BETAMETASONE 0.5 MG Tabletka musująca

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1. BETAMETASONE EG STADA 0.5 mg effervescent tablets, 1 mg effervescent tablets
   1. What is BETAMETASONE EG STADA and what is it 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

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

Betametasone

Generic medicine
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is BETAMETASONE EG STADA and what is it used for

BETAMETASONE EG STADA contains the active ingredient betamethasone which belongs to a group of
medicines called corticosteroids. These medicines work by reducing inflammation (anti-inflammatory) and
allergies.
BETAMETASONE EG STADA is indicated for the treatment of:

• breathing problems (bronchial asthma);
• severe allergic reactions (severe allergies);
• diseases that cause inflammation of the joints (rheumatoid arthritis, ankylosing spondylitis);
• diseases of the connective tissue (collagen diseases);
• skin diseases due to inflammation (inflammatory dermatoses);
• some types of cancer (in particular of the lymphatic tissue such as acute and chronic malignant hemolymphopathies, Hodgkin's disease);
• kidney problems (nephrotic syndrome);
• inflammation of the intestine (ulcerative colitis, segmental ileitis or Crohn's disease);
• severe skin disease characterized by blisters (pemphigus);
• inflammation of the connective tissue of various organs (sarcoidosis), especially if associated with increased calcium in the blood (hypercalcemic sarcoidosis);
• inflammation of the heart (rheumatic carditis);
• blood diseases associated with changes in its composition (dyscrasic hemopathies), such as reduction in the number of red blood cells (hemolytic anemia) and white blood cells (agranulocytosis) and decrease in platelets in the blood (thrombocytopenic purpura).

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

Do not take BETAMETASONE EG STADA

• if you are allergic to betamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have widespread infections throughout the body (systemic infections) caused by bacteria or fungi unless you are following specific therapy for these infections;
• if you have tuberculosis, a lung infection (see the “Warnings and precautions” section);
• if you have had a vaccine or are due to have a vaccination as complications may occur.

Warnings and precautions
Consult your doctor or pharmacist before using BETAMETASONE EG STADA.
If you are using BETAMETASONE EG STADA and are under particular stress, inform your doctor
because it may be necessary to adjust the dose.
In patients treated with betamethasone and corticosteroids in general, problems
with the adrenal glands caused by betamethasone (secondary adrenal insufficiency) may occur; in this case, your doctor will gradually reduce
the dosage of this medicine. These problems may also occur after
discontinuation of the medicine and may last for up to a year after stopping therapy. If symptoms of stress occur during
this period, inform your doctor because it may be necessary to resume therapy.
BETAMETASONE EG STADA may mask some signs of infection and infections may occur during its use due to reduced immune defenses. Inform your doctor if you think you have an infection
because they may prescribe appropriate antibiotic therapy.
Take BETAMETASONE EG STADA with caution and inform your doctor if:

• you have an ongoing lung infection (active tuberculosis). In this case, you can use betamethasone only if it is a fulminant or disseminated disease. If you have latent tuberculosis, or if you have tested positive for the tuberculin test, you must be closely monitored by your doctor because betamethasone may reactivate the disease;
• you suffer from a heart problem (congestive heart failure);
• you have been prescribed BETAMETASONE EG STADA at high doses or for prolonged treatments because you may have problems with the balance of salts in your body; in this case, the doctor may adjust the amount of sodium and potassium to be taken;
• you have any of the following conditions: diabetes, osteoporosis, if you suffer from high blood pressure (hypertension), if you have a disease that causes increased pressure inside the eye (glaucoma) or if you suffer from seizures (epilepsy), because betamethasone may worsen these conditions;
• you suffer from mood problems (emotional instability or psychotic tendencies) because betamethasone may worsen these conditions;
• you have suffered from muscle problems (myopathy) caused by the use of steroid medicines; or if you have a severe illness that causes muscle weakness (myasthenia gravis);
• you suffer from a condition characterized by lesions in the stomach or intestine (active or latent peptic ulcer);
• you suffer from liver problems (hepatic insufficiency or hepatic cirrhosis);
• you suffer from thyroid problems (hypothyroidism);
• you have an eye infection caused by a virus called herpes simplex, because serious eye damage (corneal perforation) may occur;
• if you have low levels of a substance called prothrombin in your blood (hypoprothrombinemia), caution is advised when combining acetylsalicylic acid and betamethasone (see the “Other medicines and BETAMETASONE EG STADA” section);
• if you are an elderly person. Therapy with this medicine will be established by the doctor considering the greater risk of side effects such as bone disorders with loss of bone mass (osteoporosis), worsening of diabetes, increased blood pressure (hypertension), infections, thinning of the skin (see section 4 “Possible side effects”);
• you have inflammation of the intestine (ulcerative colitis) at risk of perforation;
• you have an infection with pus formation (abscess), or infections from bacteria that cause pus (pyogenic infections);
• you have a problem with the intestine (diverticulitis);
• you have recently undergone surgery on the intestine (intestinal anastomosis);
• if you have kidney problems (renal insufficiency);
• if you have pheochromocytoma (a tumor of the adrenal gland).

