Klaribin 250 mg/500 mg Tablets

KLARIBIN 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 KLARIBIN:

• 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 KLARIBIN 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 KLARIBIN:

• 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 KLARIBIN immediately.
• If you suffer from kidney problems - the elimination of KLARIBIN is reduced in patients with renal function impairment, especially those with a creatinine clearance of <30 ml/min.
• If you are taking rifabutin and/or rifampicin as the combination will cause a decrease of KLARIBIN 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 breathe better.
• If you experience severe diarrhoea, you may be suffering from pseudomembranous colitis due to KLARIBIN.
• If you are taking benzodiazepines e.g. midazolam, triazolam or triazolam, medicines used as muscle relaxants and to treat anxiety.
• If you are taking blood glucose lowering medicines such as insulin as it may cause hypoglycaemia, where your glucose level drops too much.

Children

Safety and efficacy in infants under 6 months of age has not been established. KLARIBIN is not suitable for use in children under the age of 12 years.

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. KLARIBIN may be taken with or without food. Your doctor will prescribe an appropriate dose according to your condition.

If you take more KLARIBIN than you should:

If you forget to take KLARIBIN: Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Always take KLARIBIN 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 KLARIBIN is too strong or too weak, talk to your doctor or pharmacist. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

Do not take a double dose to make up for forgotten individual doses.

KLARIBIN can have side effects. If you experience any of the following, stop taking KLARIBIN 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
• Muscle pain

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

• Oral thrush, or a vaginal infection
• Decreased appetite
• Anxiety
• Insomnia
• Hallucinations
• Bad dreams
• Depersonalisation
• Depression
• Dizziness
• Vertigo
• Confusion
• Tremor
• Hearing loss
• Tinnitus (ringing in your ears)
• Nausea
• Vomiting
• Muscle pain

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