Septrin Forte 160 mg/800 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Septrin Forte 800 mg/160 mg tablets

(trimethoprim/sulfamethoxazole)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet

1. What Septrin Forte 800 mg/160 mg tablets are and what they are used for
2. What you need to know before taking Septrin Forte 800 mg/160 mg tablets
3. How to take Septrin Forte 800 mg/160 mg tablets
4. Possible side effects
5. How to store Septrin Forte 800 mg/160 mg tablets
6. Contents of the pack and other information

1. What Septrin Forte 80 mg/800 mg tablets are and what they are used for

Septrin Forte 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 influenza 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 should not be disposed of via wastewater or household waste.

Septrin Forte 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 Forte may also be useful in 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 Forte 160 mg/800 mg tablets

Do not take Septrin Forte 160 mg/800 mg tablets

• If you are allergic to sulfonamides, trimethoprim, co-trimoxazole, or any of the other components of this medicine (listed in section 6: Contents of the pack 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 taking Septrin Forte 160 mg/800 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 precautions. To ensure adequate renal elimination, adequate fluid intake should be maintained and urinary pH kept within normal limits, avoiding acidification of urine.
• If you have liver problems (severe hepatic parenchymal damage).
• If you have severe blood disorders, except under close medical supervision.
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD).
• Septrin Forte must not be used in the treatment of β-hemolytic streptococcal pharyngitis Group A (S. pyogenes).
• If you take Septrin Forte 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 may consider monitoring potassium and sodium levels in the blood.
• If you have phenylketonuria (a metabolic disorder affecting the enzyme phenylalanine), as trimethoprim administration alters phenylalanine metabolism. This is not a concern in patients on an appropriate restricted diet.
• Septrin Forte 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 Forte to children under 3 months.

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

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

Additional symptoms may include mouth ulcers, sore throat, nasal ulcers, genital lesions, and conjunctivitis (swollen and 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 severe skin reactions is during the first weeks of treatment.

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

If you develop a skin rash or any of these symptoms, stop taking Septrin Forte immediately, seek medical attention, 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 (increased levels of a certain type of white blood cell) and systemic symptoms have been reported with the use of Septrin.

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 skin rash occurring simultaneously or with a slight delay, contact your doctor immediately.

Taking Septrin Forte 160 mg/800 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 Forte 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). The concomitant use of diuretics with trimethoprim/sulfamethoxazole in elderly patients may increase the 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 treatment with Septrin Forte.
• Certain medicines used to control blood glucose (oral hypoglycemics or antidiabetics, such as sulfonylureas).
• Medicines used to treat heart conditions (digoxin). Concurrent use of trimethoprim and digoxin has shown increased digoxin levels in some elderly patients.
• Medicines used to treat parasitic infections (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 antiretroviral medicines used to treat human immunodeficiency virus (HIV) infection (lamivudine, zidovudine). Combined treatment with Septrin Forte 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 rheumatoid arthritis). When trimethoprim/sulfamethoxazole is administered with phenytoin, excessive phenytoin effects should be considered. When Septrin Forte is used with methotrexate, folic acid supplementation should be considered.
• Immunosuppressants used in transplant patients (cyclosporine). In patients treated with trimethoprim/sulfamethoxazole and cyclosporine, reversible deterioration in renal function has been observed after kidney transplantation.
• 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 when administered concomitantly with trimethoprim.

When trimethoprim is administered with drugs such as procainamide or amantadine, there may be an increase in the 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 Forte 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 relevant 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 infant has or is at particular risk of developing hyperbilirubinemia.

The medicine is excreted in breast milk.

Driving and using machines

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

3. How to take Septrin Forte 160 mg/800 mg tablets

Follow exactly the instructions for administering this medicine as stated in this leaflet or as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Septrin Forte 160 mg/800 mg tablets. Do not stop the treatment prematurely.

Septrin Forte 160 mg/800 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 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:

• 1 tablet of Septrin Forte 160 mg/800 mg every 12 hours.

Infants and children under 12 years: the pediatric formulations of Septrin are 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 1 tablet of Septrin Forte 160 mg/800 mg every 12 hours for three days is appropriate for urinary tract infections and infectious diarrhea.

Special dosage recommendations

Elderly patients: (see section 2: Warnings and precautions). Unless otherwise indicated, the standard dose should 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 monitor drug levels in the blood.

Pneumocystis jiroveci (P. carinii) pneumonia

Treatment

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

Prophylaxis (prevention)

Adults:

The following dosing regimens may be used:

• 1 tablet of Septrin Forte 160 mg/800 mg daily, 7 days a week.
• 1 tablet of Septrin Forte 160 mg/800 mg three times a week, on alternate days.
• 1 tablet of Septrin Forte 160 mg/800 mg twice daily, three times a week, on alternate days.

Children: for infants and children under 12 years, the pediatric formulations of Septrin are recommended.

Toxoplasmosis

Primary prophylaxis (primary prevention)

Adults and children over 12 years:

• 1 tablet of Septrin Forte 160 mg/800 mg three times a week.
• 1 tablet of Septrin Forte 160 mg/800 mg daily.
• 80 mg trimethoprim/400 mg sulfamethoxazole daily (in this case, the formulation Septrin 80 mg/400 mg tablets must be used).

Children: the pediatric formulations of Septrin are 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)

1 tablet of Septrin Forte 160 mg/800 mg twice daily for at least 3 weeks or until all lesions have completely resolved.

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 central nervous system (CNS) involvement should be treated for at least one year.

Brucellosis

Adults and children over 8 years:

1 tablet of Septrin Forte 160 mg/800 mg every 12 hours for 6 weeks.

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

Melioidosis

8 mg/kg/day trimethoprim and 40 mg/kg/day sulfamethoxazole (maximum 320 mg trimethoprim/1600 mg sulfamethoxazole) every 12 hours for 3–6 months.

If you take more Septrin Forte 160 mg/800 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, administration of fluids is recommended if urinary excretion 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 Forte 160 mg/800 mg tablets

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

4. Possible adverse effects

Like all medicines, Septrin Forte 160 mg/800 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 symptoms of shock.

The adverse effects described for Septrin Forte 160 mg/800 mg tablets are listed below by frequency:

• 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): leucopenia (decreased number of white blood cells), neutropenia (decreased number of a certain type of white blood cells), thrombocytopenia (decreased number of platelets), agranulocytosis (decreased number of a certain type of white blood cells), megaloblastic anemia (decreased number of red blood cells and increased size of red blood cells), aplastic anemia (failure of bone marrow 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 spots on the skin), hemolysis (rupture 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 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 (immune-type disease).

Hypoglycemia (low blood glucose), hyponatremia (low 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), 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 impairment), 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 be life-threatening have been observed, such as plum-colored, raised, and painful sores 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 lumps 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 jiroveci (P. carinii) pneumonia: severe hypersensitivity reactions, rashes, fever, neutropenia (decreased number of a certain type of white blood cells), thrombocytopenia (decreased number of platelets), increased liver enzymes, hyperkalemia (high potassium levels), hyponatremia (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 effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Forte 160 mg/800 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.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located 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 Forte 160 mg/800 mg tablets

• The active substances are trimethoprim and sulfamethoxazole. Each tablet contains 160 mg of trimethoprim and 800 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 Forte 160 mg/800 mg tablets are white, oval, biconvex, and scored tablets.

PVC/Aluminum blisters containing 20 tablets and 50 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 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 revision 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/