Lekoklar forte

Package leaflet: Information for the patient

Lekoklar forte, 500 mg, film-coated tablets
Clarithromycinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Clarithromycin is a medicine belonging to the group of macrolide antibiotics. It inhibits the
growth of certain bacteria.
Lekoklar forte is used in adults and adolescents (aged at least 12 years) for the treatment of
bacterial infections caused by bacteria sensitive to clarithromycin, e.g.:
infections of the throat and sinuses,
infections of the chest, such as bronchitis and pneumonia,
infections of the skin and soft tissues,
stomach ulcers caused by the bacterium Helicobacter pylori.

2. Information before using Lekoklar forte

When not to use Lekoklar forte
if the patient is allergic to clarithromycin, other macrolide antibiotics, or to any of the
other components of this medicine (listed in section 6);
if the patient (or a family member) has previously experienced certain heart rhythm disorders
(ventricular arrhythmia, including torsade de pointes type arrhythmias) or abnormalities
in the electrocardiogram (ECG, recording of the heart's electrical activity) known as "long QT syndrome";
if the patient has severe liver impairment and at the same time has kidney dysfunction;
if the patient has low blood levels of potassium or magnesium (hypokalemia or
hypomagnesemia);
if the patient is taking:

• ticagrelor, ivabradine, or ranolazine (used in the treatment of angina or to reduce the risk of heart attack or stroke)
• ergotamine or dihydroergotamine (medicines used to treat migraine)
• midazolam taken orally (anxiolytic or hypnotic medicine)
• cisapride and domperidone (medicines used for stomach disorders)
• pimozide (an antipsychotic medicine)
• terfenadine, astemizole (seasonal allergies, antihistamines)
• lovastatin or simvastatin (medicines used to lower cholesterol levels)
• a medicine containing lomitapide
• colchicine (a medicine used to treat gout)
• other medicines known to cause serious heart rhythm disturbances.

Warnings and precautions
Before taking clarithromycin, discuss with your doctor or pharmacist if:
the patient is pregnant, suspects she may be pregnant, or plans to become pregnant
the patient has been diagnosed with liver or kidney dysfunction
the patient has diabetes
the patient develops severe or persistent diarrhea during or after treatment with Lekoklar forte (pseudomembranous colitis). In such case, immediate consultation with a doctor is necessary. Colitis (pseudomembranous colitis) has been reported with nearly all antibacterial agents, including clarithromycin.
the patient has heart function disorders.

Lekoklar forte and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Lekoklar forte must not be used with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines used to treat high cholesterol, and other medicines known to cause serious heart rhythm disturbances (see "When not to use Lekoklar forte").
Some other medicines and Lekoklar forte may affect each other’s effectiveness.
These include:

Lekoklar forte may increase the effect of the following medicines:
ibrutinib (used in the treatment of chronic lymphocytic leukemia);
alprazolam, triazolam, midazolam administered intravenously or sublingually (anxiolytic or hypnotic medicines);
digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (medicines used for heart conditions);
theophylline (an anti-asthmatic medicine);
warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood);
statins (other than contraindicated lovastatin and simvastatin), such as atorvastatin, rosuvastatin (medicines that reduce cholesterol levels);
cyclosporine, sirolimus, tacrolimus (immunosuppressive medicines);
carbamazepine, phenytoin, valproate (antiepileptic medicines);
cilostazol (a medicine used to improve circulation in the legs);
insulin and other antidiabetic medicines (i.e., nateglinide, pioglitazone, rosiglitazone, or repaglinide);
methylprednisolone (a corticosteroid used to treat inflammatory conditions);
omeprazole (a medicine used for stomach disorders);
sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction);
tolterodine (a medicine used to treat overactive bladder);
vinblastine (an anticancer medicine);
medicines that may affect the patient's hearing, especially aminoglycoside antibiotics, such as gentamicin or neomycin.

