Syntarpen

Package leaflet: Information for the patient

SYNTARPEN, 500 mg, coated tablets
Cloxacillin - Cloxacillinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.

Table of contents

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

1. What Syntarpen is and what it is used for

Syntarpen contains as the active substance cloxacillin, which is an antibiotic belonging to the group of semi-synthetic penicillins. Cloxacillin acts against various strains of Gram-positive and Gram-negative bacteria, but is most commonly used in the treatment of infections caused by staphylococci.
Syntarpen is indicated in the treatment of the following staphylococcal infections:

• Skin and soft tissue infections (e.g. furunculosis);
• Lower respiratory tract infections;
• Suppurative complications following burns or surgery;
• Bone and marrow infections, mainly post-traumatic – the oral form is used in the later stages of treatment.

2. Important information before using Syntarpen

When not to use Syntarpen
Do not use Syntarpen if the patient is allergic (hypersensitive) to cloxacillin, penicillins, cephalosporins, or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If the patient has previously experienced an allergic reaction to any antibiotic or other allergic reaction, inform the doctor before using this medicine.
• If the patient is allergic to any cephalosporin antibiotic, they may also be allergic to cloxacillin (so-called cross-allergy).
• If skin reactions (e.g. urticaria, itching) or other symptoms indicating allergy occur during treatment with Syntarpen, discontinue the medicine immediately and contact a doctor as soon as possible.
• If the patient needs to take Syntarpen for a prolonged period, the doctor will usually recommend periodic monitoring of kidney and liver function, as well as peripheral blood morphology.
• Prolonged use of antibiotics may lead to overgrowth of resistant bacteria or fungi. If symptoms of new infections occur during treatment with Syntarpen, the medicine should be discontinued and medical advice sought.
• If severe, persistent diarrhoea occurs during or after completion of Syntarpen treatment, inform the doctor. This may be a sign of pseudomembranous colitis—a complication associated with antibiotic use. Treatment with Syntarpen must then be stopped, and sometimes specific treatment is required. Do not administer drugs that inhibit peristalsis or have constipating effects. If in doubt, consult a doctor or pharmacist.

Syntarpen and other medicines
Inform the doctor about all medicines currently taken or recently used,
as well as any medicines the patient plans to use.
In particular, inform the doctor if the patient is taking:
probenecid (used in the treatment of gout) – may increase the antibiotic blood concentration;
anticoagulants (medicines preventing blood clots), e.g. warfarin – may increase the risk of bleeding;
methotrexate (used in the treatment of arthritis) – its toxicity may increase;
oral contraceptives – contraceptive efficacy may be reduced; a non-hormonal method of contraception should be used additionally;
ampicillin, fusidic acid (antibiotics) – their effects may be enhanced;
erythromycin, tetracyclines, chloramphenicol (antibiotics) – the effect of Syntarpen may be reduced.

Effect on laboratory test results

• Urine glucose tests using certain methods may yield false-positive results; enzymatic tests are recommended.
• Urine steroid measurements may be altered.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine.
For safety reasons, Syntarpen should be used during pregnancy only if clearly necessary, when, in the doctor's opinion, potential benefits outweigh the risks.
The medicine passes into breast milk in small amounts. Breastfeeding women should exercise caution, as the medicine may cause adverse effects in the nursing infant (allergic reactions, diarrhoea, candidiasis).

Driving and operating machinery
There is no data available on the effect of Syntarpen on the ability to drive or operate machinery. If the patient experiences symptoms affecting concentration (e.g. headache or dizziness, drowsiness, disorientation; see section 4. Possible adverse effects), driving or operating machinery should be avoided until these symptoms resolve.

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

3. How to use Syntarpen

This medicine should always be used as directed by a physician. In case of doubt, consult your
doctor.
Adults and children with body weight above 20 kg
Typically, 1 tablet (500 mg) every 6 hours is administered. In very severe infections, cloxacillin should be given intramuscularly or intravenously.
Children with body weight up to 20 kg
Intravenous administration of cloxacillin is recommended.
Dosage in patients with renal impairment
Caution is required when administering the medicine to patients with renal impairment. Dose reduction or prolongation of the interval between doses may be necessary.
Method of administration
The medicine should be taken one hour before or two hours after a meal.
Duration of treatment
The duration of treatment is determined by the doctor, depending on the severity and type of infection, patient's condition, age, and body weight. Usually, the medicine should be continued for 2 to 4 days after symptoms have resolved.
Use of a higher than recommended dose of Syntarpen
If a higher than recommended dose of Syntarpen has been used, contact a doctor immediately or go to the nearest emergency department of a hospital. Bring the medicine in its original packaging so that medical staff can clearly identify which medicine was used.
Missed dose of Syntarpen
If a patient forgets to take the medicine, they should take it as soon as they remember and then continue treatment as directed.
Do not take a double dose to make up for a missed dose.
Discontinuation of Syntarpen
It is important to continue taking the medicine for as long as prescribed by the doctor. Do not stop treatment just because the patient feels better. If the treatment course 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 course, they should consult their doctor.
If there are any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions following administration of Syntarpen occur very rarely (less frequently than in 1 out of 10,000 patients).

Serious adverse reactions

• Allergic reactions
  Immediate allergic reactions: sudden shortness of breath and chest tightness, swelling of the eyelids, face or lips, severe skin rashes which may include blistering affecting the eyes, mouth, throat and genital organs, loss of consciousness (fainting).
  Delayed allergic reactions (may occur from 48 hours up to 2–4 weeks after starting treatment): fever, malaise, urticaria, muscle pain, joint pain, abdominal pain, skin rashes, serum sickness-like symptoms such as skin hives with a burning sensation, allergic vasculitis.

• Severe diarrhoea that persists for a prolonged period or contains blood, accompanied by abdominal pain or fever. This may be a sign of a serious intestinal inflammation (called pseudomembranous colitis), which may occur following antibiotic use.

• If any of the serious adverse reactions listed above occur, contact a doctor immediately or go directly to hospital.

Other adverse reactions that may occur during treatment

• Increase or decrease in the number of certain types of white or red blood cells and platelets, abnormal breakdown of red blood cells, bone marrow suppression.
• Transient hyperactivity, restlessness, agitation, drowsiness, disorientation, and/or dizziness, mainly in patients with renal impairment receiving high doses of the medicine.
• Nausea, vomiting, inflammation of the oral mucosa, black hairy tongue.
• Increased liver enzyme activity; in isolated cases, hepatitis may occur, as well as jaundice (manifested by yellowing of the skin and whites of the eyes) due to cholestatic jaundice caused by bile stasis. These symptoms resolve after discontinuation of the medicine.
• Kidney function disorders, reduced urine output, presence of protein or blood in urine, which resolve after discontinuation of the medicine. These occur mainly in patients receiving high doses of the medicine and/or who already have impaired kidney function. These symptoms resolve after discontinuation of the medicine.
• Fever, headache and dizziness – resolve after discontinuation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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
{current address, telephone and fax number of the above Department}
e-mail: [email protected]

5. How to store Syntarpen

Keep the medicine out of the 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 expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Syntarpen contains
The active substance is cloxacillin in the form of sodium salt. Each coated tablet contains
500 mg of cloxacillin.
The other ingredients are: potato starch, gelatin, talc, sodium carboxymethyl starch, magnesium stearate, lactose monohydrate, cellulose acetate phthalate, macrogol 6000, talc, titanium dioxide.
What Syntarpen looks like and contents of the pack
Round, biconvex tablets, white in colour, possibly with a light cream tint.
Packaging: 16 coated tablets.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: (22) 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.