Product Details

Product Information of Klatril 500mg Tablets

What you need to know before you take Klatril

Do not take Klatril if:

• you are allergic to Klatril, other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6). • you have a history of certain abnormal heart rhythms (ventricular arrhythmia, including torsades de pointes) or changes in the heart activity as measured in the electro-cardiogram called “QT prolongation”, • you suffer from severe liver failure and kidney problems at the same time, • You are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride or pimozide tablets as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines. • You are taking other medicines which are known to cause serious disturbances in heart rhythm. • you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia) • You or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsade de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”. • you are taking any of the following medicines • ergotamine, dihydroergotamine (medicines to treat migraine) • lovastatin, simvastatin (medicines to lower cholesterol), • colchicines (medicine to treat gout), • ticagrelor or ranolazine (medicines to prevent stroke or heart attack). • You are taking a medicine containing lomitapide. Consult your doctor and take this medicine if any of the above cases apply to you, or that in the past. Warnings and precautions Talk to your doctor or pharmacist before taking Klatril, • if you are allergic to lincomycin or clindamycin • if you have reduced liver or kidney function, • if you have, or have had, heart problems • if you are pregnant (see section “Pregnancy, breast-feeding and fertility”) • if you develop severe or prolonged diarrhoea (pseudomembranous colitis) during or after taking Klatril, consult your doctor immediately. Inflammation of the colon (Pseudomembranous colitis) has been reported with nearly all antibacterial medicines including Klatril. • if you have used Klatril before on several occasions or for a long time. • Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen. • if you take combination a combination of Klatril and benzodiazepines, such as alprazolam, triazolam and midazolam (see section “Other medicines and Klatril”) • if you take other drugs which affect your auditory function. Loss of hearing will be checked during and after treatment. • In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, Klatril therapy should be discontinued immediately and appropriate treatment should be urgently initiated. • Concomitant use of Klatril with lovastatin or simvastatin is contraindicated (see section “Do not take Klatril if”). Caution should be exercised when using Klatril with other statins.If you also use oral anticoagulants besides Klatril. There is a risk of serious bleeding. If any of these apply to you, consult your doctor before taking Klatril tablets. Other medicines and Klatril Certain other medicines may affect the effectiveness of Klatril or viceversa. Klatril may increase the effect of the following medicines: • astemizole, terfenadine (antiallergic), pimozide (antipsychotic), cisapride (gastric medicine), ergotamine, dihydroergotamine (migraine medicines), lovastatin, simvastatin (medicines to lower cholesterol) (see “Do not take Klatril”) • alprazolam, triazolam, midazolam (hypnotics) • atorvastatin, rosuvastatin (cholesterol lowering agents) • warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban, phenprocoumon (blood thinners): concomitant use may increase the risk of bleeding. Checking of the blood clotting should be more frequent if Klatril used concomitantly. • Nateglinide, repaglinide or insulin (antidiabetics) • carbamazepin, phenytoin, valproate (medicines to treat epilepsy) • cilostazol (used to improve circulation in the legs) • colchicine (to treat gout) • cyclosporine, sirolimus, tacrolimus (immunosuppressants) • digoxin, verapamil, quinidine, disopyramide (heart medicines), concomitant use of Klatril and these agents may cause cardiac arrhythmias.. • methylprednisolone (a cortisone to treat inflammation) • omeprazole (gastric medicine) • rifabutin (antibiotic) • sildenafil, tadalafil, vardenafil (medicines to treat erectile dysfunction) • theophylline (antiasthmatic) • tolterodine (to treat overactive bladder syndrome) • vinblastine (medicine for cancer therapy) • medicines with the risk to affect hearing, especially aminoglycosides (group of antibiotics that are given to vein) • atypical antipsychotics (e.g. quetiapine) Both, the effect of Klatril and the effect of the following medicines may be increased when taken together: • atazanavir, saquinavir (medicines to treat HIV) • itraconazole (medicine to treat fungal infections) If your doctor has specifically recommended to take Klatril and any of the above mentioned medicines at the same time, your doctor may need to monitor you more closely. Klatril may weaken the effect of following medicines: • zidovudine ((used to treat HIV infection). In order to avoid this you should leave a 4 hour interval between taking these medicines. The following medicines may weaken the effect of Klatril: • rifampicin, rifabutin, rifapentine (antibiotics) • efavirenz, nevirapine, etravirine (medicines to treat HIV) • phenytoin, carbamazepine, phenobarbitone (antiepileptic) • St John’s Wort (a herbal product used to treat depression) The following medicines may strengthen the effect of Klatril: • ritonavir (antiviral) • fluconazole (medicine to treat fungal infections) The use of Klatril at the same time as digoxin, quinidine, disopyramide or verapamil (heart medicines), or other macrolide antibiotics may cause cardiac arrhythmia. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy,breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant or breast-feeding do not take Klatril before consulting your doctor. Driving and using machines Klatril has generally no effect on the ability to drive or use machines. However, if side effects, such as dizziness, confusion and disorientation, your reaction may be adversely affected. Use caution when driving or operating machinery until you know how you react to this medicine. Klatril contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’