Lekoklar forte and the following medicines may mutually enhance their effects:
atazanavir, saquinavir (medicines used to treat HIV infection);
itraconazole (a medicine used to treat fungal infections).
If the doctor has specifically prescribed Lekoklar forte together with any of the listed medicines, the patient will be under closer monitoring.

The following medicines may reduce the effect of Lekoklar forte:
rifampicin, rifabutin, rifapentine (antibiotics);
efavirenz, etravirine, nevirapine (medicines used to treat HIV infection);
phenytoin, carbamazepine, phenobarbital (antiepileptic medicines);
St. John’s wort (a herbal medicine used to treat depression).

It is also important if the patient is taking medicines with the following names:

• hydroxychloroquine or chloroquine (used, among others, to treat rheumatoid arthritis, or to treat and prevent malaria). Taking these medicines together with clarithromycin may increase the risk of heart rhythm disturbances and other serious cardiac adverse effects.
• corticosteroids taken orally, by injection, or inhaled (used to suppress the body's immune response, which is useful in treating many different conditions).

Note
Ritonavir (an antiviral medicine) and fluconazole (a medicine used to treat fungal infections)
may enhance the effect of Lekoklar forte.
Lekoklar forte may reduce the effect of zidovudine (a medicine used to treat HIV infection).
To avoid this interaction, a 4-hour interval between administration of both medicines should be maintained.
Concurrent use of Lekoklar forte with digoxin, quinidine, disopyramide, or verapamil (medicines used for heart conditions) or other macrolide antibiotics may cause heart rhythm disturbances.
Taking Lekoklar forte together with disopyramide may cause low blood sugar (hypoglycemia).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Lekoklar forte usually does not affect the ability to drive or operate machinery, but it may cause adverse effects such as dizziness, confusion, and disorientation.
If these occur, the patient should not drive, operate machinery, or engage in activities that could put the patient 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, meaning the medicine is considered "sodium-free".

3. How to use Lekoklar forte

Your doctor will prescribe the appropriate dose of the medicine. This medicine should always be used exactly as instructed by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage

Adults and adolescents (aged at least 12 years)
The recommended dose is 250 mg (1 tablet of Lekoklar mite) twice daily.
Your doctor may increase the dose to 500 mg (1 tablet of Lekoklar forte) twice daily.

Helicobacter pylori-related gastric ulcers:
500 mg (1 tablet of Lekoklar forte) twice daily in combination with appropriate antibiotics and medications used to treat excessive production of gastric acid.

Children (under 12 years of age)
Use in children under 12 years of age is not recommended.
An alternative pharmaceutical form, such as a suspension, is available for these patients.

Severe renal impairment
Your doctor will reduce the dose of the medicine.

Method of administration
This medicine is for oral use.
Tablets should be taken with a glass of water.
The medicine can be taken independently of meals.

Duration of treatment
Treatment usually lasts from 6 to 14 days. The medicine should be continued for at least 2 more days after symptoms have resolved.
In streptococcal infections, treatment should last at least 10 days.
In the treatment of Helicobacter pylori-related gastric ulcers, the medicine should be taken for 7 days.

Overdose of Lekoklar forte
If a patient has taken too much Lekoklar forte, contact a doctor or hospital as quickly as possible. Symptoms of overdose may include gastrointestinal disturbances.

Missed dose of Lekoklar forte
If a patient forgets to take a dose, continue following the prescribed dosing schedule. Do not take a double dose to make up for the missed tablet.

Discontinuation of Lekoklar forte
It is important to take the medicine as directed by your doctor. Do not suddenly stop taking Lekoklar forte without discussing it with your doctor first, as symptoms of the disease may return.

