Leaflet: Information for the user

Dexametasona Kern Pharma 7.2 mg injectable solution

Dexamethasone phosphate

Read this 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 pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to use Dexametasona Kern Pharma.

3.How to use Dexametasona Kern Pharma.

4.Possible side effects.

5.Storage of Dexametasona Kern Pharma.

6.Contents of the pack and additional information.

The dexamethasone phosphate contained in this medication is a synthetic glucocorticoid (adrenocortical hormone) obtained from cortisol. It intervenes by regulating many of the organism's metabolic processes with anti-inflammatory and immunosuppressive activity.

This medication is used as treatment for 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) requiring supplemental oxygen therapy.

Do not use this medicine:

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

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

Warnings and precautions

The administration of this medicine may induce adrenal insufficiency, especially if high doses are administered for a prolonged period.

Avoid sudden discontinuation of treatment, especially in prolonged treatments, as it may cause a corticosteroid withdrawal syndrome 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 as well as mask the signs of an infection and/or make its diagnosis difficult. 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 (ganglia that help defend the body) after receiving the tuberculosis vaccine.
• If you have a history of tuberculosis.
• Patients with chronic hepatitis (inflammation of the liver).
• Acute viral infections (hepatitis B, herpes, varicella, poliomyelitis, measles).
• Infections caused by fungi or parasites.
• If you need to be vaccinated or have been vaccinated within approximately 8 weeks before and 2 weeks after.
• If you have diabetes, peptic ulcer, or inflammatory diseases of the digestive system, osteoporosis (bone calcium loss), heart failure, high blood pressure, and psychiatric diseases.
• If you have glaucoma (increased intraocular pressure), ulcers or lesions of the cornea, blurred vision, or other visual disturbances.

The administration of this medicine may alter the values of some laboratory tests.

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

Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.

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

If intravenous administration of this medicine is too rapid, a sensation of tingling or numbness may occur, which may 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, visual loss or alteration, and difficulty breathing, in the case that you suffer from a malignant hematological process.

If dexamethasone is administered to a premature baby, close monitoring of heart function and structure is necessary.

Children and adolescents

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

Older adults

In patients over 65 years old, the doctor should evaluate the benefits of treatment and possible risks, as these patients may be more susceptible to adverse effects, such as osteoporosis.

Use of Dexametasona Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription, homeopathic, herbal, 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 medications that have been used before or may be used later.

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

• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and salicylates, as they increase the risk of gastrointestinal ulcers and bleeding.
• Oral antidiabetic drugs and insulin, as their effect may be reduced.
• Antiepileptic drugs (carbamazepine), antiarrhythmic drugs (phenytoin), antihistamines, and bronchodilators (ephedrine), antibiotics (rifampicin), barbiturates, and primidone, as they may reduce the effects of dexamethasone.
• Medications that slow down degradation in the liver, such as some antifungal medications (ketoconazole, itraconazole) and certain antiretroviral medications, as they may increase the action of corticosteroids. Your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Coumarin derivatives (oral anticoagulants), as their anticoagulant effect may be modified.
• Estradiol (e.g., for contraceptive use) may increase the action of dexamethasone.
• Atropine and other anticholinergic medications, as they may increase intraocular pressure.
• Cardiotonic glycosides, as their effect may be increased by decreases in potassium levels.
• Diuretics/laxatives, as they may increase potassium elimination.
• Praziquantel, as glucocorticoids may cause a decrease in praziquantel levels in the blood.
• Antihypertensive medications (ACE inhibitors), as they may increase the risk of alterations in blood components.
• Antimalarial medications (chloroquine, hydroxychloroquine, mefloquine), as they may increase the risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Immunosuppressive medications, as they may increase the risk of infections. Additionally, in the case of ciclosporin, ciclosporin levels in the blood may increase, which may increase 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 the risk of hypokalemia (low potassium levels) may be increased.
• 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 medication without consulting your doctor.

Consult your doctor, pharmacist, or nurse before using Dexametasona Kern Pharma.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, treatment should only be administered after carefully weighing the risk-benefit ratio. Therefore, women should inform their doctor about any existing or impending pregnancy. Long-term treatment with glucocorticoids during pregnancy cannot be ruled out as causing fetal growth disorders. If glucocorticoids are administered near the end of pregnancy, the newborn may have impaired adrenal function, which requires initiation of a reduced-dose replacement treatment in the newborn.

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

Breastfeeding

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

Fertility

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

Driving and operating machinery

No data are available on how this medicine affects driving or operating machinery, so try not to perform tasks that require special attention until you check how you tolerate the medicine.

Dexametasona 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 results

This medicine may alter the values of some laboratory tests. Additionally, skin reactions may be masked in allergy tests.

Use in athletes

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will decide for how long you should use dexametasona. Consult your doctor or pharmacist if you have any doubts.

This medication 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 dexametasona phosphate (1 vial, which is equivalent to 6 mg of dexametasona base) by intravenous route, once a day for a maximum of 10 days.

Renal and hepatic insufficiency

No specific dose adjustment is required.

