Betamethasone EG

Patient Information Leaflet

BETAMETASONE EG 1.5 mg/2 ml solution for injection, 4 mg/2 ml solution for injection

Generic medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

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

• shock (surgical and traumatic shock, shock in burn patients);
• severe anaphylactic and allergic reactions, for example: laryngeal edema, drug allergy, allergic reaction following blood transfusion;
• severe and prolonged asthma attacks;
• cerebral edema;
• myocardial infarction;
• blood disorders with rapid deterioration;
• acute adrenal insufficiency crises in patients: with Waterhouse-Friderichsen syndrome, Addison's disease, Simmonds' disease, those who have had their adrenal gland removed (adrenalectomized), or in whom the adrenal gland no longer functions due to prolonged corticosteroid therapy;
• soft tissue injuries such as tennis elbow and periarthritis of the shoulder joint.

BETAMETASONE EG is also indicated:

• in all cases where corticosteroid treatment is beneficial and patients have specific conditions making oral therapy impossible (e.g. vomiting, persistent diarrhea, maxillofacial surgery).

2. What you need to know before using BETAMETASONE EG

Do not use BETAMETASONE EG

• if you are allergic to betamethasone, to other corticosteroid medicines, or to any of the other ingredients of this medicine (listed in section 6);
• if you have infections affecting your entire body and you are not receiving specific treatment for them;
• if you are undergoing vaccinations with attenuated viruses or other types of vaccinations;
• if you are allergic to sulfites and metabisulfites, as it contains sodium metabisulfite (see section “BETAMETASONE EG contains”).

BETAMETASONE EG injectable solution must not be injected directly into tendons.
Warnings and precautions
Talk to your doctor or pharmacist before using BETAMETASONE EG.
Contact your doctor if you experience blurred vision or other visual disturbances.
Inform your doctor before using BETAMETASONE EG if:

• you have a serious heart condition (congestive heart failure);
• you suffer from psychological or emotional disorders, as these conditions may worsen during treatment with BETAMETASONE EG;
• you have epilepsy;
• you have diabetes;
• you have increased eye pressure (glaucoma);
• you have chronic inflammation of the final portion of the intestine (ulcerative colitis);
• you have an abscess or an infection;
• you have inflammation of the diverticula, small naturally occurring or formed pouches in the terminal part of the intestine (diverticulitis);
• you or your child have recently undergone surgery to connect portions of the intestine (intestinal anastomosis);
• you have an active or latent stomach or duodenal ulcer;
• you have impaired kidney function;
• you have impaired liver function;
• you have chronic liver damage (hepatic cirrhosis);
• you have high blood pressure;
• you have a disease characterized by loss of bone tissue (osteoporosis);
• you have a disease causing severe muscle weakness (myasthenia gravis);
• you or your child have previously experienced muscle problems after treatment with medicines similar to BETAMETASONE EG (steroids);
• you have an underactive thyroid;
• you have herpes simplex infection of the eye;
• you have reduced blood clotting (hypoprothrombinemia) and need to take acetylsalicylic acid (e.g. aspirin);
• you have a pheochromocytoma (a tumor of the adrenal gland).

Inform your doctor if, during treatment with BETAMETASONE EG:

• you need to undergo radiological examination of the gallbladder using a contrast medium (cholecystography), as BETAMETASONE EG may reduce the effects of contrast agents used during this examination;
• you are subjected to significant stress, for example during surgery, as in such cases your BETAMETASONE EG dose may need to be adjusted;
• you develop psychological or emotional disturbances such as elation, excessive exuberance and happiness (euphoria), insomnia, severe depression, mood and personality changes, mental disturbances of psychological balance, delusions, or hallucinations (psychosis).

Exercise particular caution during treatment with BETAMETASONE EG:

• avoid contact with people who have measles or chickenpox if you are taking high doses of this medicine. If contact occurs, contact your doctor;
• BETAMETASONE EG must not be injected directly into tendons;
• glucocorticoids, such as BETAMETASONE EG, may:
  o mask signs of infection and, due to reduced immune defenses, infections may occur during treatment. In such cases, your doctor will assess whether appropriate antibiotic therapy is needed;
  o cause adrenal insufficiency. In such cases, your doctor will advise you whether to gradually reduce the dose or temporarily discontinue treatment. This type of insufficiency may last up to one year after stopping therapy. If you experience a stressful condition during the period after stopping BETAMETASONE EG, your doctor may advise you to resume treatment with this medicine.
  Use in active tuberculosis should be limited to cases of fulminant or disseminated disease, in which the corticosteroid should be used together 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, your doctor may prescribe for you or your child:

• appropriate therapy to prevent infections, if you or your child need to use BETAMETASONE EG for prolonged periods;
• sodium and potassium supplements if you or your child develop disturbances in body fluids and electrolytes.

Children and adolescents
Your doctor will prescribe BETAMETASONE EG to children and adolescents at the lowest possible doses and for the shortest possible duration. Depending on the case, your doctor may consider administering a single dose every other day. See section 3.
Your doctor will closely monitor growth and development in children and adolescents undergoing prolonged treatment with BETAMETASONE EG.
Children are particularly at risk of increased intracranial pressure.

