TEDIPRIMA 16 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Tediprima 16mg/ml Oral Suspension

trimethoprim

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Tediprima is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

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

2. What you need to know before you take Tediprima

Do not take Tediprima

• If you are allergic to trimethoprim, other diaminopyrimidines, or any of the other components of this medicine (listed in section 6).
• If you have severe hematological disorders such as megaloblastic anemia.
• In combination with dofetilide (a drug used to control irregular or rapid heartbeats).
• Do not administer to children under 1 year of age.
• If you could be pregnant or are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Tediprima. Be particularly 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 an elderly person, as you may be more sensitive to the medicine.
• If you have porphyria (a blood disease in which hemoglobin is not produced properly).
• If you are taking phenytoin, your doctor may perform rigorous monitoring of plasma levels.
• If you have phenylketonuria (a metabolic disorder that affects the enzyme phenylalanine), as the administration of trimethoprim alters phenylalanine metabolism. This does not pose a problem in patients with an adequate restrictive diet.
• If you are at risk of hyperkalemia (high potassium levels) and hyponatremia (low sodium levels), your doctor will consider the need for potassium and sodium blood tests.

Life-threatening skin rashes have been described with the use of Tediprima (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and acute febrile neutrophilic dermatosis or Sweet's syndrome). Initially, they appear as red, circular spots, often with a central blister.

Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These life-threatening skin rashes are often accompanied by symptoms similar to those of the flu. The rash can progress to the formation of generalized blisters or skin peeling.

The period of greatest risk of severe skin reactions is during the first few weeks of treatment.

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

If you develop a rash or these skin symptoms, stop taking Tediprima, go to a doctor immediately, 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.

As a consequence of colonization with Clostridioides difficile, the use of Tediprima may lead to the development of pseudomembranous colitis, which manifests as diarrhea.

Other medicines and Tediprima

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

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

• Medicines used to increase urine elimination (diuretics), as you may have a higher risk of hyponatremia (low sodium levels).
• Oral anticoagulant medicines such as warfarin, as trimethoprim may enhance their anticoagulant activity. Careful monitoring of anticoagulant treatment is advised during the use of Tediprima.
• Certain medicines used to control blood sugar levels: oral hypoglycemics or antidiabetics (sulfonylurea).
• Medicines used to treat heart problems (digoxin). The combined use of trimethoprim and digoxin has shown an increase in digoxin levels in some elderly patients.
• Certain medicines used to treat the human immunodeficiency virus (HIV): antiretrovirals (zidovudine). The combined treatment of Tediprima with zidovudine may increase the risk of adverse hematological reactions to trimethoprim; blood parameter monitoring should be considered.
• Medicines that are folic acid antagonists, such as phenytoin (used to treat epilepsy) and methotrexate (used to treat various types of cancer and also to treat rheumatoid arthritis). If trimethoprim and phenytoin are administered, the excessive effect of phenytoin should be taken into account. If Tediprima is administered with methotrexate, the administration of a folate supplement should be considered.
• Medicines used in transplants: immunosuppressants (cyclosporin). In patients treated with trimethoprim and cyclosporin, a reversible deterioration in renal function has been observed after kidney transplantation.
• Medicines that produce hyperkalemia (increased potassium in the blood).
• Medicines used to control heart rhythm (class III antiarrhythmics), such as dofetilide. Elevated plasma levels of dofetilide have been reported after combined administration with trimethoprim.
• May decrease the effectiveness of oral contraceptives.
• The administration of trimethoprim with antacids may decrease trimethoprim blood levels.
• When trimethoprim is administered with drugs such as procainamide or amantadine, there is a possibility of increased plasma concentration of one or both drugs.

Tediprima may interfere with the serum methotrexate test.

Taking Tediprima with food and drinks

It is recommended to take this medicine on an empty stomach to favor its digestive 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. The doctor will decide whether or not to use Tediprima.

It is not recommended to take this medicine during breastfeeding.

Driving and using machines

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

Tediprima contains methyl parahydroxybenzoate (E-218)

May cause allergic reactions (possibly delayed) because 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 that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder 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 administration instructions of this medicine as indicated by your doctor or pharmacist. In case of 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 indicate the duration of treatment. Do not suspend treatment beforehand, as the expected effect will not be achieved.

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

• Pneumocystis jirovecii pneumonia in combination with dapsone: the trimethoprim dose is 5 mg/kg every 6-8 hours, for 21 days.
• Uncomplicated acute urinary tract infections: 320 mg of trimethoprim per day, divided into every 12 hours or single dose at night, for three days. For this indication, it is recommended to use the capsule formulation.
• Prophylaxis of recurrent urinary tract infection (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 who have recurrent infections 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 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 for this indication.
• Uncomplicated acute 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 in 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 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, consult your doctor or pharmacist immediately, or the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Tediprima

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people): nausea, vomiting, abdominal pain, glossitis (inflammation of the tongue), unusual taste, pruritus, skin rashes.

Rare (may affect up to 1 in 10,000 people): exfoliative dermatitis (severe inflammation of the entire skin surface), erythema multiforme (allergic reaction that affects the skin), severe cutaneous 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 (alteration of liver function), increased liver enzymes, alteration of renal function (increased creatinine and nitrogen levels in the blood), megaloblastic anemia (decrease in the number of red blood cells and increase in their size), thrombocytopenia (decrease in the number of platelets), neutropenia (decrease in the number of a certain type of white blood cells), leucopenia (decrease in the number of white blood cells), methemoglobinemia (inability of hemoglobin to transport oxygen), fever.

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

During prolonged treatments, special attention should be paid to detecting any signs of drug toxicity, such as fever, sore throat, skin rashes, oral ulcers, blue discoloration of the tips of the fingers, lips, and skin, and bleeding. If any of these symptoms are detected, you should go to your doctor immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tediprima

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

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona - Spain

Manufacturer

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

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

Laboratorio Aldo-Unión, S.L.

C/ Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Date of last revision of this leaflet: June 2022

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