Hidrocortisone Pharmis

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

This medicine contains hydrocortisone in the form of hydrocortisone sodium succinate.
Hydrocortisone belongs to a group of medicines called corticosteroids or steroids.
Corticosteroids occur naturally in the body and are important for many bodily functions.
Taking additional corticosteroids, such as Hydrocortisone Pharmis, is an effective way to treat many diseases, including inflammatory conditions. This medicine reduces inflammation, which could otherwise worsen the disease. To get the most benefit from this medicine, you should take it regularly.
Corticosteroids can also be helpful in treating allergic reactions (anaphylaxis) or other troublesome conditions. This includes inflammatory or allergic conditions of the following organs:

• Lungs, e.g. asthma or inflammation caused by inhaling (aspirating) vomit or stomach contents,
• Skin, e.g. Stevens-Johnson syndrome (an autoimmune disorder in which the immune system causes blisters and skin peeling) or systemic lupus erythematosus (lupus).

This medicine may be prescribed to treat diseases other than those listed above, such as adrenal insufficiency and other acute medical conditions, such as shock treatment. You should consult your doctor if you do not feel better, feel worse, or are unsure why you received this medicine.

2. Important information before using Hydrocortisone Pharmis

When not to use Hydrocortisone Pharmis

• If the patient thinks they have ever had an allergic reactionor any other type of reaction after taking this medicine or any other medicine containing a corticosteroid or any of the ingredients of this medicine (section 6 contains a list of ingredients). A sign of an allergic reaction may be a skin rash or redness, swelling of the face or lips, or difficulty breathing.
• If the patient has a fungal infectionthat is not being treated.
• If the patient has recently been vaccinatedor is about to be vaccinated.

This medicine must not be injected:

• Into the spinal cord (intrathecally) [except when used with certain chemotherapy regimens] or administered epidurally. Intrathecal administration of this medicine is not recommended.

Children and adolescents

This medicine should be used with caution in children, as long-term use can disrupt growth and development and may cause cataracts in children.
If hydrocortisone is given to a premature baby, it may be necessary to monitor heart function and structure.

You should contact your doctor immediately if any of the above situations occur.

Warnings and precautions

Before starting to take hydrocortisone, you should discuss it with your doctor, pharmacist, or nurse.
Before starting to take this medicine, you should inform your doctor if you have any of the following diseases or conditions. Your doctor may decide to monitor your treatment more closely, change the dose, or prescribe a different medicine.

• Chickenpox, shingles, or herpeseye infection. If you suspect you have come into contact with someone with chickenpox or shingles, and you have not had these diseases before, or if you are not sure if you have had them.
• Severe depression or manic depression(bipolar disorder). This includes depression before taking steroid medicines like this one, or while taking them, as well as if a close relativehas had any of these diseases.
• Mood swings, insomnia, and personality changes.
• Highly stressfulsituation.
• Adrenal insufficiency.
• Cushing's syndrome(a hormonal disorder caused by high levels of cortisol in the blood).
• Diabetes(or a history of diabetes in a close relative).
• Epilepsy, seizures, or fits.
• Glaucoma(increased pressure in the eye) or glaucoma in a close relative.
• Cataracts.
• You should contact your doctor if you experience blurred vision or other vision problems.
• Heart problems, including heart failure or heart infections.
• Hypertension(high blood pressure).
• Fluid retention in the body.
• Hypothyroidism(underactive thyroid).
• Pancreatitis(inflammation of the pancreas, which causes severe abdominal or back pain).
• Peritonitis(inflammation of the thin membrane surrounding the intestines and abdomen).
• Joint infections.

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• Kidney or liver disease.
• Muscle disorders(pain or weakness) that have occurred in the past while taking steroid medicines.
• Myasthenia(a condition that causes weakness and fatigue of the muscles).
• Osteoporosis(brittle bones - susceptibility to fractures).
• Pheochromocytoma(a rare cancer of the adrenal gland tissue. The adrenal glands are glands located above the kidneys).
• Skin abscess.
• Stomach ulcers, intestinal ulcers(inflammation of the intestinal wall) or other serious stomach or intestinal problems.
• Thrombophlebitis- a vein condition caused by a blood clot (clots in the veins) (red, swollen, and tender veins).
• Brain injury.
• Tuberculosisor a history of tuberculosis.

