Package Insert: Information for the User

Solu-Moderín 125 mg Powder and Diluent for Injectable Solution

metilprednisolona

Read this package insert carefully before starting to use this 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, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, 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.

Contents of the Package and Additional Information

Solu-Moderín 125 mg containsmetilprednisolonaas the active ingredient, whichbelongs to a group of medicines called corticosteroids that acts by reducing the production of substances that cause inflammation or allergy.

Solu-Moderín is used in situations that require immediate corticosteroid treatment, in severe cases or when oral administration is not possible, including:

• Acute adrenal insufficiency crises or secondary insufficiency, secondary shock due to adrenocortical insufficiency.
• Anaphylactic shock (severe allergic reaction) and clinical situations mediated by immediate hypersensitivity mechanisms that may pose a life-threatening risk to the patient, such as generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory tracts, laryngeal edema (swelling of the throat area due to fluid accumulation).
• Prevention of anaphylactic shock in accidental poisonings, such as insect bites and snake bites.
• Severe inflammatory respiratory diseases such as acute exacerbations of bronchial asthma or in conjunction with appropriate antitubercular chemotherapy for the treatment of fulminant or disseminated tuberculosis.
• Adjunct to antineoplastic chemotherapy.
• Acute exacerbations of multiple sclerosis (a disease characterized by lesionsin the protective membranes of neurons, neurodegenerative and chronic of the central nervous system), cerebral edema (inflammation of the brain due to fluid accumulation)
• Spinal cord injuries produced at most 8 hours before.

Treatment of acute rejection of organ transplants.

Do not use Solu-Moderín 125 mg

• if you are allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6).
• if you have fungal infections in different organs of the body.
• by intrathecal (injection made inside the layer that covers the brain and spinal cord) route.
• by epidural (injection made around the spinal cord) route.
• before and after vaccination with live or attenuated microorganisms if you are going to receive immunosuppressive doses of corticosteroids.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Solu-Moderín,

• if you have stomach ulcers or duodenal ulcers,
• if you have intestinal diseases due to the risk of intestinal perforation with peritonitis, such as non-specific ulcerative colitis with imminent risk of perforation, abscesses or other pyogenic infections, as well as diverticulitis (inflammation of small sacs in the intestinal wall), intestinal anastomosis (reconstitution by suture of the intestine) or peptic ulcer,
• if you have any infection, as it may decrease your body's defenses, leading to new infections or activating existing ones. In severe infections, Solu-Moderín should be used only with the treatment for the infection,
• if you have poliomyelitis (infectious disease affecting the nervous system), except bulboencephalic,
• if you have active, latent tuberculosis or have a positive tuberculin reaction,
• if you are going to receive vaccines with killed or inactivated microorganisms and use immunosuppressive doses of corticosteroids, as the response to these vaccines may be reduced.
• if during treatment with Solu-Moderín you may be in contact with people with infections such as chickenpox or herpes zoster, even if you do not show any symptoms,
• if you have osteoporosis (severe bone demineralization),
• if you have myasthenia gravis, as you may need to adjust the dose,
• if you have diabetes, as it may increase blood glucose levels,
• if you have congestive heart failure (disease in which the heart cannot pump oxygen-rich blood),
• if you have herpes simplex keratitis due to the risk of corneal perforation,
• if during treatment with this medicine you observe any visual disturbances, including loss of vision, blurred vision or other visual changes,
• if you have Cushing's syndrome (rounded face, accumulation of fat in the cervical area, obesity in the trunk, etc.) as this medicine may cause or worsen the disease,
• if you have hypothyroidism or liver cirrhosis, as you may need to reduce the dose,
• in case of hyperthyroidism, corticosteroid levels may be reduced,
• if you have hyperactivity of the thyroid gland (hyperthyroidism),
• if you detect any symptoms of pancreatitis during treatment,
• if after administration of this medicine by intravenous injection (usually in an initial dose of ≥ 1 g/day) you detect any symptoms of liver damage, such as acute hepatitis or increased liver enzymes, as in these cases, adequate follow-up is required,
• if you have thrombosis or are predisposed to it,
• if you have hypertension,
• if you have kidney disease,
• if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder), as it may increase the risk of a serious complication called scleroderma renal crisis,
• if you have emotional instability or psychotic tendencies,

