Package Insert: Information for the User

Septin Pediatric 8 mg/40 mg/ml Oral Suspension

(trimethoprim/sulfamethoxazole)

Read this package insert carefully before starting to take 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 or pharmacist.
• This medication has been prescribed only for you and should not be given 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 or pharmacist, even if they are not listed in this package insert.

Septrin Pediatric is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called trimethoprim and sulfamethoxazole (a sulfonamide).

Septrin Pediatric is indicated for the treatment of the following infections: treatment and prevention of pneumonia caused byPneumocystis jiroveci (P.carinii), prevention of toxoplasmosis, nocardiosis, and melioidosis.

Septrin Pediatric may also be useful for other infections: middle ear infections, respiratory infections in patients with chronic bronchitis, urinary tract infections (bladder, kidneys), infectious diarrhea, treatment of toxoplasmosis, genital and/or perianal injury (inguinal granuloma or donovanosis), brucellosis.

Do not take Septrin Pediatric 8 mg/40 mg/ml oral suspension

-If you are allergic to sulfonamides, trimethoprim, co-trimoxazole, or any of the other components of this medication (listed in section 6: Contents of the pack and additional information).

-In premature children, and children under 6 weeks of age.

-If you have or think you have acute porphyria (a blood disorder in which hemoglobin is not produced adequately).

-In combination with dofetilide (a medication used to control irregular or rapid heartbeats).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Septrin Pediatric 8 mg/40 mg/ml oral suspension.

-In elderly patients, as they may be more likely to experience severe side effects.

-If you have kidney problems (known renal insufficiency). Your doctor will need to take special measures. To ensure adequate renal elimination, the patient should receive adequate fluid intake and the urine pH should be maintained within normal limits, avoiding urine acidification.

-If you have liver problems (severe liver parenchymal damage).

-If you have severe blood disorders, except in cases where close medical supervision is provided.

-If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).

-Septrin should not be used to treat streptococcal pharyngitis (Group A beta-hemolytic streptococcus, S. pyogenes).

-If you take Septrin Pediatric for a long time or have a folate deficiency or are an elderly patient, your doctor may request that you have blood tests to perform blood counts.

-If you have a risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need to monitor potassium and sodium levels in the blood.

-If you have phenylketonuria (a metabolic disorder that affects the enzyme phenylalanine), as the administration of trimethoprim alters the metabolism of phenylalanine. This is not a problem in patients with an adequate restrictive diet.

-Septrin Pediatric may interfere with the results of some laboratory tests.

-Although this medication is indicated for use in children from 6 weeks of age, your doctor may decide not to administer Septrin to children under 3 months.

There have been rare cases of death due to severe reactions, including fulminant hepatic necrosis (severe liver damage), agranulocytosis (decrease in a certain type of white blood cells), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), other blood disorders, and hypersensitivity of the respiratory system.

There have been descriptions of skin eruptions that can be life-threatening to the patient (Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized acute pustular exanthema, and febrile neutrophilic dermatosis or sweet syndrome) with the use of Septrin Pediatric, initially appearing as red circular spots or patches, often with a central blister.

Other additional signs that may appear are mouth sores, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These skin eruptions that can be life-threatening to the patient, often accompanied by flu-like symptoms. The rash may progress to the formation of generalized blisters or skin peeling.

The period of highest risk of developing severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis, or febrile neutrophilic dermatosis with the use of Septrin, do not use Septrin Pediatric again at any time.

If you develop rashes or these skin symptoms, stop taking Septrin Pediatric, immediately go to a doctor and inform them that you are taking this medication.

If you experience a severe skin reaction: a red and scaly rash with subcutaneous nodules and blisters (generalized acute pustular exanthema), contact a doctor as soon as possible and inform them that you are taking this medication.

Rare cases of hypersensitivity reactions with eosinophilia (increase in a certain type of white blood cells) and systemic symptoms associated with the use of Septrin have been reported.

As a result of colonization with Clostridium difficile, the use of Septrin may lead to pseudomembranous colitis in very rare cases, which manifests through diarrhea.

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

Lymphohistiocytosis hemophagocytosis

Rare cases of excessive immune reactions due to unregulated activation of white blood cells, causing inflammation (lymphohistiocytosis hemophagocytosis), which can be potentially fatal if not diagnosed and treated promptly. If you experience multiple symptoms such as fever, swelling of lymph nodes, feeling weak, dizziness, shortness of breath, bruises, or skin rash, contact your doctor immediately.

