Valdocef

Leaflet attached to the packaging: patient information

Valdocef, 500mg, hard capsules

Cefadroxil

Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Valdocef and what is it used for

Valdocef is an antibiotic. It belongs to a group of antibiotics called cephalosporins, which are similar to penicillin.
Valdocef kills bacteria and can be used to treat various types of infections. Like all antibiotics, cefadroxil only works on certain types of bacteria, so it is only suitable for treating certain types of infections. Valdocef can be used to treat:

• pharyngitis;
• uncomplicated urinary tract and kidney infections;
• uncomplicated skin and soft tissue infections.

2. Important information before taking Valdocef

When not to take Valdocef:

If you are not sure whether any of the above conditions apply to you, you should consult a doctor or pharmacist.

Warnings and precautions

Before taking Valdocef, you should discuss it with your doctor or pharmacist:

If you are taking Valdocef for a long time, your doctor will regularly perform blood tests.
When taking cefadroxil, you should be aware of certain symptoms of gastrointestinal disorders, such as diarrhea. See Severe side effectsin section 4.

In case of blood or urine tests

Cefadroxil may affect the results of a urine test for sugar and a blood test known as the Coombs test.
If a test is performed:
You must inform the person taking the samplethat you are taking cefadroxil.

Valdocef and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Other medicines that are excreted by the kidneys may affect the action of cefadroxil. Many medicines work in this way, so before taking Valdocef, you should consult your doctor or pharmacist.
In particular, you should inform your doctor or pharmacist if you are taking:

• blood thinners(medicines that thin the blood);
• probenecid(used in gout). It may delay the elimination of cefadroxil from the body;
• cholestyramine(used to lower high cholesterol levels).

Valdocef should never be taken with the following medicines:

• antibioticscalled aminoglycosides (such as gentamicin), polymyxin B, and colistin;
• other antibiotics that inhibit bacterial growth (such as tetracycline);
• diuretics(such as furosemide). During treatment, it may be necessary to frequently check kidney function. This can be done by testing blood and urine.

The interval between taking Valdocef and taking any of the above medicines should be 2-3 hours.

Valdocef with food, drink, and alcohol

Valdocef can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.

Driving and using machines

While taking this medicine, you may experience headaches, dizziness, nervousness, insomnia, and fatigue. This may affect your ability to drive and use machines. In such a case, you should not drive or operate machines.

Valdocef contains black iron oxide (E 151)

This medicine contains black iron oxide (E 151), which may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Valdocef

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The dose recommended by your doctor depends on the nature and severity of the infection, as well as kidney function.
Your doctor will explain this to you.
The following table helps to determine the recommended doses:

Use in children:

• in children over 6 years old weighing less than 40 kg, the usual dose is 500 mg (1 capsule) twice daily;
• in children under 6 years old, the doctor will prescribe a more suitable pharmaceutical form of the medicine - cefadroxil granules for oral suspension.
• children should not take Valdocef if they weigh less than 40 kg and have kidney problems or are undergoing hemodialysis (a procedure to remove unwanted substances from the blood).

Elderly patients and patients with impaired kidney function

The dose should be adjusted.

Patients undergoing hemodialysis

Your doctor may adjust the dose during hemodialysis. In patients undergoing hemodialysis, after the hemodialysis is completed, an additional dose of cefadroxil is given, ranging from 500 mg to 1000 mg.

Method of administration

The capsules should be swallowed whole, with a glass of water.
The capsules should not be chewed.

Duration of treatment

Treatment should be continued for at least 2-3 days after the disappearance of acute symptoms.
In the case of streptococcal infections, the minimum duration of treatment is 10 days.

Taking more than the recommended dose of Valdocef

If you take more than the recommended dose of Valdocef, you should immediately contact a doctor or hospital emergency department. Symptoms of overdose may include:
nausea, hallucinations, increased reflexes, decreased consciousness or even coma, kidney problems.

Missing a dose of Valdocef

If you miss a dose of this medicine, you should continue with the normal dosing schedule as recommended by your doctor. Do not take a double dose to make up for the missed dose.