• if you suspect or have been diagnosed with pheochromocytoma (rare tumor of the adrenal gland tissue),
• if Solu-Moderín is administered to a premature newborn, it may be necessary to monitor heart function and structure,

The tumor lysis syndrome can occur when corticosteroids are used during cancer treatment. Inform your doctor if you have cancer and symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeats, loss of vision or visual changes, and difficulty breathing.

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using methylprednisolone. These may be symptoms of a disease called periodic paralysis of the thyroid gland that can occur in patients with hyperactivity of the thyroid gland (hyperthyroidism) treated with methylprednisolone. You may need additional treatment to alleviate this condition.

Interference with diagnostic tests

If you are going to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.) during the administration of medium and high doses of glucocorticoids, inform your doctor that you are using this medicine, as it may alter the results.

Use in athletes

If you are going to undergo doping control tests, as methylprednisolone may favor a positive result.

Children and adolescents

Prolonged use of corticosteroids has been observed to cause growth and development delays in children. Therefore, it will only be used when there are important medical reasons for it.

When corticosteroids are used for prolonged periods in infants and children, there is a higher risk of intracranial pressure.

High doses of corticosteroids in this population may cause acute severe pancreatitis.

Other medicines and Solu-Moderín

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

You may need to adjust the dose of one of your medicines and monitor for the appearance of adverse reactions. This is especially important if you are taking:

Medicines that may increase methylprednisolone levels:aprepitant, fosaprepitant, ciclosporin, diltiazem, erythromycin, clarithromycin, ethinylestradiol, noretindrone, itraconazole, ketoconazole, troleandomycin, and pharmacokinetic activators (cobicistat).

Medicines that may decrease methylprednisolone levels:phenobarbital, phenytoin, primidone, carbamazepine, rifampicin.

Medicines that may increase or decrease methylprednisolone levels:tacrolimus, ciclophosphamide, carbamazepine, aprepitant, fosaprepitant, itraconazole, ketoconazole, diltiazem, ethinylestradiol, noretindrone, erythromycin, clarithromycin, phenobarbital, ciclosporin.

Medicines whose levels in the blood and/or whose effects may be affected by the administration of methylprednisolone:amphotericin B, xanthines or beta 2 agonists, oral anticoagulants, anticholinesterases, isoniazid, antidiabetics, non-steroidal anti-inflammatory drugs, salicylates, anticholinergics (neuromuscular blockers), HIV protease inhibitors, aromatase inhibitors, immunosuppressants, potassium eliminators, antihypertensives, toxoids, and vaccines.

Some medicines may increase the effects of Solu-Moderín, so your doctor may decide to perform meticulous controls if you are taking medicines such as antivirals (ritonavir, indinavir) and pharmacokinetic activators (cobicistat) used to treat HIV.

Use of Solu-Moderín with food and drinks

You should avoid consuming grapefruit juice as it may interfere with this medicine.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine, evaluating the risk-benefit ratio.

Pregnancy

This medicine may be used during pregnancy only if your doctor considers it necessary.

Children born to mothers who received high doses of corticosteroids during pregnancy should be closely monitored due to possible signs of adrenal insufficiency. Cataracts have been observed in children born to mothers treated with corticosteroids for prolonged periods during pregnancy.

The risk of low birth weight has been related to the dose and may be minimized by administering low doses of corticosteroids.

Lactation

Solu-Moderín passes into breast milk.

Driving and operating machines

Treatment with corticosteroids may cause dizziness, vertigo, visual disturbances, and fatigue.

Therefore, do not drive or operate machines if during treatment with Solu-Moderín you experience these effects.

Solu-Moderín 125 mg contains sodium

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

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

Solu-Moderín can be administered via intravenous (by injection or infusion) or intramuscular (by injection) route.

