Septrin Pediatric 20 mg/100 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Septrin Paediatric 20 mg/100 mg tablets

(trimethoprim/sulfamethoxazole)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet.

Leaflet contents:

1. What Septrin Paediatric 20 mg/100 mg tablets are and what they are used for
2. What you need to know before taking Septrin Paediatric 20 mg/100 mg tablets
3. How to take Septrin Paediatric 20 mg/100 mg tablets
4. Possible side effects
5. How to store Septrin Paediatric 20 mg/100 mg tablets
6. Contents of the pack and other information

1. What Septrin Pediátrico 20 mg/100 mg tablets are and what they are used for

Septrin Pediátrico is an antibiotic that kills bacteria causing infections. It contains two different active substances called trimethoprim and sulfamethoxazole (a sulfonamide).

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

Septrin Pediátrico may also be useful in treating other infections: middle ear infections, lung infections in patients with chronic bronchitis, urinary tract infections (bladder, kidneys), infectious diarrhoea, treatment of toxoplasmosis, genital and/or perianal lesions (granuloma inguinale or donovanosis), and brucellosis.

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

Do not take Septrin Pediátrico 20 mg/100 mg tablets

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Septrin Pediátrico 20 mg/100 mg tablets.

• In elderly patients, as they may be more likely to experience serious side effects.
• If you have kidney problems (known renal insufficiency). Your doctor should take special precautions. To ensure adequate renal elimination, it is important that the patient receives an adequate fluid intake and that urinary pH is maintained within normal limits, avoiding acidification of the urine.
• If you have liver problems (severe hepatic parenchymal damage).
• If you have severe blood disorders, except when under close medical supervision.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• Septrin Pediátrico must not be used in the treatment of pharyngitis caused by β-hemolytic streptococcus Group A (S. pyogenes).
• If you take Septrin Pediátrico for a long time, or if you have folate deficiency, or if you are elderly, your doctor may request blood tests to monitor blood counts.
• If you are at risk of hyperkalemia (high potassium levels) or hyponatremia (low sodium levels), your doctor will consider the need for monitoring blood potassium and sodium levels.
• If you have phenylketonuria (a metabolic disorder affecting the enzyme phenylalanine), as trimethoprim administration alters phenylalanine metabolism. This is not a problem in patients on an appropriate restrictive diet.
• Septrin Pediátrico may interfere with the results of certain laboratory tests.
• Although this medicine is indicated for use in children from 6 weeks of age, your doctor may decide not to administer Septrin to children under 3 months.

Rare cases of death due to severe reactions including fulminant hepatic necrosis (severe liver damage), agranulocytosis (reduction in the number of certain white blood cells), aplastic anemia (failure of the bone marrow to produce various types of blood cells), other blood disorders, and respiratory hypersensitivity have been reported.

Skin rashes that may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and acute febrile neutrophilic dermatosis or Sweet's syndrome) have been reported with the use of Septrin Pediátrico. These initially appear as spots or circular red patches, often with a central blister.

Additional symptoms that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

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 of developing severe skin reactions occurs during the first weeks of treatment.

If you have previously experienced Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis with the use of Septrin Pediátrico, you must never use Septrin Pediátrico again.

If you develop a rash or these skin symptoms, stop taking Septrin Pediátrico immediately, seek medical attention right away, and inform your doctor that you are taking this medicine.

If you experience a severe skin reaction: a red, scaly rash with lumps under the skin and blisters (acute generalized exanthematous pustulosis), contact your 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 cells) and systemic symptoms associated with the use of Septrin have been reported.

Due to colonization with Clostridium difficile, the use of Septrin may very rarely lead to pseudomembranous colitis, which presents as diarrhea.

