Klabax ec

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Package leaflet: Information for the patient

Klabax EC, 125 mg/5 ml, granules for oral suspension
Clarithromycinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Contents of the leaflet

1. What Klabax is and what it is 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 Klabax is and what it is 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 and pneumonia;
• throat and sinus infections;
• skin and soft tissue infections;
• ear infections, particularly acute otitis media.

This medicine is intended for use in children aged 6 months to 12 years.

2. Important information before using Klabax

When Klabax must not be given:

• 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 in tablet form (such as ergotamine or dihydroergotamine) or using inhaled ergot alkaloids for migraine.
• if the patient is taking terfenadine or astemizole (medicines commonly 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. Talk to your doctor for advice on alternative medicines.
• if the patient is taking other medicines that may cause serious heart rhythm disturbances.

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• if the patient is taking lovastatin or simvastatin (medicines belonging to the statin group – HMG-CoA reductase inhibitors – used to lower blood cholesterol (a type of fat)).
• if the patient is taking oral midazolam (a sedative medicine).
• if the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia).
• if the patient has severe liver disease with concomitant kidney disease.
• if the patient has had, or there is a family history of, heart rhythm disorders (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities 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 used to treat gout).
• if the patient is taking a medicine containing lomitapide.

Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Klabax if:

• the patient has heart problems (e.g. 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 (e.g. aspergillosis).

Klabax and other medicines
Do not take Klabax if the patient is taking any of the medicines listed above under "When Klabax must not be given".
Tell your doctor or pharmacist about all medicines currently taken or recently taken by the child, as well as any medicines planned for future use, because dose adjustments or regular monitoring may be necessary:

• digoxin, quinidine, disopyramide (used to treat heart disorders)
• warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood)
• carbamazepine, valproate, phenobarbital or phenytoin (antiepileptic medicines)
• atorvastatin, rosuvastatin [HMG-CoA reductase inhibitors, so-called statins, medicines that lower blood cholesterol (a type of fat)]. Statins may cause rhabdomyolysis (a condition causing muscle breakdown, which may lead to kidney damage). Monitor for symptoms of muscle injury (muscle pain or weakness).
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (medicines that lower blood glucose levels)
• gliclazide or glimepiride (sulfonylurea derivatives used in the treatment of type 2 diabetes)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam, or intravenous or mucosally administered midazolam (sedative medicines)
• cilostazol (a medicine used for circulatory disorders)
• methylprednisolone (a corticosteroid)
• ibrutinib or vinblastine (used in cancer treatment)
• cyclosporine, sirolimus and tacrolimus (immunosuppressive medicines)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (antiviral medicines used in the treatment of HIV infection)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used to treat certain bacterial or fungal infections)

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• tolterodine (a medicine used for a condition called overactive bladder)
• verapamil, amlodipine, diltiazem (used to treat 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 (an herbal medicine used for depression)
• quetiapine or other antipsychotic medicines
• other macrolide antibiotics
• lincosamide antibiotics: lincomycin and clindamycin
• hydroxychloroquine or chloroquine (used, among others, for rheumatoid arthritis or for treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of heart rhythm disturbances and other serious cardiac adverse effects.
• corticosteroids administered orally, by injection or by inhalation (used to suppress the immune system, which is helpful in treating many different conditions)
• omeprazole (used to treat stomach and/or intestinal problems).

Talk to your doctor if a female patient of childbearing age who is taking oral contraceptives experiences diarrhoea or vomiting, as additional contraceptive measures such as using condoms may be necessary.
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 suspects she may be pregnant), consult a doctor before using this medicine.
Driving and operating machinery
There are no data on the effect of clarithromycin on the ability to drive or operate machinery.
Patients should consider that dizziness, confusion and disorientation may occur while taking this medicine before driving or operating machinery.
Klabax contains sucrose
5 ml of suspension contains 3194 mg of sucrose.
This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, inform the doctor before starting treatment with this medicine.
Klabax contains aspartame
This medicine contains 1 mg of aspartame in each 5 ml of suspension, equivalent 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 impaired excretion.
Klabax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of suspension, meaning the medicine is considered "sodium-free".
Klabax contains sodium benzoate
This medicine contains 10 mg of sodium benzoate in 5 ml of suspension, equivalent to 2 mg/ml.

3. How to use Klabax

This medicine should always be used exactly as recommended by the doctor or pharmacist. In case of doubts,
consult the doctor or pharmacist.
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The recommended doses of Klabax are given below:
Dosage
The dosage depends on body weight.

