SOLDESAM 4 mg /Ml Инъекционный Раствор

Содержание инструкции

1. SOLDESAM
   1. What SOLDESAM is and what it is used for
   2. Cosa deve sapere prima di usare SOLDESAM
   3. How to use SOLDESAM
   4. Possible side effects
   5. How to store SOLDESAM
   6. Contents of the pack and other information
2. SOLDESAM 0.2% Oral Drops Solution
   1. What is SOLDESAM and what is it used for
   2. What you need to know before taking SOLDESAM
   3. How to take SOLDESAM
   4. Possible side effects
   5. How to store SOLDESAM
   6. Contents of the pack and other information

SOLDESAM

4 mg/1 ml injectable solution
8 mg/2 ml injectable solution
Desametasone

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, pharmacist or nurse.
• 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What SOLDESAM is and what it is used for

SOLDESAM contains the active ingredient desamethasone which belongs to a group of medicines
called corticosteroids. Corticosteroids are hormones that can be used as medicines and
that perform numerous activities, including the control of inflammation and allergies.
SOLDESAM 4 mg/1 ml injectable solution is used for the treatment of:

• inflammations;
• a degenerative disease of the joints called osteoarthritis and a degenerative inflammation of the joints due to an injury to the joints that has created irreparable damage or has altered the normal functioning of the joint (post-traumatic osteoarthritis);
• chronic inflammation of the joints (inflammatory arthritis), chronic inflammation that affects multiple joints (progressive chronic polyarthritis), inflammatory disease that affects joints and muscles (ankylosing spondylitis);
• asthma crises (asthmatic attacks). SOLDESAM 8 mg/2 ml injectable solution is used for the treatment of:
• accumulation of fluid in the brain (cerebral edema);
• brain tumors (as an addition to the main therapy);
• emergency and various shock conditions;
• swelling of the laryngeal mucosa (glottic edema);
• allergic reactions that can occur following a blood transfusion (post-transfusional);
• severe allergic reactions (anaphylaxis);
• trauma of various kinds (hemorrhagic, surgical, septic, cardiogenic, from burns).

2. Cosa deve sapere prima di usare SOLDESAM

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Non usi SOLDESAM

• se è allergico al desametasone sodio fosfato o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• se ha un’infezione dovuta a funghi e/o a batteri diffusa in tutto il corpo (infezioni micotiche e batteriche sistemiche), salvo nei casi in cui lei sta già facendo una terapia specifica per l’infezione;
• se si sottopone ad iniezioni locali in caso di batteri nel sangue (batteriemia), di infezioni dovute a funghi diffuse in tutto il corpo (infezioni micotiche sistemiche), di instabilità delle articolazioni, di infezioni nel sito dove viene eseguita l’iniezione, ad esempio dovuta ad infiammazione delle articolazioni causata da localizzazione nella articolazione del batterio della gonorrea, una malattia a trasmissione sessuale (artrite settica secondaria a gonorrea) o ad una infezione batterica che colpisce di solito i polmoni (tubercolosi);
• se soffre di problemi allo stomaco e all’intestino (ulcera peptica);
• se soffre di problemi della mente (psicosi);
• se ha un’infezione all’occhio da parte di un virus detto Herpes simplex.

Avvertenze e precauzioni
Si rivolga al medico, al farmacista o all’infermiere prima di usare SOLDESAM.
SOLDESAM può peggiorare un’infezione causata da funghi diffusa in tutto il corpo (infezione
fungina sistemica), a meno che sia necessario per controllare l’allergia (le reazioni da farmaco) dovuta
all’amfotericina B. D’altra parte è stato riportato che l’uso contemporaneo di amfotericina B e
idrocortisone provoca aumento del peso e del volume del tessuto cardiaco (ipertrofia cardiaca
congestizia).
L’uso di questo medicinale può:

• aumentare la predisposizione alle infezioni e la loro gravità, favorire la comparsa di infezioni da parassiti (amebiasi latente), nascondere alcuni segni di infezioni gravi e può alterare i risultati di alcuni test dando falsi risultati negativi per le infezioni causate da batteri (test del nitroblutetrazolo);
• seppur raramente, causare reazioni allergiche anche gravi (reazioni anafilattiche) che si possono manifestare con gonfiore alla gola (edema della glottide), irritazione della pelle (orticaria) e problemi di respirazione (broncospasmo), specialmente se in passato ha avuto reazioni allergiche ad altri medicinali. Informi immediatamente il medico se dovesse manifestare uno dei sintomi sopra riportati.

Assuma questo medicinale alla più bassa dose capace di controllare i sintomi. La riduzione della dose
deve essere effettuata in maniera graduale.Durante il trattamento con questo medicinale, il medico
potrà prescriverle dei medicinali per prevenire lesioni allo stomaco (medicinali antiacidi).
SOLDESAM se preso ad alte dosi può provocare:

• aumento della pressione del sangue;
• alterazione dei livelli dei sali e dei liquidi nell’organismo (ritenzione idrica e salina) o aumentata perdita di potassio; in tal caso segua una dieta povera di sale ed assuma integratori di potassio. Tutti i medicinali appartenenti alla classe di SOLDESAM (medicinali corticosteroidi) aumentano l’eliminazione del calcio. L'iniezione di un corticosteroide nelle articolazioni (iniezione intra-articolare) può provocare effetti sia in tutto il corpo che locali. Frequenti iniezioni nelle articolazioni possono provocare gravi danni alle articolazioni stesse. Se ha liquidi nelle articolazioni deve sottoporsi ad esami per escludere la presenza di infezioni. Informi il medico se accusa un forte aumento del dolore con gonfiore locale, limitazione del movimento dell’articolazione, febbre e malessere generale. Questi sono segni che suggeriscono un’infezione dell’articolazione.

