CLARITHROMYCIN 500MG POWDER FOR SOLUTION FOR INFUSION

Active substance: CLARITHROMYCIN

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PIL-572UK_CLAR_V1.qxp

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21:04

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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).

Pharmacode

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 (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.
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 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.

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

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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
• 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, and diarrhoea
• pain at the site of injection
• headache
• taste perversion
• 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 pain
• mouth or lip sores
• tongue inflamed
• abdominal bloating
• constipation
• dry mouth
• wind, belching
• build up of bile in the liver
• hepatitis
• increased liver enzymes

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.















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dermatitis
itching (pruritis)
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, and
panicking
• loss of sense of taste or smell
• deafness
• 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 StevensJohnson 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 05/2011.

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.

Watch this video series to learn about managing severe allergies (anaphylaxis).

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