Valdocef

Patient Information Leaflet

Valdocef, 250 mg/5 ml, granules for oral suspension
Cefadroxil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Valdocef is and what it is used for
2. What you need to know 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 Valdocef is and what it is 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 works only against certain types of bacteria, so it is suitable for treating only certain kinds of infections. Valdocef may be used to treat:

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

2. Important information before taking Valdocef

When not to take Valdocef:

• if the patient is allergic to cefadroxil or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to any other antibiotic in the cephalosporin group;
• if the patient has previously experienced severe allergic reactions to any penicillin antibiotic. Not all people who are allergic to penicillins are allergic to cephalosporins. However, this medicine should not be taken if the patient has ever had a severe allergic reaction to any type of penicillin, because the patient may also be allergic to this medicine (cross-allergy);
• do not use this medicine in case of allergy to peanuts or soya.

If the patient is unsure whether any of the above conditions apply, they should
consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Valdocef, discuss the following with your doctor or pharmacist:

• if the patient has ever had an allergic reaction to an antibiotic or if the patient suffers from asthma;
• if the patient has been informed that their kidneys are not functioning properly or if the patient is undergoing dialysis (due to kidney problems). The patient may take cefadroxil, but the doctor will adjust the dose;
• if the patient has ever had colitis or any other serious intestinal disorder.

If Valdocef is taken for a prolonged period, the doctor will regularly perform blood tests.
While taking cefadroxil, be alert for symptoms of gastrointestinal disturbances such as diarrhoea. See Serious adverse reactions in section 4.
Infants
Caution should be exercised when administering cefadroxil to premature infants and newborns,
as their enzymatic systems are not fully developed.
If blood or urine tests are required
Cefadroxil may affect the results of urine sugar tests and of a blood test known as the Coombs test.
If undergoing testing:
The person collecting the sample must be informed that the patient is taking cefadroxil.
Valdocef and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The action of cefadroxil may be affected by other medicines that are eliminated by the kidneys. Many medicines act in this way, so it is important to consult a doctor or pharmacist before taking Valdocef.
In particular, inform the doctor or pharmacist if the patient is taking the following medicines:

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

Valdocef must never be taken with the following medicines:

• antibiotics known as aminoglycosides (such as gentamicin), polymyxin B, and colistin;
• other antibiotics that inhibit bacterial growth (such as tetracyclines);
• diuretics (water tablets), such as furosemide. During treatment, kidney function may need to be monitored frequently. This can be done by testing blood and urine.

There should be a gap of 2–3 hours between taking Valdocef and any of the medicines listed above.
Taking Valdocef with food, drink and alcohol
Valdocef may be taken with or without food.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
While taking this medicine, the patient may experience headache, dizziness, nervousness, insomnia, and fatigue. These effects may impair the ability to drive or operate machinery. In such cases, the patient should not drive or operate machinery.
Valdocef contains sucrose
This medicine contains 2.780 g of sucrose in every 5 ml of reconstituted suspension. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Valdocef contains sodium
This medicine contains approximately 12.7 mg of sodium (the main component of table salt) in every 5 ml of reconstituted suspension. This corresponds to 0.64% of the maximum recommended daily intake of sodium in the adult diet.
Valdocef contains sodium benzoate
This medicine contains 5 mg of sodium benzoate (E 211) in every 5 ml of reconstituted suspension. Sodium benzoate (E 211) may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
Valdocef contains soya lecithin
Do not use this medicine in case of allergy to peanuts or soya. (See section 2 "When not to take Valdocef").

3. How to take Valdocef

This medicine should always be taken as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The dose recommended by the doctor depends on the nature and severity of the infection, as well as on kidney function.
The doctor will explain this to the patient and will calculate the exact dose of the medicine.
Valdocef granules for oral suspension are intended for use in children
with body weight ≥ 5 kg.
They may also be used in adults and older children who have difficulty swallowing
capsules.
The following table helps determine the recommended doses:

Adults
For adults and adolescents, the physician may prescribe a more appropriate pharmaceutical form
of the medicine – Valdocef capsules.
Patients undergoing haemodialysis
The physician may adjust the dose during haemodialysis. In patients undergoing haemodialyis, an additional dose of cefadroxil, ranging from 500 mg to 1000 mg, is administered after completion of haemodialysis.
Use in children
The daily dose is calculated based on the child's body weight. The physician will calculate the exact dose of the medicine.

