KLARICID XL 500 MG MODIFIED-RELEASE TABLETS - patient leaflet, side effects, dosage

(clarithromycin)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have further questions, ask your doctor or your pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4.

Your medicine is called Klaricid XL 500mg Modified-Release Tablets, but will be referred to as Klaricid XL tablets throughout the rest of this leaflet.

What is in this leaflet

0 What Klaricid XL tablets are and what they are used for

Q What you need to know before taking Klaricid XL tablets

Q How to take Klaricid XL tablets

0 Possible side effects

0 How to store Klaricid XL tablets

0 Contents of the pack and other information

0 What Klaricid XL tablets are and what they are used for

Each Klaricid XL tablet contains 500 mg of the active ingredient clarithromycin.

Klaricid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections.

Klaricid XL tablets are used to treat infections such as:

• 1. Chest infections such as bronchitis and pneumonia

• 2. Throat and sinus infections

• 3. Mild to moderate skin and tissue infections, e.g. cellulitis, folliculitis or erysipelas.

Klaricid XL Tablets are used in adults and children 12 years and older.

0

What you need to know before taking Klaricid XL tablets

Do not take Klaricid XL tablets if you;

• know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the tablets.

• are taking medicines called ergot alkaloid tablets (e.g. ergotamine or dihydroergotamine) or use ergotamine inhalers for migraine.

• are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride or domperidone (for stomach problems) or pimozide (for mental health problems) as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.

• are taking other medicines which are known to cause serious disturbances in heart rhythm.

• are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood).

• are taking oral midazolam (a sedative).

• are taking a medicine containing lomitapide

• have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).

• have severe liver disease with kidney disease.

• or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.

• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina)

• are taking colchicine (usually taken for gout)

Warnings and precautions

Talk to your doctor or pharmacist before taking Klaricid XL tablets

• if you have heart problems (e.g. heart disease, heart failure, an unusually slow heart rate)

• if you have any liver or kidney problems

• if you have, or are prone to, fungal infections (e.g. thrush)

• if you are pregnant or breast feeding

Children

Klaricid XL tablets are not suitable for use in children under 12 years of age.

Other medicines and Klaricid XL tablets

You should not take Klaricid XL tablets if you are taking any of the medicines listed in the section above “Do not take Klaricid XL tablets if you;” Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as your dose may need to be changed or you may need to have regular tests performed:

• digoxin, quinidine or disopyramide (for heart problems)

• ibrutinib (for cancer treatment)

• warfarin, or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (for blood thinning)

• carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)

• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used to lower levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage) and signs of myopathy (muscle pain or muscle weakness) should be monitored.

• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)

• gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes)

• theophylline (used in patients with breathing difficulties such as asthma)

• triazolam, alprazolam or intravenous or oromucosal midazolam (sedatives)

• cilostazol (for poor circulation)

• methadone (used in the treatment of opioid addiction)

• methylprednisolone (a corticosteroid)

• vinblastine (for treatment of cancer)

• ciclosporin, sirolimus and tacrolimus (immune suppressants)

• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used in the treatment of HIV)

• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial infections)

• tolterodine (for overactive bladder)

• verapamil, amlodipine, diltiazem (for high blood pressure)

• sildenafil, vardenafil and tadalafil (for impotence in adult males or for use in pulmonary arterial hypertension (high blood pressure in the blood vessels of the lung))

• St John’s Wort (a herbal product used to treat depression)

• quetiapine or other antipsychotic medicines

• other macrolide medicines

• * lincomycin and clindamycin (lincosamides – a type of antibiotic)

Please tell your doctor if you are taking oral contraceptive pills and diarrhoea or vomiting occurs, as you may need to take extra contraceptive precautions such as using a condom.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine as the safety of Klaricid XL tablets in pregnancy and breast-feeding is not known.

Driving and Using Machines:

Klaricid XL tablets may make you feel dizzy or drowsy. If they affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

Klaricid XL tablets contain lactose

This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Klaricid XL tablets contains 15.3 mg sodium (main component of cooking/table salt) in each tablet. If you receive two modified release tablets once daily, the resulting sodium amount in total is 30.6 mg per dose. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.

