Package Insert: Information for the User

TRIGON DEPOT 40 mg/ml Injectable Suspension

Triamcinolone, Acetonide

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Trigon Depot is a corticosteroid with intense anti-inflammatory effect that is administered via intramuscular, intraarticular, and intrasinovial routes.

This medication must not be used for intravenous, intradermal, intraocular, epidural, or intrathecal use.

Intramuscular route:

Trigon Depot is indicated for hormonal disorders, rheumatic and collagen diseases, skin alterations, allergic reactions, eye diseases, digestive system diseases, respiratory system diseases, blood diseases, cancerous disorders, and edematous states.

Intraarticular route:

Trigon Depot is indicated as short-term adjunctive therapy for intraarticular (within the joints) or intrasinovial (within the synovial sacs near the joints) administration, and for injection into the tendon sheath, in inflammatory alterations such as osteoarthritis synovitis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis (tennis elbow), acute non-specific tenosynovitis, and post-traumatic osteoarthritis.

No use Trigon Depot

• If you are allergic (hypersensitive) to triamcinolone acetonide or to any of the other components of this medication (listed in section 6).
• If you have a systemic infection (general).
• If you have a known decrease in the number of platelets known as idiopathic thrombocytopenic purpura (in intramuscular administration).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Trigon Depot.

This medication must be administered by deep intramuscular or intra-articular injection, excluding any other route of administration. In the case of intramuscular injection not deep enough, skin atrophy may appear.

The administration of Trigon Depot by other routes such as intranasal, subconjunctival, sub-tendinous, retrobulbar, or intraocular (intravitreal) is not authorized. After intravitreal administration, alterations in the eyes such as endophthalmitis, inflammation, increased pressure, accumulation of fluid under the retina, including macular degeneration, viral retinitis (mainly caused by cytomegalovirus), and loss of vision have been reported. Several cases of blindness have been described after injection of corticosteroids in the nasal passages and scalp.

This medication should not be administered by epidural or intrathecal route, as severe adverse effects have been described when using these routes.

In intra-articular administration, accidental injection of the medication into the soft tissues surrounding a joint may lead to the appearance of systemic (general) effects, and is the most common cause of the lack of desired local effects.

After intra-articular treatment, excessive use of the joints in which benefits have been obtained should be avoided.

Repeated intra-articular injections may cause instability in the joint. In certain cases, your doctor will perform follow-up with X-rays. In rare cases, an increase in joint discomfort has been reported. In case of increased pain accompanied by local swelling, joint mobility limitation, fever, and discomfort, visit the nearest medical center to determine if you have septic arthritis, in which case the administration of this medication will be interrupted.

This medication should be used with caution in patients with certain diseases such as herpes simplex eye infection, chronic ulceration of the colon, inflammation of a diverticulum usually of the colon, communication between two segments of the intestine (recent intestinal anastomosis), active or latent peptic ulcer, renal insufficiency, chronic or acute inflammatory renal disease with glomerular damage, hypertension, congestive heart failure, inflammation of the vessel wall, or occlusion of a vessel by a thrombus, osteoporosis, skin eruptions or patches, Cushing's syndrome, diabetes, convulsive disorders, metastatic cancer, and muscle weakness (myasthenia gravis), as well as during periods of stress, such as trauma, surgery, or severe illness.

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

Intensification of the medication's effect may occur in patients with hypothyroidism or cirrhosis.

Administration to patients with latent tuberculosis or tuberculin reaction requires careful observation, and these patients should receive chemoprophylaxis (preventive medications). Use in patients with active tuberculosis is restricted to certain cases.

During corticosteroid treatment, alterations in mental state such as euphoria, insomnia, mood and personality changes, depression (sometimes severe), and psychotic manifestations may appear. In addition, pre-existing psychotic states and emotional instability may be exacerbated. The use of antidepressant medications does not improve these mental disorders and may increase them.

Prolonged administration of corticosteroids may cause cataracts or glaucoma (a disease characterized by increased intraocular pressure), with possible damage to the optic nerve, as well as increase the risk of eye infections.

Careful monitoring of children in prolonged treatment with corticosteroids is necessary, as corticosteroids may suppress growth. Corticosteroids may also affect natural steroid production.

Corticosteroids may mask some signs of infection and during their use, new infections may appear. Chickenpox and measles may have a more severe or even fatal course in patients treated with corticosteroids, so during treatment with this medication, special precautions should be taken to avoid exposure to these and other contagious diseases.

Patients treated with corticosteroids, especially those receiving high doses, should not be vaccinated due to the lack of immune response, which may lead to neurological complications.

Irregular menstrual cycles and vaginal bleeding have been observed in postmenopausal women. Consult your doctor immediately if you experience any unexpected bleeding or significant changes in bleeding upon withdrawal.

In prolonged treatments, an adequate protein intake is necessary, as in many cases, weight loss is associated with a decrease in protein components. Irregular menstrual cycles may also appear.

