Lekoklar 125 mg. / 5 ml. 60 ml.

What is Lekoklar what it is used for

Clarithromycin is an antibiotic that belongs to the group of macrolide antibiotics. They stop the development of certain bacteria.

Levoclar is used to treat:
• Throat and sinus infections
• middle ear infections in children
• chest infections such as bronchitis and pneumonia
• infections of the skin and soft tissues
• stomach ulcers caused by Helicobacter pylori bacteria.

2. What you need to know before you take a Lekoklar

Do not take Lekoklar
• if you are allergic to clarithromycin, other macrolide antibiotics or to the other ingredients of this medicine listed in section 6,
• if you have or someone in your family has a history of certain heart rhythm abnormalities (ventricular arrhythmia including torsades de pointes) or cardiac changes measured in an electrocardiogram called "QT prolongation"
• if you suffer from severe liver insufficiency and kidney problems at the same time.
• if your blood potassium or magnesium level is low (hypokalaemia or hypomagnesaemia)
• if you are taking

ticagrelor (to prevent blood clots)
ranolazine (for the treatment of angina)
ergotamine, dihydroergotamine (medicines to treat migraine), cisapride (gastric acid), pemoside (antipsychotic), terfenadine or
astemizole (anti-allergic medicines)
lovastatin, simvastatin (cholesterol lowering medicines)
colchicine (to treat gout)
other medicines that are known to cause serious heart rhythm disturbances. Warnings and precautions
Talk to your doctor or pharmacist before taking Leoclag.
• if you have impaired hepatic or renal function,
• if you have severe or prolonged diarrhea (pseudomembranous colitis) during or after taking Levoclar, talk to your doctor immediately. Inflammation of the large intestine (pseudomembranous colitis) has been reported with the use of almost all antibacterial drugs, clarithromycin.
• if you suffer from myasthenia gravis, a rare disease that causes muscle weakness
• if you have diabetes
• if you have or have had heart problems, or
• if your magnesium levels were low before treatment
• if you have taken clarithromycin before and for a variety of reasons and for a long time.

Other Drugs and Lekoklar

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some other medicines can affect the effect of Leocclear, and vice versa. Such medicines are: Levoclar may potentiate the effects of the following medicines:
• astemizole, terfenadine (anti-allergic drug), pimozide (antipsychotic), cisapride (gastric acid), ergotamine, dihydroergotamine (migraine medicines), lovastatin, simvastatin (cholesterol lowering medicines), ticagrelor (to prevent blood clots) , ranolazine (for the treatment of angina pectoris), colchicine (for gout treatment) (see "Do not take Leoclark")
• alprazolam, triazolam, midazolam (tranquilizers)
• digoxin, verapamil, amlodipine, diltiazem (heart medicines)
• theophylline (anti-asthmatic drug)
• warfarin (anticoagulant)
• atorvastatin, rosuvastatin (cholesterol lowering agents)
• cyclosporin, sirolimus, tacrolimus (medicines that suppress the immune system)
• carbamazepine, phenytoin, valproate (medicines to treat epilepsy)
• Cilostazol (used to improve blood circulation in the legs)
• insulin and other medicines to treat diabetes (such as nateglinide or repaglinide)
• methylprednisolone (cortisone for the treatment of inflammation)
• omeprazole (a medicine for the stomach)
• sildenafil, tadalafil, vardenafil (medicines to treat erectile dysfunction)
• tolterodine (for the treatment of overactive bladder syndrome)
• vinblastine (a medicine to treat cancer)
• medicines with a risk of hearing impairment, especially aminoglycosides such as gentamicin or neomycin (a group of antibiotics)

The effect of Leoclair and the effect of the following drugs may be increased when taken together:
• atazanavir, saquinavir (medicines to treat HIV)
• itraconazole (a medicine used to treat fungal infections)
If your doctor has specifically recommended that you take Levoclar and any of the above mentioned medicines at the same time, your doctor may need to monitor you more closely.

The following drugs may weaken the effect of Leoclair:
• rifampicin, rifabutin, rifapentin (antibiotics)
• efavirenz, etravirine, nevirapine (medicines to treat HIV)
• phenytoin, carbamazepine, phenobarbital (antiepileptic drugs)
• St. John's Wort

Please note:
Rantonavir (antiviral medicine) and fluconazole (a medicine used to treat fungal infections) can enhance the effect of Leoclair.
Levoclar may weaken the effect of zidovudine (antiviral medicine). To avoid this, you should leave a 4-hour interval between taking these medicines.
The use of
Lekoklar 12S mg / 5 ml granules for oral suspension

Body weight (kg) Age (years) Dose (in ml) administered twice daily
8-11 1-2 2.5
12-19 2-4 5
20-29 4-8 7,5
30-40 8-12

Lekoklar 250 mg / 5 ml granules for oral suspension

Body weight (kg) Age (years) Dose (in ml) administered twice
daily
12-19 2-4 2.5
20-29 4-8 3,75
30-40 8-12 5
For children less than 8 kg, a dose of 0.3 ml / kg twice daily should be given.

Duration of treatment
Your doctor will tell you how long you should take a Leoclar, usually between 5 and 14 days. Do not stop treatment by your own decision, for example, because you or your child feel better. If you stop taking the medicine prematurely, the infection may recover.

Directions for use
Usually this drug is given twice daily - once in the morning and once in the evening. You can take the medicine with or without food.
After taking this medicine in the mouth may remain bitter taste. This can be avoided by eating or drinking immediately after the suspension.

