Auro Clarithromycin 250 mg/500 mg Tablets

AURO CLARITHROMYCIN is indicated for the symptomatic treatment of:

• Chest infections such as bronchitis and pneumonia.
• Throat and sinus infections such as pharyngitis and sinusitis.
• Mild to moderately severe acute otitis media (infection of your middle ear).
• Skin and soft tissue infections.
• Eradication of Helicobacter pylori (the bacteria responsible for causing gastric or duodenal ulcers) when used in combination with a proton pump inhibitor and another antibiotic to decrease recurrence of duodenal ulcer.

Do not take AURO CLARITHROMYCIN:

• If you have a hypersensitivity to clarithromycin or any macrolide antibiotics or to any component of the formulation.
• If you are taking astemizole, cisapride or pimozide.
• If you suffer from porphyria.
• If you are pregnant.
• If you are taking ergotamine or dihydroergotamine commonly used to treat migraine as the combination with AURO CLARITHROMYCIN may cause constriction of blood vessels resulting in a decrease of oxygen supply to the brain and hands and feet ultimately causing tissue damage.
• If you are taking statins e.g. simvastatin and lovastatin, medicines used to treat high cholesterol, as it may increase the risk of rhabdomyolysis which is the breakdown of damaged muscle.
• If you are taking colchicine, a medicine used to treat gout.

Take special care with AURO CLARITHROMYCIN:

• If you suffer from liver problems. If you experience yellowing of skin and white of the eyes, abdominal pain and tenderness, dark urine and severe itchy skin you should stop taking AURO CLARITHROMYCIN immediately.
• If you suffer from kidney problems - the elimination of AURO CLARITHROMYCIN is reduced in patients with renal function impairment, especially those with a creatinine clearance of <30 ml/min.

Children

Safety and efficacy in infants under 6 months of age has not been established. AURO CLARITHROMYCIN is not suitable for use in children under the age of 12 years. Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Always take AURO CLARITHROMYCIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AURO CLARITHROMYCIN is too strong or too weak, talk to your doctor or pharmacist.

Adults and children older than 12 years: 250 mg twice daily. In more severe infections, the dosage may be increased to 500 mg twice daily. AURO CLARITHROMYCIN may be taken with or without food. Your doctor will prescribe an appropriate dose according to your condition.

If you take more AURO CLARITHROMYCIN than you should: If you forget to take AURO CLARITHROMYCIN: Do not take a double dose to make up for forgotten individual doses.

AURO CLARITHROMYCIN can have side effects. If you experience any of the following, stop taking AURO CLARITHROMYCIN and tell your doctor immediately:

• An allergic reaction where you have difficulty breathing
• Dizziness, blurred vision or fainting as you may have low blood glucose levels.
• Irregular heartbeats for example too fast or too slow.
• A severe peeling rash which may spread to your mouth or eyes.
• Yellowing of your skin and white of the eyes, dark urine or a painful, tender abdomen as you may have jaundice.

If you experience any of the following symptoms, tell your doctor as soon as possible:

• Abdominal cramps or pain, tenderness, severe, watery diarrhoea which may also be bloody, fever
• Convulsions
• Disorientation

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

Store all medicines out of reach of children. Not all side effects reported for AURO CLARITHROMYCIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Store at or below 25 °C. Protect from moisture. Keep HDPE containers tightly closed. Keep the blisters in the carton until required for use.