Pag. 2di 20
Il medico la sottoporrà ad adeguata terapia antibiotica e le chiederà di non sforzare l’articolazione
anche quando il dolore si è ridotto. Infatti, l’articolazione deve essere salvaguardata fino a quando il
processo infiammatorio è ancora in atto.
Eviti l’iniezione di corticosteroidi nei tendini.
Informi il medico se è in trattamento con altri medicinali, se deve effettuare delle vaccinazioni o le
prove allergiche (prove cutanee) durante la terapia con SOLDESAM.
Usi SOLDESAM con cautela e informi il medico se:

• è molto stressato;
• ha problemi ai surreni, organi coinvolti nella produzione di diversi ormoni, dovuti a questo medicinale (insufficienza surrenalica secondaria); in tal caso il medico potrà ridurle in modo graduale la dose. Questi problemi possono continuare anche per qualche mese dopo la sospensione della terapia. Se durante questo periodo è sottoposto a stress o assume altri medicinali antinfiammatori (steroidi), si rivolga al medico;
• ha un tumore della ghiandola surrenale (feocromocitoma);
• ha un’infezione che colpisce di solito i polmoni (tubercolosi) o infezione agli occhi dovuta a virus o funghi; in tal caso il medico le prescriverà contemporaneamente una terapia contro tali infezioni (terapia antimicrobica); se ha la tubercolosi può utilizzare questo medicinale in associazione ai medicinali per la cura della tubercolosi stessa e solo se si tratta di tubercolosi fulminante o disseminata. Se ha la tubercolosi latente o se il test per la tubercolina è risultato positivo deve essere strettamente sorvegliato dal medico;
• non ha mai avuto la varicella, una malattia infettiva molto contagiosa causata da un virus, o Herpes zoster (comunemente chiamato fuoco di Sant’Antonio, una malattia causata da virus a carico della pelle e dei nervi), perché queste malattie possono essere molto pericolose se si manifestano durante il trattamento con questo medicinale. Se lei o il suo bambino non avete mai avuto queste malattie eviti il contatto con persone che possono esserne affette e se esposto si rivolga immediatamente al medico. Se lei o il suo bambino manifestate i sintomi di queste malattie durante il trattamento con SOLDESAM, si rivolga immediatamente al medico. Non deve comunque interrompere il trattamento con SOLDESAM ed il medico può anche aumentarne il dosaggio. Se è in terapia con corticosteroidi come SOLDESAM o è stato in terapia negli ultimi 3 mesi il medico la sottoporrà a trattamento di immunizzazione contro la varicella con specifici anticorpi (immunoglobulina della varicella zoster). Questo trattamento deve iniziare entro 10 giorni dalla esposizione al virus della varicella;
• se non ha mai avuto il morbillo. In caso di esposizione si rivolga immediatamente al medico che può sottoporla a terapia medica preventiva con specifici anticorpi (immunoglobuline);
• ha seguito un trattamento con dosi elevate per oltre 3 settimane; in questo caso la riduzione della dose deve avvenire in maniera graduale, poiché può avere problemi improvvisi ai surreni (insufficienza surrenalica acuta), abbassamento della pressione del sangue (ipotensione) e può andare in contro a morte;
• presenta sintomi di sindrome da lisi tumorale come crampi muscolari, debolezza muscolare, confusione, perdita o disturbi della vista e respiro corto, in caso lei soffra di neoplasie ematologiche;
• ha infiammazione persistente dell’intestino (colite ulcerosa aspecifica con pericolo di perforazione);
• ha un’infezione con formazione di pus (ascesso) o infezioni da batteri che causano pus (infezioni piogeniche);
• ha un problema all’intestino (diverticolite);
• ha recentemente subito un intervento chirurgico per la ricostruzione dell’intestino (anastomosi intestinali);
• soffre di disturbi allo stomaco o all’intestino associati alla presenza di lesioni (ulcera peptica in atto o latente);
• ha problemi ai reni (insufficienza renale);
• soffre di pressione del sangue alta (ipertensione);
• soffre di assottigliamento delle ossa (osteoporosi);

Pag. 3di 20

• soffre di una malattia caratterizzata da grave debolezza ai muscoli (miastenia grave);
• soffre di problemi alla tiroide (ipotiroidismo) o problemi al fegato (cirrosi epatica);
• è un uomo, in quanto l’uso di questo medicinale può causare l’aumento o la diminuzione della mobilità e del numero degli spermatozoi;
• ha la diarrea o se ha fatto un viaggio ai tropici, in quanto l’uso di questo medicinale può attivare una infezione (amebiasi);
• è un anziano, in quanto gli effetti indesiderati dovuti all’uso di corticosteroidi possono avere conseguenze più gravi, in particolare assottigliamento delle ossa (osteoporosi), aumento della pressione del sangue (ipertensione), diminuzione dei livelli di potassio (ipokaliemia), aumento della quantità di zucchero nel sangue (diabete), suscettibilità alle infezioni e assottigliamento della pelle. In tal caso si rivolga al medico che la terrà sotto stretto controllo.

Problemi della mente
L’uso di questo medicinale può causare effetti sulla mente (reazioni psichiatriche). Queste reazioni
cessano dopo aver ridotto o sospeso il medicinale. In caso di grave sensazione di tristezza
(depressione), pensieri di suicidio o qualsiasi altro sintomo di disturbo mentale, si rivolga al medico.
Questi disturbi possono insorgere sia durante che dopo la riduzione/sospensione della terapia.
Informi il medico prima di prendere questo medicinale se in passato, lei o qualcuno della sua famiglia,
ha manifestato disturbi della mente (depressione, malattia maniaco-depressiva, psicosi da steroidi).
Il medico la terrà attentamente sotto controllo durante il trattamento se:

• ha problemi alle ossa (osteoporosi), specialmente se è una donna in menopausa;
• ha la pressione del sangue alta (ipertensione);
• soffre di disturbi al cuore (scompenso cardiaco congestizio);
• se soffre di gravi alterazioni dell’umore (soprattutto se ha manifestato malattie mentali che alterano il controllo del comportamento e delle azioni - psicosi - in seguito a terapia con steroidi);
• lei o qualcuno della sua famiglia ha elevate quantità di zucchero nel sangue (diabete mellito);
• ha avuto in passato la tubercolosi, poiché i corticosteroidi come SOLDESAM possono riattivare la malattia;
• lei o qualcuno della sua famiglia ha aumentata pressione all’interno degli occhi (glaucoma);
• ha manifestato problemi ai muscoli in seguito a una terapia con corticosteroidi (miopatia pregressa);
• soffre di problemi al fegato (insufficienza epatica);
• soffre di problemi ai reni (insufficienza renale);
• soffre di epilessia;
• soffre di problemi allo stomaco e all’intestino dovuti alla presenza di lesioni (ulcerazioni gastro- intestinali);
• soffre di una condizione caratterizzata da frequenti mal di testa spesso associati ad altri sintomi, come nausea, vomito, aumentata sensibilità alla luce e ai suoni (emicrania);
• ha infezioni all’intestino dovute a parassiti (amebiasi);
• ha un ridotto accrescimento (crescita strutturale incompleta);
• soffre di una condizione caratterizzata da quantità eccessiva di ormoni glicocorticoidi nel sangue chiamata sindrome di Cushing;
• soffre di infiammazione dei tendini (tendiniti) o di infiammazione della membrana che riveste i tendini (tenosinoviti); il medico presterà attenzione nell’iniettare nello spazio tra i rivestimenti e il tendine stesso perché è possibile la rottura del tendine;
• lei o qualcuno della sua famiglia ha sofferto in passato di gravi disturbi affettivi (come depressione, mania, malattia maniaca depressiva o psicosi da steroidi). L’uso di questo medicinale può causare gravi effetti psichiatrici i cui sintomi compaiono entro alcuni giorni o settimane dall’inizio del trattamento e i rischi sono maggiori se vengono somministrate dosi elevate direttamente in vena.