*The single dose should not exceed 1000 mg.

• Children should not take Valdocef if they weigh less than 40 kg and have kidney disorders or are undergoing hemodialysis (a procedure used to remove unnecessary substances from the blood).

Elderly patients and patients with kidney disorders
The dose should be adjusted.
Instructions for preparing the suspension
Guidelines for preparing the suspension using the plastic measuring cup with graduations
Warning:
 The enclosed plastic measuring cup with graduations is intended solely for measuring the amount of water required to prepare the suspension.
 After preparing the suspension, the plastic measuring cup should be discarded.
 The plastic measuring cup with graduations should never be used for administering the medicine.

1. Shake the bottle to loosen the granules and remove the cap.
2. Add 60 ml of clean water to the bottle using the plastic measuring cup and replace the cap. Shake the bottle well to obtain a uniform suspension. The prepared suspension is a clear, lemon-yellow, viscous liquid with a pleasant orange odor.
3. The prepared suspension may be stored for 7 days at a temperature below 30°C or for 21 days in the refrigerator (5°C ± 3°C).

Administration method
Using the plastic oral syringe with graduations, measure the required amount of suspension.
The graduations on the plastic oral syringe indicate volumes of 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml.

1. Shake the bottle well before use and remove the cap.
2. Check the dose of medicine to be administered.
3. Remove the cap from the syringe.
4. Insert the syringe into the bottle placed on a hard, flat surface.
5. Slowly pull back the plunger of the syringe to the mark corresponding to the volume prescribed by the doctor in milliliters (ml).
6. Remove the syringe from the bottle.
7. Ensure the child is held in an upright position.
8. Gently insert the tip of the syringe into the child's mouth. The tip of the syringe should be directed toward the inside of the child's cheek.
9. Slowly push the plunger of the syringe: Avoid rapid injection of the medicine. The medicine will flow into the child's oral cavity.
10. Allow the child to swallow the medicine calmly.
11. Repeat steps 4–10 until the entire dose volume has been administered.
12. Replace the cap on the bottle. Wash the syringe according to the instructions below.

Cleaning and storage of the syringe

1. Remove the plunger from the syringe and wash both parts thoroughly with fresh drinking water.
2. Allow the plunger and syringe barrel to dry completely. Reinsert the plunger into the syringe. Store in a clean, safe place together with the medicine.

Duration of treatment
Treatment should be continued for at least 2–3 days after acute symptoms have subsided.
In streptococcal infections, the minimum duration of treatment is 10 days.
Accidental overdose of Valdocef
If a dose larger than recommended has been taken, contact a doctor or hospital emergency department immediately. Symptoms of overdose may include: nausea, hallucinations, increased reflexes, impaired consciousness, or even coma, and kidney function disturbances.
Missed dose of Valdocef
If a dose of this medicine is missed, continue with the normal dosing schedule as prescribed by the 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 directed by the doctor. Do not stop taking this medicine abruptly without first consulting your doctor, as this may cause symptoms to return.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, the medicine must be discontinued immediately and the patient should seek urgent medical advice from a doctor or go to the nearest hospital emergency department:
Serious adverse reactions requiring immediate medical attention:
Very rare (may occur in up to 1 in 10,000 patients):

• severe allergic reactions (anaphylaxis), such as:
• sudden onset of wheezing and tightness in the chest;
• swelling of the eyelids, face, or lips;
• loss of consciousness (fainting);
• severe rash with blistering affecting the eyes, mouth, throat, or genital organs (Stevens-Johnson syndrome);
• severe diarrhoea or presence of blood in the stool, indicating an inflammatory condition of the bowel known as pseudomembranous colitis.