You should be cautious when using corticosteroids, as they can cause eye disease (central serous chorioretinopathy), in which fluid accumulates under the light-sensitive tissue at the back of the inner eye (retina), causing vision problems and potentially leading to retinal detachment.
Long-term corticosteroid therapy at high doses can cause fat to accumulate in the spinal canal (exogenous lipomatosis).
Sports use
This medicine contains substances that can cause a positive result in doping control analysis.
You should inform your doctor if you suspect you have an infection, as it is known that corticosteroids increase susceptibility to infections and can mask their symptoms.

Hydrocortisone Pharmis and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken.
You should inform your doctor if you are taking any of the following medicines, as they may affect the action of Hydrocortisone Pharmis or other medicines:

• Acetazolamide- used to treat glaucoma or epilepsy.
• Anticoagulants- used to "thin" the blood, such as acenocoumarol, phenindione, and warfarin.
• Anticholinergic medicines- medicines known as neuromuscular blocking agents, which are used in some surgical procedures.
• Anticholinesterases- used to treat myasthenia (a muscle disease), such as distigmine and neostigmine.
• Antibiotics, such as isoniazid, erythromycin, clarithromycin, and troleandomycin.
• Antidiabetic medicines- medicines used to treat high blood sugar levels.
• Anti-emetic medicines- such as Aprepitant Fosaprepitantused to prevent nausea and vomiting.
• Antifungal medicines- such as ketoconazole or itraconazole.
• Antitubercular medicines- such as rifampicin and rifabutin - antibiotics used to treat tuberculosis.
• Antiviral medicines- used to treat HIV infection.
• Aromatase inhibitors- such as aminoglutethimide - used to treat cancer.

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• NSAIDs - aspirin(high dose) and non-steroidal anti-inflammatory medicines, such as ibuprofen, used to treat mild to moderate pain.
• Antiepileptic/anticonvulsant medicines -barbiturates, carbamazepine, and phenytoin - used to treat epilepsy.
• Carbenoxolone- used to treat heartburn.
• Cyclosporin- used to treat diseases such as acute rheumatoid arthritis, acute psoriasis, or after organ or bone marrow transplantation.
• Calcium channel blocker - diltiazem.
• Cardiac glycosides- such as digoxin - used in case of heart failure and/or irregular heart rhythm.
• Immunosuppressive medicines- such as tacrolimus and cyclophosphamide - used after organ transplantation to prevent rejection.
• Neuromuscular blocking agents - such as pancuronium, which are used in some surgical procedures.
• Oral contraceptives - medicines containing estrogen.
• Medicines that increase pharmacokinetics - such as cobicistat.
• Potassium-lowering medicines- such as diuretics (sometimes called water pills), amphotericin B, xanthines, or beta2 agonists (e.g. medicines used to treat asthma).
• Vaccines- the patient should inform their doctor if they have recently been vaccinated or are about to be vaccinated. During treatment with this medicine, the patient must notbe vaccinated with "live" vaccines. Other vaccines may be less effective.
• Grapefruit juice.

In case of long-term use of the medicine(s)

If the patient is being treated for diseases such as diabetes, high blood pressure, or fluid retention in the body, they should inform their doctor, as it may be necessary to adjust the dose of the medicines used to treat these diseases.
Before undergoing any surgery, the patient should inform their doctor, dentist, or anesthesiologist about the use of this medicine.
If a test is required to be performed by a doctor or in a hospital, it is important to tell the doctor or nurse that the patient is taking this medicine. This medicine may affect the results of certain tests.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine, as it may slow down the development of the baby.
Corticosteroids cross the placenta, which is associated with the risk of low birth weight in the baby.
In infants born to mothers who have been treated with corticosteroids for a long time during pregnancy, cases of cataracts have been observed.
The patient should inform their doctor if they are breastfeeding, as small amounts of corticosteroids may be present in breast milk. If the patient continues to breastfeed during treatment, the baby will need additional checks to ensure that the medicine does not affect it.
Before taking any medicines, the patient should consult their doctor.

Driving and using machines

The effect of this type of medicine on the ability to drive and use machines has not been studied.
There are side effects observed in patients taking this medicine, such as seizures (convulsions). If these occur in a given patient, they should not drive vehicles or operate machines.

This medicine contains sodium

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The medicine contains 9.36 mg of sodium (the main component of common salt) per vial. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet of adults.

3. How to use Hydrocortisone Pharmis

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.

