Etason

Patient Information Leaflet

Etason 0.5 mg effervescent tablets, 1 mg effervescent tablets

Betamethasone
Equivalent medicinal product
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Etason is and what it is used for

Etason contains the active substance betametasone, which belongs to a group of medicines called corticosteroids. Etason is a hormonal medicine belonging to the class of glucocorticoids.
Etason is indicated for the treatment of a wide range of diseases, including the main ones listed below:

• bronchial asthma
• severe allergic diseases
• chronic autoimmune joint inflammation (rheumatoid arthritis)
• skin and mucous membrane connective tissue diseases (collagenoses)
• inflammatory skin disorders
• lymphatic system tumours such as:
  • acute and chronic malignant lymphopathies
  • Hodgkin's disease

Etason is also indicated for the treatment of other diseases:

• severe kidney disease (nephrotic syndrome)
• chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
• autoimmune skin and mucous membrane diseases characterized by blister formation (pemphigus)
• a disease characterized by granuloma formation in various organs and tissues (sarcoidosis)
• heart inflammation associated with rheumatic fever (rheumatic carditis)
• chronic inflammatory and autoimmune disease of the spine (ankylosing spondylitis)
• blood disorders such as:
  • reduced number of red blood cells due to their destruction (haemolytic anaemia)
  • reduced number of a type of white blood cells (agranulocytosis)
  • impaired blood clotting due to low platelet count (thrombocytopenic purpura)

2. What you should know before taking Etason

Do not take or give Etason to a child if you or the child:

• are allergic to betamethasone, to other corticosteroid medicines, or to any of the other ingredients of this medicine (listed in section 6);
• have infections affecting the whole body and are not receiving specific treatment for them;
• are receiving vaccinations with attenuated viruses or other types of vaccines.

Warnings and precautions
Talk to your doctor or pharmacist before taking or giving Etason to a child.
Tell your doctor before taking or giving Etason to a child, if you or the child:

• have phaeochromocytoma (a tumour of the adrenal gland);
• have a serious heart condition (congestive heart failure);
• suffer from psychological or emotional disorders, as these may worsen during treatment with Etason;
• have epilepsy;
• have diabetes;
• have increased eye pressure (glaucoma);
• have chronic inflammation of the lower part of the intestine (ulcerative colitis);
• have an abscess or an infection;
• have inflammation of the diverticula, small naturally occurring or formed pouches in the lower part of the intestine (diverticulitis);
• have recently undergone surgery to connect parts of the intestine (intestinal anastomosis);
• have an active or latent stomach or duodenal ulcer;
• have impaired kidney function;
• have impaired liver function;
• have chronic liver damage (hepatic cirrhosis);
• have high blood pressure;
• have a disease characterized by loss of bone tissue (osteoporosis);
• have a disease causing severe muscle weakness (myasthenia gravis);
• have previously experienced muscle problems after treatment with medicines similar to Etason (steroids);
• have poorly functioning thyroid gland;
• have herpes simplex eye infection;
• have reduced blood clotting (hypoprothrombinemia) and need to use acetylsalicylic acid (e.g. aspirin).

Inform your doctor if, during treatment with Etason, you or the child:

• need to undergo radiological examination of the gallbladder using a contrast medium (cholecystography), as Etason may reduce the effects of the contrast agents used during this examination;
• are under particular stress, for example during surgery, as in such cases the dose of Etason may need to be adjusted;
• develop psychological or emotional disturbances such as elation, excessive exuberance and happiness (euphoria), insomnia, severe depression, mood and personality changes, disturbances of mental equilibrium, delusions, or hallucinations (psychosis). Contact your doctor if blurred vision or other visual disturbances occur.