Stopping treatment with Valdocef

It is important to take the medicine as recommended by your doctor. You should not stop taking this medicine suddenly without consulting your doctor first. This may cause a relapse of symptoms.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop taking the medicine and consult a doctor or go to the emergency department of the nearest hospital immediately
:

Severe side effects that require immediate medical attention:

Very rare(may affect up to 1 in 10,000 people):

• severe allergic reactions(anaphylaxis), such as:
• sudden onset of wheezing and feeling of chest tightness,
• swelling of the eyelids, face, or lips,
• loss of consciousness (fainting);
• severe rash with blisters, including eyes, mouth, and throat or genitals (Stevens-Johnson syndrome);
• severe diarrhea or blood in the stool, indicating a condition called pseudomembranous colitis.

Rare(may affect up to 1 in 1,000 people):

• yellowing of the eyes or skin, changes in liver function tests;
• swelling of the face, tongue, or throat;
• decrease in the number of various blood cells (symptoms may include feeling tired, new infections, fever, sudden sore throat, and mouth ulcers), increase in the number of certain types of white blood cells, decrease in the number of blood cells responsible for blood clotting, which may cause bruising or bleeding.

If you think you have any of these symptoms, you should stop taking this medicine and consult a doctor or hospital emergency department.

Other possible side effects:

Common(may affect up to 1 in 10 people):

• nausea or vomiting, stomach upset, abdominal pain, swelling of the tongue with redness and pain, and diarrhea;
• itching, rash, hives.

Uncommon(may affect up to 1 in 100 people):

• thrush, vaginal thrush.

Rare(may affect up to 1 in 1,000 people):

• allergic reactions (which include skin rash, mild allergic reactions, hives, itching);
• changes in kidney function;
• joint pain;
• fever.

Very rare(may affect up to 1 in 10,000 people):

• a type of anemia that can be severe and is caused by the breakdown of red blood cells;
• headache, insomnia, dizziness, nervousness;
• feeling tired;
• abnormal blood test results.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valdocef

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date" (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Valdocef contains

• The active substance is cefadroxil monohydrate. Each hard capsule contains 500 mg of cefadroxil, equivalent to 524.78 mg of cefadroxil monohydrate.
• The other ingredients are: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, titanium dioxide (E 171), patent blue (E 131), black iron oxide (E 151), gelatin.

What Valdocef looks like and contents of the pack

Valdocef capsules are hard gelatin capsules No. 0 (approximately 21.70 x 7.65 mm) filled with a homogeneous light yellow powder. The base of the capsule is light blue and opaque, and the cap of the capsule is blue and opaque.
The carton contains 16 capsules of 500 mg in blisters (2 blisters containing 8 capsules) and a patient information leaflet.

Marketing authorization holder and manufacturer

ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Tel.: 386 1 300 42 90
Fax: 386 1 300 42 91
email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Valdiocef 500 mg capsules, hard
Poland
Valdocef
Slovenia
Valdiocef 500 mg trde kapsule
Date of last revision of the leaflet:06.01.2021

Medical advice - warning

Antibiotics are used to treat bacterial infections (bacterial infections). They are not effective in treating viral infections (viral infections).
If your doctor prescribes you an antibiotic, it means you need it to treat the specific disease you are suffering from at the moment.
Some bacteria may survive or grow despite the use of antibiotics. This phenomenon is called resistance: some antibiotic therapies become ineffective.
Incorrect use of antibiotics increases resistance. You may even contribute to the development of resistance by bacteria, and thus delay your recovery or reduce the effectiveness of the antibiotic, if you do not follow the correct:

• doses;
• treatment schedules;
• duration of treatment.

Therefore, to maintain the effectiveness of this medicine:

• 1 – you should only use antibiotics when prescribed by a doctor;
• 2 – you should strictly follow the instructions;
• 3 – you should not reuse antibiotics without a doctor's prescription, even if you want to treat a similar disease;
• 4 – you should never give your antibiotic to another person; it may not be suitable for their disease;
• 5 – after completing the treatment, you should return all unused capsules to the pharmacist, to ensure they are disposed of properly.