Tediprima 16 mg/ml oral suspension

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Tediprima 16mg/ml oral suspension

trimethoprim

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 you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Tediprima is and what it is used for
2. What you need to know before taking Tediprima
3. How to take Tediprima
4. Possible side effects
5. How to store Tediprima
6. Contents of the pack and other information

1. What Tediprima is and what it is used for

This medicine belongs to a family of medicines called antibiotics, which kill bacteria that cause infections. It is used to treat urinary and respiratory tract infections.

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 any antibiotic remains after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the sink or in household waste.

2. What you need to know before taking Tediprima

Do not take Tediprima

• If you are allergic to trimethoprim, other diaminopyrimidines, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe hematological disorders such as megaloblastic anemia.
• In combination with dofetilide (a medicine used to control irregular or rapid heartbeats).
• Do not administer to children under 1 year of age.
• If you are pregnant (first 3 months), think you may be pregnant, or are breastfeeding (see section Pregnancy and breastfeeding).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking trimethoprim.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Tediprima. Be especially careful with Tediprima:

• If you have megaloblastic anemia (due to folate deficiency).
• If you have kidney disease.
• If you have liver disease.
• If you are elderly, as you may be more sensitive to the medicine.
• If you have porphyria (a blood disorder in which hemoglobin is not properly produced).
• If you are taking phenytoin, your doctor may closely monitor plasma levels.
• If you have phenylketonuria (a metabolic disorder affecting the phenylalanine enzyme), since administration of trimethoprim alters phenylalanine metabolism. This is not a concern in patients on an appropriate restricted diet.
• If you are at risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need to monitor blood potassium and sodium levels.

Severe skin reactions that may be life-threatening, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with trimethoprim treatment. These initially appear as red spots or circular patches, often with a central blister. Discontinue trimethoprim and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Additional signs that may occur include mouth sores, throat, nose, 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 highest risk period for developing 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 Tediprima, you must never take Tediprima again.

If you develop skin rashes or these skin symptoms, stop taking Tediprima immediately, consult a doctor without delay, and inform them 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.

Due to colonization with Clostridioides difficile, the use of Tediprima may very rarely lead to pseudomembranous colitis, which manifests as diarrhea.

Other medicines and Tediprima

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

Tediprima 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), as you may be at higher risk of hyponatremia (low sodium levels).
• Oral anticoagulants such as warfarin, as trimethoprim may enhance its anticoagulant activity. Careful monitoring of anticoagulant therapy is advised during Tediprima use.
• 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.
• Certain medicines used to treat human immunodeficiency virus (HIV): antiretrovirals (zidovudine). Combined treatment with Tediprima and zidovudine may increase the risk of hematological adverse reactions to trimethoprim; blood parameter monitoring should be considered.
• Folic acid antagonists such as phenytoin (used to treat epilepsy) and methotrexate (used to treat various types of cancer and also rheumatoid arthritis). When trimethoprim and phenytoin are co-administered, excessive phenytoin effects should be considered. If Tediprima is given with methotrexate, administration of a folic acid supplement should be considered.
• Medicines used in transplant patients: immunosuppressants (cyclosporine). In patients treated with trimethoprim 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 after co-administration with trimethoprim.
• May reduce the effectiveness of oral contraceptives.
• Administration together with antacids may reduce trimethoprim blood levels.
• When trimethoprim is administered with drugs such as procainamide or amantadine, there may be an increased plasma concentration of one or both drugs.

Tediprima may interfere with serum methotrexate testing.

Taking Tediprima with food and drinks

It is recommended to take this medicine on an empty stomach to enhance gastrointestinal absorption.

Pregnancy and breastfeeding

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. Your doctor will decide whether or not to use Tediprima.

This medicine should not be taken during the first three months of pregnancy. Treatment with trimethoprim during the first trimester of pregnancy may increase the risk of spontaneous abortion. Children born to mothers treated with trimethoprim during the first trimester may have an increased risk of congenital malformations, particularly neural tube defects (where the spine and spinal cord do not form properly), oral clefts (where the lip and palate do not form correctly), and heart defects.

This medicine is not recommended during breastfeeding.

Driving and using machines

Tediprima does not affect the ability to drive or operate machinery.

Tediprima contains methyl parahydroxybenzoate (E-218)

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate.

Tediprima contains sorbitol

This medicine contains 2.45 g of sorbitol in each 10 ml of oral suspension.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Tediprima contains propylene glycol (E-1520)

This medicine contains 37.1 mg of propylene glycol in each 10 ml of oral suspension.

