Hydrocortisone pharmis

Hydrocortisone_v04_October-2022

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hydrocortisone Pharmis, 100 mg, powder and solvent for solution for
injection/infusion
Hydrocortisonum (as sodium succinate)
Please read the following information carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately.

Table of contents

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

1. What Hydrocortisone Pharmis is and what it is 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 of treating many diseases, including inflammatory conditions. This medicine reduces inflammation, which otherwise could worsen the disease. To achieve the greatest benefit from this medicine, it should be taken regularly.
Corticosteroids may also help in treating allergic reactions (anaphylaxis) or other distressing conditions. This includes inflammatory or allergic conditions affecting the following organs:

• lungs, e.g. bronchial asthma or inflammation caused by aspiration of gastric contents or vomit,
• skin, e.g. Stevens-Johnson syndrome (an autoimmune disorder in which the immune system causes blistering and peeling of the skin) or systemic lupus erythematosus (lupus).

This medicine may be prescribed for treating other conditions not listed above, such as adrenal insufficiency and other acute medical emergencies, including treatment of associated shock.
Please consult your doctor if you do not feel better, feel worse, or are unsure why you have been given this medicine.

2. Important information before using Hydrocortisone Pharmis

When not to use Hydrocortisone Pharmis
Hydrocortisone_v04_October-2022

• If the patient has ever had an allergic reaction or any other type of reaction to this medicine or any other medicine containing corticosteroids, or to any of the ingredients of this medicine (see section 6 for a list of ingredients). Symptoms of an allergic reaction may include skin rash or redness, swelling of the face or lips, or difficulty breathing.
• If the patient has an untreated fungal infection.
• If the patient has recently been vaccinated or is due to be vaccinated.

This medicine must not be injected:

• Into the spinal cord (epidurally) [except when used as part of specific chemotherapy regimens], or administered via the extradural route. Epidural administration of this medicine is not recommended.

Children and adolescents
This medicine should be used with caution in children, as prolonged use may interfere with growth and development and may cause cataracts in children.
If hydrocortisone is administered to a premature infant, monitoring of heart function and structure may be necessary.
Contact a doctor immediately if any of the above situations occur.
Warnings and precautions
Before starting hydrocortisone, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if the patient has any of the following conditions or medical histories before starting this medicine. The doctor may decide to monitor treatment more closely, change the dose, or prescribe a different medicine.

• Chickenpox, shingles, or herpes eye infections. If the patient suspects they have been in contact with someone who has chickenpox or shingles and has not previously had these diseases, or is unsure whether they have had them.
• Severe depression or manic depression (bipolar disorder). This includes depression before or during treatment with steroid medicines such as this one, and if a close family member has had any of these conditions.
• Mood swings, insomnia, and personality changes.
• Exceptionally stressful situations.
• Development of adrenal insufficiency.
• Cushing's syndrome (a hormonal disorder caused by excessively high levels of cortisol in the blood).
• Diabetes (or family history of diabetes in a close relative).
• Epilepsy, seizures, or fits.
• Glaucoma (increased pressure in the eye) or family history of glaucoma.
• Cataracts.
• Contact a doctor if blurred vision or other visual disturbances occur.
• Heart problems, including heart failure or heart infections.
• Hypertension (high blood pressure).
• Fluid retention in the body.
• Hypothyroidism (underactive thyroid gland).
• Pancreatitis (inflammation of the pancreas causing severe abdominal or back pain).
• Peritonitis (inflammation of the thin membrane surrounding the intestines and abdomen).
• Joint infections.

Hydrocortisone_v04_October-2022

• Kidney or liver disease.
• Muscle disorders (pain or weakness) that occurred previously during treatment with steroid-containing medicines.
• Myasthenia gravis (a condition causing muscle weakness and fatigue).
• Osteoporosis (brittle bones – increased susceptibility to fractures).
• Phaeochromocytoma (a rare tumour of adrenal tissue. The adrenal glands are located above the kidneys).
• Skin abscess.
• Peptic ulcer, diverticulitis (inflammation of the intestinal wall), or other serious stomach or intestinal problems.
• Thrombophlebitis – a vein condition caused by blood clots (red, swollen, and tender veins).
• Traumatic brain injury.
• Tuberculosis or history of tuberculosis.

