KLABAX 250 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Klabax, 250 mg, coated tablets
   1. Read the leaflet carefully before taking 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. Overdose of Klabax
   2. Missed 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, 250 mg, coated tablets

Clarithromycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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),
• dental and oral infections (e.g., periapical abscess, periodontitis),
• disseminated or localized infections caused by mycobacteria.

In patients with HIV infection (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 diagnosed Helicobacter pylori infection, it is recommended to use Klabax in combination with drugs that inhibit gastric acid secretion and another antibiotic.

2. Important information before taking Klabax

When not to take Klabax

Warnings and precautions

Before starting to take Klabax, the patient should discuss it with their doctor or pharmacist if they are pregnant or breastfeeding, have liver or kidney problems, have resistance to other antibiotics, have coronary artery disease, severe heart failure, or bradycardia (slow heart rate), or are 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 rash, urticaria, angioedema, 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 infections (superinfections) with bacteria resistant to clarithromycin or fungi, especially during prolonged use of antibiotics. 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).

If symptoms of hearing or balance organ damage occur (see section 4), it is recommended to perform control tests after completing treatment.

Klabax and other medicines

The patient should tell their doctor about all medicines they are currently taking or plan to take, including those purchased without a prescription.

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 cholesterol levels in the blood)
• midazolam given orally (used in anxiety and 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 disturbances or hypertension)
• alprazolam, triazolam, midazolam given intravenously or orally (used in anxiety and insomnia)
• warfarin or other anticoagulant medicines, e.g., dabigatran, rivaroxaban, apixaban, edoxaban
• quetiapine or other atypical antipsychotics
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• methylprednisolone (anti-inflammatory medicine)
• omeprazole (medicine that reduces gastric acid secretion)
• cilostazol (used in intermittent claudication)
• 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)
• ototoxic medicines (damaging hearing), especially aminoglycoside antibiotics used in bacterial infections
• hydroxychloroquine or chloroquine (used in rheumatoid arthritis treatment or malaria prevention/treatment). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other severe 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 the doctor believes that the benefits to the mother outweigh the potential risks to the fetus.
As 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 exactly as prescribed 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 a glass of water. Do not chew or suck the tablet.
The tablets can be taken with or without food.
If a single dose of 500 mg is necessary, it is recommended to use Klabax containing 500 mg of clarithromycin per tablet.
Respiratory tract infections, skin and soft tissue infections, acute otitis media
Adults
One 250 mg tablet twice a day (every 12 hours).
In severe infections, the doctor may recommend increasing the dose to two 250 mg tablets (i.e., 500 mg) twice a day (every 12 hours).
Treatment usually lasts 5 to 14 days, except for pneumonia and sinusitis, where 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.
Treatment should not last longer than 14 days.
Dental and oral infections
One 250 mg tablet twice a day (every 12 hours). Treatment usually lasts 5 days.
Mycobacterial infections
Recommended dose for adults: two 250 mg tablets (i.e., 500 mg) twice a day.
Treatment of disseminated Mycobacterium avium complex (MAC) infection in AIDS patients 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: two 250 mg tablets (i.e., 500 mg) 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 Helicobacter pylori eradication.

Overdose of Klabax

In case of overdose, 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).

Missed dose of Klabax

If a dose is missed, it should be taken as soon as possible, and the next dose should be taken 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 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, rapid breathing, weakness, and fainting
• Allergic reactions: rash (frequent), 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 - a severe disease characterized by sudden onset of fever and blisters, which heal quickly and spontaneously after discontinuation of the medicine; 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 bursting large subepidermal blisters, extensive skin ulcers, 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 bloody or contain mucus. Diarrhea may occur even two months after completion of clarithromycin treatment. In such cases, the patient should also consult their doctor
• Jaundice, skin irritation, pale stools, dark urine, itching, or abdominal tenderness. These may be symptoms of liver failure, cholestasis (elevated 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 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

The following side effects were 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
• Restlessness
• Dizziness, drowsiness, tremors
• Balance disturbances, hearing loss, tinnitus
• Palpitations, ECG changes (QT interval prolongation)
• Gastritis, oral mucositis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence
• Increased liver enzyme activity: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase
• Fatigue, asthenia (weakness, lack of energy), chest pain, chills, tiredness
• Increased enzyme activity: 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 marketing of Klabax tablets and suspension:

• Rash
• Agranulocytosis (decreased granulocyte count), 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
• Bleeding
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Myopathy (muscle disease with muscle weakness)
• Kidney failure, interstitial nephritis
• Changes in diagnostic test results (increased INR, prolonged prothrombin time, abnormal urine color)

Patients with impaired immune systems
In addition to symptoms related to 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, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnea, insomnia
• Abnormal laboratory test results: increased aspartate aminotransferase and alanine aminotransferase, increased blood urea nitrogen, 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 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 this medicine.

5. How to store Klabax

Keep out of the 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 this medicine. Store in the original package 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 they no longer use. 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 250 mg coated tablet of Klabax contains 250 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, hydroxypropylcellulose, propylene glycol, vanillin, titanium dioxide (E171), talc, and quinoline yellow lake (E104).

What Klabax looks like and contents of the pack

Klabax, 250 mg: coated tablets are light yellow, oval, biconvex, with the inscription "C1" on one side.
Klabax, 250 mg coated tablets, are available in packs of 14 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