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CLARITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): CLARITHROMYCIN / CLARITHROMYCIN / CLARITHROMYCIN

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PIL-572UK_CLAR_V6_Victor 26/09/2016 18:57 Page 1

Distributor:

Ibigen

Product:

Clarithromycin 500mg Lyophilisate for Solution for Infusion

Reference:

PIL-572UK_CLAR_V6

MA
number:
A/W
version

Dimension
s:

PL 31745/0027
Version 6
130 x 390 mm

Inks used:

Black

Date:

26.09.16

Software:

QuarkXpress 9.5

Pages:

2 (not including this one)

Comments: Note - pharmacode position indicated by a frame, the code will be inserted
before printing.

PIL-572UK_CLAR_V6_Victor 26/09/2016 18:57 Page 2

PACKAGE L EAFL ET: INFORMATION FOR THE USER

Clarithromycin 500mg
Powder for Solution for Infusion
Clarithromycin
Pharmacode
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do NOT pass it on to others.
It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Clarithromycin Infusion is and what
it is used for
2.What you need to know before you are
given Clarithromycin Infusion
3. How Clarithromycin Infusion is given
4. Possible side effects
5. How to store Clarithromycin Infusion
6. Contents of the pack and other information
The name of your medicine is
“Clarithromycin 500mg Powder for Solution
for Infusion” (referred to as Clarithromycin
Infusion throughout this leaflet).
1. WHAT CL ARITHROMYCIN 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. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN CL ARITHROMYCIN INFUSION
You should not be given Clarithromycin
Infusion if:
• you are allergic to clarithromycin, other
macrolide antibiotics such as erythromycin
or azithromycin, or any of the other
ingredients of this medicine (listed in
section 6)
• you or someone in your family has a
history of heart rhythm problems
(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 in your
blood
• you have severe liver failure as well as
kidney problems
• you are taking certain other medicines see "Other medicines and Clarithromycin
Infusion ".
If you are unsure, talk to your doctor or nurse.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before treatment with Clarithromycin
Infusion:
• 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.
• if you have abnormally low levels of
magnesium in your blood.
Other medicines and Clarithromycin
Infusion
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)

• ticagrelor or ranolazine (for heart
problems and angina)
• colchicine (usually taken for gout).
Tell your doctor or nurse if you are taking
any of the following medicines:
• 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)
• quetiapine and other antipsychotic
medicines
• methylprednisolone (a corticosteroid)
• omeprazole (for stomach ulcers 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, amlodipine, diltiazem (for high
blood pressure and angina)
• insulin, nateglinide, pioglitazone, repaglinide
and rosiglitazone (used for diabetes)
• the herbal remedy, St. Johns Wort.
• other medicines which are known to
cause serious disturbances in heart rhythm.
Tell your doctor or nurse if you are taking, have
recently taken or might take other medicines.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, 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 CL ARITHROMYCIN 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
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.

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.

PIL-572UK_CLAR_V6_Victor 26/09/2016 18:57 Page 3

Children and adolescents under 18 years
should not be given Clarithromycin Infusion.
If you have any further questions on the use
of this medicine, ask your doctor,
pharmacist or nurse.
4. POSSIBL E 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.
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
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
• 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
• dermatitis
• itching (pruritis)
• nettle rash (hives)
• red rash with swelling

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.

• 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
• feeling elated or over-excited, which
causes unusual behaviour
• confusion, change in sense of reality, and
panicking
• loss of sense of taste or smell
• deafness
• inflamed eyes
• fast heart rate
• heart rhythm problems
• 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.
• pins and needles.
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 CL ARITHROMYCIN
INFUSION
Keep this medicine out of the sight and
reach of children.
Do not use Clarithromycin Infusion after the
expiry date which is printed on the label and
carton after EXP. The expiry date refers to
the last day of that month.
Store below 25°C.
Your doctor, pharmacist or nurse will know
how to store Clarithromycin Infusion properly.
6. CONTENTS OF THE PACK AND OTHER
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:
Ibigen Srl.
Via Fossignano, 2,
04011 Aprilia (LT), Italy
Manufacturer:
Laboratorios Alcalá Farma S.L.,
Madrid, Spain
This leaflet was last revised in 09/2016.

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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