Dosing information

The doctor will decide on the injection site, the amount of medicine, and the number of injections the patient will receive, depending on the disease being treated and its severity. The doctor will inject the smallest dose for the shortest possible time to achieve effective relief of symptoms. The doctor may also prescribe another steroid medicine or a salt supplement to ensure salt balance in the body.

Adults

This medicine will be administered by a doctor or nurse as an intravenous (into a vein) or intramuscular (into a muscle) injection. The first dose is usually given into a vein, especially in emergency situations.
The injection will be given slowly over a period of 1 to 10 minutes. Depending on the patient's condition, subsequent doses may be given at intervals of 2 to 6 hours. Large doses can usually be used for only two or three days.
This medicine is first dissolved in sterile water for injections. If the medicine is to be given as an infusion (using a pump or drip), it is then also mixed with another suitable fluid. No other medicines should be added to the mixture.

Elderly

Treatment usually proceeds in the same way as for younger patients. However, the doctor may decide that regular checks are required to see how the patient's body is reacting to this medicine.

Use in children and adolescents

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

Using a higher dose of Hydrocortisone Pharmis than recommended

If the patient thinks they have received too many injections of this medicine, they should talk to their doctor immediately.

Missing a dose of Hydrocortisone Pharmis

Since this medicine will be administered to the patient under close medical supervision, it is unlikely that the patient will miss a dose. However, if the patient thinks they have missed a dose, they should inform their doctor.

Stopping treatment with Hydrocortisone Pharmis

The doctor will decide when to stop treatment. This treatment must be discontinued slowly, if the patient:

• has been taking corticosteroids like this medicine for a long time,
• has received large doses of corticosteroids like this medicine,
• has taken corticosteroids in tablets or injections in the last year,
• has had adrenal problems (adrenal insufficiency) before starting this treatment.

This treatment must be discontinued slowly to avoid withdrawal symptoms. These symptoms may include itching of the skin, fever, muscle and joint pain, runny nose, sticky discharge in the eyes, sweating, and weight loss.
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If symptoms recur or worsen as the dose of this medicine is reduced, the patient should inform their doctor immediately.

Psychological problems during treatment with this medicine

During treatment with steroids like this medicine, psychological problems (see also section 4: Possible side effects) may occur.

• These diseases can be severe.
• They usually occur a few days or weeks after starting treatment with this medicine.
• They are more likely to occur with high doses.
• Most of these problems disappear after reducing the dose or stopping the medicine. However, if they occur, they may require treatment.

The patient should contact their doctor if they (or another person taking this medicine) show any signs of psychological problems. This is extremely important in cases of depression or potential suicidal thoughts. In a few cases, psychological problems have occurred during dose reduction or withdrawal of the medicine. If the patient has any further questions about the use of this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The doctor has prescribed this medicine to treat a disease that may worsen if left untreated.

In the case of certain diseases, medicines like Hydrocortisone Pharmis (steroids) should not be stopped abruptly. If the patient experiences any of the following symptoms, they should seek help immediately. The doctor will decide whether the patient should continue treatment with this medicine.

• Allergic reactions, such as skin rash, swelling of the face or lips, or wheezing and difficulty breathing. Side effects of this type are rare but can be serious.
• Acute pancreatitis, abdominal pain that may radiate to the back; may also cause vomiting, shock, and loss of consciousness.
• Ulcers, including bleeding, characterized by severe abdominal pain that may radiate to the back and may be associated with bleeding from the anus, black or bloody stools, and/or vomiting blood.
• Infections.This medicine can mask or change the symptoms of some infections, making them difficult to diagnose in the early stages. Symptoms may include fever and malaise. The worsening of tuberculosis may be characterized by coughing up blood and chest pain. This medicine also increases the risk of acute infections. It may also increase susceptibility to infections, which can mask or change normal reactions to skin tests, such as the tuberculosis test.
• Pulmonary embolism(a clot in the lung) characterized by sudden severe chest pain, difficulty breathing, and coughing up blood.
• Increased intracranial pressurein children (pseudotumor cerebri) characterized by headache, vomiting, lack of energy, and drowsiness. This adverse effect usually occurs after treatment has stopped.
• Thrombophlebitis(clots or thrombosis in the veins) characterized by pain and swelling of the veins, their redness and tenderness.

If the patient experiences any of the following side effects or notices any other unusual symptoms not listed in this leaflet, they should contact their doctor immediately.

