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INFORMATION FOR THE HEALTHCARE PROFESSIONAL KLARICID® I.V. 500 mg ²    500 mg clarithromycin

Refer to the Summary of Product Characteristics for the full prescribing information

Method of administration

Refer to the summary of product characteristics for posology information.

Clarithromycin should not be given as a bolus or an intramuscular injection. Klaricid IV should be administered into one of the larger proximal veins as an IV infusion over 60 minutes, using a solution concentration of about 2mg/ml.

STEP 1    STEP 2

10 ml

PATIENT INFORMATION LEAFLET ON

ft II    ®IV 500 mg

500mg 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 IV is and what it is used for

2.    What you need to know before receiving Klaricid IV

3.    How is Klaricid IV given?

4.    Possible side effects

5.    How to store Klaricid IV

6.    Contents of the pack and other information

1. What Klaricid IV is and what it is used for

Add 10 ml sterilised Water for Injections into the vial and shake Use within 24 hours May be stored from 5°C up to room temperature

Add 10ml from Step 1 to 250ml of a suitable diluent (see below)

This provides a 2mg/ml solution

Use within 6 hours (at room temperature) or within 24 hours if stored at 5°C

DO NOT USE

•    Diluents containing preservatives

•    Diluents containing inorganic salts

DO NOT USE

•    Solution strengths greater than 2mg/ml (0.2%)

•    Rapid infusion rates (< 60 minutes)

•    Failure to observe these precautions may result in pain along the vein

Klaricid IV contains the active ingredient clarithromycin. Klaricid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections.

Klaricid IV is used whenever an intravenous (injection into the vein) antibiotic is required to treat severe infections or, alternatively, if a patient cannot swallow Klaricid tablets.

It is used to treat infections such as:

1.    Chest infections such as bronchitis and pneumonia

2.    Throat and sinus infections

3.    Skin and tissue infections

Klaricid IV is indicated in adults and children 12 years and older.

2. What you need to know before you receive Klaricid IV

Recommended Diluents

5% dextrose in Lactated Ringer’s Solution,

5% dextrose, Lactated Ringer’s solution, 5% dextrose in 0.3% sodium chloride, Normosol-M in 5% dextrose, Normosol-R in 5% dextrose, 5% dextrose in 0.45% sodium chloride, or 0.9% sodium chloride.

Compatibility with other IV additives has not been established.

Storage: Do not store above 30°C. Store in the original container as the powder is sensitive to light. See carton and vial for expiry date. The product should not be used after this date.

Product Licence Number:

Legal Category: POM Marketing Authorisation Holder:

BGP Products Ltd. Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead , Berkshire, SL6 4XE

Revised: February 2013.

B

Abbott

Do not receive Klaricid IV if you;

know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in Klaricid IV. 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 disorders) 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)

Warnings and precautions

Talk to your doctor or pharmacist before being given Klaricid IV;

•    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 Other medicines and Klaricid IV

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)

•    omeprazoie (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 IV 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 receiving Klaricid IV as the safety of clarithromycin in pregnancy or breast-feeding is not known.

Driving and Using Machines:

Klaricid IV 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 is Klaricid IV given?

Klaricid IV is not suitable for use in children under 12 years of age.

Klaricid IV is prepared by your doctor or nurse by dissolving the powder in the vial in sterile water. The solution obtained is added to a

Other less common side effects include:

•    swelling, redness or itchiness of the skin

•    acne

•    asthma

•    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

•    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) or loss of consciousness