Patient Information Leaflet

BETAMETASONE ZENTIVA 0.5 mg effervescent tablets, 1 mg effervescent tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BETAMETASONE ZENTIVA is and what it is used for
What you need to know before taking BETAMETASONE ZENTIVA
How to take BETAMETASONE ZENTIVA
Possible side effects
How to store BETAMETASONE ZENTIVA
Contents of the pack and other information

1. What BETAMETASONE ZENTIVA is and what it is used for

BETAMETASONE ZENTIVA contains the active substance betamethasone, which belongs to a group of medicines
called corticosteroids. These medicines work by reducing inflammation (anti-inflammatory effect) and allergic reactions.
BETAMETASONE ZENTIVA is indicated for the treatment of:

respiratory problems (bronchial asthma);
severe allergic reactions (severe allergic disorders);
diseases causing joint inflammation (rheumatoid arthritis, ankylosing spondylitis);
connective tissue diseases (collagenoses);
inflammatory skin diseases (inflammatory dermatoses);
certain types of cancer (particularly lymphatic tissue cancers such as acute and chronic malignant lymphopathies, Hodgkin's disease);
kidney problems (nephrotic syndrome);
intestinal inflammations (ulcerative colitis, segmental ileitis or Crohn's disease);
a severe skin disease characterized by blistering (pemphigus);
inflammation of connective tissue in various organs (sarcoidosis), especially when associated with increased calcium levels in the blood (hypercalcemic sarcoidosis);
heart inflammation (rheumatic carditis);
blood disorders associated with changes in blood composition (dyscrasic blood disorders), such as reduced number of red blood cells (haemolytic anaemia), white blood cells (agranulocytosis), and decreased platelets in the blood (thrombocytopenic purpura).

2. What you need to know before taking BETAMETASONE ZENTIVA

Do not take BETAMETASONE ZENTIVA

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 receiving specific treatment for such infections;
if you have tuberculosis or a lung infection (see section “Warnings and precautions”);
if you have recently received or are due to receive a vaccine, as complications may occur.

Warnings and precautions
Talk to your doctor or pharmacist before using BETAMETASONE ZENTIVA.

If you are using BETAMETASONE ZENTIVA and are under particular stress, inform your doctor, as your dose may need to be adjusted.
If you have phaeochromocytoma (a tumour of the adrenal gland).
Patients treated with betamethasone and corticosteroids in general may develop adrenal-related problems caused by betamethasone (secondary adrenal insufficiency). In such cases, your doctor will gradually reduce the dosage of this medicine. These problems may also occur after discontinuation of the medicine and may persist for up to one year after stopping treatment. If you experience symptoms of stress during this period, inform your doctor, as treatment may need to be resumed.
BETAMETASONE ZENTIVA may mask certain signs of infection, and infections may occur during treatment due to reduced immune defences. Inform your doctor if you suspect you have an infection, as they may prescribe appropriate antibiotic therapy.

Take BETAMETASONE ZENTIVA with caution and inform your doctor if:

you currently have a lung infection (active tuberculosis). In this case, betamethasone may only be used if the disease is fulminant or disseminated. If you have latent tuberculosis or have tested positive for tuberculin, you must be closely monitored by your doctor, as betamethasone may reactivate the disease;
you suffer from a heart condition (congestive heart failure);
you have been prescribed BETAMETASONE ZENTIVA at high doses or for prolonged treatment, as you may experience electrolyte imbalances; in such cases, your doctor may adjust your intake of sodium and potassium;
you have any of the following conditions: diabetes, osteoporosis, high blood pressure (hypertension), a disease causing increased pressure inside the eye (glaucoma), or suffer from seizures (epilepsy), as betamethasone may worsen these conditions;
you suffer from mood disorders (emotional instability or psychotic tendencies), as betamethasone may exacerbate these conditions;
you have previously experienced muscle problems (myopathy) caused by steroid medicines; or if you have a serious condition causing muscle weakness (myasthenia gravis);
you have a condition characterised by stomach or intestinal lesions (active or latent peptic ulcer);
you suffer from liver problems (hepatic insufficiency or liver cirrhosis);
you suffer from thyroid problems (hypothyroidism);
you have an eye infection caused by a virus called herpes simplex, as serious eye damage (corneal perforation) may occur;
you have low levels of a substance called prothrombin in the blood (hypoprothrombinemia); caution is advised when combining acetylsalicylic acid and betamethasone (see section “Other medicines and BETAMETASONE ZENTIVA”);
you are elderly. Treatment with this medicine will be determined by your doctor, considering the higher risk of side effects such as bone disorders with loss of bone mass (osteoporosis), worsening of diabetes, increased blood pressure (hypertension), infections, and skin thinning (see section 4 “Possible side effects”);
you have intestinal inflammation (ulcerative colitis) at risk of perforation;
you have a pus-forming infection (abscess), or bacterial infections causing pus (pyogenic infections);
you have a bowel condition (diverticulitis);
you have recently undergone bowel surgery (intestinal anastomosis);
you have kidney problems (renal insufficiency).

During treatment with BETAMETASONE ZENTIVA:

calcium excretion increases;
certain mental problems (psychic disturbances) may occur, such as euphoria, difficulty sleeping (insomnia), mood or personality changes, severe depression, or symptoms of true psychosis;
reduced nitrogen levels in the body (negative nitrogen balance); therefore, if you take this medicine for a long time, your protein intake should be adequately increased.

Contact your doctor if you experience blurred vision or other visual disturbances.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
It is necessary to monitor the growth and development of children and adolescents receiving this medicine for prolonged periods.
In very early infancy, this medicine should only be administered when strictly necessary and under direct medical supervision.
Other medicines and BETAMETASONE ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Take BETAMETASONE ZENTIVA with caution and inform your doctor if you are taking the following medicines:

medicines used to treat epilepsy (such as phenobarbital, primidone, carbamazepine, phenytoin), as dose adjustments may be needed;
medicines used to thin the blood (warfarin);
non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, used to reduce pain and inflammation, as betamethasone may reduce their effectiveness and increase the risk of stomach and intestinal damage (ulcers);
medicines called anticholinesterases, used to treat a serious muscle disorder (myasthenia gravis);
vaccines, as complications may occur (see section “Do not take BETAMETASONE ZENTIVA”);
ephedrine, a medicine used to treat sudden breathing difficulties due to bronchial narrowing (acute bronchospasm) or to treat and prevent low blood pressure (during anaesthesia for various surgical procedures), as it may reduce the effect of betamethasone;
rifampicin, an antibiotic used for certain infections, as it may reduce the effect of betamethasone;
contrast agents used in radiography for examination of the biliary tract and gallbladder (cholecystography); inform your doctor if you are scheduled for this examination.

Some medicines may increase the effects of Betametasone Zentiva, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
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.
Do not take BETAMETASONE ZENTIVA during pregnancy or while breastfeeding, except in cases of absolute necessity and under strict medical supervision.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery. However, if you experience side effects that reduce your alertness, such as mental or mood disturbances (psychotic, cognitive, or mood-related), avoid driving or operating machinery (see section 4 “Possible side effects”).
BETAMETASONE ZENTIVA contains sodium benzoate
This medicine contains sodium benzoate, which is mildly irritating to the skin, eyes, and mucous membranes (if administered by nebulisation).

3. How to take BETAMETASONE ZENTIVA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine can be dissolved in water and taken by mouth (oral use) or dissolved in purified water or physiological solution and administered by inhaling the nebulized solution (nebulization administration).
The tablets are divisible in half to facilitate dosing.