Caution should be exercised when using corticosteroids, as they may cause eye disease (central serous chorioretinopathy), in which fluid accumulates beneath the light-sensitive layer at the back of the inner eye (retina), leading to visual disturbances and potentially retinal detachment.
Prolonged high-dose corticosteroid therapy may lead to fat deposition within the spinal dural sac (extradural lipomatosis).
Use in sport
This medicine contains substances that may result in a positive analytical finding in anti-doping controls.
Inform the doctor if infection is suspected, as corticosteroids are known to increase susceptibility to infections and may mask their symptoms.
Hydrocortisone Pharmis and other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently.
The patient should inform the doctor if they are taking any of the following medicines, as they may affect the action of Hydrocortisone Pharmis or other medicines:

• Acetazolamide – used in the treatment of glaucoma or epilepsy.
• Anticoagulants – used to "thin" the blood, such as acenocoumarol, phenindione, and warfarin.
• Anticholinergic agents – medicines known as neuromuscular blocking agents, used in certain surgical procedures.
• Anticholinesterases – used in the treatment of myasthenia gravis (a muscle disorder), such as distigmine and neostigmine.
• Antibacterial agents, such as isoniazid, erythromycin, clarithromycin, troleandomycin.
• Antidiabetic agents – medicines used to treat high blood sugar levels.
• Antiemetics – such as Aprepitant and Fosaprepitant, used to prevent nausea and vomiting.
• Antifungal agents – ketoconazole or itraconazole.
• Antituberculosis agents – rifampicin and rifabutin – antibiotics used in the treatment of tuberculosis.
• Antiviral agents – used in the treatment of HIV infection.
• Aromatase inhibitors – aminoglutethimide – used in the treatment of cancer.

Hydrocortisone_v04_October-2022

• NSAIDs – aspirin (high dose) and non-steroidal anti-inflammatory drugs such as ibuprofen, used to treat mild to moderate pain.
• Antiepileptic/anticonvulsant medicines – barbiturates, carbamazepine, and phenytoin – used in the treatment of epilepsy.
• Carbenoxolone – used in the treatment of heartburn.
• Cyclosporine – used in the treatment of conditions such as acute rheumatoid arthritis, acute psoriasis, or after organ or bone marrow transplantation.
• Calcium channel blocker – diltiazem.
• Cardiac glycosides – digoxin – used in heart failure and/or irregular heartbeat.
• Immunosuppressive agents – tacrolimus and cyclophosphamide – used after organ transplantation to prevent organ rejection.
• Neuromuscular blocking agents – pancuronium, used in certain surgical procedures.
• Oral contraceptives – estrogen-containing preparations.
• Pharmacokinetic enhancers – agents containing cobicistat.
• Medicines that lower potassium levels – such as diuretics (sometimes called water tablets), amphotericin B, xanthines, or beta2 agonists (e.g. medicines used in the treatment of asthma).
• Vaccines – the patient should inform the doctor if they have recently been vaccinated or are due to be vaccinated. While being treated with this medicine, the patient must not receive "live" vaccines. Other vaccines may be less effective.
• Grapefruit juice.

If long-term treatment is required
If the patient is being treated for conditions such as diabetes, high blood pressure, or fluid retention (oedema), inform the doctor, as dosage adjustments of medicines used to treat these conditions may be necessary.
Before undergoing any surgery, inform the doctor, dentist, or anaesthetist that this medicine is being used.
If a medical examination or hospital test is required, it is important to inform 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, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine, as it may slow the child's development.
Corticosteroids cross the placenta, which carries a risk of low birth weight in the newborn.
Cataracts have been observed in infants born to mothers who were treated with corticosteroids during pregnancy.
Inform the doctor if the patient is breastfeeding, as small amounts of corticosteroids may pass into human milk. If breastfeeding is continued during treatment, the infant will require additional monitoring to ensure the medicine does not affect them.
Consult a doctor before taking any other medicines.
Driving and operating machinery
The effect of this type of medicine on the ability to drive and operate machinery has not been studied.
Adverse effects observed in patients taking this medicine include seizures (convulsive fits). If these occur in a patient, they should not drive or operate machinery.
This medicine contains sodium
Hydrocortisone_v04_October-2022
This medicine contains 9.36 mg of sodium (the main component of table salt) per vial. This corresponds to 0.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Hydrocortisone Pharmis