During treatment with BETAMETASONE EG STADA:

• increases the elimination of calcium;
• some mental problems (psychiatric alterations) such as euphoria, difficulty sleeping (insomnia), changes in mood or personality, severe depression or symptoms of real psychosis may occur;
• reduction of the amount of nitrogen in the body (negative nitrogen balance), therefore, if you take this medicine for a long time, the amount of protein in the diet must be adequately increased.
• Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes:the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive anti-doping test.

Children and adolescents
It is necessary to monitor the growth and development of children and adolescents who use this medicine for
a long time.
In early infancy, this medicine may only be administered in cases of actual necessity and under
direct medical supervision.

Other medicines and BETAMETASONE EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines, including medicines obtained without a prescription.
Take BETAMETASONE EG STADA with caution and inform your doctor if you are taking the following
medicines:

• medicines used for the treatment of epilepsy (such as phenobarbital, primidone, carbamazepine, phenytoin), because it may be necessary to adjust the doses;
• medicines used to make the blood more fluid (Warfarin);
• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, used to reduce pain and inflammation because betamethasone may reduce its effect and may increase the risk of having lesions to the stomach and intestines (ulcers);
• medicines called cholinesterase inhibitors and used to treat a severe muscle disorder (myasthenia gravis);
• vaccines, as complications may occur (see the “Do not take BETAMETASONE EG STADA” section);
• ephedrine, a medicine used to treat sudden breathing difficulties due to narrowing of the bronchi (acute bronchospasm) or for the treatment and prevention of low blood pressure (during anesthesia for various types of surgical operations) because it may reduce the effect of betamethasone;
• rifampicin, an antibiotic used for some infections because it may reduce the effect of betamethasone;
• contrast agents used in radiography in the examination of the bile ducts and gallbladder (cholecystography), inform your doctor if you need to undergo this examination.
• Some medicines may increase the effects of BETAMETASONE EG STADA and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take BETAMETASONE EG STADA if you are pregnant or breastfeeding, unless in cases of
absolute necessity and under strict medical supervision.

Driving and using machines
No data are available to establish the effect of this medicine on the ability to drive and operate
machinery. However, if you experience side effects that make you less alert, such as mental and
mood disorders (psychotic, cognitive and mood), avoid driving or using machinery (see section 4 “Possible
side effects”).

BETAMETASONE EG STADA contains sodium benzoate
This medicine contains sodium benzoate, which is mildly irritating to the skin, eyes and mucous membranes (if
administered by nebulization).

3. How to take BETAMETASONE EG STADA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
This medicine can be dissolved in water and taken orally (oral use) or it can be dissolved in
purified water or saline solution and taken by inhaling the nebulized solution (administration by
nebulization).
The tablets are divisible in half to facilitate dosage.

Oral use
Use in adults
The dose will be established based on the severity of the disease, the duration of therapy and your response to therapy:

• Short-term therapy: The recommended dose is 4-6 effervescent tablets of 0.5 mg per day or 2-3 effervescent tablets of 1 mg per day (equivalent to 2-3 mg per day), the doctor will gradually reduce this dose based on your response to therapy.
• Long-term therapy: In the treatment of chronic or subacute diseases (collagenoses, hemolytic anemias, chronic bronchial asthma, nephrotic syndrome, ulcerative colitis, pemphigus, see paragraph 1 “What is BETAMETASONE EG STADA and what is it used for”) after an initial high-dose therapy, the doctor will gradually reduce the dosage until reaching the maintenance dose.

