Betamethasone L.F.M.

Package leaflet: Information for the patient

BETAMETASONE L.F.M. 4 mg/1 ml solution for injection

Generic medicine
Please read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What BETAMETASONE L.F.M. is and what it is used for
2. What you need to know before using BETAMETASONE L.F.M.
3. How to use BETAMETASONE L.F.M.
4. Possible side effects
5. How to store BETAMETASONE L.F.M.
6. Contents of the pack and other information

1. What BETAMETASONE L.F.M. is and what it is used for

BETAMETASONE L.F.M. 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 L.F.M. is indicated for the treatment of:

• a state of inadequate blood circulation to major organs, which may be caused by surgery, trauma or burns (surgical and traumatic shock, shock in burn patients);
• even severe allergic reactions (anaphylaxis), including those caused by medicines or blood transfusions (post-transfusion allergies), which may manifest as swelling due to fluid accumulation in the throat area (laryngeal edema);
• severe and prolonged respiratory distress (asthmatic crisis);
• fluid accumulation in the brain (cerebral edema);
• heart attack (myocardial infarction);
• blood disorders (hemopathies in rapid acute exacerbation);
• acute adrenal gland dysfunction (acute adrenal insufficiency) caused by certain specific diseases (such as Waterhouse-Friderichsen syndrome, Addison's disease, Simmonds' disease), or in patients who have undergone surgical removal of the adrenal glands (adrenalectomized), or who have impaired adrenal function due to prolonged use of corticosteroid medicines (adrenosuppressed);
• soft tissue injuries such as inflammation of the tendons in the elbow (tennis elbow) and inflammation of the tissues surrounding the shoulder joint (periarthritis of the shoulder joint); in these cases, BETAMETASONE L.F.M. must be administered by local injection;
• situations where, due to specific patient conditions (vomiting, persistent diarrhea, maxillofacial surgery), oral administration of a corticosteroid is not possible; in these cases, oral administration is replaced by intravenous or intramuscular administration.

BETAMETASONE L.F.M. cannot replace, but may significantly enhance the effectiveness of other therapies in the treatment of:

• a state of inadequate blood circulation to major organs, which may be caused by numerous factors including surgery, trauma, allergies, burns, hemorrhages, etc.;
• severe and prolonged breathing difficulty (status asthmaticus).

2. What you should know before using BETAMETASONE L.F.M.

Do not use BETAMETASONE L.F.M.

• 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) for which you are not receiving specific treatment;
• if you have recently received or are due to receive a vaccination or other procedures to immunize the body against infectious diseases, as complications may occur. Do not inject BETAMETASONE L.F.M. directly into tendons.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BETAMETASONE L.F.M.
If you are using BETAMETASONE L.F.M. and are under particular physical stress,
inform your doctor, as your dose may need to be adjusted.
BETAMETASONE L.F.M. may mask certain signs of infection, and during treatment, infections may occur due to reduced immune defenses. Inform your doctor if you suspect you have an infection, as antibiotic therapy may be prescribed.
Treatment with betamethasone and corticosteroids in general may cause problems with the adrenal glands, two small glands located above the kidneys (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 during this period you experience symptoms of stress (including fatigue, drowsiness, easy exhaustion, loss of appetite, nausea and vomiting, bone and muscle pain), inform your doctor, as treatment may need to be resumed.

Use BETAMETASONE L.F.M. with caution and inform your doctor if:

• you currently have tuberculosis (active), a bacterial infection usually affecting the lungs. In this case, betamethasone may be used only if the disease is rapidly progressive (fulminant) or disseminated. If you have latent tuberculosis or have tested positive for the tuberculin skin test, you must be closely monitored by your doctor, as betamethasone may reactivate the disease; if long-term treatment with betamethasone is required, your doctor may prescribe preventive therapy for tuberculosis (chemoprophylaxis);
• you suffer from heart problems (congestive heart failure);
• if this medicine has been prescribed at high doses or for prolonged treatment, your doctor may adjust your intake of sodium and potassium, as you may experience electrolyte imbalances;
• you have any of the following conditions: diabetes mellitus (a metabolic disorder characterized by unstable blood sugar levels), bone problems (osteoporosis), high blood pressure (hypertension), increased pressure within the eye (glaucoma), or 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 steroid-induced muscle problems (myopathy), or suffer from severe muscle disorders (myasthenia gravis);
• you have a condition involving stomach or intestinal lesions (active or latent peptic ulcer);
• you have liver problems (hepatic insufficiency or cirrhosis), or thyroid problems (hypothyroidism);
• you have an eye infection caused by a virus called herpes simplex, as serious eye damage (corneal perforation) may occur;
• you are elderly. Treatment with this medicine will be determined by your doctor, considering the higher risk of adverse effects such as bone disorders with loss of bone mass (osteoporosis), worsening of diabetes, increased blood pressure (hypertension), infections, and skin thinning (see section “Possible side effects”);
• you have chronic inflammation of the colon (ulcerative colitis) at risk of perforation;
• you have a pus-forming infection (abscess), or infections caused by pus-forming bacteria (pyogenic infections);
• you have intestinal problems (diverticulitis);
• you have recently undergone surgery for intestinal reconstruction (intestinal anastomosis);
• you have kidney problems (renal insufficiency);
• you have pheochromocytoma (a tumor of the adrenal gland).

