DEXAMETHASONE NOVAMIS 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dexamethasone Novamis 4 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Dexamethasone Novamis is and what it is used for

Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) derived from cortisone, which regulates many of the body's metabolic processes.

Dexamethasone is used to treat:

• Inflammatory processes secondary to tumors and brain abscesses and neurosurgical procedures.
• Severe acute asthma.
• Severe skin diseases.
• Certain autoimmune diseases (lupus erythematosus).
• Active rheumatoid arthritis.
• Prevention and treatment of nausea and vomiting that occur during treatment with anticancer agents.

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

2. What you need to know before you take Dexamethasone Novamis

Do not takeDexamethasoneNovamis

• If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Depending on the dose and duration of treatment, glucocorticoid-induced adrenocortical insufficiency may persist for months and in individual cases up to one year after treatment is stopped. Acute adrenocortical insufficiency induced by therapy can be minimized by gradual dose reduction if withdrawal is planned.

Treatment with this medicine may increase the risk of infections and diagnosis of these may be more difficult. Latent infections (infections that do not show symptoms) such as tuberculosis or hepatitis B may be reactivated.

Long-term treatment with dexamethasone should only be established when it is strictly necessary and should be associated with specific treatment corresponding to each case.

In some cases, strict control of treatment by your doctor will be necessary. You should inform your doctor if you have any of the following symptoms:

• Patients with acute and chronic bacterial infections should receive specific antibiotic treatment, such as patients with a history of tuberculosis (infectious disease), who can only receive dexamethasone treatment under the protection of antitubercular drugs.
• Generally, in patients who have received or are going to receive any vaccine, particularly if lymph node inflammation (glands that help defend the body) is observed after receiving the tuberculosis vaccine.
• In viral infections: hepatitis B, chickenpox, herpes, measles, poliomyelitis, herpetic keratitis. Special precautions are recommended if you are immunosuppressed or if you have not had measles or chickenpox and are in contact with people with measles or chickenpox.
• Infections caused by fungi or parasites.
• In patients with chronic hepatitis (liver inflammation).
• Difficult-to-control diabetes mellitus (increased blood sugar).
• Osteoporosis (loss of calcium in bones).
• Severe heart failure.
• Difficult-to-control high blood pressure.
• Peptic ulcer.
• Inflammatory diseases of the digestive system.
• If you suffer from psychiatric diseases.
• If you have lymph node inflammation (glands that help defend the body) after being administered the tuberculosis vaccine.
• If you have glaucoma (increased pressure inside the eye) or eye ulcers.
• Symptoms of tumor lysis syndrome such as: muscle cramps, muscle weakness, confusion, vision loss or alteration, and difficulty breathing, in case you have a malignant hematological process.

Long-term treatment with this medicine requires periodic medical monitoring, including vision checks every 3 months.

Contact your doctor if you experience blurred vision or other visual disturbances.

Signs of peritoneal irritation due to gastrointestinal perforation may not appear if you are taking high doses of this medicine.

If you take fluoroquinolones (substances with antibacterial activity) and corticosteroids (substances with anti-inflammatory properties), the risk of tendon disorders increases.

In cases of fever, accidents, surgery, or childbirth, it may be necessary to temporarily increase the daily dose of this medicine.

Severe allergic reactions may occur.

Treatment with this medicine may worsen existing myasthenia gravis (a neuromuscular disease).

High doses of dexamethasone require adequate potassium supplements and sodium restrictions in the diet; and plasma potassium levels should be monitored.

Administration of high doses of dexamethasone may cause a slower heart rate.

Children and Adolescents

Dexamethasone should not be used routinely in premature infants with respiratory problems.

Growth in children should be regularly monitored (see section 4).

Elderly Patients

In elderly patients, the doctor should weigh the benefits and risks of treatment.

Other Medicines and Dexamethasone Novamis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may increase the effects of dexamethasone, so your doctor will perform thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Taking dexamethasone with some of the following medicines may alter the effect of both dexamethasone and the other medicine:

• Estrogens (e.g., birth control pills),
• Enzyme inhibitors such as antifungal medicines (itraconazole, ketoconazole, and amphotericin B),
• Antacids (e.g., aluminum hydroxide, magnesium hydroxide), the intake of these medicines should be spaced 2 hours apart,
• Enzyme inducers such as tuberculosis medicines (rifampicin), epilepsy medicines (phenytoin, carbamazepine, and primidone),
• Sedatives (barbiturates),
• Central nervous system stimulants (ephedrine),
• Heart medicines (digitalis),
• Medicines for high blood pressure or to promote urine elimination (diuretics),
• Laxatives,
• Medicines for diabetes treatment (oral antidiabetics and insulin),
• Medicines to control blood coagulation (oral anticoagulants). The dose of the anticoagulant may need to be adjusted,
• NSAIDs: anti-inflammatory or antirheumatic medicines (e.g., indomethacin or salicylates) increase the risk of ulcers and gastrointestinal bleeding,
• Medicines that relax muscles used for relief of spasms or contractions of the stomach, intestine, and bladder (rocuronium, vecuronium, atropine, or other anticholinergic medicines),
• Antiparasitic medicine (praziquantel),
• Malaria medicines (chloroquine, hydroxychloroquine, mefloquine), as they may increase the risk of myopathy and cardiomyopathy (muscle or heart muscle disease, respectively),
• Growth hormone (somatotropin),
• Medicines for diagnosis of thyroid gland problems (protylerin),
• Immunosuppressive substances and cyclosporine (medicines to prevent organ transplant rejection),
• Some antibiotics (fluoroquinolones), which may increase the risk of tendon disorders.