The intravenous route is the preferred administration route in case of shock or other acute situation.

The open route for metilprednisolona administration should not be used for the administration of any other drug. A different intravenous route other than the bolus injection should be used for infusion administration.

The dose will be individual for each patient and may be modified depending on the severity of the case and the patient's response. The most effective dose should be used to control the disease and treatment should be prolonged for the shortest time possible.

It should also be evaluated whether the administration will be daily or intermittent.

The dose reduction should be done gradually, particularly with relatively high doses.

Your doctor will decide when to switch to oral therapy.

In situations that pose a threat to the patient's life, it is recommended to start treatment with doses of 250 mg to 1,000 mg of metilprednisolona.

• Adrenal insufficiency:16 to 32 mg by intravenous infusion, followed by other 16 mg over 24 hours.

In these crises and in Waterhouse/Friderichsen Syndrome, simultaneous administration of mineralocorticoids is indicated.

• Anaphylactic shock and situations mediated by immediate hypersensitivity mechanisms:250 mg to 500 mg of metilprednisolona.

• Severe inflammatory respiratory diseases:30 to 90 mg/day.

Instatus asthmaticus250 to 500 mg of metilprednisolona is recommended.

• Acute exacerbations of multiple sclerosis:administer 500 mg/day or1 g/day for 3 or 5 days, intravenous injection.

• Cerebral edema:250 to 500 mg of metilprednisolona.
• Acute spinal cord injury:30 mg of metilprednisolona per kg of body weight in a single bolus IV dose over a minimum period of 15 minutes. After a 45-minute pause, a continuous intravenous infusion of 5.4 mg/kg/hour for 23 hours should be administered for patients in whom treatment was initiated before 3 hours from the time of injury, and for 47 hours for patients in whom treatment was initiated 3-8 hours from the time of injury.

• Transplant rejection crisis:up to 30 mg/kg of body weight.

Use in children and adolescents

The dose should be based on the severity of the disease and the patient's response, rather than their age or weight.

In any case, the pediatric dose should not be less than 0.5 mg/kg every 24 hours.

In situations that pose a threat to the patient's life, it is recommended to start treatment with single doses of 4 to 20 mg/kg of body weight in children.

If you use more Solu-Moderín than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Solu-Moderín

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Solu-Moderín

Do not stop using this medication without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following adverse reactions have been reported with the following contraindicated administration routes: intrathecal/epidural: arachnoiditis, functional gastrointestinal disorders/vesical dysfunction, headache, meningitis, paraparesia/paraplegia, seizures, sensory alterations.

The reported adverse effects are classified according to their frequency order as frequent side effects (can affect up to 1 in 10 people) and unknown frequency (cannot be estimated from available data).

Infections and infestations

Frequent: infection.

Unknown frequency: opportunistic infection, peritonitis (may be the first sign or symptom of a gastrointestinal disorder such as perforation, obstruction, or pancreatitis).

Blood and lymphatic system disorders

Unknown frequency: elevated white blood cell count (leukocytosis).

Immune system disorders

Unknown frequency: hypersensitivity to the drug, anaphylactic reaction, anaphylactoid reaction.

Endocrine disorders

Frequent: Cushing's syndrome.

Unknown frequency: suppression of the hypothalamic-pituitary-adrenal axis, steroid suppression syndrome.

Metabolism and nutrition disorders

Frequent: sodium retention, fluid retention.

Unknown frequency: metabolic acidosis, epidural lipomatosis, hypokalemic alkalosis, dyslipidemia, decreased glucose tolerance, increased need for insulin (or oral hypoglycemics in diabetics), localized adipose tissue accumulation (lipomatosis), increased appetite (which may lead to weight gain).

Mental and behavioral disorders

Frequent: mood disorder (including depressed mood, euphoric mood).

Unknown frequency: mood disorder (including affective lability, drug dependence, suicidal ideation), psychotic disorder (including mania, delirium, hallucination, and schizophrenia), mental disorder, personality change, confusional state, anxiety, mood changes, abnormal behavior, insomnia, irritability.

