Leaflet: Information for the user

Dexametasona Kern Pharma 4 mg/ml injectable solution EFG

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.

Dexamethasone is a synthetic glucocorticoid (adrenal cortical hormone)with very high anti-inflammatory and immunosuppressive activity and minimal mineralocorticoid action.

By intramuscular or intravenous route, it is indicated for the treatment of:

• Acute and chronic inflammatory processes of various causes and different locations.
• Endocrine diseases.
• Hypercalcemia associated with cancer and congenital adrenal hyperplasia.
• Severe allergic states.
• Severe inflammatory and allergic processes, both acute and chronic, affecting the eyes.
• Systemic treatment in critical periods of ulcerative colitis and regional enteritis.
• Skin diseases, respiratory diseases, and blood diseases.
• Idiopathic nephrotic syndrome (without uremia) or caused by lupus erythematosus (autoimmune disease).
• Cerebral edema associated with brain tumor, craniotomy, or head injury.

It is also indicated as:

• Short-term adjunctive treatment during acute episodes or exacerbations of rheumatic diseases.
• During an exacerbation or as maintenance therapy, in some cases of systemic lupus erythematosus and acute rheumatic carditis.
• Palliative treatment of leukemias and lymphomas in adults and acute leukemias in children.

By intravenous route:

• This medication is used as treatment for coronavirus disease 2019 (COVID-19) in adult and adolescent patients (12 years of age or older with a body weight of at least 40 kg) requiring supplemental oxygen therapy.

By intravenous, intraarticular, intralesional, or injection into soft tissues, it is indicated for:

• Short-term associated therapy in acute episodes or exacerbations of rheumatic diseases.
• Intralesional injection in inflammatory processes.

No use Dexametasona Kern Pharma

• If you are allergic or have had an allergic reaction to the active ingredient of this medication or any of its components or to any other medication. These reactions are more common in patients with a history of allergy to any medication.
• If you have fungal infections, tuberculosis, or parasites, herpes, measles, and chickenpox, unless you receive appropriate chemotherapy and are under close medical supervision.
• In prolonged treatments, if you have congestive heart failure, myasthenia gravis (severe muscle weakness), peptic ulcer or esophagitis (inflammation of the esophagus), diabetes, and herpes simplex eye infection.
• If you need to be vaccinated.

Warnings and Precautions

• If you have inflammatory diseases of the digestive system, kidney insufficiency, hypertension, osteoporosis, or myasthenia gravis (severe muscle weakness).
• With high doses, there may be a risk of fatty embolism (accumulation of fat).
• Avoid exposure to the varicella and measles viruses.
• During chronic treatment in children, due to the risk of adrenal suppression, growth retardation.
• During treatment in the elderly, as there may be cases of osteoporosis, fluid retention, and increased blood pressure.
• Concomitant administration of antibiotics and corticosteroids should be closely monitored, as it may disperse the infection if the causative germ is not sensitive to the antibiotic used.
• When using corticosteroids, always use the lowest possible dose until the pathological situation is controlled.
• In patients with hypothyroidism or in patients with cirrhosis, corticosteroids have an increased pharmacological effect.
• Intra-articular administration of a corticosteroid by injection may produce systemic and local effects.
• Avoid injecting a corticosteroid into an infected area.Do not inject into unstable joints. Frequent intra-articular injections may cause joint tissue damage.
• Inform your doctor if you have any of the following symptoms:Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual loss or alteration, and difficulty breathing, in the case of malignant hematological disease.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Monitor the function and structure of the heart if dexamethasone is administered to a premature baby.

Use of Dexametasona Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, 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 afterwards.

