CLARITHROMYCIN 500MG POWDER FOR SOLUTION FOR INFUSION

Active substance: CLARITHROMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clarithromycin 500mg
Powder for Solution for Infusion
Clarithromycin
Read all of this leaflet carefully before you start using 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
You should not be given 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 have a history of heart rhythm problems
• you have low levels of potassium in your blood
• 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.
Before treatment with Clarithromycin
Infusion you should tell your doctor:

• if you are pregnant
• if you have severe kidney problems
• if you have liver problems
• if you have "myasthenia gravis" (resulting in muscle weakness)
• if you have heart disease , a slow heart beat or a history of heart rhythm problems.
Taking other medicines:
Do not take Clarithromycin Infusion if you are taking any of the following medicines:
• 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).
Tell your doctor or nurse if you are taking any of the following medicines:
• colchicine (usually taken for gout)
• 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. Johns Wort.
• diltiazem, amlodipine (used to treat angina)
• sulphonyluries, insulin, nateglinide, repaglinide (used to treat diabetes)
Please tell your doctor 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 breast-feeding, you must tell your
doctor 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 25 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
• infections e.g. vaginal infections, fungal infections, gastroenteritis
• cellulitis (bacterial infection of the skin).
Uncommon side effects (probably affecting fewer than 1 in 100 patients)
• changes in the number of white blood cells
• increased number of blood platelets
• allergic reactions (see above)
• anorexia, decreased appetite
• anxiety, nervousness
• screaming
• loss of consciousness
• abnormal muscle movements
• dizziness
• drowsiness
• tremor
• vertigo
• hearing problems
• "ringing" in the ears
• heart attack
• changes in heart rhythm
• palpitations
• asthma
• nose bleed
• blockage of pulmonary artery
• inflammation of the esophagus
• 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 (pruritis)
• 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
• fast heart rate
• 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 (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.
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.
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:
Bowmed Limited,
Unit 2, Eastman Way, Stevenage,
Herts SG1 4SZ, UK
Manufacturer:
Laboratorios Alcalá Farma S.L.,
Madrid, Spain
This leaflet was last revised in January 2014
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 - 25ºC when reconstituted in 10ml water for injections, and for 6 hours (at 25ºC) or
24 hours (at 5ºC) 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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