Soltrim 160 mg/800 mg powder and solution for injection solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Soltrim 160 mg/800 mg powder and solution for injection solution

trimethoprim/sulfamethoxazole (lisinate)

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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Soltrim is and what it is used for

Soltrim is a medicine that contains two antibiotics (trimethoprim and a sulfonamide called sulfamethoxazole) belonging to a group of medicines known as sulfonamide-trimethoprim combinations, which act against a wide range of microorganisms that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as indicated by your doctor. Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines down the drain or in the trash.

Soltrim is indicated in adults and children from 2 months of age for the treatment of the following infections:

• Treatment of pneumonia caused by Pneumocystis jiroveci (P. carinii)
• Treatment of nocardiosis (lung infection caused by Nocardia spp.)

Soltrim may also be useful in the treatment of:

• Toxoplasmosis.
• Listeriosis (infection caused by a bacterium).
• Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria.

2. What you need to know before using Soltrim

Do not use Soltrim

• if you are allergic to sulfonamides, trimethoprim, cotrimoxazole, or any of the other components of this medicine (listed in section 6).
• in children under 2 months of age.
• if you have a blood disorder called megaloblastic anemia due to folate deficiency.
• if you have severe liver disease.
• if you have severe kidney disease.
• if you have or are at risk of developing a metabolic disorder called acute porphyria, which involves deficiency of substances capable of synthesizing a blood component.
• if you are pregnant (or could be pregnant) or breastfeeding.
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking trimethoprim.

You must immediately stop treatment with this medicine at the first sign of skin rash, sore throat, fever, arthralgia (joint pain), cough, difficulty breathing, pallor, purpura (purple spots on the skin), jaundice (yellowing of the skin and mucous membranes), or serious blood disorders. These signs may indicate the onset of serious adverse reactions.

Serious skin reactions, which may be life-threatening, have been reported with the use of Soltrim, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). You must discontinue treatment if red, circular spots appear on the skin, often with a central blister. Other signs may include mouth sores, sore throat, nose, genital lesions, and conjunctivitis (swollen, red eyes). Seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

The highest risk period for the occurrence of serious skin reactions is during the first weeks of treatment.

If you have previously developed Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, or drug reaction with eosinophilia and systemic symptoms while using Soltrim, you must never use this medicine again.

If you develop skin rashes or these symptoms, stop using Soltrim immediately, seek medical help, and inform your doctor that you are taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Soltrim:

• if you have kidney problems.
• if you are in conditions that predispose you to folic acid deficiency (advanced age, chronic alcoholism, rheumatoid arthritis, treatment with anticonvulsant medicines, malabsorption syndrome, or malnutrition) or if you have a congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase.
• if you are elderly, especially if you have liver or kidney problems or are taking other medicines, as your risk of adverse effects is higher.
• if you have severe allergies or bronchial asthma.
• if you have acquired immunodeficiency syndrome (AIDS).
• if you are at risk of hyperkalemia (increased blood potassium) or hyponatremia (decreased blood sodium).
• if you are on a high-potassium diet or taking other medicines that may increase blood potassium levels.
• if you have hypoalbuminemia (low blood albumin), as your risk of crystalluria (uric acid crystals in urine) is higher.

During prolonged treatment, your doctor may request blood tests and may recommend folic acid supplements.

If you experience unexpected worsening of cough or shortness of breath, inform your doctor immediately.

Hemophagocytic lymphohistiocytosis

Very rare cases of excessive immune reactions due to unregulated activation of white blood cells causing inflammation (hemophagocytic lymphohistiocytosis) have been reported. These reactions can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen lymph nodes, weakness, dizziness, shortness of breath, bruising, or concurrent or slightly delayed skin rash, contact your doctor immediately.

If local irritation or inflammation occurs after administration of Soltrim, treatment should be discontinued and restarted at another site.

Like most antibiotics, Soltrim may cause pseudomembranous colitis (inflammation of the large intestine causing diarrhea and abdominal pain) due to the microorganism Clostridium difficile. If you develop diarrhea, consult your doctor to rule out this diagnosis.

Consult your doctor if you have had or currently have any of the conditions listed above.

Other medicines and Soltrim

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter products, vaccines, or herbal remedies.

