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KLARICID IV 500 MG

Active substance(s): CLARITHROMYCIN

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MKP-03517-2014

PATIENT INFORMATION LEAFLET ON
®

INFORMATION FOR THE HEALTHCARE
PROFESSIONAL
KLARICID® I.V. 500 mg
500 mg clarithromycin
Refer to the Summary of Product Characteristics
for the full prescribing information
Method of administration
Refer to the summary of product characteristics for
posology information.
Clarithromycin should not be given as a bolus or
an intramuscular injection. Klaricid IV 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

STEP 2
10
ml

10 ml

Add 10 ml sterilised Water
for Injections into the vial
and shake
Use within 24 hours
May be stored from 5°C
up to room temperature

DO NOT USE
• 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
Use within 6 hours (at
room temperature) or
within 24 hours if stored at
5°C
DO NOT USE
• Solution strengths
greater than 2mg/ml
(0.2%)
• Rapid infusion rates
(< 60 minutes)
• Failure to observe
these precautions
may result in pain
along the vein

Recommended Diluents
5% dextrose in Lactated Ringer’s Solution,
5% dextrose, Lactated Ringer’s solution, 5% dextrose
in 0.3% sodium chloride, Normosol-M in 5% dextrose,
Normosol-R in 5% dextrose, 5% dextrose in 0.45%
sodium chloride, or 0.9% sodium chloride.
Compatibility with other IV additives has not been
established.
Storage: Do not store above 30°C. 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 Number: PL 43900/0018
Legal Category: POM
Marketing Authorisation Holder:
BGP Products Ltd. Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead , Berkshire, SL6 4XE

Revised: February 2013.

MKP-03517-2014_d1

IV 500 mg

500mg clarithromycin
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 further questions, ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
• If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in the leaflet.
See section 4.
What is in this leaflet:
1. What Klaricid IV is and what it is used for
2. What you need to know before receiving
Klaricid IV
3. How is Klaricid IV given?
4. Possible side effects
5. How to store Klaricid IV
6. Contents of the pack and other information
1. What Klaricid IV is and what it is used for
Klaricid IV contains the active ingredient
clarithromycin. Klaricid belongs to a group of
medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs)
that cause infections.
Klaricid IV is used whenever an intravenous
(injection into the vein) antibiotic is required
to treat severe infections or, alternatively, if a
patient cannot swallow Klaricid tablets.
It is used to treat infections such as:
1. Chest infections such as bronchitis and
pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
Klaricid IV is indicated in adults and children 12
years and older.
2. What you need to know before you
receive Klaricid IV
Do not receive Klaricid IV if you;
• know that you are allergic to
clarithromycin, other macrolide
antibiotics such as erythromycin
or azithromycin, or any of the
other ingredients in Klaricid IV.
• are taking medicines called ergotamine
or dihydroergotamine tablets or use
ergotamine inhalers for migraine.
• are taking medicines called terfenadine
or astemizole (widely taken for hay fever
or allergies) or cisapride (for stomach
disorders) or pimozide (for mental health
problems) as combining these drugs can
sometimes cause serious disturbances in
heart rhythm.
• are taking lovastatin or simvastatin
(HMG-CoA reductase inhibitors, commonly
known as statins, used to lower levels of
cholesterol (a type of fat) in the blood).
• have low levels of potassium in the blood (a
condition known as hypokalaemia).
• have severe liver disease with kidney
disease.
• have an irregular heart rhythm.
• are taking medicines called ticagrelor or
ranolazine (for heart attack, chest pain or
angina).
• are taking colchicine (usually taken for gout)
Klaricid IV is not suitable for use in children
under 12 years of age.

FRONT

Warnings and precautions
Talk to your doctor or pharmacist before being
given Klaricid IV;
• if you have any liver or kidney problems
• if you have, or are prone to, fungal
infections (e.g. thrush)
• if you are pregnant or breast feeding
Other medicines and Klaricid IV
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. as your dose may need to be
changed or you may need to have regular tests
performed:
• digoxin, quinidine or disopyramide (for
heart problems)
• warfarin (for thinning the blood)
• carbamazepine, valproate, phenobarbital or
phenytoin (for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA
reductase inhibitors, commonly known
as statins, and used to lower levels of
cholesterol (a type of fat) in the blood).
Statins can cause rhabdomyolosis (a
condition which causes the breakdown of
muscle tissue which can result in kidney
damage) and signs of myopathy (muscle
pain or muscle weakness) should be
monitored.
• nateglinide, pioglitazone, repaglinide,
rosiglitazone or insulin (used to lower blood
glucose levels)
• theophylline (used in patients with
breathing difficulties such as asthma)
• triazolam, alprazolam or midazolam
(sedatives)
• cilostazol (for poor circulation)
• omeprazole (for treatment of indigestion
and gastric ulcers)
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus
(immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir,
zidovudine, atazanavir, saquinavir (anti- viral
drugs used in the treatment of HIV)
• rifabutin, rifampicin, rifapentine,
fluconazole, itraconazole (used in the
treatment of certain bacterial infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high
blood pressure)
• sildenafil, vardenafil and tadalafil (for
impotence in adult males or for use in
pulmonary arterial hypertension (high blood
pressure in the blood vessels of the lung))
• St John’s Wort (a herbal product used to
treat depression)
• aminoglycosides (a group of antibiotic
to treat certain bacteria for example
gentamicin, neomycin) and other medicines
that may be toxic to the ear.
Klaricid IV does not interact with oral
contraceptives.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
before receiving Klaricid IV as the safety of
clarithromycin in pregnancy or breast-feeding
is not known.
Driving and Using Machines:
Klaricid IV may make you feel dizzy or drowsy.
If they affect you in this way do not drive,
operate machinery or do anything that requires
you to be alert.
3. How is Klaricid IV given?
Klaricid IV is prepared by your doctor or nurse
by dissolving the powder in the vial in sterile
water. The solution obtained is added to a

