Valdocef

Patient Information Leaflet

Valdocef 500 mg, hard capsules
Cefadroxil

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same. If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Valdocef is and what it is 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 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 in the treatment of various types of infections. Like all antibiotics, cefadroxil acts only against certain types of bacteria, and therefore is suitable for treating only certain kinds of infections. Valdocef may be used in the treatment of:

• throat infections (e.g. pharyngitis, tonsillitis);
• uncomplicated urinary tract infections (bladder 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 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).

If the patient is unsure whether any of the above conditions apply,
consult a doctor or pharmacist.
Warnings and precautions
Before starting 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 side effects in section 4.
If blood or urine tests are required
Cefadroxil may affect test results for glucose in urine and for a blood test known as the Coombs test.
If undergoing testing:
Inform the person collecting the sample 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 effect of cefadroxil may be influenced by other medicines that are eliminated by the kidneys. Many medicines act in this way, so consult your doctor or pharmacist before taking Valdocef.
In particular, inform your 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.

An interval of 2–3 hours should be maintained between taking Valdocef and any of the medicines listed above.
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 baby, 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 may affect the ability to drive or operate machinery. In such cases, the patient should not drive or operate machinery.
Valdocef contains Brilliant Black BN (E 151)
This medicine contains Brilliant Black BN (E 151), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Valdocef

This medicine should always be taken according to the instructions given by the doctor or pharmacist.
If in doubt, consult the 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.
The following table helps determine the recommended doses:

Use in children:

• for children over 6 years of age weighing less than 40 kg, the usual dose is 500 mg (1 capsule) twice daily;
• for children under 6 years of age, 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 disorders or are undergoing haemodialysis (a procedure used to remove unnecessary substances from the blood).

Elderly people and patients with renal function disorders
The dose should be adjusted.
Patients undergoing haemodialysis
The doctor may adjust the dose during haemodialysis. In patients undergoing haemodialysis, an additional dose of cefadroxil, ranging from 500 mg to 1000 mg, should be administered after completion of haemodialysis.
Method of administration
The capsules should be swallowed whole with a glass of water.
Do not chew the capsules.
Duration of treatment
Treatment should continue for at least 2–3 days after acute symptoms have subsided.
In streptococcal infections, the minimum duration of treatment is 10 days.
Overdose of Valdocef
If an overdose of Valdocef 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 disorders.
Missed dose of Valdocef
If a dose of this medicine is missed, continue following the normal dosing schedule prescribed by the doctor. Do not take a double dose to make up for the missed dose.
Discontinuation of Valdocef
It is important to take the medicine as directed by the doctor. Do not abruptly stop taking this medicine without first consulting your doctor, as this may cause symptoms to recur.
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 should be discontinued immediately
and the patient should seek immediate medical advice from a doctor or go to the emergency department
of the nearest hospital:
Severe 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 and throat or genital organs (Stevens-Johnson syndrome);
• severe diarrhoea or presence of blood in stool, indicating an inflammatory condition of the intestine 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 feeling tired, 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 and contact a doctor or the emergency department of the nearest
hospital.
Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients):

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

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

• fungal infection, vaginal fungal infection.

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 breakdown of red blood cells;
• headache, insomnia, dizziness, restlessness;
• feeling of fatigue;
• abnormal blood test results. Reporting of adverse reactions If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorisation holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Valdocef

Keep this medicine out of the sight and reach of children.
No special storage conditions are required 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging 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), brilliant black BN (E 151), gelatin.

What Valdocef looks like and contents of the pack
Valdocef capsules are hard gelatin capsules size 0 (approximately 21.70 x 7.65 mm) filled with a homogeneous light yellow powder. The capsule body is light blue and opaque, and the cap is blue and opaque.
The cardboard box contains 16 capsules of 500 mg in blisters (2 blisters containing 8 capsules each) and a leaflet with instructions.

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 in the European Economic Area countries under the following names:
Bulgaria Valdiocef 500 mg capsules, hard
Poland Valdocef
Slovenia Valdiocef 500 mg trde kapsule

Medical advice – information for patients
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 you an antibiotic, it means that you need it to treat exactly the illness you currently have.
Some bacteria may survive or grow despite antibiotic treatment. This phenomenon is called resistance: certain antibiotic therapies become ineffective.
Improper use of antibiotics increases resistance. You may even contribute to the development of resistance in bacteria, thereby delaying your recovery or reducing the effectiveness of the antibiotic, if you do not follow the appropriate:

• dosages;
• 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;
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; it may not be suitable for their condition;
5 – after completing treatment, return all unused capsules to the pharmacist to ensure they are properly disposed of.