Soltrim may interact with:

• immunosuppressants used to reduce the body's immune defenses (cyclosporine, pyrimethamine, methotrexate, mercaptopurine, or azathioprine), increasing their toxicity.
• hypoglycemic agents used to regulate blood sugar levels.
• diuretics used to promote fluid elimination, as the risk of hyperkalemia (increased blood potassium) increases.
• local anesthetics.
• potassium aminobenzoate, used to treat certain conditions where the skin becomes less flexible.
• angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure.
• antipsychotics (such as chlorpromazine or haloperidol).
• antidepressants (such as imipramine).
• antifungals (such as ketoconazole).
• antibiotics (such as erythromycin).
• antihistamines (such as terfenadine or astemizole).

Soltrim may increase the concentrations and enhance the effects of:

• antiviral medicines used to treat viral infections (zidovudine, zalcitabine, lamivudina, and amantadine).
• immunosuppressants used to reduce the body's immune defenses (tacrolimus).
• oral anticoagulants used to prevent blood clotting (warfarin).
• antiarrhythmics used to regulate heart rhythm (procainamide and digoxin).
• antiepileptics used to prevent seizures (phenytoin).
• antibiotics used to treat infections (rifampicin and dapsone).
• methotrexate.

Use of Soltrim with food, drinks, and alcohol

Alcohol consumption should be avoided during treatment with Soltrim.

Caution is advised in patients on diets high in potassium.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will assess the benefit-risk balance of the treatment.

You must not take this medicine during pregnancy or breastfeeding. Treatment with trimethoprim during the first three months of pregnancy may increase the risk of spontaneous abortion. Babies born to mothers treated with trimethoprim during the first trimester of pregnancy may have an increased risk of congenital malformations, particularly neural tube defects (where the spine and spinal cord do not form properly), oral clefts (where the lip and palate do not form properly), and heart defects.

Driving and use of machines

No effects on driving or machine use have been reported.

Soltrim contains benzyl alcohol and sodium metabisulfite.

This medicine contains 200 mg of benzyl alcohol per dose unit. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with a risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically advised by your doctor. This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

3. How to use Soltrim

Soltrim will be prepared and administered by trained healthcare personnel.

Before administration, the vial containing the lyophilized powder (which contains sulfamethoxazole) must be reconstituted with the ampoule of solution (which contains trimethoprim), and then administered by intravenous infusion after prior dilution over a period of one to one and a half hours.

Parenteral administration of Soltrim should only be performed in patients who cannot take medication orally or when it is necessary to rapidly achieve high serum concentrations.

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

Use in adults and children over 12 years of age

Depending on the severity of the infection, doses may range between 160 – 320 mg of trimethoprim and 800 – 1,600 mg of sulfamethoxazole (1 vial + 1 ampoule or 2 vials + 2 ampoules), administered two to four times daily, i.e., every 6–12 hours.

Children between 2 months and 12 years of age

The average dose based on body weight is as follows: 3.2 mg of trimethoprim and 16 mg of sulfamethoxazole per kg of body weight, administered every 12 hours (corresponding to 0.12 ml/kg every 12 hours).

Recommended doses regardless of body weight are:

Children aged 6 to 12 years

The usual dose is half a vial (80 mg trimethoprim and 400 mg sulfamethoxazole) every 12 hours.

Children aged 6 months to 5 years

The usual dose is one-quarter of a vial (40 mg trimethoprim and 200 mg sulfamethoxazole) every 12 hours.

Children aged 2 to 5 months

The usual dose is 0.75 ml (20 mg trimethoprim and 100 mg sulfamethoxazole) every 12 hours.

Elderly patients

The usual dose is the same as for adults. If there is renal impairment, the dose will be adjusted according to kidney function.

Patients with renal impairment

In case of renal impairment, your doctor will decide whether it is necessary to reduce the usual dose based on creatinine clearance (a value indicating kidney function).

Pneumocystis jiroveci pneumonia

In children over 2 months of age and adults, the recommended intravenous dose is 15 – 20 mg of trimethoprim/kg/day and 75 – 100 mg of sulfamethoxazole/kg/day. The daily dose should be divided into 3 – 4 equal doses administered by intravenous infusion, until oral therapy can be initiated.

Treatment should continue for a total treatment period of at least 2 weeks, with a recommended duration of 21 days.