Children weighing less than 8 kg should receive a dose of 0.3 ml/kg body weight twice daily.
In certain situations, the physician may prescribe doses higher or lower than those described.
Klabax should be taken twice daily (in the morning and early evening). The medicine may be
administered with food if this is more convenient for the patient.

Method of administration
Medicinal product for oral use after reconstitution of the suspension. The instructions for
preparing the suspension are provided below.

Before each administration, shake the bottle well. After administration, tightly close the cap.

Duration of treatment
Klabax is usually administered for 5 to 10 days.

Instructions for preparing the suspension

Step A
Remove the bottle from the carton.

Step B
Turn the bottle upside down and shake to ensure the powder does not adhere to the bottom. Check
this by holding the inverted bottle up to the light. Open the cap according to the instructions below,
pry off and remove the protective foil (see Figure 2).
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Step C
Slowly add water up to the level of the ring on the bottle. Hold the bottle up to the light to check
whether it is filled to the correct level. Close the bottle, turn it upside down, and shake vigorously
for about 1 minute until the powder no longer adheres to the bottom of the bottle (see Figure 3).
Check this by holding the inverted bottle up to the light.

Wait a moment, and if necessary, add more water up to the level of the ring, as described in Step D.

Step D
If necessary, add more water up to the level of the ring on the bottle. If needed, hold the bottle up
to the light to verify that it is filled to the correct level. Close the bottle. Turn it upside down and
shake vigorously until the powder no longer adheres 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
An oral syringe and adapter are included in the Klabax packaging to facilitate accurate measurement
of the required dose to be administered to the child. Please strictly follow the instructions below.

1. To open the bottle, remove the child-resistant cap by pressing down and simultaneously turning it counterclockwise.
2. Remove the plastic, round adapter from the packaging and firmly insert it into the neck of the bottle. The adapter should fit tightly and must not be removed once inserted.
3. Remove the oral syringe from the packaging and ensure the plunger is fully depressed. This will expel any air that may be present in the syringe.
4. Insert the tip of the oral syringe into the opening of the adapter.
5. Turn the bottle upside down. Hold the bottle in one hand and the oral syringe in the other.
6. While holding the oral syringe, slowly pull back the plunger until the syringe is filled with the appropriate amount of suspension to be administered to the child.
7. Turn the bottle right-side up. While holding the syringe barrel, remove the syringe from the adapter.
8. Place the tip of the syringe into the child's mouth. Administer the medicine by gently pushing the plunger, while continuing to hold the syringe. Do not rush the child; allow sufficient time for slow swallowing. Alternatively, the measured dose may be poured from the syringe onto a spoon and administered this way.
9. Close the bottle with the cap.
10. Wash the oral syringe with warm soapy water, then rinse thoroughly. While holding the syringe under water, repeatedly move the plunger up and down to ensure the inside is clean. Store the syringe hygienically, together with the medicine.

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Administration of the suspension dose
Klabax may cause a bitter taste. This can be prevented by eating something or drinking juice or water
shortly after taking the suspension.

Administration of water or juice after dosing.
Alternatively, the following volumes of water may be added once to the bottle, depending on the
package size:

Close the bottle and shake vigorously.
Taking more Klabax than recommended
If a child has accidentally been given more Klabax than prescribed in one day, or if a child has accidentally swallowed more of the medicine, seek immediate medical advice from a doctor or go to the nearest hospital emergency department.
Overdose of Klabax may cause vomiting and abdominal pain.
Missing a dose of Klabax
If you forget to give a dose of the medicine to the child, administer it as soon as possible. Do not give more Klabax in one day than prescribed by the doctor.
Stopping treatment with Klabax
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Do not stop giving this medicine even if the child feels better. It is important to continue using this medicine for as long as prescribed by the doctor; otherwise, symptoms of the disease may return.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
If any of the following adverse reactions occur in a patient, STOP administering the medicine and
consult a doctor immediately:

• severe or prolonged diarrhoea, possibly with blood or mucus. Diarrhoea may occur even up to two months after completing clarithromycin treatment; in such a case, contact a doctor as well.
• rash, difficulty breathing, fainting, or swelling of the face, tongue, lips, eyes, or throat. These are symptoms of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale-coloured stools, dark-coloured 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, or genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome / toxic epidermal necrolysis).
• red, scaly rash with nodules under the skin and blisters (acute generalised exanthematous pustulosis). The frequency of this adverse reaction is unknown (cannot be estimated from available data).
• rare skin allergic reactions causing severe illness with ulceration of the mouth, lips, and skin, accompanied by rash, fever, and inflammation of internal organs (DRESS syndrome).
• muscle pain or weakness known as rhabdomyolysis (a condition causing muscle breakdown, which may lead to kidney damage).

