DEXAMETHASONE KERN PHARMA 7.2 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Dexamethasone Kern Pharma 7.2 mg solution for injection

Dexamethasone phosphate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Dexamethasone Kern Pharma is and what it is used for

The dexamethasone phosphate contained in this medicine is a synthetic glucocorticoid (adrenocortical hormone) derived from cortisone. It regulates many of the body's metabolic processes with anti-inflammatory and immunosuppressive activity.

This medicine is used to treat coronavirus disease 2019 (COVID-19) in adult and adolescent patients (at least 12 years of age with a body weight of at least 40 kg) who require supplemental oxygen therapy.

2. What you need to know before you use Dexamethasone Kern Pharma

Do not use this medicine:

• If you are allergic or have had an allergic reaction to dexamethasone or any of the other ingredients of this medicine (listed in section 6). These reactions are more common in patients with a history of allergy to any medicine.

• By intravenous administration if you have any systemic infection, unless you are receiving specific anti-infective treatment.

Warnings and precautions

Administration of this medicine may induce adrenocortical insufficiency, especially if high doses are administered for a prolonged period.

Avoid sudden withdrawal of treatment, especially in prolonged treatments, as a corticosteroid withdrawal syndrome may occur, characterized by general malaise, weakness, and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, decreased blood pressure, and decreased blood glucose levels.

This medicine may increase the risk of infection and hide the signs of an infection and/or make it difficult to diagnose. Latent infections may reactivate during corticosteroid use.

In the following cases, close monitoring of treatment by your doctor will be necessary:

• In acute and chronic bacterial infections.
• If you have lymph node inflammation (nodes that help the body's defense) after being administered the tuberculosis vaccine.
• If you have a history of tuberculosis.
• Patient with chronic hepatitis (liver inflammation).
• Acute viral infections (hepatitis B, herpes, chickenpox, poliomyelitis, measles).
• Infections caused by fungi or parasites.
• If you need to be vaccinated or have been vaccinated between approximately 8 weeks before and 2 weeks after.
• If you have diabetes, peptic ulcer, or inflammatory diseases of the digestive system, osteoporosis (calcium loss in bones), heart failure, high blood pressure, and psychiatric disorders.
• If you have glaucoma (increased intraocular pressure), corneal ulcers or injuries, blurred vision, or other visual disturbances.

Administration of this medicine may alter the value of some laboratory tests.

Administration of high doses of dexamethasone may cause a decrease in heart rate in some patients.

Severe anaphylactic reactions (immune system hyperreaction) may occur.

If you have myasthenia gravis (severe muscle weakness), it may initially worsen during treatment with this medicine.

If the intravenous administration of this medicine is too rapid, a sensation of tingling or numbness may occur, which can last for a few minutes.

In postmenopausal women, this medicine may increase the risk of osteoporosis.

You should inform your doctor if you have any of the following symptoms of tumor lysis syndrome (TLS) such as muscle cramps, muscle weakness, confusion, vision loss or alteration, and difficulty breathing, in case you have a malignant hematological process.

If dexamethasone is administered to a premature baby, it is necessary to monitor the function and structure of the heart.

Children and adolescents

In children, the doctor should assess the benefits of treatment, as the use of glucocorticoids may affect their growth.

Elderly

In patients over 65 years of age, the doctor should assess the benefits of treatment and possible risks, as it is possible that these patients may experience more side effects, such as osteoporosis.

Using Dexamethasone Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of some of them. Note that these instructions may also apply to medicines that have been used before or may be used after.

This is especially important if you are taking the following medicines:

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and salicylates, as they increase the risk of gastrointestinal ulcer and bleeding.
• Oral antidiabetics and insulin, as their effect may be reduced.
• Antiepileptics (carbamazepine), antiarrhythmics (phenytoin), anti-asthmatics, and bronchodilators (ephedrine), antitubercular antibiotics (rifampicin), barbiturates, and primidone, as they may decrease the effects of dexamethasone.
• Medicines that delay degradation in the liver, such as some antifungal medicines (ketoconazole, itraconazole) and certain antiretroviral medicines, as they may increase the action of corticosteroids. Therefore, your doctor will perform thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).
• Coumarin derivatives (oral anticoagulants), as their anticoagulant effect may be modified.
• Estrogens (e.g., for contraceptive use) may increase the action of dexamethasone.
• Atropine and other anticholinergic medicines, as they may increase intraocular pressure.
• Medicines used to treat heart diseases, such as cardiac glycosides, as their effect may be increased by decreased potassium levels.
• Diuretics/laxatives, as they may increase potassium elimination.
• Praziquantel, as glucocorticoids may cause a decrease in praziquantel blood levels.
• Antihypertensive medicines (ACE inhibitors), as they may increase the risk of alterations in blood components.
• Malaria medicines (chloroquine, hydroxychloroquine, mefloquine), as they may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Immunosuppressive substances, as they may increase the risk of infection. Additionally, in the case of cyclosporine, cyclosporine blood levels may be elevated, which increases the risk of seizures.
• Non-depolarizing muscle relaxants, as muscle relaxation may be prolonged.
• Protirelin, as its effects on thyroid-stimulating hormone (TSH) may be affected.
• Fluoroquinolones, as they may increase the risk of tendon alterations.
• Amphotericin B, as it may increase the risk of decreased potassium levels (hypokalemia).
• Albendazole, as it may increase the levels of its active metabolite in the blood.
• Vaccines, as the immune response to the vaccine may be inadequate.