0

How to take Klaricid XL tablets

(clarithromycin)

Patient Information Leaflet (continued)

If you forget to take Klaricid XL tablets

If you forget to take a dose of Klaricid XL tablets, take it as soon as you remember. Do not take more tablets in one day than your doctor has told you to.

If you stop taking Klaricid XL tablets

Do not stop taking Klaricid XL tablets, even if you feel better. It is important to take the tablets for as long as the doctor has told you to, otherwise the problem might come back.

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

0

Possible side effects

Like all medicines, Klaricid XL tablets can cause side effects although not everybody gets them.

If you suffer from any of the following at any time during your treatment STOP TAKING your tablets and contact your doctor immediately:

• severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor.

• a rash, difficulty breathing, fainting or swelling of the face, tongue, lips, eyes and throat. This is a sign that you may have developed an allergic reaction.

• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite. These are signs that your liver may have inflammation and not be working properly.

• 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). The frequency of this side effect is not known (cannot be estimated from the available data).

• 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).

• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).

Other side effects

Common side effects (may affect up to 1 in 10 people) include;

• difficulty sleeping

• changes in sense of taste

• headache

• widening of blood vessels

• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea

• increased sweating

Uncommon side effects (may affect up to 1 in 100 people) include:

• high temperature

• swelling, redness or itchiness of the skin.

• oral or vaginal ‘thrush’ (a fungal infection)

• inflammation of the stomach and intestines

• decrease of the levels of blood platelets (blood platelets help stop bleeding)

• decrease in white blood cells (leukopenia)

• decrease in neutrophils (neutropenia)

• stiffness

• chills

• increase of eosinophils (white blood cells involved in immunity)

• exaggerated immune response to a foreign agent

• lack or loss of appetite

• anxiety, nervousness

• drowsiness, tiredness, dizziness or shaking

• involuntary muscle movements

• vertigo

• ringing in the ears or hearing loss

• chest pain or changes in heart rhythm such as palpitations or an irregular heartbeat

• asthma: lung disease associated with tightening of air passages, making breathing difficult

• nose bleed

• blood clot that causes sudden blockage in a lung artery (pulmonary embolism)

• inflammation of the lining of the gullet (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)

• inflammation of the skin characterized by the presence of the bullae which are filled with fluid, itchy and painful rash

• muscle spasms, muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily), clarithromycin may worsen these symptoms.

• raised abnormal kidney and liver function blood test and raised blood tests feeling weak, tired and having no energy

Not known side effects (frequency cannot be estimated from the available data):

• Inflammation of the colon

• bacterial infection of the outer layers of the skin

• reduction in the level of certain blood cells (which can make infections more likely or increase the risk of bruising or bleeding)

• confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares and mania (feeling of elation or over-excitement)

• convulsion (fits)

• paraesthesia, more commonly known as ‘pins and needles’

• loss of taste or smell or inability to smell properly

• type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia)

• loss of blood (haemorrhage)

• inflammation of the pancreas

• discolouration of the tongue or teeth

• acne

How to store Klaricid XL tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Do not store above 30°C.

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of that month.

If your medicine becomes discoloured or shows any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

0

Contents of the pack and other information

What Klaricid XL tablets contain:

Each modified release tablet contains 500mg clarithromycin.

The other ingredients are: citric acid, sodium calcium alginate, lactose monohydrate, povidone, talc, stearic acid, magnesium stearate, hypromellose, macrogol 400, macrogol 8000, titanium dioxide (E171), sorbic acid and quinoline yellow aluminium lake.

What Klaricid XL tablets look like and contents of the pack

Klaricid XL tablets are yellow, oval, tablets.

Klaricid XL tablets are available in blister packs of 7 tablets.

Manufacturer and Licence Holder

Manufactured by AbbVie S.r.l., Campoverde di Aprilia (LT), Italy, and procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM PL 15184/1549 Klaricid XL 500mg Modified-Release Tablets

Klaricid XL is a registered trademark of BGP Products S.a.r.l.

Revision date: 12/10/21

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