Other adverse reactions
Common (occur in less than 1 in 10 patients):

• insomnia
• taste disturbances
• headache
• vasodilation
• gastrointestinal disturbances such as nausea, vomiting, abdominal pain, indigestion, diarrhoea
• excessive sweating

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

• high temperature
• swelling, redness, or itching of the skin
• oral or vaginal fungal infection (candidiasis)
• gastritis and enteritis
• reduced platelet count (which helps stop bleeding)
• reduced white blood cell count (leukopenia)
• reduced neutrophil count (neutropenia)
• muscle stiffness
• chills
• increased eosinophil count (white blood cells involved in immune response)
• excessive immune response to foreign substances
• loss of appetite or anorexia
• restlessness, nervousness
• drowsiness, fatigue, dizziness, or tremor
• involuntary muscle contractions
• loss of balance
• tinnitus or hearing loss
• chest pain or heart rhythm disturbances such as palpitations or irregular heartbeat
• asthma: a lung disease involving airway constriction, making breathing difficult
• nosebleeds
• blood clots causing sudden blockage of blood flow in the pulmonary artery (pulmonary embolism)
• inflammation of the mucous membrane of the oesophagus and stomach
• anal pain
• bloating, constipation, flatulence, belching
• dryness of the mouth
• condition in which bile (a fluid produced by the liver and stored in the gallbladder) does not flow from the gallbladder into the duodenum (biliary stasis)
• skin inflammation with fluid-filled blisters, itchy and painful rash
• muscle cramps, muscle pain, or loss of muscle tissue. If a child has myasthenia (a disease in which muscles are weak and tire easily), clarithromycin may worsen these symptoms
• abnormal, increased blood test results indicating kidney and liver function, abnormal increased blood test results
• feeling of weakness, fatigue, and lack of energy

Frequency unknown (frequency cannot be estimated from available data):

• intestinal inflammation
• bacterial skin infection
• decreased number of certain blood cells (which may lead to more frequent infections or increased risk of bruising or bleeding)
• confusion, psychotic disorder, hallucinations (seeing things that are not there), altered perception of reality, panic attacks, depression, unusual dreams or nightmares, and mania (feeling of excessive happiness or excitement)
• seizures (convulsions)
• sensory disturbances (tingling)
• loss of taste or smell, or inability to properly perceive odours
• deafness
• heart rhythm disturbances such as torsade de pointes, ventricular tachycardia
• blood loss (haemorrhage)
• pancreatitis
• discolouration of the tongue or teeth
• acne
• changes in levels of substances produced by the kidneys, kidney inflammation, kidney failure (may present as fatigue, facial swelling, puffiness under the eyes, abdominal swelling, or swelling of the thighs or ankles, or difficulty urinating)

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

5. How to store Klabax EC

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 the cardboard
package. The expiry date refers to the last day of the stated month.
Store below 30°C. Do not refrigerate or freeze the prepared suspension.
The shelf life of the prepared suspension is 14 days.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Package contents and other information

What Klabax contains
The active substance is clarithromycin.
5 ml of prepared suspension contains 125 mg of clarithromycin.
The other ingredients are: methacrylic acid and 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 flavour (containing flavouring substances, modified starch), tutti frutti flavour (containing corn maltodextrin, flavourings identical to natural, propylene glycol (E 1520), modified corn starch (E 1450), synthetic flavouring and fragrance components).

What Klabax looks like and contents of the pack
Granules for oral suspension
Klabax EC is a white to off-white granule for preparing an oral suspension.
Pack sizes:
1 bottle containing 41.66 – 46.04 g of granules to prepare 60 ml of oral suspension, or
1 bottle containing 48.61 – 53.72 g of granules to prepare 70 ml of oral suspension, or
1 bottle containing 69.44 – 76.75 g of granules to prepare 100 ml of oral suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Phone: 22 642 07 75
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Manufacturer/Importer
SUN Pharmaceutical Industries (Europe) B.V.
Polarisavenue 87
2132JH Hoofddorp
The 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany: CLARITHROMYCIN BASICS 125 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen
Italy: Claritromicina SUN
Romania: Klabax 125mg/5ml granule pentru suspensie orală
United Kingdom (Northern Ireland): Clarithromycin 125 mg/5ml granules for oral suspension