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

• Antiepileptics (phenobarbital and carbamazepine), antiarrhythmics (phenytoin), antihistamines, and bronchodilators (adrenaline and ephedrine), antitubercular antibiotics (rifampicin), and anticancer drugs (aminoglutethimide) may reduce the therapeutic effect of dexamethasone.
• Estrogens may increase the effect of dexamethasone.
• Salicylates and antihelmintics (albendazole) may increase the therapeutic effect of dexamethasone.
• Dexamethasone may reduce the effects of antidiabetic medications.
• Concomitant use with medications used to treat heart disease (cardiotonic glucosides and potassium-depleting diuretics) may cause a decrease in potassium levels and an increase in cardiac toxicity.
• Concomitant use with inhibitors of prostaglandin synthesis (indomethacin) may potentiate the toxicity.
• Plasma reduction of some antitubercular drugs (isoniazid).
• Aspirin should be used with caution during treatment with dexamethasone.
• Anticoagulants (coumarins and indandione derivatives).
• Some medications may increase the effects of Dexametasona Kern Pharma, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Do not stop taking any other steroid medication without consulting your doctor.

Consult your doctor, pharmacist, or nurse before taking this medication..

Pregnancy and Lactation

Pregnancy

Consult your doctor or pharmacist before using a medication.

It is not recommended to use Dexametasona Kern Pharma during pregnancy. However, your doctor will evaluate the risk/benefit of its use.

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

Lactation

Consult your doctor or pharmacist before using any medication.

It is not recommended to breastfeed while taking dexamethasone, as this medication passes into breast milk.

Driving and operating machinery

No information is available on how Dexametasona Kern Pharma affects driving or operating machinery, so avoid performing tasks that require special attention until you check how you tolerate the medication.

Important information about some components of Dexametasona Kern Pharma

This medication contains less than 23 mg of sodium per dose; that is, it is essentially "sodium-free".

Influence on laboratory results

This medication may alter the valuesof certain laboratory tests:

- Blood: increased cholesterol and glucose and decreased calcium, potassium, and thyroid hormones.

- Urine:increased glucose.

- Skin tests: tuberculin and patch tests for allergy.

Inform your doctor if you are scheduled to undergo any laboratory tests, as you are using Dexametasona Kern Pharma.

Use in athletes

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

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

Dexametasona Kern Pharma 4 mg/ml is normally administered by a doctor or nurse.

Dexametasona Kern Pharma contains 4 mg of dexamethasone phosphate (equivalent to 3.33 mg of dexamethasone base) per ampoule to be administered by intravenous, intramuscular, intraarticular, intralesional, or soft tissue injection. It may be applied directly or may be added to physiological saline solution or glucose solution and administered by infusion.

The dosage should be adjusted in patients with renal and hepatic insufficiency.

THE DOSING REQUIREMENTS ARE VARIABLE AND SHOULD BE INDIVIDUALIZED BASED ON THE DISEASE AND THE PATIENT'S RESPONSE

Intravenous and intramuscular

As with other steroids, whenever possible, the most suitable dosage ofDexametasona Kern Pharmais:

1. Single daily dose in the morning.

1. Single dose every other day.

The initial dose ofDexametasona Kern Pharma 4 mg/ml, expressed as dexamethasone phosphate,varies between 0.5 and 9 mg per day, depending on the disease to be treated. In less severe processes, lower doses of 0.5 mg may be sufficient, while in more severe diseases, more than 9 mg may be required. The initial dose should be maintained or adjusted until the patient's response is satisfactory, and if, after a reasonable period of time, an adequate clinical response is not achieved, it should be discontinued and the treatment changed for the patient.

Use in children:

In children, the recommended daily dose is 0.08‑0.3 mg/kg or 2.5‑10 mg/m², expressed as dexamethasone phosphate.

Intraarticular, intralesional, and soft tissue injection

This form of administration is used when the affected joints or areas are limited to one or two places. The dosage and frequency of administration vary depending on the condition and location of administration, being the usual dose of 0.2 to 6 mg, expressed as dexamethasone phosphate, and the frequency from once every 3‑5 days to once every 2‑3 weeks. Repeated administration of intraarticular injections may cause damage to the joint tissues.

If you estimate that the action of Dexametasona Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

For the treatment of Covid-19

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

Use in adolescents

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

If you use more Dexametasona Kern Pharma than you should

Consult your doctor or pharmacist immediately, or call the Toxicological Information Service. Telephone 91 562 04 20.

