Lekoklar

Package Leaflet: Information for the Patient

Lekoklar, 250 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, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Lekoklar and What is it Used For
• 2. Important Information Before Taking Lekoklar
• 3. How to Take Lekoklar
• 4. Possible Side Effects
• 5. How to Store Lekoklar
• 6. Package Contents and Other Information

1. What is Lekoklar and What is it Used For

Clarithromycin is a macrolide antibiotic that inhibits 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 the patient is allergic to clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medication (listed in section 6);

if the patient has a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or abnormal electrocardiogram (ECG) readings, known as "long QT syndrome";

if the patient has severe liver and kidney impairment at the same time;

if the patient has low levels of potassium or magnesium in the blood (hypokalemia or hypomagnesemia);

if the patient is 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 anxiolytic or sedative)
• cisapride and domperidone(for stomach disorders)
• pimozide(an antipsychotic)
• terfenadineor
• astemizole(for allergies)
• lovastatin or simvastatin(to lower cholesterol)
• a medication containing lomitapide
• colchicine(for gout)
• other medications that can cause significant heart rhythm disorders.

Warnings and Precautions

Before starting Lekoklar, the patient should discuss it with their doctor or pharmacist.

The patient should consult their doctor if:

they have liver or kidney disorders;

they experience severe or prolonged diarrhea (pseudomembranous colitis) during or after taking Lekoklar; they should consult their doctor immediately. Pseudomembranous colitis has been reported with almost all antibacterial agents, including clarithromycin.

the patient has myasthenia gravis, a rare disease that causes muscle weakness;

the patient has diabetes;

the patient has a history of heart rhythm disorders or has taken clarithromycin for a long time.

Lekoklar and Other Medications

The patient should inform their doctor or pharmacist about all medications they are taking, 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 severe heart rhythm disorders (see "When Not to Take Lekoklar").

Some medications and Lekoklar may interact with each other. These include:

Lekoklar May Increase the Effects of the Following Medications:

ibrutinib (for chronic lymphocytic leukemia)

alprazolam, triazolam, given intravenously or sublingually (under the tongue)

midazolam (anxiolytic or sedative);

digoxin, verapamil, amlodipine, diltiazem (for heart conditions);

theophylline (for asthma);

warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood);

atorvastatin, rosuvastatin (to lower cholesterol);

cyclosporine, sirolimus, tacrolimus (to suppress the immune system);

carbamazepine, phenytoin, valproate (for epilepsy);

cilostazol (to improve blood flow in the legs);

insulin and other antidiabetic medications (such as nateglinide or repaglinide);

methylprednisolone (corticosteroid for inflammation);

omeprazole (for stomach disorders);

sildenafil, tadalafil, vardenafil (for erectile dysfunction);

tolterodine (for overactive bladder);

vinblastine (anticancer medication);

medications that can affect hearing, especially aminoglycoside antibiotics, such as gentamicin or neomycin.

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

atazanavir, saquinavir (for HIV infection);

itraconazole (for fungal infections).

If the doctor has explicitly recommended taking Lekoklar and any of the above medications at the same time, they will closely monitor the patient.

The Following Medications May Decrease the Effect of Lekoklar:

rifampicin, rifabutin, rifapentine (antibiotics);

efavirenz, etravirine, nevirapine (for HIV infection);

phenytoin, carbamazepine, phenobarbital (for epilepsy);

St. John's Wort.

This is also important if the patient is taking:

• hydroxychloroquine or chloroquine(for rheumatoid arthritis, malaria treatment or prevention). Taking these medications with clarithromycin may increase the risk of heart rhythm disorders and other serious side effects affecting the heart.
• corticosteroidstaken orally, by injection, or inhaled (to suppress the immune system, which is useful in treating many different conditions)

Warning:

Ritonavir(an antiviral medication) and fluconazole(an antifungal medication) may increase the effect of Lekoklar.

