PACKAGE LEAFLET: INFORMATION FOR THE USER

Clarithromycin 500 mg

Powder for Concentrate for Solution for Infusion

Read all this leaflet carefully before you are given Clarithromycin.

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

•    If you have any further questions, please ask your doctor or nurse

•    This medicine has been prescribed for you.

Do not pass it on to others. It may harm then, 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 nurse

In this leaflet:

1.    What Clarithromycin is and what it is used for

2.    Before you are given Clarithromycin

3.    How Clarithromycin is given

4.    Possible side effects

5.    How to store Clarithromycin

6.    Further information

1.    What Clarithromycin is and what it is used for

Clarithromycin contains the active substance clarithromycin, which belongs to a group of medicines called 'macrolide antibiotics'. These are used to kill bacteria or 'germs' that cause infections.

Clarithromycin is used whenever an intravenous (injection into a vein) antibiotic is required to treat severe infections or alternatively if a patient is unable to swallow clarithromycin tablets. It is used to treat infections such as: a flare-up of chronic bronchitis caused by bacteria

infection of the lungs (pneumonia) caused by bacteria

infection of the sinuses (sinusitis) caused by bacteria

infection of the throat and tonsils (pharyngitis

and tonsillitis) caused by bacteria

skin and tissue infections caused by bacteria.

Clarithromycin is for use in adults and children 12 years and older.

2.    Before you are given Clarithromycin

You should not be given Clarithromycin:

if you are allergic (hypersensitive) to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin or to any of the other ingredients in this medicine, listed in section 6 of this leaflet if you are taking ergotamine or dihydroergotamine tablets or ergotamine inhalers (used to treat migraine) if you are taking terfenadine or astemizole (widely used for hay fever or allergies) or cisapride or pimozide tablets, as combining these drugs whilst receiving Clarithromycin sometimes can cause serious disturbances in heart rhythm.

Take special care with Clarithromycin

if you are taking colchicine (usually used to treat gout), as this can cause serious side effects if you have a liver or kidney problem as prolonged or repeated use of clarithromycin may result in the overgrowth of bacteria and fungi

if you develop severe or prolonged diarrhea during or after receiving Clarithromycin.

You should inform your doctor immediately if you are concerned about your treatment with Clarithromycin.

Taking other medicines Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines, including those obtained without prescription and herbal medicines.

Clarithromycin MUST NOT be used with the following medicines:

ergotamine or dihydroergotamine (used to treat migraine) as there is an increased risk of ergotism (fungal poisoning), pimozide (used in the treatment of psychiatric conditions) as there is an increased risk of ventricular arrhythmias (abnormal heart rhythms).

If you are taking these medicines you should tell your doctor before you are given Clarithromycin

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Clarithromycin

Tell your doctor if you are taking any of the following medicines (listed below): -clarithromycin increases the levels of the medicinal products in the blood, which results in the increased risk of side effects digoxin, quinidine or disopyramide (used to treat heart conditions)

carbamazepine, valproate or phenytoin (drugs used to treat epilepsy)

theophylline (used to treat breathing difficulties) terfenadine or astemizole (used to treat hay fever or allergies)

triazolam, alprazolam or midazolam (sedatives) cilostazol (used to treat poor circulation) cisapride (used to treat stomach disorders) methylprednisolone (a corticosteroid) vinblastine (used in the treatment of cancer) sildenafil (used to treat impotence) cyclosporine (immune suppressant drug) tacrolimus (used after organ transplants)

Also, tell your doctor or nurse if you are taking any of the following medicinal products:

•    warfarin or other drugs used to thin the blood -use with clarithromycin will enhance the effect of warfarin

•    simvastatin or lovastatin (used to treat high cholesterol) - use with clarithromycin, increases the risk of myopathy (disease resulting in muscle weakness), use with clarithromycin should be avoided

•    zidovudine (anti-viral agent) - use of clarithromycin tablets reduces absorption of zidovudine and can reduce its effectiveness in treating your viral disease

•    rifabutin (used in the treatment of some infections) - clarithromycin increases the levels of rifabutin in the blood, increased risk of uveitis (inflammation of the eye).

Your doctor may reduce the dose of rifabutin.