Acute intoxication or death from overdose can occur in a very low percentage. The symptoms that may be observed are anxiety, depression, mental confusion, spasms, or gastrointestinal bleeding, hyperglycemia, hypertension, and edema.In these cases, the administration of phenobarbitalin addition to symptomatic and supportive treatment, which includes oxygen therapy, maintenance of body temperature, adequate fluid intake, and electrolyte control in serum and urine, is indicated. The gastrointestinal bleeding should be treated similarly to a peptic ulcer.

If you interrupt the treatment with Dexametasona Kern Pharma

Your doctor will indicate the duration of your treatment with Dexametasona Kern Pharma. Do not discontinue treatment before, as your condition will worsen.

Like all medications, Dexametasona Kern Pharmamay cause side effects, although not everyone will experience them.

The following is a list of side effects. They have been classified using the following frequency definitions: very common (in at least 1 in 10 patients), Common (in at least 1 in 100 patients), Uncommon (in at least 1 in 1,000 patients), Rare (in at least 1 in 10,000 patients), and Very Rare (less than 1 in 10,000 patients).

The following side effects have been reported with dexamethasone:

Common:

• Immune system disorders: decreased resistance to infections, oral thrush.
• Endocrine disorders: hyperglycemia, adrenal insufficiency.
• With high doses: signs of hyperadrenal activity (Cushing's syndrome) with eruptions.
• Metabolism and nutrition disorders: polyphagia (increased appetite).
• Eye disorders: cataracts.
• Vascular disorders: with high doses, hot flashes.
• Gastrointestinal disorders: with high doses: gastric ulcer.
• Skin and subcutaneous tissue disorders: delayed wound healing, skin allergic reaction. With high doses: hirsutism (excessive hair growth), skin hyperpigmentation (darkening of the skin), scleroderma (disease of the subcutaneous tissue).
• Musculoskeletal and connective tissue disorders: osteoporosis, bone fragility. With prolonged treatment: muscle atrophy.

Uncommon:

• Blood and lymphatic system disorders: lymphopenia, eosinopenia.
• Immune system disorders: generalized allergic reaction.
• Endocrine disorders: amenorrhea (absence of menstruation). With long-term administration, requiring medical attention: Cushing's syndrome, endocrine imbalance.
• Metabolism and nutrition disorders: hypokalemia (decrease in plasma potassium concentration), acute pancreatitis, pancreatitis.
• Nervous system disorders: intracranial hypertension, neurological changes, psychotic states.
• Cardiac disorders: heart failure.
• Vascular disorders: thromboembolism, edema, hypertension. With long-term administration, requiring medical attention: avascular necrosis, edema.
• Skin and subcutaneous tissue disorders: sweating. With long-term administration, requiring medical attention: acne or other skin problems, scars at the injection site.
• Musculoskeletal and connective tissue disorders: myasthenia (muscle weakness). With long-term administration, requiring medical attention: steroid myopathy (muscle weakness), striae, tendon rupture, osteoporosis or bone fractures.
• General disorders and administration site conditions: With rapid intravenous administration of high doses: allergic reactions and local injection site infection, anaphylactic shock, facial flushing, irregular heartbeats or palpitations, convulsions. With local injection: unusual hematomas, wounds that do not heal.
• Gastrointestinal disorders: With long-term administration, requiring medical attention: gastrointestinal irritation, peptic ulcer or intestinal perforation.

Unknown frequency (cannot be estimated from available data):

• Eye disorders: visual disturbances, vision loss, blurred vision.
• General disorder: hipo
• Cardiac muscle thickening (hypertrophic cardiomyopathy) in premature babies, which usually returns to normal after treatment is stopped.

If you notice the appearance of adverse reactions, discontinue treatment and consult a doctor.

Reporting of adverse reactions

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

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

Do not freeze.Do not store 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 disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

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

Other presentations: Clinical packaging of 100 ampoules.

Composition

• The active principle is dexamethasone. Each ampoule contains: 4 mg of Dexamethasone phosphate (as dexamethasone phosphate sodium, 4.37 mg), which is equivalent to 3.33 mg of dexamethasone base.
• The other components (excipients) are: disodium edetate, sodium citrate (E-331i), sodium hydroxide (E-524) 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 3 ampoules of 1 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/

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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 4 mg/ml 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.