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

Haemophagocytic lymphohistiocytosis

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

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

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

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

• Medicines used to increase urine output: diuretics (especially thiazides). Concomitant administration of diuretics with trimethoprim/sulfamethoxazole in elderly patients may carry a higher risk of thrombocytopenia (reduced platelet count) and hyponatremia (low sodium levels).
• Oral anticoagulants such as warfarin. Trimethoprim/sulfamethoxazole enhances the anticoagulant activity of warfarin. Careful monitoring of anticoagulant therapy is advised during the use of Septrin Pediátrico.
• Certain medicines used to control blood glucose or blood sugar: oral hypoglycemics or antidiabetics (sulfonylureas).
• Medicines used to treat heart problems (digoxin). Combined use of trimethoprim and digoxin has shown increased digoxin levels in some elderly patients.
• Medicines used to treat infections caused by certain parasites (pyrimethamine). Concomitant administration of trimethoprim/sulfamethoxazole with pyrimethamine doses exceeding 25 mg per week may lead to the development of megaloblastic anemia (reduced number of red blood cells and increased size of the cells).
• Certain medicines used to treat human immunodeficiency virus (HIV): antiretrovirals (lamivudine, zidovudine). Combined treatment with Septrin Pediátrico and zidovudine may increase the risk of hematological adverse reactions to trimethoprim/sulfamethoxazole; monitoring of blood parameters should be considered.
• Folic acid antagonists such as phenytoin (used in the treatment of epilepsy) and methotrexate (used to treat various types of cancer and also rheumatoid arthritis). When trimethoprim/sulfamethoxazole and phenytoin are administered together, excessive phenytoin effects should be considered. If Septrin Pediátrico is administered with methotrexate, administration of a folic acid supplement should be considered.
• Medicines used in organ transplantation: immunosuppressants (cyclosporine). In patients treated with trimethoprim/sulfamethoxazole and cyclosporine, reversible deterioration in renal function after kidney transplantation has been observed.
• Medicines that may cause hyperkalemia (increased blood potassium levels).
• 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 together with drugs such as procainamide or 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 during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. A high-dose folic acid supplement (up to 4 or 5 mg/day) may be considered if trimethoprim/sulfamethoxazole is used during pregnancy.

Administration of Septrin Pediátrico to the mother before delivery may pose a theoretical risk of kernicterus (a serious neurological complication due to elevated bilirubin levels in the blood) in the newborn. This theoretical risk is particularly important in infants at higher risk of hyperbilirubinemia, such as premature infants or those with glucose-6-phosphate dehydrogenase deficiency.

Administration of trimethoprim/sulfamethoxazole should be avoided in the late stages of pregnancy and in breastfeeding mothers when either the mother or the infant has, or is particularly at risk of developing, hyperbilirubinemia.

The medicine is excreted in breast milk.

Driving and using machines

The influence of Septrin Pediátrico on the ability to drive and use machines is none or negligible.

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

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

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Septrin Paediatric 20 mg/100 mg tablets. Do not stop treatment prematurely.

Septrin Paediatric 20 mg/100 mg tablets should preferably be taken after food. Swallow the tablets with a sufficient amount of liquid. If desired, the specified doses may 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 required dose.

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

Standard dose

• Adults and children over 12 years of age: Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

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

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

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

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

• 6 to 12 years: 4 tablets of Septrin Paediatric 20 mg/100 mg tablets every 12 hours or 10 ml of Septrin Paediatric 8 mg/40 mg/ml oral suspension every 12 hours (80 mg trimethoprim/400 mg sulfamethoxazole every 12 hours).

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

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

Special dosing

Elderly patients: (see section 2: Warnings and precautions). If not otherwise indicated, the standard dose should be used.

Renal impairment:

Adults and children over 12 years (information not available for children under 12 years):

Creatinine clearance (ml/min) Recommended dose

30 Standard dose

15–30 Half the standard dose

< 15 Not recommended

Your doctor may perform blood tests every 2–3 days to monitor drug levels in the blood.

Pneumocystis jiroveci pneumonia (P. carinii)

Treatment

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

Prophylaxis (prevention)

Adults: Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

The following dosing regimens may be used:

• 160 mg trimethoprim/800 mg sulfamethoxazole daily, 7 days per week.
• 160 mg trimethoprim/800 mg sulfamethoxazole three times weekly, on alternate days.
• 160 mg trimethoprim/800 mg sulfamethoxazole twice daily, three times weekly, on alternate days.

Children

The following dosing regimens may be used:

• 6 weeks to 5 months: Septrin Paediatric 8 mg/40 mg/ml is recommended, administering 2.5 ml oral suspension (20 mg trimethoprim/100 mg sulfamethoxazole) twice daily, 7 days per week, or 3 times weekly on alternate days, or 3 times weekly on consecutive days.

• 6 months to 5 years: 2 tablets of Septrin Paediatric 20 mg/100 mg tablets or 5 ml of Septrin Paediatric 8 mg/40 mg/ml oral suspension (40 mg trimethoprim/200 mg sulfamethoxazole) twice daily, 7 days per week, or 3 times weekly on alternate days, or 3 times weekly on consecutive days.

• 6 to 12 years: 4 tablets of Septrin Paediatric 20 mg/100 mg tablets or 10 ml of Septrin Paediatric 8 mg/40 mg/ml oral suspension (80 mg trimethoprim/400 mg sulfamethoxazole) twice daily, 7 days per week, or 3 times weekly on alternate days, or 3 times weekly on consecutive days.

The above doses may also be administered as a single daily dose, three times weekly on consecutive days. The daily dose administered on a treatment day should approximate 150 mg trimethoprim/m²/day and 750 mg sulfamethoxazole/m²/day. The total daily dose must not exceed 320 mg trimethoprim and 1,600 mg sulfamethoxazole.