•    ritonavir (an anti-viral (anti-HIV) agent) ) -clarithromycin increases the levels of ritonavir in the blood, the dose of clarithromycin should be reduced if the patient suffers from kidney problems

•    colchicine (used to treat gout) - clarithromycin increases the risk of colchicine poisoning (side effects include burning in the mouth and throat, fever, vomiting, diarrhoea, abdominal pain and kidney failure, death from respiratory failure can follow)

Pregnancy and breast-feeding

Clarithromycin should not be given during oregnancy or breast-feeding unless there is no effective alternative treatment. In this situation the doctor should assess the risk/benefit ratio.

You should ask your doctor for advice before taking any medicine.

Driving and using machines

t is unlikely that after using Clarithromycin your ability to drive and use machines will be affected. However, if you feel unwell you must speak to your doctor or nurse before driving or operating machinery.

Discuss with your doctor if you are unsure about your treatment and its effects.

3. How Clarithromycin is given

Clarithromycin is prepared by dissolving the powder in the vial in sterile water. The solution prepared is then added to a larger volume of sterile liquid, and this is then given into one of your veins for at least an hour.

The usual dose of Clarithromycin for adults and children over 12 years is 1.0 grams per day in two doses, for 2 to 5 days. Your doctor will work out the correct dose for you.

Children under 12 years should not be given Clarithromycin. Your doctor will prescribe a more suitable medicine for your child.

Length of treatment:

Treatment with intravenous clarithromycin should oe between 2 to 5 days. The patient should then be switched to oral clarithromycin when necessary.

The total treatment period should not exceed more than 14 days. The usual duration of treatment is 6 to 14 days.

Always use your medicine exactly as your doctor has told you. You should check with your doctor or nurse if you are not sure.

Continued overleat

If you think you have been given too much Clarithromycin

This medicine will be given to you by your doctor so it is unlikely that you will receive too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment please talk to your doctor.

If a child accidentally swallows some of this medicine, seek medical advice urgently. An overdose of Clarithromycin is likely to cause vomiting and stomach pains.

4.Possible side effects

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

If any of the following happens, tell your doctor immediately:

Swelling of the lips, face and neck (allergic

reaction) possibly with difficulty in swallowing

or breathing, wheezing, dizziness

Severe or prolonged diarrhoea which may

contain blood or mucous

Blistering of the skin, lining of the mouth or

genitals

Some side effects that have been reported following treatment with clarithromycin are listed below.

Frequency:

Very common side effects occur in more than 1 out of 10 patients

Common side effects occur in less than 1 out of 10 patients but in more than 1 out of 100 patients Uncommon side effects occur in less than 1 out of 100 patients but in more than 1 out of 1,000 patients

Rare side effects occur in less than 1 out of 1,000 patients but in more than 1 out of 10,000 patients Very rare side effects occur in less than 1 out of 10,000 patients

Very rare (inc. isolated cases)

•    anxiety

•    insomnia (difficulty sleeping)

•    hallucinations (seeing things)

•    psychoses (loss of contact with reality)

•    disorientation (loss of bearings)

•    depersonalisation (changes in self awareness)

•    unpleasant dreams

•    confusion

•    muzziness (confused, muddled, blurred state of mind)

•    dizziness

•    paresthesias (sensation of tingling, pricking or numbness of skin)

•    pancreatitis (inflammation of the pancreas)

•    pseudomembranous colitis (infection of the colon caused by bacteria)

•    fatal hepatic insufficiency (particularly in patients with existing liver disease or patients who are currently using medicinal products for liver problems)

•    Steven-Johnson's disease (severe illness with ulceration of the mouth, lip and skin)

•    toxic epidermal necrolysis (severe illness with sloughing of the skin)

•    interstitial nephritis (inflammation within the kidneys)

•    renal insufficiency (reduced function of the kidneys with buildup of waste products in the blood)

Common

Uncommon

Rare

•    oral candidiasis (fungal infection of the mouth)

•    headache

•    altered sense of smell

•    phlebitis (inflammation of vein)

•    nausea (feeling sick)

•    vomiting (being sick)

•    diarrhoea

•    dyspepsia (indigestion)

•    abdominal pains

•    discolouration of teeth and tongue (reversible)

•    glossitis (inflammation or infection of tongue)

•    stomatitis (inflammation of the mouth)

•    taste disorders

•    tenderness or pain at site of injection

•    increased blood levels of breakdown product of proteins

•    leucopoenia (low levels of white blood cells - detected during a blood test)

•    allergic reactions (ranging from skin rash and hives to severe anaphylactic reactions)

•    hepatic dysfunction (liver problems) usually reversible and temporary

•    hepatitis (liver inflammation)

•    cholestasis (liver/gall bladder disorders)