Taking Septrin Pediatric 8 mg/40 mg/ml oral suspension with other medications

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

Septrin Pediatric may potentiate the effect and/or toxicity of some medications. It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Medications used to increase urine elimination: diuretics (especially thiazides). The concomitant administration of diuretics with trimethoprim/sulfamethoxazole in elderly patients may have a higher risk of thrombocytopenia (decrease in platelet count) and hyponatremia (low sodium levels).
• Oral anticoagulants such as warfarin. Trimethoprim/sulfamethoxazole potentiates the anticoagulant activity of warfarin. A careful control of anticoagulant treatment is recommended during the use of Septrin Pediatric.
• Some medications used to control blood sugar or glucose in the blood: hypoglycemics or oral antidiabetics (sulfonilurea).
• Medications used to treat heart problems (digoxin). The concomitant use of trimethoprim and digoxin has shown an increase in digoxin levels in some elderly patients.
• Medications used to treat infections caused by some parasites (pirimetamina). The concomitant administration of trimethoprim/sulfamethoxazole with doses of pirimetamina greater than 25 mg per week may lead to the development of megaloblastic anemia (decrease in red blood cell count and increase in size).
• Certain medications used to treat HIV: antiretrovirals (lamivudine, zidovudine). The concomitant treatment of Septrin Pediatric with zidovudine may increase the risk of adverse hematological reactions to trimethoprim/sulfamethoxazole, and a follow-up of blood parameters should be considered.
• Medications that antagonize folic acid, such as phenytoin (used to treat epilepsy) and methotrexate (used to treat various types of cancer and also to treat rheumatoid arthritis). If trimethoprim/sulfamethoxazole is administered and phenytoin is administered, the excessive effect of phenytoin should be taken into account. If Septrin Pediatric is administered with methotrexate, the administration of a folate supplement should be considered.
• Medications used in transplants: immunosuppressants (ciclosporin). In patients treated with trimethoprim/sulfamethoxazole and ciclosporin, a reversible deterioration in renal function has been observed after a kidney transplant.

-Medications that cause hyperkalemia (elevated potassium levels).

-Medications used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated dofetilide plasma levels have been reported after concomitant administration with trimethoprim.

When trimethoprim is administered with medications such as procainamide, amantadine, there is a possibility of increased plasma concentration of one or both medications.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Trimethoprim and sulfamethoxazole cross the placenta, and their safety in pregnant women has not been established. Trimethoprim/sulfamethoxazole should be avoided in pregnancy, unless the potential benefit to the mother outweighs the potential risk to the fetus, and a folate supplement may be considered if trimethoprim/sulfamethoxazole is used during pregnancy.

When Septrin Pediatric is administered to the mother before birth, there may be a theoretical risk of kernicterus (a severe neurological complication due to increased bilirubin in the blood) in the newborn. This theoretical risk is particularly important in premature infants or those with a deficiency of glucose-6-phosphate dehydrogenase.

Administration of trimethoprim/sulfamethoxazole should be avoided in the final stages of pregnancy and in breastfeeding mothers, especially when mothers or children are at risk of developing hyperbilirubinemia.

The medication is excreted in breast milk.

Driving and operating machines

The influence of Septrin Pediatric on the ability to drive and operate machines is negligible or insignificant.

Important information about some of the components of Septrin Pediatric 8 mg/40 mg/ml oral suspension

This medication contains 0.27% ethanol (alcohol), which corresponds to 0.00216 mg per 1 ml.

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate methyl ester (E-218).

This medication contains sorbitol (E-420). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Septrin Pediatric 8 mg/40 mg/ml oral suspension. Do not stop treatment before.

Preferably administer Septrin Pediatric 8 mg/40 mg/ml oral suspension after food intake. It is recommended to shake well before use.

Your doctor will prescribe the most appropriate pharmaceutical form of Septrin according to age, weight, and dose.

Septrin pediatric 8 mg/40 mg/ml oral suspension and Septrin pediatric 20 mg/100 mg tablets are the most appropriate presentations for infants and children.

Standard Dose

• Adults and children over 12 years: It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

160 mg of trimethoprim/800 mg of sulfamethoxazole/12 hours (2 Septrin 80 mg/400 mg tablets every 12 hours or 1 Septrin Forte 160 mg/800 mg tablet every 12 hours or 20 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension every 12 hours or 8 Septrin Pediatric 20 mg/100 mg tablets every 12 hours).

• Infants and children under 12 years(doses approximate 6 mg of trimethoprim/30 mg of sulfamethoxazole/kg/24 hours):

If after 7 days of treatment no clinical improvement is observed, the patient will be reevaluated.

As an alternative to the standard dose, a treatment with 160/800 mg of trimethoprim-sulfamethoxazole in adults and 5mg of trimethoprim/25 mg of sulfamethoxazole/kg in children every 12 hours for three days is appropriate for the treatment of urinary tract infections and infectious diarrhea.

Special Dosages

Older patients: (see section 2: Warnings and precautions). If no other dosage is indicated, the standard dose will be used.

