SEPTRIN PEDIATRIC 20 mg/100 mg TABLETS

2. What you need to know before taking Septrin Pediatric 20 mg/100 mg tablets

Do not take Septrin Pediatric 20mg/100 mg tablets

• If you are allergic to sulfonamides, trimethoprim, cotrimoxazole, or any of the other components of this medicine (listed in section 6: Package contents and additional information).
• In the case of premature infants and full-term infants under 6 weeks.
• If you have acute porphyria (a blood disorder in which hemoglobin is not produced properly).
• In combination with dofetilide (a drug used to control irregular or rapid heartbeats).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Septrin Pediatric 20 mg/100 mg tablets.

• In elderly patients, as they may be more likely to experience severe side effects.
• If you have kidney problems (known renal insufficiency). Your doctor should take special measures. To ensure adequate renal elimination, the patient should receive adequate fluid intake and the urinary pH should be maintained within normal limits, avoiding acidification of the urine.
• If you have liver problems (severe liver parenchymal damage).
• If you have severe blood disorders, except in cases where there is close medical supervision.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• Septrin Pediatric should not be used to treat streptococcal pharyngitis (S. pyogenes).
• If you take Septrin Pediatric for a long time or have a folate deficiency, or if you are an elderly patient, your doctor may request that you undergo blood tests to perform blood counts.
• If you are at 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 phenylalanine metabolism. This is not a problem in patients with a restrictive diet.
• Septrin Pediatric may interfere with the results of some laboratory tests.
• Although this medicine is indicated for use in children from 6 weeks, your doctor may decide not to administer Septrin to children under 3 months.

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

Life-threatening skin rashes have been described with the use of Septrin Pediatric, initially appearing as red or circular spots, often with a central blister.

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

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of generalized blisters or skin peeling.

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

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

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

If you experience a severe skin reaction: a red and scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis), contact a doctor as soon as possible and inform them that you are taking this medicine.

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

As a consequence of colonization with Clostridium difficile, the use of Septrin may lead to the development of pseudomembranous colitis, which manifests as diarrhea.

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

Hemophagocytic lymphohistiocytosis

Very rare cases of excessive immune reactions have been reported due to unregulated activation of white blood cells, causing inflammation (hemophagocytic lymphohistiocytosis), which can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swelling of the lymph nodes, weakness, dizziness, shortness of breath, bruising, or a rash, either simultaneously or with a slight delay, contact your doctor immediately.

Taking Septrin Pediatric 20 mg/100 mg tablets with other medicines

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

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

• Medicines 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 the number of platelets) and hyponatremia (low sodium levels).
• Oral anticoagulant medicines such as warfarin. Trimethoprim/sulfamethoxazole potentiates the anticoagulant activity of warfarin. Careful monitoring of anticoagulant treatment is recommended during the use of Septrin Pediatric.
• Certain medicines used to control blood sugar levels: oral hypoglycemics or antidiabetics (sulfonylurea).
• Medicines used to treat heart problems (digoxin). The concomitant use of trimethoprim and digoxin has shown an increase in digoxin levels in some elderly patients.
• Medicines used to treat parasitic infections (pyrimethamine). The concomitant administration of trimethoprim/sulfamethoxazole with doses of pyrimethamine greater than 25 mg per week may lead to the development of megaloblastic anemia (decrease in the number of red blood cells and increase in their size).
• Certain medicines used to treat the human immunodeficiency virus (HIV): antiretrovirals (lamivudine, zidovudine). The concomitant treatment of Septrin Pediatric with zidovudine may increase the risk of hematological adverse reactions to trimethoprim/sulfamethoxazole; consideration should be given to monitoring blood parameters.
• Medicines that are antagonists of 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 and phenytoin are administered, the excessive effect of phenytoin should be taken into account. If Septrin Pediatric is administered with methotrexate, consideration should be given to the administration of a folate supplement.
• Medicines used in transplants: immunosuppressants (cyclosporin). In patients treated with trimethoprim/sulfamethoxazole and cyclosporin, a reversible deterioration in renal function has been observed after kidney transplantation.

