Septrin 80 mg/400 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Septrin 80 mg/400 mg tablets

(trimethoprim/sulfamethoxazole)

Read the entire leaflet carefully before you start taking 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What Septrin 80 mg/400 mg tablets are and what they are used for
2. What you need to know before taking Septrin 80 mg/400 mg tablets
3. How to take Septrin 80 mg/400 mg tablets
4. Possible side effects
5. How to store Septrin 80 mg/400 mg tablets
6. Contents of the pack and other information

1. What Septrin 80 mg/400 mg tablets are and what they are used for

Septrin is an antibiotic that kills bacteria causing infections. It contains two different drugs 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 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 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 80 mg/400 mg tablets

Do not take Septrin 80 mg/400 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 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

Consult your doctor or pharmacist before starting to take Septrin 80 mg/400 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 will need to take special precautions. To ensure adequate renal elimination, ensure the patient receives adequate fluid intake and that urinary pH is maintained within normal limits, avoiding acidification of 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 should not be used in the treatment of Group A β-hemolytic streptococcal pharyngitis (S. pyogenes).
• If you take Septrin for a long time or if you have folate deficiency or 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 potassium and sodium levels in the blood.
• If you have phenylketonuria (a metabolic disorder affecting the phenylalanine enzyme), as trimethoprim administration alters phenylalanine metabolism. This is not a concern in patients on an appropriate restricted diet.
• Septrin 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 have occurred, 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.

Life-threatening skin rashes (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. These initially appear as red spots or circular lesions, often with a central blister.

Additional symptoms that may occur include mouth ulcers, sore throat, nasal ulcers, genital ulcers, and conjunctivitis (swollen, red eyes).

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

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

If you have previously experienced Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis while taking Septrin, you must never take Septrin again.

If you develop a skin rash or any of these symptoms, stop taking Septrin 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 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 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 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, which may 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.

Taking Septrin 80 mg/400 mg tablets with other medicines

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

Septrin 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 effect of warfarin. Close monitoring of anticoagulant therapy is advised during use of Septrin.

• Certain medicines used to control blood glucose (sugar): oral hypoglycemics or antidiabetics (sulfonylureas).

• Medicines used to treat heart problems (digoxin). Concurrent 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 megaloblastic anemia (reduced number of red blood cells with increased size).

• Certain medicines used to treat human immunodeficiency virus (HIV): antiretrovirals (lamivudine, zidovudine). Combined treatment with Septrin and zidovudine may increase the risk of hematological adverse reactions to trimethoprim/sulfamethoxazole; blood parameter monitoring should be considered.

• Folic acid antagonists such as phenytoin (used in the treatment of epilepsy) and methotrexate (used to treat various cancers and also rheumatoid arthritis). If trimethoprim/sulfamethoxazole and phenytoin are administered together, excessive phenytoin effects should be considered. If Septrin is given with methotrexate, folic acid supplementation 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 transplant has been observed.

• Medicines that may cause hyperkalemia (increased blood potassium).

• Medicines used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported following concomitant administration with trimethoprim.

When trimethoprim is administered 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. High-dose folic acid supplementation (up to 4 or 5 mg/day) may be considered if trimethoprim/sulfamethoxazole is used during pregnancy.

Administration of Septrin to the mother before delivery may pose a theoretical risk of kernicterus (a serious neurological complication due to elevated bilirubin levels in 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 at particular risk of developing, hyperbilirubinemia.

The medicine is excreted in breast milk.

Driving and using machines

The influence of Septrin on the ability to drive and operate machinery is negligible or none.

3. How to take Septrin 80 mg/400 mg tablets

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take Septrin 80 mg/400 mg tablets. Do not stop treatment early.

Septrin 80 mg/400 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 dose required.

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

Standard dose

Adults and children over 12 years:

• 2 tablets of Septrin 80 mg/400 mg tablets every 12 hours (160 mg trimethoprim/800 mg sulfamethoxazole/12 hours).

Infants and children under 12 years: Use of pediatric formulations of Septrin is recommended.

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 2 tablets of Septrin 80 mg/400 mg (160/800 mg trimethoprim-sulfamethoxazole) every 12 hours for three days is appropriate for the treatment of urinary tract infections and infectious diarrhea.