Do not stop taking any other steroid medicine unless your doctor has told you to.

Talk to your doctor, pharmacist, or nurse before using Dexamethasone Kern Pharma.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, treatment should only be administered after careful consideration of the risk/benefit ratio. Therefore, women should inform their doctor about an existing or suspected pregnancy. With long-term treatment with glucocorticoids during pregnancy, fetal growth disorders cannot be ruled out. If glucocorticoids are administered at the end of pregnancy, inadequate adrenal function may occur in the newborn, requiring substitution therapy with reduced doses in the newborn.

Newborns of mothers who received Dexamethasone Kern Pharma near the end of pregnancy may have low blood sugar levels after birth.

Breast-feeding

Glucocorticoids, including dexamethasone, pass into breast milk. So far, no harm has been reported in the infant. However, the need for administration during breast-feeding should be carefully examined. If high doses are necessary for medical reasons, breast-feeding should be interrupted. Consult your doctor immediately.

Fertility

The effects of this medicine on fertility have not been studied.

Driving and using machines

There is no data on how this medicine affects driving or using machines, so try not to perform tasks that require special attention until you know how you tolerate the medicine.

Dexamethasone Kern Pharma contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule, so it is considered essentially "sodium-free".

Influence on laboratory tests

This medicine may alter the values of certain laboratory tests. Skin reactions in allergy tests may also be masked.

Use in athletes

This medicine contains a component that may produce a positive result in doping tests.

3. How to use Dexamethasone Kern Pharma

Follow exactly the administration instructions of this medicine as indicated by your doctor. Your doctor will decide how long you should use dexamethasone. Ask your doctor or pharmacist if you have any doubts.

This medicine is administered slowly (over 2-3 minutes) by intravenous route.

For the treatment of Covid-19

In adult patients, it is recommended to administer 7.2 mg of dexamethasone phosphate (1 ampoule, equivalent to 6 mg of dexamethasone base) by intravenous route, once a day, for a maximum of 10 days.

Renal and hepatic impairment

No specific dose adjustment is necessary.

Use in adolescents

It is recommended to administer to pediatric patients (adolescents at least 12 years of age) a dose of 7.2 mg of dexamethasone phosphate (1 ampoule, equivalent to 6 mg of dexamethasone base) by intravenous route, once a day, for a maximum of 10 days.

If you use more Dexamethasone Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

Acute overdoses with dexamethasone are not known. In the event of an overdose, it is expected that the adverse reactions described in this leaflet will occur to a greater extent.

If you stop using Dexamethasone Kern Pharma

Do not stop treatment before your doctor indicates or abruptly, as your disease may worsen.

Dose reduction should be done progressively. Similarly, treatment suspension should always be done progressively.

Excessive rapid reduction of the dose after long-term treatment may cause symptoms such as muscle and joint pain. Your doctor will gradually reduce the dose you should use.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects have been reported with dexamethasone:

Frequent(may affect up to 1 in 10 patients):

• Immune system disorders: decreased resistance to infections, oropharyngeal candidiasis.
• Endocrine disorders: adrenocortical insufficiency.
• • With high doses: signs of adrenal hyperactivity (Cushing's syndrome) with eruptions, moon face, and adiposity in the trunk.
• Metabolic and nutritional disorders: hyperglycemia (increased blood glucose).
• Ocular disorders: cataracts.
• Vascular disorders: with high doses, flushing.
• Gastrointestinal disorders: with high doses, gastric ulcer.
• Skin and subcutaneous tissue disorders: delayed wound healing, allergic skin reaction.
• • With high doses: hirsutism (excessive hair growth), skin hyperpigmentation (skin darkening), scleroderma (subcutaneous tissue disease).
• Musculoskeletal and connective tissue disorders: osteoporosis, bone fragility.
• • With prolonged treatment: muscle atrophy.

