Solu-Moderin 1 g powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solu-Moderín 500 mg powder and solvent for solution for injection

Solu-Moderín 1 g powder and solvent for solution for injection

methylprednisolone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Solu-Moderín is and what it is used for

2. What you need to know before using Solu-Moderín

3. How to use Solu-Moderín

4. Possible side effects

5. How to store Solu-Moderín

6. Contents of the pack and other information

1. What Solu-Moderín is and what it is used for

Solu-Moderín 500 mg and Solu-Moderín 1 g contain methylprednisolone as the active substance, which belongs to a group of medicines called corticosteroids that act by reducing the production of substances that cause inflammation or allergic reactions.

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

• Acute crises due to primary or secondary adrenal insufficiency, shock secondary to adrenocortical insufficiency.
• Anaphylactic shock (severe allergic reaction) and clinical conditions mediated by immediate hypersensitivity mechanisms that may be life-threatening, such as angioedema (generalized urticaria accompanied by swelling of feet, hands, throat, lips, and airways), laryngeal edema (swelling of the throat area due to fluid accumulation).
• Prevention of anaphylactic shock in accidental poisonings, such as insect stings and snake bites.
• Severe inflammatory respiratory diseases, such as acute exacerbations of bronchial asthma or in combination with appropriate antituberculous chemotherapy for the treatment of fulminant or disseminated tuberculosis.
• As an adjunct to antineoplastic chemotherapy.
• Acute exacerbations of multiple sclerosis (a disease characterized by lesions in the protective membranes of neurons, neurodegenerative and chronic conditions of the central nervous system), cerebral edema (brain inflammation due to fluid accumulation).
• Spinal cord injuries occurring no more than 8 hours previously.

Treatment of acute organ transplant rejection.

2. What you need to know before using Solu-Moderín

Do not use Solu-Moderín

• if you are allergic to methylprednisolone or to any of the other ingredients of this medicine (listed in section 6).

• if you have fungal infections affecting various organs of the body.

• via intrathecal route (injection administered within the membrane covering the brain and spinal cord).

• via epidural route (injection administered around the spinal cord).

• before and after vaccination with live or live attenuated microorganisms if immunosuppressive doses of corticosteroids are to be administered.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Solu-Moderín,

• if you have gastric or duodenal ulcers,

• if you have intestinal diseases due to 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 pouches in the intestinal wall), intestinal anastomoses (surgical reconnection of the intestine), or peptic ulcer,

• if you have any infection, treatment with Solu-Moderín may reduce your resistance to various infections, mask signs of infection, worsen existing infections, or cause reactivation or worsening of old or latent infections. New infections may also occur during treatment with Solu-Moderín. Your doctor will closely monitor you for the development of infections and may consider interrupting treatment or reducing the dose as necessary,

• if you have poliomyelitis (an infectious disease affecting the nervous system), except bulboencephalic poliomyelitis,

• if you have active tuberculosis, latent tuberculosis, or tuberculin reactivity,

• if you are to receive vaccines containing killed or inactivated microorganisms while receiving immunosuppressive doses of corticosteroids, as your immune response to these vaccines may be reduced,

• if during treatment with Solu-Moderín you may come into contact with individuals infected with diseases such as chickenpox or herpes zoster, even if you do not have symptoms,

• if you have osteoporosis (severe bone demineralization),

• if you have myasthenia gravis, as dose adjustment may be required,

• if you have diabetes, as blood glucose levels may increase,

• if you have congestive heart failure (a condition in which the heart cannot pump oxygen-rich blood effectively),

• if you have simple ocular herpes due to the risk of corneal perforation,

• if during treatment with this medicine you notice any visual disturbances, including vision loss, blurred vision, or other visual changes,

• if you have Cushing's syndrome (rounded face, fat accumulation in the neck area, trunk obesity, etc.), as this medicine may cause or worsen the condition,

• if you have hypothyroidism or hepatic cirrhosis, as dose reduction may be needed.

