Lekoklar

Package leaflet: Information for the patient

Lekoklar, 250 mg/5 ml, granules for oral suspension
Clarithromycinum
Please read carefully all the information in this leaflet before taking the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 is a medicine belonging to the group of macrolide antibiotics. It inhibits the growth of certain bacteria.
Lekoklar is used to treat:
infections of the throat and sinuses,
middle ear infections in children,
chest infections such as bronchitis and pneumonia,
skin and soft tissue infections,
stomach ulcers caused by Helicobacter pylori bacteria.

2. Important information before using Lekoklar

When not to use Lekoklar
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 heart rhythm disorders
(ventricular arrhythmia, including torsade de pointes type arrhythmia) 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 function disorders;
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 pectoris 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 or
• astemizole (medicines used to treat hay fever, 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 significant heart rhythm disturbances.

Warnings and precautions
Before starting treatment with Lekoklar, discuss this with your doctor or pharmacist.
Contact your doctor if:
the patient has been diagnosed with liver or kidney function disorders,
the patient develops severe or prolonged diarrhea during or after treatment with Lekoklar (pseudomembranous colitis); in such case, contact your doctor immediately. Colitis (pseudomembranous colitis) has been reported with the use of nearly all antibacterial agents, including clarithromycin.
the patient suffers from myasthenia gravis, a rare disease causing muscle weakness,
the patient has diabetes,
the patient currently has or has previously had heart function disorders, or
the patient has previously received clarithromycin for various reasons or has used it for a prolonged period.

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

Lekoklar may increase the effect of the following medicines:
ibrutinib (used to treat chronic lymphocytic leukemia),
alprazolam, triazolam, intravenous or sublingual midazolam (anxiolytic or hypnotic medicines),
digoxin, verapamil, amlodipine, diltiazem (medicines used for heart conditions),
theophylline (an anti-asthma medicine),
warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (medicines used to thin the blood),
atorvastatin, rosuvastatin (cholesterol-lowering medicines),
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 (such as nateglinide 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 and the following medicines may mutually increase each other’s effects:
atazanavir, saquinavir (medicines used to treat HIV infection),
itraconazole (a medicine used to treat fungal infections).
If your doctor has specifically prescribed concomitant use of Lekoklar and any of the above medicines, close monitoring will be required.

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

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

• hydroxychloroquine or chloroquine (used, among others, to treat rheumatoid arthritis, and for treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of heart rhythm disturbances and other serious adverse effects on the heart.
• corticosteroids taken orally, by injection, or by inhalation (used to suppress the immune system, which is helpful in treating many different conditions).

Note:
Ritonavir (an antiviral medicine) and fluconazole (a medicine used to treat fungal infections)
may increase the effect of Lekoklar.
Lekoklar may reduce the effect of zidovudine (an antiviral medicine). To avoid this interaction, a 4-hour interval should be maintained between administration of both medicines.
Concomitant administration of Lekoklar and medicines used for heart conditions (i.e., digoxin, quinidine, disopyramide, or verapamil) or other macrolide antibiotics may cause heart rhythm disturbances.
Concomitant use of Lekoklar and disopyramide may lead to decreased blood sugar levels (hypoglycemia).

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

Driving and operating machinery
Lekoklar generally does not affect the ability to drive or operate machinery, but it may cause adverse effects such as dizziness, confusion, and disorientation. If the patient experiences these symptoms, driving, operating machinery, or performing tasks that could be hazardous to the patient or others should be avoided.
Visual disturbances and blurred vision may affect the ability to drive or operate machinery.

Lekoklar contains sucrose and sodium
5 ml of ready-to-use suspension contains 2.4 g of sucrose. This should be considered in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Lekoklar

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Below are instructions on how much medicine to take and how often. Please read them carefully.
The dose prescribed by your doctor depends on the type and severity of the infection. It also
depends on the patient's kidney function. Your doctor will provide further explanation on this.
Adults and adolescents
The usual dose is 250 mg twice daily.
For the treatment of severe infections or gastric ulcers caused by Helicobacter pylori, the usual dose is
500 mg twice daily.
Children aged 6 months to 12 years
The daily dose is determined based on the child's body weight.
The following table shows the commonly used dosing:
250 mg/5 ml granules for oral suspension:

Children with body weight less than 8 kg should receive a dose of 7.5 mg/kg b.i.d.
Duration of treatment
Your doctor will determine how long Lekoklar should be taken. Treatment usually lasts from 5 to 14 days.
Do not discontinue treatment on your own, for example due to the child feeling better. Premature discontinuation of treatment may result in recurrence of infection.
Method of administration
The medicine is usually administered twice daily: once in the morning and once in the early evening.
The medicine can be taken regardless of meals.
Residual medicine in the oral cavity may cause a bitter taste. This can be prevented by eating or drinking something immediately after taking the suspension.
How to measure the dose of medicine
The package contains a 5 ml oral syringe with volume markings at 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 of medicine:

• Shake the bottle
• Insert the connector into the bottle neck
• Insert the syringe tip into the connector
• Invert the bottle
• Pull back the plunger of the syringe to draw the required amount of medicine
• Return the bottle to upright position, remove the syringe while leaving the connector in place, and close the bottle.
  Always remember to shake the bottle before drawing each dose of medicine.
  Administration of medicine using the syringe
  Ensure the child remains in a stable upright position.
  Carefully insert the syringe tip into the child's mouth, directing it towards the inside of the cheek.
  Slowly press the plunger of the syringe. Do not inject the medicine rapidly.
  Allow the child to swallow the medicine calmly.
  Alternatively, the measured dose in the syringe may be poured onto a spoon and administered to the child in this way.
  How to prepare the medicine
  The doctor or pharmacist may prepare the medicine for the patient. To open the bottle, press the cap with the palm and turn it to the left.
  If the patient prepares the medicine independently, the bottle should be filled with cooled boiled water almost up to the mark indicated on the label, closed with the cap, and shaken well. Then, fill with water up to the mark and shake again.
  The suspension should be prepared only once, at the beginning of treatment.
  Use of a higher than recommended dose of Lekoklar
  If the patient has taken too much medicine, contact a doctor or hospital as quickly as possible. Symptoms of overdose may include gastrointestinal disturbances.
  Missed dose of Lekoklar
  If the patient forgets to take a dose, continue following the dosing schedule recommended by the doctor. Do not take a double dose to make up for the missed dose.
  Discontinuation of Lekoklar
  It is important to take the medicine as directed by the doctor. Do not abruptly stop taking Lekoklar without discussing it with the doctor first, as the infection may recur.
  If you have any further questions regarding 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 occur, stop taking the medicine immediately and contact your doctor or go to the emergency room of the nearest hospital:
Serious adverse reactions occurring not very commonly (may occur in no more than 1 in 100 people):
allergic reactions such as sudden difficulty in breathing, speaking or swallowing, swelling of the lips, face and neck, severe dizziness or fainting, itching, raised skin rash
irregular heartbeat (changes in the electrical activity of the heart)
risk of blood clots due to a high number of platelets
bullous dermatitis
Serious adverse reactions occurring with unknown frequency:
fever, sore throat, frequent infections due to a marked decrease in white blood cells (agranulocytosis)
rash, fever, changes in blood tests (which may be symptoms of drug hypersensitivity syndrome, also known as DRESS – Drug Reaction with Eosinophilia and Systemic Symptoms)
yellowing of the skin and eyes, nausea, loss of appetite, abnormal liver function tests (symptoms of hepatitis)
severe diarrhoea that persists or contains blood, accompanied by abdominal pain or fever; may be a sign of severe inflammation of the large intestine. Your doctor may advise stopping treatment.
Do not take medicines that inhibit intestinal motility (peristalsis).
severe abdominal and back pain caused by inflammation of the pancreas
large or small urine output, drowsiness, confusion and nausea caused by inflammation of the kidneys
severe or itchy skin rash, especially if blisters develop and there is pain in the eyes, mouth or genital organs
unusual bruising or bleeding due to low platelet count
rapid or irregular heartbeat
red, scaly rash with formation of subcutaneous nodules and blisters (acute generalized exanthematous pustulosis)
All of these are serious adverse reactions which may require urgent medical attention.
Other possible adverse reactions
Tell your doctor if the patient experiences any of the following adverse reactions:
Common (may occur in no more than 1 in 10 people):
headache
taste disturbances (e.g. metallic or bitter taste in the mouth)
abdominal pain, nausea, vomiting, diarrhoea, indigestion
sleep disturbances
abnormal liver function tests
rash
excessive sweating
vasodilation
Not very common (may occur in no more than 1 in 100 people):
low white blood cell count
gastroenteritis
increased liver enzyme activity in blood
decreased neutrophil count (neutropenia)
increased eosinophil count (white blood cells involved in immune response)
fungal infection (candidiasis)
infection, e.g. vaginal infection
loss or decrease in appetite
anxiety, restlessness, crying
involuntary muscle movements
drowsiness, dizziness, tremor, somnolence, seizures, fainting
sensation of spinning, hearing disturbances, tinnitus (ringing in the ears)
chest pain or changes in heart rhythm such as palpitations or irregular heartbeat
awareness of heartbeat
inflammation of the gastric mucosa, constipation, flatulence, dry mouth, belching
itching, urticaria, red raised rash
muscle cramps
fever, fatigue
muscle cramps, muscle pain or loss of muscle tissue. In children with myasthenia (a condition in which muscles become weak and tire easily), clarithromycin may worsen these symptoms.
anal pain
asthma: a lung disease associated with narrowing of the airways, making breathing difficult
nosebleeds
blood clots causing sudden blockage of the pulmonary artery (pulmonary embolism)
inflammation of the mucous membrane lining the oesophagus and stomach
elevated abnormal kidney and liver function test results and elevated blood test results
Frequency unknown (frequency cannot be determined from available data):
discoloration of teeth and tongue
some bacterial infections of the skin and subcutaneous tissue
smell disturbances, loss of smell or taste
deafness
acne
depression
muscle pain or weakness
abnormal urine color
nightmares, disorientation, confusion, loss of orientation, seeing, feeling or hearing things that are not there, loss of contact with reality, feelings of detachment, mania (feelings of euphoria or excessive excitement)
seizures, tingling and numbness of the skin
bleeding
visual disturbances
vision problems (blurred vision)
Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Lekoklar