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your
doctor or pharmacist.
Dosage instructions
Your doctor will decide on the injection site, the amount of medicine and the number of injections you will
receive, depending on the condition being treated and its severity. Your doctor will administer the lowest
possible dose for the shortest possible time needed to effectively relieve your symptoms. Your doctor may
also prescribe another steroid medicine or a salt supplement to maintain the body's salt balance.
Adults
This medicine will be given as an injection by your doctor or nurse into a vein (intravenously) or into a
muscle (intramuscularly). The first dose is usually given intravenously, especially in emergency situations.
The injection will be given slowly over a period of 1 to 10 minutes. Depending on your condition, subsequent
doses may be administered at intervals of 2 to 6 hours. High doses are usually only used for two or three
days.
This medicine is first dissolved in sterile water for injections. If the medicine is to be given by infusion (using
a pump or drip), it is then also mixed with another suitable fluid. Do not add any other medicines to the
solution.
Elderly patients
Treatment is usually the same as for younger patients. However, your doctor may decide that regular
monitoring is needed to check how your body responds to this medicine.
Use in children and adolescents
Corticosteroids may affect children's growth. Therefore, your doctor will prescribe the lowest effective dose
(not less than 25 mg per day).
If you use more Hydrocortisone Pharmis than you should
If you think you have been given too many injections of this medicine, contact your doctor immediately.
If you miss a dose of Hydrocortisone Pharmis
Since this medicine will be administered under strict medical supervision, it is unlikely that you will miss a
required dose. However, if you think you have not received a dose, inform your doctor.
Stopping Hydrocortisone Pharmis
Your doctor will decide when to stop treatment. This treatment must be discontinued gradually if you:

• have been taking corticosteroids such as this medicine for a long time,
• have received high doses of corticosteroids such as this medicine,
• have taken corticosteroids in tablet form or by injection within the past year,
• had adrenal gland problems (adrenal insufficiency) before starting this treatment.

This treatment must be tapered off gradually to avoid withdrawal symptoms. These symptoms may
include itchy skin, fever, muscle and joint pain, runny nose, sticky eye discharge, sweating and weight loss.
Hydrocortisone_v04_October-2022
If your symptoms return or worsen as the dose of this medicine is reduced, inform your doctor immediately.
Psychiatric problems during treatment with this medicine
Psychiatric problems may occur during treatment with steroids such as this medicine (see also section 4:
Possible side effects).

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

Contact your doctor if you (or another person being treated with this medicine) show any signs of
psychiatric problems. This is especially important in cases of depression or suicidal thoughts. In some
cases, psychiatric problems have occurred during dose reduction or discontinuation of the medicine. If
you have any further questions about using this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like any medicine, this medicine can cause side effects, although not everyone will experience them. The doctor has prescribed this medicine to treat a condition which, if left untreated, may worsen.
Medicines such as Hydrocortisone Pharmis (steroids) should not be stopped suddenly in certain conditions. If any of the following symptoms occur, seek medical help immediately. The doctor will decide whether the patient should continue treatment with this medicine.

• Allergic reactions, such as skin rash, facial swelling, wheezing and shortness of breath. Such side effects are rare but may be serious.
• Acute pancreatitis, abdominal pain which may radiate to the back; vomiting, shock and loss of consciousness may also occur.
• Ulcers, including bleeding ulcers, presenting as severe abdominal pain which may radiate to the back and may be associated with rectal bleeding, black or bloody stools and (or) vomiting blood.
• Infections. This medicine may mask or alter the subjective and objective symptoms of certain infections or reduce resistance to infections, making them difficult to diagnose in the early stages. Symptoms may include fever and malaise. Reactivation of tuberculosis may present as coughing up blood and chest pain. This medicine also increases the risk of acute infections. It may also increase susceptibility to infections, which may mask or alter normal responses to skin tests, such as the tuberculosis test.
• Pulmonary embolism (blood clot in the lung), symptoms include sudden sharp chest pain, shortness of breath and coughing up blood.
• Increased intracranial pressure in children (pseudotumor cerebri), presenting as headache, vomiting, lack of energy and drowsiness. This adverse effect usually occurs after stopping treatment.
• Thrombophlebitis (blood clots or atherosclerosis in the veins of the legs), presenting as pain and swelling of the veins, redness and tenderness.