• in case of hyperthyroidism, corticosteroid levels may be reduced,

• if you have hyperactivity of the thyroid gland (hyperthyroidism),

• if symptoms of pancreatitis develop during treatment,

• if after receiving this medicine by intravenous injection (usually at an initial dose of ≥ 1 g/day) you develop signs of liver injury, such as acute hepatitis or elevated liver enzymes, which require appropriate monitoring,

• 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 pheochromocytoma (a rare tumor of adrenal gland tissue) is suspected or has been diagnosed,

• if Solu-Moderín is administered to a premature newborn, monitoring of heart function and structure may be necessary.

Tumor lysis syndrome may occur when corticosteroids are used in cancer treatment. Inform your doctor if you have cancer and experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or visual disturbances, and difficulty breathing.

Oral anticoagulants (medicines taken by mouth to prevent blood clotting), when used together with Solu-Moderín, may increase the risk of bleeding. In some cases, the effect of oral anticoagulants may also be reduced. Your doctor may need to monitor your bleeding risk more frequently through additional blood tests while you are on Solu-Moderín. The dose of Solu-Moderín may also be adjusted if necessary.

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or stiffness while using methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which can occur in patients with hyperactivity of the thyroid gland (hyperthyroidism) treated with methylprednisolone. Additional treatment may be needed to relieve this condition.

Interference with diagnostic tests

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

Use in athletes

If you are subject to doping control tests, note that methylprednisolone may lead to a positive result.

Children and adolescents

Prolonged corticosteroid use has been associated with delayed growth and development in children. Therefore, it should only be used when there are strong medical reasons.

When corticosteroids are used over prolonged periods in infants and children, there is an increased risk of elevated intracranial pressure (increased pressure inside the skull).

If high doses of corticosteroids are administered to this population, severe acute pancreatitis may occur.

Other medicines and Solu-Moderín

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Dosage adjustments and monitoring for adverse reactions may be necessary. This is especially important if you are taking:

Medicines that may increase methylprednisolone levels: aprepitant, fosaprepitant, cyclosporine, diltiazem, erythromycin, clarithromycin, ethinylestradiol, norethindrone, itraconazole, ketoconazole, troleandomycin, and pharmacokinetic enhancers (cobicistat).

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

Medicines that may increase or decrease methylprednisolone levels: tacrolimus, cyclophosphamide, carbamazepine, aprepitant, fosaprepitant, itraconazole, ketoconazole, diltiazem, ethinylestradiol, norethindrone, erythromycin, clarithromycin, phenobarbital, cyclosporine.

Medicines whose blood levels and/or effects may be affected by methylprednisolone: amphotericin B, xanthines or beta-2 agonists, oral anticoagulants (medicines taken orally to prevent blood clots), anticholinesterases, isoniazid, antidiabetic agents, non-steroidal anti-inflammatory drugs (NSAIDs), salicylates, anticholinergics (neuromuscular blockers), HIV protease inhibitors, aromatase inhibitors, immunosuppressants, potassium-depleting agents, antihypertensives, toxoids, and vaccines.

Some medicines may enhance the effects of Solu-Moderín, so your doctor may decide to perform close monitoring if you are taking medications such as antivirals (ritonavir, indinavir) and pharmacokinetic enhancers (cobicistat), used in the treatment of HIV.

Use of Solu-Moderín with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, weighing the risks and benefits.

Pregnancy

This medicine should only be used during pregnancy if considered necessary by your doctor.

Infants born to mothers who received high doses of corticosteroids during pregnancy should be carefully monitored for possible signs of adrenal insufficiency. Cataracts have been reported in infants born to mothers who received prolonged corticosteroid treatment during pregnancy.

The risk of low birth weight is related to dose and can be minimized by using low doses of corticosteroids.

Breastfeeding

Solu-Moderín passes into breast milk.

Driving and use of machines

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

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

Solu-Moderín 500 mg contains sodium

This medicine contains 58.3 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 2.92% of the maximum daily recommended sodium intake for an adult.

Solu-Moderín 1g contains sodium

This medicine contains 116.8 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 5.84% of the maximum daily recommended sodium intake for an adult.

