LEKOKLAR 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lekoklar Forte, 500 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Lekoklar Forte and what is it used for
4. Important information before taking Lekoklar Forte
   1. When not to take Lekoklar Forte
   2. Warnings and precautions
   3. Lekoklar Forte and other medicines
   4. Lekoklar Forte may increase the effects of the following medicines:
   5. Lekoklar Forte and the following medicines may enhance each other's effects:
   6. The following medicines may reduce the effect of Lekoklar Forte:
   7. Caution
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Lekoklar Forte contains sodium
5. How to take Lekoklar Forte
   1. Dosage
   2. Adults and adolescents (aged 12 years and above)
   3. Children (under 12 years)
   4. Severe kidney problems
   5. Method of administration
   6. Duration of treatment
   7. Taking more than the prescribed dose of Lekoklar Forte
   8. Missing a dose of Lekoklar Forte
   9. Stopping treatment with Lekoklar Forte
6. Possible side effects
   1. Severe side effects
   2. Other side effects
   3. Reporting side effects
7. How to store Lekoklar Forte
8. Contents of the pack and other information
   1. What Lekoklar Forte contains
   2. What Lekoklar Forte looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For further information about this medicine, please 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 Forte, 500 mg, Film-Coated Tablets

Clarithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Lekoklar Forte and what is it used for

Clarithromycin is an antibiotic belonging to the macrolide group. It inhibits the growth of certain bacteria.
Lekoklar Forte is used in adults and adolescents (aged 12 years and above) for the treatment of infections caused by bacteria susceptible to clarithromycin, such as:
throat and sinus infections,
chest infections, such as bronchitis and pneumonia,
skin and soft tissue infections,
gastric ulcers caused by Helicobacter pyloribacteria.

2. Important information before taking Lekoklar Forte

When not to take Lekoklar Forte

if you are allergicto clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6);
if you have had certain heart rhythm disorders(ventricular arrhythmias, including torsades de pointes) or abnormal heart rhythms (ECG) known as "QT 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 the treatment of angina or to reduce the risk of heart attack or stroke)
• ergotamine or dihydroergotamine(for the treatment of migraine)
• oral midazolam(an anxiolytic or sedative)
• cisapride or domperidone(for the treatment of stomach disorders)
• pimozide(an antipsychotic)
• terfenadine, astemizole(for the treatment of allergies)
• lovastatin or simvastatin(for the treatment of high cholesterol)
• a medicine containing lomitapide
• colchicine(for the treatment of gout)
• other medicines that may 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;
have experienced severe or persistent diarrheaduring or after treatment with Lekoklar Forte. You should consult your doctor immediately. Diarrhea is a common side effect of almost all antibiotics, including clarithromycin.
have heart problems.

Lekoklar Forte and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Lekoklar Forte should not be taken with certain medicines, including:
ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, tikagrelor, ranolazine, colchicine, certain cholesterol-lowering medicines, or medicines known to cause serious heart rhythm disorders (see "When not to take Lekoklar Forte").
Some medicines may interact with Lekoklar Forte and affect its efficacy.

Lekoklar Forte may increase the effects of the following medicines:

ibrutinib (a medicine for the treatment of chronic lymphocytic leukemia);
alprazolam, triazolam (anxiolytics or sedatives);
midazolam (an anxiolytic or sedative);
digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines for heart conditions);
theophylline (a medicine for asthma);
warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, edoxaban (medicines to thin the blood);
statins (other than contraindicated lovastatin and simvastatin), such as atorvastatin, rosuvastatin (medicines to lower cholesterol);
cyclosporin, sirolimus, tacrolimus (medicines to suppress the immune system);
carbamazepine, phenytoin, valproate (medicines for epilepsy);
cilostazol (a medicine to improve blood flow in the legs);
insulin and other antidiabetic medicines (such as nateglinide, pioglitazone, rosiglitazone, or repaglinide);
methylprednisolone (a corticosteroid);
omeprazole (a medicine for stomach disorders);
sildenafil, tadalafil, vardenafil (medicines for erectile dysfunction);
tolterodine (a medicine for overactive bladder);
vinblastine (a medicine for cancer);
medicines that may affect hearing, especially aminoglycoside antibiotics, such as gentamicin or neomycin.

Lekoklar Forte and the following medicines may enhance each other's effects:

atazanavir, saquinavir (medicines for HIV infection);
itraconazole (a medicine for fungal infections).
If your doctor has explicitly prescribed Lekoklar Forte and any of these medicines, they will monitor you more closely.

