Klabax

Patient Information Leaflet

Klabax, 500 mg, film-coated tablets
Clarithromycinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and should not be passed 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. 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 is a macrolide antibiotic that inhibits 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 Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and confirmed Helicobacter pylori infection, Klabax should be used in combination with agents that inhibit gastric acid secretion 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, in migraine) or oral midazolam (a medicine used in anxiety states 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 in allergy), cisapride or domperidone (a medicine used in gastrointestinal motility disorders), pimozide (a medicine used in psychiatric disorders), as concomitant use with Klabax may cause severe heart rhythm disturbances;
• if the patient is taking ticagrelor (a platelet aggregation inhibitor), ivabradine or ranolazine (cardiac medicines);
• if the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia);
• if the patient is taking lovastatin, simvastatin (statin group medicines used to reduce blood cholesterol levels);
• if the patient has severe hepatic insufficiency with concomitant renal insufficiency;
• if the patient has previously experienced cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome", either personally or in family history;
• if the patient is taking colchicine (a medicine used in the treatment of 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, lincomycin;
the patient has coronary artery disease, severe heart failure, or bradycardia;
the patient is taking any of the medicines listed in the section "Klabax and 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, bronchospasm. Immediate medical attention is required, and appropriate treatment will 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 antidiarrhoeal medicines.
• Symptoms suggesting impaired liver function such as loss of appetite, jaundice, dark urine, pruritus, or abdominal pain. Discontinue treatment and consult a doctor immediately.
• New infection (superinfection) with organisms resistant to clarithromycin or 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 emergence of drug-resistant microorganisms).

Klabax and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
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, in migraine)
• astemizole or terfenadine (medicines used in allergy)
• cisapride or domperidone (a medicine used in gastrointestinal motility disorders)
• pimozide (a medicine used in psychiatric disorders)
• ticagrelor, ranolazine (medicines used in heart and circulatory diseases)
• colchicine (a medicine used in gout)
• statins – lovastatin, simvastatin (cholesterol-lowering medicines)
• midazolam administered orally (a medicine used in anxiety states 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 tuberculosis treatment)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in HIV infection treatment)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in treatment of cardiac arrhythmias or hypertension)
• alprazolam, triazolam, intravenous or oral mucosal midazolam (medicines used in anxiety states or insomnia)
• warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban, edoxaban
• quetiapine or other atypical antipsychotics
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• methylprednisolone (anti-inflammatory medicine)
• omeprazole (a medicine reducing gastric acid secretion)
• cilostazol (a medicine used in intermittent claudication, which causes leg muscle pain during exercise, relieved by short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• theophylline (a medicine used in bronchial asthma)
• tolterodine (a medicine used in urinary incontinence)
• phenobarbital (an anticonvulsant)
• St. John's wort (a herbal medicine used in mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes)
• hydroxychloroquine or chloroquine (used in treatment, among others, of rheumatoid arthritis, and in treatment or prevention of malaria). Concomitant use of these medicines with clarithromycin may increase the risk of cardiac arrhythmias and other serious adverse cardiac effects.
• corticosteroids administered orally, by injection, or by inhalation (used to suppress immune system activity, beneficial in treating many different conditions)

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

Driving and operating machinery
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, meaning the medicine is considered "sodium-free".

3. How to use Klabax

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult your
doctor or pharmacist.
This is an oral medicine.
The tablet should be swallowed whole with water. Do not chew or suck the tablet.
Tablets may be taken with or without food.

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
Use of Klabax oral suspension is recommended.

Patients with renal impairment
The doctor may recommend reducing the dose by half, i.e. one 250 mg tablet once daily.
In severe infections – one 250 mg tablet twice daily.
In such cases, use of Klabax tablets containing 250 mg of clarithromycin is recommended.
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 patients with AIDS should be continued as long as directed by the doctor. Klabax should be used concomitantly with other anti-Mycobacterium agents.
Treatment of other non-tuberculous Mycobacterium infections should be continued according to the doctor’s instructions.

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

Helicobacter pylori infections
In patients with gastric or duodenal ulcer disease associated with Helicobacter pylori infection, clarithromycin may be administered at a dose of 500 mg twice daily for 7 to 14 days, in combination with other appropriate antibacterial agents and proton pump inhibitors, in accordance with national and international guidelines for Helicobacter pylori eradication.

Use of a higher than recommended dose of Klabax
If more Klabax has been taken than recommended, contact your doctor or pharmacist immediately.
Taking more Klabax than prescribed may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missed dose of Klabax
If a dose is missed, 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 treatment with Klabax
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop treatment even if you feel better and symptoms disappear after a few days of taking the medicine.

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 time during treatment, stop taking Klabax immediately and consult a doctor without delay:

• Anaphylactic shock – an acute, life-threatening allergic reaction characterized, among others, by confusion, pale skin, drop in blood pressure, sweating, reduced 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 nodules and blisters
  • Stevens-Johnson syndrome (erythema multiforme major) – sudden onset of fever and blistering rash, which resolves spontaneously after discontinuation of the drug; a serious condition characterized 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 rupturing of giant subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever
  • DRESS syndrome – a severe (life-threatening) drug-induced rash associated with eosinophilia 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 completing clarithromycin treatment. In such cases, contact a doctor immediately.
• Yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tenderness upon touching the abdomen, or loss of appetite. These may be symptoms of liver failure, cholestasis (increased bile components in the blood), or hepatitis (uncommon). These reactions occur at an unknown frequency unless otherwise specified.

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

• Insomnia
• Disturbances in taste, 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
• Loss of balance, hearing loss, tinnitus
• Palpitations, ECG changes (QT interval prolongation)
• Gastritis, oral inflammation, glossitis, abdominal distension, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT)
• Malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• Increased blood levels of alkaline phosphatase and lactate dehydrogenase (LDH)

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

• Roseola
• Agranulocytosis (reduced granulocyte count in blood), thrombocytopenia (reduced 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 such as torsade de pointes, 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 (increased 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 adult patients with impaired immunity:

• Nausea, vomiting, altered taste perception, constipation, abdominal pain, diarrhoea, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnoea, insomnia
• Abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased blood urea nitrogen (BUN), decreased platelet and white blood cell counts

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, 02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Klabax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the mentioned month.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from moisture.
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. Package contents and other information

What Klabax contains

• The active substance is clarithromycin. One 500 mg coated tablet of Klabax contains 500 mg of clarithromycin.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, talc, colloidal anhydrous silica, stearic acid, and the coating agent Opadry 20H 52875 containing hypromellose, hydroxypropylcellulose, propylene glycol, vanillin, titanium dioxide (E171), talc, and quinoline yellow lake (E104).

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.
Packaging of Klabax coated tablets 500 mg contains 10, 14, or 20 tablets.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132JH - Hoofddorp
The Netherlands

Terapia SA
Fabricii Street No. 124
400 632 Cluj Napoca
Romania