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CLARITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): CLARITHROMYCIN

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150 mm

Clarithromycin 500 mg
Powder For Solution For Infusion

Read all of this leaflet carefully before
you start using this medicine.
- Keep this leaflet. You may need to read
it again.

- 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.

Clarithromycin powder contains the active
substance clarithromycin and is an antibiotic
that belongs to a group of substances called
“macrolide antibiotics”. Antibiotics inhibit the
growth of bacteria (germs) that cause
infections.

Clarithromycin is indicated in adults and
children 12 years and older

3. How to use Clarithromycin
Clarithromycin is administered intravenously
by your doctor or nurse.
The recommended daily dose of intravenous
clarithromycin for adults 18 years of age and
older is 1000 mg/day, divided into two equal
doses of 500 mg and perfused over a period
of 60 minutes after appropriate dilution.
Adults: The recommended dosage is
1 gram daily, divided into two 500 mg doses,
appropriately diluted as described below.
Children older than 12 years: As for adults.
Children under 12 years: Use of
Clarithromycin 500 mg powder for solution
for infusion is not recommended for children
younger than 12 years.
Elderly: As for adults.
Renal impairment: In patients with renal
impairment who have creatinine clearance
less than 30 ml/min, the dosage of
clarithromycin should be reduced to one half
of the normal recommended dose.
Hepatic impairment: Clarithromycin should
not be used in patients who suffer from
severe hepatic failure in combination with
renal impairment.

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Method of administration
Clarithromycin should be administered into
one of the larger proximal veins as an
intravenous infusion over 60 minutes, using
a solution concentration of about 2 mg/ml.

As Clarithromycin is given to you by a
doctor, an overdose is unlikely but
symptoms may include vomiting and
stomach pains.

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If you use more Clarithromycin than you
should

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If you forgot to use Clarithromycin
Do not take a double dose to make up for a
forgotten dose.
If you have any further question about the
use of this product, ask your doctor or
pharmacist.

The recommended daily dose of intravenous clarithromycin is 1000 mg/day, divided into two
equal doses of 500 mg and perfused over a period of 60 minutes after appropriate dilution.
Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin
therapy when appropriate.

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The reconstituted solution can be diluted in 250 ml of the following diluents:
• sodium chloride 9 mg/ml (0.9%) solution for infusion
• dextrose 5 mg/ml (5%) solution
• dextrose 0.05 mg/ml (5%) in sodium chloride (0.003 mg/ml (0.3%) or 0.0045 mg/ml (0.45%))
solution for infusion
• dextrose 0.05 mg/ml (5%) in Ringers solution
• dextrose 0.05 mg/ml (5%) in Ringers Lactate solution

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Reconstitute each vial with 10 ml sterile water for injections. The reconstitution of the drug
product can take up to 3 minutes.

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

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Children and adolescents (aged under
18 years) should not be given this medicine.
Your doctor will prescribe another medicine
for your child.

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Use in children and adolescents

Do not drive or use machines because there
are no data on the effect of clarithromycin to
undertake these tasks. If you wish to do so,
please ask your doctor.

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Talk to your doctor, pharmacist or nurse
before using Clarithromycin
- if you suffer from severe or prolonged
diarrhoea during or after the treatment
with this medicine, ask your doctor
immediately
- if you suffer from coronary artery disease,
severe cardiac insufficiency or
bradycardia
- if you are taking other medicinal products
with a QT-prolongation effect
- if you have hepatic insufficiency
- if you have moderate to severe kidney
disease
- if you are taking other macrolides, such
as lincomycin and clindamycin
- if you are an elderly patient.

Driving and using machines

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Warnings and precautions

Ask your doctor or pharmacist before you
take any medicine.

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- if you are allergic to clarithromycin
- if you are taking ticagrelor or ranolazine
- if you are taking any of the following
medicinal products:
- Astemizole (for allergic rhinitis and
allergies), cisapride (for stomach
problems), pimozide (for psychiatric
disorders), terfenadine (for allergic
rhinitis and allergies) as this may
cause specific heart problems (e.g. QT
prolongation and cardiac arrhythmias,
including ventricular tachycardia,
ventricular fibrillation, and torsade de
pointes) and midazolam
- if you suffer from hypokalaemia (low
potassium concentration in the blood)
- if you suffer from severe hepatic failure in
combination with renal impairment
- if you suffer from QT prolongation
(congenital or documented acquired) or
ventricular cardiac arrhythmia, including
torsades de pointes, in the past
- if you are taking statins (e.g. HMG-CoA
reductase inhibitors as lovastatin or
simvastatin), to lower your blood
cholesterol level, as concomitant use may
cause severe muscle problems
- if you are taking ergotamine or
dihydroergotamine (medicines for
migraine headaches)
- if you are taking colchicine (for treatment
of gout).