During treatment with BETAMETASONE L.F.M.:

• calcium excretion increases;
• certain mental problems (psychic disturbances) may occur, such as an unjustified sense of happiness (euphoria), difficulty sleeping (insomnia), mood changes or personality alterations, severe feelings of sadness (severe depression), or the onset of mental illnesses affecting behavioral control (psychosis);
• the maintenance dose should always be the lowest effective dose needed to control your symptoms.

If BETAMETASONE L.F.M. has been prescribed to treat a widespread and severe infection (septic shock), pay particular attention and consult your doctor if:

• before starting treatment, blood tests showed elevated levels of a substance called serum creatinine;
• a secondary infection occurred during treatment; in patients treated with medicines similar to betamethasone, an increased risk of death has been reported.

If you are taking high doses of BETAMETASONE L.F.M., avoid contact with people who have measles or chickenpox. If contact occurs, contact your doctor immediately.

Contact your doctor if you experience blurred vision or other visual disturbances.

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

Children and adolescents
If BETAMETASONE L.F.M. is used in children and adolescents, your doctor will closely monitor them, as treatment may delay growth and development.

Other medicines and BETAMETASONE L.F.M.
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

Use BETAMETASONE L.F.M. with caution and inform your doctor if you are taking the following medicines, as betamethasone may reduce their effectiveness:

• medicines called anticholinesterases, used to treat a serious muscle disorder (myasthenia gravis);
• substances used in radiographic imaging (contrast media) of the biliary tract and gallbladder (cholecystography); inform your doctor if you are scheduled for this procedure;
• non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and inflammation;
• medicines called salicylates, used to thin the blood and reduce pain and inflammation.

Use BETAMETASONE L.F.M. with caution and inform your doctor if you are taking the following medicines, as they may reduce the effect of betamethasone:

• phenytoin or phenobarbital, medicines used to treat seizures (epilepsy);
• ephedrine, a medicine used to treat severe and sudden breathing difficulties due to bronchial narrowing (acute bronchospasm) or to treat and prevent low blood pressure (during anesthesia for various surgical procedures);
• rifampicin, an antibiotic used for certain infections.

If you are taking anticoagulants (medicines used to thin the blood), your doctor may consider adjusting their dosage. If you have low levels of a substance in the blood called prothrombin (hypoprothrombinemia), caution is advised when combining acetylsalicylic acid with betamethasone.

Inform your doctor if you are taking or are about to take one or more of the following medicines:

• medicines that increase urine production (diuretics), particularly furosemide and thiazide diuretics;
• medicines used to treat fungal infections (mycoses), such as amphotericin or ketoconazole;
• medicines used to treat asthma symptoms (bronchodilators), such as xanthines, for example theophylline;
• medicines used to treat diabetes, such as insulin;
• medicines used to prevent organ transplant rejection (immunosuppressants such as cyclosporine);
• a medicine used against the HIV virus (ritonavir).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use BETAMETASONE L.F.M. during pregnancy, except in cases of absolute necessity and under strict medical supervision.
Newborns of mothers who received BETAMETASONE L.F.M. near the end of pregnancy may have low blood sugar levels after birth.

Breastfeeding
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or treatment with BETAMETASONE L.F.M.

Driving and using machines
There are no available data on the effect of this medicine on the ability to drive and operate machinery. However, if you notice that your level of alertness is impaired (neurological side effects), avoid driving or operating machinery (see section “Possible side effects”).

BETAMETASONE L.F.M. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use BETAMETASONE L.F.M.

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine may be administered by intramuscular injection (injection into the muscle), by intravenous injection (intravenous bolus), or, if necessary, by infusion (via intravenous drip) added to other infusion fluids. In such cases, it will be administered by healthcare personnel.

