Cefaleksina Tzf

Package Leaflet: Information for the Patient

CEFALEKSYNA TZF, 500 mg, Hard Capsules

Cefalexin

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

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

Table of Contents of the Leaflet

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

1. What is Cefaleksyna TZF and what is it used for

Cefaleksyna TZF contains the active substance cefalexin, which is an oral semi-synthetic antibiotic from the group of cephalosporins. Cephalosporins have a bactericidal effect.
Cefaleksyna TZF is indicated for use in the following infections caused by susceptible bacterial strains:

• respiratory tract infections;
• skin and soft tissue infections;
• urinary tract infections.

2. Important information before taking Cefaleksyna TZF

When not to take Cefaleksyna TZF

If you are allergic (hypersensitive) to cefalexin, other cephalosporins (similar antibiotics) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If you have any of the following conditions, tell your doctor before taking the medicine:

• a history of allergic reactions to any antibiotic;
• kidney disease.

If you experience any of the following symptoms while taking the medicine, contact your doctor immediately:

• severe hypersensitivity reactions, such as rash, urticaria, purpura, laryngeal edema, bronchospasm; in such cases, seek medical attention immediately, who will provide appropriate treatment;
• prolonged diarrhea;
• symptoms of a new bacterial infection or fungal infection (superinfection), especially during prolonged use of antibiotics.

Cefaleksyna TZF and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor or pharmacist if you are taking:

• probenecid(used to treat gout).

Effect of Cefaleksyna TZF on laboratory test results
If you are taking Cefaleksyna TZF and are to have blood or urine tests, tell your doctor, as this medicine may affect the results of some of these tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Cefaleksyna TZF can be used during pregnancy only if your doctor considers it absolutely necessary.
Caution should be exercised when taking Cefaleksyna TZF in breastfeeding women, as cefalexin passes into breast milk.

Driving and using machines

The effect of cefalexin on the ability to drive and use machines is not known.

3. How to take Cefaleksyna TZF

Cefaleksyna TZF should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

Adults and children over 12 years

Usually, 1 g to 4 g per day is taken, in divided doses.
In moderate and uncomplicated urinary tract infections, streptococcal pharyngitis, and skin and soft tissue infections, the average daily dose is 250 mg every 6 hours or 500 mg every 12 hours.
In the treatment of more severe infections or infections caused by moderately susceptible microorganisms, your doctor may use higher doses of the medicine.

Children under 12 years

Cefalexin is used in doses of 25 to 50 mg/kg body weight per day, in divided doses, usually every 12 hours.
In severe infections, your doctor may use double the dose of cefalexin.

Elderly patients

In elderly patients with normal kidney function, dose adjustment is not necessary.
If you feel that the effect of the medicine is too strong or too weak, contact your doctor.
contact your doctor.

Duration of treatment

The duration of treatment depends on the severity and type of infection.
Your doctor will determine the appropriate duration of treatment, which should be followed.

Method of administration

The capsules should be taken orally with a small amount of water, regardless of meals.

Taking a higher dose of Cefaleksyna TZF than recommended

Symptoms of overdose may include: nausea, vomiting, abdominal discomfort, diarrhea, and hematuria. Appropriate treatment may be necessary.
If you have taken more than the recommended dose of the medicine, contact your doctor or go to the nearest emergency department immediately. Take the medicine in its original packaging so that the medical staff can check exactly which medicine was taken.

Missing a dose of Cefaleksyna TZF

If you miss a dose, take the medicine as soon as you remember.
If it is almost time for your next dose, skip the missed dose and take the next dose at the right time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Cefaleksyna TZF

It is important to take the medicine as directed for the entire treatment period. Do not stop treatment just because you feel better. If treatment is stopped too soon, the infection may return.
If you feel worse during treatment or do not feel well after completing the recommended treatment period, contact your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:

• very common: (affect more than 1 in 10 people);
• common: (affect 1 to 10 people in 100);
• uncommon: (affect 1 to 10 people in 1,000);
• rare: (affect 1 to 10 people in 10,000);
• very rare: (affect less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

If you experience any of the following serious side effects, stop taking the medicine and contact your doctor or go to the nearest emergency department immediately. These symptoms usually occur rarely, but can be life-threatening.

• swelling of the face, lips, tongue, or throat (angioedema);
• shortness of breath, rash, wheezing, and low blood pressure (anaphylactic reaction);
• itching patches or rash on hands and feet or severe, widespread rash with blisters on the skin (erythema multiforme, Stevens-Johnson syndrome);
• fever, sore throat, and joint pain with severe skin peeling, blistering, and red rash (toxic epidermal necrolysis);
• diarrhea with high water content or blood (may be a sign of severe colitis).

Other side effects that may occur when taking Cefaleksyna TZF

Common

• nausea and diarrhea.

Uncommon

• increased number of certain types of white blood cells;
• rash, urticaria;
• changes in blood test results to check liver function.

Rare

• itching of the genitals and anus, vaginal inflammation;
• blood changes: decreased number of different types of blood cells (manifested by new infections and a tendency to bruise or bleed), increased number of small blood cells necessary for blood clotting; hemolytic anemia (anemia caused by red blood cell breakdown, can be very severe);
• headache, dizziness;
• abdominal pain, vomiting, indigestion;
• hepatitis, jaundice;
• kidney inflammation;
• fatigue.

Frequency not known

• fungal infections of the vagina (caused by yeast);
• hallucinations, agitation, disorientation;
• joint pain, arthritis;
• fever;
• changes in some blood or urine test results (positive direct Coombs test results; false positive glucose test results in urine).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 {current address, phone and fax number of the Department}
e-mail: adr@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cefaleksyna TZF

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater 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 Cefaleksyna TZF contains

The active substance of the medicine is cefalexin in the form of cefalexin monohydrate.
One capsule contains 500 mg of cefalexin.
The other ingredients are: magnesium stearate, talc
Capsule composition:
lower part - titanium dioxide (E 171), yellow iron oxide (E 172), gelatin;
lid - yellow iron oxide (E 172), indigo carmine (E 132), titanium dioxide (E 171), gelatin

What Cefaleksyna TZF looks like and what the pack contains

The capsule lid is green, the lower part is cream-colored.

Packaging

16 hard capsules

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: (22) 811-18-14
To obtain more detailed information, contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: