Klaribin 125 mg/5 ml

KLARIBIN belong to broad and medium spectrum antibiotics. KLARIBIN 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 KLARIBIN :

• If you have previously had an allergic reaction to clarithromycin, other macrolides antibiotics such as erythromycin or azithromycin, or to any of the ingredients of KLARIBIN listed in section 6 (an allergic reaction may include rash, itching, swelling of the face, lips, hands/feet or breathing difficulties).
• If you are pregnant or intend to become pregnant.
• If you are currently breast - feeding.
• If you suffer severe dysfunction of the kidneys (you have creatinine clearance of less than 30 ml/min).
• If you are taking any of the following medicines: astemizole, cisapride, pimozide and terfenadine.

Warnings and precautions

Take special care with KLARIBIN

• If you have sugar diabetes (there are reports of drop in blood sugar levels in patients taking insulin or oral hypoglycaemic drugs for treatment of diabetes).

Other medicines and KLARIBIN

• ergot derivatives such as ergotamine tablets or inhalers (used for treatment of migraine)
• terfenadine or astemizole (used for treatment of allergies), cisapride (used for treatment of digestive problems), pimozide (used for treatment of mental illnesses).
• warfarin or other anticoagulants (blood thinning medicines).
• theophylline (an anti - asthma medicine).
• cyclosporin or tacrolimus (used following organ transplants).
• digoxin (used for treatment of heart failure).
• disopyramide or quinidine (used for treatment of certain abnormal heart rhythms).
• midazolam, alprazolam or triazolam (used as tranquilizers) phenytoin, valproic acid or carbamazepine (used for treatment of seizures).
• insulin or oral hypoglycaemic agents (used for treatment of diabetes).
• rifabutin (used for treatment certain infections).
• lovastatin or simvastatin (used for lowering elevated cholesterol levels).
• zidovudine (used for treatment of Human Immunodeficiency Virus [HIV] infection).
• methylprednisolone (a medicine that suppresses the immune system).
• vinblastine (used in treatment of cancers).
• sildenafil (used for treatment of impotence in men).
• omeprazole (used for gastric ulcers).

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

KLARIBIN with food, drink and alcohol

KLARIBIN may be taken with or without meals and can be taken with milk.

Pregnancy, breast - feeding and fertility

The safety of this medicine for use during pregnancy and lactation has not been established. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Driving and using machines

Clarithromycin is not known to affect the ability to drive or use machines. However, make sure you know how to react to KLARIBIN before you drive, use machines or engage in any other activity that could be dangerous if you are not alert.

• KLARIBIN contains sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking KLARIBIN.
• KLARIBIN contains aspartame This medicine contains 20 mg aspartame in each 5 ml suspension which is equivalent to 4 mg/ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
• KLARIBIN contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium - free'.

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 KLARIBIN should be reduced by half. Do not continue treatment in these patients for more than 14 days.

Weight

Approximate age

Dose in ml of 125 mg/5 ml suspension

Dose in ml of 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. The safety and efficacy of KLARIBIN in combination with proton - pump inhibitors other than omeprazole has not been established. Atypical mycobacterial infections (MAC) in HIV patients Adults: 500 mg twice daily Treatment of disseminated MAC infections in AIDS patients should continue as long as clinical and microbiological benefit is demonstrated. A decrease in efficacy has been noted in patients taking KLARIBIN for more than 12 weeks. KLARIBIN should be used in conjunction with other antimycobacterial agents.

If you take more KLARIBIN If you take more KLARIBIN than you should, you may experience an increase in side effects listed below (see section 4). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take KLARIBIN Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. If you stop taking KLARIBIN If you are unsure when to stop using KLARIBIN, consult your doctor or pharmacist.

Not all side effects reported for KLARIBIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KLARIBIN, please consult your health care provider for advice.

If any of the following happens, stop taking / using KLARIBIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Rashes, hives, itching, chest constriction, shortness of breath or swelling of the face, lips, tongue and hands/feet, fainting, high temperature.
• Severe skin reactions with blisters, sores or ulceration. These are all very serious side effects. If you have them, you may have had a serious reaction to. You may need urgent medical attention or hospitalisation.
• Severe diarrhoea (which may contain blood or mucous) along with stomach cramps.
• Any irregular or fast heart beat
• Mental confusion
• Disorientation
• Ringing in the ears
• Convulsions
• Hallucinations
• Marked behaviour or mood changes
• Change in sense of reality
• Excessive anxiety
• Jaundice (yellowing of whites of eyes and skin), loss of appetite, pain in right upper abdomen, and general feeling of being unwell
• Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent Infections
• Symptoms such as dizziness, palpitations, sweating, anxiety and sometimes fainting (these are manifestations of a drop in your blood sugar levels). (These are more likely if you are already receiving insulin or oral hypoglycaemic drugs for treatment of diabetes. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following :

• Dizziness, headache, lack of sleep, bad dreams, nervousness.
• Nausea (feeling sick) or vomiting (being sick), abdominal pain, loose stools (diarrhoea), indigestion.
• Inflammation and discolouration of tongue, inflammation of the mouth, tooth discolouration (usually reversible with professional tooth cleaning).
• Impaired sense of taste
• Hearing loss
• White patches inside the mouth and/or on the tongue (oral thrush).

There may be changes in the results of certain laboratory tests:

• Abnormal liver function test.
• Increased creatinine levels in serum.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of KLARIBIN.

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.
• Discard the unused portion of constituted suspension after 14 days.
• Shake The Bottle Well Before Use.
• 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).