Sintarpen

Leaflet attached to the packaging: patient information

SYNTARPEN, 500 mg, coated tablets

Cloxacillin - Cloxacillinum

Table of contents of the leaflet

• 1. What is Syntarpen and what is it used for
• 2. Important information before taking Syntarpen
• 3. How to take Syntarpen
• 4. Possible side effects
• 5. How to store Syntarpen
• 6. Package contents and other information

1. What is Syntarpen and what is it used for

Syntarpen contains the active substance cloxacillin, which is a semi-synthetic penicillin antibiotic. Cloxacillin acts on various strains of Gram-positive and Gram-negative bacteria, but it is most commonly used to treat infections caused by staphylococci. Syntarpen is indicated for the treatment of the following staphylococcal infections:

• skin and soft tissue infections (erysipelas);
• lower respiratory tract infections;
• purulent post-burn and post-operative complications;
• bone and bone marrow infections, mainly post-traumatic - the oral form is administered at a later stage

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should 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 nurse.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

treatment.

2. Important information before taking Syntarpen

When not to take Syntarpen

If the patient is allergic (hypersensitive) to cloxacillin, penicillins, cephalosporins, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If the patient has had an allergic reaction to any antibiotic or other allergic reaction in the past, they should tell their doctor before taking the medicine.
• If the patient is allergic to any cephalosporin antibiotic, they may also be allergic to cloxacillin (so-called cross-allergy).
• If the patient develops skin changes (e.g., hives, itching) or other symptoms indicating an allergy while taking Syntarpen, they should stop taking the medicine and consult their doctor as soon as possible.
• If the patient needs to take Syntarpen for a long time, the doctor will usually order periodic checks of kidney and liver function, as well as blood morphology.
• Long-term administration of antibiotics may cause excessive growth of insensitive bacteria or fungi. If symptoms of new infections occur during treatment with Syntarpen, the patient should stop taking the medicine and consult their doctor.
• If severe, persistent diarrhea occurs during or after treatment with Syntarpen, the patient should tell their doctor. This may be a sign of pseudomembranous colitis - a complication associated with antibiotic use. It is then necessary to discontinue the medicine and sometimes administer appropriate treatment. The patient should not take anti-peristaltic medicines or other constipating agents. In case of doubt, the patient should consult their doctor or pharmacist.

Syntarpen and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor if they are taking:

probenecid (used to treat gout) - the concentration of the antibiotic in the blood may increase;

anticoagulant medicines (medicines that prevent blood clots), e.g., warfarin - the risk of bleeding may increase;

methotrexate (used to treat arthritis) - its toxicity may increase;

oral contraceptives - their effectiveness may decrease; the patient should use additional non-hormonal contraceptive methods;

ampicillin, fusidic acid (antibiotics) - their effect may be enhanced;

erythromycin, tetracyclines, chloramphenicol (antibiotics) - the effect of Syntarpen may be reduced.

Effect on laboratory test results

• The results of glucose tests in urine using certain methods may be falsely positive - enzymatic tests are recommended.
• The results of steroid tests in urine may be changed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. For safety reasons, Syntarpen can be used during pregnancy only if necessary, when the potential benefits outweigh the risks, as determined by the doctor. The medicine passes into breast milk in small amounts. Breastfeeding mothers should be cautious, as the medicine may cause side effects in the breastfed child (allergy, diarrhea, fungal infection).

Driving and using machines

There is no data on the effect of Syntarpen on the ability to drive and use machines. If the patient experiences symptoms that impair concentration (e.g., pain or dizziness, drowsiness, disorientation; see section 4. Possible side effects), they should not drive vehicles or operate machines until these symptoms resolve.

Syntarpen contains lactose

One coated tablet contains up to 680 mg of lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should discuss this with their doctor before taking the medicine.

3. How to take Syntarpen

This medicine should always be taken according to the doctor's recommendations. In case of doubt, the patient should consult their doctor.

Adults and children over 20 kg

Usually, 1 tablet (500 mg) is taken every 6 hours. In very severe infections, cloxacillin is recommended to be administered intramuscularly or intravenously.

Children under 20 kg

Cloxacillin is recommended to be administered intravenously.

Dosage in patients with renal impairment

Cautious use of the medicine is recommended in patients with renal impairment. It may be necessary to reduce the dose or increase the interval between doses.

Method of administration

The medicine should be taken 1 hour before or 2 hours after a meal.

Duration of treatment

The duration of treatment is determined by the doctor, depending on the severity and type of infection, the patient's condition, age, and weight. Usually, the medicine is taken for 2 to 4 days after the symptoms have resolved.

Overdose of Syntarpen

In case of overdose, the patient should immediately consult their doctor or go to the nearest emergency department in a hospital. They should take the medicine in its original packaging, so that the medical staff can check exactly which medicine was taken.

Missed dose of Syntarpen

If the patient forgets to take a dose, they should do so as soon as they remember and continue treatment according to the doctor's recommendations. The patient should not take a double dose to make up for the missed dose.

Discontinuation of Syntarpen

It is important to take the medicine for as long as the doctor recommends. The patient should not stop treatment just because they feel better. If the treatment cycle is interrupted too early, the infection may recur. If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor. In case of any further doubts about taking the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

• Allergic reactions Immediate allergic reactions: sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes that may be accompanied by blisters on the eyes, mouth, throat, and genitals, loss of consciousness (fainting).

Delayed allergic reactions (may occur 48 hours to 2-4 weeks after starting treatment): fever, malaise, hives, muscle pain, joint pain, abdominal pain, skin rashes, symptoms of serum sickness, such as hives on the skin with a burning sensation, allergic vasculitis.

• Severe diarrhea lasting for a long time or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe colitis (pseudomembranous colitis), which can occur after antibiotic use.
• In case of any of the above severe side effects, the patient should immediately consult their doctor or go to the hospital.

Other side effects that may occur during treatment

• Increased or decreased number of certain types of white or red blood cells, or platelets, abnormal breakdown of red blood cells, bone marrow suppression.
• Transient excessive restlessness, excitement, anxiety, drowsiness, disorientation, and (or) dizziness, mainly in patients with renal impairment receiving large doses of the medicine.
• Nausea, vomiting, inflammation of the oral mucosa, black hairy tongue.
• Increased liver enzyme activity, in rare cases, liver inflammation may occur, and jaundice (yellowing of the skin and whites of the eyes) may appear. These symptoms resolve after discontinuation of the medicine.
• Kidney function disorders, urinary retention, white or blood in the urine, resolving after discontinuation of the medicine. These occur mainly in patients who receive large doses of the medicine and (or) have pre-existing kidney function disorders. These symptoms resolve after discontinuation of the medicine.
• Fever, pain, and dizziness - resolving after discontinuation of the medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the Department} e-mail: [email protected]

5. How to store Syntarpen

The medicine should be stored out of sight and reach of children. Store at a temperature not exceeding 25°C. Protect from light and moisture. Do not use the medicine after the expiration date stated on the packaging after: EXP. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Syntarpen contains

The active substance of the medicine is cloxacillin in the form of sodium salt. One coated tablet contains 500 mg of cloxacillin. The other ingredients are: potato starch, gelatin, talc, sodium carboxymethylcellulose, magnesium stearate, lactose monohydrate, cellulose acetophthalate, macrogol 6000, talc, titanium dioxide.

What Syntarpen looks like and what the package contains

The tablets are round, biconvex, white, and may have a light cream color. Package:16 coated tablets.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: