Package Insert: Information for the Patient

Cefadroxilo Desgen 500 mg Hard Capsules

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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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.

Cefadroxilo is an antibiotic. It belongs to a group of medications called cephalosporins. These antibiotics are similar to penicillin.

Cefadroxilo eliminates bacteria and can be used to treat various types of infections. Like all antibiotics, Cefadroxilo is only effective against certain types of bacteria. Therefore, it is useful for treating certain types of infections. Cefadroxilo can be used to treat:

- Pharyngotonsillitis.

-Uncomplicated urinary tract infections

-Uncomplicated skin and soft tissue infections.

Do not take Cefadroxilo Desgen:

-If you are allergic to Cefadroxilo or any of the other components of this medication (listed in section 6).

-If you are allergic to other cephalosporins.

-If you have had severe allergic reactions to any penicillin.

Not everyone allergic to penicillins is allergic to cephalosporins. However, you should not take this medication if you have had a severe allergic reaction to any penicillin, as you may be allergic to this medication (cross-allergic reaction).

If you are unsure about the above, ask your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefadroxilo:

-If you have had an allergic reaction to an antibiotic or suffer from asthma,

-If you have been warned that your kidneys do not function correctly or if you are undergoing dialysis (due to kidney function problems). You can take Cefadroxilo, but your doctor will adjust the dose you should take,

-If you have ever had an inflammation of the large intestine, known as colitis, or any other disease affecting the intestine.

If you are being treated with Cefadroxilo for a prolonged period, your doctor will perform periodic blood tests.

You should monitor the possibility of certain gastrointestinal disorders, such as diarrhea, while being treated with Cefadroxilo. See section 4.

If you need a blood test

Cefadroxilo may affect the results of urine sugar tests and the blood test known as the Coombs test.

If you are to have this test, inform the person taking your samples that you are taking Cefadroxilo.

Taking Cefadroxilo Desgen with other medications

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

Cefadroxilo may be affected by other medications that are eliminated by the kidneys.

Many medications have this effect, so you should consult with your doctor or pharmacist before taking Cefadroxilo.

You should consult with your doctor or pharmacist if you are taking the following medications:

-Anticoagulants (used to prevent blood clotting);

-Probenecid (used for gout). It may delay the elimination of Cefadroxilo from your body;

-Cholestyramine (used to lower high cholesterol).

Never take Cefadroxilo Desgen with the following medications:

-Aminoglycoside antibiotics (such as gentamicin), polymyxin B, and colistin;

-Other antibiotics that stop bacterial growth (such as tetracyclines, erythromycin, sulfonamides, chloramphenicol).

-Diuretics such as furosemide. It may be necessary to evaluate kidney function during treatment.

You should leave a gap of 2 to 3 hours between taking Cefadroxilo and other medications.

Taking Cefadroxilo Desgen with food, drinks, and alcohol

Cefadroxilo can be taken with meals or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

While taking this medication, you may experience headaches, dizziness, nervousness, insomnia, and fatigue. This may affect your ability to drive or operate machinery. If this occurs, do not drive or operate machinery.

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

The dose prescribed by your doctor will depend on the nature and severity of the infection. It will also depend on how your kidneys are functioning. Your doctor will explain this to you.

The following table will help you define the recommended dose:

Use in children 6 years of age or older with a body weight of less than 40 kg:

Cefadroxilo 500 mg capsules cannot provide an adequate dose for children 6 years of age or older with a body weight of less than 40 kg.

Cefadroxilo capsules are not suitable for the treatment of children and adolescents who cannot swallow the capsules. There are other available oral liquid forms (Cefadroxilo 250 mg/5 ml oral suspension powder).

Children under 6 years of age

Cefadroxilo 500 mg capsules are not recommended for children under 6 years of age. For children under 6 years of age, there are available oral liquid forms (Cefadroxilo 250 mg/5 ml oral suspension powder).