Patients with renal insufficiency:

Adults and children over 12 years (no information is available for children under 12 years):

Creatinine clearance (ml/min)Recommended Dose

> 30Standard dose

15-30Half the standard dose

<15Not recommended

Your doctor may perform blood tests every 2-3 days to measure the amount of medication in the blood.

Pneumonia byPneumocystis jiroveci(P. carinii)

Treatment

Adults and children:20 mg of trimethoprim and 100 mg of sulfamethoxazole/kg/day, in two or more divided doses, for two weeks.

Prophylaxis (prevention)

Adults:It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

The following dosage regimens may be used:

• 160 mg of trimethoprim/800 mg of sulfamethoxazole daily, 7 days a week..
• 160 mg of trimethoprim/800 mg of sulfamethoxazole three times a week, on alternate days.
• 160 mg of trimethoprim/800 mg of sulfamethoxazole, twice a day, three times a week, on alternate days.

Children

The following dosage regimens may be used:

• 6 weeks to 5 months: 2.5 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension (20 mg of trimethoprim/ 100 mg of sulfamethoxazole) twice a day, 7 days a week, or 3 times a week on alternate days or 3 times a week on consecutive days.
• 6 months to 5 years: 5 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension or 2 Septrin Pediatric 20 mg/100 mg tablets (40 mg of trimethoprim/ 200 mg of sulfamethoxazole) twice a day, 7 days a week, or 3 times a week on alternate days or 3 times a week on consecutive days.
• 6 to 12 years: 10 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension or 4 Septrin Pediatric 20 mg/100 mg tablets (80 mg of trimethoprim/400 mg sulfamethoxazole) twice a day, 7 days a week, or 3 times a week on alternate days or 3 times a week on consecutive days.

The doses indicated above may also be administered as a single dose, 3 times a week on consecutive days. The daily dose administered on a treatment day approximates 150 mg of trimethoprim/m2/day and 750 mg of sulfamethoxazole/m2/day. The total daily dose should not exceed 320 mg of trimethoprim and 1,600 mg of sulfamethoxazole.

Toxoplasmosis

Primary prophylaxis (primary prevention)

Adults and children over 12 years:It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

• 80 mg of trimethoprim/ 400 mg of sulfamethoxazole daily.
• 160 mg of trimethoprim/ 800 mg of sulfamethoxazole three times a week.
• 160 mg of trimethoprim/ 800 mg of sulfamethoxazole daily.

Children

150 mg of trimethoprim/m2of body surface/day and 750 mg of sulfamethoxazole/m2of body surface/day in two doses. The total daily dose should not exceed 320 mg of trimethoprim and 1,600 mg of sulfamethoxazole.

Treatment

Adults: 5 mg/kg of trimethoprim/ 25mg/kg of sulfamethoxazole/12 hours for 6 weeks. It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

Children: No data is available.

Granuloma Inguinal (Donovanosis)

Adults:160 mg of trimethoprim/ 800 mg of sulfamethoxazole, twice a day for a period of at least 3 weeks or until all lesions have disappeared completely. It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

Nocardiosis

10-15 mg/kg/day of trimethoprim /50-75 mg/kg/day of sulfamethoxazole in two or more divided doses for a period of 3-6 months.In immunocompromised patients, treatment should be prolonged. All patients with CNS involvement should be treated for at least one year.

Brucelosis

Adults and children over 8 years: It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

160 mg of trimethoprim/ 800 mg of sulfamethoxazole/ 12 hours (1 Septrin Forte 160 mg/ 800 mg tablet/ 12 hours or 2 Septrin 80 mg/400 mg tablets/ 12 hours) for 6 weeks.

Children under 8 years(in this age group, it is considered first-line treatment):

10 mg/kg/day of trimethoprim and 50 mg/kg/day of sulfamethoxazole divided into two doses (i.e., 5 mg/kg of trimethoprim/ 25 mg/kg of sulfamethoxazole/ 12 hours) for 6 weeks.

Melioidosis

8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole (maximum 320 mg of trimethoprim/1,600 mg of sulfamethoxazole) every 12 hours for 3-6 months.

If you take more Septrin Pediatric 8 mg/40 mg/ml oral suspension than you should

The symptoms of overdose include: nausea, vomiting, dizziness, and confusion.

In acute overdose with trimethoprim, bone marrow depression has been observed.

In case of vomiting does not appear, it should be induced. Gastric lavage should be performed. Depending on the state of renal function, the administration of fluids should be performed if renal elimination is low.

Both substances, trimethoprim and sulfamethoxazole, are dialyzable by hemodialysis. Peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Tel.: 91 562 04 20.

If you forget to take Septrin Pediatric 8 mg/40 mg/ml oral suspension

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

Like all medicines, Septrin Pediatric 8 mg/40 mg/ml oral suspension may cause side effects, although not everyone will experience them.

