Klabax

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Klabax (Clarithromycin SUN 500 mg), 500 mg, film-coated tablets

Clarithromycin
Klabax and Clarithromycin SUN 500 mg are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine because it contains important information for the patient.

• Keep this leaflet so that you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically 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, pharmacist, or nurse. 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 packaging 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 or 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 or simvastatin (statins used to lower cholesterol levels in the blood);
• 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);
• 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 or lincomycin;
• the patient has coronary artery disease, severe heart failure, or slow 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 allergic reactions such as rash, urticaria, angioedema, anaphylaxis, or Stevens-Johnson syndrome. 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 infections (superinfections) 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);
• drug resistance of bacteria (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.

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 or ranolazine (used in heart and circulation diseases)
• colchicine (used in gout)
• statins - lovastatin, simvastatin (used to lower cholesterol levels in the blood)
• 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, such as dabigatran, rivaroxaban, apixaban
• quetiapine or other atypical antipsychotic medicines
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• methylprednisolone (anti-inflammatory medicine)
• omeprazole (medicine that reduces stomach acid secretion)
• cilostazol (used in intermittent claudication, which is characterized by leg pain during exercise that disappears after a short rest)
• cyclosporine, tacrolimus, sirolimus (used in organ transplantation)
• sildenafil, tadalafil, vardenafil (used in erectile dysfunction)
• ibrutinib or vinblastine (used in cancer chemotherapy)
• theophylline (used in asthma)
• tolterodine (used in urinary incontinence)
• phenobarbital (antiepileptic medicine)
• St. John's wort (herbal medicine used in mild depression)
• sulfonylureas, nateglinide, repaglinide, insulin (used in diabetes)
• hydroxychloroquine and chloroquine (used in autoimmune 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 the doctor believes that the benefits to the mother outweigh the potential risks to the fetus.
Since clarithromycin passes into breast milk, breastfeeding women should exercise 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 it is considered "sodium-free".

3. How to take Klabax

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The medicine is for oral use.
The tablet should be swallowed whole with water. Do not chew or suck the tablet.
The 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
Dosing 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 250 mg tablets are recommended.
Treatment should not last more 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 are effective 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 ulcers 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 therapy and proton pump inhibitors, in accordance with national and international guidelines for the eradication of Helicobacter pylori.

Overdose of Klabax

If the patient takes more Klabax than recommended, they should contact their doctor or pharmacist immediately. Taking more Klabax than recommended by the doctor may cause gastrointestinal symptoms (vomiting, abdominal pain).

Missing a dose of Klabax

If the patient misses a dose, they 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

If the patient has any further doubts about taking this medicine, they 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, they should stop takingKlabax and consult their doctor immediately:

• anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, decreased urine production, 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 - a red, scaly rash with bumps under the skin and blisters
• Stevens-Johnson syndrome, characterized by sudden onset of fever and blisters that heal quickly and spontaneously after stopping the medicine; a severe disease characterized by blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by large, bursting blisters under the skin, extensive ulcers on the skin, and shedding of large skin flakes, as well as 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 contain blood or mucus in the stool. The patient should consult their doctor immediately. Diarrhea may occur even two months after stopping clarithromycin treatment. In this case, the patient should also consult their doctor
• jaundice, skin irritation, light-colored stools, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver failure, cholestasis (increased bile components in the blood), or hepatitis (uncommon). These reactions occur with unknown frequency, unless otherwise specified.

Other side effects

In clinical trials and after the introduction of clarithromycin to the market, 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 uncommonly(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, oral thrush, tongue discoloration, abdominal distension, constipation, dry mouth, belching, bloating with gas
• 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 available data) after the introduction of Klabax to the market 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, loss of taste, abnormal smell, loss of smell, paresthesia (numbness, tingling)
• deafness
• heart rhythm disturbances of the torsades de pointes type, ventricular tachycardia, atrial fibrillation
• bleeding
• acute pancreatitis, tongue discoloration, tooth discoloration
• myopathy (muscle disease with muscle weakness)
• kidney failure, interstitial nephritis
• changes in diagnostic test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immune systems
In addition to symptoms related to the course of the disease, the following side effects have been observed in adult patients with impaired immune systems:

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, bloating with gas
• headache, hearing disturbances
• rash
• shortness of breath, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, 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, 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 side effects will help gather more information on the safety of this medicine.

5. How to store Klabax

Keep 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 month.
There are no special storage temperature requirements. Store in the original packaging.
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 packaging and other information

What Klabax contains

• The active substance of Klabax is clarithromycin. One 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 Opadry 20H 52875 coating containing hypromellose, hydroxypropyl cellulose, propylene glycol, vanillin, titanium dioxide (E 171), talc, and quinoline yellow (E 104), lacquer.

What Klabax looks like and what the packaging contains

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 packaging contains 14 or 21 film-coated tablets, 500 mg.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

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

Manufacturer:

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH, Hoofddorp, 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.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number:RVG 29850

Parallel import authorization number: 99/23

Leaflet approval date: 01.06.2023

[Information about the trademark]