Klaryvid Film-Coated Tablets

KLARYVID contains clarithromycin, an antibiotic of the macrolide group which is used for the treatment of various infections such as:

• chest infections (like pneumonia and bronchitis),
• infections of the middle ear,
• skin and soft tissue infections,
• infections of the throat and sinuses.

KLARYVID in combination with another antibiotic e.g. amoxicillin and a specific medicine indicated to reduce stomach acid, can also be used for the treatment of a duodenal ulcer when this ulcer is caused by a bacteria, Helicobacter pylori.

Your doctor will tell you what you are being treated for.

Do not take KLARYVID

• If you are hypersensitive (allergic) to clarithromycin or other macrolide antibiotics (erythromycin or azithromycin) or any of the other ingredients of KLARYVID (listed in section 6).
• If you are taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines).
• If you are taking oral midazolam (a medicine used to treat anxiety and insomnia).
• If you are taking a medicine containing lomitapide (a medicine, use to treat high cholesterol).
• If you are taking astemizole or terfenadine (medicines used to treat allergies), cisapride or domperidone (a medicine used to treat gastrointestinal tract disorders), pimozide (a medicine used to treat mental disorders), because they may cause serious disturbances in heart rhythm when taken together with KLARYVID.
• If you have or anyone in your family has had a history of heart rhythm disturbances (ventricular cardiac arrhythmias, including torsades de pointes) or abnormal electrocardiogram results (ECG, measurement of the electrical activity of the heart) called “long QT syndrome”.
• If you are taking ticagrelor (a medicine that prevents bold clotting) or ranolazine (a cardiac medicine).
• If you are taking lovastatin or simvastatin (statin medicines used to lower blood cholesterol) as the combination with KLARYVID can cause rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage) and myopathy (muscle pain or muscle weakness).
• If you are taking quetiapine, cariprazine, and aripiprazole (antipsychotic medicines).
• If you are taking colchicine (a medicine used to treat gout).
• If you have been diagnosed with low level of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia).
• If you have been diagnosed with severe liver failure with kidney failure.
• If you suffer from porphyria.

Do not share medicines prescribed for you with any other person. Always take KLARYVID exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This medicine may be taken with food or milk or on an empty stomach. Your doctor or healthcare professional will know and tell you the correct dosage for KLARYVID tablets. It also depends on how your kidneys are working. KLARYVID is not suitable for use in children under the age of 12 years. For mild to moderate infections, the usual dose in adults and children over 12 years of age is 250 mg twice daily. For more severe infections, 500 mg twice daily. For peptic ulcer caused by the bacteria Helicobacter pylori (in combination with an appropriate antibiotic e.g. amoxicillin and a medicine that specifically reduces stomach acid): 500 mg twice daily for 7 to 10 days. Prevention of infections in AIDS patients with very low CD4 cells, Clarithromycin 500 mg twice daily. Your doctor will tell you how long your treatment with KLARYVID will last. If you have the impression that the effect of KLARYVID is too strong or too weak, tell your doctor or pharmacist.

If you take more KLARYVID than you should

In the event of an overdose, contact your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take KLARYVID Do not take a double dose to make up for forgotten individual doses.

Not all side effects reported for KLARYVID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KLARYVID, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking KLARYVID 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,
• rash or itching,
• fainting,
• 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 KLARYVID. 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,
• severe or prolonged diarrhoea, which may contain blood and/or mucus in it (this could be antibiotic associated colitis including pseudomembranous colitis). Diarrhoea may occur over two months after treatment with KLARYVID, in which case you should still contact your doctor.

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,
• irregular taste,
• nausea,
• vomiting,
• stomach pain,
• diarrhoea,
• indigestion,
• irregular liver function test,
• rash
• excessive sweating.
• Less frequent side effects:
• thrush,
• inflammation of the stomach and intestines mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a bacteria or virus,
• infection,
• vaginal infection,
• if you are getting sick more often (colds), these may be signs of a decrease in your white blood cells (leukopenia),
• signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms or weakness, bruising, pale skin and/or breathlessness. This may be the result of a blood disorders (such as and neutropenia),
• coughing, wheezing, shortness of breath, a high temperature and a general ill feeling associated with an increase of white blood cells (eosinophilia),
• weight loss,
• lack of appetite,
• anxiety, nervousness,
• dizziness,
• sleepiness
• shaking,
• ringing in the ear or hearing loss,
• vertigo (balance disorder),
• changes in heart rhythm such as palpitations or an irregular heartbeat,
• nosebleed,
• inflammation of the lining of the oesophagus and lining of the stomach,
• pain, tenderness and swelling of the mouth and/or tongue,
• anal pain,
• bloating, constipation, dry mouth, burping, wind,
• situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis),
• raised abnormal liver function blood test and raised blood tests,
• itching or itchy rash,
• muscle spasms or muscle pain,
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue.

Store at or below 25 °C and protect from light. Keep the blisters in the carton until required for use. Store all medicines out of reach of children. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).