Claride XL 500 mg Modified-Release Tablets

CLARIDE XL is an antibiotic which belongs to a group of medicines called macrolides. Antibiotics stop the growth of bacteria which causes infections.

CLARIDE XL tablets are used to treat infections such as:

• Chest infections such as bronchitis and pneumonia (infection of the lungs).
• Sinusitis (infection of the sinuses).
• Pharyngitis and tonsilitis (infection of the throat and tonsils).
• Skin and soft tissue infections that are not severe.

Do not take CLARIDE XL

• if you are hypersensitive (allergic) to clarithromycin, other macrolide antibiotics or any of the other ingredients of CLARIDE XL (listed in section 6).
• if you taking the following medications. Consult your doctor for advice on alternative medicines or ask if you are not sure:

• Ergotamine or dihydroergotamine tablets or use ergotamine inhalers (medicines used to treat migraines). Combining these with CLARIDE XL tablets may cause your blood vessels to narrow. This will lead to a decrease of blood supply to tissues.
• Cisapride (to treat stomach disorders), pimozide (to treat some mental illnesses), terfenadine or astemizole (to treat hay fever or allergy). Combining these medicines with CLARIDE XL tablets can cause serious changes in your heart rhythm.
• Lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood as this may increase your chances of developing rhabdomyolysis (a condition where muscle tissue is broken down, causing a release of a damaging protein into the blood).
• Colchicine which is used to treat gout.
• Oral midazolam (used as a sedative).
• Ticagrelor or ranolazine (for heart attack, chest pain or angina).

If your potassium levels are low (hypokalaemia).

If you have severe liver disease with kidney disease.

If you have an irregular heart rhythm.

Warnings and precautions

Take special care with CLARIDE XL and tell your doctor or healthcare provider:

• If you have a heart condition.
• If you have any kidney problems.
• If you have liver problems.
• If you have or are prone to fungal infections (such as thrush).
• If you suffer from myasthenia gravis which is a condition that causes weakness of the muscles.
• If you take a group of medicines called benzodiazepines to calm you down.
• If you take an antibiotic from a group of antibiotics called aminoglycosides.
• If you take medicine to lower your cholesterol (fat in the blood).
• If you take medicine to lower your blood sugar or thin your blood.

Children

CLARIDE XL is not suitable for children younger than 12 years.

Other medicines and CLARIDE XL

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines).

Do not share medicines prescribed for you with any other person.

Always take CLARIDE XL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of CLARIDE XL for adults is one tablet (500 mg) once daily swallowed whole with food.

Your doctor may increase the dose to two tablets (1000 mg) once daily to treat severe infections.

Your doctor will tell you how long your treatment with CLARIDE XL will last. Do not stop treatment early. If you have the impression that the effect of CLARIDE XL is too strong or too weak, tell your doctor or pharmacist.

If you take more CLARIDE XL than you should

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

An overdose of CLARIDE XL tablets is likely to cause vomiting, stomach pains, changes in awareness, movement and behaviour (altered mental status and/or paranoid behaviour).

If you forget to take CLARIDE XL

Take the dose as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

If you stop taking CLARIDE XL

Do not stop taking CLARIDE XL because you feel better. It is important to take the tablets for as long as your doctor has told you to, otherwise the infection might come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

CLARIDE can have side effects.

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

If any of the following happens, stop taking CLARIDE XL 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,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS).

These are all very serious side effects. If you have them, you may have had a serious reaction to CLARIDE XL. 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:

• Severe or prolonged diarrhoea, which may have blood or mucus in it (pseudomembranous colitis).
• Deafness.
• Upper abdominal pain that may radiate to the back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Abnormal heart rhythm, sudden collapse, no pulse, chest pain, no breathing, loss of consciousness as these may be symptoms of a serious heart condition.
• Dark, reddish urine, a decreased amount of urine, weakness and muscle aches as these may be symptoms of rhabdomyolysis (a life-threatening condition caused by muscle breakdown and muscle death).
• Decreased urine output, fluid retentions, shortness of breath, fatigue, confusion, irregular heartbeat as these may be symptoms of kidney failure.
• Convulsion.
• Bleeding.
• Shortness of breath or other problems with breathing including asthma.
• Agranulocytosis (a blood cell disorder that makes it easier for you to get infections), thrombocytopenia (a decrease in a type of blood cell that causes you to bleed easily).
• Leukopenia (reduction in the number of white blood cells, which makes infections more likely), eosinophilia and neutropenia (white blood cell disorder), thrombocythaemia (increase in blood platelets, which increases the risk of bleeding or blood clots).

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

• Abnormal liver function tests (doctor will let you know),
• change in sense of taste (dysgeusia, taste perversion), headache,
• abdominal pain, diarrhoea, indigestion, feeling sick, vomiting, bloating,
• difficulty sleeping (insomnia),
• increased sweating,
• thrush, ulcers in your mouth (oral candidiasis),
• vasodilation can cause dizziness when standing up for example or flushing,
• increased sweating (hyperhidrosis).

Less frequent side effects:

• Gastroenteritis (inflammation of the stomach and intestines), vaginal bacterial or fungal infection, bacterial skin infection (erysipelas),
• anorexia (loss of appetite), or decreased appetite
• anxiety (feeling anxious) and nervousness,
• dizziness, tremor (shaking),somnolence (sleepiness),
• tinnitus (ringing in the ears) or hearing loss, vertigo (spinning sensation),
• epistaxis (nose bleeds),
• constipation, dry mouth, belching, flatulence (wind), bleeding from stomach and intestines,
• increased liver enzymes found on doing a laboratory blood tests,
• dry skin,
• muscle pain (myalgia),
• asthenia (weakness or lack of energy)

Side effects with an unknown frequency:

• Hypoglycaemia (low blood sugar which can cause fatigue, fast heartbeat, pale skin, excessive hunger, shakiness, anxiety, sweating and irritability).
• Psychotic disorder (disorder of the mind), depersonalisation (the feeling of your surroundings being unreal), depression (low mood), hallucination (seeing or hearing things that are not real), abnormal dreams, mania (high mood), confusional state.
• Ageusia (loss of taste), parosmia (smell disorder), anosmia (loss of smell), paraesthesia (feeling of ‘pins and needles’).
• Tongue discolouration, tooth discolouration.
• Acne.
• Changes in liver or kidney function tests or blood tests, prothrombin time prolongation (increased blood clotting time).

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

Store all medicines out of reach of children.

Store at or below 30 °C. Protect from light and moisture.

Keep in original packaging until required for use.

Do not store in a bathroom.

Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist.

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