Interference with Laboratory Tests

Skin tests for allergy tests may give false results.

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

Talk to your doctor, pharmacist, or nurse before this medicine is administered to you.

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 taking this medicine.

This medicine is not recommended during pregnancy and breast-feeding, unless your doctor prescribes it. He will indicate whether you should stop breast-feeding or interrupt the administration of this medicine.

Driving and Using Machines

No studies have been performed on the ability to drive and use machines.

Use in Athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

Dexamethasone Novamis contains Lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Dexamethasone Novamis

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The tablets should be taken whole, during or after meals, with sufficient liquid. The tablet can be divided into equal doses.

Generally, the total daily dose will be taken in one intake, preferably in the morning, during or after breakfast, although it may be necessary to divide the dose into several intakes per day in patients who require high doses to achieve the maximum effect.

The treatment dose will depend on the type and severity of the disease and the individual patient's response. Your doctor will indicate the dose you should take, adjusting it to your needs, as well as the duration of treatment.

The dose should be high enough and the duration of treatment long enough, but on the other hand, the minimum effective dose should be maintained for the shortest possible time.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

For the treatment of Covid-19

In adult patients, it is recommended to take 6 mg orally once a day, for a maximum of 10 days.

Use in Adolescents

It is recommended to administer to pediatric patients (adolescents from 12 years of age) a dose of 6 mg orally once a day, for a maximum of 10 days.

If you take more Dexamethasone 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. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

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

No antidote for dexamethasone is known.

If you forget to take Dexamethasone

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at its usual time.

If you stop taking Dexamethasone

Do not stop treatment before your doctor indicates, nor suddenly, as it may worsen your disease.

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 muscle and joint pain. Your doctor will gradually reduce the dose you should take.

If you interrupt long-term treatment, it may cause an increase in symptoms of your disease or a relapse, acute adrenocortical insufficiency (alteration of the production of certain hormones), and cortisone withdrawal syndrome characterized by general malaise, weakness, and muscle pain, difficulty breathing, loss of appetite, nausea, vomiting, fever, drop in blood pressure and blood sugar levels, among other symptoms.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of this medicine, the following side effects have been observed, whose frequency could not be established with precision:

• Alteration of blood cells (white blood cells and lymphocytes, among others).
• Localized obesity in the abdomen and face (Cushing's syndrome).
• Glaucoma, cataracts, worsening of corneal ulcers, and infections.
• Peptic ulcer, gastrointestinal bleeding, pancreatitis, stomach discomfort.
• Wounds take longer to heal.
• Hypersensitivity reactions, severe allergic reactions such as: heart rhythm problems, bronchospasm, blood pressure changes, circulatory failure, cardiac arrest.
• Existing infections may worsen, and new infections may appear, which are difficult to diagnose.
• Fluid retention (edema), potassium loss (which can cause heart rhythm changes), weight gain, increased blood sugar, diabetes mellitus, increased cholesterol and triglyceride levels in the blood, increased appetite, delayed growth in children.
• Muscle diseases and muscle weakness, tendon disorders, tendinitis, tendon ruptures, loss of calcium in bones, osteoporosis, delayed growth in children.
• Reducing the dose too quickly after long-term treatment may cause muscle and joint pain.
• Increased intracranial pressure (especially in children), increased spasms in epileptic patients, or onset of epilepsy.
• Depression, hallucinations, emotional instability, irritability, increased activity, psychosis, mania, euphoria, anxiety, sleep disturbances, suicidal thoughts.
• Irregular or absent menstruation, sexual impotence, excessive hair growth.
• Acne or other skin problems (allergy, bruising, stretch marks), edema, changes in skin color, dermatitis around the mouth.
• Hypertension, increased risk of arteriosclerosis (narrowing and hardening of the arteries) and thrombosis (blood clot formation), vasculitis, capillary fragility.
• Visual disturbances, vision loss, blurred vision.
• Hiccups

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexamethasone Novamis

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Dexametasona Novamis Composition

• The active ingredient is dexamethasone. Each tablet contains 4 mg of dexamethasone.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, crospovidone, corn starch, and magnesium stearate.

Product Appearance and Packaging Content

The 4 mg dexamethasone tablets are white, round, flat, with beveled edges, and uncoated. The tablet is engraved with a "D" and a "4" separated by a scored line on one side and smooth on the other, with an approximate diameter of 9.2 mm. The tablet can be divided into equal doses.

The 4 mg dexamethasone tablets are available in boxes with PVC/PVdC/aluminum foil blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Novamis Limited

Unit 1A, Block 1, Bracken Business Park

Bracken Road, Sandyford,

D18H283

Dublin,

Ireland

Manufacturer

SANTA S.A.

Panselelor str. no.25, no.27 and no.29,

Brasov Municipality, Brasov County, 500419

Romania

Date of the Last Revision of this Leaflet: August 2025

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