DEXAMETHASONE KERN PHARMA 4 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Dexamethasone Kern Pharma 4 mg/ml injectable solution EFG

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. Storage of Dexamethasone Kern Pharma.
6. Contents of the pack and other information.

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

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

Via intramuscular or intravenous, it is indicated in 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 conditions.
• 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 adjuvant 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.
• For the palliative treatment of leukemias and lymphomas in adults and acute leukemias in children.

Via intravenous:

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

Via intra-articular, intralesional, or injection into soft tissues, it is indicated in:

• As short-term associated therapy in acute episodes or exacerbations of rheumatic diseases.
• Via intralesional injection in inflammatory processes.

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

Do not use Dexamethasone Kern Pharma

• If you are allergic or have had an allergic reaction to the active substance of this medicine or any of its components or to any other medicine. These reactions are more common in patients with a history of allergy to any medicine.
• If you have fungal infections, tuberculosis, or parasitic infections, herpes, measles, and chickenpox, unless you are receiving adequate chemotherapeutic treatment and are under close medical supervision.
• In prolonged treatments, if you have congestive heart disease, severe myasthenia (muscle weakness), peptic ulcer, or esophagitis (inflammation of the esophagus), diabetes, and ocular herpes simplex.
• If you need to be vaccinated.

Warnings and precautions

• If you have inflammatory diseases of the digestive system, kidney failure, hypertension, osteoporosis, or myasthenia gravis (muscle weakness).
• With high doses, fat embolism (fat accumulation) may occur.
• Exposure to the varicella and measles viruses should be avoided.
• During chronic treatment in children, due to the risk of adrenal suppression, growth delay.
• During treatment in the elderly, as cases of osteoporosis, fluid retention, and increased blood pressure may occur.
• The concomitant administration of antibiotics and corticosteroids should be controlled, as it may spread the infection if the causative germ is not sensitive to the antibiotic used.
• In corticosteroid treatment, the lowest possible dose should always be used until the pathological situation is controlled.
• In patients with hypothyroidism or in patients with cirrhosis, corticosteroids have an increased pharmacological effect.
• The intra-articular route of a corticosteroid administered by injection may produce systemic and local effects.
• Injection of a corticosteroid into an infected area should be avoided. They should also not be injected into unstable joints. Frequent intra-articular injections may cause damage to joint tissues.
• You should inform your doctor if you have any of the following symptoms: Symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or alteration, and difficulty breathing, in case you suffer from a malignant hematological process.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If dexamethasone is administered to a premature baby, it is necessary to monitor the function and structure of the heart.

Use of 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:

• Antiepileptics (phenobarbital and carbamazepine), antiarrhythmics (phenytoin), anti-asthmatics and bronchodilators (adrenaline and ephedrine), antitubercular antibiotics (rifampicin), and anticancer drugs (aminoglutethimide) may decrease the therapeutic effect of dexamethasone.
• Estrogens may increase the effect of dexamethasone.
• Increased therapeutic effect of salicylates and anthelmintics (albendazole).
• May reduce the effects of antidiabetics.
• With medicines used to treat heart diseases (cardiac glycosides and potassium-depleting diuretics), it may produce a decrease in potassium levels and an increase in cardiac toxicity.
• With inhibitors of prostaglandin synthesis (indomethacin), there is a mutual potentiation of toxicity.
• Plasma reduction of some antituberculars (isoniazid).
• Dexamethasone should be used with caution during treatment with acetylsalicylic acid.
• Anticoagulants (coumarins and indandione derivatives).
• Some medicines may increase the effects of Dexamethasone Kern Pharma, so your doctor will perform thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

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

Talk to your doctor, pharmacist, or nurse before taking this medicine.

Pregnancy and Breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

The use of Dexamethasone Kern Pharma is not recommended during pregnancy. However, the doctor will assess the risk/benefit of its use.

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

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Breastfeeding is not recommended for mothers treated with dexamethasone, as this medicine passes into breast milk.

Driving and using machines

It is not known whether Dexamethasone Kern Pharma affects the ability to drive or use machines, so avoid performing tasks that require special attention until you verify how you tolerate the medicine.