Use in adolescents

It is recommended to administer to pediatric patients (adolescents of at least 12 years of age) a dose of7.2 mg of dexametasona phosphate (1 vial, which is equivalent to 6 mg of dexametasona base)by intravenous route once a day for a maximum of 10 days.

If you use more Dexametasona Kern Pharma than you should

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

No acute intoxications with dexametasona have been reported. In the case of overdose, it is expected that the adverse reactions described in this prospectus will occur to a greater degree.

If you interrupt treatment with Dexametasona Kern Pharma

Do not discontinue treatment before the indicated time by your doctor or abruptly, as this could worsen your condition.

The dose reduction should be done progressively. Similarly, the suspension of treatment should always be done progressively.

Excessive rapid reduction of the dose after a long treatment period may cause symptoms such as muscle and joint pain. Your doctor will reduce your dose progressively.

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

The following side effects have been reported with dexamethasone:

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

• Immune system disorders: decreased resistance to infections, oral thrush.
• Endocrine disorders: adrenal insufficiency.
• • With high doses: signs of hyperactivity of the adrenal glands (Cushing's syndrome) with acne, moon face, and truncal obesity.
• Metabolism and nutrition disorders: hyperglycemia (elevated blood glucose).
• Eye disorders: cataracts.
• Vascular disorders: with high doses, hot flashes.
• Gastrointestinal disorders: with high doses: gastric ulcer.
• Disorders of the skin and subcutaneous tissue: delayed wound healing, skin allergic reaction.
• • With high doses: hirsutism (excessive hair growth), hyperpigmentation of the skin (darkening of the skin), scleroderma (disease of the subcutaneous tissue).
• Musculoskeletal and connective tissue disorders: osteoporosis, bone fragility.
• • With prolonged treatment: muscle atrophy.

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

• Blood and lymphatic system disorders: decreased number of white blood cells called lymphocytes (lymphopenia), decreased number of white blood cells called eosinophils (eosinopenia).
• Immune system disorders: generalized allergic reaction.
• Metabolism and nutrition disorders: hypokalemia (decreased plasma potassium concentration).
• Psychiatric disorders: psychotic disorder.
• Nervous system disorders: increased intracranial pressure, neurological alterations.
• Cardiac disorders: heart failure.
• Vascular disorders: thromboembolism, hypertension.
• • With long-term administration, requiring medical attention: avascular necrosis, edema.
• Gastrointestinal disorders: acute pancreatitis.
• • With long-term administration, requiring medical attention: gastrointestinal irritation, peptic ulcer or intestinal perforation.
• Disorders of the skin and subcutaneous tissue: sweating.
• Musculoskeletal and connective tissue disorders: muscle weakness.
• • With long-term administration, requiring medical attention: steroid myopathy (muscle weakness).
• Reproductive 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 injection site infection, anaphylaxis, generalized flushing, irregular heartbeat or palpitations, convulsions. With local injection: unusual hematomas, non-healing wounds.

Unknown frequency(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 intestinal parasitic 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 alterations, circulatory failure, cardiac arrest.
• Metabolism and nutrition disorders: potassium loss (which may cause arrhythmias), diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, increased appetite.
• Psychiatric disorders: mania, depression, hallucinations, emotional instability, irritability, increased activity, euphoria, anxiety, sleep alterations, suicidal ideas.
• Nervous system disorders: increased spasms in epileptic patients or appearance of epilepsy (seizures), hyperactivity, epidural lipomatosis (growth of adipose tissue around the spine).
• Eye disorders: Glaucoma (increased intraocular pressure), worsening of symptoms of corneal ulcers; eye infections, ptosis, pupil dilation (mydriasis), burning, perforation of the sclera, in rare cases reversible exophthalmos, visual alterations, blurred vision, loss of vision.
• Vascular disorders: increased risk of arteriosclerosis, vasculitis (also as a symptom of withdrawal after long-term treatment), fragility of small blood vessels.
• Gastrointestinal disorders: hiccups, gastrointestinal discomfort, gastrointestinal bleeding.
• Disorders of the skin and subcutaneous tissue: acne, dermatitis around the mouth, striae, skin atrophy, petechiae, telangiectasias, ecchymoses, hypertrichosis.
• Musculoskeletal and connective tissue disorders: tendon alterations, tendon rupture, osteonecrosis, growth delay in children.
• General disorders and administration site conditions: erectile dysfunction.
• Complementary examinations: increased weight, decreased glucose tolerance.
• Cardiac muscle hypertrophy (hypertrophic cardiomyopathy) in premature babies, which usually returns to normal after treatment is discontinued.

Reporting of side effects

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

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

Do not freeze.Do not store at a temperature above 30°C.Keep in the original packaging to protect it from light.

Do not use this medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment..

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

Composition

• The active principle is dexamethasone. Each ampule contains: 7.2 mg of Dexamethasone phosphate (as sodium phosphate of 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 contents of the packaging

Dexametasona Kern Pharma is a transparent injectable solution that is presented in packaging containing 10 ampules of 1.8 ml.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es /

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

It is preferable that this medication be administered directly via intravenous injection or injected into a perfusion line.

However, Dexametasona 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.