Klaricid SR 500 mg. 7 tablets
Klaricid SR is an antibiotic belonging to the group of so-called macrolide antibiotics. Antibiotics are drugs that inhibit or stop the growth of certain microorganisms (bacteria) that cause the occurrence of various infections.
Klaricid SR is indicated for treatment of infections caused by susceptible microorganisms thereto. This includes:
Infections of the lower respiratory tract infections such as bronchitis and pneumonia;
Infections of the upper respiratory tract, such as sinusitis and pharyngitis;
Infections of skin and soft tissue, such as folliculitis, cellulitis and erysipelas.
As with other antibiotics before prescribing Klaricid SR, your doctor will take into consideration the frequency of resistance (resistance of microorganisms to an antibiotic) and the related recommendations for prescribing antibiotics.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE Klaricid SR
Do not take Klaricid SR, if:
you are allergic to the active substance (clarithromycin) or any of the 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).
As the dose of 500 mg daily can be reduced Klaricid SR is contraindicated in patients with severe renal insufficiency.
Warnings and precautions for use of Klaricid SR
Talk to your doctor or pharmacist before taking Klaricid.
Clarithromycin may be administered to pregnant women only when careful consideration of benefits and risks, particularly in the first three months of pregnancy.
Application of almost all antibiotics, including Klaricid can lead to imbalance present in the colon bacteria overgrowth of certain causing inflammation of the colon bacteria. This condition is known as pseudomembranous colitis and most frequently occurs with the onset of diarrhea during or after discontinuation of the antibiotic. Therefore, it is very important to tell your doctor about the occurrence 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 disorder most commonly characterized by muscle weakness) during treatment with the medicinal product.
Your doctor may decide that this medicine is not suitable for you if you have a violation of liver or kidney function. It may be necessary to perform additional studies, which will be advised by your doctor.
Tell your doctor if you are taking a medicine containing colchicine because of possible toxic effects when co-administered with clarithromycin (the active ingredient in Klaricid), especially if you are elderly and / or suffer from renal failure.
Tell your doctor if you are taking medication to reduce blood sugar (taken by mouth or insulin). Concomitant administration of clarithromycin with these drugs can lead to a drop in blood sugar, which requires to be managed often.
Tell your doctor if you are taking means to suppress the formation of clots in the blood (anticoagulants). Concomitant administration of these drugs with clarithromycin may 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. The occurrence of such infections is necessary to start determined by your doctor treatment.
Each tablet contains 115 mg of lactose. You should not take this product if you know that you have an intolerance to some sugars.
Other medicines and Klaricid
Please tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This medicinal product may alter the effect of a number of drugs, as other medicines may change the effect of Klaricid.
It is particularly important to tell your doctor if you are 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) -ANNEX these drugs Klaricid is absolutely prohibited (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);
disopyramide (cardiovascular medicine);
lovastatin or simvastatin (for high cholesterol);
cimetidine (for stomach problems);
cyclosporine and tacrolimus (to suppress 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).
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, 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 with you the benefits and risks associated with its use (including possible risks to the fetus).
Driving and using machines
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 Klaricid SR
Always take Klaricid SR, just as you have been told your doctor or pharmacist. If you are unsure ask your doctor or pharmacist.
The recommended dose is:
Recommended dose clarithromycin modified release tablets in adults is 500 mg once daily with food. In severe infections, the dosage should be increased to 1000 mg once daily (2 x 500 mg). The usual duration of treatment is 5 to 14 days, except in pneumonia, community-acquired and sinusitis that require therapy from 6 to 14 days. Tablets should not be crushed or chewed.
Children over 12 years: as in adults.
Children under 12 years: it is necessary to use the oral suspension of Klaricid for children.
In the absence of severe renal insufficiency, the dose as adults.
The minimum dose for patients with severe impairment of renal function is 500 mg. No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30 to 60 ml / min).
In patients with significantly impaired renal function the product should not be used because it is not possible dose reduction. These patients can be applied Klaricid immediate release tablets.
Based on studies with clarithromycin immediate release no dose adjustment is necessary for patients with moderate and severe hepatic impairment and normal renal function.
If you take more dose Klaricid SR
If you take more than you should, contact your doctor immediately or go to the nearest place for medical care.
If you forget to take a dose of Klaricid SR
Take the missed dose as soon as you remember and then switch to the 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.
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.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist.
This includes any possible effects not listed in this leaflet.
As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
The most commonly reported adverse reactions are violations by 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 the vagina, skin, gastrointestinal tract, nose 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 (platelets, clotting)).
Disorders from nutrition and metabolism, decrease in blood glucose (blood sugar).
Psychiatric disorders: depression, insomnia, nervousness, somnolence, abnormal dreams, anxiety, confusion, disorientation, hallucinations.
Nervous system disorders: (loss) of taste and smell, dizziness, headache, involuntary muscle twitching, numbness.
Eye disorders, ear and labyrinth disorders: inflammation of the lining of the eye (conjunctivitis), hearing impairment (incl. Deafness) and vision, dizziness.
Cardiovascular disorders: vasodilation, abnormal heart rhythm, including changes in the electrocardiogram.
Disorders of respiratory system: asthma, impaired breathing and impaired lung function.
Gastrointestinal disorders: abdominal swelling, inflammation of the colon (pseudomembranous colitis, see. The above,) constipation, dry mouth, belching, bleeding, inflammation of the oral mucosa, a discoloration of the tongue and the teeth.
Hepatobiliary disorders: inflammation of the liver (hepatitis) and jaundice (yellow skin and whites of the eyes).
Skin and subcutaneous tissue disorders: dry skin, eczema, increased sweating, itching, rash, urticaria.
Disturbances of bone and muscle: muscle pain, destruction of certain type muscle tissue.
Renal and urinary disorders: kidney inflammation, the presence of albumin, blood or pus in the urine.
Immune system: various allergic reactions, some of which are serious.
General disorders: fatigue, edema, chest pain, malaise, pain.
Research: It is possible deviations from normal 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 if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Klaricid SR
To keep out of reach of children
This medicinal product must not be stored above 30 ° C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
What Klaricid SR
The active substance is clarithromycin. Each modified-release tablet contains 500 mg of clarithromycin.
Other ingredients are: anhydrous citric acid (E333), sodium alginate (E401), sodium calcium alginate, lactose monohydrate, povidone K30, talc, stearic acid, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), sorbic acid, and quinoline yellow aluminum lake (E104).