CLAXIRIT 500 mg. 7 tablets
Clarithromycin is an antibiotic belonging to the group of medicines called macrolides. Antibiotics stop the growth of bacteria that cause infections.CLAXIRIT are tablets prolonged-release means that the active ingredient is released slowly from the tablet, so you need to take it only once a day.
be used to treat infections such as:
infections of the lower respiratory tract, e. bronchitis and pneumonia;
throat infections eg. pharyngitis;
infections of the sinuses (sinusitis);
infections of the skin and tissues, e. folliculitis, cellulitis and erysipelas.
2. BEFORE YOU TAKE CLAXIRIT
Do not use CLAXIRIT
if you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics, for example. erythromycin or azithromycin or to any of the excipients of Klaksirit (see "What Klaksirit" in Section 6);
if you are taking any of these medicines, talk to your doctor about alternative treatment:
ergotamine or dihydroergotamine tablets (for migraine);
cisapride (for stomach disorders), pimozide (for some mental illnesses), terfenadine and astemizole (for hay fever or allergy), as the combination of these drugs with clarithromycin can sometimes cause serious heart rhythm disturbances;
lovastatin or simvastatin (high cholesterol).
if you have kidney problems;
if you have low levels of potassium in your blood (hypokalemia);
if you have or have had a prolonged QT interval deviation in the electrocardiogram (ECG), or irregular heartbeat (ventricular arrhythmia);
if you have severe liver problems and kidney problems.
Take special care with Klaksirit:
if you are pregnant;
if you have liver problems:
if you develop severe or persistent diarrhea during or after taking Klaksirit, consult your doctor immediately;
if you suffer from myasthenia gravis (a disease causing muscle weakness), because the symptoms may worsen while taking Klaksirit;
if you are taking aminoglycosides (a group of medicines to treat certain infections);
if you have coronary artery disease, severe heart failure, abnormally low blood magnesium levels (hypomagnesemia), slow heart rate (bradycardia);
if you have recurrent infections with bacteria or fungi.
Ask your doctor:
if you are taking atorvastatin or rosuvastatin (for high cholesterol);
if you are taking certain anti-diabetic medications (eg. nateglinide, pioglitazone, repaglinide and rosiglitazone) as Klaksirit can lower blood sugar levels.
Upon the occurrence of severe acute hypersensitivity reactions, eg. anaphylaxis syndrome, Stevens-Johnson and toxic epidermal necrolysis, Klaksirit therapy should be discontinued immediately and urgently initiate appropriate treatment.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Consult your doctor if you are taking any of the following medications:
cisapride (for stomach disorders);
pimozide (an antipsychotic drug);
terfenadine or astemizole (for hay fever or allergy);
ergotamine or dihydroergotamine (for migraine);
itraconazole or fluconazole (antifungal medicines);
zidovudine, ritonavir, atazanavir, saquinavir, nevirapine or efavirenz (antivirus [anti-HIV] drugs);
rifabutin (antibiotic active against some infections);
rifampicin and rifapentine (used to treat tuberculosis);
digoxin, quinidine or disopyramide (heart medicine);
carbamazepine, valproate, phenobarbital or phenytoin (medicines for epilepsy);
drugs for high cholesterol (eg. lovastatin or simvastatin);
warfarin (blood thinning);
sildenafil, tadalafil or vardenafil (for the treatment of erectile dysfunction);
theophylline (helps breathing);
tolterodine (for the treatment of the symptoms of the symptoms of overactive bladder);
triazolam, alprazolam or midazolam (sedatives);
omeprazole (for stomach disorders);
tacrolimus, sirolimus or cyclosporine (for organ transplantation);
methylprednisolone (a corticosteroid for the treatment of inflammation);
vinblastine (a chemotherapeutic agent used to treat cancer);
cilostazol (used to improve circulation in the legs);
St. John's wort (herbal medicine);
Taking Klaksirnt with food and drink
Klaksirit should be taken with food and tablets should be swallowed whole and not chewed.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or breast-feeding, do not take Klaksirit without consulting your doctor first, as the safety of Klaksirit during pregnancy and lactation is not known.
Driving and using machines
Klaksirit may affect your ability to drive or operate machinery, as it may cause dizziness, confusion and disorientation.
Important information about some of the ingredients of Klaksirit
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
3. HOW TO TAKE KLAKSIRIT
Always take Klaksirit exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Klaksirit should be taken with food and tablets should be swallowed whole and not chewed. You should take each dose at the same time each day throughout the course of treatment.
Adults and children over 12 years
The usual dose is one Klaksirit 500 mg prolonged-release tablet once a day for 6 to 14 days.
Your doctor may increase the dose to two prolonged-release tablets 500 mg in severe infections. You should take both tablets simultaneously.
Children under 12 years
These tablets are not suitable for children under 12 years. Your doctor will prescribe a suitable drug to your child.
Patients with kidney problems
These tablets are not suitable for patients with kidney problems. Your doctor will prescribe a suitable drug.
If you take more dose CLAXIRIT
If you accidentally take more than the amount Klaksirit or child accidentally swallows some tablets, seek immediate medical attention. Klaksirit overdose can cause vomiting and stomach pains. It is also possible to get allergic reactions.
If you forget to take CLAXIRIT
If you forget to take a tablet Klaksirit, take it as soon as you remember. Do not take a double dose to make up the missed dose.
