KLABAX 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Klabax, 500 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Klabax and what is it used for
4. Important information before taking Klabax
   1. When not to take Klabax
   2. Warnings and precautions
   3. Klabax and other medicines
   4. The patient must inform their doctor if they are taking any of the following medicines, as their use with Klabax is contraindicated:
   5. The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when taking them with Klabax:
   6. Klabax:
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Klabax contains sodium
5. How to take Klabax
   1. Using a higher dose of Klabax than recommended
   2. Missing a dose of Klabax
   3. Stopping treatment with Klabax
6. Possible side effects
   1. Other side effects
   2. Reporting side effects
7. How to store Klabax
8. Contents of the pack and other information
   1. What Klabax contains
   2. What Klabax looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: information for the user

Klabax, 500 mg, film-coated tablets

Clarithromycin

You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you and should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Klabax and what is it used for
• 2. Important information 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 is Klabax and what is it used for

Klabax contains the active substance – clarithromycin. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.
Klabax is indicated for use in adults and adolescents over 12 years of age for the treatment of infections caused by microorganisms susceptible 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., infectious eczema, folliculitis, cellulitis, abscesses),
• disseminated or localized infections caused by mycobacteria.

In patients with HIV infection (CD4 cell count ≤100/mm), Klabax is indicated for the prevention of disseminated infections caused by the Mycobacterium avium complex (MAC).
In patients with duodenal ulcer and confirmed diagnostic infection with Helicobacter pylori, it is recommended to use Klabax simultaneously with drugs that inhibit gastric acid secretion and another antibiotic.

2. Important information before taking Klabax

When not to take 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 (used in migraine), or midazolam given orally (used in anxiety and insomnia);
• if the patient is taking drugs that may cause severe heart rhythm disturbances;
• if the patient is taking astemizole or terfenadine (used in allergies), cisapride or domperidone (used in gastrointestinal disorders), pimozide (used in psychiatric disorders), as concomitant use with Klabax may cause severe heart rhythm disturbances;
• if the patient is taking ticagrelor, ranolazine (used in heart and circulation diseases);
• if the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia);
• if the patient is taking lovastatin, simvastatin (statins used to lower blood cholesterol levels);
• if the patient has severe liver failure with concomitant kidney failure;
• if the patient or their family members have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome";
• if the patient is taking colchicine (used in gout treatment);
• if the patient is taking a medicine containing lomitapide.

Warnings and precautions

Before starting to take Klabax, the patient should discuss it with their doctor or pharmacist if:
the patient is pregnant or thinks they may be pregnant;
the patient has liver or kidney problems;
the patient has resistance to other antibiotics, such as clindamycin, lincomycin;
the patient has coronary artery disease, severe heart failure, slowed heart rate;
the patient is taking any of the medicines listed in the "Klabax and other medicines" section.
If any of the following situations occur while taking Klabax, the patient should tell their doctor.

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, angioedema of the face, tongue, lips, eyes, and throat, and anaphylaxis. The patient should immediatelyconsult a doctor, who will provide appropriate treatment.
• Diarrhea, especially acute or prolonged. The patient should tell their doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment. The patient should not take anti-diarrheal medicines.
• Symptoms of liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain. The patient should stop treatment and consult a doctor.
• New infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged use of the antibiotic. The doctor will prescribe appropriate treatment.

In addition, while taking Klabax, the following may occur:

• Cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides);
• Antibiotic resistance (e.g., treatment of Helicobacter pylori infection may lead to the selection of resistant microorganisms).

Klabax and other medicines

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

The patient must inform their doctor if they are taking any of the following medicines, as their use with Klabax is contraindicated:

• ergot alkaloids, such as ergotamine or dihydroergotamine (used in migraine)
• astemizole or terfenadine (used in allergies)
• cisapride or domperidone (used in gastrointestinal disorders)
• pimozide (used in psychiatric disorders)
• ticagrelor, ranolazine (used in heart and circulation diseases)
• colchicine (used in gout treatment)
• statins - lovastatin, simvastatin (used to lower blood cholesterol levels)
• midazolam given orally (used in anxiety or insomnia)

The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when taking them with Klabax:

Klabax:

• rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in HIV treatment)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in heart rhythm disorders or hypertension)
• alprazolam, triazolam, midazolam given intravenously or orally (used in anxiety or insomnia)
• warfarin or other anticoagulant medicines, e.g., dabigatran, rivaroxaban, apixaban, edoxaban
• quetiapine or other atypical antipsychotic medicines
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• methylprednisolone (anti-inflammatory medicine)
• omeprazole (medicine that reduces stomach acid secretion)
• cilostazol (medicine used in intermittent claudication, which is characterized by leg pain during exercise that subsides after a short rest)
• cyclosporin, tacrolimus, sirolimus (medicines used, among others, after transplants)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• theophylline (medicine used in asthma)
• tolterodine (medicine used in urinary incontinence)
• phenobarbital (antiepileptic medicine)
• St. John's wort (herbal medicine used in mild depression)
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes)
• hydroxychloroquine or chloroquine (used, among others, in rheumatoid arthritis treatment or to prevent malaria). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.
• oral, injectable, or inhaled corticosteroids (used to suppress the immune system, which is useful in treating many different diseases)

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 or pharmacist before taking this medicine, as the safety of clarithromycin during pregnancy or breastfeeding is not known.
Klabax may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Since clarithromycin passes into breast milk, breastfeeding women should exercise special caution when taking Klabax.

