Klabax Ec

1. What is Klabax and what is it used for

Klabax contains the active substance clarithromycin.
Clarithromycin belongs to a group of medicines called macrolide antibiotics, which inhibit the growth of certain bacteria.
Klabax is indicated for the treatment of:

• lower respiratory tract infections, such as bronchitis, pneumonia;
• throat and sinus infections;
• skin and soft tissue infections;
• ear infections, especially acute otitis media.

This medicine is used in children from 6 months to 12 years old.

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) or using ergot alkaloids for migraine in an inhalation form.
• if the patient is taking terfenadine or astemizole (medicines often used for hay fever or allergies), cisapride or domperidone (a medicine used for stomach disorders), pimozide (a medicine used for psychiatric disorders), as concomitant use of these medicines may cause serious heart rhythm disturbances.

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This may cause serious heart rhythm disturbances. Consult your doctor for advice on taking other medicines.

• if the patient is taking other medicines that may cause serious heart rhythm disturbances.
• if the patient is taking lovastatin or simvastatin (statins - HMG-CoA reductase inhibitors, used to lower cholesterol levels in the blood).
• if the patient is taking midazolam orally (a sedative medicine).
• if the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia).
• if the patient has severe liver disease with concomitant kidney disease.
• if the patient or their family members have had heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or abnormalities in the electrocardiogram (ECG - a recording of the heart's electrical activity) known as "long QT syndrome".
• if the patient is taking ticagrelor, ivabradine, or ranolazine (for angina or to reduce the risk of heart attack or stroke).
• if the patient is taking colchicine (usually for gout).
• if the patient is taking a medicine containing lomitapide.

Warnings and precautions

Tell your doctor or pharmacist before taking Klabax if:

• the patient has heart problems (such as heart disease, heart failure, very slow heart rate).
• the patient has kidney or liver problems.
• the patient has a fungal infection or is prone to fungal infections (such as thrush).

Klabax and other medicines

Do not take Klabax if the patient is taking any of the medicines listed above in "When not to take Klabax".
Tell your doctor or pharmacist about all medicines the child is taking or has recently taken, as well as any medicines planned to be given to the child, as a dose adjustment or regular monitoring may be necessary:

• digoxin, quinidine, disopyramide (used for heart rhythm disorders)
• warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood)
• carbamazepine, valproate, phenobarbital, or phenytoin (antiepileptic medicines)
• atorvastatin, rosuvastatin [HMG-CoA reductase inhibitors, also known as statins, medicines that lower cholesterol levels (a type of fat) in the blood]. Statins may cause rhabdomyolysis (a condition that causes muscle tissue to break down, which can lead to kidney damage). Monitor for signs of muscle damage (muscle pain or weakness).
• nateglinide, pioglitazone, repaglinide, rosiglitazone, or insulin (medicines that lower blood sugar levels)
• glipizide or glimepiride (sulfonylurea derivatives used for type 2 diabetes)
• theophylline (used for breathing difficulties, such as asthma)
• triazolam, alprazolam, or midazolam given intravenously or orally (sedative medicines)
• cilostazol (a medicine used for circulation disorders)
• methylprednisolone (a corticosteroid)
• ibrutinib or vinblastine (used for cancer treatment)
• cyclosporine, sirolimus, and tacrolimus (medicines that suppress the immune system)

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• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (antiviral medicines used for HIV treatment)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used for certain bacterial or fungal infections)
• tolterodine (a medicine used for overactive bladder)
• verapamil, amlodipine, diltiazem (used for high blood pressure)
• sildenafil, vardenafil, and tadalafil (medicines used for erectile dysfunction in adult men or pulmonary hypertension [high blood pressure in the blood vessels of the lungs])
• St. John's Wort (a herbal medicine used for depression)
• quetiapine or other antipsychotic medicines
• other macrolide antibiotics
• lincosamide antibiotics: lincomycin and clindamycin
• hydroxychloroquine or chloroquine (used for rheumatoid arthritis or for the treatment or prevention of 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)
• omeprazole (used for stomach and/or intestinal disorders).

Tell your doctor if a woman of childbearing age taking oral contraceptives experiences diarrhea or vomiting, as additional contraceptive measures may be necessary, such as using a condom.

Pregnancy and breastfeeding

The safety of clarithromycin during pregnancy and breastfeeding has not been established.
If the medicine is to be given to a woman of childbearing age (who is pregnant or thinks she may be pregnant), consult a doctor before taking this medicine.

Driving and using machines

There is no data on the effect of clarithromycin on the ability to drive and use machines.
Before driving or using machines, the patient should consider that while taking the medicine, dizziness, confusion, and disorientation may occur.

Klabax contains sucrose

5 ml of the suspension contains 2889 mg of sucrose.
This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, tell your doctor before starting to take this medicine.