Lekoklar may decrease the effect of zidovudine(an antiviral medication). To avoid this, a 4-hour interval should be maintained between taking both medications.

Taking Lekoklar and medications for heart conditions (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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medication.

Driving and Using Machines

Lekoklar does not normally affect the ability to drive or use machines, but it may cause side effects such as dizziness, confusion, and disorientation. If the patient experiences these symptoms, they should not drive, use machines, or perform tasks that could put themselves or others at risk.

Visual disturbances and blurred vision may affect the ability to drive or use machines.

Lekoklar Contains Sucrose and Sodium

5 ml of the ready-to-use suspension contains 2.4 g of sucrose. This should be taken into account for patients with diabetes.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

The medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to Take Lekoklar

This medication should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.

The following information is about how much and how often to take the medication. Read it carefully.

The dose prescribed by the doctor depends on the type and severity of the infection and the patient's kidney function. The doctor will provide more information.

Adults and Adolescents

The usual dose is 250 mg twice a day.

For 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:

250 mg/5 ml granules for oral suspension:

Children with a body weight of less than 8 kg should receive 7.5 mg/kg twice a day.

Duration of Treatment

The doctor will decide how long to take Lekoklar. Treatment usually lasts from 5 to 14 days.

Do not stop taking the medication without consulting the doctor, as the infection may return.

If the patient has any further questions about taking this medication, they should consult their doctor or pharmacist.

How to Take the Medication

The medication is usually taken twice a day: once in the morning and once in the early evening.

The medication can be taken with or without food.

A bitter taste may remain in the mouth after taking the medication. This can be avoided by eating or drinking something immediately after taking the suspension.

Measuring the Dose

A measuring syringe with a capacity of 5 ml is provided with the medication, marked with volumes of 2.5 ml, 3.75 ml, and 5 ml. The syringe is attached to a connector that fits the bottle neck.

To measure the dose, follow these steps:

shake the bottle

insert the connector into the bottle neck

insert the syringe tip into the connector

turn the bottle upside down

pull the syringe plunger to draw the desired amount of medication

turn the bottle back to its normal position, remove the syringe, and close the bottle.

Always Remember to Shake the Bottle Before Measuring Each Dose.

Administering the Medication with a Syringe

Make sure the child is in a stable upright position.

Gently insert the syringe tip into the child's mouth, aiming for the cheek.

Slowly press the syringe plunger. Do not inject the medication quickly.

Allow the child to swallow the medication calmly.

The measured dose can also be poured onto a spoon and given to the child in this way.

Preparing the Medication

A doctor or pharmacist may prepare the medication for the patient. To open the bottle, press the cap with your hand and turn it to the left.

If the patient is preparing the medication themselves, fill the bottle with boiled cold water almost to the mark on the label, close the bottle, and shake it well. Then, fill the bottle with water to the mark and shake it again.

The suspension is prepared only once, at the beginning of treatment.

Overdose of Lekoklar

If the patient has taken too much medication, they should contact their doctor or hospital as soon as possible. Symptoms of overdose may include gastrointestinal disturbances.

Missing a Dose of Lekoklar

If the patient forgets to take a dose, they should 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 directed by the doctor. Do not stop taking Lekoklar without consulting the doctor first, as the infection may return.

If the patient has any further questions about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Lekoklar can cause side effects, although not everyone will experience them.

Severe Side Effects

If the Patient Experiences Any of the Following, They Should Stop Taking the Medication and Immediately Inform Their Doctor or Go to the Emergency Room:

Severe Side Effects that Occur Uncommonly(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 neck, severe dizziness or fainting, itching, hives

irregular heartbeat (changes in the electrical activity of the heart)

risk of blood clots, caused by a high platelet count

blistering skin rash

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 test results (which may be symptoms of a hypersensitivity reaction, also known as DRESS syndrome)

yellowing of the skin and eyes, nausea, loss of appetite, abnormal liver function test results (symptoms of hepatitis)

severe diarrhea, which is long-lasting or bloody, with abdominal pain or fever; may be a sign of severe colitis. The doctor may recommend stopping the treatment.