How to measure the dose
A 5 ml syringe with 2.5, 3.75 and 5 ml was administered to the drug. The medicine has an adapter that is placed in the bottle. To measure the dose of the medicine:
• Shake the bottle
• Insert the adapter into the bottle opening
• Place the syringe tip in the adapter
• Turn the bottle back
• Pull the syringe plunger to measure the required dose
• Return the bottle upright, remove the syringe, leave the adapter in the bottle and block it.
Always shake the bottle before you measure the dose.

Applying the medicine with a syringe:
• The child must be stable in an upright position.
• Carefully place the tip of the syringe in the child's mouth. Point the end of the syringe toward the inside of the cheek.
• Push the syringe plunger down slowly. Do not spray quickly,
• Allow the child to swallow the medicine.
The other option is to empty the metered dose of the dropper into a spoon from which the child will take the medicine.

How to prepare the medicine
A doctor or pharmacist will prepare this medicine for you. To open the medication bottle, you must push down the child-resistant cap and rotate it.
If you have to prepare the medicine yourself, fill the bottle with cold water, just below the marker marked on the label. Immediately then shake the bottle well, then pour more water slightly above the marker marker on the label and shake again.
You should prepare the suspension only once, at the beginning of the course of treatment.

If you take more Leoclair than you should
If you take too much of this medicine, contact your doctor or hospital as soon as possible.
Signs of overdose may be gastric symptoms.

If you have forgotten to take a Leoclake
If you forget to take this medicine, continue treatment with the usual dose recommended by your doctor. Do not take a double dose to make up for the missed dose.

If you stop taking Lekoklar
It is important to take your medicine as directed by your doctor. Do not stop taking this medicine suddenly without first discussing it with your doctor. Otherwise, the symptoms may recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the emergency room of the nearest hospital:

Uncommon serious side effects (occurring in less than 1 in 100 people):
• allergic reactions such as sudden difficulty in breathing, speech and swallowing, swelling of the lips, face and neck, severe dizziness or collapse, skin rash with blisters and itching
• irregular heart rhythm (change in electrical activity of the heart)
• risk of clotting of the blood due to high blood levels of platelets
Serious adverse reactions of unknown frequency:
• fever, sore throat, more common infections caused by severe white blood cell deficiency (agranulocytosis)
• rash, fever, changes in blood count (which may be a sign of hypersensitivity syndrome (called DRESS).
• Yellow skin and eyes, abnormal fatigue or fever, dark urine coloring (signs of inflammation of the liver)
• Diarrhea that is serious lasts a long time or has blood in the stool, with stomach or fever pain. This may be a sign of serious inflammation of the intestine. Your doctor may stop treatment. Do not take medicines that slow down the bowel movement.
• severe pain in the abdomen and back,
How to Store a Lekoklar
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store below 25 ° C.
After dilution: Store below 25 ° C.
The suspension should be used for up to 14 days after preparation.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What the Leoclar contains

The active substance is clarithromycin
After reconstitution, 1 ml of oral suspension contains 25 rag of clarithromycin, 5 ml of oral suspension contains 125 mg of clarithromycin.

After reconstitution, 1 ml of oral suspension contains 50 mg clarithromycin, 5 ml oral suspension contains 250 mg clarithromycin.

The other ingredients are poloxamer 188, povidone K30 (E1201), hypromellose (E464), macrogol 6000, titanium dioxide (E171), methacrylic acid - ethyl acrylate copolymer (1: 1), triethyl dibat (E1505), glycerol monostearate, polysorbate 80 (E433), sucrose, maltodextrin, potassium sorbate (E202), colloidal anhydrous silica (E551), xanthan gum (E415), fruit flavor (natural and artificial flavors, including maltodextrin, modified starch and maltol).
What Leoclacle looks like and what the package contains
Granules for oral suspension
60 ml, 120 ml, and 240 ml white to beige beads in a HDPE bottle with a child-resistant closure with a PP screw and a PE / PP oral syringe (5 ml) with 2.5 ml graduations , 3.75 ml and 5.0 ml and / or a measuring spoon of PE / PP with casting characteristics of 1.25 ml, 2.5 ml and 5.0 ml.

Lekoklar 125 mg / 5 ml granules for oral suspension

Types of packaging:
1 bottle contains 34.1 grams of oral suspension for the preparation of 50 ml of suspension (required amount of water: 29.5 ml) or
41.0 g granules for oral suspension to prepare 60 ml of suspension (required amount of water: 35.4 ml) or
54.6 g granules for oral suspension to prepare 80 ml of suspension (required amount of water:
47.2 ml) or
68.3 g granules for oral suspension to prepare 100 ml of suspension (required amount of water: 59.0 ml) or
81.9 g granules for oral suspension to prepare 120 ml of suspension (required amount of water: 70.8 ml).

Not all pack sizes may be marketed.

Lekoklar 250 mg / 5 ml granules for oral suspension

Types of packaging:
1 bottle contains 34.1 g granules for oral suspension to prepare 50 ml of suspension (required amount of water: 28.5 ml) or
41.0 g granules for oral suspension to prepare 60 ml of suspension (required amount of water: 34.2 ml) or
54.6 g granules for oral suspension to prepare 80 ml of suspension (required amount of water: 45.6 ml) or
68.3 g granules for oral suspension to prepare 100 ml of suspension (required amount of water: 57.0 ml).

Not all pack sizes may be marketed.

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