If you have any further questions about 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 symptoms of a severe allergic reaction occur in a patient, seek immediate medical advice or go to the accident and emergency department of the nearest hospital:
sudden difficulty breathing, speaking or swallowing, swelling of the lips, face and neck
severe dizziness or collapse
severe or itchy skin rash, especially if blisters develop and are painful
eyes, mouth or genital organs
severe and persistent diarrhoea during or after treatment, sometimes with blood and mucus and (or) with cramping abdominal pain. This may be a sign of severe inflammation of the large intestine (colitis). Your doctor may advise stopping treatment. Do not take medicines that inhibit intestinal peristalsis.
liver function disorders with symptoms such as:

• loss of appetite
• yellowing of the skin and whites of the eyes (jaundice)
• abnormally dark urine, pale stools
• skin itching
• abdominal pain
• sensation of heart palpitations or irregular heartbeat
• pancreatitis, causing severe abdominal and back pain
• redness and peeling of the skin with formation of subcutaneous nodules and blisters (erythema multiforme)

Other adverse reactions
Common (may affect up to 1 in 10 people):
insomnia
headache
changes in taste sensation or unpleasant taste in the mouth (e.g. metallic or bitter)
abdominal pain, nausea or vomiting, diarrhoea, indigestion
abnormal liver function test results
rash
excessive sweating
vasodilation

Uncommon (may affect up to 1 in 100 people):
yeast infection (candidiasis), e.g. of the mouth
vaginal infection
decreased number of white blood cells (leukopenia, neutropenia)
increased number of certain white blood cells (eosinophilia)
allergic reactions
anorexia, loss or reduced appetite
anxiety, dizziness, drowsiness, tremor
sensation of spinning
hearing disorders, ringing in the ears (tinnitus)
changes in heart activity on electrocardiogram (ECG), so-called QT interval prolongation
sensation of heart palpitations
inflammation of the mucous membrane of the stomach, mouth and tongue
gas, constipation, belching, bloating
dry mouth
biliary flow disorders
hepatitis
increased liver enzyme activity
itching, urticaria
general malaise
weakness
chest pain
chills
fatigue
fainting
bullous skin inflammation (see "Serious adverse reactions" above)

Frequency not known (frequency cannot be estimated from available data):
inflammation of the large intestine, ranging from mild to severe (see above "Serious adverse reactions")
certain bacterial skin and subcutaneous tissue infections (erysipelas)
marked decrease in certain white blood cells (agranulocytosis)
decreased platelet count: symptoms may include unusual bruising and bleeding
severe allergic reaction (anaphylactic reaction, see above "Serious adverse reactions")
psychosis, feeling of loss of identity
feelings of unreality, confusion
depression, unusual dreams, disorientation, hallucinations, mania
seizures
smell disorders, loss of smell and taste
tingling or numbness of the skin
deafness
heart rhythm disorders, including life-threatening cases (ventricular arrhythmias, torsade de pointes type arrhythmias, see above "Serious adverse reactions")
prolonged bleeding time
acute pancreatitis (see above "Serious adverse reactions")
discoloration of teeth and tongue
severe liver failure, including life-threatening cases (see above "Serious adverse reactions")
yellowing of the skin or whites of the eyes (jaundice)
severe skin diseases with discomfort, redness, peeling and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis [Lyell's syndrome], drug reaction with eosinophilia and systemic symptoms [DRESS], see above "Serious adverse reactions")
acne
muscle pain or weakness
kidney inflammation, kidney failure
abnormal urine colour
vision problems (blurred vision)
visual disturbances

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lekoklar forte

Keep the medicine out of 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 stated month.
The batch number on the packaging is marked as "Lot".
No special temperature storage conditions apply.
Store in the original packaging to protect from light.
Medicines must 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 coated tablet contains 500 mg of clarithromycin.
The other ingredients are: sodium croscarmellose, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica, talc.
Coating: hypromellose, propylene glycol, titanium dioxide (E171), hydroxypropylcellulose, sorbitan monooleate, quinoline yellow (E104), vanillin.

What Lekoklar forte looks like and contents of the pack
Light yellow, oval coated tablets with dimensions of 18.8 mm x 8.8 mm.
Blister packs made of PVC/PVDC/Aluminium in cardboard boxes contain 14 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
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 Warszawa, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr. 7A
540472 Targu-Mures, Romania

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area countries 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

(logo of the Marketing Authorisation Holder)