Document: leaflet MAH BRAND_PL 46302-0020 change

• leaflet MAH BRAND_PL 43900-0060
• leaflet MAH BRAND_PL 46302-0020

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2 PATIENT INFORMATION LEAFLET

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KLARICiXL 500 mcj tablets

(Clarithromycin)

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.

What is in this leaflet:

1.    What Klaricid XL tablets are and what they are used for

2.    What you need to know before you take Klaricid XL tablets

3.    How to take Klaricid XL tablets

4.    Possible side effects

5.    How to store Klaricid XL tablets

6.    Contents of the pack and other information

1. 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.

2. 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 ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.

•    are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride (for stomach problems) or pimozide (for mental health problems) as combining these drugs can sometimes 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).

•    have low levels of potassium in the blood (a condition known as hypokalaemia).

•    have severe liver disease with kidney disease.

•    have an irregular heart rhythm.

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

•    are taking colchicine (usually taken for gout)

Klaricid XL tablets are not suitable for use in

children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Klaricid XL tablets

•    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

•    if you have an intolerance to any sugars as Klaricid XL tablets contain lactose

Other medicines and Klaricid XL tablets

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)

•    warfarin (for thinning the blood)

•    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 rhabdomyolosis (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)

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

•    triazolam, alprazolam or midazolam (sedatives)

•    cilostazol (for poor circulation)

•    omeprazole (for treatment of indigestion and gastric ulcers)

•    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)

•    aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin) and other medicines that may be toxic to the ear.

Klaricid does not interact with oral contraceptives.

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.

3. How to take Klaricid XL tablets

Do not give these tablets to children under 12 years. Your doctor will prescribe another suitable medicine for your child.

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

The usual dose of Klaricid XL tablets for adults and children over 12 years is one 500 mg tablet once a day for 6 to 14 days.

Your doctor may increase the dose to two 500 mg tablets daily in severe infections. Klaricid XL tablets should be taken with food and must be swallowed whole and not chewed.

If you take more Klaricid XL tablets than you should

If you accidentally take more Klaricid XL tablets in one day than your doctor has told you to, or if a child accidentally swallows some tablets, contact your doctor or nearest hospital emergency department immediately. An overdose of Klaricid XL tablets is likely to cause vomiting and stomach pains.

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.

4. Possible side effects

Like all medicines, Klaricid XL .AX    tablets can cause side effects

although not everybody gets I    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 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 not be working properly.

•    severe skin reactions such as blistering of the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).

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

Common side effects of Klaricid XL tablets

include;

•    headache

•    difficulty sleeping

•    changes in sense of taste

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

•    a change in the way your liver works

•    skin rash

•    increased sweating

Other less common side effects include:

•    swelling, redness or itchiness of the skin

•    acne

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

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

•    loss of appetite, heartburn, bloating, constipation, wind

•    rectal pain

•    inflammation of the pancreas

•    anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking

•    confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares

•    convulsion (fits)

•    ringing in the ears or hearing loss

•    vertigo

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

•    nose bleeds

•    leaking of blood from blood vessels (haemorrhage)

•    inflammation of the mouth or tongue

•    discolouration of the tongue or teeth

•    dry mouth

•    loss of taste or smell or inability to smell properly

•    joint pain

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

•    chest pain or changes in heart rhythm such as palpitations

•    a change in the levels of products made by the liver, inflammation of the liver or an inability of the liver to function properly (you may notice yellowing of the skin, dark urine, pale stools

or itchiness of the skin)

•    a change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness

in the face, abdomen, thighs or ankles or problems with urination)

•    a change in levels of certain cells or products found in the blood

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Klaricid XL tablets

Keep this medicine out of the sight and reach of children

Do not use these tablets after their use-by (exp) date which is printed on the blister pack.

Do not store above 30°C. Store in the original package.

Do not throw away any medicines via wastewater or household water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Klaricid XL tablets contain

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

The other ingredients are: citric acid, sodium alginate, sodium, calcium alginate, lactose, povidone, talc, stearic acid, magnesium stearate, methyl hydroxypropyl cellulose, polyethylene glycol 400, macrogol 8000, titanium dioxide (E171), sorbic acid, quinoline yellow dye (E104).

What Klaricid XL tablets look like and contents of the pack

Klaricid XL tablets are yellow, oval, modified release tablets.

Klaricid XL tablets are available in blister packs or bottles containing 7 or 14 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder - Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK Manufacturer - AbbVie S.r.l.

S.R. 148 Pontina km 52 snc 04011 Campoverde di Aprilia (LT) Italy

This leaflet was last revised in June 2016

H Mylan

20011610