Clarihexal Tablets

CLARIHEXAL 500 belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections. CLARIHEXAL 500 contains the active ingredient, clarithromycin. Clarithromycin is used to treat bacterial infections in many different parts of the body.

Your doctor will prescribe CLARIHEXAL 500 to treat the following infections such as:

• Lower respiratory tract such as bronchitis and pneumonia (chest infections).
• Upper respiratory tract infections such as pharyngitis (throat) and sinusitis (sinus) infections.
• Mild to moderately severe acute acute otitis media (ear infections, particularly inflammation of the middle ear).
• Skin and soft tissue infections such as folliculitis, cellulitis or erysipelas.
• CLARIHEXAL 500 may also be used to treat gastrointestinal ulcers caused by an organism called Helicobacter pylori. Together with CLARIHEXAL 500, your doctor will also prescribe other medication that you must use at the same time, to prevent the ulcer from coming back.

Do not take CLARIHEXAL 500:

• If you are hypersensitive (allergic) to clarithromycin, any macrolide antibiotics (erythromycin or azithromycin) or any of the other ingredients of CLARIHEXAL 500 (listed in section 6).
• If you are taking medicines called ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.
• If you are taking oral midazolam (a sedative).
• If you are taking lomitapide, lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood).
• If you are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies), domperidone or cisapride (for stomach problems) or pimozide (for mental health problems), as combining these medicines can sometimes cause serious disturbances in heart rhythm.
• Have a history of QT prolongation (an abnormality if the electrocardiogram (ECG)) or an irregular heartbeat (ventricular cardiac dysrhythmia).
• If you are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).
• If you are taking colchicine (usually taken for gout).
• If you have hypokalaemia (a condition characterized by low levels of potassium in the blood).
• If you have severe liver disease with kidney disease.
• If you suffer from porphyria.

Warnings and precautions

Take special care with CLARIHEXAL 500:

• If you have kidney and severe liver disease. You may have an increased chance of side effects.
• If you experience rhabdomyolysis, which is a condition in which skeletal muscle tissue dies, releasing substances into the blood that cause kidney failure.
• If you develop severe or prolonged diarrhoea (pseudomembranous colitis), which may have blood or mucus in it, during or after taking CLARIHEXAL 500, contact your doctor immediately.
• 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 in the blood (hypomagnesaemia).
• 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, CLARIHEXAL 500 therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
• If you suffer from blood clots or currently using blood thinning medicine.
• 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. Always take CLARIHEXAL 500 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual duration of treatment is 5 to 10 days and will depend on the type of infection and its seriousness. Children who weigh less than 8 kg will usually be given a dose of approximately 7,5 mg/kg twice a day. The usual dose in adults is 250 mg twice a day, which could be increased to 500 mg twice a day for more severe infections.

If you suffer from severe renal impairment, your doctor will reduce the dosage of CLARIHEXAL 500 by half.

If you take more CLARIHEXAL 500 than you should

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 CLARIHEXAL 500

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

CLARIHEXAL 500 can have side effects. Not all side effects reported for CLARIHEXAL 500 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLARIHEXAL 500, please consult your health care provider for advice.

If any of the following happens, stop taking CLARIHEXAL 500 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.
• 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 CLARIHEXAL 500. 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.
• Watery and severe diarrhoea, which may be bloody.

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 or irregular taste
• Nausea
• Vomiting
• Stomach pain
• Diarrhoea
• Indigestion
• Irregular liver function test
• Rash
• Excessive sweating

Less frequent side effects:

• Thrush
• Mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus
• Infection
• Irregular blood cells that may cause fever, severe chills, sore throat or mouth ulcers, bleeding or bruising more easily than normal
• Weight loss
• Lack of appetite
• Anxiety
• Nervousness
• Dizziness
• Sleepiness
• Shaking
• Ringing in the ear or hearing loss
• Vertigo
• Nosebleed
• Inflammation of the lining of the oesophagus and lining of the stomach
• Anal pain
• Bloating, constipation, wind, burping
• Dry mouth
• Situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis)
• Itching or itchy rash
• Muscle spasms or muscle pain
• Aching muscles, muscle tenderness or weakness, not caused by exercise

Frequency unknown:

• Bacterial infection of the skin
• Confusion
• Depression
• Seeing things (hallucinations)
• Abnormal dreams or nightmares
• Mood of excitement, over activity and uninhibited behaviour
• Loss of taste or smell
• Tingling feeling in hands and feet also known as “pins and needles”
• Deafness
• Bleeding
• Teeth or mouth discolouration
• Acne
• Generally feeling unwell
• Fever
• Chest pain
• Chills
• Fatigue

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

• Store at or below 25 °C.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.