3. How to use Solu-Moderín

Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Solu-Moderín may be administered intravenously (by injection or infusion) or intramuscularly (by injection).

The intravenous route is the preferred route of administration in cases of shock or other acute situations.

The intravenous access used for metilprednisolone administration must not be used for any other drug. A separate intravenous line must be used for infusion administration when administering by bolus injection.

The dose will be individual for each patient and may be adjusted depending on the severity of the condition and the patient's response. The lowest effective dose required to control the disease should be used, and treatment should be continued for the shortest possible duration.

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

Dose reduction should be performed gradually, particularly with relatively high doses.

Your doctor will decide when to switch to oral therapy.

In life-threatening situations, treatment is recommended to be initiated with doses of 250 mg to 1,000 mg of metilprednisolone.

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

In these crises and in Waterhouse-Friderichsen syndrome, simultaneous administration of mineralocorticoids is indicated.

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

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

In status asthmaticus, 250 to 500 mg of metilprednisolone is recommended.

• Acute relapses of multiple sclerosis: administer 500 mg/day or 1 g/day for 3 or 5 days, by intravenous injection.

• Cerebral edema: 250 to 500 mg of metilprednisolone.

• Acute spinal cord injury: 30 mg of metilprednisolone per kg of body weight as an IV bolus dose administered over a minimum period of 15 minutes. After a 45-minute pause, a continuous intravenous infusion of 5.4 mg/kg/hour should be administered for 23 hours for patients in whom treatment was initiated within 3 hours of injury, and for 47 hours for patients in whom treatment was initiated between 3 and 8 hours after injury.

• 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 on age or weight.

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

In situations involving a life-threatening risk for the patient, treatment initiation with single doses of 4 to 20 mg/kg of body weight in children is recommended.

If you use more Solu-Moderín than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Solu-Moderín

Do not use a double dose to make up for forgotten doses.

If you stop using Solu-Moderín

Do not stop using this medicine without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Reported adverse effects are classified according to their frequency as frequent adverse effects (may affect up to 1 in 10 people) and frequency not known (cannot be estimated from the available data).

Infections and infestations

Frequent: infection.

Frequency not known: opportunistic infection, peritonitis (may be the first sign or symptom present in a gastrointestinal disorder such as perforation, obstruction, or pancreatitis).

Blood and lymphatic system disorders

Frequency not known: elevated white blood cell count (leukocytosis).

Immune system disorders

Frequency not known: drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction.

Endocrine disorders

Frequent: Cushingoid.

Frequency not known: suppression of the hypothalamic-pituitary-adrenal axis, steroid suppression syndrome.

Metabolism and nutrition disorders

Frequent: sodium retention, fluid retention.

Frequency not known: metabolic acidosis, epidural lipomatosis, hypokalemic alkalosis, dyslipidemia, decreased glucose tolerance, increased insulin requirement (or increased need for oral hypoglycemics in diabetics), accumulation of adipose tissue in localized areas of the body (lipomatosis), increased appetite (which may lead to weight gain).

Psychiatric disorders

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

Frequency not known: affective disorder (including affective lability, drug dependence, suicidal ideation), psychotic disorder (including mania, delusional disorder, hallucination, and schizophrenia), mental disorder, personality change, confusional state, anxiety, mood changes, abnormal behavior, insomnia, irritability.

Nervous system disorders

Frequency not known: increased intracranial pressure (with papilledema [benign intracranial hypertension]), epileptic seizures, amnesia, cognitive disorder, dizziness, headache.

Eye disorders

Frequent: cataract.

Frequency not known: retinal and choroidal membrane disease (chorioretinopathy), glaucoma, exophthalmos, blurred vision.

Ear and labyrinth disorders

Frequency not known: vertigo.

Cardiac disorders

Frequency not known: congestive heart failure (in susceptible patients), arrhythmia.

Vascular disorders

Frequent: hypertension.

Frequency not known: blood clots (thrombotic events), hypotension, skin warmth and redness (rubefaction).

