PACKAGE LEAFLET: INFORMATION FOR THE USER

Clarithromycin 500mg/vial Powder for Infusion

The name of your medicine is Clarithromycin 500mg/vial powder for infusion, which will be referred to as Clarithromycin infusion throughout this 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 any further questions, ask your doctor or pharmacist.

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

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

What is in this leaflet:

1.    What Clarithromycin Infusion is and what it is used for

2.    What you need to know before you are given Clarithromycin Infusion

3.    How you are given Clarithromycin Infusion

4.    Possible side effects

5.    How to store Clarithromycin Infusion

6.    Contents of the pack and other information

1.    What Clarithromycin Infusion is and what it is used for

Clarithromycin Infusion contains 500mg/vial of the active ingredient clarithromycin, which is made into a solution for intravenous (into a vein) infusion. Clarithromycin is an antibiotic, which can be used to treat the following bacterial infections in adults and children over 12 years old:

•    Upper respiratory (nose and throat)

•    Bronchopulmonary (the lungs and airways)

•    Cutaneous (skin)

2.    What you need to know before you are given Clarithromycin Infusion Do not take Clarithromycin Infusion if you

•    are allergic (hypersensitive) to clarithromycin, other macrolides (similar antibiotics), or any of the other ingredients of Clarithromycin Infusion (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    are taking ergotamine-like drugs (usually used for migraine)

•    are taking cisapride (for stomach disorders)

•    are taking pimozide (for mental illness)

•    are taking terfenadine or astemizole (for hayfever or allergy)

•    are taking simvastatin or lovastatin (cholesterol lowering drugs)

•    are under 12 years of age

•    have ever suffered from a heart problem known as ‘QT-prolongation’. This problem can only be confirmed by an electrocardiogram (ECG). An ECG measures the electrical activity of your heart

•    have ever had irregular heart beats (arrhythmia)

•    have lower than normal levels of potassium or magnesium (electrolytes) in your blood (hypokalaemia or hypomagnesaemia)

•    are suffering from severe liver failure in combination with kidney impairment.

•    are taking ticagrelor or ranolazine (used to treat stroke and heart attack)

•    are taking colchicine (a treatment for gout - inflammation of joints which causes swelling and pain), especially if you are elderly or have a kidney disorder

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

Take special care with Clarithromycin Infusion Warnings and precautions

Talk to your doctor before taking Clarithromycin Infusion if you:

•    have a liver or kidney disorder

•    have had loose stools following antibiotic use

•    are suffering from myasthenia gravis (A disorder in which the muscles are weak and tire easily)

•    are suffering from any heart problems

•    are suffering from pneumonia

•    are suffering from skin infection

•    are suffering from serious illness with blistering of the skin, mouth, eyes and genitals

•    are taking other statins

Other infections may develop if clarithromycin is used for a long time. If this occurs tell your doctor.

If any of the above applies to you, speak to your doctor.

Other medicines and Clarithromycin Infusion:

Tell your doctor or pharmacist if you are taking have recently taken or might take any of the following:

•    terfenadine or astemizole (for hayfever or allergy),

•    cisapride (for stomach disorders),

•    pimozide (for mental illness),

•    ergotamine type drugs (usually used for migraine)

•    macrolide antibiotics e.g. erythromycin, azithromycin

•    simvastatin, lovastatin or fluvastatin (used to treat high cholesterol)

•    colchicine (a treatment for gout - inflammation of joints which causes swelling and pain), especially if you are elderly or have a kidney disorder

Your doctor may need to control blood levels or effects, to adjust the dosage, or to interrupt (for some time) the treatment if clarithromycin is used at the same time with medicines containing one of the substances listed below:

•    digoxin (for heart failure)

•    quinidine or disopyramide (for heartbeat disorders)

•    midazolam (sedatives/sleeping pills)

•    triazolam (sleeping pills)

•    alprazolam (for anxiety)

•    ciclosporin, sirolimus, or tacrolimus (help prevent rejection after a transplant)

•    theophylline (for asthma)