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP".
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Prepared suspension: do not store above 25°C.
The suspension should be used within 14 days of preparation.
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 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 components 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 flavour (natural and artificial flavouring substances, including maltodextrin, modified starch and maltol).

What Lekoklar looks like and contents of the pack

Granules for the preparation of oral suspension
White or beige granules in HDPE bottles with a capacity of 60 ml, 120 ml and 240 ml, with a child-resistant PP screw cap, supplied with either a PE/PP oral syringe (5 ml) marked at 2.5 ml, 3.75 ml and 5.0 ml or a PE/PP dosing spoon marked at 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 ready-to-use oral suspension (required amount of water: 34.2 ml) or
68.3 g of granules to prepare 100 ml of ready-to-use oral suspension (required amount of water: 57.0 ml).

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 S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Novartis Pharmaceuticals S.R.L.
Livezeni Street no 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 Warsaw, Poland
Tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie
Belgium: Clarithromycin Sandoz 250 mg/5 ml granulaat voor orale suspensie
Bulgaria: LEKOKLAR 250 mg/5 ml granules for oral suspension
Italy: CLARITROMICINA SANDOZ GMBH
Poland: LEKOKLAR
Slovakia: LEKOKLAR 250 mg/5 ml granulát na perorálnu suspenziu

(logo of the Marketing Authorisation Holder)

Information intended exclusively for healthcare professionals:

To prepare the suspension, fill the bottle with the following amount of water:
For a 60 ml bottle, add 34.2 ml of water
For a 100 ml bottle, add 57.0 ml of water
Immediately after adding water, shake the bottle vigorously. The resulting suspension is white to beige in color.