Diabetic patients may require an increase in insulin or oral antidiabetic medication doses.

This medication may cause increased blood pressure, water and salt retention, and increased excretion of potassium and calcium, making a low-sodium diet and potassium supplementation necessary. In cases of renal impairment, edema (fluid retention) may occur.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Other medications and Trigon Depot

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The administration of Trigon Depot and amphotericin B injection or medications that eliminate potassium may decrease blood potassium levels. It may also block the effect of anticholinesterase medications, potentiate or decrease the effect of oral anticoagulants, increase blood glucose levels in patients treated with antidiabetic medications or insulin, decrease the concentrations of antitubercular medications in the blood, increase the activity of cyclosporine (immunosuppressant) and its toxicity, and decrease the effect of anti-hypertensive medications.

This medication decreases its effect when administered concurrently with sedatives (barbiturates), anticonvulsants (phenytoin, carbamazepine), and the antibiotic rifampicin, and increases its effect when administered with estrogens (including oral contraceptives). It also interacts with human growth hormone, certain muscle relaxants, non-steroidal anti-inflammatory drugs, and salicylates (e.g., aspirin), medications used for thyroid disorders, and vaccines.

Some medications may increase the effects of Trigon Depot, so your doctor will perform meticulous controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

The concomitant therapy of this medication with medications used for cardiac rhythm and conduction disorders such as disopyramide, quinidine, procainamide, amiodarone, bepridil, and sotalol is not recommended.

This medication should be administered with extreme caution, evaluating its use, in patients taking medications for psychosis (phenothiazines, sulpiride), depression (tricyclic antidepressants), allergy (terfenadine, astemizol), increased cerebral blood flow (vincamine), and certain infections (intravenous erythromycin, pentamidine, halofantrine).

The concomitant use of Trigon Depot with medications that produce electrolyte imbalances (salts such as sodium, potassium...) such as certain diuretics and laxatives is not recommended.

Use in the elderly

Elderly patients should have close medical supervision when using this medication.

Use in children

This medication is not recommended for children under 6 years old.

If you observe any alteration in the growth and development of children in prolonged treatment with this medication, or any other reaction of concern, consult your doctor as soon as possible.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

This medication should not be used during pregnancy and lactation, or in women who may become pregnant, unless your doctor considers that the expected benefits outweigh the possible risks.

Driving and operating machinery

No data are available on the effects of the medication on driving and operating machinery.

Important information about some of the components of Trigon Depot

This medication contains less than 1 mmol (23 mg) of sodium per vial; it is essentially "sodium-free".

This medication contains 9.9 mg of benzyl alcohol in each vial. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is variable depending on the disease being treated and the patient's response. Your doctor will use the lowest possible dose for your case.

Administration Form:

STRICT ASEPSIS TECHNIQUES ARE MANDATORY: To ensure a uniform suspension, shake the vial before use. Before extracting, inspect the suspension for accumulation or granular appearance (agglomeration). Agglomeration occurs when the medication substance separates from the solution and appears as a white precipitate in the vial. A product that has agglomerated must be discarded and not used. After extracting the suspension, inject it without delay to avoid sedimentation in the syringe.

The initial dose of Trigon Depot can vary from2.5 to60 mg per day depending on the disease being treated..The normal dose is:

Intramuscular Route:

Adults and children over 12 years old:theinitial recommended dose is 60 mg, in deep injection into the gluteal muscle. Normally, your doctor will adjust the dose within the range of40 to80 mg. Since the dose depends on the patient's response and the duration of improvement, there may be situations in which doses of 20 mg or less are sufficient. For the treatment of pollen allergy, doses of up to 100 mg may be necessary.

Children 6 to 12 years old:theinitial recommended dose is 40 mg, although dosing depends more on the severity of symptoms than on age or weight.

Intraarticular or intrasinovial injection and tendon sheath injection:

The initial dose is 2.5 to 5 mg in small joints and 5 to 15 mg in large joints. In adults, doses of up to 10 mg in small areas and up to 40 mg in larger areas are usually sufficient to alleviate symptoms. A single injection can also be administered in several joints, up to a total dose of 80 mg.

The duration of effects is variable and in some patients may be permanent or sustained for several weeks.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment prematurely, as the desired effect may not be achieved.

If after prolonged therapy treatment with this medication is suspended, your doctor will do so gradually.

It is essential that your doctor performs continuous monitoring after interrupting treatment with this medication.

If you estimate that the action of this medicationis too strong or too weak, inform your doctor or pharmacist.

If you use moreTrigon Depot than you should

In case of administration of more doses than prescribed, and despite the fact that it is unlikely that you will suffer a severe overdose, visit your doctor as soon as possible or contact the nearest Hospital Emergency Service.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone: 91 562 04 20.

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

Frequent side effects (may affect up to 1 in 10 people):

-Infection

-Headache

-Cataracts

-Reactions at the injection site.

