Klarithran Tablets

KLARITHRAN belong to broad and medium spectrum antibiotics. KLARITHRAN is are used to treat bacterial infections, such as chest infections e.g. bronchitis and pneumonia, infections of throat and sinuses and skin infections.

Do not take KLARITHRAN :

• If you are hypersensitive (allergic) to clarithromycin or other macrolide antibiotics (erythromycin or azithromycin) or any of the other ingredients of KLARITHRAN (listed in section 6).
• If you are taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines).
• If you are taking oral midazolam (a medicine used to treat anxiety and insomnia).
• If you are taking a medicine containing lomitapide (a medicine, use to treat high cholesterol).
• If you are taking astemizole or terfenadine (medicines used to treat allergies), cisapride or domperidone (a medicine used to treat gastrointestinal tract disorders), pimozide (a medicine used to treat mental disorders), because they may cause serious disturbances in heart rhythm when taken together with KLARITHRAN.
• If you have or anyone in your family has had a history of heart rhythm disturbances (ventricular cardiac arrhythmias, including torsades de pointes) or abnormal electrocardiogram results (ECG, measurement of the electrical activity of the heart) called “long QT syndrome”.
• If you are taking ticagrelor (a medicine that prevents bold clotting) or ivabradine or ranolazine (a cardiac medicines).
• If you are taking lovastatin or simvastatin (statin medicines used to lower blood cholesterol) as the combination with KLARITHRAN can cause rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage) and myopathy (muscle pain or muscle weakness).
• If you are taking quetiapine, cariprazine, and aripiprazole used to treat certain mental/mood disorders.
• If you are taking colchicine (a medicine used to treat gout).
• If you have been diagnosed with low level of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia).
• If you have been diagnosed with severe liver failure with kidney failure.
• If you suffer from porphyria.

Warnings and precautions

Take special care with KLARITHRAN

• If you have or have had any liver or kidney problems.
• If you are taking rifabutin and/or rifampicin as the combination will cause a decrease of KLARITHRAN in your blood. Co-administration has been reported to cause a higher incidence of uveitis, an inflammation of part of the eye compared to when rifabutin is taken alone.
• If you are taking theophylline, a medicine used to open your airways to help you breath better.
• If you develop severe or prolonged diarrhoea (pseudomembranous colitis), which may have blood or mucus in it, during or after taking KLARITHRAN, contact your doctor immediately. In this situation, you should not take medicines that stop or slow bowel movement.
• If you are taking colchicine (a medicine used to treat gout).
• If you are taking certain medicines called benzodiazepines (e.g. midazolam, triazolam) as sedatives and calmatives.
• If you have, or have had, heart problems (e.g. heart disease, heart failure, an unusually slow heart rate) or abnormally low levels of magnesium or potassium the blood.
• If you have pneumonia (serious lung infection with fever, chills, shortness of breath, cough, phlegm or coughing blood).
• In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, KLARITHRAN therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
• If you are taking certain medicines called statins (used to lower blood cholesterol) and you experience rhabdomyolysis, which is a condition in which skeletal muscle tissue dies, releasing substances into the blood that cause kidney failure.
• If you are taking certain medicines to lower blood sugar (sulphonylureas used in the treatment of type II diabetes) or insulin.
• If you are currently using a blood thinning medicine (e.g. warfarin).
• If you have a weak immune system (immunocompromised) you may experience nausea, vomiting, irregular taste, stomach pain, runny stomach, rash, flatulence (gas), headache, hearing disturbance, irregular liver test results and irregular low white blood cell and platelet counts or difficulty breathing, restlessness and dry mouth.

Do not share medicines prescribed for you with any other person. Check with your doctor or pharmacist if you are not sure. Children Safety and efficacy in infants under 6 months of age has not been established. The recommended dose for children under 6 months is based upon a 7,5 mg/kg dose administered twice daily. See dosage table below. The usual duration of treatment is 5 to 10 days, depending on the pathogen involved and the severity of infection. In patients with severe renal function impairment (creatinine clearance <30 ml/min), the dosage of KLARITHRAN should be reduced by half. Do not continue treatment in these patients for more than 14 days. Weight Approximate age Dose in ml of Dose in ml of 125 mg/5 ml suspension 250 mg/5 ml suspension 8 to 11 kg 1 to 2 years 2,5 ml twice daily - 12 to 19 kg 2 to 4 years 5 ml twice daily 2,5 ml twice daily 20 to 29 kg 4 to 8 years 7,5 ml twice daily 3,75 ml twice daily 30 to 40 kg 8 to 12 years 10 ml twice daily 5 ml twice daily Reconstitution instructions: The quantity of distilled water specified for the pack size in the table below should be added to the granules and the contents shaken well. Pack size Volume of water to be added 60 ml 34 ml 70 ml 40 ml 100 ml 55 ml Adults: 250 mg twice daily. In more severe infections, the dosage may be increased to 500 mg twice daily. Renal impairment Creatinine clearance (<30 ml/min): Reduce dose by half i.e. 250 mg once daily or 250 mg twice daily for severe infections. Limit the duration of treatment to 14 days Eradication of H. pylori Adults: 500 mg twice daily, in combination with an appropriate antibiotic and an acid lowering agent, for 7 to 10 days.