The frequency of side effects is unknown. The frequency cannot be estimated from the available data.
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Blood, heart, and circulation

• Problems with pumping blood through the heart (heart failure) characterized by swelling of the ankles, difficulty breathing.
• High blood pressure (hypertension) characterized by headache or malaise.
• Increased white blood cell count (leukocytosis).
• Low blood pressure.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants.

Water and salt in the body

• Swelling and high blood pressure, caused by increased water and salt levels.
• Swelling of the limbs, e.g. ankles.
• Cramps and seizures due to potassium loss. In rare cases, this can lead to congestive heart failure (the heart is unable to pump blood properly).

Digestive system

• Nausea or vomiting.
• Ulcers or thrush in the esophagus (difficulty swallowing).
• Indigestion.
• Bloating of the abdomen.
• Abdominal pain.
• Diarrhea.

Ears

• Dizziness or a feeling of spinning.

Eyes

• Glaucoma (increased pressure inside the eye, causing eye pain and headaches).
• Swelling of the optic nerve (causing a condition called papilledema, which can cause vision problems).
• Damage to the optic nerve or cataracts (causing vision impairment).
• 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.
• Bulging of the eyeballs.
• Visual disturbances, such as blind spots, blurred vision, and distortion of shapes, caused by fluid accumulation under the light-sensitive tissue at the back of the inner eye (retina).
• Blurred vision.

General disorders

• Fatigue or malaise.
• Reactions at the injection site.

Endocrine and metabolic disorders

• Slowing of normal growth in infants, children, or adolescents, which may be permanent.
• Irregular periods or absence of periods.
• Round or moon-shaped face (moon face).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Long-term therapy may lead to a decrease in the level of certain hormones, which can cause low blood pressure and dizziness. This symptom may persist for several months.
• Increased blood urea levels.

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• After corticosteroid therapy, there may be an increase in the level of certain chemical compounds (enzymes) called alanine transaminase, aspartate transaminase, and alkaline phosphatase, which help the body digest medicines and other substances. The change is usually small, and the enzyme levels return to normal after the medicine is naturally eliminated from the body. If this happens, the patient will not experience any symptoms, but it will be shown by possible blood tests.
• Withdrawal syndrome includes 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.
• Unusual fat accumulation in the body.

Muscles and bones

• Muscle pain.
• Muscle weakness or wasting.
• Bone fragility (susceptibility to fractures).
• Fractures or cracks in bones.
• Fracture of a bone or joint due to insufficient blood circulation, causing hip pain.
• Tendon rupture causing pain and/or swelling.
• Muscle spasms or twitching.

Nervous system and mood changes

Steroids, including this medicine, can cause serious mental health problems.
They occur frequently in both adults and children. They may occur in about 5 out of 100 people taking medicines like this one.

• Feeling depressed, and in some cases, suicidal thoughts.
• Feeling euphoric (mania) or mood swings.
• Feeling anxious, insomnia, problems with concentration, or disorientation and memory loss. Tactile, visual, and auditory hallucinations. Strange and frightening thoughts, changing behavior, feeling of loneliness. If the patient notices any of these symptoms, they should contact their doctor immediately.

Other nervous system side effects may include:

• Seizures (convulsions), dizziness, drowsiness, shortness of breath, irritability, feeling of cold, heat, or numbness, ringing in the ears, or loss of consciousness.
• Headache.
• Back pain, decreased strength or sensation in the legs, or balance problems, caused by fat accumulation in the spinal canal (exogenous lipomatosis).

Skin

• Abscess, especially near the injection site.
• Acne.
• Slow-healing wounds.
• Thinning of the skin with stretch marks.
• Stretch marks on the skin.
• Bruises.
• Small purple/red spots on the skin.
• Pale or darker spots on the skin, or raised spots with an unusual color.
• Excessive hair growth on the body and face.
• Rash, itching, hives.
• Excessive sweating.

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Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl . Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hydrocortisone Pharmis

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vials and carton. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Store in the original package to protect from light.
Solution after reconstitution and dilution:
Do not store in the refrigerator.
Chemical and physical stability during use has been demonstrated for 24 hours at 2-8°C.
Unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
If the product is not used immediately, the user is responsible for the storage conditions and time.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Environmental risk assessment studies have shown that dexamethasone has endocrine-disrupting adverse effects on fish species.

6. Contents of the package and other information

What does Hydrocortisone Pharmis contain

• The active ingredient is hydrocortisone sodium succinate. Each vial contains 100 mg of hydrocortisone (equivalent to 133.7 mg of hydrocortisone sodium succinate).
• The other ingredients are sodium dihydrogen phosphate monohydrate and disodium phosphate.

