse due to poor blood supply, causing hip pain.
Torn muscle tendons causing pain and/or inflammation.
Muscle cramps or spasms.

Nerves and mood problems

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

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

Feeling depressed, even with thoughts of suicide.
Feeling euphoric (mania) or having mood swings.
Feeling anxious, having trouble sleeping, difficulty thinking, confusion, or memory loss.

Experiencing hallucinations—seeing, hearing, or feeling things that are not real. Having strange or frightening thoughts, changes in behavior, or feelings of isolation. If you notice any of these problems, speak to a doctor immediately.

Other nervous system side effects may include:

Seizures (fits), dizziness, drowsiness, difficulty breathing, irritability, sensations of cold, heat, or numbness, tinnitus, or loss of consciousness.
Headache.
Back pain, decreased strength or sensation in the legs, or imbalance, caused by fat accumulation within the spinal canal (epidural lipomatosis).

Skin

Abscess, especially near injection sites.
Acne.
Poor wound healing.
Thinning of the skin with stretch marks.
Striae (stretch marks on the skin).
Bruising.
Small purple/red spots on the skin.
Pale or dark patches on the skin, or increased unusual pigmentation.
Excessive growth of body and facial hair.
Rash, itching, hives.
Increased sweating.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, 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: https://www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydrocortisone Pharmis

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

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

Store below 25°C.

Keep in the original packaging to protect from light.

Solution after reconstitution and dilution:

Do not refrigerate.

Chemical and physical stability of the solution has been demonstrated for 24 hours when stored at 2–8°C.

From a microbiological standpoint, unless the reconstitution method excludes the risk of microbial contamination, the product should be used immediately.

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

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

Environmental risk assessment studies have shown that dexamethasone caused endocrine effects in fish species.

6. Package contents and other information

Composition of Hidrocortisona Pharmis

The active substance is hydrocortisone sodium succinate.

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

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

Each solvent ampoule contains 2 ml of water for injectable preparations.

The solvent contains no excipients.

Appearance of the medicinal product and contents of the container

This medicine 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 supplied in 4 ml colourless type I glass vials and the solvent in 2 ml colourless type I glass ampoules.

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

Marketing Authorization Holder

Pharmis Biofarmacêutica, Lda.

Rua Professor Branquinho da Fonseca, nº 269

2775-078 Parede

Portugal

Tel.: +351 214823850

Fax: +351 214823859

e-mail: [email protected]

Further information on this medicine can be requested from the local representative of the Marketing Authorization Holder in Spain:

Local representative:

Pharmis Biofarmacéutica, S.L.

C/ San Germán, nº 52, 1st floor D,

28020 - Madrid.

Tel.: 91 640 22 88

Fax: 91 640 08 45

Email: [email protected]

Manufacturer

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 medicine is authorized in the Member States of the European Economic Area under the following names:

France: Hydrocortisone Pharmis

Poland: Hydrocortisone Pharmis

Portugal: Hidrocortisona Pharmis

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

Date of the most recent revision of this leaflet: 10/2022

The following information is intended for healthcare professionals only.

For further information, please consult the Summary of Product Characteristics.

Dosage and method of administration

This medicine can be administered by intravenous injection, intravenous infusion, or intramuscular injection. The preferred route for initial emergency use is intravenous injection. After the initial emergency period, consideration should be given to using a long-acting injectable formulation or an oral preparation.

The usual dose ranges 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, according to the patient's response and clinical status.

Dosage requirements are variable and must be individualized according to the disease being treated, its severity, and the patient's response throughout the duration of treatment. A continuous risk/benefit assessment must be made in each individual case.

The appropriate maintenance dose should be determined by gradually reducing the initial dose in small decrements at appropriate time intervals until the lowest dose that maintains an adequate clinical response is reached.

In general, high-dose corticosteroid therapy should be continued only until the patient's condition has stabilized, which usually does not exceed 48 to 72 hours. When high-dose hydrocortisone treatment must continue beyond 72 hours, hypernatremia may occur. In such circumstances, it may be necessary to switch to another corticosteroid such as methylprednisolone sodium succinate, as it causes little or no sodium retention.

If discontinuation of the drug is required after long-term treatment, it should be withdrawn gradually rather than abruptly (see section 4.4 of the Summary of Product Characteristics).

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 4.4 of the Summary of Product Characteristics).

Corticosteroid therapy is a supplement and not a substitute for conventional treatment.

In patients with hepatic impairment, an increased effect may occur (see section 4.4 of the Summary of Product Characteristics), so dose reduction should be considered.

Elderly population: Hydrocortisone is primarily used for short-term acute conditions. When used according to instructions, there is no information justifying a dosage adjustment in elderly patients. However, treatment in elderly patients should be planned considering the more severe consequences of common corticosteroid adverse effects in this age group, and closer clinical monitoring is required (see section 4.4 of the Summary of Product Characteristics).

Paediatric population: Although dosage may be reduced for infants and children, it is governed more by the severity of the condition and the patient's response than by age or body weight, but should not be less than 25 mg per day (see section 4.4 of the Summary of Product Characteristics).

Use of this medicine by the intrathecal route is not recommended.

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 injectable preparations to the vial containing the lyophilized powder, shake, and withdraw the required amount.

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 injectable preparations to the vial. This solution may then be added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline if the patient has no sodium restriction).

This medicine must not be mixed with other medicinal products except those mentioned in section 6.6 of the Summary of Product Characteristics.

After reconstitution, the pH of the solution will range from 7.0 to 8.0.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution must be clear and free from visible particles.

Disposal:

Any unused medicine or waste material must be disposed of in accordance with local requirements.