Claribax 500 mg Film-Coated Tablets

CLARIBAX contains the active ingredient clarithromycin which belongs to a group of medicines called macrolide antibiotics. Macrolide antibiotics stop the growth of certain bacteria that cause infections. CLARIBAX is used to treat infections such as:

• Lower respiratory tract infections, e.g. bronchitis, pneumonia.
• Upper respiratory tract infections, e.g. pharyngitis, sinusitis.
• Skin and soft tissue infections, e.g. folliculitis, cellulitis, erysipelas.
• Helicobacter pylori infections, associated with duodenal ulcers.
• Infections in human immunodeficiency virus - positive (HIV - positive) adults caused by a group of organisms called Mycobacteria.

Your doctor may prescribe CLARIBAX to you together with another medicine for the treatment of duodenal ulcers. Your doctor will prescribe CLARIBAX to you based on the type of bacteria causing the infection.

Do not take CLARIBAX:

• If you are hypersensitive (allergic) to clarithromycin, macrolide antibiotics or any of the other ingredients of CLARIBAX listed in section 6 of this leaflet.
• If you or someone in your family has a history of certain abnormal heart rhythms (ventricular arrhythmia, ventricular fibrillation including torsade’s de pointes) or changes in the heart activity as measured in the electrocardiogram called “QT prolongation”.
• If your blood potassium is low (hypokalaemia).
• If you suffer from severe liver failure and kidney problems at the same time.
• If you are taking:
• ergotamine, dihydroergotamine (medicines to treat migraine)
• oral midazolam (a sedative)
• terfenadine or astemizole (anti-allergics)
• cisapride (gastric medicine)
• domperidone (gastric medicine)
• pimozide, quetiapine, cariprazine, and aripiprazole (antipsychotic)
• ticagrelor (to prevent blood clotting)
• ranolazine (to treat angina pectoris)
• lovastatin, simvastatin (medicines to lower cholesterol)
• colchicine (to treat gout).
• other medicines which are known to cause serious disturbances in heart rhythm.

Warnings and precautions

Take special care with CLARIBAX:

Tell your doctor, pharmacist or health care provider immediately if you develop diarrhoea during or after your treatment with CLARIBAX. Tell your doctor or health care provider:

• If you have any liver problems.
• If you have kidney problems.
• If you are taking medicine for insomnia or anxiety.
• If you have heart problems.
• If you have abnormally low levels of potassium in your body (hypokalaemia).
• If you have abnormally low levels of magnesium in your body (hypomagnesaemia).
• If you are taking any medicines that might affect your heart rhythm.
• If you have ever had any hypersensitivity (allergic) reaction such as rash, swelling of the face, lips, tongue or throat. Stop taking CLARIBAX and contact your doctor immediately.
• If you are taking medicine to lower your blood sugar levels.
• If you are taking any anticoagulants (used to prevent blood clots).
• If you have used clarithromycin before on several occasions or for a long time as you may get other infections.

Tell your doctor immediately if you develop anorexia, dark urine, itching of your skin or a tender abdomen during your treatment with CLARIBAX. These are signs and symptoms of liver disease and your doctor may test your liver function.

Do not share medicines prescribed for you with any other person. Always take CLARIBAX exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and children older than 12 years: The usual dose is 250 mg twice a day. In more severe infections, the dosage can be increased to 500 mg twice a day.

Your doctor will decide your dose and tell you how long your treatment with CLARIBAX will last, depending on the type of infection and your kidney function. Your doctor may prescribe you CLARIBAX with other medicines to treat your infection.

If you have the impression that the effect of CLARIBAX is too strong or too weak, tell your doctor or pharmacist.

If you take more CLARIBAX than you should

In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre.

If you forget to take CLARIBAX

If you forget to take a dose, take it as soon as you remember unless it is nearly time to take your next dose. Do not take a double dose to make up for a forgotten dose.

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

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

• Swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to CLARIBAX. 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.
• Signs of recurrent infections, such as fever, chills or sore throat.
• Liver disease (causing unusual tiredness, nausea (feeling sick), vomiting (being sick), yellowing of skin or eyes).
• Fast or irregular heartbeats.
• Pseudomembranous colitis (abdominal or stomach cramps and pain, severe abdominal tenderness, severe watery or bloody diarrhoea, fever).
• Kidney failure (drowsiness, shortness of breath, fatigue, confusion, nausea (feeling sick), fits, passing less urine than is normal for you).
• Liver diseases or liver failure (stomach pain, clay coloured stool, dark urine, unpleasant breath odour, unusual tiredness, nausea (feeling sick), vomiting (being sick) of blood, yellowing of skin or eyes).
• Interstitial nephritis (passing more or less urine than what is normal for you, blood in your urine, dark urine, nausea, vomiting).
• Painful, blistering or peeling skin rash, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Pancreatitis (nausea, vomiting, fever, pain in your stomach area radiating to your back).
• Bleeding or bruising more easily than normal.
• Red, blister forming rash with fever.
• Seizures (fits).
• Temporary paralysis or weakness of muscles.

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:
• Change in results when testing your liver function.
• Difficulty sleeping.
• Distortion of the sense of taste.
• Diarrhoea, pain in the stomach area and stomach cramps.
• Nausea (feeling sick) and vomiting (being sick).
• Headache.
• Excessive sweating.
• Less frequent side effects:
• Vertigo (causing dizziness and nausea), hearing impairment or ringing in the ears.
• Changes in results when testing your blood enzymes and blood cell types, including deceased white blood cells, neutrophils and eosinophils.
• Candidiasis or vaginal infection (causing vaginal itching, redness or irritation and a burning sensation when urinating).
• Gastritis (pain, nausea, vomiting, vomiting blood, blood in the stool), gastroesophageal reflux disease (GORD), rectal pain, abdominal distension (causing belching, nausea and vomiting), constipation or flatulence.
• Mouth sores, a dry mouth or glossitis (causing swelling and pain of your tongue).
• Nosebleeds.
• Change in results when testing your liver enzymes.
• Abnormal physical weakness or lack of energy.
• Chest pain.
• Anxiety, nervousness.
• Loss of appetite and losing weight.
• Low blood sugar levels.
• Feeling excessively tired, dizziness or tremors (involuntary trembling or shaking of hands and feet).
• Muscle spasms, muscle pain.
• General feeling of being unwell, fever, weakness, fatigue and chills.
• The following side effects have been reported with unknown frequency:
• Low levels of white blood cells, increased number of certain white blood cells (agranulocytosis), decrease of the levels of blood platelets that help stop bleeding (thrombocytopenia).
• Psychotic disorder (causing anxiety, suspiciousness, depressed mood).
• Confusion, depersonalisation, depression, feeling disorientated or mania (causing racing thoughts, feeling energetic, talking fast and taking more risks).
• Hallucinations or having abnormal dreams.
• Haemorrhage (rupturing of a blood vessel).
• Erysipelas (causing a red, swollen and painful area of the skin, blisters and fever).
• Convulsions.
• Loss of taste or loss or distortion of smell.
• Tingling or numbness of your hands and feet (pins and needles).
• Deafness.
• Easy or excessive bruising or bleeding and blood clotting slower than usual.
• Tongue or tooth discolouration.
• Abnormal urine colour.
• Acne.

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

• Store at or below 30 °C.

• Keep the blister strip(s) in the outer carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).