The side effects described for Septrin Pediatric 8 mg/40 mg/ml oral suspension are classified by frequency and are as follows:

• Very common (may affect more than 1 in 10 people): hyperkalemia (elevated potassium level).

-Common (may affect up to 1 in 10 people): candidiasis (candida overgrowth), headache, nausea, diarrhea, and skin rash.

-Uncommon (may affect up to 1 in 100 people): vomiting.

-Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions with eosinophilia (increased eosinophils) and systemic symptoms.

-Very rare (may affect up to 1 in 10,000 people): leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), thrombocytopenia (decreased platelet count), agranulocytosis (decreased granulocyte count), megaloblastic anemia (decreased red blood cell count and increased red blood cell size), aplastic anemia (bone marrow failure), hemolytic anemia (insufficient red blood cells), methemoglobinemia (inability of hemoglobin to transport oxygen), eosinophilia (abnormally high eosinophil count), purpura (red spots on the skin), hemolysis (red blood cell rupture) in G-6-PD deficient patients.

Serum disease (hypersensitivity reaction similar to an allergy), anaphylaxis (severe allergic reaction), allergic myocarditis (allergic reaction affecting the heart), angioedema (fluid retention in the skin and mucous membranes), fever, allergic vasculitis similar to Schoenlein-Henoch purpura (inflammation affecting small blood vessels), periarteritis nodosa (vascular disease), systemic lupus erythematosus (immune system disease).

Hypoglycemia (decreased blood glucose), hyponatremia (decreased sodium level), anorexia (metabolic disorder). Depression, hallucinations, aseptic meningitis, convulsions, peripheral neuritis (nerve damage), ataxia (loss of coordination), vertigo, tinnitus (ringing in the ears), dizziness, cough, difficulty breathing, pulmonary infiltrates, glossitis (inflammation of the tongue), stomatitis (mouth lesions), pseudomembranous colitis (inflammation of the colon), pancreatitis (inflammation of the pancreas), hepatobiliary disorders (liver function alteration), photosensitivity (skin reaction caused by light interaction), exfoliative dermatitis (severe skin inflammation), fixed drug eruption (allergic reaction), erythema multiforme (allergic reaction affecting the skin), arthralgia (joint pain), myalgia (muscle pain), renal function alteration, uveitis (inflammation of the eye). Life-threatening skin eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2: Warnings and precautions).

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

In some cases, life-threatening skin eruptions have been observed, such as purple-colored, elevated, and painful lesions on the extremities and sometimes on the face and neck, with fever (Sweet syndrome) (see section 2: Warnings and precautions).

Consult a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (acute generalized pustular psoriasis). (See section 2: Warnings and precautions)

-Very rare (may affect up to 1 in 10,000 people) side effects related to the treatment of Pneumocystis jiroveci (P.carinii) pneumonia: severe hypersensitivity reactions, rashes, fever, neutropenia (decreased neutrophil count), thrombocytopenia (decreased platelet count), increased liver enzymes, hyperkalemia (elevated potassium level), hyponatremia (decreased sodium level), and rhabdomyolysis (muscle destruction or inflammation with severe muscle pain and weakness).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects:

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

Do not store at a temperature above25ºC.

Store in the original packaging to protect it from light.

After the first opening of the bottle,use before 1 month.

Keep this medication out of 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.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Septrin Pediatric 8 mg/40 mg/ml oral suspension

• The active principles are trimethoprim and sulfamethoxazole. Each ml of Septrin Pediatric oral suspension contains 8 mg of trimethoprim and 40 mg of sulfamethoxazole.
• The other components are: sorbitol (70%), glycerol (E-422), dispersible cellulose, sodium caramel, polisorbate 80, methyl parahydroxybenzoate (E-218), sodium benzoate (E-211), sodium saccharin, banana flavor (propylene glycol E-1520, sodium citrate E-331), 96° ethanol, vanilla flavor (benzyl alcohol, caramel color E-150d, propylene glycol E-1520, glycerol E-422, water) and purified water.

Appearance of the product and contents of the packaging

Septrin Pediatric 8 mg/40 mg/ml oral suspension is a white-colored suspension with a characteristic banana and vanilla odor.

Topaz glass bottles with a metal screw cap containing 100 ml.

Holder of the marketing authorization

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Responsible for manufacturing

Alcalá Farma, S.L

Avenida de Madrid 82, Alcalá de Henares

28802 Madrid Spain

or

Teofarma S.r.l.

Viale Certosa, 8/A

27100 Pavia

Italy

Other presentations

• Septrin Pediatric 20 mg/100 mg tablets.

Blister packs of 20 and 100 tablets.

• Septrin 80 mg/400 mg tablets.

Blister packs of 20 and 100 tablets.

• Septrin Forte 160 mg/ 800 mg tablets.

Blister packs of 20 and 50 tablets.

Last review date of this leaflet: January 2025

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