Klabax contains aspartame

This medicine contains 1 mg of aspartame in each 5 ml of the suspension, which corresponds to 0.2 mg/ml.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Klabax contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of the suspension, which means the medicine is considered "sodium-free".

Klabax contains sodium benzoate

This medicine contains 10 mg of sodium benzoate in 5 ml of the suspension, which corresponds to 2 mg/ml.
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3. How to take Klabax

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended doses of Klabax are as follows:
Dosage
The dosage depends on body weight.

Children who weigh less than 8 kg should receive a dose of 0.15 ml/kg body weight twice a day. In certain situations, the doctor may prescribe higher or lower doses than described.
Klabax should be taken twice a day (in the morning and early evening). The medicine can be taken with food if it is more convenient for the patient.
Method of administration
The medicine is for oral use, after preparing the suspension. The instructions for preparing the suspension are given below.
Before each administration of the medicine, shake the bottle well, and after administration, tighten the cap firmly.
Duration of treatment
Klabax is usually given for 5 to 10 days.
Instructions for preparing the suspension

Step A

Remove the bottle from the box.

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Step B

Invert the bottle and shake it to loosen the powder from the bottom. Check this by looking at the inverted bottle in the light. Open the cap according to the instructions below, peel off, and remove the protective foil (see Figure 2).

Step C

Slowly add water to the ring mark on the bottle. Looking at the light, you can check if the bottle is filled to the correct level. Close the bottle, invert, and shake vigorously for about 1 minute, until the powder is no longer stuck to the bottom of the bottle (see Figure 3). Check this by looking at the inverted bottle in the light.
If necessary, wait a moment and add more water to the ring mark, as described in Step D.

Step D

If necessary, add more water to the ring mark on the bottle. If necessary, hold the bottle up to the light to check if it is filled to the correct level.
Close the bottle. Invert and shake vigorously until the powder is no longer stuck to the bottom of the bottle (see Figure 4). Check this by holding the inverted bottle up to the light.
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Figure 4

Instructions for use

A measuring spoon and adapter are included with the Klabax packaging to facilitate measuring the correct amount of medicine to be given to the child. Follow the instructions below carefully.

• 1. To open the bottle, remove the cap (which has a child-resistant closure) by pressing it and twisting it in the opposite direction to the arrow.
• 2. Remove the plastic, round adapter from the packaging and push it into the neck of the bottle. The adapter should fit tightly and should not be removed after it has been put on.
• 3. Remove the oral measuring spoon from the packaging and make sure the plunger is pushed in all the way. This will remove any air that may be in the spoon.
• 4. Place the tip of the oral measuring spoon into the adapter opening.
• 5. Invert the bottle and hold it in one hand, and the measuring spoon in the other.
• 6. Holding the measuring spoon, slowly pull out the plunger until the spoon is filled with the correct amount of suspension to be given to the child.
• 7. Turn the bottle right side up. Holding the measuring spoon container, remove the spoon from the adapter.
• 8. Place the tip of the measuring spoon into the child's mouth. Give the medicine by pressing the plunger gently, while still holding the spoon. Do not rush the child; give them time to swallow the medicine slowly. The measured dose can also be poured into a spoon and given to the child in this way.
• 9. Close the bottle with the cap.
• 10. Wash the oral measuring spoon with warm water and soap, and then rinse well. Hold the spoon under running water, moving the plunger up and down several times to make sure the inside is clean. Store the spoon in a hygienic manner, together with the medicine.

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Administration of the suspension

Klabax may cause a bitter taste. This can be prevented by eating something, drinking juice, or water immediately after taking the suspension.

Administration of water or juice after taking the medicine.

It is also possible to add the following amounts of water to the bottle once:

Tighten the cap and shake the bottle vigorously.

Overdose of Klabax

If the child is accidentally given a larger amount of Klabax within a day than prescribed by the doctor, or if the child accidentally swallows more medicine, seek medical attention immediately or go to the nearest hospital emergency department.
Overdose of Klabax may cause vomiting and stomach pain.

Missed dose of Klabax

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If a dose of Klabax is missed, give it as soon as possible. Do not give more Klabax in a day than prescribed by the doctor.

Stopping Klabax treatment

Do not stop giving this medicine even if the child feels better. It is important to take this medicine for as long as the doctor has prescribed, otherwise, the symptoms of the disease may return.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Klabax can cause side effects, although not everybody gets them.

Serious side effects

If the patient experiences any of the following side effects, stop taking the medicine and consult a doctor immediately:

• severe or prolonged diarrhea, possibly with blood or mucus. Diarrhea may occur even two months after finishing clarithromycin treatment, in which case consult a doctor.
• rash, difficulty breathing, fainting, or swelling of the face, tongue, lips, eyes, and throat. These are symptoms of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, abdominal tenderness, or loss of appetite. These may be symptoms of liver inflammation and liver failure.
• severe skin reactions, such as painful blisters on the skin, in the mouth, on the lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome / toxic epidermal necrolysis).
• red, scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis). The frequency of this side effect is unknown (cannot be estimated from the available data).
• rare allergic skin reactions causing severe diseases with ulcers in the mouth, lips, and skin, accompanied by a rash, fever, and inflammation of internal organs (DRESS syndrome)
• muscle pain or weakness called rhabdomyolysis (a condition that causes muscle tissue to break down, which can lead to kidney damage).