•    jaundice

•    joint pains

•    muscle pain

•    increased prothrombin time (the time taken for blood to clot is increased)

•    increased plasma creatinine levels (raised levels of proteins excreted by the kidneys)

•    increased liver transaminases levels (raised levels of liver enzymes - detected during a blood test)

•    thrombocytopenia (decreased numbers of platelets - type of blood cell)

•    hypoglycaemia (low blood glucose levels)

•    convulsions

•    tinnitus ('ringing' in the ears)

•    hearing loss (normally reversible)

•    extended QT interval (life threatening irregular heartbeat)

•    ventricular tachycardia (life threatening irregular heartbeat)

•    Torsades de Pointes (life threatening irregular heartbeat)

.■*L

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

Reporting of side effects f you or your child gets 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 ard Scheme at www.mhra.gov.uk/yellowcard.

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

5.Storing Clarithromycin

Keep out of the reach and sight of children.

Do not store above 30°C. The reconstituted olution will be stored for up to 6 hours at 25°C. Keep the vials in the outer carton in order to protect from light.

The expiry date is stated on the end-flap of the carton, please make sure this has not expired. The doctor will also check that the product does not how signs of visible damage or discoloration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer equired. These measures will help protect the environment.

This product should only be used in a hospital environment and will be safely disposed of by your doctor.

6.Further Information

What Clarithromycin contains:

The active substance is clarithromycin 500 mg. When reconstituted and diluted, the final solution pas a concentration of 2 mg/ml of clarithromycin.

The other ingredient is lactobionic acid.

What Clarithromycin looks like and contents of the pack:

larithromycin is a white to off-white powder and when dissolved is a clear solution.

This medicinal product is presented in glass containers called vials.

Each vial contains 500 mg of clarithromycin.

The product is supplied in cartons each containing one vial.

Marketing Authorisation

Holder:    Manufacturer:

Martindale    Laboratorios Alcala

Pharmaceuticals Ltd Farma, S.L.

Bampton Road, Avenida de Madrid 82 Harold Hill, Romford, 28802 Alcala de Henares, Essex RM3 8UG    Madrid,

United Kingdom    Spain

Product licence numbers: PL 00156/0333 This leaflet was last approved in: April 2015

f you would like any more information, or would like the leaflet in a different format, «> please contact medical information at the above address.

TECHNICAL PRESCRIBING INFORMATION

Clarithromycin 500 mg

Powder for Concentrate for Solution for Infusion

Clarith

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

Recommended Administration

larithromycin should not be given as a bolus or an

ro

mycin

STEP 2

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ntramuscular injection.

larithromycin 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

•    Add 10 ml sterilised Water for Injections into the vial and shake

•    May be stored from 5°C up to room temperature

DO NOTUSE

•    Diluents containing preservatives

•    Diluents containing inorganic salts

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

•    This provides a 2mg/ml solution

DO NOTUSE

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

•    Rapid infusion rates (< 60 minutes)

Recommended Diluents

Dextrose 50 mg/ml (5%) solution for infusion in

Lactated Ringer's Solution

Dextrose 50 mg/ml (5%) solution for infusion

Lactated Ringer's Solution

Dextrose 50 mg/ml (5%) in Sodium Chloride 3

mg/ml (0.3%) solution for infuContinued overleat

•    Dextrose 50 mg/ml (5%) in Sodium Chloride 4.5 mg/ml (0.45%) solution for infusion

•    Sodium Chloride 9 mg/ml (0.9%) solution for infusion.

Eompatibility with other IV additives has not been stablished.

Recommended Dosage

ntravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate. The total duration of treatment should not exceed more than 14 days.

Adults: The recommended dosage of larithromycin is 1.0 gram daily, divided into two 500 mg doses, appropriately diluted as described below.

Children: At present, there are insufficient data to recommend a dosage regime for routine use in children.

Adolescents & Elderly: As for adults.

Renal Impairment: In patients with renal mpairment who have creatinine clearance less than 30ml/min, the dosage of clarithromycin should be reduced to one half of the normal ecommended dose.

Shelf life

4 years unopened.

Reconstituted/Diluted Solutions: Chemical and physical in use stability has been demonstrated for 6 hours at 25oC.

From a microbiological point of view, the reconstituted and diluted 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 8oC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Storage

As packaged for sale: Do not store above 30oC. 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 numbers:

PL 00156/0333

100mm Measurement Verification Bar

2970-E

Component Code: D03028 Prod: CLARITHROMYCIN 500MG UK

Trim size: 130 x 420 mm