The following medicines may reduce the effect of Lekoklar Forte:

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

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

Caution

Ritonavir(an antiviral medicine) and fluconazole(a medicine for fungal infections) may enhance the effect of Lekoklar Forte.
Lekoklar Forte may reduce the effect of zidovudine(a medicine for HIV infection).
To avoid this effect, a 4-hour interval should be maintained between the administration of both medicines.
Taking Lekoklar Forte at the same time as digoxin, quinidine, disopyramide, or verapamil(medicines for heart conditions) or other macrolide antibioticsmay cause heart rhythm disorders.
Taking Lekoklar Forte 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 become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lekoklar Forte 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 operate machinery.

Lekoklar Forte contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is considered "sodium-free".

3. How to take Lekoklar Forte

Your doctor will prescribe the appropriate dose of Lekoklar Forte. This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage

Adults and adolescents (aged 12 years and above)

The recommended dose is 250 mg (1 tablet of Lekoklar) twice a day.
Your doctor may increase the dose to 500 mg (1 tablet of Lekoklar Forte) twice a day.
Gastric ulcers caused by Helicobacter pyloribacteria:
500 mg (1 tablet of Lekoklar Forte) twice a day in combination with appropriate antibiotics and medicines used to treat excessive stomach acid production.

Children (under 12 years)

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

Severe kidney problems

Your doctor will reduce the dose of Lekoklar Forte.

Method of administration

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

Duration of treatment

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

Taking more than the prescribed dose of Lekoklar Forte

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

Missing a dose of Lekoklar Forte

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

Stopping treatment with Lekoklar Forte

It is important to take Lekoklar Forte as prescribed by your doctor. Do not stop taking Lekoklar Forte suddenly without consulting your doctor, as the symptoms of the disease may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

If you experience any of the following symptoms of a severe allergic reaction, seek medical help immediatelyor go to the emergency room of your nearest hospital:
sudden difficulty in breathing, speaking, or swallowing, swelling of the lips, face, and neck
severe dizziness or fainting
severe or itchy skin rash, especially with blisters, or peeling of the skin, and mouth, eyes, or genitals
severe or persistent diarrheaduring or after treatment, sometimes with blood and mucus, and abdominal cramps. This may be a sign of severe colitis (inflammation of the colon). Your doctor may stop the treatment. Do not take medicines 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 of the skin with blistering and pustules (pustular psoriasis)

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
anxiety, dizziness, drowsiness, tremors
feeling of spinning
hearing disturbances, ringing in the ears (tinnitus)
changes in heart activity in the electrocardiogram (ECG), known as "QT prolongation"
feeling of heartbeat
inflammation of the stomach lining, mouth, and tongue
gas, constipation, belching, bloating
dry mouth
disturbances in bile flow
inflammation of the liver
increased liver enzyme activity
itching, hives
general malaise
weakness
chest pain
chills
fatigue
fainting
blisters on the skin (see "Severe side effects" above).
Frequency not known(frequency cannot be estimated from the available data):
inflammation of the colon (see "Severe 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 "Severe 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 ones (ventricular arrhythmias, torsades de pointes, see "Severe side effects" above)
prolonged bleeding time
acute pancreatitis (see "Severe side effects" above)
discoloration of teeth and tongue
severe liver failure, including life-threatening cases (see "Severe 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, drug reaction with eosinophilia and systemic symptoms, see "Severe side effects" above)
acne
muscle pain or weakness
inflammation of the kidneys, 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 leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lekoklar Forte

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lekoklar Forte contains

The active substance is clarithromycin.
Each film-coated tablet contains 500 mg of clarithromycin.
The other ingredients are: croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate, silicon dioxide, talc.
Coating: hypromellose, propylene glycol, titanium dioxide (E171), hydroxypropyl cellulose, sorbitan monooleate, quinoline yellow (E104), vanillin.

What Lekoklar Forte looks like and contents of the pack

Light yellow, oval, film-coated tablets, 18.8 mm x 8.8 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 further information about this medicine, please 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 500 mg, filmomhulde tabletten
Belgium
Clarithromycine Sandoz 500 mg filmomhulde tabletten
Bulgaria
Lekoklar 500 mg film-coated tablets
Poland
LEKOKLAR FORTE
Spain
Claritromicina Sandoz 500 mg comprimidos recubiertos con película EFG
Lithuania
Lekoklar 500 mg plėvele dengtos tabletės
Romania
LEKOKLAR 500 mg comprimate filmate
Slovakia
LEKOKLAR 500 mg filmom obalené tablety
Date of last revision of the leaflet:05/2024
(logo of the marketing authorization holder)