The safety of clarithromycin during
pregnancy and breastfeeding has not been
established. Do not use this medicine if you
are breastfeeding.

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Do not use Clarithromycin:

Pregnancy and breastfeeding

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2. What you need to know before you use
Clarithromycin

Clarithromycin does not interact with oral
contraceptives.

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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.

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Clarithromycin is indicated whenever an
intravenous (injection into the vein) antibiotic
is required to treat severe infections or,
alternatively, if a patient cannot swallow
tablets.

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1. What Clarithromycin is and what it is
used for

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1. What Clarithromycin is and what it is
used for
2. What you need to know before you use
Clarithromycin
3. How to use Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other
information

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What is in this leaflet:

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- 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
pharmacist. See section 4.

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- If you have any further questions, ask
your doctor or pharmacist.

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
- Rifampicin (antibiotic)
- Carbamazepine, valproate, phenytoin or
phenobarbital (medicinal products for
epilepsy)
- St John’s Wort (treatment for depression)
- Efavirenz (antiretroviral agent)
- Nevirapine (antiviral medicine (anti-HIV))
- Rifabutin (for the treatment of some
infections)
- Rifapentine (antibiotic)
- Etravirine (antiretroviral agent)
- Fluconazole (treatment for fungal
infections)
- Ritonavir (antiviral medicine (anti-HIV))
- Digoxine, quinidine or disopyramide
(medicines for the heart)
- Sildenafil, tadalafil, vardenafil (for erectile
dysfunction)
- Theophylline (it makes breathing easier)
- Tolterodine (used for symptomatic
treatment of urinary incontinence)
- Aminoglycosides (antibacterial agents)
- Triazolam, alprazolam or midazolam
(sedative medicinal products)
- Oral hypoglycemic agents (antidiabetic
medicinal products)
- Insulin (antidiabetic medicinal product)
- Omeprazole (for stomach problems)
- CYP3A-based interactions (medicinal
product interaction in oncology)
- Cilostazol (for circulation problems)
- Cyclosporine (immunosuppressant)
- Methylprednisolone (a corticosteroid)
- Warfarin or other anticoagulant medicinal
products
- Tacrolimus (for organ transplants)
- Vinblastine (for treatment of cancer)
- Antiarrhythmics (treatment for cardiac
arrhythmias)
- Atazanavir (antiretroviral medicinal product)
- Calcium channel blockers (e.g. verapamil,
amlodipine, diltiazem)
- Itraconazole (antifungal agent)
- Saquinavir (antiretroviral medicinal
product)
- Zidovudine (antiviral agent).

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clarithromycin

Other medicines and Clarithromycin

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Package leaflet:
Information for the user

150 mm

4. Possible side effects
Like all medicines, Clarithromycin can cause
side effects, although not everyone gets
them.
Very common side effects (may affect
more than 1 in 10 people):
• Infusion site phlebitis (vein inflammation)