L’uso prolungato di questo medicinale può causare opacità della parte posteriore del cristallino
dell’occhio con riduzione della capacità visiva (cataratta subcapsulare posteriore). Inoltre l’uso del
medicinale può favorire infezioni agli occhi dovute a batteri e a funghi.
Pag. 4di 20
Contatti il medico se si presentano visione offuscata o altri disturbi visivi.
Porti sempre con sé una scheda sanitaria che riporti la terapia con corticosteroidi alla quale è
sottoposto, il medico curante, il medicinale che sta assumendo, la dose e la durata del trattamento.

Per chi svolge attività sportiva
L’uso di questo medicinale senza necessità terapeutica costituisce doping e può determinare comunque
positività ai test anti-doping.

Bambini e adolescenti
SOLDESAM non deve essere usato in neonati prematuri con problemi di respirazione.
Se il desametasone viene somministrato a neonati prematuri, è necessario monitorare la funzione e la
struttura cardiaca.
Nella primissima infanzia SOLDESAM deve essere somministrato solo in caso di assoluta necessità e
sotto il diretto controllo del medico.
È necessario controllare la crescita e lo sviluppo di bambini e di adolescenti in trattamento prolungato
con questo medicinale, poiché SOLDESAM può ritardare la crescita in modo non reversibile.

Other medicines and SOLDESAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Use SOLDESAM with caution and inform your doctor if you are taking the following medicines because
specific checks may be necessary:

• medicines used for the treatment of epilepsy (difenilidantoina, phenytoin, phenobarbital, carbamazepine, primidone);
• ephedrine, a medicine used to reduce nasal congestion (nasal decongestant);
• phenylbutazone, a medicine used for the treatment of inflammation and pain;
• aminoglutethimide, a medicine used to treat a hormonal disorder (Cushing's syndrome) or breast cancer;
• ketoconazole, amphotericin B, medicines used to treat infections caused by fungi;
• macrolide antibiotics, such as erythromycin, used to treat infections caused by bacteria;
• indinavir, a medicine used to treat AIDS;
• hydrocortisone, a medicine used for the treatment of skin allergies;
• medicines used for the treatment of infections caused by bacteria (rifabutin, rifampicin);
• medicines called cholinesterase inhibitors and used for the treatment of muscle problems (myasthenia gravis);
• medicines used to thin the blood (coumarinic anticoagulants);
• medicines that promote urine excretion (potassium-depleting diuretics and diuretics in general, such as acetazolamide, loop diuretics, thiazide diuretics);
• medicines used to lower blood sugar levels (hypoglycemic agents) including insulin;
• medicines used to lower blood pressure (antihypertensives);
• medicines used for the treatment of some heart problems (cardiac glycosides);
• carbenoxolone, a medicine against stomach lesions;
• non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone). If you stop taking SOLDESAM you may have salicylate poisoning, used for the treatment of inflammation and pain. Also, if you have low levels of prothrombin (hypoprothrombinemia), you may have an interaction with salicylates. During treatment with this medicine, do not undergo vaccination against smallpox and other types of vaccination (immunizing procedures), especially if you are taking high doses of this medicine, due to the possible risk of neurological complications and insufficient response of the body's defense system (insufficient antibody response).

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Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Since dexamethasone, the active ingredient contained in this medicine, crosses the placenta, if you
are pregnant or of childbearing potential, your doctor will assess the need to start treatment with
this medicine only if the benefits to you outweigh the risks to your baby.
Newborns of mothers who have received high doses of corticosteroids during pregnancy must
be carefully monitored because they may develop adrenal problems (adrenal insufficiency).
Premature babies of mothers who have received SOLDESAM towards the end of pregnancy may
have low blood sugar levels after birth.

Breastfeeding
Do not use SOLDESAM if you are breastfeeding, as it passes into breast milk.

Driving and operating machinery
This medicine does not impair the ability to drive and operate machinery.

SOLDESAM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is practically “sodium-free”.
SOLDESAM injectable solution contains phenol. It must not be ingested.

3. How to use SOLDESAM

This medicine will be administered to you by a doctor or specialized personnel. If you have any doubts
consult your doctor, pharmacist or nurse.
This medicine can be administered with an injection into the muscles (intramuscular route) or with
an injection directly into a vein (intravenous route). Do not ingest(see “SOLDESAM injectable
solution contains phenol”).
The doctor will adjust the dose based on your case and your response to treatment. In general, the recommended dose is:

• for SOLDESAM 4 mg/1 ml of one vial per day. The doctor may decide to repeat the injection if necessary. If you respond positively to treatment, the doctor will gradually reduce the dose.
• For SOLDESAM 8 mg/2 ml of 32-96 mg per day, divided into 6-4 administrations per day.

SOLDESAM 4 mg/1ml can also be administered directly into the membrane lining the
joints (intrasinovial route) or into soft tissues. This type of administration must be
performed in an environment completely free of contaminating agents such as bacteria, viruses, fungi and
parasites (asepsis) and by specialized personnel.

If you use more SOLDESAM than you should
An overdose of this medicine can cause: severe weight gain (obesity), reduced
muscle function (muscle atrophy), thinning of the bones (osteoporosis), excessive hair growth (hirsutism), a skin condition characterized by red spots and increased tendency
to bleeding (purpura), the appearance of pimples and irritation (acne), excitement and agitation (neuropsychic symptoms), the presence of sugar in the urine and blood (glycosuria, hyperglycemia), reduced
levels of potassium in the blood (hypokalemia), a condition known as Cushing's syndrome characterized
by an excessive amount of glucocorticoid hormones in the blood with symptoms such as facial swelling,
fat accumulation especially on the abdomen and neck, excessive hairiness, menstrual cycle disorders,
fatigue and irritability, growth arrest in children (see the paragraph “Children
and adolescents”).
In case of ingestion/use of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to use SOLDESAM
Do not use a double dose to make up for a missed dose.