Toxoplasmosis

Primary prophylaxis (primary prevention)

Adults and children over 12 years: Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

• 80 mg trimethoprim/400 mg sulfamethoxazole daily.
• 160 mg trimethoprim/800 mg sulfamethoxazole three times weekly.
• 160 mg trimethoprim/800 mg sulfamethoxazole daily.

Children: 150 mg trimethoprim/m² body surface area/day and 750 mg sulfamethoxazole/m² body surface area/day in two divided doses. The total daily dose must not exceed 320 mg trimethoprim and 1,600 mg sulfamethoxazole.

Treatment

Adults: 5 mg/kg trimethoprim/25 mg/kg sulfamethoxazole every 12 hours for 6 weeks. Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

Children: No data available.

Granuloma inguinale (Donovanosis)

Adults: 160 mg trimethoprim/800 mg sulfamethoxazole twice daily for at least 3 weeks or until all lesions have completely resolved. Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

Nocardiosis

10–15 mg/kg/day trimethoprim / 50–75 mg/kg/day 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 must be treated for at least one year.

Brucellosis

Adults and children over 8 years: Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets are recommended.

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

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

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

Melioidosis

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

If you take more Septrin Paediatric 20 mg/100 mg tablets than you should

Symptoms of overdose include: nausea, vomiting, dizziness, and confusion.

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

If vomiting does not occur, it should be induced. Gastric lavage should be performed. Depending on renal function, administration of fluids is recommended if urinary excretion is low.

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

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

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

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

4. Possible adverse effects

Like all medicines, Septrin Pediatric 20 mg/100 mg tablets can cause adverse effects, although not everyone will experience them.

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

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

• Common (may affect up to 1 in 10 people): candidiasis (overgrowth of 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 (reduced number of white blood cells), neutropenia (reduced number of a certain type of white blood cells), thrombocytopenia (reduced number of platelets), agranulocytosis (reduced number of a certain type of white blood cells), megaloblastic anemia (reduced number of red blood cells with increased size), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (characterized by insufficient number of red blood cells), methemoglobinemia (inability of hemoglobin to carry oxygen), eosinophilia (abnormally high number of a certain type of white blood cells), purpura (reddish skin spots), hemolysis (rupture of red blood cells) in certain susceptible patients with G-6-PD deficiency.

Serum sickness (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 resembling Henoch-Schönlein purpura (inflammation mainly affecting small blood vessels), polyarteritis nodosa (vascular disease), systemic lupus erythematosus (autoimmune disease).

Hypoglycemia (decreased blood glucose), hyponatremia (decreased blood sodium), anorexia (metabolic disorder). Depression, hallucinations, aseptic meningitis, seizures, peripheral neuritis (damage and deterioration of peripheral nerves), ataxia (loss of coordination), dizziness, tinnitus (ringing in the ears), vertigo, 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 abnormalities), photosensitivity (skin reaction caused by interaction with light), exfoliative dermatitis (severe inflammation of the entire skin surface), fixed drug eruption (allergic reaction), erythema multiforme (allergic reaction affecting the skin), arthralgia (joint pain), myalgia (muscle pain), renal function impairment, uveitis (inflammation of the eye). Skin rashes may occur that could be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2: Warnings and precautions).

• Frequency not known (cannot be estimated from available data): In some cases, skin rashes that may threaten the patient's life have been observed, such as plum-colored, raised, and painful lesions on the limbs and sometimes on the face and neck, accompanied by fever (Sweet's syndrome) (see section 2: Warnings and precautions).

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

• Very rare adverse effects (may affect up to 1 in 10,000 people) associated with treatment of Pneumocystis jiroveci (P. carinii) pneumonia: severe hypersensitivity reactions, rashes, fever, neutropenia (reduced number of a certain type of white blood cells), thrombocytopenia (reduced number of platelets), increased liver enzymes, hyperkalemia (high potassium levels), hyponatremia (decreased blood sodium), and rhabdomyolysis (muscle breakdown or inflammation causing severe muscle pain and weakness).

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

Reporting of adverse effects:

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

5. Storage 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Dispose of unused containers and medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Septrin Pediátrico 20 mg/100 mg tablets

• The active substances 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 contents of the pack

Septrin Pediátrico 20 mg/100 mg tablets are white, round (with an approximate diameter of 7.4 mm), biconvex, and scored tablets.

PVC/Aluminum blisters containing 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.

Packs of 20 and 100 tablets.

• Septrin Forte 160 mg/800 mg tablets.

Packs of 20 and 50 tablets.

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

100 ml bottle.

Date of the most recent revision of this leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/