Klacid 125 mg. / 5 ml. 60 ml.

WHAT IS Klacid granules for oral suspension AND WHAT IT IS USED
Klacid granules for oral suspension is an antibiotic belonging to the so-called macrolide antibiotics. Antibiotics are drugs that inhibit or stop the growth of certain microorganisms (bacteria) that cause the occurrence of various infections.

Klacid granules for oral suspension is indicated for the treatment of infections caused by microorganisms sensitive to it. This includes:
Infections of the upper respiratory tract (pharyngitis, sinusitis);
Infections of the lower respiratory tract (bronchitis, pneumonia);
Acute otitis media;
Infections of the skin and subcutaneous tissue (impetigo, folliculitis, cellulitis, abscesses);
Distributed or localized infections caused by certain types of mycobacteria (Mycobacterium avium intracellulare and Mycobacterium; localized infections of Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii).
As with other antibiotics before prescribing Klaricid granules for oral suspension, your doctor will comply with the frequency of resistance (resistance of microorganisms to an antibiotic) and related recommendations for prescribing antibiotics.

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE Klacid granules for oral suspension
Do not take or give your child Klacid granules for oral suspension:
If you are allergic or your child is allergic to the active substance (any of the other ingredients of this medicine (listed in section 6);
when taking the following medicines: astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine, lovastatin or simvastatin (see written below).
Warnings and precautions for use of Klaricid granules for oral suspension
Talk to your doctor or pharmacist before taking Klaricid granules for oral suspension.
If you are considering the implementation of clarithromycin suspension in patients after puberty, the physician should carefully weigh the benefits against the risk if it is suspected or confirmed pregnancy.
Application of almost all antibiotics, including Klaricid can lead to imbalance present in the large intestine bacteria overgrowth and certain causing inflammation of the colon bacteria. This condition is known as pseudomembranous colitis and most often occurs with the onset of diarrhea during or after discontinuation of the antibiotic. Therefore, it is important to tell your doctor about the appearance of diarrhea, even a long time (1-2 months) after cessation of antibiotic treatment.
It is possible that symptoms of the disease exacerbation myasthenia gravis (neuromuscular disease most commonly characterized by muscle weakness) during treatment with this product.
Your doctor may decide that this medicine is not suitable for you or your child in the event of a violation of liver or kidney function. It may be necessary to carry out further research, which will be advised by your doctor.
Tell your doctor in case of a medicine containing colchicine because of possible toxic effects when co-administered with clarithromycin (active substance in Klaricid), especially if you are elderly and / or in the presence of renal insufficiency.
Tell your doctor if you take a medicine to reduce blood sugar (taken by mouth or insulin). Concomitant administration of these drugs with clarithromycin can cause a drop in blood sugar, which requires that it be monitored frequently.
Tell your doctor if you are taking means to suppress the formation of blood clots in the blood (anticoagulants). Co-administration of these drugs with clarithromycin can lead to increased risk of bleeding.
As with other antibiotics, prolonged treatment with clarithromycin can lead to the development of multiple-resistant (sensitive to an antibiotic) bacteria and fungi. Upon the occurrence of such infections it is necessary to start determined by your doctor treatment.

Other medicines and Klacid granules for oral suspension
Tell your doctor or pharmacist if your child is taking other medicines, has recently taken or might take including medicines obtained without a prescription.
This medicine may alter the effect of many drugs as other drugs may alter the effects of Klacid.

It is particularly important to tell your doctor if your child is taking any of the following medications:
cisapride (for stomach problems), pimozide (for psychiatric disorders), terfenadine (for allergies or hay fever), ergotamine or dihydroergotamine (for migraine) - the use of these drugs with Klaricid is absolutely forbidden (see above);
Digoxin (cardiovascular medicine);
warfarin and other anticoagulants (drugs to thin the blood);
carbamazepine or phenytoin (for epilepsy);
astemizole (for allergies and hay fever);
theophylline (for relief in breathing);
triazolam, alprazolam and midazolam (sedatives);
quinidine and disopyramide (cardiovascular medicine);
lovastatin or simvastatin (for high cholesterol);
cimetidine (for stomach problems);
cyclosporine and tacrolimus (for suppression of the immune response, most frequently in organ transplantation);
fluconazole, itraconazole (in the treatment of fungal infections);
sildenafil, tadalafil and vardenafil (with erection problems or erectile dysfunction etc.);
zidovudine, ritonavir, saquinavir, atazanavir (medicines to treat HIV / AIDS);
rifabutin (to treat certain infections);
verapamil (a medicine for heart disease).
Pregnancy, lactation and fertility
This product is intended for use primarily in children. However, if ingested by adults is necessary to consider the following:
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Your doctor will assess the possibility of applying this product in case of pregnancy or breastfeeding, and will discuss the benefits and risks associated with its use (including possible risks to the fetus).