If you stop using SOLDESAM
Do not suddenly stop treatment with SOLDESAM injectable solution or without first
agreeing with your doctor. It is necessary to gradually reduce the dose before stopping the
treatment.
Discontinuation of prolonged treatment can cause fever, pain in the joints and muscles
(arthralgia, myalgia), allergic rhinitis, eye inflammation (conjunctivitis),
formation of nodules on the skin with itching and pain, weight loss.
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:

Frequency not known(the frequency cannot be estimated from the available data):

• alteration of sodium levels and fluids in the body (sodium and water retention), reduction of potassium levels and consequent alteration of blood acidity (potassium depletion, hypokalemic alkalosis);
• increase in blood sugar levels and possible diabetes (reduced carbohydrate tolerance and manifestation or unmasking of diabetes mellitus), this condition promotes an increased need for insulin or the use of medicines that lower blood sugar levels (oral hypoglycemic agents) in diabetic patients;
• increased elimination of proteins (negative nitrogen balance due to protein catabolism); in case of prolonged treatments it is necessary to increase protein intake with the diet;
• increase in body weight and increased appetite;
• increased elimination of calcium;
• alteration of fluid and salt levels in the body (electrolyte imbalance), which rarely can cause an increase in blood pressure (hypertension) and heart problems (congestive heart failure) if you have a predisposition to these problems;
• reduced heart function if you are predisposed to heart disorders (congestive heart failure), changes in heart rhythm (arrhythmias), blockage of blood flow (circulatory collapse) if a high dose is administered rapidly directly into a vein;
• increase in the number of white blood cells (leukocytosis), disorders of the lymphatic system (decrease in lymphatic tissue);
• increase or decrease in blood pressure (hypertension, hypotension), insufficient blood flow to the main organs (shock), blockage of blood vessels due to a blood clot (thromboembolism), collection of blood in a tissue or cavity of the body (hematomas);
• muscle weakness (muscle asthenia), muscle problems (steroid myopathy and proximal myopathy), loss of muscle mass, thinning of bones (osteoporosis), fractures to the

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vertebrae (compression fractures of the vertebrae), death of bone cells (aseptic necrosis
of the femoral and humeral head), painless destruction of joints (reminiscent
of Charcot arthropathy, particularly after repeated injections into the joints), blockage of
the growth of long bones (premature closure of the epiphyses), destruction of bone (avascular osteonecrosis);

• spontaneous fracture of long bones, tendon rupture, bone fragility;
• damage, poisoning and procedural complications such as tendon rupture;
• formation of lesions in the stomach (gastric ulcer) with possible perforation and bleeding (hemorrhage), lesions of the intestine (intestinal perforations) especially if you have inflammation of the intestine;
• inflammation of the pancreas (pancreatitis), abdominal distension, inflammation of the esophagus with formation of lesions (ulcerative esophagitis), nausea, malaise, digestive problems (dyspepsia);
• delay in wound healing, thinning and fragility of the skin, alteration of test results for allergies (skin tests), appearance of red spots (petechiae) and bruises (ecchymoses), facial redness (erythema), increased sweating, burning and itching, especially in the area near the anus (after intravenous injection), other skin reactions such as irritation (allergic dermatitis, urticaria), swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema), increased or decreased skin pigmentation (hyperpigmentation or hypopigmentation), increased hair growth (hirsutism), dilation of small blood vessels (telangiectasia), appearance of stretch marks (striae), appearance of pimples and irritation (acne), small collections of non-infected fluid within tissues (sterile abscesses);
• behavioral disorders such as unjustified feeling of happiness (euphoria), insomnia, changes in mood and personality, thoughts of suicide, severe sadness (severe depression), mania, delusions, hallucinations and worsening of schizophrenia, irritability, anxiety, confusion, need to continue using this medicine (psychological dependence), memory problems (amnesia), symptoms of real psychoses. These effects may be more pronounced if you have suffered from mental disorders in the past;
• convulsions, increased pressure in the head (intracranial pressure); these effects usually appear after stopping treatment;
• speech disorders, memory disorders (cognitive dysfunction), worsening of epilepsy;
• blockage of the production of some hormones (suppression of the hypothalamus-pituitary-adrenal axis), deposition of fat around the shoulder blades, on the back of the neck, on the upper back and alterations in hormone levels (cushingoid state), alterations in the regulation of hormone production (secondary hypopituitarism-adrenal insufficiency), especially if you are under stress (e.g. for trauma, surgery, or serious illness);
• irregularities of the menstrual cycle, absence of menstruation (amenorrhea);
• increase in the levels of some enzymes produced by the liver (in most cases reversible after discontinuation of treatment);
• opacity of the posterior part of the lens of the eye with reduced visual acuity (posterior subcapsular cataract), increased pressure inside the eye (intraocular pressure), disease due to problems with the optic nerve (glaucoma), marked protrusion of one or both eyes (exophthalmos), swelling of the eyes (papilledema), problems with the cornea (thinning of the cornea or sclera);
• visual disturbances, loss of vision, blurred vision;
• rarely loss of vision, after use of desamethasone directly in the lesion at the level of the face and head;
• increased susceptibility and severity of infections without symptoms and without signs (including opportunistic infections), activation of tuberculosis (manifestation or unmasking of dormant tuberculosis), worsening of eye diseases due to viruses or fungi, infections caused by a species of fungus (candidiasis);
• severe allergic reactions (anaphylaxis) or less severe (hypersensitivity), reduced functionality of the body's defense system, reduced response to vaccinations and allergy tests (skin tests);

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• hiccups.

Additional side effects in children and adolescents
Frequency not known(the frequency cannot be estimated from the available data):

• growth arrest in children and adolescents;
• increased pressure in the head (intracranial pressure) associated with swelling (pseudotumor cerebri); these effects generally disappear after discontinuation of treatment;
• problems with the adrenal glands (adrenal insufficiency) in newborns from mothers who have received high doses of corticosteroids during pregnancy.
• thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually returns to normal after discontinuation of treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 SOLDESAM

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 the vials in the original packaging to protect the medicine from light.
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 SOLDESAM contains

• The active ingredient is desamethasone sodium phosphate. 1 vial of 1 ml contains 4 mg of desamethasone sodium phosphate. 1 vial of 2 ml contains 8 mg of desamethasone sodium phosphate.
• The other ingredients are: phenol, sodium citrate, citric acid, water for injections.