Nocardiosis

The recommended intravenous dose is 15 mg/kg/day of trimethoprim and 75 mg/kg/day of sulfamethoxazole, administered in 2–4 divided doses for 3–4 weeks. Afterwards, reduce the dose to 10 mg/kg/day of trimethoprim / 50 mg/kg/day of sulfamethoxazole in 2–4 divided doses, for a duration of 3 to 6 months.

Toxoplasmosis

The recommended intravenous dose in adults is 10 mg/kg/day of trimethoprim and 50 mg/kg/day of sulfamethoxazole every 12 hours, for 30 days.

Listeriosis

The recommended intravenous dose in adults is 10–20 mg/kg/day of trimethoprim and 50–100 mg/kg/day of sulfamethoxazole, given in 2–4 divided doses for at least 2 weeks.

The recommended intravenous dose in children is 10–12 mg/kg/day of trimethoprim and 50–60 mg/kg/day of sulfamethoxazole, given in 4 divided doses for a period of 14 to 21 days.

Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) strains, such as osteomyelitis, septic arthritis, or skin and soft tissue infections.

• Osteomyelitis: The adult dose is 3.5–4 mg/kg per dose every 8–12 hours. There is insufficient evidence to recommend a pediatric dosage regimen.
• Purulent cellulitis: The adult dose ranges from 160 mg trimethoprim/800 mg sulfamethoxazole every 12 hours to 320 mg/1,600 mg every 12 hours. The pediatric dose is 4–6 mg/kg per dose of trimethoprim and 20–30 mg/kg per dose every 12 hours.
• Septic arthritis: The adult dose is 3.4–4 mg/kg per dose every 8–12 hours. There is insufficient evidence to recommend a pediatric dosage regimen.
• Skin and soft tissue infections: The adult dose is 160 mg/800 mg every 12 hours.

If you take more Soltrim than you should

Contact your doctor or pharmacist immediately, go to an emergency room, or call the Toxicology Information Service at telephone number 915 620 420.

Symptoms of overdose include loss of appetite, vomiting, nausea, dizziness, colic, headache, somnolence, unconsciousness, depression, confusion, and bone marrow suppression.

Treatment should be discontinued. If urine output is low, administration of fluids is recommended. This medicine is dialyzable by hemodialysis, but peritoneal dialysis is not effective.

Calcium folinate administered intramuscularly at a dose of 3 to 6 mg for 5–7 days is an effective antidote against adverse reactions caused by trimethoprim. There is no antidote for sulfamethoxazole overdose.

If you forget to take Soltrim

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

If you stop taking Soltrim

Do not stop taking this medicine or reduce the dose without consulting your doctor.

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

4. Possible adverse effects

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

Call emergency services immediately if you experience multiple symptoms such as fever, very low blood pressure, or increased heart rate after taking this medicine, as these may be symptoms of shock.

Stop using Soltrim and seek immediate medical attention if you notice any of the following symptoms:

• Red spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN))
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Skin reactions such as exfoliative dermatitis (generalized peeling), rash, itching, purpura (small spots on the skin) may occur with Soltrim treatment. Fever, liver problems (elevated liver enzymes or transaminases, hepatitis (liver inflammation)), kidney problems (elevated blood creatinine, tubulointerstitial nephritis, crystal formation in urine), hyperkalemia (increased potassium concentration in blood), hyponatremia (decreased sodium concentration in blood), and hypoglycemia (decreased blood sugar levels) may also occur.

With unknown frequency, plum-colored, raised, and painful sores may appear on the limbs and sometimes on the face and neck, accompanied by fever (Sweet's syndrome). With unknown frequency, cases of acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (also known as DRESS) have also been reported (see section 2).

More severe adverse reactions may occur, such as blood disorders (neutropenia or agranulocytosis (reduced or absent number of granulocytes in blood), aplastic anemia, bone marrow failure, leucopenia (reduced white blood cells), thrombocytopenia (reduced number of platelets in blood)), severe liver problems (hepatic necrosis), and allergic reactions.

Very rarely, severe skin reactions that may be life-threatening can occur (Stevens-Johnson syndrome, characterized by red blisters, erosion, and crusted, bleeding skin, or toxic epidermal necrolysis, characterized by skin peeling and blisters in the superficial layers of the skin) (see section 2). Also very rarely, hallucinations, chest pain, muscle or joint pain, muscle weakness, sudden headache, or neck stiffness accompanied by high fever and/or acute pancreatitis may occur.

