Betamethasone Eg Stada

Package leaflet: Information for the patient

BETAMETASONE EG STADA 0.5 mg effervescent tablets, 1 mg effervescent tablets

Betamethasone
Generic medicine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BETAMETASONE EG STADA is and what it is used for

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

• bronchial asthma
• severe allergic diseases
• chronic and autoimmune inflammation of the joints (rheumatoid arthritis)
• connective tissue diseases of the skin and mucous membranes (collagenoses)
• inflammatory skin disorders
• lymphatic system tumours such as:
  o acute and chronic malignant lymphoproliferative disorders
  o Hodgkin's disease

BETAMETASONE EG STADA 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 disorders 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 autoimmune and inflammatory disease of the spine (ankylosing spondylitis)
• blood disorders such as:
  o reduced number of red blood cells due to their destruction (haemolytic anaemia)
  o reduced number of a specific type of white blood cells (agranulocytosis)
  o impaired blood clotting due to reduced platelets (thrombocytopenic purpura)

2. What you need to know before taking BETAMETASONE EG STADA

Do not take or give BETAMETASONE EG STADA to the 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 entire 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 BETAMETASONE EG STADA to the child.
Inform your doctor before taking or giving BETAMETASONE EG STADA to the child,
if you or the child:

• have phaeochromocytoma (a tumour of the adrenal gland)
• have a serious heart problem (congestive heart failure)
• suffer from psychological or emotional disorders, as these conditions may worsen during treatment with BETAMETASONE EG STADA
• have epilepsy
• have diabetes
• have increased eye pressure (glaucoma)
• have chronic inflammation of the final 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 terminal 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 had muscle problems after previous treatment with medicines similar to BETAMETASONE EG STADA (steroids)
• have poorly functioning thyroid
• 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 BETAMETASONE EG STADA, you or the child:

• need to undergo radiological examination of the gallbladder using a contrast medium (cholecystography), because BETAMETASONE EG STADA may reduce the effects of contrast agents used during this examination;
• are subjected to particular stress, for example due to surgery, because in these
  situations it might be necessary to adjust the dose of BETAMETASONE EG STADA;
• develop psychological or emotional disturbances such as elation, excessive exuberance and happiness (euphoria), insomnia, severe depression, changes in mood and personality, disturbances of mental balance, delusions and hallucinations (psychosis). Contact your doctor if blurred vision or other visual disturbances occur.

Pay special attention during treatment with BETAMETASONE EG STADA:

• you or the child should not come into contact with people affected by measles or chickenpox if taking high doses of this medicine. If this occurs, contact your doctor;
• glucocorticoids, such as BETAMETASONE EG STADA, 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 should be prescribed.
  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 BETAMETASONE EG STADA, 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; for this reason, your doctor will prescribe the lowest possible inhaled dose to maintain effective asthma control. These effects are less likely than with oral corticosteroid treatment.

Use in active tuberculosis should be limited to cases of fulminating or disseminated disease, in which the
glucocorticoid should be used 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 BETAMETASONE EG STADA, your doctor may prescribe for you or the
child:

• appropriate therapy to prevent infections, if you or the child need to use BETAMETASONE EG STADA 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 BETAMETASONE EG STADA 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 on alternate days as a single dose. See section 3.
Your doctor will closely monitor growth and development in children and adolescents undergoing prolonged treatment with BETAMETASONE EG STADA.
Children are particularly at risk of increased intracranial pressure.
Elderly patients
In elderly patients, treatment with BETAMETASONE EG STADA, especially if prolonged, may more frequently cause adverse effects such as loss of bone tissue (osteoporosis), worsening of diabetes, high blood pressure, increased susceptibility to infections, and skin thinning.
Taking this into account, your doctor will evaluate the most appropriate dose of BETAMETASONE EG STADA for you. See section 3.
Other medicines and BETAMETASONE EG STADA
Inform 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
• 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 phenobarbitone (used to treat epileptic seizures)
• ephedrine
• rifampicin (antibiotic)
• anticoagulants (medicines that reduce blood clotting)

Some medicines may increase the effects of BETAMETASONE EG STADA, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for HIV treatment: ritonavir, cobicistat).
Laboratory tests
BETAMETASONE EG STADA may reduce the effects of contrast agents in cholecystography.
Inform your doctor that you or the child are being treated with BETAMETASONE EG STADA if a cholecystography is planned.
Alterations in electrolyte levels (such as sodium or potassium) may occur, especially during prolonged treatment and with high doses of BETAMETASONE EG STADA; 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 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 BETAMETASONE EG STADA.
Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery. However, rare neurological adverse effects have been reported.
BETAMETASONE EG STADA 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 the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take BETAMETASONE EG STADA

Take or administer this medicine to the child exactly as directed by your doctor or pharmacist. If you have any doubts, 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 per day or 2–3 tablets of 1 mg per day.
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 initial dose is 6–8 tablets of 0.5 mg per day or 3–4 tablets of 1 mg per day.
Your doctor will then 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 per day or 1–2 effervescent tablets of 1 mg per day (1–2 mg per day). In any case, it should be the lowest dose sufficient to control 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 BETAMETASONE EG STADA to the child via aerosol. Dissolve 0.5–1 mg of BETAMETASONE EG STADA in 1–2 ml of water immediately before use.

Elderly patients
Your doctor will determine the most appropriate dose of BETAMETASONE EG STADA for you.
Your doctor will prescribe the lowest effective maintenance dose needed to control 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 treatment.

If you take or administer more BETAMETASONE EG STADA than prescribed
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Generally, an overdose of glucocorticoids, including BETAMETASONE EG STADA, 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 other medicines, e.g. digitalis (a heart medicine), anticoagulant medicines (coumarins), or potassium-depleting diuretics.

If you forget to take or administer BETAMETASONE EG STADA
Do not take or administer a double dose to make up for the missed dose.

If you or the child stop treatment with BETAMETASONE EG STADA
Treatment with BETAMETASONE EG STADA must not be stopped without first consulting your doctor.
If you have any questions about the use of 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 of the posterior lens capsule (subcapsular cataract)
• increased ocular tension
• perforation of a pre-existing stomach or intestinal ulcer before starting treatment with BETAMETASONE EG STADA
• 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 redness
• 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, please inform your doctor or pharmacist. You may 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 BETAMETASONE EG STADA

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What BETAMETASONE EG STADA 0.5 mg effervescent tablets contain

• 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 hydrogen citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearyl fumarate, sodium saccharin.

What BETAMETASONE EG STADA 1 mg effervescent tablets contain

• 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 hydrogen citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearyl fumarate, sodium saccharin.

Description of the appearance of BETAMETASONE EG STADA and contents of the pack
Each pack contains 10 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)