CLARITHROMYCIN 500MG/VIAL LYOPHILISATE FOR SOLUTION FOR INFUSION

Active substance: CLARITHROMYCIN

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Transcript
11/8/11

1

PATIENT
INFORMATION

Clarithromycin
500mg/vial
Lyophilisate for
Solution for Infusion*
*For easier reading the product is
called “Clarithromycin 500mg/vial”
in the rest of this leaflet.

Please read all of this leaflet
carefully before you receive
this medicine
- Keep this leaflet. You may
need to read it again.
- 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.
- If you have any further questions,
ask your doctor or nurse.

In this leaflet:
1. What Clarithromycin
500mg/vial is and what
it is used for
2. Before you are given
Clarithromycin 500mg/vial
3. How Clarithromycin
500mg/vial is given

14:51

Page 1

2

1. What Clarithromycin 500mg/vial
is and what it is used for
Clarithromycin 500mg/vial contains
clarithromycin. Clarithromycin
belongs to a group of drugs called
macrolides and is an antibiotic which
stops the growth of many types of
“bugs” that cause infections.
Clarithromycin 500mg/vial may be
used to treat:
• Chest infections such as
bronchitis and pneumonia.

Taking these medicines with
Clarithromycin 500mg/vial can
sometimes cause serious changes
in the rhythm of your heart.
• Suffering from certain forms of
irregular heartbeat, or abnormal
levels of potassium in your blood.
• Taking drugs to lower your
cholesterol level ('Statins' or
HMG-CoA reductase inhibitors)
such as simvastatin, lovastatin
or atorvastatin, as this can cause
muscle breakdown leading to
kidney problems.

• Throat and sinus infections.
• Skin and soft tissue infections.

2. Before you are given
Clarithromycin 500mg/vial
Do not take Clarithromycin 500mg/vial
if you are;
• Allergic to clarithromycin or other
macrolide antibiotics such as
erythromycin or azithromycin,
or if you are allergic to any of the
other ingredients listed in section 6,
Further information.
• Taking any medicines for
headaches containing ergotamine
or dihydroergotamine, since
taking these medicines with
Clarithromycin may cause your
blood vessels to narrow.
• Taking any medicines containing;
- pimozide (a drug for psychiatric
conditions).

4. Possible side effects

- cisapride (a drug for stomach
disorders).

5. How Clarithromycin
500mg/vial is stored

- terfenadine or astemizole
(drugs for hay fever or allergy).

6. Further information

3

• Suffering from severe liver
failure with kidney problems.

4

• Sildenafil, tadalafil or vardenafil
(drugs for impotence).

• Suffer from heart or blood vessel
disease, abnormally slow
heartbeat, abnormal heart rhythm,
abnormal levels of potassium or
magnesium in your blood, or you
are taking other medicines that
affect your heart rhythm.

• Cyclosporin, tacrolimus or
sirolimus (drugs that affect
your immune system).

Taking other medicines:

• Tacrolimus (a drug taken to prevent
rejection of organ transplants).

You should tell your doctor or nurse
if you are taking, or have recently
taken, any of the following medicines
as they may interact with
Clarithromycin 500mg/vial:
• Any other antimicrobial, antibiotic,
lincomycin or clindamycin.

• Any medicine from a group known
as 'aminoglycosides' for example
• You experience any symptoms
streptomycin or neomycin, or any
of allergic reaction such as
drug known to cause hearing or
breathing difficulties, dizziness,
balance problems. These functions
swelling of the face or throat,
should be monitored during and
or blistering of the skin. Stop taking
after treatment with clarithromycin.
clarithromycin immediately and
• Digoxin, quinidine, disopyramide
consult your doctor if you
or verapamil (drugs for the heart).
experience any of these symptoms.
• You have any liver or kidney
problems.

• Warfarin or other drugs to thin
the blood.

• You have been given
Clarithromycin 500mg/vial
for a long period of time or on
a regular basis, as this may allow
resistant “bugs” to grow.

• Carbamazepine, valproate or
phenytoin (drugs for epilepsy).

• You are sensitive to or have
suffered a reaction to other
macrolide antibiotics,
clindamycin or lincomycin.
• Suffer from diarrhoea while taking
clarithromycin, as this may be a
sign of bacterial infection.

Tech 1

• Notice worsening muscle
weakness/tiredness.

Take special care with Clarithromycin
500mg/vial and tell your doctor if;

• You are taking colchicine, a drug
used to treat gout.

5

• Theophylline (a drug to help
breathing).
• Triazolam, alprazolam or midazolam
(drugs to help you sleep).
• Cilostazol (drugs for poor
circulation).

Clarithromycin
500mg/vial

• Zidovudine (an anti-viral drug).

Lyophilisate for
Solution for Infusion

• Rifabutin (a drug for treatment
of some infections).