Not all side effects reported for KLARITHRAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KLARITHRAN, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking KLARITHRAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• severe skin reactions such as painful blistering of the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis),
• a red, scaly rash with bumps under the skin and blisters (symptoms of exanthematous pustulosis),
• a rare allergic skin reactions which cause severe illness with ulceration of the mouth, lips and skin which causes severe illness with rash, fever and inflammation of internal organs (DRESS).

These are all very serious side effects. If you have them, you may have had a serious reaction to KLARITHRAN. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• changes in the way your heart beats for example if you notice it beating faster.
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).
• fits,
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems,
• severe or prolonged diarrhoea, which may contain blood and/or mucus in it (this could be antibiotic associated colitis including pseudomembranous colitis). Diarrhoea may occur over two months after treatment with KLARITHRAN, in which case you should still contact your doctor.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent side effects:
• difficulty sleeping,
• headache,
• irregular taste,
• nausea,
• vomiting,
• stomach pain,
• diarrhoea,
• indigestion,
• irregular liver function test,
• rash
• excessive sweating.

Less frequent side effects:

• thrush,
• inflammation of the stomach and intestines mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a bacteria or virus,
• infection,
• vaginal infection,
• if you are getting sick more often (colds), these may be signs of a decrease in your white blood cells (leukopenia),
• signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms or weakness, bruising, pale skin and/or breathlessness. This may be the result of a blood disorders (such as and neutropenia),
• coughing, wheezing, shortness of breath, a high temperature and a general ill feeling associated with an increase of white blood cells (eosinophilia),
• weight loss,
• lack of appetite,
• anxiety, nervousness,
• dizziness,
• sleepiness
• shaking,
• ringing in the ear or hearing loss,
• vertigo (balance disorder),
• changes in heart rhythm such as palpitations or an irregular heartbeat,
• nosebleed,
• inflammation of the lining of the oesophagus and lining of the stomach,
• pain, tenderness and swelling of the mouth and/or tongue,
• anal pain,
• bloating, constipation, dry mouth, burping, wind,
• situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis),
• raised abnormal liver function blood test and raised blood tests,
• itching or itchy rash,
• muscle spasms or muscle pain,
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue.

Frequency not known:

• large, raised red patches on the skin, especially that of the face and legs, with fever and severe general illness which can sometimes recur and is caused by a bacterial infection (erysipelas)
• reduction in the level of certain blood cells (which can make infections more likely or increase the risk of bruising or bleeding),
• psychotic disorders, confusion, depersonalization, depression, disorientation,
• seeing things (hallucinations),
• abnormal dreams or nightmares,
• mood of excitement, over activity and uninhibited behaviour,
• lack of taste, change in the sense of smell (parosmia), loss of smell,
• paraesthesia (numbness, tingling)
• deafness,
• type of heart rhythm disorder (torsade de pointes, ventricular tachycardia, ventricular fibrillation),
• bleeding,
• teeth or mouth discolouration,
• acute inflammation of the pancreas,
• acne
• myopathy (a muscle disease involving muscle strength reduction),
• change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs or ankles or problems with urination),
• change in diagnostic test results (increased international normalized ratio [INR], prolonged prothrombin time,
• abnormal urine colour.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of KLARITHRAN is important. It allows continued monitoring of the benefit/risk balance of KLARITHRAN. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: Suspected adverse reactions can also be reported directly to the Holder of Certificate of Registration via e mail: [email protected] or tel: +27(0) 12 643 2000

Store all medicines out of reach of children.

• Store at or below 25 o C.
• Keep the bottle tightly closed.
• Do not refrigerate or freeze.
• Store in the original package / container
• Discard the unused portion of constituted suspension after 14 days.
• Shake The Bottle Well Before Use.
• Protect from light / moisture
• Do not store in a bathroom
• Do not use medicine after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).