Lekoklar

Package Leaflet: Information for the Patient

Lekoklar, 125 mg/5 ml, Granules for Oral Suspension

Clarithromycin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Lekoklar is and what it is used for
• 2. Important information before taking Lekoklar
• 3. How to take Lekoklar
• 4. Possible side effects
• 5. How to store Lekoklar
• 6. Contents of the pack and other information

1. What Lekoklar is and what it is used for

Clarithromycin belongs to a group of antibiotics called macrolides. It stops the growth of certain bacteria.
Lekoklar is used to treat:
throat and sinus infections,
middle ear infections in children,
chest infections such as bronchitis and pneumonia,
skin and soft tissue infections,
stomach ulcers caused by Helicobacter pyloribacteria.

2. Important information before taking Lekoklar

When Not to Take Lekoklar

if you are allergic to clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6);
if you have a history of certain heart rhythm disorders (arrhythmias, including torsades de pointes) or abnormal electrocardiogram (ECG) findings known as "QT prolongation";
if you have severe liver and kidney problems at the same time;
if you have low potassium or magnesium levels in your blood (hypokalemia or hypomagnesemia);
if you are taking:

• tikagrelor, ivabradine, or ranolazine(for angina or to reduce the risk of heart attack or stroke)
• ergotamine or dihydroergotamine(for migraine),
• oral midazolam(an anti-anxiety or sedative medication)
• cisapride and domperidone(for stomach disorders),
• pimozide(an antipsychotic medication),
• terfenadineor
• astemizole(for allergies),
• lovastatin or simvastatin(to lower cholesterol),
• a medication containing lomitapide
• colchicine(for gout).
• other medications that can cause serious heart rhythm disorders.

Warnings and Precautions

Before taking Lekoklar, discuss with your doctor or pharmacist.
Consult your doctor if:
you have liver or kidney problems,
you experience severe or prolonged diarrhea (pseudomembranous colitis) during or after taking Lekoklar; you should contact your doctor immediately. Pseudomembranous colitis has been reported with almost all antibacterial agents, including clarithromycin.
you have myasthenia gravis, a rare disease that causes muscle weakness,
you have diabetes,
you have a history of heart rhythm disorders or have taken clarithromycin for a long time.

Lekoklar and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take, including those available without a prescription.
Lekoklar should not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, tikagrelor, ranolazine, colchicine, certain cholesterol-lowering medications, or medications known to cause serious heart rhythm disorders (see "When Not to Take Lekoklar").
Certain medications and Lekoklar may interact with each other. These include:

Lekoklar May Increase the Effects of the Following Medications:

ibrutinib (a medication for chronic lymphocytic leukemia)
alprazolam, triazolam, given intravenously or sublingually (under the tongue)
midazolam (anti-anxiety or sedative medications);
digoxin, verapamil, amlodipine, diltiazem (heart medications);
theophylline (an asthma medication);
warfarin or other anticoagulant medications, such as dabigatran, rivaroxaban, apixaban, edoxaban (blood thinners);
atorvastatin, rosuvastatin (cholesterol-lowering medications);
cyclosporine, sirolimus, tacrolimus (immunosuppressant medications);
carbamazepine, phenytoin, valproate (anti-seizure medications);
cilostazol (a medication to improve blood flow in the legs);
insulin and other anti-diabetic medications (such as nateglinide or repaglinide);
methylprednisolone (a corticosteroid);
omeprazole (a stomach medication);
sildenafil, tadalafil, vardenafil (medications for erectile dysfunction);
tolterodine (a medication for overactive bladder);
vinblastine (a cancer medication);
medications that may affect hearing, especially aminoglycoside antibiotics such as gentamicin or neomycin.

Lekoklar and the Following Medications May Increase Each Other's Effects:

atazanavir, saquinavir (medications for HIV infection);
itraconazole (an antifungal medication).
If your doctor has explicitly prescribed taking Lekoklar and any of the above medications at the same time, they will closely monitor you.