The recommended initial dose is 6-8 effervescent tablets of 0.5 mg per day or 3-4 effervescent tablets
of 1 mg per day (equivalent to 3-4 mg per day).
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), and in any case it must be the minimum dose capable of
controlling your symptoms.

Use for nebulization
Adults and children
The recommended dose is 0.5-1 mg per day dissolved at the time of use in 1-2 ml of purified water or
saline solution.
If you take this medicine by inhalation, at high doses and for prolonged treatments, the dose should be the
lowest possible to minimize side effects.

Use in children
The recommended dose is 0.1-0.2 mg per kilogram of body weight per day.
A treatment with minimal doses and the shortest possible duration is recommended. In addition, your doctor will assess
the possibility of administering a single dose on alternate days (one day yes and one day no) to minimize delays
in growth and disorders of the normal activity of the adrenal glands (suppression of the hypothalamus-pituitary-
adrenal axis) that can be caused by the use of BETAMETASONE EG STADA.

If you use more BETAMETASONE EG STADA than you should
In case of accidental ingestion/intake of an excessive dose of BETAMETASONE EG STADA, immediately
inform your doctor or go to the nearest hospital.

If you forget to take BETAMETASONE EG STADA
Do not take a double dose to make up for the missed dose.
If you have any doubts 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.
The following side effects may occur, with frequency and severity depending on the dosage and
duration of treatment:

• heart problems (congestive heart failure);
• stomach and intestinal problems associated with the appearance of lesions (peptic ulcer);
• skin problems, such as delayed wound healing, thinning and fragility of the skin;
• mental problems (psychic instability), mental and physical hyperactivity (psychomotor), sleep disorders, anxiety, depression, aggression, behavioral disorders (especially in children);
• headache, dizziness, increased pressure inside the head (intracranial pressure);
• menstrual irregularities, excessive production of hormones by the adrenal glands (hypercortisolism);
• condition characterized by an excess of glucocorticoid hormones (Cushing's syndrome), with a full moon face, accumulation of fat on the upper back, trunk obesity, increased hair growth, acne (cushingoid appearance), growth disorders in children and adolescents;
• disorders in the regulation of hormone production by the adrenal gland (interference with the pituitary-adrenal axis function), particularly in times of stress;
• alteration of blood sugar levels, diabetes (latent diabetes mellitus), in diabetic patients this increases the need to take medicines used for diabetes (hypoglycemic agents);
• eye problems, such as increased pressure inside the eye (glaucoma), problems with a part of the eye called the lens (posterior subcapsular cataract), increased pressure inside the eye (intraocular pressure);
• alteration of salt levels in the body, especially reduced levels of potassium in the blood (hypokalemia), increased elimination of proteins (negative nitrogen balance);
• increased blood pressure (hypertension);
• weakening of the bones (reduction in bone mineral density), loss of bone mass (osteoporosis), death of bone tissue without infection (aseptic osteonecrosis), particularly in the femoral head, muscle problems (myopathies), bone fragility;
• acute pancreatitis (frequency not known);
• blurred vision (frequency not known);
• hiccups (frequency not known);
• reduction of lymphocytes (white blood cells) in the blood (frequency not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
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.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month, for the product in intact packaging and
correctly stored.
Store the medicine at a temperature below 25°C, in the original packaging to protect the medicine
from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETAMETASONE EG STADA 0.5 mg effervescent tablets contain

• The active ingredient is betamethasone. Each tablet contains 0.5 mg of betamethasone (as disodium phosphate).
• The other ingredients are: dibasic sodium 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 ingredient is betamethasone. Each tablet contains 1 mg of betamethasone (as disodium phosphate).
• The other ingredients are: dibasic sodium 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
Pack containing 10 effervescent tablets.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Exclusive distributor for sales:
EG S.p.A. Via Pavia, 6 20136 Milano

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)