Elderly patients
In elderly patients, treatment with BETAMETASONE EG, 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 determine the most appropriate dose of BETAMETASONE EG for you. See section 3.

Other medicines and BETAMETASONE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the effects of BETAMETASONE EG, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

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

• anticholinesterases;
• anti-inflammatory medicines:
  o other salicylates,
  o non-steroidal anti-inflammatory drugs (NSAIDs);
• 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);
• ritonavir (medicine used against HIV virus);
• ketoconazole (medicine used to treat fungal infections);
• phenytoin and phenobarbital (used to treat epileptic seizures);
• ephedrine;
• rifampicin (antibiotic);
• anticoagulants (medicines that reduce blood clotting).

Laboratory tests
BETAMETASONE EG may reduce the effects of contrast agents in cholecystography.
Inform your doctor that you are being treated with BETAMETASONE EG if you are scheduled for cholecystography.
Electrolyte imbalances (such as sodium or potassium) may occur, especially during prolonged treatment or with high doses of BETAMETASONE EG; 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 are breastfeeding, consult your doctor or pharmacist before using 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.
Newborns of mothers who received BETAMETASONE EG towards the end of pregnancy may have low blood sugar levels after birth.

Driving and using machines
It is not known whether this medicine affects the ability to drive vehicles or use machinery. However, rare neurological adverse effects have been reported.

BETAMETASONE EG contains sodium metabisulfite and sodium
Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is practically “sodium-free”.

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

3. How to use BETAMETASONE EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults
Your doctor will determine the most appropriate dose of BETAMETASONE EG for you, depending on the severity of your condition and your response to treatment.
The recommended dose ranges from 1.5 mg to 4 mg per administration. If necessary, administration may be repeated until the desired response is achieved.
In special cases, your doctor may prescribe 10–15 mg or more as a single injection, up to 3–4 times within 24 hours.
If needed, the medicine can be directly added to standard infusion fluids.

Use in children and adolescents
Treatment with the lowest possible dose for the shortest possible duration is recommended. Furthermore, your doctor may 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 (hypothalamic-pituitary-adrenal axis suppression) that may be caused by the use of BETAMETASONE EG.

Elderly patients
Your doctor will determine the most appropriate dose of BETAMETASONE EG for you.
Your doctor will prescribe the lowest effective maintenance dose capable of controlling the disease.
If necessary, your doctor will advise you to gradually reduce the dose over several weeks or months, depending on the initial dose and duration of treatment.

How to open the vial
The vials are equipped with a safety pre-break and must be opened as follows:

1. Position the vial as shown in the figure

2. Apply pressure with your thumb placed over the colored spot as indicated in the figure

If you use more BETAMETASONE EG than you should
If you accidentally ingest an excessive dose of BETAMETASONE EG, inform your doctor immediately or go to the nearest hospital.
Generally, ingestion of an excessive dose of glucocorticoids, including BETAMETASONE EG, 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 eye pressure (glaucoma);
• stomach or duodenal ulcer;
• concomitant treatment with medicines such as digitalis (a heart medicine), anticoagulant medicines (coumarins), or potassium-depleting diuretics.

If you forget to use BETAMETASONE EG
Do not take a double dose to make up for the forgotten dose.

If you stop using BETAMETASONE EG
Treatment with BETAMETASONE EG must not be stopped without first consulting your doctor.
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 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 in the posterior capsule of the lens (posterior subcapsular cataract);
• increased ocular tension;
• perforation of a pre-existing stomach or intestinal ulcer prior to starting treatment with BETAMETASONE EG;
• stomach and duodenal ulcers;
• acute inflammation of the pancreas;
• inflammation of the oesophagus;
• 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 retention (oedema);
• 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 (papilloedema);
• dizziness;
• headache;
• psychiatric disorders;
• anxiety;
• irritability;
• changes in menstrual cycle;
• thinning of the skin;
• acne;
• bruising;
• skin redness;
• skin disorders such as delayed wound healing;
• excessive sweating;
• high blood pressure;
• blurred vision;
• hiccups.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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

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 kept in its original unopened packaging and
properly stored.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What BETAMETASONE EG 1.5 mg/2 ml injectable solution contains

• The active substance is betamethasone. Each vial contains betamethasone 1.5 mg (as betamethasone disodium phosphate 1.975 mg).
• The other components are: phenol, sodium chloride, sodium metabisulfite (E223), sodium edetate, sodium hydroxide (pH adjuster), water for injections.

What BETAMETASONE EG 4 mg/2 ml injectable solution contains

• The active substance is betamethasone. Each vial contains betamethasone 4 mg (as betamethasone disodium phosphate 5.263 mg).
• The other components are: phenol, sodium chloride, sodium metabisulfite (E223), sodium edetate, sodium hydroxide (pH adjuster), water for injections.

Description of the appearance of BETAMETASONE EG and contents of the pack
BETAMETASONE EG 1.5 mg/2 ml injectable solution
Pack of 6 vials.
BETAMETASONE EG 4 mg/2 ml injectable solution
Pack of 3 vials.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6 - 20136 Milan
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello, 15 – 00071 Pomezia (Rome)