Treatment with antibiotics, including Soltrim, may alter the colonic flora due to overgrowth of a bacterium called Clostridium difficile, leading to intestinal symptoms (ranging in severity from mild diarrhea to fatal colitis). If you develop severe and persistent diarrhea, even if it occurs up to two months after taking Soltrim, you should consult your doctor.

Special populations

Patients with glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency: A hemolytic reaction (destruction of red blood cells) may occur, which is often dose-dependent.

Elderly patients: The most frequent adverse reactions are severe skin reactions or those related to bone marrow function, such as a reduced number of platelets in blood (with or without red spots on the skin). An increased incidence of thrombocytopenia has been reported in patients treated simultaneously with drugs used to eliminate urine (diuretics, mainly thiazides).

HIV-infected patients: More frequent severe adverse reactions include reduced number of a certain type of white blood cells (neutropenia), intense redness of the skin with peeling in layers or scales (exfoliative dermatitis), and appearance of blisters on the skin and mucous membranes, which may be life-threatening (toxic epidermal necrolysis).

Patients with AIDS: Experience skin and bone marrow adverse reactions more frequently than the general population. They may develop reduced white blood cell count (leucopenia), reduced platelet count (thrombocytopenia), skin rash (exanthema), and elevated liver enzymes (indicators of liver function) and creatinine (indicator of kidney function), usually around the 7th to 14th day of treatment. Increased blood potassium levels (hyperkalemia) and decreased blood sodium levels (hyponatremia) have also been observed.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Soltrim

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

Before reconstitution:

No special storage conditions are required.

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

After reconstitution:

Once the powder has been reconstituted with the solution, the medicine should be used within 24 hours. This solution should be stored at room temperature.

For intravenous infusion, Soltrim must be mixed extemporaneously by combining 1 ml from the reconstituted vial with the ampoule of solution per 50 ml of infusion solution. See the section containing information intended for doctors or healthcare professionals at the end of the leaflet.

Once prepared, the solution should be used within 6 hours. This solution may be stored at room temperature.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Soltrim

• The active substances in Soltrim are trimethoprim and sulfamethoxazole.

• Each ampoule of solution contains 160 mg of trimethoprim, and each vial of lyophilized powder contains 800 mg of sulfamethoxazole.

• The other components present in the ampoule are: benzyl alcohol (200 mg), glycofurol, formaldehyde glycerin, sodium metabisulfite, hydrochloric acid (to adjust pH), and water for injections.

Appearance of the product and pack contents

Powder and solution for concentrate for intravenous infusion solution.

The powder in the vial is white in colour. The solution in the ampoule is clear and colourless.

Both components must be mixed before administration. The total volume of the reconstituted injectable solution is 6 ml. The appearance of this reconstituted solution is clear and slightly yellowish.

Each pack of Soltrim contains:

• 5 glass ampoules containing 5 ml of trimethoprim solution
• 5 glass vials containing lyophilized sulfamethoxazole powder

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A. General Mitre, 151 08022 – Barcelona (Spain)

Manufacturer

Famar Health Care Services Madrid, S.A.U. Avda. Leganés, 62 28923 Alcorcón – Madrid (Spain).

and/or

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61 (Sant Andreu de la Barca (Barcelona)) - 08740 - Spain

Date of the most recent revision of this leaflet: 02/2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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This information is intended for healthcare professionals only:

Intravenous infusion

Soltrim must not be injected directly by intravenous route.

Instructions for dilution of the medicinal product prior to intravenous infusion:

Soltrim must be mixed extemporaneously at a rate of 1 ml from the reconstituted vial with the solution ampoule (containing trimethoprim) per 50 ml of diluent, resulting in the following:

• ½ reconstituted vial of Soltrim in 125 ml of infusion solution.
• 1 reconstituted vial of Soltrim in 250 ml of infusion solution.
• 2 reconstituted vials of Soltrim in 500 ml of infusion solution.

The following solutions may be used:

• Ringer's solution
• Sodium chloride 0.9% solution (physiological saline)
• Glucosaline solution (sodium chloride 0.18% + glucose 4%)
• Glucose 5% or 10% solution
• Levulose 10% solution
• Sodium bicarbonate 1.6 M solution

Sodium lactate 1/6 Molar, glucose 15%, or high molecular weight solutions such as dextran must not be used.

If, after preparation, cloudiness or precipitates are observed upon agitation, the solution must be discarded and a fresh one prepared.

Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.