Pay special attention during treatment with Etason:

• you or the child must not come into contact with people who have measles or chickenpox if taking high doses of this medicine. If such contact occurs, contact your doctor;
• glucocorticoids, such as Etason, may:
  o mask certain signs of infection and, during their use, infections may occur due to reduced immune defences. In such cases, your doctor will assess whether appropriate antibiotic therapy is needed.
  o cause adrenal insufficiency; in such cases, your doctor will advise whether to gradually reduce the dose or temporarily discontinue treatment. This type of insufficiency may last up to one year after stopping therapy. If a stressful condition occurs during the period after stopping Etason, your doctor may advise resuming treatment with this medicine.
  o cause systemic effects when used by inhalation (via aerosol) at high doses and for prolonged periods; therefore, your doctor will prescribe the lowest possible inhaled dose needed to maintain effective asthma control. These effects are less likely than with oral corticosteroid treatment.

The use of glucocorticoids in active tuberculosis should be limited to cases of fulminant or disseminated disease, in which the glucocorticoid should be used together with appropriate antitubercular therapy.
If glucocorticoids are administered to patients with latent tuberculosis or with a positive tuberculin reaction, close monitoring is required as reactivation of the disease may occur (see section 4).
During treatment with Etason, your doctor may prescribe for you or the child:

• appropriate therapy to prevent infections, if you or the child need to use Etason for long periods;
• sodium and potassium supplements if you or the child develop disturbances in body fluids and electrolytes.

Children and adolescents
Your doctor will prescribe Etason to children and adolescents at the lowest possible doses and for the shortest possible duration. Depending on the case, your doctor may consider administering the medicine as a single dose on alternate days. See section 3.
Your doctor will closely monitor growth and development in children and adolescents undergoing prolonged treatment with Etason.
Children are particularly at risk of increased intracranial pressure.

Elderly patients
In elderly patients, treatment with Etason, especially if prolonged, may more frequently cause unwanted effects such as loss of bone tissue (osteoporosis), worsening of diabetes or high blood pressure, increased susceptibility to infections, and skin thinning. Taking this into account, your doctor will determine the most appropriate dose of Etason for you. See section 3.

Other medicines and Etason
Tell your doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Inform your doctor if you or the child are taking or need to take one or more of the following medicines:

• anticholinesterases;
• anti-inflammatory medicines:
  o acetylsalicylic acid or other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines that increase urine production (diuretics), particularly furosemide and thiazide diuretics;
• amphotericin (antifungal);
• xanthines, e.g. theophylline;
• medicines for diabetes, e.g. insulin;
• cyclosporine (immunosuppressant);
• ketoconazole (medicine used to treat fungal infections);
• phenytoin and phenobarbital (used to treat epileptic seizures);
• ephedrine;
• rifampicin (antibiotic);
• anticoagulants (medicines that reduce blood clotting).

Some medicines may increase the effects of Etason, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Laboratory tests
Etason may reduce the effects of contrast agents in cholecystography. Inform your doctor that you or the child are being treated with Etason if undergoing cholecystography.
Electrolyte imbalances (such as sodium or potassium) may occur, especially during prolonged treatment or with high doses of Etason; in such cases, your doctor will arrange laboratory tests and provide appropriate advice.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/child before prescribing Etason.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery. However, rare neurological side effects have been reported.

Etason contains sodium and sodium benzoate
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically 'sodium-free'.
This medicine contains 3.8 mg of sodium benzoate per tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Etason

Take or administer this medicine to the child exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The tablet may be divided into equal parts.

Use in adults

Short-term therapy
The recommended dose is 4–6 tablets of 0.5 mg daily or 2–3 tablets of 1 mg daily.
Your doctor will then advise you on how to gradually reduce the dose according to the progression of your disease.

Long-term therapy
The recommended starting dose at the beginning of treatment is 6–8 tablets of 0.5 mg daily or 3–4 tablets of 1 mg daily.
Subsequently, your doctor will advise you on how to gradually reduce the dose until reaching the maintenance dose needed to control your condition.