Other side effects

Common (occurring in less than 1 in 10 patients):

• insomnia
• taste disorders
• headache
• vasodilation
• stomach disorders, such as nausea, vomiting, abdominal pain, indigestion, diarrhea
• excessive sweating

Uncommon (occurring in less than 1 in 100 patients):

• high temperature
• swelling, redness, or itching of the skin
• oral or vaginal thrush
• gastritis or enteritis

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• decreased platelet count (which helps stop bleeding)
• decreased white blood cell count (leukopenia)
• decreased neutrophil count (neutropenia)
• muscle stiffness
• chills
• increased eosinophil count (white blood cells responsible for immunity)
• excessive immune response to foreign substances
• loss of appetite or decreased appetite
• anxiety, nervousness
• drowsiness, fatigue, dizziness, or tremors
• involuntary muscle contractions
• balance disorders
• ringing in the ears or hearing loss
• chest pain or heart rhythm disorders, such as palpitations or irregular heartbeat
• asthma: a lung disease related to bronchial constriction, making breathing difficult
• nosebleeds
• blood clots causing sudden blockage of blood flow in a pulmonary artery (pulmonary embolism)
• esophagitis or gastritis
• anal pain
• bloating, constipation, gas, belching
• dry mouth
• a condition in which bile (a fluid produced by the liver and stored in the gallbladder) does not flow from the gallbladder into the duodenum (bile stasis)
• skin inflammation with blistering, itching, and painful rash
• muscle cramps, muscle pain, or muscle tissue loss. If the child has myasthenia (a disease in which the muscles are weak and easily get tired), clarithromycin may worsen these symptoms
• abnormal, elevated blood test results indicating kidney and liver function, abnormal, elevated blood test results
• feeling of weakness, fatigue, and lack of energy

Frequency not known (frequency cannot be estimated from the available data):

• enteritis
• bacterial skin infection
• decreased count of certain blood cells (which may cause more frequent infections or increase the risk of bruising or bleeding)
• confusion, psychotic disorder, hallucinations (seeing things that are not there), change in perception of reality, or panic attacks, depression, unusual dreams or nightmares, and mania (feeling of excessive joy or excitement)
• seizures (convulsions)
• sensory disturbances (tingling)
• loss of taste or smell or inability to perceive smells correctly
• deafness
• heart rhythm disorders, such as torsades de pointes, ventricular tachycardia
• bleeding (hemorrhage)
• pancreatitis
• discoloration of the tongue or teeth
• acne
• changes in kidney function, kidney inflammation, kidney failure (may cause fatigue, swelling of the face, bags under the eyes, swelling in the abdomen, legs, or ankles, or difficulty urinating)

Reporting side effects

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If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle or carton. The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Do not store the prepared suspension in the refrigerator or freeze it.
The shelf life of the prepared suspension is 14 days.
Medicines should not be disposed of via wastewater or household waste. Ask your 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.
5 ml of the prepared suspension contains 250 mg of clarithromycin.
The other ingredients are: methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, macrogol 1500, talc, carbomer, colloidal anhydrous silica, sucrose, aspartame (E 951), xanthan gum (E 415), sodium citrate, sodium benzoate (E 211), titanium dioxide (E 171), peppermint flavor (containing flavoring substances, modified starch), tutti-frutti flavor (containing corn maltodextrin, natural identical flavoring substances, propylene glycol (E 1520), modified corn starch (E 1450), flavoring and aroma substances of synthetic origin).

What Klabax looks like and contents of the pack

Granules for oral suspension
Klabax is a white to off-white granule for preparing a suspension.
Pack sizes:
1 bottle containing 41.66 - 46.04 g of granules for preparing 60 ml of oral suspension or
1 bottle containing 48.61 - 53.72 g of granules for preparing 70 ml of oral suspension or
1 bottle containing 69.44 - 76.75 g of granules for preparing 100 ml of oral suspension.
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Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

SUN Pharmaceutical Industries (Europe) B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29.
4440 Tiszavasvári
Hungary
S.C. Terapia S.A.
Str. Fabricii nr.124,
400632 Cluj-Napoca, Jud. Cluj
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany
CLARITHROMYCIN BASICS 250 mg/5 ml Granules for oral suspension
Italy
Claritromicina SUN
Romania
Klabax 250 mg/5ml granules for oral suspension
United Kingdom
Clarithromycin 250 mg/5ml granules for oral suspension
(Northern Ireland)
Date of last revision of the leaflet:31.07.2024