3. How to take Tediprima

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

Depending on the nature of your illness, age, and weight, your doctor will prescribe the appropriate dose and inform you of the duration of treatment. Do not stop treatment early, as otherwise the intended effect will not be achieved.

The recommended dose in adults and children over 12 years of age is as follows:

• Pneumocystis jirovecii pneumonia in combination with dapsone: the dose of trimethoprim is 5 mg/kg every 6–8 hours for 21 days.
• Acute uncomplicated urinary tract infections: 320 mg of trimethoprim per day, divided into doses every 12 hours or as a single dose at night, for three days. For this indication, the capsule formulation is recommended.
• Prophylaxis of recurrent urinary tract infection (more than 3 per year): Once the infection has resolved, administration of 100 mg of trimethoprim per day (6.5 ml of suspension) is recommended. Nighttime administration helps achieve high urinary concentrations. In women whose recurrent infections are related to sexual activity, it is recommended to take the dose immediately after intercourse.

Use in patients with renal impairment

Your doctor will adjust the dose according to the degree of renal impairment.

The dose should be adjusted based on creatinine clearance (CrCl):

• CrCl greater than 30 ml/min: normal dose.
• CrCl 30–15 ml/min: half the normal dose.
• CrCl less than 15 ml/min: not recommended.

Use in children

• Pneumocystis jirovecii pneumonia in combination with dapsone: safety and efficacy have not been established in children under 12 years of age for this indication.
• Acute uncomplicated urinary tract infections:
  • Children 6–12 years: 80 mg of trimethoprim (5 ml of suspension) every 12 hours.
  • Children 3–6 years: 40 mg of trimethoprim (2.5 ml of suspension) every 12 hours.
  • Children 1–3 years: 40 mg of trimethoprim (2.5 ml of suspension) per day.
• Prophylaxis of recurrent urinary tract infection: 2–3 mg/kg/day as a single daily dose. Nighttime administration helps achieve high urinary concentrations.

The minimum dose is 40 mg of trimethoprim per day (2.5 ml of suspension). The average dose is 160 mg of trimethoprim per day (10 ml of suspension). The maximum dose is 240 mg of trimethoprim per day (15 ml of suspension).

The use of Tediprima is not recommended in children under one year of age.

If you take more Tediprima than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount ingested.

Symptoms of Tediprima overdose are mainly fever, nausea, vomiting, and diarrhea.

If you forget to take Tediprima

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Common (may affect between 1 and 10 out of 100 patients): nausea, vomiting, abdominal pain, glossitis (inflammation of the tongue), unusual taste, pruritus, skin rashes.

Rare (may affect between 1 and 10 out of 10,000 patients): exfoliative dermatitis (severe inflammation of the entire skin surface), erythema multiforme (allergic reaction affecting the skin), serious skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis), photosensitivity reactions (skin reaction caused by interaction with light), hepatobiliary disorders (liver function abnormalities), increased liver enzymes, renal function impairment (increased blood creatinine and nitrogen levels), megaloblastic anemia (decreased number of red blood cells with increased size), thrombocytopenia (decreased number of platelets), neutropenia (decreased number of a certain type of white blood cells), leucopenia (decreased number of white blood cells), methemoglobinemia (inability of hemoglobin to carry oxygen), fever.

Very rare: severe hypersensitivity reactions, anaphylaxis (severe allergic reaction), angioedema (fluid retention in the skin and mucous membranes), aseptic meningitis, hallucinations.

Stop using trimethoprim and seek immediate medical attention if you notice any of the following symptoms:

• Red spots on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)).
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

During prolonged treatment, special attention should be paid to detecting any signs of drug toxicity such as fever, sore throat, skin rashes, mouth ulcers, bluish discoloration of fingertips, lips, and skin, and bleeding. If any of these symptoms occur, you should immediately consult your doctor.

Reporting of adverse effects

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

5. Storage of Tediprima

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to 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 the SIGRE point at your pharmacy. If in doubt, 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 Tediprima

• The active substance is trimethoprim. Each 5 ml of suspension contains 80 mg of trimethoprim.
• The other components are microcrystalline cellulose, methyl parahydroxybenzoate (E 218), sodium carboxymethylcellulose, sodium saccharin, sorbitol (E 420), polysorbate 60, strawberry flavour (containing propylene glycol E-1520 and triacetin E-1518), and purified water.

Appearance of the medicine and contents of the pack

Tediprima is a white oral suspension with a strawberry odour and flavour. It is supplied in 100 ml amber PET bottles containing oral suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona - Spain

Manufacturer

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Laboratorio Aldo-Unión, S.L.

C/ Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

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

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