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

Short-term therapy: The recommended dose is 4–6 effervescent tablets of 0.5 mg daily or 2–3 effervescent tablets of 1 mg daily (equivalent to 2–3 mg daily). Your doctor will gradually reduce this dose according to your response to treatment.
Long-term therapy: In the treatment of chronic or subacute diseases (collagenoses, haemolytic anaemias, chronic bronchial asthma, nephrotic syndrome, ulcerative colitis, pemphigus; see section 1 “What BETAMETASONE ZENTIVA is and what it is used for”), after an initial high-dose treatment, your doctor will gradually reduce the dosage until reaching the maintenance dose.

The recommended initial dose is 6–8 effervescent tablets of 0.5 mg daily or 3–4 effervescent tablets of 1 mg daily (equivalent to 3–4 mg daily).
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), and should always be the lowest dose capable of controlling your symptoms.

Use by nebulization
Adults and children
The recommended dose is 0.5–1 mg daily, dissolved immediately before use in 1–2 ml of purified water or physiological solution.
If you are taking this medicine by inhalation, at high doses and for prolonged treatments, the dose should be as low as possible to minimize adverse effects.

Use in children
The recommended dose is 0.1–0.2 mg per kilogram of body weight daily.
Treatment with the lowest possible doses for the shortest possible duration is recommended. Furthermore, your doctor will evaluate the possibility of administering a single dose on alternate days (one day on, one day off) to minimize growth retardation and disturbances in normal adrenal gland function (hypothalamic-pituitary-adrenal axis suppression) that may be caused by the use of BETAMETASONE ZENTIVA.

If you take more BETAMETASONE ZENTIVA than you should
In case of accidental ingestion/overdose of BETAMETASONE ZENTIVA, contact your doctor immediately or go to the nearest hospital.

If you forget to take BETAMETASONE ZENTIVA
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 development 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 disturbances, anxiety, depression, aggression, behavioural disorders (especially in children), suicidal thoughts and confusion (frequency not known);
headache (cephalalgia), dizziness, increased pressure inside the skull (increased intracranial pressure);
menstrual irregularities, excessive hormone production by the adrenal glands (hypercorticism);
condition characterized by excess glucocorticoid hormones (Cushing's syndrome), with moon face, fat accumulation on the upper back, trunk obesity, increased hair growth, acne (Cushingoid appearance), growth disturbances in children and adolescents;
disturbances in the regulation of adrenal hormone production (interference with hypothalamic-pituitary-adrenal axis function), particularly during periods of stress;
changes in blood sugar levels, diabetes (latent diabetes mellitus); in diabetic patients this increases the need for antidiabetic medications (hypoglycaemic agents);
eye problems, such as increased pressure inside the eye (glaucoma), problems affecting a part of the eye called the lens (posterior subcapsular cataract), increased pressure inside the eye (increased intraocular pressure);
changes in electrolyte levels in the body, especially reduced potassium levels in the blood (hypokalaemia), increased protein loss (negative nitrogen balance);
increased blood pressure (hypertension);
weakened bones (reduced 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 in lymphocytes (white blood cells) in the blood (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 ZENTIVA

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 "Expiry".
The expiry date refers to the last day of that month, for the product in intact packaging and
correctly stored.
Store the medicine below 25°C, in the original packaging to protect the medicine
from moisture.
Do not dispose of any medicine 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 BETAMETASONE ZENTIVA 0.5 mg effervescent tablets contain

The active substance is betamethasone. Each tablet contains 0.5 mg of betamethasone (as disodium phosphate).
The other components are: dibasic sodium citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearil fumarate, sodium saccharin.

What BETAMETASONE ZENTIVA 1 mg effervescent tablets contain

The active substance is betamethasone. Each tablet contains 1 mg of betamethasone (as disodium phosphate).
The other components are: dibasic sodium citrate sesquihydrate, effersoda (sodium bicarbonate and sodium carbonate), povidone K30, sodium benzoate, sodium stearil fumarate, sodium saccharin.

Description of the appearance of BETAMETASONE ZENTIVA and contents of the pack
Pack containing 10 effervescent tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 – 20121 Milano
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)