Klabax

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Klabax (Claritromycine SUN 500 mg), 500 mg, film-coated tablets
Clarithromycinum
Klabax and Claritromycine SUN 500 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and must not be passed on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Klabax is and what it is used for

Klabax contains the active substance clarithromycin. It belongs to a class of antibiotics called macrolides, which inhibit the growth of bacteria causing infections.
Klabax is indicated for use in adults and adolescents over 12 years of age for the treatment of infections caused by microorganisms sensitive to clarithromycin. These infections include:

• upper respiratory tract infections (e.g. streptococcal pharyngitis, sinusitis),
• lower respiratory tract infections (e.g. bronchitis, pneumonia),
• acute otitis media,
• skin and soft tissue infections (e.g. impetigo, folliculitis, cellulitis, abscesses),
• disseminated or localized infections caused by mycobacteria.

In HIV-infected patients (CD4 cell count ≤100/mm³), Klabax is indicated for the prevention of disseminated infections caused by the Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and confirmed Helicobacter pylori infection, Klabax should be used in combination with gastric acid secretion inhibitors and another antibiotic.

2. Important information before using Klabax

When not to use Klabax

• if the patient is allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine) or oral midazolam (a medicine used for anxiety and insomnia);
• if the patient is taking medicines that may cause severe heart rhythm disorders;
• if the patient is taking astemizole or terfenadine (medicines used for allergies), cisapride or domperidone (a medicine used for gastrointestinal motility disorders), pimozide (a medicine used for psychiatric disorders), as concomitant use with Klabax may lead to severe heart rhythm disturbances;
• if the patient is taking ticagrelor (an antiplatelet agent) or ranolazine (a heart medication);
• if the patient has been diagnosed with low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia);
• if the patient is taking lovastatin or simvastatin (statin medicines used to reduce blood cholesterol levels);
• if the patient has been diagnosed with severe hepatic impairment with concomitant renal impairment;
• if the patient has a history, or family history, of heart rhythm disorders (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome";
• if the patient is taking colchicine (a medicine used to treat gout);
• if the patient is taking a medicine containing lomitapide.

Warnings and precautions
Before starting treatment with Klabax, consult a doctor or pharmacist if:

• the patient is pregnant or suspects she may be pregnant;
• the patient has impaired liver or kidney function;
• the patient has resistance to other antibiotics such as clindamycin or lincomycin;
• the patient has coronary artery disease, severe heart failure, or bradycardia (slow heart rate);
• the patient is taking any of the medicines listed in the section "Klabax with other medicines".

If any of the following situations occur during treatment with Klabax, inform the doctor immediately:

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm. Immediate medical attention is required, and appropriate treatment should be initiated.
• Diarrhoea, especially acute or prolonged. Inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment. Do not use anti-diarrhoeal medicines.
• Symptoms suggesting liver dysfunction such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. Discontinue treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or with fungi, especially during prolonged antibiotic use. The doctor will recommend appropriate treatment.

Additionally, during treatment with Klabax the following may occur:

• Cross-resistance of bacteria (bacteria resistant to clarithromycin may also show resistance to other macrolide antibiotics, as well as to lincomycin and clindamycin);
• Bacterial resistance (e.g. treatment of Helicobacter pylori infection may lead to the emergence of drug-resistant microorganisms).

Klabax with other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
It is essential to inform the doctor if the patient is taking any of the following medicines, as concomitant use with Klabax is contraindicated:

• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, for migraine)
• astemizole or terfenadine (medicines used for allergies)
• cisapride or domperidone (a medicine used for gastrointestinal motility disorders)
• pimozide (a medicine used for psychiatric disorders)
• ticagrelor, ranolazine (medicines used for cardiovascular diseases)
• colchicine (a medicine used for gout)
• statins – lovastatin, simvastatin (medicines used to lower blood cholesterol levels)
• oral midazolam (a medicine used for anxiety or insomnia)

Inform the doctor if the patient is taking any of the following medicines, as special caution is required when using them concomitantly with Klabax:

• rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in the treatment of HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used for heart rhythm disorders or hypertension)
• alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used for anxiety or insomnia)
• warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban
• quetiapine or other atypical antipsychotics
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine reducing gastric acid secretion)
• cilostazol (a medicine used in intermittent claudication, characterised by leg muscle pain during exercise that resolves with short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction)
• ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• theophylline (a medicine used in bronchial asthma)
• tolterodine (a medicine used for urinary incontinence)
• phenobarbital (an anticonvulsant medicine)
• St. John’s wort (a herbal medicine used for mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)
• hydroxychloroquine and chloroquine (medicines used in autoimmune diseases).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine, as the safety of clarithromycin during pregnancy or breastfeeding is not established.
Klabax may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the foetus.
Since clarithromycin passes into human milk, women who are breastfeeding should exercise special caution when using Klabax.

Driving and using machines
The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive or operate machinery.

Klabax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Klabax

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
The tablet should be swallowed whole with water. Do not chew or suck the tablet.
Tablets may be taken with food or on an empty stomach.

Respiratory tract, skin and soft tissue infections, acute otitis media
Adults
For severe infections – one 500 mg tablet twice daily (every 12 hours).
Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, for which treatment lasts 6 to 14 days.

Adolescents over 12 years of age
Dosage as for adults.

Children aged 12 years and younger
It is recommended to use Klabax oral suspension.

