Package Insert: Information for the Patient

Tediprima 16mg/ml Oral Suspension

Trimethoprim

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 not listed in this package insert. See section 4.

This medication belongs to a family of medications called antibiotics, which eliminate bacteria that cause infections. It is used for the treatment of urinary and respiratory infections.

Do not take Tediprima

• If you are allergic to trimetoprima, other diaminopirimidinas, or any of the other components of this medication (listed in section 6).
• If you have severe hematological disorders such as megaloblastic anemia.
• In combination with dofetilida (a medication used to control irregular or rapid heartbeats).
• Do not administer to children under 1 year.
• If you may be pregnant or are breastfeeding (see Pregnancy and lactation section).

Warnings and precautions

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

• If you have megaloblastic anemia (folate deficiency).
• If you have kidney diseases.
• If you have liver diseases.
• If you are an elderly person as you may be more sensitive to the medication.
• If you have porphyria (a blood disorder in which hemoglobin is not produced adequately).
• If you are taking phenytoin, your doctor may perform a strict plasma level check.
• If you have phenylketonuria (a metabolic disorder that affects the enzyme phenylalanine), as trimetoprima administration alters phenylalanine metabolism. This does not pose a problem in patients with an adequate restrictive diet.
• If you have a risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need for a blood potassium and sodium check.

Severe skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular psoriasis, and acute febrile neutrophilic dermatosis or Sweet syndrome) have been described with the use of Tediprima. Initially, they appear as red circular spots or patches, often with a central blister.

Additional signs that may appear include mouth, throat, nose, genital, and conjunctivitis (swollen and red eyes) lesions.

These life-threatening skin eruptions, often accompanied by flu-like symptoms, may progress to generalized blistering or skin peeling.

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

If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute febrile neutrophilic dermatosis with Tediprima use, do not use Tediprima again at any time.

If you develop skin eruptions or these symptoms, stop taking Tediprima, immediately see a doctor, and inform them that you are taking this medication.

If you experience a severe skin reaction: a red, scaly rash with subcutaneous nodules and blisters (acute generalized pustular psoriasis), contact a doctor as soon as possible and inform them that you are taking this medication.

As a result of colonization with Clostridioides difficile, Tediprima use may lead to very rare cases of pseudomembranous colitis, which manifests through diarrhea.

Other medications and Tediprima

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

Tediprima may potentiate the effect and/or toxicity of some medications. It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Diuretics, as you may have a higher risk of hyponatremia (low sodium levels).
• Oral anticoagulants such as warfarin, as trimetoprima may potentiate their anticoagulant activity. A careful anticoagulant treatment control is recommended during Tediprima use.
• Some medications used to control blood sugar or glucose levels: hypoglycemics or oral antidiabetics (sulfonilurea).
• Medications used to treat heart problems (digoxin). The concurrent use of trimetoprima and digoxin has shown an increase in digoxin levels in some elderly patients.
• Certain medications used to treat HIV: antiretrovirals (zidovudine). The concurrent treatment of Tediprima with zidovudine may increase the risk of adverse hematological reactions to trimetoprima, and a blood parameter follow-up should be considered.
• Medications that antagonize folic acid, such as phenytoin (used to treat epilepsy) and methotrexate (used to treat various types of cancer and also to treat rheumatoid arthritis). If trimetoprima and phenytoin are administered, the excessive effect of phenytoin should be considered. If Tediprima is administered with methotrexate, the administration of a folate supplement should be considered.
• Medications used in transplants: immunosuppressants (ciclosporina). In patients treated with trimetoprima and ciclosporina, a reversible deterioration in renal function has been observed after a kidney transplant.
• Medications that cause hyperkalemia (elevated potassium levels).
• Medications used to control heart rhythm (class III antiarrhythmics), such as dofetilida. Elevated plasma levels of dofetilida have been reported after concurrent administration with trimetoprima.
• Tediprima may decrease the effectiveness of oral contraceptives.
• The administration with antacids may decrease trimetoprima levels in the blood.
• When trimetoprima is administered with medications such as procainamide or amantadine, there is a possibility of increased plasma concentrations of one or both medications.