Special dosing

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

Patients with 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 measure the drug concentration in the blood.

Pneumocystis jiroveci pneumonia (P. carinii)

Treatment

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

Prophylaxis (prevention)

Adults:

The following dosing regimens may be used:

• 2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole) daily, 7 days per week.
• 2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole) three times per week, on alternate days.
• 2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole), twice daily, three times per week, on alternate days.

Children: In infants and children under 12 years, use of pediatric formulations of Septrin is recommended.

Toxoplasmosis

Primary prophylaxis (primary prevention)

Adults and children over 12 years:

• 1 tablet of Septrin 80 mg/400 mg daily.
• 2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole) three times per week.
• 2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole) daily.

Children: Use of pediatric formulations of Septrin is recommended.

Treatment

Adults (no data available in children): 5 mg/kg trimethoprim / 25 mg/kg sulfamethoxazole every 12 hours for 6 weeks.

Granuloma Inguinale (Donovanosis)

2 tablets of Septrin 80 mg/400 mg (160 mg trimethoprim/800 mg sulfamethoxazole) twice daily for a period of at least 3 weeks or until all lesions have completely healed.

Nocardiosis

10–15 mg/kg/day trimethoprim / 50–75 mg/kg/day sulfamethoxazole in two or more divided doses over 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.

Brucellosis

Adults and children over 8 years:

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

Children under 8 years (considered first-line treatment in this group): Use of pediatric formulations of Septrin is recommended.

Melioidosis

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

If you take more Septrin 80 mg/400 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 spontaneously, it should be induced. Gastric lavage should be performed. Depending on renal function status, administration of fluids is recommended if urinary elimination is low.

Both substances, trimethoprim and sulfamethoxazole, are dialyzable by hemodialysis. 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 80 mg/400 mg tablets

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

4. Possible adverse effects

Like all medicines, Septrin 80 mg/400 mg tablets can cause adverse effects, although not everyone will experience them.

Serious adverse effects

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 signs of shock.

The adverse effects described for Septrin 80 mg/400 mg tablets are listed below in order of frequency:

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

• Common (may affect up to 1 in 10 people): candidiasis (overgrowth of Candida fungus), headache, nausea, diarrhoea, 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): leucopenia (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 anaemia (reduced number of red blood cells with increased size), aplastic anaemia (failure of bone marrow to produce various types of blood cells), haemolytic anaemia (characterized by insufficient number of red blood cells), methaemoglobinaemia (inability of haemoglobin to carry oxygen), eosinophilia (abnormally high levels of a certain type of white blood cells), purpura (reddish skin spots), haemolysis (breakdown of red blood cells) in certain susceptible patients with G-6-PD deficiency. Serum sickness (hypersensitivity reaction similar to allergy), anaphylaxis (severe allergic reaction), allergic myocarditis (allergic reaction affecting the heart), angioedema (fluid retention in skin and mucous membranes), fever, allergic vasculitis resembling Henoch-Schönlein purpura (inflammation mainly affecting small blood vessels), polyarteritis nodosa (vascular disease), systemic lupus erythematosus (immune-type disease).

Hypoglycaemia (low blood glucose), hyponatraemia (low blood sodium), anorexia (metabolic disorder). Depression, hallucinations, aseptic meningitis, seizures, peripheral neuritis (nerve damage and deterioration), ataxia (loss of coordination), dizziness, 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 (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 have been observed that may be life-threatening, such as plum-coloured, 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 as soon as possible 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) related to treatment of Pneumocystis jirovecii (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, hyperkalaemia (high potassium levels), hyponatraemia (low 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 adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 80 mg/400 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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are 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 80 mg/400 mg tablets

• The active substances are trimethoprim and sulfamethoxazole. Each tablet contains 80 mg of trimethoprim and 400 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 80 mg/400 mg tablets are white, round (with an approximate diameter of 11 mm), biconvex and scored tablets.

PVC/Aluminum blisters of 20 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 Forte 160 mg/800 mg tablets.

Packs of 20 and 50 tablets.

• Septrin Pediatric 20 mg/100 mg tablets.

Packs of 20 and 100 tablets.

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

100 ml bottle.

Date of the most recent review of this leaflet: July 2025

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