larger volume of sterile liquid. Klaricid IV is
given to you slowly through a needle, into your
vein over a period of at least an hour.
The usual dose of Klaricid IV for adults and
children over 12 years is 1.0g per day, split
into 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
Klaricid IV. Your doctor will prescribe another
suitable medicine for your child.
If a child accidentally swallows some of this
medicine, seek medical advice urgently.
If you are given more Klaricid IV than you
should have
As Klaricid IV is given to you by a doctor,
an overdose is unlikely but symptoms may
include vomiting and stomach pains.
4. Possible side effects
Like all medicines, Klaricid IV can
cause side effects although not
everybody gets them.
If you suffer from any of the
following at any time during your
treatment tell your doctor immediately as your
treatment may need to be stopped:
• severe or prolonged diarrhoea, which may
have blood or mucus in it. Diarrhoea may
occur over two months after treatment with
clarithromycin, in which case you should
still contact your doctor.
• a rash, difficulty breathing, fainting or
swelling of the face and throat. This is
a sign that you may have developed an
allergic reaction.
• yellowing of the skin (jaundice), skin
irritation, pale stools, dark urine, tender
abdomen or loss of appetite. These may
be signs that your liver may not be working
properly.
• severe skin reactions such as blistering
of the skin, mouth, lips, eyes and genitals
(symptoms of a rare allergic reaction
called Stevens-Johnson syndrome/toxic
epidermal necrolysis).
• muscle pain or weakness known as
rhabdomyolysis (a condition which causes
the breakdown of muscle tissue which can
result in kidney damage).
Common side effects of Klaricid IV include;
• inflammation, tenderness or pain at the site
of the injection
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick,
vomiting, stomach pain, indigestion,
diarrhoea
• a change in the way your liver works
• skin rash
• increased sweating
Other less common side effects include:
• swelling, redness or itchiness of the skin
• acne
• asthma
• oral or vaginal ‘thrush’ (a fungal infection)
• reduction in the level of certain blood cells
(which can make infections more likely or
increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating,
constipation, wind
• inflammation of the pancreas
• anxiety, nervousness, drowsiness,
tiredness, dizziness, tremor or shaking
• confusion, loss of bearings, hallucinations
(seeing things), change in sense of reality
or panicking, depression, abnormal dreams
or nightmares
• convulsion (fits) or loss of consciousness

MKP-03517-2014_d1

• ringing in the ears or hearing loss
• vertigo
• paraesthesia, more commonly known as
‘pins and needles’
• nose bleeds
• leaking of blood from blood vessels
(haemorrhage)
• inflammation of the mouth or tongue
• discolouration of the tongue or teeth
• dry mouth
• loss of taste or smell or inability to smell
properly
• joint pain
• muscle pain or loss of muscle tissue. If you
suffer from myasthenia gravis (a condition
in which the muscles become weak and
tire easily) or rhabdomyolysis (a condition
which causes the breakdown of muscle
tissue), clarithromycin may worsen these
symptoms
• heart attack, chest pain or changes in heart
rhythm such as palpitations
• a change in the levels of products made
by the liver, inflammation of the liver or an
inability of the liver to function properly (you
may notice yellowing of the skin, dark urine,
pale stools or itchiness of the skin)
• a change in the levels of products
produced by the kidney, inflammation of
the kidney or an inability of the kidney to
function properly (you may notice tiredness,
swelling or puffiness in the face, abdomen,
thighs or ankles or problems with urination)
• a change in the levels of certain cells or
products found in the blood
Reporting 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.
5. How to store Klaricid IV
Keep out of the sight and reach
of children
Do not use after the expiry date on
the carton and vial.
Do not store above 30°C. Store
in the original container. The
reconstituted solution will be
stored for either 6 hours at room
temperature or for 24 hours at
5° - 25°C.
6. Content of the pack and other
information
What Klaricid IV contains
Klaricid IV contains the active ingredient
clarithromycin.
The other ingredients are; lactobionic acid,
sodium hydroxide, and nitrogen.
This medicinal product contains less than
23mg sodium (1mmol) per 500mg i.e.
essentially “sodium-free”.
What Klaricid IV looks like and contents of
the pack
Klaricid IV is available in vials containing
500mg of clarithromycin as the active
ingredient. When made up with Water for
Injections, each millilitre (ml) of solution
contains 2mg of clarithromycin.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder BGP Products Ltd. Abbott House, Vanwall
Business Park, Vanwall Road, Maidenhead ,
Berkshire, SL6- FAMAR
4XE
Manufacturer
L’Aigle Usine St
Remy, Rue de L’Isle, 28380 Saint Remy sur
Avre, France.
This leaflet was last
revised in December 2014
MKP-03517-2014

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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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