BETAMETASONE 0.5 MG Эффервесцентная таблетка

Содержание инструкции

1. BETAMETASONE DOC Generici 0.5 mg effervescent tablets, 1 mg effervescent tablets
   1. What is BETAMETASONE DOC Generici and what it is used for
   2. What you need to know before taking BETAMETASONE DOC Generici
   3. How to take BETAMETASONE DOC Generici
   4. Possible side effects
   5. How to store BETAMETASONE DOC Generici
   6. Contents of the pack and other information

BETAMETASONE DOC Generici 0.5 mg effervescent tablets, 1 mg effervescent tablets

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• 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 DOC Generici is and what it is used for
• 2. What you need to know before you take BETAMETASONE DOC Generici
• 3. How to take BETAMETASONE DOC Generici
• 4. Possible side effects
• 5. How to store BETAMETASONE DOC Generici
• 6. Contents of the pack and other information

1. What is BETAMETASONE DOC Generici and what it is used for

BETAMETASONE DOC Generici 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 DOC Generici is indicated for the treatment of:

• breathing problems (bronchial asthma);
• severe allergic reactions (severe allergies);
• joint inflammation (rheumatoid arthritis, ankylosing spondylitis);
• connective tissue diseases (collagenopathies);
• 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 DOC Generici

Do not take BETAMETASONE DOC Generici

• if you are allergic to betamethasone, to similar substances 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 a lung infection (tuberculosis, see the “Warnings and precautions” section);
• if you have had a vaccine or if you are to undergo vaccination because complications may occur;
• if you are pregnant;
• if you are breastfeeding (see the “Pregnancy and breastfeeding” section).

Warnings and precautions
Consult your doctor or pharmacist before using BETAMETASONE DOC Generici.
If you are using BETAMETASONE DOC Generici and are under particular stress, inform your
doctor because it may be necessary to adjust the dose.
In patients treated with betamethasone and with 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 can also
manifest after discontinuation of the medicine and can last even a year after
suspension of therapy. If you experience symptoms of stress during this period (including
fatigue, drowsiness, easy tiredness, loss of appetite, nausea and vomiting, bone and muscle pain), inform your doctor because it may be necessary to resume therapy.
BETAMETASONE DOC Generici 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 therapy with antibiotics.
Take BETAMETASONE DOC Generici 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 can reactivate the disease; if you need to use betamethasone for a long time, your doctor will prescribe a therapy to prevent the onset of tuberculosis (chemoprophylaxis);
• you suffer from a heart problem (congestive heart failure);
• you have been prescribed BETAMETASONE DOC Generici 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 one of the following diseases: diabetes, osteoporosis, if you suffer from high blood pressure (hypertension), if you have increased pressure inside the eye (glaucoma) or if you suffer from seizures (epilepsy), because betamethasone can worsen these diseases;
• you suffer from mood problems (emotional instability or psychotic tendencies) because betamethasone can aggravate these conditions;
• you have suffered from muscle problems (myopathy) caused by the use of steroid medicines; or if you have severe muscle problems (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 DOC Generici” 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 an 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 in the intestine (diverticulitis);
• you have recently undergone surgery on the intestine (intestinal anastomoses);
• if you have kidney problems (renal insufficiency).
• if you have pheochromocytoma (a tumor of the adrenal gland)

During treatment with BETAMETASONE DOC Generici:

• increases the elimination of calcium;
• some mental problems (psychic alterations) such as euphoria, difficulty sleeping (insomnia), changes in mood or personality, severe depression or symptoms of real psychoses may occur;
• reduction of the amount of nitrogen in the body (nitrogen balance negativization), 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 need constitutes doping and
may still result in positive doping tests.

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 can only be administered in cases of actual
need and under the direct control of the doctor.

Other medicines and BETAMETASONE DOC Generici
Tell your doctor if you are taking or have recently taken other medicines, including medicines
obtained without a prescription.
Take BETAMETASONE DOC Generici 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), used to reduce pain and inflammation because betamethasone may reduce their effect and may increase the risk of having lesions in the stomach and intestine (ulcers);
• acetylsalicylic acid, used to treat inflammation and to thin the blood;
• medicines called anticholinesterases and used to treat a serious muscle disorder (myasthenia gravis);
• vaccines, because complications may occur (see the “Do not take BETAMETASONE DOC Generici” section);
• ephedrine, a medicine used to treat sudden breathing difficulties due to a 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 betamethasone 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, if you suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Do not take BETAMETASONE DOC Generici if you are pregnant or if you are breastfeeding,
unless in cases of absolute necessity and under the strict control of the doctor (see the “Do not
take BETAMETASONE DOC Generici” section).

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

BETAMETASONE DOC Generici 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 DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
This medicine can be dissolved in water and taken by mouth (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 DOC Generici effervescent tablets and what it is used for”) after an initial therapy at a high dosage, 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 tablets
effervescent 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
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 evaluate the possibility of administering a single dose every other day (one day yes and one day no)
to minimize delays in growth and disturbances to the normal activity of the adrenal glands
(suppression of the hypothalamus-pituitary-adrenal axis) that may be caused by the use of
BETAMETASONE DOC Generici.

Oral Administration
The tablets are divisible in half to facilitate dosage adjustment.
The tablets should be dissolved in a little water.

Administration by nebulization (aerosol)
Adults and children
The recommended dose is 0.5-1 mg dissolved at the time of use in 1-2 ml of purified water or
saline solution.

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

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

• heart problems (congestive heart failure);
• problems with the stomach and intestines associated with the appearance of lesions (peptic ulcer); acute pancreatitis (with frequency unknown);
• skin problems, such as delays in wound healing, thinning and fragility of the skin;
• problems with the mind (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);
• alteration of the production of some hormones (Cushing's syndrome), accumulation of fat on the face and abdomen (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), blurred vision;
• alteration of salt levels in the body, especially a reduction in potassium levels in the blood (hypokalemia), increased elimination of proteins (negative nitrogen balance);
• reduction of lymphocytes (white blood cells) in the blood (with frequency unknown);
• 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.

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 www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store BETAMETASONE DOC Generici

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 stored correctly.
Store at a temperature below 25°C.
Store 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BETAMETASONE DOC Generici 0.5 mg effervescent tablets contain

• The active ingredient is betamethasone. Each tablet contains betamethasone 0.5 mg (as betamethasone disodium phosphate 0.6578 mg).
• The other ingredients are: disodium citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearyl fumarate, sodium saccharin.

What BETAMETASONE DOC Generici 1 mg effervescent tablets contain

• The active ingredient is betamethasone. Each tablet contains betamethasone 1 mg (as betamethasone disodium phosphate 1.316 mg).
• The other ingredients are: disodium citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearyl fumarate, sodium saccharin.

Description of the appearance of BETAMETASONE DOC Generici and contents of the pack
Pack containing 10 effervescent tablets.

Marketing Authorisation Holder
DOC Generici Srl - Via Turati 40 - 20121 Milan - Italy

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