Driving and using machines
Klaricid granules for oral suspension is intended for use primarily in children. There are no data on the impact of the product on the ability to drive. When driving or operating machinery should be given the possibility of dizziness.

3. HOW TO TAKE Klacid granules for oral suspension
Always take or give your child Klacid granules for oral suspension, just as you have been told your doctor or pharmacist. If you are not sure ask your doctor or pharmacist.
The table below presents the recommended dosage in children, determined on the basis of body weight (kg). The required dose is taken twice daily and is measured, using the standardized measuring spoon or syringe, which are marked accordingly 2,5 ml and 5 ml.
Weight * (kg) twice daily dose (125 mg / 5 ml) twice daily dose (250 mg / 5 ml)
* 8-11 2.5 ml 1.25 mg
12-19 5.00 ml 2.5 ml
20-29 7.50 ml 3.75 ml
30-40 10.00 ml 5 ml
C * In children weighing less than 8 kg, the dose should be determined on the basis kilogram of body weight (about 7,5 mg / kg, twice daily).

The duration of treatment is usually 5 to 10 days, depending on the type of the agent and the severity of the condition. The reconstituted suspension may be taken with or without food and can be accepted as milk.
Preparation of oral suspension: granules in the bottle to add water to the measuring line and shake well. Make up with water again to the line and shake. 5 ml of reconstituted suspension so contains 125 mg of clarithromycin.

Patients with renal impairment in patients with renal failure, the dose should be reduced by half (ie. 250 mg once daily or 250 mg twice daily, in case of more severe infections). In these patients, treatment should not exceed 14 days.

Dosage in patients with mycobacterial infections
In children with disseminated or localized mycobacterial infections, the recommended dose is 7.5 to 15 mg / kg clarithromycin daily in two divided doses.

Dosing in children with mycobacterial infections based on body weight
Weight * (kg)
Dosage per ml twice a day (250 mg clarithromycin / 5 ml)

7.5 mg / kg 15 mg / kg
* 8-11 1.25 ml 2.50 ml
12-19 2.50 ml 5.00 ml
20-29 3.75 ml 7.50 ml
30-40 5.00 ml 10.00 ml
C * In children weighing less than 8 kg, the dose should be determined on the basis kilogram of body weight (about 7.5 to 15 mg / kg daily).

If you take (if your child) more than the amount Klacid granules for oral suspension
If you take (if your child) more than the amount, contact your physician immediately or go to the nearest facility for medical care.

If you forget to take (give your child) dose Klacid granules for oral suspension
Accept (give your child) missed dose as soon as you remember and then switch to normal mode of treatment. If it is almost time for your next dose, skip the missed. Do not take a double dose to make up for a missed dose.

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 everybody gets them.

The most commonly reported adverse reactions were violations on the part of the gastrointestinal tract (nausea, vomiting, Darius, indigestion, abdominal pain). Below are presented other adverse reactions observed during clinical trials and post-marketing. Do not worry about a long list of side effects when you can not have any of them.
Infections: fungal infections of the mouth and vagina.
Disorders of the blood, anemia and a change in the number of individual blood cells (mostly decreases in white blood cells and platelets (platelet, clotting)).
Disorders by nutrition and metabolism: decrease in blood glucose (blood sugar).
Psychiatric disorders: depression, insomnia, nervousness, somnolence, abnormal dreams, anxiety, confusion, disorientation, hallucinations, mania.
Nervous system disorders: (loss) of taste and smell, dizziness, headache, involuntary muscle twitching, numbness.
Ear and labyrinth disorders: hearing impairment (incl. Deafness), vertigo, tinnitus.
Cardiac disorders: the rhythm of the heart, including changes in the electrocardiogram.
Gastrointestinal disorders: inflammation of the lining of the mouth and tongue discoloration of the tongue and teeth, acute inflammation of the pancreas.
Hepatobiliary disorders: inflammation of the liver (hepatitis) and jaundice (yellow skin and whites of the eyes); impaired liver function.
Skin and subcutaneous tissue disorders: rash, hives, severe skin reactions with the detachment of the epidermis and blistering, drug rash with blood dyscrasias.
Disturbances of bone and muscle, muscle pain, destruction of a certain type of muscle tissue.
Renal and urinary disorders: kidney inflammation.
Immune system: various allergic reactions, some severe.
Research: May occurrence of abnormal values in the conduct of a number of laboratory tests (eg. Elevations in bilirubin, serum creatinine, urea, certain liver enzymes, etc.).
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Klacid granules for oral suspension
To keep out of reach of children.
This medicinal product must be stored at temperatures above 25 ° C. Once constituted, the oral suspension Klacid can be used within 14 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.