Important information about some of the components of Dexamethasone Kern Pharma

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

Influence on laboratory test results

This medicine may alter the values of certain laboratory tests:

• Blood: increase in cholesterol and glucose and decrease in calcium, potassium, and thyroid hormones.
• Urine: increase in glucose.
• Skin tests: tuberculin and patch tests for allergy.

If you are prescribed any laboratory test, inform your doctor that you are using Dexamethasone Kern Pharma.

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 indicated by your doctor. Your doctor will decide how long you should take dexamethasone. Consult your doctor or pharmacist if you have doubts.

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

Dexamethasone Kern Pharma contains 4 mg of dexamethasone phosphate (equivalent to 3.33 mg of dexamethasone base) per ampoule to be administered by intravenous, intramuscular, intra-articular, intralesional, or injection into soft tissues. It can be applied directly or added to physiological serum solution or glucose serum and administered by drip.

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

THE DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED BASED ON THE DISEASE AND THE PATIENT'S RESPONSE

Intravenous and intramuscular route

As with other steroids, whenever the pathology allows it, the most suitable dosage of Dexamethasone Kern Pharma is:

1. Single daily dose in the morning.

1. Single dose every other day.

The initial dose of Dexamethasone 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, an adequate clinical response is not achieved, treatment should be suspended and changed.

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.

Intra-articular, intralesional, and injection into soft tissues route

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 place of administration, with the usual dose being 0.2 to 6 mg, expressed as dexamethasone phosphate, and the frequency ranging from once every 3-5 days to once every 2-3 weeks. Repeated administration of intra-articular injections may cause damage to joint tissues.

If you think the action of Dexamethasone Kern Pharma is too strong or too weak, tell 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) intravenously, once a day for a maximum of 10 days.

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 (equivalent to 6 mg of dexamethasone base) intravenously once a day for a maximum of 10 days.

If you use more Dexamethasone Kern Pharma than you should

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

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

If you stop treatment with Dexamethasone Kern Pharma

Your doctor will indicate the duration of your treatment with Dexamethasone Kern Pharma. Do not suspend treatment before, as your disease may worsen again.

4. Possible side effects

Like all medicines, Dexamethasone Kern Pharma can cause side effects, although not everyone gets them.

The following is a list of side effects. They have been classified using the following frequency definitions: very common (at least 1 in 10 patients), common (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (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, oropharyngeal candidiasis.
• Endocrine disorders: hyperglycemia, adrenocortical insufficiency.
• With high doses: signs of adrenal hyperactivity (Cushing's syndrome) with eruptions.
• Metabolism and nutrition disorders: polyphagia (increased appetite).
• Eye disorders: cataracts.
• Vascular disorders: with high doses, flushing.
• 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 (skin darkening), scleroderma (subcutaneous tissue disease).
• 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 disorders, 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, injection site scars.
• 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: local allergic reactions and infection at the injection site, generalized anaphylaxis, facial or cheek flushing, irregular heartbeat or palpitations, convulsive crises. With local injection: unusual hematomas, non-healing wounds.
• Gastrointestinal disorders: With long-term administration, requiring medical attention: gastrointestinal irritation, peptic ulcer, or intestinal perforation.

Frequency unknown (cannot be estimated from available data):

• Eye disorders: visual disturbances, vision loss, blurred vision.
• General disorder: hypothermia.
• Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature babies, which usually returns to normal after treatment is discontinued.

In case of observing the appearance of adverse reactions, treatment should be suspended and a doctor should be consulted.

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dexametasona Kern Pharma

Keep this medicine out of the 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 expiry date stated on the packaging after "CAD". The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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.

Other presentations: Clinical package of 100 ampoules.

Composition

• The active ingredient is dexamethasone. Each ampoule contains: 4 mg of Dexamethasone phosphate (as sodium dexamethasone phosphate, 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 Package Contents

Dexametasona Kern Pharma is a clear injectable solution presented in packages containing 3 ampoules of 1 ml each.

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 Leaflet: 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/

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

This information is intended exclusively for healthcare professionals:

Preferably, this medicine should be administered directly by intravenous route 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.