• Medicines that produce hyperkalemia (increase in potassium levels in the blood).
• Medicines used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported after concomitant administration with trimethoprim.

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

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.

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; consideration may be given to supplementation with high doses of folate (up to 4 or 5 mg/day) 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 (severe neurological complication due to increased bilirubin levels in the blood) in the newborn. This theoretical risk is particularly important in children with a higher risk of hyperbilirubinemia, such as premature infants or those with glucose-6-phosphate dehydrogenase deficiency.

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

The medicine is excreted in breast milk.

Driving and using machines

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

3. How to take Septrin Pediatric 20mg/100 mg tablets

Follow the administration instructions of the medicine contained in this prospectus or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Septrin Pediatric 20 mg/100 mg tablets. Do not suspend treatment before.

Septrin Pediatric 20 mg/100 mg tablets will be administered preferably after food intake. Swallow the tablets with a sufficient amount of liquid. If desired, the specified doses can be taken diluted in a small amount of water.

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 suitable presentations for infants and children.

Standard dosage

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

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

• 6 weeks to 5 months:it is recommended to use Septrin Pediatric 8 mg/40 mg/ml administering 2.5 ml of oral suspension every 12 hours (20 mg of trimethoprima/ 100 mg of sulfamethoxazole/ 12 hours).

• 6 months to 5 years:2 tablets of Septrin Pediatric 20 mg/100 mg tablets every 12 hours or 5 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension every 12 hours (40 mg of trimethoprima/ 200 mg of sulfamethoxazole/ 12 hours).

• 6 to 12 years:4 tablets of Septrin Pediatric 20 mg/100 mg tablets every 12 hours or 10 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension every 12 hours (80 mg of trimethoprim/ 400 mg sulfamethoxazole/ 12 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 5 mg of trimethoprim/25 mg of sulfamethoxazole/kg in children every 12 hours for three days is suitable for the treatment of urinary tract infections and infectious diarrhea.

Special dosages

Elderly patients: (see section 2: Warnings and precautions). If no other posology 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

> 30 Standard dose

15-30 Half of the standard dose

< 15 Not recommended

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

Pneumocystis jiroveci pneumonia(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 guidelines can 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 guidelines can be used:

• 6 weeks to 5 months: it is recommended to use Septrin Pediatric 8 mg/40 mg/ml administering 2.5 ml of 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: 2 tablets of Septrin Pediatric 20 mg/100 mg tablets or 5 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension (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: 4 tablets of Septrin Pediatric 20 mg/100 mg tablets or 10 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension (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.

It is also possible to administer the above doses in a single dose, 3 times a week on consecutive days. The daily dose administered on a treatment day is approximately 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 3 times a week.
• 160 mg of trimethoprim/ 800 mg of sulfamethoxazole daily.

Children:150 mg of trimethoprim/m2 of body surface/day and 750 mg of sulfamethoxazole/m2 of 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 available

Granuloma Inguinale (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 completely disappeared. 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 immunodepressed patients, treatment should be longer. All patients with CNS involvement should be treated for at least one year.

Brucellosis

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 tablet of Septrin Forte 160 mg/ 800 mg tablets/ 12 hours or 2 tablets of 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 20 mg/100 mg tablets than you should

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

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

If vomiting does not appear, it should be induced. Gastric lavage should be performed. Depending on the state of renal function, it is recommended to administer fluids if urine 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 Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Septrin Pediatric 20 mg/100 mg tablets

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

4. Possible side effects

Like all medicines, Septrin Pediatric 20 mg/100 mg tablets can cause side effects, although not everyone gets them.