Each ampoule contains 2 ml of water for injections.
The solvent does not contain excipients.

What Hydrocortisone Pharmis looks like and contents of the package

This medicine is supplied in vials containing a white lyophilized powder, hydrocortisone (as sodium succinate), and in ampoules containing the solvent, water for injections.
The lyophilized powder is supplied in 4 ml vials made of type I colorless glass,
the solvent in 2 ml ampoules made of type I colorless glass.
This medicine is supplied in packages containing 50 vials and 50 ampoules of solvent.

Marketing authorization holder

Pharmis Biofarmacêutica, Lda.
Praceta do Farol, 77
2750-610 Cascais
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Portugal
Phone: +351 214823850
Fax: +351 214823859
e-mail: info@pharmis.com

Importer

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 for marketing in the Member States of the European Economic Area under the following names:
France:Hydrocortisone Pharmis
Poland:Hydrocortisone Pharmis
Portugal:Hydrocortisone Pharmis
Spain:Hydrocortisone Pharmis 100 mg powder and solvent for solution for injection and infusion
EFG
Date of last revision of the leaflet: {MM/RRRR}
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Information intended for healthcare professionals only

To obtain more information, please refer to the Summary of Product Characteristics.

Dosing and administration

This medicine may be administered by intravenous injection, intravenous infusion, or intramuscular injection, with intravenous injection being the preferred method for initial administration in emergency situations. After the initial intervention in an emergency situation, consideration should be given to using a longer-acting injectable form or an oral form.
The dose is usually 100 mg to 500 mg, depending on the severity of the disease, and is administered by intravenous injection over 1 to 10 minutes. This dose may be repeated at intervals of 2, 4, to 6 hours, depending on the patient's response to treatment and their clinical condition.
Dosing requirements are varied and the dose must be individualized based on the disease being treated, its severity, and the patient's response throughout the treatment period. In each individual case, the benefit-to-risk ratio should be continuously assessed.
The appropriate maintenance dose should be determined by gradually reducing the initial dose of the medicine by a small amount and at appropriate time intervals until the smallest dose is reached that will maintain an adequate clinical response.
Essentially, treatment with high doses of corticosteroid should only be continued until the patient's condition has stabilized - usually no longer than 48 to 72 hours. When high-dose hydrocortisone treatment is continued after 48 to 72 hours, hypernatremia may occur, so it may be better to replace this medicine with a corticosteroid such as methylprednisolone sodium succinate, after which there is little sodium retention or no sodium retention at all.
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If the medicine is to be discontinued after long-term therapy, it should be discontinued gradually rather than abruptly (see section 4.4 of the Summary of Product Characteristics).
Side effects can be minimized by using the smallest effective dose for the minimum period (see section 4.4 of the Summary of Product Characteristics).
Corticosteroid therapy is supplementary and does not replace conventional therapy.
In patients with liver disease, the effect may be enhanced (see section 4.4 of the Summary of Product Characteristics) and a dose reduction may be considered.
Elderly:Hydrocortisone is used mainly in acute, short-term conditions. There are no data to suggest that dose adjustment is justified in the elderly, provided the medicine is used as recommended. However, treatment of elderly patients should be planned, taking into account that common side effects of corticosteroids have more serious consequences in the elderly and require close clinical monitoring (see section 4.4 of the Summary of Product Characteristics).
Use in children:In the case of children and infants, the dose should be reduced, with the dose depending on the patient's condition rather than their age or weight. The dose should not be less than 25 mg per day (see section 4.4 of the Summary of Product Characteristics).
Administration via the intrathecal route is not recommended.

Administration

Preparation of the solution:
For intravenous or intramuscular use, the solution should be aseptically prepared by adding no more than 2 ml of sterile water for injections to the contents of one vial of lyophilized powder, shaking, and withdrawing for use. The prepared solution is isotonic or nearly isotonic.
For intravenous infusion, the solution should first be prepared by adding no more than 2 ml of sterile water for injections to the vial. The solution is then added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose solution in water (or isotonic saline solution, if sodium restriction is necessary for the patient).
The medicinal product should not be mixed with other medicinal products, except those mentioned in section 6.6 of the Summary of Product Characteristics.
After dissolution, the pH of the solution is between 7.0 and 8.0.
Medicines for injection should be inspected visually for particulate matter and discoloration prior to administration. The prepared solution should be clear and free of visible particles.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
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