Rare (may occur in up to 1 in 1,000 patients):

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

If a patient experiences any of these symptoms, they should stop taking this medicine immediately and contact a doctor or go to the nearest hospital emergency department.
Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients):

• nausea or vomiting, stomach irritation, abdominal pain, swollen, red, and painful tongue, diarrhoea;
• itching, rash, urticaria.

Uncommon (may occur in up to 1 in 100 patients):

• fungal infection, vaginal candidiasis.

Rare (may occur in up to 1 in 1,000 patients):

• hypersensitivity reactions (including skin rash, allergic reactions less severe than those described above, urticaria, itching);
• changes in kidney function;
• joint pain;
• fever.

Very rare (may occur in up to 1 in 10,000 patients):

• a type of anaemia, which may be severe, caused by the breakdown of red blood cells;
• headache, insomnia, dizziness, restlessness;
• feeling of fatigue;
• abnormal blood test results.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Valdocef

Keep this medicine out of sight and reach of children.
The granules should be stored at a temperature below 25°C.
After adding water to the granules, a sticky, liquid suspension is formed, which may be stored
for 7 days at a temperature below 30°C or for 21 days in the refrigerator (5°C ± 3°C).
Do not use this medicine after the expiry date stated on the carton and bottle under
"Expiry date (EXP)". The expiry date refers to the last day of the specified month.
After completion of treatment, any remaining suspension should be discarded.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Valdocef contains

• The active substance is cefadroxil monohydrate. 5 ml of oral suspension contains 250 mg of cefadroxil, equivalent to 262.39 mg of cefadroxil monohydrate.

1 ml of oral suspension contains 50 mg of cefadroxil, equivalent to 52.478 mg of cefadroxil
monohydrate.

• The other ingredients are: microcrystalline cellulose and sodium croscarmellose, sucrose, xanthan gum, sodium benzoate (E 211), citric acid monohydrate, sodium citrate, polysorbate 80, orange flavour (flavouring substances, corn maltodextrin, sucrose, soy lecithin, silicon dioxide), quinoline yellow (E 104), lac.

What Valdocef looks like and contents of the pack
Valdocef is a light yellow granulate with visible dark yellow granules and a pleasant orange smell.
The granulate for oral suspension is contained in a brown, chemically inert, glass bottle with a capacity of 150 ml, fitted with an aluminium cap with a PE seal.
The cardboard box contains one (1) bottle, one measuring cup graduated to indicate a volume of 60 ml intended solely for dissolving the granulate, one 5 ml oral syringe with graduations indicating volumes of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml for dosing, and the package leaflet.
Each bottle contains 65 g of granulate for preparing 100 ml of oral suspension.

Marketing Authorisation 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 authorised for sale in the European Economic Area under the following names:
Bulgaria Valdiocef 250 mg/5 ml granules for oral suspension
Poland Valdocef
Slovenia Valdiocef 250 mg/5 ml zrnca za peroralno suspenzijo

Medical advice – important information
Antibiotics are used to treat infections caused by bacteria (bacterial infections). They are not effective in treating infections caused by viruses (viral infections).
If your doctor prescribes an antibiotic, it means that you need it to treat the specific illness you currently have.
Some bacteria may survive or grow despite antibiotic treatment. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even contribute to the development of bacterial resistance, thereby delaying your recovery or reducing the effectiveness of the antibiotic, if you do not follow the appropriate:

• doses;
• treatment regimens;
• duration of treatment.

Therefore, to maintain the effectiveness of this medicine:
1 – use antibiotics only when prescribed by a doctor;
2 – strictly follow the instructions given;
3 – do not reuse antibiotics without a doctor's prescription, even if you wish to treat a similar illness;
4 – never give your antibiotics to another person; they may not be appropriate for their illness;
5 – after completing treatment, return any unused medicines to a pharmacist to ensure they are properly disposed of.