Description of the appearance of SOLDESAM and contents of the pack
Pack of 3 or 6 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LABORATORIO FARMACOLOGICO MILANESE s.r.l. - Via Monterosso 273, 21042 Caronno
Pertusella (VA) – Italy

Manufacturer
Laboratorio Farmacologico Milanese S.r.l., via Monterosso 273, 21042 Caronno Pertusella (VA) - Italy
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The following information is intended exclusively for healthcare professionals:
Special warnings and precautions for use
Live vaccines should not be administered to subjects with insufficient immune response. The
antibody response to other vaccines may be reduced.
In patients who have received systemic corticosteroid dosages greater than physiological doses (approximately
1 mg of desamethasone) for more than 3 weeks, discontinuation of treatment cannot occur abruptly. Gradual
reduction of the dosage depends on the risk of disease recurrence, clinical assessment of disease activity
during treatment discontinuation and the potential
degree of HPA axis suppression. Upon reaching a daily dosage of 1 mg the
dosage reduction must occur more slowly to allow for the full recovery of
efficiency by the HPA.
Abrupt interruption of dosages up to 6 mg/day of desamethasone for treatments lasting up to
3 weeks hardly leads to clinically relevant suppression of the HPA axis, however, there are some groups of
patients in whom a gradual suspension of therapy is appropriate even for
treatment courses lasting 3 weeks or less. For example, in patients receiving
repeated systemic corticosteroid treatments, in patients treated with short-term therapy within one year
from the cessation of chronic therapy, in patients with other disorders responsible for adrenal insufficiency,
in patients treated with daily dosages up to 6 mg of desamethasone and in patients
chronically treated with evening dosages.
A sudden decrease in the corticosteroid dosage, after prolonged treatments, can cause
acute adrenal insufficiency, hypotension and death. Discontinuation of corticosteroids after chronic therapy
can cause symptoms (corticosteroid withdrawal syndrome) such as fever, myalgia,
arthralgia, rhinitis, conjunctivitis, itchy and painful skin nodules and weight loss. These
symptoms may occur in patients even without symptoms of adrenal insufficiency.
During chronic treatment, any intercurrent illness, trauma or surgery requires a
temporary increase in dosage; if the corticosteroid has been discontinued after prolonged therapy, it may be
necessary to temporarily restore treatment.
Cases of anaphylactic reactions in patients treated with systemic corticosteroids have been occasionally reported.
When such reactions occur, it is recommended to follow these procedures: immediate and slow intravenous
injection of adrenaline, intravenous administration of aminophylline and, if
necessary, artificial respiration.
Corticosteroids should not be used in the management of brain damage or stroke, as their clinical utility is uncertain and they are even dangerous for the patient.
Corticosteroids can suppress responses to skin tests. Patients undergoing corticosteroid therapy should not be vaccinated against smallpox. Other immunization procedures should not be
carried out in patients treated with corticosteroids, especially at high doses, due to the risk of neurological
complications and a lack of antibody response.
In the presence of hypoprothrombinemia, acetylsalicylic acid must be used with caution during
corticosteroid therapy. In patients with hypothyroidism or liver cirrhosis, the response to corticosteroids
may increase.
Local injection of a steroid into infected areas should be avoided. Corticosteroids should not be injected
into unstable joints.
In the treatment of tendinitis or tenosynovitis, care must be taken when injecting into
the space between the coverings and the tendon itself, as cases of tendon rupture have been reported.

Interactions
Prothrombin time and INR should be monitored frequently to prevent spontaneous bleeding in patients receiving corticosteroids and coumarin anticoagulants at the same time,
because in some cases corticosteroids have altered the response to these anticoagulants. Some studies
have shown that the effect usually caused by the addition of corticosteroids is the inhibition of the
response to coumarin compounds, although there have been some conflicting reports indicating a
potentiation.
Patients undergoing corticosteroid therapy should not be vaccinated against smallpox.
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Other immunization procedures should not be undertaken in patients receiving corticosteroids
especially at high doses, due to possible risks of neurological complications and insufficient
antibody response.

Dosage and administration
SOLDESAM 4mg/1ml:

• by intramuscular and intravenous route: to be adapted according to cases and therapeutic response: as a guide, one vial (4 mg) per day, possibly repeated. As soon as a positive result is achieved, gradually reduce the dose.
• by intrasynovial route in soft tissues: to be carried out with perfect asepsis and with good injection technique using the following indicative dosages:

SOLDESAM 8mg/2ml:
The dosage of SOLDESAM 8mg/2ml must be individualized based on the disease to be treated,
its severity and the patient's therapeutic response. As a guide, in the indicated therapies it is
recommended to administer 32-96 mg per day divided into 4-6 administrations.

For further information, see the Summary of Product Characteristics.
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SOLDESAM 0.2% Oral Drops Solution

Desametasone

Read this leaflet carefully before taking 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is SOLDESAM and what is it used for

SOLDESAM contains the active ingredient desamethasone which belongs to a group of medicines
called corticosteroids. Corticosteroids are hormones that can be used as medicines and
that perform numerous activities, including the control of inflammation and allergies.
SOLDESAM is indicated for the treatment:

• of allergies and inflammation;
• of a degenerative inflammatory disease of the joints called “osteoarthritis” and of the degenerative inflammation of the joints due to an injury of the joints that has created irreparable damage or has altered the normal functioning of the joint (post-traumatic osteoarthritis);
• of chronic inflammation that affects multiple joints (chronic progressive polyarthritis) and of a disease, inflammatory that affects muscles and joints (ankylosing spondylitis);
• of breathing disorders that cause difficulty in breathing, cough and a feeling of tightness in the chest (asthma);
• of inflammatory and allergic skin diseases (dermatitis and dermatoses).

This medicine is also indicated in all cases where anti-inflammatory therapy is necessary
(corticoid therapy).