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Common side effects (may affect up to
1 in 10 people):
• Insomnia
• Dysgeusia (distortion of the sense of taste)
• Headache
• Taste perversion
• Vasodilation
• Diarrhoea
• Vomiting
• Dyspepsia (indigestion)
• Nausea
• Abdominal pain
• Liver function test abnormal
• Rash
• Hyperhidrosis (excessive sweating)
• Infusion site pain
• Infusion site inflammation
Uncommon side effects (may affect up to
1 in 100 people):
• Cellulitis
• Candidiasis
• Gastroenteritis
• Infection
• Vaginal infection
• Leukopenia
• Neutropenia
• Thrombocythemia
• Eosinophilia
• Anaphylactoid reaction
• Hypersensitivity
• Anorexia
• Decreased appetite
• Anxiety
• Nervousness
• Screaming
• Loss of consciousness
• Dyskinesia (movement disorders)
• Dizziness
• Somnolence
• Tremor
• Vertigo
• Hearing impaired
• Tinnitus
• Cardiac arrest
• Atrial fibrillation
• Electrocardiogram QT prolonged
• Extrasystoles
• Palpitations
• Asthma
• Epistaxis
• Pulmonary embolism
• Esophagitis
• Gastroesophageal reflux disease
• Gastritis
• Proctalgia
• Stomatitis
• Glossitis
• Abdominal distension
• Constipation
• Dry mouth
• Eructation
• Flatulence
• Cholestasis
• Hepatitis
• Alanine aminotransferase increased
• Aspartate aminotransferase increased
• Gamma-glutamyltransferase increased
• Dermatitis bullous
• Pruritus (severe itching of the skin)
• Urticaria
• Rash maculo-papular
• Muscle spasms
• Musculoskeletal stiffness
• Myalgia
• Blood creatinine increased
• Blood urea increased
• Malaise
• Pyrexia
• Asthenia
• Chest pain
• Chills
• Fatigue
• Albumin globulin ratio abnormal
• Blood alkaline phosphatase increased
• Blood lactate dehydrogenase increased






















Deafness
Torsade de pointes
Ventricular tachycardia
Haemorrhage
Pancreatitis acute
Tongue discolouration
Tooth discolouration
Hepatic failure
Jaundice hepatocellular
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Drug rash with eosinophilia and systemic
symptoms (DRESS)
Acne
Rhabdomyolysis
Myopathy
Renal failure
Nephritis interstitial
International normalised ratio increased
Prothrombin time prolonged
Urine colour abnormal

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 website
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects
you can help provide more information on
the safety of this medicine.
5. How to store Clarithromycin
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton or label.
The expiry date refers to the last day of that
month.
This medicinal product does not require any
special storage conditions.
For reconstituted solution (500 mg in 10 ml of
water for infusion): it can be stored up to
24 hours at room temperature and up to
48 hours refrigerated (2ºC-8ºC). The final
reconstituted solution (reconstituted solution
for infusion added to 250 ml of diluent,
respectively to each mentioned diluent) can
be stored up to 24 hours at room temperature
(25ºC) or up to 48 hours refrigerated
(2ºC-8ºC). The reconstitution of the drug
product can take up to 3 minutes.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other
information
What Clarithromycin powder contains
The active substance is clarithromycin as
clarithromycin lactobionate. Each vial
contains 500 mg clarithromycin (equivalent
to 739.5 mg clarithromycin lactobionate).
1 ml contains 25 mg clarithromycin
(equivalent to 36.98 mg clarithromycin
lactobionate).
Excipients: lactobionic acid, sodium
hydroxide and water for injection.
What Clarithromycin looks like and
contents of the pack
Clarithromycin is a white or almost white
powder for concentrate for solution or
infusion.
Pack size: 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley, East Yorkshire,
HU17 0LD, United Kingdom
Manufacturer
GENFARMA Laboratorio S.L, Avda. de la
Constitución, 198-199, Polígono Industrial
Monte Boyal, Casarrubios del Monte,
45950 (Toledo) Spain
This leaflet was last revised in 01/2018

Not Known (cannot be estimated from the
available data):
• Pseudomembranous colitis
• Erysipelas bacterial skin infection
• Agranulocytosis
• Thrombocytopenia
• Anaphylactic reaction
• Angioedema
• Hypoglycaemia
• Psychotic disorder
• Confusional state
• Depersonalisation
• Depression
• Disorientation
• Hallucination
• Abnormal dreams
• Convulsion
• Ageusia
• Parosmia (distortion of sense of smell)
• Anosmia
• Paraesthesia

After reconstitution/dilution the solution is to be visually inspected prior to use. Only clear
solutions practically free from particles should be used.
The ready to use solution for Infusion should be administered into one of the larger proximal veins
as an intravenous infusion over 60 minutes, using a solution concentration of about 2 mg/ml.
The medicinal product should not be given as a bolus or an intramuscular injection.
For reconstituted solution (500 mg in 10 ml of water for infusion): it can be stored up to 24 hours
at room temperature and up to 48 hours refrigerated (2ºC-8ºC). The final reconstituted solution
(reconstituted solution for infusion added to 250 ml of diluent, respectively to each mentioned
diluent) can be stored up to 24 hours at room temperature (25ºC) or up to 48 hours refrigerated
(2ºC-8ºC). The reconstitution of the drug product can take up to 3 minutes.

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