Tediprima may interfere with the methotrexate serum test.

Taking Tediprima with food and drinks

It is recommended to administer this medication on an empty stomach to favor its digestive absorption.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. The doctor will decide whether or not to use Tediprima.

This medication is not recommended during lactation.

Driving and operating machines

Tediprima does not interfere with the ability to drive or operate machines.

Tediprima contains parahydroxybenzoate methyl ester (E-218)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate methyl ester.

Tediprima contains sorbitol

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

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Tediprima contains propylene glycol (E-1520)

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Depending on the nature of your disease, age, and weight, your doctor will prescribe the appropriate dose and indicate the duration of treatment. Do not stop treatment beforehand, as this will not achieve the desired effect.

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

• Pneumocystis jirovecii pneumonia in combination with dapsone: The trimethoprim dose 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 a single nighttime dose, for three days. For this indication, it is recommended to use the capsule presentation.
• Prophylaxis of recurrent urinary tract infections (more than 3 per year): Once the infection has subsided, it is recommended to administer 100 mg of trimethoprim per day (6.5 ml of suspension). Nighttime administration favors achieving high urinary concentrations. In women in whom recurrent infections are related to sexual activity, it is recommended to take the dose immediately after intercourse.

Use in patients with renal insufficiency

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

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

• CCr greater than 30 ml/min: normal dose.
• CCr 30-15 ml/min: half the normal dose.
• CCr 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 old for this indication.
• Acute uncomplicated urinary tract infections:
• Children 6-12 years old: 80 mg of trimethoprim (5 ml of suspension) every 12 hours.
• Children 3-6 years old: 40 mg of trimethoprim (2.5 ml of suspension) every 12 hours.
• Children 1-3 years old: 40 mg of trimethoprim (2.5 ml of suspension) per day.
• Prophylaxis of recurrent urinary tract infections: 2-3 mg/kg/day as a single dose. Nighttime administration favors achieving high urinary concentrations.

The minimum dose is 40 mg of trimethoprim per day (2.5 ml of suspension). The median 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 old.

If you take more Tediprima than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of Tediprima overdose are mainly the appearance of fever, nausea, vomiting, and diarrhea.

If you forgot to take Tediprima

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Rare (may affect between 1 and 10 of every 10,000 patients): exfoliative dermatitis (severe inflammation of the entire skin surface), erythema multiforme (allergic reaction affecting the skin), severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular exanthema), photosensitivity reactions (skin reaction caused by interaction with light), hepatobiliary disorders (alteration of liver function), increased liver enzymes, alteration of renal function (increase in creatinine and nitrogen concentration in the blood), megaloblastic anemia (decrease in red blood cell count and increase in size), thrombocytopenia (decrease in platelet count), neutropenia (decrease in a certain type of white blood cell count), leukopenia (decrease in white blood cell count), methemoglobinemia (inability of hemoglobin to transport oxygen), fever.

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

During prolonged treatments, special attention should be paid to the detection of any signs of medication toxicity such as fever, sore throat, skin eruptions, mouth ulcers, blue discoloration of the fingertips, lips, and skin, and bleeding. If any of these symptoms are detected, the patient should seek immediate medical attention.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration datethat appears on the box after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tediprima

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

Appearance of the product and contents of the packaging

Tediprima is a white oral suspension with a strawberry odor and taste. It is presented in amber PET containers with 100 ml of oral suspension.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Estedi Laboratory, S.L.

Montseny, 41

08012 Barcelona - Spain

Responsible for manufacturing

Estedi Laboratory, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aldo-Union Laboratory, S.L.

C/ Baronesa de Maldá, 73

08950 Esplugues de Llobregat(Barcelona)

Last review date of this leaflet: June 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)