Septrin Pediatric 8 mg/40 mg/ml oral suspension

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Septrin Pediatric 8 mg/40 mg/ml oral suspension

(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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet.

Leaflet Contents

1. What Septrin Pediatric 8 mg/40 mg/ml oral suspension is and what it is used for
2. What you need to know before taking Septrin Pediatric 8 mg/40 mg/ml oral suspension
3. How to take Septrin Pediatric 8 mg/40 mg/ml oral suspension
4. Possible side effects
5. How to store Septrin Pediatric 8 mg/40 mg/ml oral suspension
6. Contents of the pack and other information

1. What Septrin Pediatric 8 mg/40 mg/ml oral suspension is and what it is used for

Septrin Pediatric 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 dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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

2. What you need to know before taking Septrin Pediatric 8 mg/40 mg/ml oral suspension

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

• If you are allergic to sulfonamides, trimethoprim, cotrimoxazole, or any of the other components of this medicine (listed in section 6: Contents of the pack and further information).
• In case of premature infants and full-term infants under 6 weeks of age.
• If you have or think 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 starting to take Septrin Pediatric 8 mg/40 mg/ml oral suspension.

• 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 urine acidification.
• If you have liver problems (severe hepatic parenchymal damage).
• If you have serious 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 pharyngitis caused by Group A β-hemolytic streptococcus (S. pyogenes).
• If you take Septrin Pediatric 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 enzyme phenylalanine), as trimethoprim administration alters phenylalanine metabolism. This is not a problem in patients on an appropriate restricted diet.
• Septrin Pediatric 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 of age.

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 (bone marrow failure to produce various 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 Pediatric. These initially appear as red spots or circular lesions, often with a central blister.

Additional symptoms that may occur include mouth sores, sore throat, nasal ulcers, genital ulcers, and conjunctivitis (swollen, 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 period of highest risk 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, you must never use Septrin Pediatric again.

If you develop a skin rash or any of these symptoms, stop taking Septrin Pediatric 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 lumps 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 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 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 can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen lymph nodes, feeling weak, dizziness, shortness of breath, bruising, or concurrent or slightly delayed skin rash, contact your doctor immediately.

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

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

Septrin Pediatric may enhance the effect and/or toxicity of certain medicines. It is important to 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 combined 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. Careful monitoring of anticoagulant therapy is advised during the use of Septrin Pediatric.
• Certain medicines used to control blood glucose or blood sugar: oral hypoglycemics or antidiabetics (sulfonylureas).
• Medicines used to treat heart conditions (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). Concurrent 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 Pediatric 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 to treat epilepsy) and methotrexate (used to treat various cancers and rheumatoid arthritis). When trimethoprim/sulfamethoxazole and phenytoin are co-administered, excessive phenytoin effects should be considered. If Septrin Pediatric is administered 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 levels).
• Medicines used to control heart rhythm (Class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported after co-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 Pediatric 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 significant 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 influence of Septrin Pediatric on the ability to drive and use machines is negligible or none.

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

This medicine contains 0.27% ethanol (alcohol), corresponding to 0.00216 mg per 1 ml.

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

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

3. How to take Septrin Pediatric 8 mg/40 mg/ml oral suspension

Follow exactly the dosing instructions 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 determine how long your treatment with Septrin Pediatric 8 mg/40 mg/ml oral suspension should last. Do not stop treatment prematurely.

Septrin Pediatric 8 mg/40 mg/ml oral suspension should preferably be administered after food intake. It is recommended to shake well before use.

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

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

Standard Dose

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

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 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 of age (doses approximate 6 mg trimethoprim/30 mg sulfamethoxazole per kg/24 hours):

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

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

• 6 to 12 years: 10 ml of Septrin Pediatric 8 mg/40 mg/ml oral suspension every 12 hours or 4 tablets of Septrin Pediatric 20 mg/100 mg 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 re-evaluated.

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

Special Dosage Adjustments

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 of age (no data 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 per kg/day, divided into two or more 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 regimens may be used:

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

Children

The following regimens may be used:

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

The above doses may also be administered as a single dose three times per week on consecutive days. The daily dose administered on a treatment day approximates 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: It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

• 80 mg trimethoprim/400 mg sulfamethoxazole daily.
• 160 mg trimethoprim/800 mg sulfamethoxazole three times per week.
• 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. 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 trimethoprim/800 mg sulfamethoxazole twice daily for at least 3 weeks or until all lesions have completely resolved. 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 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: It is recommended to use Septrin 80 mg/400 mg tablets or Septrin Forte 160 mg/800 mg tablets.

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 Pediatric 8 mg/40 mg/ml oral suspension 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 Pediatric 8 mg/40 mg/ml oral suspension

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

4. Possible adverse effects

Like all medicines, Septrin Pediatric 8 mg/40 mg/ml oral suspension may cause adverse effects, although not everyone experiences 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 Pediatric 8 mg/40 mg/ml oral suspension 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 and increased size of these cells), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (characterized by insufficient red blood cells), methemoglobinemia (inability of hemoglobin to transport 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 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 (reduced blood glucose), hyponatremia (reduced 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 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 have been observed that may threaten the patient's life, such as plum-colored, raised, and painful lesions on the extremities 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, hyperkalemia (high potassium levels), hyponatremia (reduced 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, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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 Pediatric 8 mg/40 mg/ml oral suspension

Do not store above 25°C.

Keep in the original packaging to protect from light.

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

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 unused medicines and their containers at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substances are trimethoprim and sulfamethoxazole. Each ml of Septrin Pediátrico oral suspension contains 8 mg of trimethoprim and 40 mg of sulfamethoxazole.
• Other components are: sorbitol (70%), glycerol (E-422), dispersible cellulose, sodium carboxymethylcellulose, polysorbate 80, methyl 4-hydroxybenzoate (E-218), sodium benzoate (E-211), sodium saccharin, banana flavour (propylene glycol E-1520, sodium citrates E-331), 96% ethanol, vanilla flavour (benzyl alcohol, caramel colouring E-150d, propylene glycol E-1520, glycerol E-422, water) and purified water.

Nature of the product and pack size

Septrin Pediátrico 8 mg/40 mg/ml oral suspension is a whitish suspension with a characteristic banana and vanilla odour.

Amber glass bottles with metallic screw caps containing 100 ml.

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

or

Teofarma S.r.l.

Viale Certosa, 8/A

27100 Pavia

Italy

Other presentations

• Septrin Pediátrico 20 mg/100 mg tablets.

Pack sizes of 20 and 100 tablets.

• Septrin 80 mg/400 mg tablets.

Pack sizes of 20 and 100 tablets.

• Septrin Forte 160 mg/800 mg tablets.

Pack sizes of 20 and 50 tablets.

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/