•    ritonavir, efavirenz, nevirapine, zidovudine, atazanavir, etravirine or saquinavir (HIV treatments)

•    rifabutin (an antibiotic, used to treat infection)

•    quetiapine (antipsychotics)

•    warfarin (blood thinner)

•    atorvastatin or rosuvastatin, used to treat high cholesterol

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

•    cilostazol (a treatment for leg cramps)

•    methylprednisolone (used to treat inflammation)

•    sildenafil, tadalafil and vardenafil (a treatment for erection problems)

•    vinblastine (a cancer treatment)

•    colchicine (a treatment for gout)

•    aminoglycosides (e.g. gentamycin, tobramycin, streptomycin), used to treat infections

•    sulphonylurias, insulin, nateglinide, pioglitazone, repaglinide and rosiglitazone, used to treat high blood sugar

•    rifampicin, lincomycin and clindamycin, used to treat infection

•    St John’s wort, used to treat depression

•    rifapentine, used for the treat tuberculosis

•    fluconazole, itraconazole used to treat fungal infection

•    omeprazole, used to treat stomach acidity

•    tolterodine, used to treat urinary urgency

•    verapamil, used to treat high blood pressure.

•    calcium channel blocker used to lower blood pressure and to treat anginal chest pain, e.g verapamil,amlodipine,diltiazem

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

It may still be all right for you to be given Clarithromycin Infusion and your doctor will be able to decide what is suitable for you.

Pregnancy, breast-feeding and fertility

Do NOT take Clarithromycin Infusion if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Driving and using machines

There are no reported effects of Clarithromycin Infusion on driving or using machines. However, dizziness, ringing sensation in the ears, confusion and disorientation may occur with the medication. If affected please do not drive or operate machinery.

3.    How you are given Clarithromycin Infusion Dosage

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

The dose depends on the infection to be treated and the condition of the patient.

Adults and the elderly

Clarithromycin Infusion may be given for 2 to 5 days and then changed to oral clarithromycin therapy when suitable.

The recommended dose is 1 gram daily, divided into two 500mg doses.

Children under 12 years old:

Clarithromycin Infusion is not recommended for use in children under 12 years of age.

A suspension is available for children.

Kidney problems

In patients with a severe kidney disorder, the dose may need to be halved.

If you are given more Clarithromycin Infusion than you should

Your doctor or nurse will know how much infusion to give you. If you think you have been given too much Clarithromycin Infusion you should talk to your nurse or doctor.

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

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens, stop using the infusion and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    torsade de pointes, a life threatening irregular heart beat

•    angioedema, a serious allergic reaction which causes swelling of the face or throat

•    blistering of the skin, mouth eyes and genitals; this could be caused by Stevens-Johnson syndrome or toxic epidermal necrosis, which are serious illnesses

•    prolonged attacks of diarrhoea, which has blood or mucus in it.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation

The following side effects have been reported:

Very common (affecting more than one person in 10)

injection-site tenderness and phlebitis (inflamed veins).

Common (affecting less than one person in 10 but more than one person in 100)

•    taste disorder (decreased sense of taste or funny taste in your mouth)

•    insomnia (sleeplessness)

•    widening of blood vessels

•    nausea (feeling sick)

•    vomiting

•    diarrhoea

•    dyspepsia (indigestion)

•    abdominal (tummy) pain

•    headache

•    altered liver function tests

•    rash

•    excessive sweating

•    injection-site inflammation and pain

Uncommon (affecting less than one person in 100 but more than one person in 1,000)

•    cellulites (spreading infection below the skin)

•    thrush in the genital area or the mouth (causing soreness of the mouth sometimes accompanied by white spots), vaginal infection

•    leucopenia (decrease in the number of white blood cells)

•    serious allergic reaction which causes difficulty in breathing or dizziness

•    hypersensitivity (inflammation of the mouth or tongue, dry mouth)

•    decrease in appetite and abdominal bloating

•    anxiety

•    loss of consciousness

•    dyskinesia (abnormal muscle movements)