Maintenance therapy
The recommended maintenance dose is 2–4 effervescent tablets of 0.5 mg daily or 1–2 effervescent tablets of 1 mg daily (1–2 mg daily). The dose should always be the lowest effective dose capable of controlling your symptoms.

Use in children
The recommended dose is 0.1–0.2 mg per kg of body weight per day.
You may also administer Etason to the child via aerosol. Dissolve 0.5–1 mg of Etason in 1–2 ml of water immediately before use.

Elderly patients
Your doctor will determine the most appropriate dose of Etason for you.
Your doctor will prescribe the lowest maintenance dose capable of controlling the disease.
If necessary, your doctor will instruct you to gradually reduce the dose over several weeks or months, depending on the initial dose and duration of therapy.

If you take or administer more Etason than you should
In case of accidental ingestion of an excessive dose of Etason, contact your doctor immediately or go to the nearest hospital.
Generally, accidental overdose of glucocorticoids, including Etason, is not life-threatening, except when very high doses are taken or if you or the child have specific clinical conditions such as:

• diabetes mellitus
• increased intraocular pressure (glaucoma)
• stomach or duodenal ulcer
• concomitant treatment with medicines such as digitalis (a heart medicine), anticoagulants (coumarins), or potassium-depleting diuretics.

If you forget to take or administer Etason to the child
Do not take or administer a double dose to make up for the missed dose.

If you or the child stop taking Etason
Treatment with Etason must not be stopped without first consulting your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• severe heart failure (congestive heart failure)
• adrenal insufficiency
• reduction in adrenal gland size (adrenal atrophy)
• disorders of the adrenal glands such as Cushing's syndrome, hyperadrenocorticism
• diabetes mellitus
• increased blood sugar levels
• excessive hair growth or beard growth
• increased eye pressure (glaucoma)
• opacity in the posterior capsule of the lens (subcapsular cataract)
• increased ocular tension
• perforation of a pre-existing stomach or intestinal ulcer before starting treatment with Etason
• stomach and duodenal ulcer
• acute inflammation of the pancreas
• inflammation of the esophagus
• nausea
• incomplete healing
• severe allergic reaction
• urticaria
• skin inflammation due to allergy
• reactivation of tuberculosis
• infections caused by fungi or viruses
• reduction in potassium levels
• reduction in blood nitrogen levels
• reduction in proteins
• reduction in lymphocytes (white blood cells) in the blood
• reduced glucose tolerance
• weight gain or weight loss
• loss of bone tissue (osteoporosis)
• death of bone tissue (osteonecrosis)
• swelling due to fluid accumulation (edema)
• increased appetite
• growth retardation
• muscle disorders
• collagen disorders
• fracture
• tendon rupture
• increased intracranial pressure
• swelling of the optic nerve head due to increased intracranial pressure (papilledema)
• blurred vision
• dizziness
• headache
• psychiatric disorders
• anxiety
• irritability
• menstrual cycle disturbances
• thinning of the skin
• acne
• bruising
• skin erythema
• skin changes such as delayed wound healing
• excessive sweating
• high blood pressure
• hiccups

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etason

Keep this medicine out of the sight and reach of children. Store below 25°C in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the container after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Etason 0.5 mg effervescent tablets contains

• The active substance is betamethasone. Each effervescent tablet contains 0.6578 mg of betamethasone disodium phosphate equivalent to 0.5 mg of betamethasone.
• The other components are: disodium dihydrogen citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearoyl fumarate, sodium saccharin.

What Etason 1 mg effervescent tablets contains

• The active substance is betamethasone. Each effervescent tablet contains 1.316 mg of betamethasone disodium phosphate equivalent to 1 mg of betamethasone.
• The other components are: disodium dihydrogen citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearoyl fumarate, sodium saccharin.

Description of the appearance of Etason and contents of the pack
Each pack contains 10 or 30 effervescent tablets in PA/AL/PVC-AL blisters.
Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)