Respiratory, thoracic and mediastinal disorders

Frequency not known: pulmonary embolism, hiccups.

Gastrointestinal disorders

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

Frequency not known: intestinal perforation, gastric hemorrhage, pancreatitis, ulcerative esophagitis, esophagitis, abdominal distension, abdominal pain, diarrhea, dyspepsia, nausea.

Hepatobiliary disorders

Frequency not known: methylprednisolone may harm your liver; cases of hepatitis and increased liver enzymes have been reported.

Skin and subcutaneous tissue disorders

Frequent: bruising, skin atrophy, acne.

Frequency not known: angioedema, hirsutism, petechiae, erythema, hyperhidrosis, striae of the skin, rash, pruritus, urticaria, hypopigmentation of the skin, inflammation of the fatty tissue under the skin, which may cause the skin to feel hard and painful red lumps or patches to appear (panniculitis), which has been reported after dose reduction or discontinuation of prolonged treatment. Most cases resolve spontaneously.

Musculoskeletal and connective tissue disorders

Frequent: muscle weakness, osteoporosis, growth retardation.

Frequency not known: myalgia, myopathy, muscle atrophy, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia.

Reproductive system and breast disorders

Frequency not known: irregular menstruation.

General disorders and administration site conditions

Frequent: impaired healing.

Frequency not known: peripheral edema, fatigue, malaise, injection site reaction.

Investigations

Frequent: decreased blood potassium.

Frequency not known: increased intraocular pressure, decreased carbohydrate tolerance, elevated urinary calcium, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated blood alkaline phosphatase (ALP), elevated blood urea.

Injury, poisoning and procedural complications

Frequency not known: 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 effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solu-Moderín

No special storage conditions are required.

Shelf life after reconstitution with the ampoule of water for injections: 48 hours.

Store in a refrigerator (between 2 °C and 8 °C) or at a temperature not exceeding 25 °C.

Physical and chemical stability in use has been demonstrated for 48 hours after reconstitution when stored between 2 °C and 8 °C or at a temperature not exceeding 25 °C.

From a microbiological standpoint, the reconstituted medicinal product should be used immediately. If not used immediately, the duration and storage conditions prior to use shall be the responsibility of the user and must not exceed 24 hours at 2 °C to 8 °C, unless reconstitution has been carried out under validated aseptic and controlled conditions.

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE collection point at your pharmacy. In case of doubt, ask your pharmacist how to dispose of unused medicines and packaging. This helps protect the environment.

6. Package contents and other information

Composition of Solu-Moderín 500 mg and Solu-Moderín 1 g, powder and solvent for injectable solution

• The active substance is methylprednisolone (sodium succinate). Each vial of powder contains 500 mg and 1 g (1000 mg), respectively, of methylprednisolone (as sodium succinate).
• The other components (excipients) are: monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injections.

Appearance of the product and contents of the pack

Solu-Moderín 500 mg and Solu-Moderín 1 g are supplied as powder and solvent for injectable solution.

White lyophilized powder in a vial and colorless, clear solvent in another vial.

Solu-Moderín 500 mg and Solu-Moderín 1 g are packaged in packs containing 1 vial of powder and 1 vial of solvent.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L.

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

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Date of most recent review of this summary: July 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

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

• Reconstitution of the solution for injection:

The powder in the vial should be reconstituted with the solvent provided in the solvent vial. Shake well until a clear solution is obtained.

• Reconstitution of the solution for infusion:

First, reconstitute the powder in the vial as described above. The reconstituted solution may be administered in diluted solutions of 5% dextrose in water, isotonic saline, or 5% dextrose in 0.45% or 0.9% sodium chloride.

Physical and chemical stability in use has been demonstrated for 48 hours after dilution when stored between 2°C and 8°C, or for 24 hours at temperatures not exceeding 25°C.

From a microbiological standpoint, the diluted medicinal product should be used immediately. If not used immediately, the duration and conditions of storage prior to use shall be the responsibility of the user and should not exceed 24 hours at 2°C to 8°C, unless reconstitution has been carried out under validated and controlled aseptic conditions.