Renal insufficiency

Adults and adolescents (12 to less than 18 years of age) with a body weight of 40 kg or more

The dose should be adjusted according to creatinine clearance rates to avoid cefadroxilo accumulation.

Children 6 years of age or older with a body weight of less than 40 kg with renal insufficiency

The doctor may adjust the dosing interval based on creatinine clearance rates.

Patients undergoing hemodialysis

The doctor may adjust the dose during hemodialysis. Patients undergoing hemodialysis will be treated with an additional dose of 500 to 1,000 mg of Cefadroxilo at the end of hemodialysis.

Hepatic insufficiency

No dose adjustment is necessary.

Method of administration

The capsules should be swallowed whole with a little water. Do not chew the capsules.

Duration of treatment

Treatment should be continued for at least 2-3 days after the acute symptoms have disappeared.

In case of streptococcal infections, the minimum duration of treatment will be 10 days.

If you take more Cefadroxilo Desgen than you should

If you take more Cefadroxilo than prescribed, contact your doctor immediately or go to the hospital. Symptoms of overdose include: nausea, hallucinations, increased reflexes, decreased consciousness, and even coma.

If you have taken more Cefadroxilo Desgen than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the package insert to the healthcare professional.

If you forget to take Cefadroxilo Desgen

If you forget to take your medication, continue with the normal dose recommended by your doctor. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cefadroxilo Desgen

It is essential to take the medication as indicated by your doctor. Do not stop taking it without consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If any of the following side effects appear, stop taking this medication and consult your doctor immediately or go to the nearest emergency service:

Severe side effects (anaphylactic reaction) requiring emergency care:

Very rare(may affect 1 in 10,000 patients):

-sudden onset of hissing and chest tightness;

-swelling of eyelids, face, or lips;

-loss of consciousness (fainting);

-severe rash associated with blisters, in eyes, mouth, and throat, or genitals (Stevens-Johnson syndrome).

-severe diarrhea or bleeding in stools, indicating inflammation of the intestinollamada colitis pseudomembranosa.

Rare(may affect 1 in 1,000 patients):

-yellowish eyes or yellowish skin, alterations in blood tests for kidney function;

-swelling of tongue and throat;

-decrease in the number of blood cells (symptoms may include fatigue, new infections, fever, sudden throat pain, and mouth ulcers), increase in the number of certain types of white blood cells, decrease in the number of blood cells necessary for coagulation may cause bruising or bleeding.

If you think you have one of these signs, stop taking this medication and contact a doctor or the nearest emergency service.

Other possible side effects:

Frequent(may affect 1 in 10 patients):

-nausea or feeling sick, stomach upset, abdominal pain, swelling of the tongue with redness, pain, and diarrhea;

-itching, rash, urticaria.

Occasional(may affect 1 in 100 patients):

-aphthae, vaginal aphthae.

Rare(may affect 1 in 1,000 patients):

-allergic reactions (which include skin rash, less severe allergic reactions mentioned earlier, urticaria, itching);

-kidney function impairment;

-joint pain;

-fever.

Very rare(may affect 1 in 10,000 patients):

-a type of anemia that can be severe, caused by the rupture of red blood cells;

-headache, numbness, dizziness, nervousness;

-insomnia, fatigue;

-abnormal blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side 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.

Keep the container perfectly closed.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the Sigre point of pharmacies. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cefadroxilo Desgen

• The active ingredient is Cefadroxilo. Each capsule contains 500 mg of Cefadroxilo, corresponding to 528 mg of Cefadroxilo monohydrate.
• The other components (excipients) are magnesium stearate, colloidal anhydrous silica.

Appearance of the product and contents of the packaging

White gelatin capsules containing a slightly yellowish powder.

Each package contains 28 capsules.

A clinical package of 500 capsules is available, with strips of 10 capsules.

Holder of the marketing authorization and responsible for manufacturing

Generfarma, S.L.

c/Isaac Peral, 6

Parque Tecnológico

46980 Paterna. Valencia.

Spain.

Last review date of this leaflet: December 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

https://www.aemps.gob.es/