Uncommon(may affect up to 1 in 100 patients):

• Blood and lymphatic system disorders: decrease in the number of white blood cells called lymphocytes (lymphopenia), decrease in the number of white blood cells called eosinophils (eosinopenia).
• Immune system disorders: generalized allergic reaction.
• Metabolic and nutritional disorders: hypokalemia (decrease in plasma potassium concentration).
• Psychiatric disorders: psychotic disorder.
• Nervous system disorders: increased intracranial pressure, neurological disturbances.
• Cardiac disorders: heart failure.
• Vascular disorders: thromboembolism, hypertension.
• • With long-term administration, requiring medical attention: avascular necrosis, edema.
• Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas).
• • With long-term administration, requiring medical attention: gastrointestinal irritation, peptic ulcer or intestinal perforation.
• Skin and subcutaneous tissue disorders: sweating.
• Musculoskeletal and connective tissue disorders: muscle weakness.
• • With long-term administration, requiring medical attention: steroid myopathy (muscle weakness).
• Reproductive system and breast disorders: amenorrhea (absence of menstruation).
• General disorders and administration site conditions: fluid retention (edema).
• • With rapid intravenous administration of high doses: allergic reactions and local infection at the injection site, generalized anaphylaxis, facial or cheek flushing, irregular heartbeats or palpitations, convulsive crises. With local injection: unusual hematomas, non-healing wounds.

Frequency Unknown(cannot be estimated from available data):

• Infections and infestations: masking of infections, existing infections may worsen or reactivate, and new infections may appear, activation of parasitic intestinal diseases (strongyloidiasis).
• Blood and lymphatic system disorders: alteration of blood cells (white blood cells and lymphocytes, among others).
• Immune system disorders: severe allergic reactions such as cardiac rhythm problems, bronchospasm, blood pressure changes, circulatory failure, cardiac arrest.
• Metabolic and nutritional disorders: potassium loss (which can cause arrhythmias), diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, increased appetite.
• Psychiatric disorders: mania, depression, hallucinations, emotional instability, irritability, increased activity, euphoria, anxiety, sleep disturbances, suicidal thoughts.
• Nervous system disorders: increased spasms in epileptic patients or onset of epilepsy (convulsions), hyperactivity, epidural lipomatosis (growth of fatty tissue around the spine).
• Ocular disorders: glaucoma (increased intraocular pressure), worsening of corneal ulcer symptoms; ocular infections, ptosis, pupil dilation (mydriasis), burning, scleral perforation, in rare cases reversible exophthalmos, visual disturbances, blurred vision, loss of vision.
• Vascular disorders: increased risk of arteriosclerosis, vasculitis (also as a withdrawal symptom after long-term treatment), fragility of small blood vessels.
• Gastrointestinal disorders: hiccups, gastric discomfort, gastrointestinal bleeding (bleeding).
• Skin and subcutaneous tissue disorders: acne, dermatitis around the mouth, stretch marks, skin atrophy, petechiae, telangiectasias, purpura, hirsutism.
• Musculoskeletal and connective tissue disorders: tendon alterations, tendon rupture, osteonecrosis, delayed growth in children.
• General disorders and administration site conditions: erectile dysfunction.
• Investigations: weight gain, decreased glucose tolerance.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature babies, which usually returns to normal after treatment is discontinued.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dexamethasone Kern Pharma

Keep this medicine out of sight and reach of children.

Do not freeze. Do not store above 30°C. Keep in the original package to protect from light.

Do not use this medicine after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

This medicine is for single use and must be administered immediately after opening. Any unused portion must be discarded.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Only clear solutions that remain free of turbidity and precipitates should be used.

Composition

• The active ingredient is dexamethasone. Each ampoule contains: 7.2 mg of dexamethasone phosphate (as sodium phosphate dexamethasone, 7.87 mg), equivalent to 6 mg of dexamethasone base.
• The other components (excipients) are: disodium edetate, sodium citrate, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Package Contents

Dexamethasone Kern Pharma is a clear injectable solution presented in packages containing 10 ampoules of 1.8 ml.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: February 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Preferably, this medicine should be administered directly by intravenous route or injected into a perfusion line.

However, Dexamethasone Kern Pharma 7.2 mg injectable solution is compatible with the following perfusion solutions (250 ml each) and must be used within 24 hours: sodium chloride 0.9%, Ringer's solution, or 5% glucose solution.