Patients with renal impairment
The doctor may recommend reducing the dose by half, which means taking one 250 mg tablet once daily.
In severe infections – one 250 mg tablet twice daily.
In such cases, it is recommended to use Klabax tablets containing 250 mg clarithromycin.
Treatment should not last longer than 14 days.

Infections caused by mycobacteria
Recommended dose for adults: one 500 mg tablet twice daily.
Treatment of disseminated infection caused by Mycobacterium avium complex (MAC) in AIDS patients should be continued as long as directed by the physician. Klabax should be used concomitantly with other anti-Mycobacterium agents.
Treatment of other non-tuberculous Mycobacterium infections should be continued according to physician's instructions.

Prevention of MAC infections
Recommended dose for adults: one 500 mg tablet twice daily.

Helicobacter pylori infections
In patients with peptic ulcer disease of the stomach or duodenum caused by Helicobacter pylori infection, clarithromycin may be administered for 7 to 14 days at a dose of 500 mg twice daily, in combination with other appropriate antibacterial therapy and proton pump inhibitors, in accordance with national and international guidelines for Helicobacter pylori eradication.

Taking more Klabax than recommended
If you take more Klabax than recommended, contact your doctor or pharmacist immediately. Taking a higher than recommended dose of Klabax may cause gastrointestinal symptoms (vomiting, abdominal pain).

If you forget to take Klabax
If you miss a dose, take it as soon as possible, then take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Klabax treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment prematurely, even if you start feeling better and symptoms improve after a few days of treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in the patient at any stage of treatment,
discontinue Klabax immediately and consult a doctor without delay:

• Anaphylactic shock – acute, life-threatening allergic reaction, manifested, among others, by confusion, skin pallor, drop in blood pressure, sweating, low urine output, rapid breathing, weakness, and fainting
• Allergic reactions: rash (common), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
• Acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous pustules and blisters
• Bullous erythema multiforme (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, which resolve rapidly and spontaneously after discontinuation of the drug; a severe condition manifested by blisters and erosions on the skin, in the oral cavity, eyes, and genital organs, accompanied by fever and joint pain
• Toxic epidermal necrolysis (Lyell's syndrome) – a severe, rapidly progressing disease characterized by ruptured giant subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever
• DRESS syndrome – severe (life-threatening) drug-induced rash associated with increased eosinophil count and internal organ involvement
• Severe or prolonged diarrhoea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhoea may occur even up to two months after completion of clarithromycin treatment. In such cases, medical advice should also be sought.
• Yellowing of the skin (jaundice), skin irritation, pale stool, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver failure, cholestasis (increased bile components in blood), or hepatitis (uncommon). These reactions occur at an unknown frequency, unless otherwise stated.

Other adverse reactions
In clinical trials and post-marketing experience with clarithromycin, the following adverse reactions have been reported commonly (occurring in 1 to 10 out of 100 patients):

• Insomnia
• Taste disturbances, headache
• Diarrhoea, vomiting, dyspepsia, nausea, abdominal pain
• Abnormal liver function test results
• Excessive sweating

Adverse reactions reported uncommonly (occurring in 1 to 10 out of 1,000 patients):

• Candidiasis (fungal infection), vaginal infection
• Leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count), and eosinophilia (increased eosinophil count)
• Anorexia, decreased appetite
• Restlessness
• Dizziness, somnolence, tremor
• Balance disorders, hearing loss, tinnitus
• Palpitations, ECG changes (prolongation of QT interval)
• Gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity: alanine aminotransferase, increased aspartate aminotransferase activity, increased gamma-glutamyl transferase activity
• Malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• Increased blood levels of alkaline phosphatase and lactate dehydrogenase enzymes

The following adverse reactions have been reported after marketing of Klabax in tablet and suspension forms, with unknown frequency (frequency cannot be estimated from available data):

• Roseola
• Agranulocytosis (reduction in granulocyte count), thrombocytopenia (reduction in platelet count)
• Acne
• Psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• Seizures, ageusia (loss of taste), parosmia (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling)
• Deafness
• Cardiac arrhythmias of the torsade de pointes type, ventricular tachycardia, ventricular fibrillation
• Bleeding
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness)
• Renal failure, interstitial nephritis
• Changes in diagnostic test results (elevated International Normalized Ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immunity
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in immunocompromised adult patients:

• Nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnoea, insomnia
• Abnormal laboratory findings: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen, decreased platelet and white blood cell counts

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Klabax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to
the last day of the stated month.
No special temperature storage requirements. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Klabax contains

• The active substance is clarithromycin. One Klabax coated tablet contains 500 mg of clarithromycin.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, talc, colloidal anhydrous silica, stearic acid, and Opadry 20H 52875 coating containing hypromellose, hydroxypropylcellulose, propylene glycol, vanillin, titanium dioxide (E 171), talc, and quinoline yellow (E 104), lac.

What Klabax looks like and contents of the pack
Klabax 500 mg: coated tablets are light yellow, oval-shaped, biconvex, with the imprint
“C” on one side and “2” on the other side of the dividing line, scored on both sides.
The tablet can be divided into equal doses.
Klabax pack sizes of coated tablets 500 mg contain 14 or 21 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH, Hoofddorp, the Netherlands
Manufacturer:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH, Hoofddorp, the Netherlands
Terapia S.A., Fabricii 124, 400632 Cluj-Napoca, Cluj, Romania
Alkaloida Chemical Company Zrt, Kabay János u. 29, 4440 Tiszavasvári, Hungary
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Netherlands, country of export: RVG 29850
Parallel import authorisation number: 99/23