If any of the following adverse effects occur, or if the patient notices any other unusual symptoms not listed in this leaflet, contact a doctor immediately.
The frequency of adverse effects is unknown. Frequency cannot be estimated from the available data.
Hydrocortisone_v04_October-2022
Blood, heart and circulation

• Problems with the heart pumping blood (heart failure), presenting as swollen ankles and shortness of breath.
• High blood pressure (hypertension), presenting as 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 balance in the body

• Swelling and high blood pressure due to increased water and salt levels.
• Swelling of limbs, e.g. ankles.
• Cramps and convulsions due to potassium loss. In rare cases, this may lead to congestive heart failure (the heart cannot pump blood properly).

Digestive system

• Nausea or vomiting.
• Ulcers or thrush in the oesophagus (difficulty swallowing).
• Indigestion.
• Abdominal bloating.
• Abdominal pain.
• Diarrhoea.

Ears

• Dizziness or a spinning sensation.

Eyes

• Glaucoma (increased pressure inside the eye, causing eye pain and headaches).
• Optic nerve swelling (causing a condition called papilloedema, which may lead to visual disturbances).
• Damage to the optic nerve or cataracts (presenting as worsening vision).
• Thinning of the transparent 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.
• Visual disturbances such as blind spots, blurred vision and distortion of shapes, caused by fluid accumulation under the tissue lining the back of the eye (retina).
• Blurred vision.

General disorders

• Fatigue or malaise.
• Skin reactions at the injection site.

Endocrine system and metabolism

• Slowed normal growth in infants, children or adolescents, which may be permanent.
• Irregular or absent menstrual periods.
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and body weight.
• Diabetes or worsening of existing diabetes.
• Long-term therapy may lead to decreased levels of certain hormones, which in turn may cause low blood pressure and dizziness. This symptom may persist for several months.
• Increased blood urea levels.

Hydrocortisone_v04_October-2022

• After corticosteroid treatment, increased levels of certain chemical compounds (enzymes) called alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, which help the body metabolise medicines and other substances, may occur. The change is usually minor, and enzyme levels return to normal after the medicine is naturally eliminated from the body. If this occurs, the patient will not feel any symptoms, but it may be detected in blood tests.
• 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 lipids, e.g. cholesterol in the blood.
• Unusual fat distribution in the body.

Muscles and bones

• Muscle pain.
• Muscle weakness or wasting.
• Bone fragility (increased susceptibility to fractures).
• Bone fractures or cracks.
• Fracture or joint damage due to inadequate blood supply, causing hip pain.
• Tendon rupture causing pain and (or) swelling.
• Muscle cramps or twitching.

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

• Feelings of depression, and in some cases, suicidal thoughts.
• Feelings of euphoria (mania) or mood changes.
• Feelings of anxiety, insomnia, difficulty concentrating or disorientation and memory loss. Tactile, visual and auditory hallucinations. Strange and frightening thoughts, changes in behaviour, feelings of isolation. If the patient experiences any of these symptoms, they should contact a doctor immediately.

Other nervous system adverse effects may include:

• Seizures (convulsions), dizziness, drowsiness, shortness of breath, irritability, feelings of cold, heat or numbness, tinnitus or loss of consciousness.
• Headache.
• Back pain, reduced strength or sensation in the legs or balance problems, caused by accumulation of fat within the spinal canal (extradural lipomatosis).

Skin

• Abscess, especially near the injection site.
• Acne.
• Poor wound healing.
• Skin thinning with stretch marks.
• Skin striae.
• Bruising.
• Small purple/red spots on the skin.
• Pale or darker patches on the skin, or raised patches with an unusual colour.
• Excessive body and facial hair growth.
• Rash, itching, urticaria.
• Excessive sweating.

Hydrocortisone_v04_October-2022
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl . Adverse effects can also be reported to the responsible entity. By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store 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 outer packaging. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light.