2. What you need to know before taking SOLDESAM

Do not take SOLDESAM

• if you are allergic to desametasone sodium phosphate or to any of the other ingredients of this medicine (listed in section 6);
• if you have a widespread fungal and/or bacterial infection throughout the body (systemic fungal and bacterial infections), unless you are already receiving specific therapy for the infection;
• if you are undergoing local injections in case of blood infections (bacteremia), widespread fungal infections (systemic fungal infections), joint instability, or infection at the injection site, for example due to inflammation of the joints caused by localization of the bacterium in the joint

Pag. 12of 20
gonorrhea, a sexually transmitted disease (septic arthritis secondary to gonorrhea) or a bacterial infection that usually affects the lungs (tuberculosis);

• if you suffer from problems with your stomach and intestines (peptic ulcer);
• if you suffer from mental health problems (psychosis);
• if you have an eye infection caused by a virus called Herpes simplex.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLDESAM.
Take the medicine at the lowest dose capable of controlling the symptoms. The dose reduction must be carried out gradually. During treatment with this medicine, your doctor may prescribe you medicines to prevent stomach injuries (antacids).
If you are affected by acute and chronic infections, during treatment the doctor will take all appropriate precautions.
Medicines belonging to the same class as SOLDESAM (corticosteroids) can:

• hide some signs of infection and during their use, intercurrent infections may occur as they can reduce the body's defenses. In these cases, the doctor will assess whether to subject you to adequate therapy with antibiotics;
• alter test results and give false negative results for bacterial infections (nitroblutetrazolium test);
• activate infectious diseases due to parasites (latent amebiasis) and therefore, before starting therapy with corticosteroids, the presence of latent or active amebiasis must be ascertained, especially if you have been to the tropics or have diarrhea;
• worsen fungal infections throughout the body (systemic fungal infection). Do not use SOLDESAM in the presence of these infections, unless it is necessary to control the allergy (drug reaction) due to amphotericin B, a medicine used for the treatment of fungal infections. The simultaneous use of amphotericin B and hydrocortisone can cause heart problems (congestive cardiac hypertrophy);
• increase calcium loss;
• cause reduced function of the "adrenal glands", the organs involved in the production of various hormones (secondary adrenal insufficiency). In this case, the doctor will modify the dosage, in any stressful situation that occurs during this period, the doctor may have you resume therapy with hormones;
• rarely, cause severe allergic reactions (anaphylactic reactions) such as swelling of the glottis, urticaria, narrowing of the bronchi with increased difficulty breathing (bronchospasm), especially if you are already allergic to other medicines;
• cancel the responses to allergy tests (skin tests).

If you suffer from malignant blood diseases (malignant hematological diseases) with the use of SOLDESAM alone or in combination with other medicines called chemotherapeutic agents, you may develop a disease due to the death of tumor cells with release into the body of substances that can cause kidney damage (tumor lysis syndrome). In this case, the doctor will subject you to careful monitoring.
Injections of corticosteroids into the joints can cause pain and fever. If you have fluid in the joints, you must undergo examinations. If you have an increase in pain with local swelling, limitation of movement, fever and general malaise, which are symptoms of a possible joint infection (septic arthritis), consult your doctor.
The administration of SOLDESAM at medium or high doses can cause an increase in blood pressure, alteration of the levels of salts and fluids in the body (water and salt retention), or increased potassium loss. In these cases, you must follow a low-salt diet and take potassium supplements.
If you are undergoing therapy with corticosteroids such as SOLDESAM and are subjected to particular stress, the doctor will increase the dose of corticosteroids.
Pag. 13of 20
During treatment with SOLDESAM, chickenpox, a highly contagious infectious disease caused by a virus, can be very dangerous. If you have never had chickenpox or herpes zoster (commonly called Shingles, a disease caused by a virus affecting the skin and nerves), avoid contact with people who may be affected and if exposed, consult your doctor immediately. If you are undergoing therapy with corticosteroids such as SOLDESAM or have been in therapy in the last 3 months, the doctor will subject you to immunization treatment against chickenpox with specific antibodies (varicella zoster immunoglobulin).
Also avoid contact with people affected by the measles virus. If exposed, consult your doctor immediately, who may subject you to preventive medical therapy with specific antibodies (immunoglobulins).
Do not undergo vaccinations with live vaccines and the smallpox vaccine during therapy with SOLDESAM. In addition, the response to other types of vaccines may be reduced.
Prolonged treatment with corticosteroids such as SOLDESAM can cause reduced secretion of the adrenal glands that produce hormones (adrenal cortical atrophy). This condition can persist even several years after discontinuation of therapy. If you have taken high doses of corticosteroids and for more than 3 weeks, treatment should not be stopped abruptly. In addition, the reduction of the dosage must occur gradually taking into account the risk of worsening of the disease and the activity of the disease during the suspension of therapy. The rapid reduction of the dose of corticosteroids taken at high dosage and for prolonged treatments can cause reduced function of the "adrenal glands", the organs involved in the production of various hormones (acute adrenal insufficiency), lowering of blood pressure (hypotension) and death.
If you are taking SOLDESAM, especially at high doses, you should not take other medicines that affect the body's defense systems (immunizing procedures), due to possible risks of neurological complications or insufficient response of the body's defense system (antibody response).
During therapy with SOLDESAM, you must take acetylsalicylic acid with caution if you have a low amount of prothrombin in the blood (hypoprothrombinemia).
Take SOLDESAM with caution and inform your doctor if:

• you suffer from thyroid problems (hypothyroidism) or liver problems (hepatic cirrhosis);
• you have latent tuberculosis or if the tuberculin test has resulted positive. In these cases you must be closely monitored by the doctor;
• you have persistent inflammation of the intestine (ulcerative colitis) or if you suffer from stomach or intestinal disorders associated with the presence of lesions (gastric ulcer in progress or latent);
• you have an infection with pus formation (abscess) or pus-causing bacterial infections (pyogenic infections);
• you have a problem with the intestine (diverticulitis) or if you have recently undergone surgery to reconstruct the intestine (intestinal anastomoses);
• you suffer from a disease characterized by severe muscle weakness (myasthenia gravis);
• you are a man, as the use of this medicine can cause an increase or decrease in sperm mobility and number;
• you suffer from severe thinning of the bones (osteoporosis) or if you are elderly, as the side effects due to the use of corticosteroids can have more serious consequences, increased blood pressure (hypertension), decreased levels of potassium (hypokalemia), increased blood sugar (diabetes), susceptibility to infections and thinning of the skin. In this case, the doctor will keep you under strict control;
• you present symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, loss or disturbances of vision and shortness of breath, if you suffer from hematological neoplasms
• you have a tumor of the adrenal gland (pheochromocytoma)

Pag. 14of 20
The doctor will carefully monitor you during treatment if:

• you suffer from thinning of the bones (osteoporosis), especially if you are a postmenopausal woman;
• you have high blood pressure (hypertension);
• you suffer from heart problems (congestive heart failure);
• you suffer from severe mood disorders (especially if you have experienced mental illnesses that alter the control of behavior and actions - psychosis - following steroid therapy);
• you or someone in your family has high amounts of sugar in the blood (diabetes mellitus);
• you or someone in your family has increased pressure inside the eyes (glaucoma);
• you have experienced muscle problems following corticosteroid therapy (myopathy);
• you suffer from liver (hepatic insufficiency) or kidney (renal insufficiency) problems;
• you suffer from epilepsy;
• you suffer from stomach and intestinal problems due to the presence of lesions (gastrointestinal ulcers);
• you suffer from a condition characterized by frequent headaches, often associated with other symptoms such as nausea, vomiting, increased sensitivity to light and sounds (migraine);
• you have parasitic infections in the intestine (amebiasis);
• you have reduced growth (incomplete structural growth);
• you suffer from a condition characterized by an excessive amount of glucocorticoid hormones in the blood and called Cushing's syndrome;
• you suffer from inflammation of the tendons (tendinitis) or inflammation of the sheath covering the tendons (tenosynovitis); the doctor will pay attention to injecting into the space between the coverings and the tendon itself because its rupture is possible.