Do not take medications that suppress bowel movements.

severe abdominal and back pain, caused by pancreatitis

high or low urine output, lethargy, confusion, and nausea caused by kidney inflammation

severe or itchy rash, 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 red, scaly rash with pustules and blisters)

These are Severe Side Effects that May Require Emergency Medical Attention.

Other Possible Side Effects

The patient should inform their doctor if they experience any of the following side effects:

Common(may occur in less than 1 in 10 people):

headache

changes in taste (e.g., metallic or bitter taste in the mouth)

abdominal pain, nausea, vomiting, diarrhea, indigestion

sleep disturbances

abnormal liver function test results

rash

excessive sweating

vasodilation

Uncommon(may occur in less than 1 in 100 people):

low white blood cell count

gastritis and enteritis

increased liver enzyme activity in the blood

neutropenia (low neutrophil count)

increased eosinophil count (a type of white blood cell involved in the immune response)

fungal infections (candidiasis)

infections, such as vaginal infections

loss of appetite or decreased appetite

anxiety, nervousness, crying

involuntary muscle movements

lethargy, dizziness, trembling, drowsiness, seizures, fainting

vertigo, hearing disturbances, tinnitus (ringing in the ears)

chest pain or changes in heart rhythm, such as palpitations or irregular heartbeat

feeling of heartbeat

gastritis, constipation, gas, dry mouth

pruritus, urticaria, red rash

muscle spasms

fever, weakness

muscle spasms, muscle pain, or muscle loss. If the child has myasthenia gravis (a disease that causes muscle weakness), clarithromycin may worsen these symptoms.

anal pain

asthma: a lung disease associated with bronchial constriction, making breathing difficult

nasal bleeding

blood clots that block the pulmonary artery (pulmonary embolism)

esophagitis (inflammation of the esophagus)

abnormal kidney and liver function test results and abnormal blood test results

Frequency Not Known(frequency cannot be estimated from the available data):

tooth discoloration and tongue discoloration

certain bacterial skin and soft tissue infections

smell disturbances, loss of smell or taste

deafness

acne

depression

muscle pain or weakness

abnormal urine color

nightmares, disorientation, confusion, hallucinations, or loss of touch with reality

seizures, tingling, and numbness of the skin

bleeding

visual disturbances

vision problems (blurred vision)

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety, Ministry of Health: Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 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 to gather 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 package 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.

Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Lekoklar Contains

• The active substance is clarithromycin. 1 ml of the prepared oral suspension contains 50 mg of clarithromycin. 5 ml of the oral suspension contains 250 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, silica colloidal anhydrous, xanthan gum, fruit punch flavor (natural and artificial flavorings, including maltodextrin, modified starch, and maltol).

What Lekoklar Looks Like and Package Contents

Granules for oral suspension

White or beige granules in HDPE bottles with a capacity of 60 ml, 120 ml, and 240 ml, with a PP child-resistant cap and 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.

Package sizes:

1 bottle contains:

41.0 g of granules to prepare 60 ml of the ready-to-use oral suspension (required amount of water: 34.2 ml) or

68.3 g of granules to prepare 100 ml of the ready-to-use oral suspension (required amount of water: 57.0 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 the Local Representative of the Marketing Authorization Holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

Phone: 22 209 70 00

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

Netherlands

Clarithromycin Sandoz 250 mg/5 ml granules for oral suspension

Belgium

Clarithromycin Sandoz 250 mg/5 ml granules for oral suspension

Bulgaria

LEKOKLAR 250 mg/5 ml granules for oral suspension

Italy

CLARITROMICINA SANDOZ GMBH

Poland

LEKOKLAR

Slovakia

LEKOKLAR 250 mg/5 ml granules for oral suspension

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 34.2 ml of water

For a 100 ml bottle, add 57.0 ml of water

After adding water, shake the bottle immediately. The resulting suspension is white to beige in color.