Reconstituted and diluted solution:
Do not store in the refrigerator.
Chemical and physical stability has been demonstrated for 24 hours at 2-8°C during use.
Unless the reconstitution method excludes the risk of microbiological contamination, the product should be used immediately.
If the product is not used immediately, responsibility for storage conditions and duration lies with the user.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
Environmental risk assessments have shown that dexamethasone may cause undesirable endocrine effects in fish species.

6. Contents of the pack and other information

What Hydrocortisone Pharmis contains

• 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 ingredients are monosodium dihydrogen phosphate monohydrate and disodium phosphate.

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

What Hydrocortisone Pharmis looks like and contents of the pack
This medicine is supplied as vials containing a white lyophilised powder, hydrocortisone (as sodium succinate), and ampoules containing the solvent, water for injections.
The lyophilised powder is supplied in 4 ml vials made of colourless type I glass, and the solvent in 2 ml ampoules made of colourless type I glass.
This medicine is supplied in packs containing 50 vials and 50 solvent ampoules.

Marketing Authorisation Holder
Pharmis Biofarmaceutica, Lda.
Praceta do Farol, 77
2750-610 Cascais
Hydrocortisone_v04_October-2022
Portugal
Tel.: +351 214823850
Fax: +351 214823859
e-mail: [email protected]

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 authorised for marketing in the European Economic Area countries 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 for infusion EFG

Information intended exclusively for medical professionals

For more information, refer to the Summary of Product Characteristics.
Dosage and administration
This medicinal product may be administered as an intravenous injection, intravenous infusion, or intramuscular injection. Intravenous injection is the preferred initial route of administration in emergency situations. After initial emergency intervention, consideration should be given to using a longer-acting injectable formulation or an oral formulation.
The usual dose ranges from 100 mg to 500 mg, depending on the severity of the condition, and is administered as an intravenous injection over 1 to 10 minutes. This dose may be repeated at intervals of 2, 4, or 6 hours, depending on the patient's response to treatment and clinical status.
Dosage requirements vary, and the dose must be individually adjusted based on the disease being treated, its severity, and the patient's response throughout the course of treatment. In each individual case, the benefit-risk ratio should be continuously assessed.
The appropriate maintenance dose should be established by gradually reducing the initial dose in small increments at appropriate time intervals until the lowest dose that maintains an adequate clinical response is reached.
High-dose corticosteroid therapy should generally continue only until the patient's condition has stabilized—usually no longer than 48 to 72 hours. If hydrocortisone therapy at high doses must continue beyond 48 to 72 hours, hypernatraemia may occur; therefore, it may be preferable to replace this agent with a corticosteroid such as sodium succinate of methylprednisolone, which causes minimal or no sodium retention.
Hydrocortisone_v04_October-2022
If discontinuation of the drug is required after prolonged therapy, 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 adjunctive and does not replace conventional therapy.
In patients with liver disease, enhanced effects may occur (see section 4.4 of the Summary of Product Characteristics), and dose reduction may be considered.
Elderly patients: Hydrocortisone is primarily used in acute, short-term conditions. There are no data indicating that dosage adjustment is warranted in elderly patients when the drug is used as recommended. However, treatment in elderly patients should be carefully planned, bearing in mind that common adverse effects of corticosteroids may have more serious consequences in this population, necessitating close clinical monitoring (see section 4.4 of the Summary of Product Characteristics).
Use in children: In children and infants, the dose should be reduced, and the dose should be based more on the patient's clinical condition than on age or body weight. The dose should in no case be less than 25 mg per day (see section 4.4 of the Summary of Product Characteristics).
Intrathecal administration of this medicinal product is not recommended.
Method of administration
Preparation of the solution:
For intravenous or intramuscular use, prepare the solution aseptically by adding no more than 2 mL of sterile water for injections to the contents of one vial containing lyophilized powder, shaking, and drawing up for use. The prepared solution is isotonic or nearly isotonic.
For intravenous infusion, first prepare the solution by adding no more than 2 mL of sterile water for injections 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 in isotonic saline solution if sodium restriction is not required in the patient).
Do not mix this medicinal product with other medicinal products except those mentioned in section 6.6 of the Summary of Product Characteristics.
After reconstitution, the pH of the solution ranges from 7.0 to 8.0.
Parenteral medicinal products should be visually inspected 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.
Hydrocortisone_v04_October-2022