Prolonged use of this medicine can cause eye problems (opacity of the eye lens, posterior subcapsular cataract, infections).
Contact your doctor if you experience blurred vision or other visual disturbances.
You or whoever cares for you should be informed that during treatment, serious mental disorders may occur which are more likely with high doses and which generally resolve with dose reduction or discontinuation of treatment or with specific therapy. If you experience severe sadness (depression), suicidal thoughts or any other symptom of mental disorder, consult your doctor immediately. Always carry with you the health card reporting: the corticosteroid therapy you are undergoing, the attending physician, the medicine you are taking, the dose and the duration of the treatment.

For those who play sports
The use of this medicine without therapeutic necessity constitutes doping and may in any case result in positive anti-doping tests.

Children and adolescents
Children and adolescents undergoing therapy with corticosteroids such as SOLDESAM must be subjected to careful medical monitoring regarding growth and development. In fact, corticosteroids can cause growth retardation that is not reversible.
In early infancy, SOLDESAM should be administered only in case of absolute necessity and under the direct control of the doctor.
SOLDESAM should not be used in premature infants with breathing problems.

Other medicines and SOLDESAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The effects of SOLDESAM may be influenced by or influence the following medicines:
Page. 15of 20

• barbiturates such as phenytoin, carbamazepine, diphenylhydantoin, phenobarbital, used for the treatment of epilepsy;
• ephedrine, a medicine used to reduce nasal congestion (nasal decongestant);
• phenylbutazone, a medicine used for the treatment of inflammation and pain, and aminoglutethimide, a medicine used to treat a hormonal disorder (Cushing's syndrome) or breast cancer, because it may be necessary to increase the dose of SOLDESAM;
• ketoconazole, used for the treatment of fungal infections, and macrolides such as erythromycin, medicines used for the treatment of bacterial infections;
• indinavir, a medicine used to treat AIDS, and erythromycin, a medicine used for the treatment of bacterial infections;
• amphotericin B, used for the treatment of fungal infections, and hydrocortisone, a medicine used for the treatment of skin allergies;
• medicines called cholinesterase inhibitors used for the treatment of muscle problems (myasthenia gravis) as their effectiveness may be reduced by concomitant use with SOLDESAM;
• medicines used to thin the blood (coumarinic anticoagulants);
• medicines that promote urine excretion such as potassium-depleting diuretics and diuretics in general, such as loop diuretics, thiazide diuretics;
• medicines used to lower blood sugar levels (hypoglycemic agents) including insulin;
• medicines used to lower blood pressure (antihypertensives);
• medicines used for the treatment of certain heart problems (digitalis glycosides);
• acetazolamide, a medicine mainly used for epilepsy and the treatment of glaucoma;
• carbenoxolone, a medicine for stomach lesions;
• salicylates, used for pain and inflammation;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of inflammation and pain.

During treatment with this medicine, do not undergo vaccination against smallpox and other
types of vaccinations (immunizing procedures), especially if you are taking high doses of this
medicine, due to the possible risk of neurological complications (neurological complications) and
insufficient response of the body's defense system (insufficient antibody response).

Pregnancy, breastfeeding and fertility
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.
Pregnancy
Since dexamethasone, the active ingredient of this medicine, crosses the placenta, if you are pregnant or of
childbearing potential, the doctor will assess the need to start treatment with this
medicine only if the benefits for you outweigh the risks to your baby.
Newborns of mothers who have received high doses of corticosteroids during pregnancy must
be carefully monitored because they may develop adrenal problems (adrenal insufficiency).
Breastfeeding
Do not take SOLDESAM if you are breastfeeding, as it passes into breast milk.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.
Soldesam 0.2% Oral drops solution contains 1.50 mg of sodium benzoate per ml. Sodium benzoate
may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
This medicine contains 700 mg of propylene glycol per ml, equivalent to 32 drops.
Page. 16of 20
If the child is under 5 years of age, talk to your doctor or pharmacist before administering
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol. If you suffer from liver or kidney disease or are pregnant or breastfeeding, do not
take this medicine unless otherwise recommended by your doctor. The doctor may perform further
checks during therapy.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is essentially
‘sodium-free’.

3. How to take SOLDESAM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will establish and monitor the dose and duration of treatment based on the disease to be treated, your
health conditions and your response. If after prolonged treatment it is necessary to
interrupt it, the dose reduction must occur gradually (see the paragraph “If
you stop taking SOLDESAM”).
Dissolve the drops in water and shake before taking them.
Generally, the recommended dose ranges from 2 mg to 5 mg to be taken in 3 separate doses per day.
As soon as an improvement occurs, it is necessary to gradually reduce the dose to the minimum
possible dose, which can range from 0.25 mg to 2 mg per day.
1 ml of SOLDESAM, equivalent to 32 drops, corresponds to 2 mg.

If you take more SOLDESAM than you should
Overdosage of this medicine can cause: severe weight gain (obesity), reduced
muscle function (muscle atrophy), thinning of the bones (osteoporosis), excessive growth of hair (hirsutism), skin disease characterized by red spots on the skin and
increased tendency to bleeding (purpura), appearance of pimples and irritation (acne), excitement,
agitation (neuropsychiatric symptoms), presence of sugars in urine and blood (glycosuria,
hyperglycemia), reduction of potassium in the blood (hypokalemia), a condition known as
Cushing's syndrome, characterized by excessive glucocorticoid hormones in the blood with
symptoms such as facial swelling, accumulation of fat especially on the abdomen and neck, excess
hair, menstrual cycle disorders, fatigue and irritability; growth arrest in children
(see the paragraph “Children and adolescents”).
In case of accidental ingestion/taking of an excessive dose of SOLDESAM, immediately
inform your doctor or go to the nearest hospital.

If you forget to take SOLDESAM
Do not take a double dose to make up for a missed dose.