• Colchicine (a drug for gout).
• Ritanovir, atazanavir or saquinavir
(drugs for the treatment of HIV).
• Insulin or other drugs for diabetes
taken by mouth, such as
nateglinide, pioglitazone,
repaglinide or rosiglitazone.
• Tolterodine (a drug for urinary
incontinence).

Recommended Administration
Clarithromycin 500mg/vial
Lyophilisate 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 as an
intramuscular injection

Recommended Preparation
and Storage

• Efavirenz, nevirapine, rifampicin,
rifabutin, rifapentine, phenytoin,
carbamazepine, phenobarbital
and St. John's Wort. The way
these drugs work may make
clarithromycin less effective.

Do not use after the expiry date
which is stated on the vial and carton.
The expiry date refers to the last day
of that month.
This product should be prepared
as follows:

• Omeprazole (for stomach
problems) and Pimozide (for
psychosis). Clarithromycin may
affect the way these drugs work.

STEP 1

• Itraconazole (for fungal infections)
as this may affect or be affected
by clarithromycin.
10 ml

Clarithromycin 500mg/vial does
not interfere with the effect of oral
contraceptives.

• Simvastatin, lovastatin, atorvastatin, Please tell your doctor or nurse
rosuvastatin or cerivastatin (drugs
if you are taking or have recently
for high cholesterol).
taken any other medicines,
including medicines you bought
• Methylprednisolone
without a prescription.
(a corticosteroid).
• Vinblastine (a drug for the
treatment of cancer).

TECHNICAL
INFORMATION

Turn over

Add 10ml of sterile water for
injections into the vial and shake
until fully dissolved.

Tear here to remove

Clarithromycin PIL UK002 5734-03

Storage
The infusion must be administered
immediately after preparation.
DO NOT USE

• Diluents containing preservatives.
• Diluents containing inorganic salts.

Clarithromycin PIL UK002 5734-03

11/8/11

Tech 2

10
ml

STEP 2

250 ml

Add the solution from Step 1 to
250ml of a suitable infusion diluent
to provide approximately a 2mg/ml
solution.
Storage
The infusion must be administered
immediately after preparation.
DO NOT USE
• Solution strengths greater than
2mg/ml (2%).
• Rapid infusion rates
(< 60 minutes).
Failure to observe these precautions
may result in pain along the vein.
KEEP OUT OF THE REACH AND
SIGHT OF CHILDREN

Recommended Diluents
Recommended infusion
solutions/diluents are;
5% Dextrose in Lactated Ringers
solution, 5% Dextrose, Lactated
Ringers 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
intravenous additives has not been
established.
Do not use diluents containing
preservatives or inorganic salts.

Other information
This medicinal product contains
less than 1 mmol sodium (23mg)
per 500mg, i.e. it is essentially
‘sodium free’.
Full prescribing information is
available in the Summary of
Product Characteristics.

14:51

Page 2

6

Continued from other side
Your doctor or nurse may need to
test you before starting treatment
with Clarithromycin 500mg/vial,
because certain infections are
resistant to this type of antibiotic.
Pregnancy and breast-feeding:
If you think you are pregnant, likely
to become pregnant or are breast
feeding, you must tell your doctor
or nurse before being given this
medicine.
Driving and using machines:
Clarithromycin 500mg/vial may
affect your ability to drive or operate
machines if you experience any
side-effects such as dizziness,
vertigo, confusion or disorientation.

3. How Clarithromycin 500mg/vial
is given
Clarithromycin 500mg/vial will be
prepared by your doctor or nurse.
It will be given to you by infusion
into one of your veins (like a blood
transfusion) over a period of at least
one hour.
Adults, the elderly, and children older
than 12 years:
The usual dose of Clarithromycin
500mg/vial is 500 mg (1 vial) taken
twice a day for a period of 2 to
5 days. Your doctor or nurse will
work out the correct dose for you.
If you suffer from weak or
damaged kidneys then your dose
should be reduced to half of the
normal adult recommended dose.
Children:
Not recommended for children
younger than 12 years.

4. Possible side effects
Like all medicines, Clarithromycin
500mg/vial can cause side effects,
although not everybody gets them.

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All medicines can cause allergic
reactions although serious allergic
reactions are very rare. If you get any of
the following symptoms after receiving
Clarithromycin 500mg/vial, you should
contact your doctor immediately;
• Any sudden wheeziness, difficulty
in breathing, swelling of the face,
eyelids, lips or throat.
• Peeling and blistering of the skin,
mouth and lips.
The most common side effects with
Clarithromycin 500mg/vial are:
• Swelling of the vein, causing
inflammation, pain or tenderness
at the point of infusion (affects
more than 1 in 10 patients).
Common side effects
(affects fewer than 1 in 10 patients):
• ‘Thrush’ in mouth
• Difficulty sleeping
• Changes in taste
• Headache
• Changes in smell
• Widening of blood vessels
• Severe or prolonged diarrhoea
• Being sick
• Indigestion
• Feeling sick
• Abdominal pain
• Abnormal liver function tests
• Rash
• Excessive sweating
• Pain, swelling or tenderness at
the site of the infusion.
Uncommon side effects
(affects fewer than 1 in 100 patients):
• Swelling under the skin
• Infections
• Stomach irritation
• Vaginal infections
• Low levels of white cells that
fight infection
• Low levels of cells that help blood
clot (which may result in bruising)
• Other abnormal blood tests
• Allergic reactions including
breathing difficulties, swelling
of the face, skin rashes, possibly
severe
• Loss of appetite, possibly severe
• Anxiety or nervousness
• Screaming
• Loss of consciousness
• Uncontrolled muscle movements
or shaking