Nervous system disorders

Unknown frequency: increased intracranial pressure (with papilledema [benign intracranial hypertension]), seizures, amnesia, cognitive disorder, dizziness, headache.

Eye disorders

Frequent: cataract.

Unknown frequency: retinal and choroidal membrane disease (chorioretinopathy), glaucoma, exophthalmos, blurred vision.

Ear and labyrinth disorders

Unknown frequency: vertigo.

Cardiac disorders

Unknown frequency: congestive heart failure (in susceptible patients), arrhythmia.

Vascular disorders

Frequent: hypertension.

Unknown frequency: blood clots (thrombotic events), hypotension, skin redness and warmth (rubefaction).

Respiratory, thoracic, and mediastinal disorders

Unknown frequency: pulmonary embolism, hiccups.

Gastrointestinal disorders

Frequent: peptic ulcer (with possible perforation and hemorrhage).

Unknown frequency: intestinal perforation, gastric hemorrhage, pancreatitis, ulcerative esophagitis, esophagitis, abdominal distension, abdominal pain, diarrhea, dyspepsia, nausea.

Hepatobiliary disorders

Unknown frequency: methylprednisolone may damage your liver; cases of hepatitis and elevated liver enzymes have been reported.

Skin and subcutaneous tissue disorders

Frequent: ecchymosis, skin atrophy, acne.

Unknown frequency: angioedema, hirsutism, petechiae, erythema, hyperhidrosis, skin striations, rash, pruritus, urticaria, hypopigmentation of the skin.

Musculoskeletal and connective tissue disorders

Frequent: muscle weakness, osteoporosis, growth retardation.

Unknown frequency: myalgia, myopathy, muscle atrophy, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia.

Reproductive and breast disorders

Unknown frequency: irregular menstruation.

General disorders and administration site conditions

Frequent: wound healing impairment.

Unknown frequency: peripheral edema, fatigue, general malaise, reaction at the injection site.

Investigations

Frequent: decreased potassium in blood.

Unknown frequency: increased intraocular pressure, decreased tolerance to carbohydrates, elevated calcium in urine, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated alkaline phosphatase (ALP) in blood, elevated blood urea.

Injury, poisoning and procedural complications

Unknown frequency: compression fracture of the spine, tendon rupture (especially Achilles tendon).

Other adverse effects in children

The following reactions were more frequent in children: mood changes, abnormal behavior, insomnia, irritability.

Reporting of adverse reactions

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

No requires special conditions for conservation.

Shelf life after reconstitution: 48 hours.

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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Solu-Moderín 125 mgpowder and solvent for injectable solution

• The active ingredient is methylprednisolone (sodium succinate).Each vial of powder contains 125 mg of methylprednisolone (as sodium succinate).
• The other components (excipients) are: monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injectable preparations.

Appearance of the product and contents of the package

Solu-Moderín 125 mg is presented in powder and solvent for injectable solution.

Lyophilized powder vial of white color and transparent and colorless ampoule of solvent.

Solu-Moderín 125 mg is packaged in containers of 1 vial with powder and 1 ampoule with solvent, 3 vials with powder and 3 ampoules with solvent, 50 vials with powder and 50 ampoules with solvent.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20-B. Parque Empresarial La Moraleja - 28108 Alcobendas (Madrid)

Responsible for manufacturing

Valdepharm

Parc Industriel d’Incarville, BP 606

27106 Val de Reuil Cedex. France

Date of the last review of this leaflet:November 2024

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

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This information is intended solely for healthcare professionals:

Solu-Moderin must be reconstituted before use. Aseptic technique is required for its preparation.

• Reconstitution of the injection solution:

The powder contained in the vial must be reconstituted with the solvent included in the ampoule.

Agitate well until a clear solution is obtained.

• Reconstitution of the perfusion solution:

First, the powder contained in the vial must be reconstituted as indicated previously. The reconstituted solution can be administered in diluted solutions of 5% dextrose in water, isotonic saline solution, or 5% dextrose in 0.45% or 0.9% sodium chloride solution.