If you stop taking CLAXIRIT
Do not stop taking Klaksirit you feel better. It is important to take the tablets for as long as your doctor has told you, otherwise the problem might come back.
If you have further questions about the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Klaksirit can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you notice any of the following serious side effects, stop taking Klaksirit and contact a doctor immediately:
severe pain in the abdomen and back, caused by inflammation of the pancreas. This effect is not known;
dark urine, light stools, jaundice (yellowing of the skin and / or eyes), nausea and fever, which can be symptoms of liver problems. This effect is not known;
sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulties in swallowing (severe allergic reaction). This effect is not known;
severe and painful diarrhea caused by inflammatory bowel disease (pseudomembranous colitis). This effect is not known;
skin redness blistering or peeling, which may be associated with fever, and joint pain. There may also be a serious condition with blisters and bleeding from the lips, eyes, mouth, nose and genitals. This may be a syndrome or Stevens-Johnson toxic epidermal necrolysis. This effect is not known.
Common: affects 1 to 10 in 100 patients:
stomach pain, diarrhea, vomiting, digestive discomfort and nausea;
changes or loss of taste (dysgeusia), headache;
expansion of the blood vessel;
abnormal liver function tests;
rash, excessive sweating.
Uncommon: affects 1 to 10 of 1000 patients:
thrush and vaginal thrush (candidiasis), stomach flu, infections, vaginal infections, inflammation of the skin caused by infections;
reduced number of platelets in the blood (thrombocytopenia), neutrophils (neutropenia), or white blood cells (leukopenia);
an increased number of white blood cells called eosinophils (eosinophilia);
anorexia, decreased appetite;
anxiety, nervousness, screaming;
loss of consciousness, difficulty in controlling movements, dizziness, drowsiness and tremor;
ringing in the ears (tinnitus), a feeling of dizziness (vertigo) and hearing impairment;
cessation of heartbeat (cardiac arrest), irregular heartbeat and heart rate, abnormal electrical activity of the heart (ECG), feeling of heart beat (palpitations), premature heart beats (beats);
asthma, nose bleeding, obstruction of the pulmonary arteries;
inflammation of the esophagus, heartburn, gastric irritation, pain in the rectum (proctalgia), inflammation within the mouth (stomatitis), inflammation of the tongue (glossitis);
constipation, bloated stomach (abdominal distension), belching, dry mouth, flatulence;
insufficient bile flow (cholestasis), inflammation of the liver (hepatitis), increase in some liver enzymes (aspartate aminotransferase and gamma glutamyltransferase);
skin irritation, blistering (bullous dermatitis), itching, skin rash and urticaria, hives, wherein flat red patches on the skin, covered with small protrusions merging (maculopapular rash);
muscle cramps, muscle pain, musculoskeletal stiffness;
lack of energy, weakness or loss of strength, fever, chest pain, chills, mental and physical fatigue;
increase of creatinine and blood urea nitrogen;
change of some blood tests (increased alkaline phosphatase and lactate dehydrogenase), abnormal albumin-globulin ratio.
Side effects with unknown frequency:
inflammation of the intestines, causing severe and painful diarrhea, bacterial skin infections;
severe acute deficiency of neutrophils (a type of blood cell), the symptoms include fever and ulcers in the mouth and throat; reduction in blood platelets (thrombocytopenia);
sudden allergic reactions (swelling of face, lips, throat or tongue, or difficulty in breathing or swallowing);
low blood sugar (hypoglycemia);
abnormal dreams, confused state, depersonalization, depression, disorientation, hallucinations (seeing things), psychotic disorder;
seizures, changes in taste or smell;
irregular heart rhythm, fast heartbeat;
discoloration of the tongue, sudden pancreas inflammation, discoloration of the teeth;
liver failure, jaundice;
allergic reactions including rash, in rare cases may occur difficulty in breathing, fainting and swelling of the face and throat that may require emergency treatment. The severity of allergic rashes may vary from mild itchy skin eruptions to a rarer, more serious condition called syndrome of Stevens-Johnson (which can cause ulceration of the mouth, lips and skin) or toxic epidermal necrolysis (which causes severe condition and peeling of the skin);
muscle weakness, tenderness or pain (rhabdomyolysis), muscle weakness;
kidney failure, inflammation of the kidneys (interstitial nephritis);
variations in the color of urine;
increased clotting time (increased INR [international normalized ratio] and prothrombin time).
Klaksirit may aggravate symptoms of myasthenia gravis (a condition in which the muscles weaken and get tired easily) in patients who already suffer from this condition.
5. HOW TO STORE CLAXIRIT
Keep out of the reach and sight of children.
This product is no special storage conditions.
Klaksirit not use after the expiry date stated on the blister and carton after "EXP".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is clarithromycin. Each prolonged-release tablet contains clarithromycin citrate equivalent to 500 mg of clarithromycin.
The other ingredients are:
Tablet core: lactose monohydrate, hypromellose, hypromellose phthalate, talc, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, quinoline yellow aluminum lake (E104), titanium dioxide (E171), talc, macrogol / PEG 4000, macrogol / PEG 400.
CLAXIRIT looks like and contents of the pack
Yellow, oval, biconvex film-coated tablets with a length of 19, 15 ± 0,2 mm, a width of 8,95 ± 0,2 mm and a thickness of 7,55 ± 0,2 mm, without marking.
Blister PVC / PVDC aluminum carton.