Valdocef

Leaflet attached to the packaging: patient information

Valdocef, 250 mg/5 ml, granules for oral suspension

Cefadroxil

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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:

• tonsillitis;
• 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 had severe allergic reactions to any penicillin antibiotic. Not everyone allergic to penicillins is allergic to cephalosporins. However, do not take this medicine if the patient has ever had a severe allergic reaction to any type of penicillin, as they may also be allergic to this medicine (cross-allergy).
• do not use this medicine if the patient is allergic to peanuts or soy.

If the patient is unsure whether they have any of the above conditions, they should consult their doctor or pharmacist.

Warnings and precautions

Before starting to take Valdocef, the patient should discuss the following with their doctor or pharmacist:

• if the patient has ever had an allergic reaction to an antibiotic or if the patient has asthma;
• if the patient has been told that their kidneys do not work 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 (inflammation of the colon) or any other serious disease affecting the intestines.

During long-term treatment with Valdocef, the doctor will regularly perform blood tests.
When taking cefadroxil, the patient should be aware of certain symptoms of gastrointestinal disorders, such as diarrhea. See Serious side effectsin section 4.

Infants

When using cefadroxil in premature infants and newborns, caution should be exercised, as their enzyme system is not fully developed.

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.
In case of a test:
The person taking the sample should be informedthat the patient is taking cefadroxil.

Valdocef and other medicines

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

Taking Valdocef with food, drink, and alcohol

Valdocef can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

While taking this medicine, the patient may experience headaches, dizziness, nervousness, insomnia, and fatigue. This may affect their ability to drive and use machines. In such cases, the patient should not drive or operate machines.

Valdocef contains sucrose

This medicine contains 2.780 g of sucrose per 5 ml of prepared suspension. This should be taken into account for patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Valdocef contains sodium

This medicine contains approximately 12.7 mg of sodium (the main component of common salt) per 5 ml of prepared suspension. This corresponds to 0.64% of the maximum recommended daily intake of sodium in the diet for adults.

Valdocef contains sodium benzoate

This medicine contains 5 mg of sodium benzoate (E 211) per 5 ml of prepared 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 soy lecithin

Do not use this medicine if the patient is allergic to peanuts or soy. (See section 2 "When not to take Valdocef").

3. How to take Valdocef

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

Adults

In the case of adults and adolescents, the doctor may prescribe a more suitable pharmaceutical form of the medicine - Valdocef capsules.

Patients undergoing hemodialysis

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

Use in children

The daily dose is calculated based on the child's body weight. The doctor 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 problems or are undergoing hemodialysis (a procedure to remove unnecessary substances from the blood).

Elderly patients and patients with kidney problems

The dose should be adjusted.

Instructions for preparing the suspension

Instructions for preparing the suspension using a plastic measuring cup with a scale

Warning:

 The attached plastic measuring cup with a scale is only for measuring the amount of water needed to prepare the suspension.

 After preparing the suspension, the plastic measuring cup should be discarded.
 The plastic measuring cup with a scale should never be used to administer the medicine.

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

Method of administration

Using a plastic oral syringe with a scale, measure the required amount of suspension.
The scale on the plastic oral syringe indicates 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 what dose of the medicine should 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 the syringe plunger to the mark on the syringe corresponding to the amount of medicine prescribed by the doctor, expressed in milliliters (ml).
• 6. Remove the syringe from the bottle.
• 7. Make sure the child is held in an upright position.
• 8. Carefully insert the tip of the syringe into the child's mouth. The tip of the syringe should be directed towards the inside of the child's cheek.
• 9. Slowly press the syringe plunger: Do not inject the medicine quickly.The medicine will flow into the child's mouth.
• 10. Allow the child to swallow the medicine calmly.
• 11. Repeat steps 4-10 until the entire dose volume has been administered.
• 12. Put the cap back on the bottle. Wash the syringe according to the following instructions.

Cleaning and storing the syringe

• 1. Pull the plunger out of the syringe and wash both parts thoroughly with fresh drinking water.
• 2. Leave the plunger and syringe body to dry. Push the plunger back into the syringe. Store it in a clean, safe place with the medicine.

Duration of treatment

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

Taking a higher dose of Valdocef than recommended

In case of taking a higher dose of Valdocef than recommended, the patient should immediately contact their doctor or hospital emergency department. Symptoms of overdose may include:
nausea, hallucinations, increased reflexes, decreased consciousness, or even coma, kidney function disorders.

Missing a dose of Valdocef

In case of missing a dose of this medicine, the patient should continue with the normal dosing schedule prescribed by the doctor. The patient should 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. The patient should not suddenly stop taking this medicine without consulting their doctor first. This may cause a relapse of symptoms.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Serious side effects that require 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 feeling of tightness in the chest;
• swelling of the eyelids, face, or lips;
• loss of consciousness (fainting);
• severe rash involving the eyes, mouth, and throat or genitals (Stevens-Johnson syndrome);
• severe diarrhea or blood in the stool, indicating a condition called pseudomembranous colitis.

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

• 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 the patient thinks they have any of these symptoms, they should stop taking the medicine and consult their doctor or hospital emergency department.

Other possible side effects:

Common(may occur in up to 1 in 10 patients):

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

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

• thrush, vaginal thrush.

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

• allergic reactions (which include skin rash, allergic reactions of lesser severity than those described above, hives, itching);
• changes in kidney function;
• joint pain;
• fever.

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

• 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 side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw,
Phone: + 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, more information can be collected on the safety of the medicine.

5. How to store Valdocef

The medicine should be stored 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 viscous, liquid suspension is formed, which can 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, bottle, or label after "Expiry date". The expiry date refers to the last day of the month.
After completing the treatment, the remaining suspension should be disposed of.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Valdocef contains

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

1 ml of oral suspension contains 50 mg of cefadroxil, which corresponds 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 flavor (flavoring substances, corn maltodextrin, sucrose, soy lecithin, silicon dioxide), quinoline yellow (E 104), lacquer.

What Valdocef looks like and contents of the pack

Valdocef is a light yellow granule with visible dark yellow granules and a pleasant, orange odor.
The granules for oral suspension are in a brown, chemically inert, glass bottle with an aluminum cap with a PE seal.
The carton contains one (1) bottle, one measuring cup with a scale for measuring 60 ml of water and intended only for dissolving the granules, one 5 ml oral syringe for dosing with a scale indicating volumes of 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml, and a leaflet with instructions.
Each bottle contains 65 g of granules to prepare 100 ml of oral suspension.

Marketing authorization holder and manufacturer

ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Phone: 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 250 mg/5 ml granules for oral suspension
Poland
Valdocef
Slovenia
Valdiocef 250 mg/5 ml granules for oral suspension
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 the doctor prescribes an antibiotic to the patient, it means that the patient needs it to treat their current illness exactly.
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. The patient may even contribute to the development of resistance by bacteria, and thus delay their recovery or reduce the effectiveness of the antibiotic, if they do not follow the appropriate:

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

Therefore, to maintain the effectiveness of this medicine:

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