PACKAGE LEAFLET: INFORMATION FOR THE USER

Clarithromycin 500mg Powder for Solution for Infusion

Clarithromycin

Read all of this leaflet carefully before you have this medicine.

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

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

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

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

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

2.    Before you are given Clarithromycin Infusion

3.    How Clarithromycin Infusion is given

4.    Possible side effects

5.    Storing Clarithromycin Infusion

6.    Further information

The name of your medicine is

“Clarithromycin 500mg Powder for Solution for Infusion” (referred to as Clarithromycin Infusion throughout this leaflet).

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

Your medicine contains the active substance clarithromycin, which is one of a group of medicines called “macrolide antibiotics”.

These are used to kill the bacteria or ‘germs’ that cause infections.

Your doctor has decided to give you Clarithromycin Infusion to treat:

•    A chest infection such as bronchitis or pneumonia

•    A throat or sinus infection

•    A skin or soft tissue infection.

2.    Before you are given Clarithromycin Infusion Do not have Clarithromycin Infusion if:

•    you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Clarithromycin Infusion (see section 6 "Further Information")

•    you 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”

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

•    you have severe liver failure as well as kidney problems

•    you are taking certain other medicines - see "Taking other medicines".

If you are unsure, talk to your doctor or nurse.

Check with your doctor or pharmacist before having Clarithromycin Infusion if you:

•    are pregnant

•    have severe kidney problems

•    have liver problems

•    have "myasthenia gravis" (resulting in muscle weakness)

•    have heart disease or a slow heart beat (see also “Do not take Clarithromycin Infusion if’).

Taking other medicines:

Do not have Clarithromycin Infusion if

you are taking any of the following medicines:

•    colchicine (usually taken for gout)

•    ergotamine or dihydroergotamine (for migraine headaches)

•    cisapride (for stomach problems)

•    terfenadine or astemizole (for hayfever or allergies)

•    pimozide (for schizophrenia)

•    simvastatin or lovastatin (used to reduce cholesterol)

•    ticagrelor, ranolazine (for angina) or

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

Consult your doctor or pharmacist for advice on alternative medicines.

Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

•    clindamycin, lincomycin (for bacterial infections)

•    rifampicin, rifapentine (antibiotics)

•    fluconazole or itraconazole (anti-fungals)

•    cilostazol (for poor circulation)

•    digoxin, disopyramide or quinidine (medicines for certain heart conditions)

•    warfarin (used to "thin" the blood)

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

•    theophylline (used to treat asthma)

•    alprazolam, triazolam or midazolam (make you feel sleepy before an operation)

•    cyclosporine (suppresses the immune system)

•    zidovudine (anti-viral agent)

•    ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine (anti-HIV medicine)

•    rifabutin (used to treat some infections)

•    tacrolimus and sirolimus (for organ transplants)

•    methylprednisolone (a corticosteroid)

•    omeprazole (for stomach ulsers and indigestion)

•    sildenafil, tadalafil, and vardenafil (for erectile dysfunction)

•    vinblastine (for treatment of cancer)

•    aminoglycoside antibiotics (e.g. gentamycin, neomycin)

•    statins (used to reduce cholesterol)

•    tolterodine (for urinary incontinence)

•    verapamil (for high blood pressure and angina)

•    the herbal remedy, St. John’s Wort.

•    diltiazem, amlodipine (used to treat angina)

•    sulfonylurias, insulin, nateglinide, repaglinide (used to treat diabetes)

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

Pregnancy and breast-feeding: If you are pregnant, likely to become pregnant or are breastfeeding, you must tell your doctor, pharmacist or nurse before you are given this medicine.

Driving and using machines

After taking this medicine, you may suffer dizziness, vertigo, confusion, and disorientation. If these side effects occur, you should not drive or use machines.

3.    How Clarithromycin Infusion is given

Clarithromycin Infusion will usually be given by a doctor or nurse by an intravenous infusion (‘drip’).

The infusion is prepared by dissolving the powder in sterile water. The solution obtained is added to a larger volume of sterile liquid, and this is then infused (like being given a blood transfusion) into one of your veins for at least an hour.

Adults and children over 12 years: The usual dose is 1 gram per day given in two doses, for 2-5 days.

Patients with kidney problems may be given a smaller dose.

The correct dose will be decided by your doctor.

Children under 12 years should not be given Clarithromycin Infusion.

4.    Possible side effects

Like all medicines, Clarithromycin Infusion can cause side effects, although not everybody gets them.

If you get any of the following side effects soon after receiving this medicine, tell your doctor or nurse immediately. If you get them, you may have had a serious allergic reaction or other type of reaction to this medicine. You may need urgent medical attention:

•    Skin rash and itching

•    Swollen face, lips, throat or tongue

•    Peeling, blistering or crusting of the skin

•    Ulcers on the skin or in the mouth

•    Any sudden wheeziness, difficulty in breathing

•    Yellow colouration of the skin or the eyes (jaundice)

•    anorexia, dark urine, tender abdomen (signs of liver disease).