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• Dizziness
• Feeling sleepy
• Abnormal feeling of movement
(Vertigo)
• Hearing problems
• ‘Ringing’ sound in the ears
• Heart attack
• Changes in heart rhythm
• Irregular heart beat
• Asthma
• Breathing difficulties
• Nosebleeds
• Blood clot signified by chest pain,
breathing problems, fainting,
changes to heart rate, lips or
extremities turning blue
• Irritation of the gullet
• Heartburn and swallowing
difficulties (Reflux)
• Irritation of the stomach
• Sudden sharp pain in the
rectal area
• Inflammation of the mouth or
tongue
• Tooth or tongue discolouration
• Swollen belly
• Constipation
• Dry mouth
• Increased belching or wind
• Liver dysfunction or irritation
• Abnormal levels of certain enzymes
• Blistering of the skin
• Hives
• Itchy rashes including swellings
on the skin
• Muscle spasms
• Joint pain
• Muscle pain
• Abnormal kidney tests
• Loss of bearing
• Fever
• Muscle weakness
• Chest pain
• Chills
• Tiredness
• Abnormal blood tests
• Abnormal liver function tests.
Rare side effects (affects fewer
than 1 in 1,000 patients)
• Inflammation of the eye, especially
if also taking rifabutin (reversible).
Very rare side effects (affects fewer
than 1 in 10,000 patients):
• ‘Pins and needles’ (only if
Clarithromycin is taken by mouth).

9

Frequency not known:
• Irritation or swelling of the bowel
• Swelling of the skin and nearby
tissues (erysipelas)
• Contagious skin condition
affecting warm moist areas of the
body (erythrasma)
• Fever with swollen neck, sore
throat and occasionally ulcers
(agranulocytosis)
• Blood changes (low platelet count)
• Allergic skin rashes
• Serious allergic reaction
(anaphylaxis) including breathing
difficulty, swelling of the face,
eyelids, lips or throat
• Low blood sugar level
• Loss of contact with reality
• Confusion
• Loss of sense of identity
• Depression
• Disorientation
• Seeing or hearing things
• Abnormal dreams or nightmares
• Fits (convulsions)
• Abnormal sense of smell
• Loss of the sense of taste or smell
• Hearing loss, which usually gets
better when treatment stops
• Changes in heart rhythm
• Faster than normal heartbeat
• Abnormal bleeding
• Inflammation of the pancreas
• Tooth or tongue discolouration
(reversible)
• Liver failure resulting in death
• Yellowing of the skin and/or white
of the eyes
• Severe lesions in the skin,
including mouth, nose, gullet,
genital area, and inside of eyelids
(Stevens-Johnson syndrome)
• Reddening of the skin followed
by extensive peeling
• Allergic skin disease with patches
of swelling beneath the skin
(Angioedema)
• Drug reaction involving rashes,
fever and irritation to certain
internal organs (DRESS)
• Spots (Acne)
• Muscle weakness, pain or swelling
which can lead to breakdown of
the muscle
• Kidney failure
• Kidney problems
• Abnormal urine colour
• Abnormal blood or liver function
tests.

10

If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or nurse.

5. How Clarithromycin 500mg/vial
is stored
The hospital will ensure that
Clarithromycin 500mg/vial is
stored correctly and that it is not
used after the expiry date stated
on the vial label and carton.

6. Further information
What Clarithromycin 500mg/vial contains:
Each vial of Clarithromycin
500mg/vial contains:
Active ingredient:
500mg of sterile clarithromycin
as the active ingredient, which
provides approximately 2mg/ml of
clarithromycin when reconstituted
as recommended.
Other ingredients:
Lactobionic acid and
sodium hydroxide.
What Clarithromycin 500mg/vial
looks like:
Clarithromycin 500mg/vial
Lyophilisate for Solution for
Infusion is a white/almost white
sterile freeze-dried powder in a
glass vial.
Marketing Authorisation Holder
and Manufacturer:
Britannia Pharmaceuticals Ltd,
Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.
Marketing authorisation number:
PL 04483/0063
If you have any questions about
your treatment with Clarithromycin
500mg/vial which are not answered
by this leaflet, please ask your
doctor or nurse.
This leaflet was last approved in:
August 2011.

UK002

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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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