•    dizziness, feeling sleepy

•    feeling shaky

•    vertigo (spinning sensation)

•    ringing in the ears (tinnitus), disturbances in hearing

•    heart problems such as cardiac arrest, changes in heart beat/rhythm

•    blood clot in the lungs which causes chest pain and breathlessness (pulmonary embolism)

•    shortness of breath (asthma)

• inflammation of the gullet (esophagitis)

•    stomatitis (inflammation of the mouth)

•    glossitis (inflammation of the tongue)

•    constipation, flatulence

•    burping

•    liver or gall bladder problems sometimes detected by blood tests

•    skin reaction causing large blisters (bullous dermatitis)

•    itching, rash

•    stiff body

•    increased serum creatinine or urea levels (a waste product)

•    lethargy

•    abnormal urine colour

Other side effects

•    pseudomembranous colitis (infection of the bowel)

•    skin infections

•    oral monilia (a fungal infection)

•    angioedema (swelling of the hands and face)

•    low blood sugar levels in diabetic and non diabetic patients

•    confusion, change in the sense of reality, feeling panicky, disorientation, delusions, depression, mania

•    hallucinations, strange or bad dreams

•    fits

•    change in the sense of smell or loss of smell

•    loss of taste sensation, hearing loss (usually reversible on withdrawal of treatment)

•    abnormal bleeding

•    pancreatitis (inflammation of the pancreas),

•    tongue discolouration, tooth discolouration (this can usually be corrected by professional cleaning)

•    liver failure

•    jaundice - yellowing of the skin and the whites of the eyes

•    stevens-Johnson syndrome or toxic epidermal necrolysis (severe peeling and blistering of the skin)

•    acne

•    joint pain, back pain, muscle pain and muscle weakness

•    kidney failure or kidney problems (diagnosed by urine or blood tests), abnormal urine colour

•    sensation of tingling, tickling, prickling or burning of a skin

Reporting of 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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clarithromycin Infusion

Keep this medicine out of the sight and reach of children.

You will not be asked to store your medicine. It will be brought to you ready to be administered straight away.

Your doctor, nurse or pharmacist will ensure that you do not receive Clarithromycin Infusion after the expiry date which is stated on the label after Exp. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. 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 Clarithromycin Infusion contains:

The active substance is Clarithromycin.

The powder for infusion also contains the following ingredients: lactobionic acid and sodium hydroxide.

What Clarithromycin Infusion looks like and contents of the pack

20ml glass vial and stopper with an aluminium and plastic flip-off cap.

Vials are packed in units of 1, 4 and 6.

Each vial contains 500 mg of clarithromycin.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG.

Manufacturer

Reig Jofre, S.A.,

Gran Capita,

10 08970 Sant Juan Despi (Barcelona),

Spain

This leaflet was last revised in: December 2015

PL 00289/1484

The following information is intended for medical or healthcare professionals only:

Please refer to the Summary of Product Characteristics for further information

Preparation and administration of Clarithromycin 500mg/vial Powder for Infusion

Clarithromycin 500mg/vial Powder for Infusion 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. Clarithromycin should not be given as a bolus or an intramuscular injection.

Reconstitution

The method of dilution is:

Step 1. Reconstitute with 10ml Water for Injections.

Step 2. Dilute solution from Step 1 to 250ml with recommended diluents to form a solution of approximately 2mg/ml.

The recommended diluents are:

0.9% sodium chloride solution or 5.0% glucose solution or Ringer’s lactate solution.

The appearance of the product after reconstitution is a clear solution.

Both dilution steps must be followed before administration.

Special precautions for disposal

For single use only. Any unused solution and the vial should be adequately disposed of, in accordance with local requirements.

Incompatibilities

None known. However, Clarithromycin 500mg/vial Powder for Infusion should only be diluted with the diluents recommended.

Shelf life and storage conditions

24 months unopened. This medicinal product does not require any special storage conditions. Chemical and physical in-use stability has been demonstrated for 8 hours at room temperature and 24 hours at 2 to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.