The Following Medications May Decrease the Effect of Lekoklar:

rifampicin, rifabutin, rifapentine (antibiotics);
efavirenz, etravirine, nevirapine (medications for HIV infection);
phenytoin, carbamazepine, phenobarbital (anti-seizure medications);
St. John's Wort.
This is also important if you are taking medications with the following names:
hydroxychloroquineor chloroquine(used to treat rheumatoid arthritis, malaria, or lupus). Taking these medications with clarithromycin may increase the risk of heart rhythm disorders and other serious side effects.
corticosteroidstaken orally, by injection, or inhaled (used to suppress the immune system, which is helpful in treating many different conditions)

Important:

Ritonavir(an antiviral medication) and fluconazole(an antifungal medication) may increase the effects of Lekoklar.
Lekoklar may decrease the effect of zidovudine(an antiviral medication). To avoid this interaction, maintain a 4-hour interval between taking both medications.
Taking Lekoklar and heart medications (such as digoxin, quinidine, disopyramide, or verapamil) or other macrolide antibiotics at the same time may cause heart rhythm disorders.
Taking Lekoklar and disopyramideat the same time may cause low blood sugar (hypoglycemia).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medication.

Driving and Using Machines

Lekoklar usually does not affect the ability to drive or use machines, but it may cause side effects such as dizziness, confusion, and disorientation. If you experience these symptoms, do not drive, operate machinery, or perform tasks that may put you or others at risk.
Visual disturbances and blurred vision may affect your ability to drive or operate machinery.

Lekoklar Contains Sugar and Sodium

5 ml of the prepared suspension contains 2.4 g of sugar. This should be taken into account for patients with diabetes.
If you have previously been diagnosed with intolerance to some sugars, contact your doctor before taking this medication.
The medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to Take Lekoklar

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Below are instructions on how much and how often to take the medication. Read them carefully. The dose prescribed by your doctor depends on the type and severity of the infection and your kidney function. Your doctor will provide more information.

Adults and Adolescents

The usual dose is 250 mg twice a day.
In the treatment of severe infections or stomach ulcers caused by Helicobacter pylori, the usual dose is 500 mg twice a day.

Children Aged 6 Months to 12 Years

The daily dose is determined based on the child's body weight.
The following table shows the usual dosing:

Dosage Table:

Allow the child to swallow the medication calmly.
You can also pour the measured dose into a spoon and give it to the child.

How to Prepare the Medication

Your doctor or pharmacist may prepare the medication for you. To open the bottle, press the cap and turn it to the left.
If you are preparing the medication yourself, fill the bottle with boiled cold water up to the mark on the label, close the bottle, and shake it well. Then, fill it with water up to the mark and shake again.
The suspension is prepared only once, at the beginning of treatment.

Taking a Higher Than Recommended Dose of Lekoklar

If you have taken more than the recommended dose, contact your doctor or hospital as soon as possible. Symptoms of overdose may include gastrointestinal disturbances.

Missing a Dose of Lekoklar

If you forget to take a dose, continue with the prescribed dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping Lekoklar Treatment

It is important to take the medication as prescribed by your doctor. Do not stop taking Lekoklar suddenly without discussing it with your doctor, as the infection may return.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Lekoklar can cause side effects, although not everybody gets them.

Severe Side Effects

If You Experience Any of the Following, Stop Taking the Medication and Inform Your Doctor or Go to the Emergency Room Immediately:

Severe side effects that occur not too frequently(may occur in less than 1 in 100 people):
allergic reactions, such as sudden difficulty breathing, speaking, or swallowing, swelling of the lips, face, and throat, severe dizziness or fainting, itching, hives
abnormal heart rhythms (changes in the electrical activity of the heart)
risk of blood clots, caused by a high platelet count
blisters on the skin

Severe Side Effects with Unknown Frequency:

fever, sore throat, frequent infections due to a significant decrease in white blood cell count (agranulocytosis)
rash, fever, changes in blood tests (which may be symptoms of a hypersensitivity reaction, also known as DRESS).
yellowing of the skin and eyes, nausea, loss of appetite, abnormal liver function tests (symptoms of hepatitis)
severe diarrhea, which is long-lasting or contains blood, accompanied by abdominal pain or fever; may be a sign of severe colitis. Your doctor may recommend stopping the treatment. Do not take anti-diarrheal medications.
severe abdominal pain and back pain, caused by pancreatitis
excessive or decreased urination, lethargy, confusion, and nausea caused by kidney inflammation
severe or itchy rash on the skin, especially if blisters occur and there is eye, mouth, or genital pain
unusual bruising or bleeding due to a low platelet count
rapid or irregular heartbeat
acute generalized exanthematous pustulosis (a skin condition with red, scaly patches and blisters)

This is Not a Complete List of Side Effects. If You Experience Any Unusual Symptoms, Consult Your Doctor or Pharmacist.

