CEFADROXIL DESGEN 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Cefadroxil Desgen 500 mg Hard Capsules

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Cefadroxil Desgen is and what it is used for

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

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

• Pharyngotonsillitis.

-Uncomplicated urinary tract infections

-Uncomplicated skin and soft tissue infections.

2. What you need to know before taking Cefadroxil Desgen

Do not take Cefadroxil Desgen:

-If you are allergic to Cefadroxil 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 Cefadroxil:

-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 properly or if you are undergoing dialysis (due to kidney function problems). You can take Cefadroxil, but your doctor will adjust the dose you should take,

-If you have ever had inflammation of the large intestine, called colitis, or any other disease that affects the intestine.

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

You should be monitored for the possibility of certain gastrointestinal disorders, such as diarrhea, while being treated with Cefadroxil. See section 4.

If you need a blood test

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

If you are going to have this test, tell the person taking the samples that you are taking Cefadroxil.

Taking Cefadroxil Desgen with other medications

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

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

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

You should consult 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 Cefadroxil from your body;

-Cholestyramine (used to lower high cholesterol).

Never take Cefadroxil Desgen with the following medications:

-Antibiotics called aminoglycosides (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.

There should be an interval of 2 to 3 hours between taking Cefadroxil and other medications.

Taking Cefadroxil Desgen with food, drinks, and alcohol

Cefadroxil 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

3. How to take Cefadroxil Desgen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The following table will help you define the recommended dose:

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

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

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

Children under 6 years of age

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

Renal impairment

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

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

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

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

Patients on 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 Cefadroxil at the end of hemodialysis.

Hepatic impairment

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 continue for at least 2-3 days after acute symptoms disappear.

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

If you take more Cefadroxil Desgen than you should

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

If you have taken more Cefadroxil 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.

You should recommend taking the packaging and the package leaflet of the medication to the healthcare professional.

If you forget to take Cefadroxil Desgen

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

If you stop taking Cefadroxil Desgen

It is important that you 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Severe side effects (anaphylactic reaction) that require emergency care:

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

-sudden onset of wheezing 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 the stool, indicating a condition called pseudomembranous colitis.

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

-yellowing of the eyes or skin, alterations in blood tests of kidney function;

-swelling of the tongue and throat;

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

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

Other possible side effects:

Common(may affect 1 in 10 patients):

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

-itching, rash, urticaria.

Uncommon(may affect 1 in 100 patients):

-thrush, vaginal thrush.

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

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

-alteration in kidney function;

-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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cefadroxil Desgen

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

Keep the packaging tightly closed.

Do not use this medication after the expiration date shown on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre collection point in pharmacies. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefadroxil Desgen

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

Appearance of the product and packaging contents

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.

Marketing authorization holder and manufacturer

Generfarma, S.L.

c/Isaac Peral, 6

Parque Tecnológico

46980 Paterna. Valencia.

Spain.

Date of the last revision of this package leaflet: December 2021

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

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