Rare side effects (may affect up to 1 in 100 people)

-Non-infectious inflammation (sterile abscess at the injection site), worsening or masking of infections

-Allergic reactions, anaphylactic shock

-Development of Cushing's syndrome-like symptoms (a hormonal imbalance), hormonal insensitivity (adrenocortical), growth delays in children and adolescents

-Fluid and sodium retention, hypokalemia (low potassium levels in the blood), hyperglycemia (high blood sugar levels), diabetes mellitus, inadequate control of diabetes mellitus

-Psychiatric symptoms, depression, euphoria, mood changes, psychotic disorders, personality changes, insomnia

-Seizures, loss of consciousness (syncope), elevated intraarterial pressure, neuritis (inflammation of the nerves), paresthesia (numbness, tingling)

-Blindness, glaucoma, exophthalmos (bulging eyes), corneal perforation

-Dizziness

-Heart failure, arrhythmia

-Elevated blood pressure, embolism (blockage of a vessel by a blood clot), inflammation of the vessel wall (thrombophlebitis), necrotizing vasculitis

-Peptic ulcer, with possible perforation or hemorrhage, pancreatitis (inflammation of the pancreas), abdominal distension, ulcerative esophagitis (inflammation of the esophagus with ulcers)

-Urticaria, rash, increased or decreased skin pigmentation, skin atrophy or fragility

-Petechiae (skin spots formed by blood leakage), ecchymosis (subcutaneous lesions characterized by extravasated blood under intact skin), increased body sweating, purpura, skin striations, hirsutism (excessive hair growth), acneiform dermatitis, lesions similar to systemic lupus erythematosus

-Osteoporosis, osteonecrosis, pathological fractures of long bones, delayed fracture healing, musculoskeletal discomfort, muscle weakness, myopathy (muscle pain), muscle mass loss, growth delay, neuropathic arthropathy

-Glycosuria (high blood sugar levels in urine)

-Irregular menstrual cycles, amenorrhea, postmenopausal vaginal bleeding

-Synovitis (inflammation of the synovial membrane), pain, irritation, and discomfort at the injection site, fatigue, alterations in wound healing

-Potassium blood loss, electrocardiogram changes, decreased carbohydrate tolerance, negative nitrogen balance, increased intraocular pressure

-Laboratory test interference

-Vertebral compression fractures

Side effects of unknown frequency (cannot be estimated from available data):

• Blurred vision
• Visual impairment

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store between 15 °C and 25 °C. Do not refrigerate or freeze. Store in the original packaging to protect it from light. Shake before use. See section 3.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.At the pharmacy SIGRE collection point.In case of doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Trigon Depot

• The active principle is triamcinolone acetonide. Each vial contains 40 mg of triamcinolone acetonide.
• The other components are benzyl alcohol, sodium caramelose, polisorbate 80, sodium chloride, and water for injectable preparations.

Appearance of Trigon Depot and contents of the package

Glass vial with 1 ml of injectable aqueous suspension. Each package contains 3 vials.

Marketing Authorization Holder:

Bristol-Myers Squibb, S.A.

C/ Quintanadueñas, 6

28050 Madrid

Responsible for manufacturing:

CATALENT ANAGNI S.R.L.

Loc.Fontana del Ceraso snc

Strada Provinciale 12 Casilina N. 41

03012 ANAGNI (FR)

Italy

Swords Laboratories Unlimited Company T/A Bristol-Myers

Squibb Pharmaceutical Operations,

External Manufacturing Plaza 254

Blanchardstown Corporate Park 2,

Dublin 15, D15 T867,

Ireland

Last review date of this leaflet:08/2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals:

Instructions for correct administration

This medicine must be administered under aseptic conditions. To restore the homogeneity of the suspension, shake the vial before use. Agglomeration occurs when the substance of the medicine separates from the solution and appears as a white precipitate in the vial. A product that has agglomerated must be discarded and not used. Once the syringe has been loaded, it must be injected immediately to avoid sedimentation.

This formulation must not be used for intravenous, intradermal, intraocular, epidural, or intrathecal use.

Before administration, the necessary precautions must be taken, especially in patients with a history of allergy to any medication, ascases of severe allergic reactions and anaphylactic shock have been described after the injection of this medicine, regardless of the administration route.

For intramuscular administration, the injection must be deep in the gluteal muscle and not in the deltoid area. In adults, needles of a minimum length of 3.8 cm are recommended; in obese patients, longer needles may be necessary.

For intra-articular administration, the medicine must be avoided in the surrounding tissues, as this can cause atrophy of the same. Similarly,excessive distension of the joint capsule and deposition of the steroid in the path of the needle must be avoided, as this can lead to subcutaneous atrophy.

In the treatment of acute nonspecific tenosynovitis, precautions must be taken to ensure that the medicine is injected within the tendon sheath rather than in the tendon itself.

During the handling of this medicine, the skin and eyes must be avoided, as well as inhalation of the medicine.