Other Possible Side Effects

Tell your doctor if you experience any of the following side effects:
Frequent(may occur in less than 1 in 10 people):
headache
changes in taste (e.g., metallic or bitter taste)
abdominal pain, nausea, vomiting, diarrhea, indigestion
sleep disturbances
abnormal liver function tests
rash
excessive sweating
vasodilation
Not Too Frequent(may occur in less than 1 in 100 people):
low white blood cell count
gastritis and enteritis
increased liver enzyme activity in the blood
decreased neutrophil count (neutropenia)
increased eosinophil count (eosinophilia)
thrush (candidiasis)
vaginal infection
loss of appetite
anxiety, nervousness, crying
involuntary muscle movements
lethargy, dizziness, trembling, drowsiness, seizures, fainting
feeling of spinning, hearing disturbances, ringing in the ears (tinnitus)
chest pain or changes in heart rhythm, such as palpitations or irregular heartbeat
feeling of heartbeat
gastritis, constipation, gas, dry mouth, belching
itching, hives, red, raised rash
muscle cramps
fever, weakness
muscle cramps, muscle pain, or muscle loss. If your child has myasthenia gravis (a disease that causes muscle weakness), clarithromycin may worsen these symptoms.
anal pain
asthma: a lung disease associated with airway constriction, making breathing difficult
nosebleeds
blood clots causing sudden blockage of a pulmonary artery (pulmonary embolism)
esophagitis (inflammation of the esophagus)
elevated abnormal liver and kidney function tests and elevated blood test results
Unknown Frequency(frequency cannot be determined from available data):
tooth discoloration and tongue discoloration
certain bacterial skin and soft tissue infections
smell disturbances, loss of smell or taste
hearing loss
acne
depression
muscle pain or weakness
abnormal urine color
nightmares, disorientation, confusion, hallucinations, seeing, feeling, or hearing things that are not there, loss of contact with reality, feeling of strangeness, mania (feeling of euphoria or excessive excitement)
seizures, tingling, and numbness of the skin
bleeding
vision disturbances
eye problems (blurred vision)

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Lekoklar

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and bottle after "EXP".
The expiration date refers to the last day of the month.
Do not store above 25°C.
Prepared suspension: do not store above 25°C.
Use the suspension within 14 days of preparation.
Do not throw away any medications via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Lekoklar Contains

• The active substance is clarithromycin. 1 ml of the prepared oral suspension contains 25 mg of clarithromycin. 5 ml of the oral suspension contains 125 mg of clarithromycin.
• Other ingredients are: poloxamer 188, povidone K-30, hypromellose, macrogol 6000, titanium dioxide (E171), copolymer (1:1) of methacrylic acid and ethyl acrylate, triethyl citrate, glycerol monostearate, polysorbate 80, sucrose, maltodextrin, potassium sorbate, colloidal anhydrous silica, xanthan gum, fruit punch flavor (natural and artificial flavoring substances, including maltodextrin, modified starch, sodium, and maltol).

The medication also contains sugar and sodium.

What Lekoklar Looks Like and Contents of the Pack

Granules for Oral Suspension
White or beige granules in HDPE bottles of 60 ml, 120 ml, and 240 ml with a PP cap, child-resistant, with a measuring syringe made of PE/PP (5 ml) with markings for 2.5 ml, 3.75 ml, and 5.0 ml, or a measuring spoon made of PE/PP with markings for 1.25 ml, 2.5 ml, and 5.0 ml.
Pack sizes:
1 bottle contains:
41.0 g of granules to prepare 60 ml of the oral suspension (required amount of water: 35.4 ml) or
68.3 g of granules to prepare 100 ml of the oral suspension (required amount of water: 59.0 ml).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz S.R.L.
Livezeni Street no 7A
540472 Targu Mures, Romania

For More Information About This Medication, Contact Your Local Representative of the Marketing Authorization Holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands
Clarithromycin Sandoz 125 mg/5 ml, granules for oral suspension
Belgium
Clarithromycin Sandoz 125 mg/5 ml granules for oral suspension
Estonia
LEKOKLAR
Bulgaria
Lekoklar 125 mg/5 ml Granules for oral suspension
Italy
CLARITROMICINA SANDOZ GMBH
Lithuania
Lekoklar 125 mg/5 ml granules for oral suspension
Poland
Lekoklar
Date of Last Revision of the Package Leaflet:05/2024
(logo of the marketing authorization holder)

Information Intended for Healthcare Professionals Only:

To prepare the suspension, add the following amount of water to the bottle:
For a 60 ml bottle, add 35.4 ml of water
For a 100 ml bottle, add 59.0 ml of water
After adding water, shake the bottle immediately. The resulting suspension is white to beige in color.