LEKOKLAR 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lekoklar Mite, 250 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet:
3. What is Lekoklar Mite and What is it Used For
4. Important Information Before Taking Lekoklar Mite
   1. When Not to Take Lekoklar Mite
   2. Warnings and Precautions
   3. Lekoklar Mite and Other Medications
   4. Lekoklar Mite May Increase the Effects of the Following Medications:
   5. Lekoklar Mite and the Following Medications May Enhance Each Other's Effects:
   6. The Following Medications May Reduce the Effect of Lekoklar Mite:
   7. Caution
   8. Pregnancy and Breastfeeding
   9. Driving and Using Machines
   10. Lekoklar Mite Contains Sodium
5. How to Take Lekoklar Mite
   1. Dosage
   2. Adults and Adolescents (Aged 12 Years and Older)
   3. Children (Under 12 Years)
   4. Severe Kidney Problems
   5. Method of Administration
   6. Duration of Treatment
   7. Overdose of Lekoklar Mite
   8. Missing a Dose of Lekoklar Mite
   9. Stopping Treatment with Lekoklar Mite
6. Possible Side Effects
   1. Serious Side Effects
   2. Other Side Effects
   3. Reporting Side Effects
7. How to Store Lekoklar Mite
8. Contents of the Package and Other Information
   1. What Lekoklar Mite Contains
   2. What Lekoklar Mite Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. For More Information About This Medication, Contact the Local Representative of the Marketing Authorization Holder:
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Package Leaflet: Information for the Patient

Lekoklar Mite, 250 mg, Film-Coated Tablets

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Lekoklar Mite and What is it Used For

Clarithromycin is a macrolide antibiotic that inhibits the growth of certain bacteria. Lekoklar Mite is used in adults and adolescents (aged 12 years and older) to treat infections caused by bacteria susceptible to clarithromycin, such as:

infections of the throat and sinuses,
infections in the chest, such as bronchitis and pneumonia,
infections of the skin and soft tissues,
stomach ulcerscaused by Helicobacter pyloribacteria.

2. Important Information Before Taking Lekoklar Mite

When Not to Take Lekoklar Mite

if you are allergicto clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medication (listed in section 6);
if you have a history of certain heart rhythm disorders(ventricular arrhythmia, including torsades de pointes) or abnormal heart rhythms (QT interval prolongation);
if you have severe liver and kidney problemsat the same time;
if you have low levels of potassium or magnesium in the 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 or domperidone(for stomach disorders)
• pimozide(an antipsychotic medication)
• terfenadine, 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 clarithromycin, discuss with your doctor or pharmacist if you:

are pregnant, think you may be pregnant, or plan to become pregnant;
have liver or kidney problems;
have diabetes;
experience severe or persistent diarrheaduring or after treatment with Lekoklar Mite. You should consult your doctor immediately. Diarrhea is a common side effect of almost all antibiotics, including clarithromycin;
have heart problems.

Lekoklar Mite 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 Mite should not be taken with certain medications, such as:

Lekoklar Mite May Increase the Effects of the Following Medications:

ibrutinib (for chronic lymphocytic leukemia);
alprazolam, triazolam (anti-anxiety or sedative medications);
midazolam (anti-anxiety or sedative medication);
digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (heart medications);
theophylline (for asthma);
warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood);
statins (other than contraindicated lovastatin and simvastatin), such as atorvastatin, rosuvastatin (to lower cholesterol);
cyclosporine, sirolimus, tacrolimus (immunosuppressants);
carbamazepine, phenytoin, valproate (anti-epileptic medications);
cilostazol (to improve blood flow in the legs);
insulin and other anti-diabetic medications (such as nateglinide, pioglitazone, rosiglitazone, or repaglinide);
methylprednisolone (corticosteroid);
omeprazole (for stomach disorders);
sildenafil, tadalafil, vardenafil (for erectile dysfunction);
tolterodine (for overactive bladder);
vinblastine (anti-cancer medication);
medications that can affect hearing, especially aminoglycoside antibiotics, such as gentamicin or neomycin;

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

atazanavir, saquinavir (for HIV infection);
itraconazole (for fungal infections). If your doctor has explicitly instructed you to take Lekoklar Mite and any of these medications at the same time, they will monitor you more closely.

The Following Medications May Reduce the Effect of Lekoklar Mite:

rifampicin, rifabutin, rifapentine (antibiotics);
efavirenz, etravirine, nevirapine (for HIV infection);
phenytoin, carbamazepine, phenobarbital (anti-epileptic medications);
St. John's Wort (a herbal remedy for depression). This is also important if you are taking medications with the following names:

hydroxychloroquine or chloroquine(for rheumatoid arthritis, malaria, or prevention of malaria). 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)

Caution

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

Pregnancy and Breastfeeding

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

Driving and Using Machines

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

Lekoklar Mite Contains Sodium

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

3. How to Take Lekoklar Mite

Your doctor will prescribe the appropriate dose of Lekoklar Mite. Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Dosage

Adults and Adolescents (Aged 12 Years and Older)

The recommended dose is 250 mg (1 tablet of Lekoklar Mite) twice a day.
Your doctor may increase the dose to 500 mg (2 tablets of Lekoklar Mite) twice a day.
For stomach ulcers caused by Helicobacter pylori: 500 mg (2 tablets of Lekoklar Mite) twice a day, in combination with appropriate antibiotics and medications that reduce stomach acid.

Children (Under 12 Years)

Use in children under 12 years is not recommended.
For these patients, a different pharmaceutical form of the medication is available, such as a suspension.

Severe Kidney Problems

Your doctor will reduce the dose of Lekoklar Mite.

Method of Administration

This medication is for oral use.
Swallow the tablets with a glass of water.
Lekoklar Mite can be taken with or without food.

Duration of Treatment

Treatment usually lasts from 6 to 14 days. You should continue taking Lekoklar Mite for at least 2 days after the symptoms have resolved.
In streptococcal infections, treatment should last at least 10 days.
For the treatment of stomach ulcers caused by Helicobacter pylori, Lekoklar Mite should be taken for 7 days.

Overdose of Lekoklar Mite

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

Missing a Dose of Lekoklar Mite

If you forget to take a dose, continue with the next dose as prescribed by your doctor. Do not take a double dose to make up for the missed tablet.

Stopping Treatment with Lekoklar Mite

It is important to take Lekoklar Mite as instructed by your doctor. Do not stop taking Lekoklar Mite without consulting your doctor first, as your symptoms may return.
If you have any further questions about taking Lekoklar Mite, ask your doctor or pharmacist.

4. Possible Side Effects

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

Serious Side Effects

If you experience any of the following symptoms of a severe allergic reaction, seek medical help immediatelyor go to the emergency room at your nearest hospital:

sudden difficulty breathing, speaking, or swallowing, swelling of the lips, face, and neck
severe dizziness or fainting
severe or itchy skin rash, especially with blisters, fever, and swollen lymph nodes
severe and persistent diarrheaduring or after treatment with Lekoklar Mite, sometimes with blood and mucus, and (or) abdominal cramps. This may be a sign of severe colitis (inflammation of the colon). Your doctor may stop the treatment. Do not take medications that slow down bowel movements.
liver problemswith symptoms such as:

• loss of appetite
• yellowing of the skin and whites of the eyes (jaundice)
• dark urine, pale stools
• itching of the skin
• abdominal pain
• feeling of heart beating or irregular heartbeat
• pancreatitis, which causes severe abdominal and back pain.
• redness, peeling, and blistering of the skin (exfoliative dermatitis)

Other Side Effects

Common(may affect up to 1 in 10 people):
insomnia
headache
changes in taste or unpleasant taste in the mouth (e.g., metallic or bitter)
abdominal pain, nausea, vomiting, diarrhea, indigestion
abnormal liver function tests
rash
excessive sweating
dilation of blood vessels.
Uncommon(may affect up to 1 in 100 people):
fungal infections (e.g., thrush)
vaginal infections
decreased white blood cell count (leukopenia, neutropenia)
increased white blood cell count (eosinophilia)
allergic reactions
loss of appetite, decreased appetite
restlessness, dizziness, drowsiness, tremors
feeling of spinning
hearing disturbances, ringing in the ears (tinnitus)
changes in heart activity on an electrocardiogram (ECG), known as QT interval prolongation
feeling of heartbeat
inflammation of the stomach lining, mouth, and tongue
gas, constipation, belching, bloating
dry mouth
disturbances in bile flow
liver inflammation
increased liver enzyme activity
itching, hives
general feeling of being unwell
weakness
chest pain
chills
fatigue
fainting
blistering skin rash (see "Serious Side Effects" above).
Frequency Not Known(frequency cannot be estimated from the available data):
colitis (inflammation of the colon), ranging from mild to severe (see "Serious Side Effects" above)
certain bacterial skin and soft tissue infections (erysipelas)
significant decrease in the number of certain white blood cells (agranulocytosis)
decrease in platelet count: symptoms may include unusual bruising and bleeding
severe allergic reaction (anaphylaxis, see "Serious Side Effects" above)
psychosis, feeling of loss of identity
feeling of strangeness, confusion
depression, unusual dreams, disorientation, hallucinations, mania
seizures
disturbances in smell, loss of smell and taste
tingling or numbness of the skin
deafness
heart rhythm disorders, including life-threatening cases (ventricular arrhythmias, torsades de pointes, see "Serious Side Effects" above)
prolonged bleeding time
acute pancreatitis (see "Serious Side Effects" above)
discoloration of teeth and tongue
severe liver failure, including life-threatening cases (see "Serious Side Effects" above)
yellowing of the skin or whites of the eyes (jaundice)
severe skin disorders with discomfort, redness, peeling, and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis [Lyell's syndrome], drug reaction with eosinophilia and systemic symptoms [DRESS], see "Serious Side Effects" above)
acne
muscle pain or weakness
kidney inflammation, kidney failure
abnormal urine color
vision problems (blurred vision)
visual disturbances

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 Mite

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
The batch number is indicated on the packaging as "Lot".
There are no special storage instructions.
Store in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Lekoklar Mite Contains

The active substance is clarithromycin.
Each film-coated tablet contains 250 mg of clarithromycin.
The other ingredients are: croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate, silicon dioxide, and talc.
Coating: hypromellose, propylene glycol, titanium dioxide (E171), hydroxypropyl cellulose, sorbitan monooleate, quinoline yellow (E104), and vanillin.

What Lekoklar Mite Looks Like and Contents of the Package

Dark yellow film-coated tablets in a capsule shape, 15.6 mm x 7.9 mm in size.
Blisters of PVC/PVDC/Aluminum in a cardboard box containing 14 film-coated tablets.

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 Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, 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.
Str. Livezeni nr. 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 Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands
Claritromycine Sandoz 250 mg, film-coated tablets
Belgium
Clarithromycine Sandoz 250 mg film-coated tablets
Bulgaria
Lekoklar 250 mg film-coated tablets
Poland
LEKOKLAR MITE
Spain
Claritromicina Sandoz 250 mg film-coated tablets EFG
Romania
LEKOKLAR 250 mg film-coated tablets
Slovakia
LEKOKLAR 250 mg film-coated tablets
Date of Last Revision of the Package Leaflet:05/2024
(logo of the marketing authorization holder)