Driving and using machines

The medicine may cause dizziness, confusion, and disorientation, which may affect the ability to drive and use machines.

Klabax contains sodium

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

3. How to take Klabax

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is for oral use.
The tablet should be swallowed whole, with a glass of water. Do not chew or suck the tablet.
Tablets can be taken with or without food.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
In severe infections - one 500 mg tablet twice a day (every 12 hours).
Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, when treatment lasts 6 to 14 days.
Adolescents over 12 years of age
Dosage is the same as for adults.
Children under 12 years of age
Klabax oral suspension is recommended.
Patients with renal impairment
The doctor may recommend reducing the dose by half, which means taking one 250 mg tablet per day.
In severe infections – one 250 mg tablet twice a day.
Klabax containing 250 mg of clarithromycin per tablet is recommended in this case.
Treatment should not last longer than 14 days.
Infections caused by mycobacteria
Recommended dose for adults: one 500 mg tablet twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in patients with AIDS should be continued for as long as the doctor recommends. Klabax should be used in combination with other medicines that act against Mycobacterium.
Treatment of other non-tuberculous mycobacterial infections should be continued according to the doctor's recommendations.
Prevention of MAC infections
Recommended dose for adults: one 500 mg tablet twice a day.
Helicobacter pylori infections
In patients with gastric or duodenal ulcer caused by Helicobacter pylori infection, clarithromycin can be given for 7 to 14 days at a dose of 500 mg twice a day, in combination with other appropriate antibacterial treatment and proton pump inhibitors, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

Using a higher dose of Klabax than recommended

In case of taking a higher dose of Klabax than recommended, the patient should immediately contact their doctor or pharmacist. Taking a higher dose of Klabax than recommended by the doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klabax

In case of missing a dose, the patient should take it as soon as possible, and then take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Klabax

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.
The patient should not stop treatment, even if they feel better and the symptoms of the disease disappear after a few days of taking the medicine.

4. Possible side effects

Like all medicines, Klabax can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects at any stage of taking the medicine, they should stop takingKlabax and consult their doctor immediately:

• Anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• Hypersensitivity reactions: rash (frequent), itching, urticaria (infrequent), angioedema of the face, tongue, lips, eyes, and throat, and difficulty breathing
• Severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and blisters
• Stevens-Johnson syndrome - a severe disease characterized by sudden onset of fever and blisters, which resolve spontaneously after discontinuation of the medicine; a severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by bursting large subepidermal blisters, extensive skin necrosis, and fever
• DRESS syndrome - a severe (life-threatening) drug rash that occurs with an increased number of eosinophils and involvement of internal organs
• Severe or prolonged diarrhea, which may be accompanied by blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after the end of treatment with clarithromycin. In this case, the patient should also consult their doctor
• Jaundice, skin irritation, pale stools, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver failure, cholestasis (elevated bile components in the blood), or hepatitis (not frequent). These reactions occur with unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after the marketing of clarithromycin, the following side effects were frequentlyreported (occurring in 1 to 10 out of 100 patients):

• insomnia
• taste disturbances, headache
• diarrhea, vomiting, nausea, abdominal pain
• abnormal liver function test results
• excessive sweating

Side effects reported infrequently(occurring in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), vaginal infection
• decreased white blood cell count, decreased neutrophil count, and increased eosinophil count
• anorexia, decreased appetite
• anxiety
• dizziness, drowsiness, tremors
• balance disorders, hearing loss, tinnitus
• palpitations, changes in ECG (QT interval prolongation)
• gastritis, stomatitis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence
• increased liver enzyme activity: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• increased enzyme activity in the blood: alkaline phosphatase and lactate dehydrogenase

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from the available data) after the marketing of Klabax in tablet and suspension form:

• rosacea
• agranulocytosis (decreased granulocyte count in the blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania
• seizures, ageusia, parosmia, anosmia, paresthesia (numbness, tingling)
• deafness
• heart rhythm disturbances of the torsades de pointes type, ventricular tachycardia, atrial fibrillation
• hemorrhage
• 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 immune function
In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immune function:

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence with gas release, dry mouth
• headache, hearing disturbances
• rash
• dyspnea, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased blood urea nitrogen levels, and decreased platelet and white blood cell counts

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Klabax

Store 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 month.
There are no special storage instructions for the medicine. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Klabax contains

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

What Klabax looks like and contents of the pack

Klabax, 500 mg: film-coated tablets, are light yellow, oval, biconvex, with the inscription "C" on one side and "2" on the other side of the dividing line, with a notch on both sides. The tablet can be divided into equal doses.
Klabax film-coated tablets, 500 mg, are available in packs of 10, 14, or 20 tablets.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw
phone: 22 642 07 75

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132JH- Hoofddorp
Netherlands
Terapia SA
Fabricii Street 124
400 632 Cluj Napoca
Romania
Date of last revision of the leaflet:07.03.2024