The side effects described for Septrin Pediatric 20 mg/100 mg tablets are classified by frequency and are as follows:

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

• Frequent (may affect up to 1 in 10 people): candidiasis (overgrowth of the Candida fungus), headache, nausea, diarrhea, and skin rashes.

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

• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions with eosinophilia (increase in a certain type of white blood cells) and systemic symptoms.

• Very rare (may affect up to 1 in 10,000 people): leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of a certain type of white blood cells), thrombocytopenia (decrease in the number of platelets), agranulocytosis (decrease in the number of a certain type of white blood cells), megaloblastic anemia (decrease in the number of red blood cells and increase in their size), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (characterized by an insufficient number of red blood cells), methemoglobinemia (inability of hemoglobin to transport oxygen), eosinophilia (abnormally high amount of a certain type of white blood cells), purpura (red spots on the skin), hemolysis (breakdown of red blood cells) in certain susceptible patients deficient in G-6-PD.

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

Hypoglycemia (low blood sugar), hyponatremia (low sodium in the blood), anorexia (metabolic disorder). Depression, hallucinations, aseptic meningitis, seizures, peripheral neuritis (lesion and deterioration of peripheral nerves), ataxia (loss of coordination), vertigo, tinnitus (ringing in the ears), dizziness, cough, difficulty breathing, pulmonary infiltrates, glossitis (inflammation of the tongue), stomatitis (lesions in the mouth), pseudomembranous colitis (inflammation of the colon), pancreatitis (inflammation of the pancreas), hepatobiliary disorders (alteration of liver function), photosensitivity (skin reaction produced by interaction with light), exfoliative dermatitis (severe inflammation of the entire skin surface), fixed drug eruption (allergic reaction), erythema multiforme (allergic reaction that affects the skin), arthralgia (joint pain), myalgia (muscle pain), alteration of renal function, uveitis (inflammation of the eye). Skin rashes that can threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2: Warnings and precautions).

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

some cases, skin rashes that can threaten the patient's life have been observed, such as purple-colored, raised, and painful blisters on the extremities and sometimes on the face and neck, with fiber (Sweet's syndrome) (see section 2: Warnings and precautions).

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

• Very rare side effects (may affect up to 1 in 10,000 people) related to the treatment of Pneumocystis jiroveci pneumonia (P. carinii): severe hypersensitivity reactions, rashes, fever, neutropenia (decrease in the number of a certain type of white blood cells), thrombocytopenia (decrease in the number of platelets), increase in liver enzymes, hyperkalemia (high potassium level), hyponatremia (low sodium in the blood), and rhabdomyolysis (destruction or inflammation of muscle tissue that causes severe muscle pain and weakness).

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this prospectus.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Septrin Pediatric 20 mg/100 mg tablets

No special storage conditions are required.

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

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

Deposit the packaging and medicines that are no longer needed in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Septrin Pediatric 20 mg/100 mg tablets

• The active ingredients are trimethoprim and sulfamethoxazole. Each tablet contains 20 mg of trimethoprim and 100 mg of sulfamethoxazole.
• The other components are: sodium carboxymethyl starch (type A) (derived from potato starch), polyvinylpyrrolidone K30 (povidone), sodium docusate, magnesium stearate.

Appearance of the product and package contents

Septrin Pediatric 20 mg/100 mg tablets are white, round (with a diameter of approximately 7.4 mm), biconvex, and scored tablets.

PVC/Aluminum blisters of 20 tablets and 100 tablets.

Marketing authorization holder

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Manufacturer

Alcalá Farma, S.L

Avenida de Madrid 82, Alcalá de Henares

28802 Madrid Spain

Other presentations

• Septrin 80 mg/400 mg tablets.

Packaging of 20 and 100 tablets.

• Septrin Forte 160 mg/800 mg tablets.

Packaging of 20 and 50 tablets.

• Septrin Pediatric 8 mg/40 mg/ml oral suspension.

Package with 100 ml.

Date of the last revision of this prospectus: August 2021

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