• The dose will be determined by your doctor according to the severity of the disease and your response to treatment. The maintenance dose should be the lowest dose capable of controlling symptoms. The recommended dose is 4 mg per dose, repeated as needed until the desired response is achieved. In some cases, the dose may reach 10–15 mg or more in a single injection; this dosage may be repeated 3–4 times within 24 hours.

Use in children and adolescents
Treatment with the lowest possible doses for the shortest possible duration is recommended. Furthermore, your doctor will consider administering a single dose on alternate days (one day on, one day off) to minimize growth retardation and disturbances in normal adrenal gland function (suppression of the hypothalamic-pituitary-adrenal axis) that may be caused by the use of BETAMETASONE L.F.M.

If you use more BETAMETASONE L.F.M. than you should
In case of accidental ingestion/overdose of BETAMETASONE L.F.M., inform your doctor immediately or go to the nearest hospital.

If you forget to use BETAMETASONE L.F.M.
Do not take a double dose to make up for the missed dose.

If you stop using BETAMETASONE L.F.M.
Do not stop treatment with BETAMETASONE L.F.M. suddenly or without first discussing it with your doctor. The dose must be gradually reduced before treatment is discontinued.

If you have any questions 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 everybody will experience them.
The following side effects may occur, especially during prolonged treatment and at high doses:

• changes in electrolyte levels in the body, particularly reduced potassium levels in the blood (hypokalaemia), which rarely and in particularly predisposed patients may lead to high blood pressure (hypertension) and a serious heart problem (congestive heart failure);
• disorders of muscles and bones (musculoskeletal disorders), such as loss of bone mass (osteoporosis), death of bone tissue without infection (aseptic osteonecrosis), particularly in the femoral head, muscle problems (myopathies), fragile bones, fractures, collagen diseases, tendon rupture;
• complications affecting the stomach and intestines (gastrointestinal system), which may even lead to the appearance or worsening of lesions (peptic ulcer); inflammation of the pancreas (acute pancreatitis) with unknown frequency;
• inflammation of the oesophagus;
• delayed healing of wounds and injuries (impaired wound healing), thinning and fragility of the skin;
• skin and skin appendage disorders (nails, hair, sebaceous and sweat glands), such as skin inflammation due to allergy, urticaria, acne, bruising, skin erythema, excessive sweating, excessive hair growth or beard growth, infections caused by fungi or viruses;
• dizziness, headache (cephalalgia), nausea, increased pressure inside the head (intracranial pressure), swelling of the optic nerve head due to increased intracranial pressure (papilledema), mental disturbances (emotional instability), anxiety, irritability;
• hormonal disorders (endocrine disturbances) such as menstrual irregularities, signs of excessive hormone production by the adrenal glands (hyperadrenocorticism), fat accumulation in the face and abdomen (Cushingoid appearance), growth disturbances in children;
• disturbances in the regulation of hormone production by the adrenal gland (interference with hypothalamic-pituitary-adrenal axis function), particularly during periods of stress;
• reduced absorption of sugars (carbohydrates), leading to increased blood sugar levels (latent diabetes mellitus), thereby increasing the need for antidiabetic medications (hypoglycaemics); reduced glucose tolerance;
• eye disorders such as optic nerve disease, characterised by increased pressure inside the eye (glaucoma), problems affecting a part of the eye called the lens (posterior subcapsular cataract), increased pressure inside the eye (intraocular pressure), blurred vision;
• reduced nitrogen levels (negative nitrogen balance) and reduced protein levels, therefore, during prolonged treatment, protein intake in the diet should be adequately increased;
• incomplete healing;
• severe allergic reaction;
• reactivation of tuberculosis;
• reduced number of white blood cells (lymphocytes) in the blood;
• weight gain or weight loss; increased appetite;
• swelling due to fluid retention (oedema);
• 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 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 L.F.M.

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.
Store in the original packaging to protect the medicine from light.
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. Pack contents and other information

What BETAMETASONE L.F.M. contains

• The active substance is betametasone. Each vial contains betametasone 4 mg (as betametasone disodium phosphate 5.263 mg).
• The other components are: phenol, sodium citrate dihydrate, anhydrous citric acid, water for injections.

Description of the appearance of BETAMETASONE L.F.M. and pack contents
BETAMETASONE L.F.M. 4 mg/1 ml solution for injection
Pack of 3 vials.
Marketing Authorization Holder
LABORATORIO FARMACOLOGICO MILANESE S.r.l. - Via Monterosso 273, 21042 Caronno Pertusella (VA)
Manufacturer
Laboratorio Farmacologico Milanese S.r.l., Via Monterosso 273, 21042 Caronno Pertusella (VA)