If you develop severe or prolonged diarrhoea, which may have blood or mucus in it, tell your doctor or nurse immediately.

The most frequent and common side effects that occur are abdominal pain, diarrhoea, nausea, vomiting and taste perversion.

These are usually mild in nature.

Other side effects that can occur are as follows:

Very common side effects (probably affecting more than 1 in 10 patients)

•    inflammation and swelling at the site of injection.

Common side effects (probably affecting fewer than 1 in 10 patients)

•    rash

•    increased sweating

•    nausea (feeling sick), vomiting (being sick), tummy pain, indigestion and diarrhoea

•    pain and swelling at the site of injection

•    headache

•    taste perversion or disturbance

•    changes in liver function tests

•    widening of blood vessels (causing redness)

•    difficulty sleeping

Uncommon side effects (probably affecting fewer than 1 in 100 patients)

•    infections e.g. vaginal infections, fungal infections, gastroenteritis

•    cellulitis (bacterial infection of the skin).

•    changes in the number of white blood cells

•    increased number of blood platelets

•    allergic reactions (see above)

•    anorexia, decreased appetite

•    anxiety, nervousness

•    loss of consciousness

•    abnormal muscle movements

•    dizziness

•    drowsiness

•    tremor

•    vertigo

•    hearing problems

•    "ringing" in the ears

•    heart attack

•    palpitations

•    asthma

•    nose bleed

•    blockage of pulmonary artery

•    inflammation of the oesophagus

•    acid reflux

•    inflammation of stomach lining

•    rectal inflammation or pain

•    swelling of the mouth or lip sores

•    tongue inflamed

•    abdominal bloating

•    constipation

•    dry mouth

•    wind, belching

•    build-up of bile in the liver

•    hepatitis

•    increased liver enzymes

•    dermatitis

•    itching (pruritus)

•    blistering

•    nettle rash (hives)

•    red rash with swelling

•    muscle spasms and stiffness

•    muscle pain

•    increased levels of creatinine and urea in the blood

•    generally feeling unwell

•    fever

•    weakness

•    chest pain, chills, tiredness (fatigue)

•    altered protein levels in the blood

•    increased levels of certain enzymes in the blood.

Side effects occurring with unknown frequency

•    severe or prolonged diarrhoea, which may contain blood or mucus (see above)

•    skin infections

•    reduced number of blood platelets

•    reduced number of white blood cells

•    reduced blood sugar levels

•    hallucinations (seeing things), bad dreams

•    confusion, change in sense of reality, panicking, depression and disorientation

•    loss of sense of taste or smell

•    deafness

•    pins and needles

•    inflamed eyes

•    changes in heart rhythm (palpitations, an abnormally fast, slow or irregular pulse, dizziness or feeling faint, shortness of breath, chest pains)

•    blood taking longer to clot after a cut to the skin

•    convulsions (fits)

•    inflammation of the pancreas

•    tooth or tongue discolouration

•    liver failure and jaundice (see above)

•    acne

•    rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis/DRESS (which causes severe illness with ulceration of the mouth, lips and skin)

•    rare allergic reaction which causes swelling of the face or throat

•    progressive muscle weakness

•    loss of muscle tissue

•    kidney failure

•    inflammation of kidney

•    abnormal urine colour

•    feeling elated or over-excited, which causes unusual behaviour (manic reactions).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 out of the reach and sight of children.

Do not use Clarithromycin Infusion after the expiry date which is printed on the label and carton.

Store below 25°C. Your doctor, pharmacist or nurse will know how to store Clarithromycin Infusion properly.

6. Further information

What Clarithromycin Infusion contains

•    The active substance is Clarithromycin 500mg

•    The other ingredient is Lactobionic acid.

What Clarithromycin Infusion looks like and contents of the pack: Clarithromycin Infusion is a vial containing a white to off-white powder. Each vial contains 500mg clarithromycin.

Each carton contains 1 or 5 vials.

Marketing Authorisation Holder:

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 HafnarfjorQur Iceland

Manufacturer:

Laboratorios Alcala Farma S.L.,

Madrid, Spain

This leaflet was last revised in April 2016

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

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

Instructions for use and handling:

Reconstitute each vial of Clarithromycin 500mg Powder for Solution for Infusion with 10ml sterile water for injections (final volume: 10.75ml).

The reconstituted solution can be diluted in 250ml of the following diluents:

•    0.9% sodium chloride solution

•    5% dextrose solution

•    5% dextrose in 0.3% or 0.45% sodium chloride solution

•    5% dextrose in Ringers solution

•    5% dextrose in Ringers Lactate solution.

Clarithromycin 500mg Powder for Solution 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.

For single use only. The vial and any unused solution should be disposed of in accordance with local requirements.

Storage precautions: Store below 25°C Shelf life:

Unopened vial: 48 months.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5 - 25°C when reconstituted in 10ml water for injections, and for 6 hours (at 25°C) or 24 hours (at 5°C) once diluted in 250ml of appropriate diluent.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.