If you stop taking SOLDESAM
Do not abruptly interrupt the treatment with this medicine. Interruption after prolonged
therapy can cause symptoms such as fever, muscle pain (myalgia), joint pain
(arthralgia), cold (rhinitis), red and swollen eyes (conjunctivitis), skin nodules causing
itching and pain, weight loss.
Before interrupting the treatment, consult your doctor, who will gradually reduce the dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur, especially with prolonged therapy:

• alteration of sodium levels and fluids in the body (sodium and water retention), reduced levels of potassium in the blood (potassium depletion and subsequent alteration of blood acidity (hypokalemic alkalosis), increased blood sugar levels and possible diabetes (reduced carbohydrate tolerance and unmasking of diabetes mellitus), this condition promotes an increased need for insulin or the use of medicines that lower blood sugar levels (oral hypoglycemic agents) in diabetic patients;
• increased elimination of proteins (negative nitrogen balance due to protein catabolism); in case of prolonged treatments it is necessary to increase protein intake with the diet;
• increased body weight and increased appetite;
• increased elimination of calcium;
• alteration of the balance of fluids and salts in the body (electrolyte imbalance) which can rarely cause an increase in blood pressure (hypertension) and heart problems (congestive heart failure), if you have a predisposition to these problems;
• reduced heart function if you are predisposed to heart disorders (congestive heart failure) alterations of the heartbeat (arrhythmias), blockage of blood circulation (circulatory collapse) if a rapid administration of a high dose is given intravenously;
• increased number of white blood cells (leukocytosis), disorders of the lymphatic system (decrease of lymphatic tissue);
• increase or decrease in blood pressure (hypertension, hypotension), insufficient blood circulation to the main organs (shock), blockage of blood vessels due to a blood clot (thromboembolism), collection of blood in a tissue or in a cavity of the body (hematomas);
• muscle weakness (muscle asthenia), muscle problems (steroid myopathy and proximal myopathy), loss of muscle mass, thinning of the bones (osteoporosis), vertebral fractures (compression vertebral fractures), death of bone cells (aseptic necrosis of the femoral head and humerus), painless destruction of the joints (reminiscence of Charcot arthropathy, particularly after repeated injections into the joints), blockage of the growth of long bones (premature closure of the epiphyses), destruction of bone (avascular osteonecrosis);
• spontaneous rupture of long bones, rupture of tendons, bone fragility;
• damage, poisoning and complications such as tendon rupture;
• compression fractures of the vertebrae;
• formation of lesions in the stomach (gastric ulcer) with possible perforation and bleeding (hemorrhage), lesions of the intestine (intestinal perforations) especially if you have inflammation of the intestine;
• inflammation of the pancreas (pancreatitis), abdominal distension, inflammation of the esophagus with formation of lesions (ulcerative esophagitis), nausea, malaise, digestive problems (dyspepsia);
• delayed wound healing, thinning and fragility of the skin, alteration of the results of allergy tests (skin tests), appearance of red spots (petechiae) and bruises (ecchymoses), redness of the face (erythema), increased sweating, burning and itching especially in the area near the anus (after injection into veins), other skin reactions such as irritation (allergic dermatitis, urticaria), swelling of the face, lips, mouth, tongue or throat due to an accumulation of fluids (angioedema), increased or decreased skin pigmentation (hyperpigmentation or hypopigmentation), increased hair growth (hirsutism), dilation of small blood vessels (telangiectasia), appearance of stretch marks (striae), appearance of pimples and irritation (acne); small collections of non-infected fluid within the tissues (sterile abscesses);
• behavioral disorders such as unjustified feeling of happiness (euphoria), insomnia, alterations of mood and personality, thoughts of suicide, severe feeling of

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sadness (severe depression), mania, delusions, hallucinations and worsening of schizophrenia,
irritability, anxiety, confusion, need to continue using this medicine
(psychological dependence), memory problems (amnesia), symptoms of real psychoses;
These effects may be more pronounced if you have suffered from mental disorders in the
past;

• convulsions, increased pressure in the head (intracranial pressure) and these effects generally appear after discontinuation of treatment;
• disorders of speech, memory (cognitive dysfunction), worsening of epilepsy;
• blockage of the production of some hormones (suppression of the hypothalamus-pituitary-adrenal axis), deposition of fat around the shoulder blades and on the upper back, alteration of hormone levels (cushingoid state), alterations in the regulation of hormone production (secondary hypopituitarism-adrenal insufficiency), especially if you are under stress (e.g. for trauma, surgery, or serious illness);
• irregularities of the menstrual cycle, absence of menstruation (amenorrhea);
• increased levels of enzymes produced by the liver (in most cases reversible after discontinuation of treatment);
• opacity of the posterior part of the lens of the eye with reduction of visual capacity (posterior subcapsular cataract), increased pressure inside the eye (intraocular pressure), disease due to problems with the optic nerve (glaucoma), marked protrusion of one or both eyes (exophthalmos), swelling of the eyes (papilledema), problems with the cornea (thinning of the cornea or sclera);
• visual disturbances, loss of vision, blurred vision (with frequency “not known” - the frequency cannot be defined based on available data);
• rarely, loss of vision after use of dexamethasone directly in lesions on the face and head;
• increased susceptibility and severity of infections without symptoms and without clinical signs (including opportunistic infections), activation of tuberculosis (unmasking of dormant tuberculosis), worsening of eye diseases due to viruses or fungi, infections caused by a species of fungus (candidiasis);
• severe allergic reactions (anaphylaxis) or less severe (hypersensitivity), reduced functionality of the body's defense system, reduced response to vaccinations;
• hiccups (with frequency “not known” - the frequency cannot be defined based on available data).

Reporting of side effects
If you experience any side effects, including 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.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 SOLDESAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires”. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Storage conditions after opening: after the first opening of the bottle, use within 60
days. After this period, any remaining medicine must be discarded.
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.
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6. Contents of the pack and other information

What SOLDESAM contains

• The active ingredient is desamethasone sodium phosphate. 100 ml of solution contains 200 mg of desamethasone sodium phosphate.
• The other ingredients are sodium benzoate, propylene glycol, disodium hydrogen phosphate dihydrate, sodium saccharin, hydroxypropyl beta-cyclodextrin, sodium EDTA, sodium hydroxide, purified water.

Description of the appearance of SOLDESAM and contents of the pack
SOLDESAM is available as oral drops, solution in a pack of 1 glass bottle of 10
ml or 30 ml with a dropper.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LABORATORIO FARMACOLOGICO MILANESE S.r.l. - Via Monterosso 273, 21042 Caronno
Pertusella (VA)

Distributor for sale:
EG S.p.A. – Via Pavia, 6-20136 Milano (MI)
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