TARIVID IV INFUSION SOLUTION

Active substance: OFLOXACIN HYDROCHLORIDE

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513766

• A general feeling of being unwell
• Pain, redness or swelling on the vein or area
you have been injected with Tarivid
Very Rare (affects less than 1 in 10,000 people)
• Feeling tired, faint, dizzy and having pale skin.
These could be signs of anaemia
• You may feel weak, bruise more easily and get
more infections than usual. This could be
because of a blood problem called
‘pancytopenia’
• Cough or shortness of breath, caused by lung
inflammation

5. How to store Tarivid
This medicine will be kept by your doctor or
pharmacist in a safe place where children cannot
see or reach it.
Store in the original carton in order to protect
from light.
Do not use Tarivid after the expiry date, which is
stated on the label. The expiry refers to the last
day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

It is possible that Tarivid may trigger an attack of
porphyria (a rare illness which affects the
metabolism) in some patients.
Talk to your doctor or pharmacist if any of the
side effects gets serious or lasts longer than a
few days, or if you notice any side effects not
listed in this leaflet.

6. Further Information
What Tarivid contains
• Each 1ml contains 2mg of the active substance,
ofloxacin
• The other ingredients are sodium chloride,
hydrochloric acid and water for injections
What Tarivid looks like and contents of the
pack
Tarivid® is a clear greenish-yellow solution in glass
vials with grey chlorobutyl rubber closures and
aluminium caps containing either 50ml, 100ml or
200ml. Not all pack size may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1
4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi-Aventis Deutschland GmbH
Bruningstrasse 50, D-65926 Frankfurt am Main,
Germany
This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in 05/2012
© Sanofi, 2002 – 2012

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Tarivid® 2mg/ml
Solution for
Infusion
ofloxacin

2. Before you have Tarivid

Is this leaflet hard
to see or read?
Phone 01483 505515
for help
Read all of this leaflet carefully before you
start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your
doctor or 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Tarivid is and what it is used for
2. Before you have Tarivid
3. How Tarivid is given
4. Possible side effects
5. How to store Tarivid
6. Further information

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1. What Tarivid is and what it
is used for
The name of your medicine is Tarivid 2mg/ml
Solution for Infusion (called Tarivid throughout
this leaflet). Tarivid infusion contains a medicine
called ofloxacin. This belongs to a group of
medicines called antibiotics. It works by killing
bacteria that cause infections.
Tarivid is used for infections of the:
• Kidneys or bladder (urinary tract)
• Chest or lungs
• Blood
• Skin and soft tissue. Soft tissue is
underneath the skin and includes muscle

Do not take this medicine and tell
your doctor if:
× You are allergic (hypersensitive) to ofloxacin or
any of the other ingredients of Tarivid (listed in
Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
× You have ever had swelling of the tendons
(called tendinitis) which can affect areas such as
the wrist or the achilles tendon
× You have epilepsy or are at risk of fits
× You have a problem with your red blood cells
known as ‘glucose-6-dehydrogenase deficiency’
× You are pregnant or breast-feeding (see
‘Pregnancy and breast-feeding’ section)
× You are under 18 years of age or are still
growing
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
nurse, doctor or pharmacist before having Tarivid.

SRZ-Nr.: 508940

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Format 420 x 148 mm

Take special care with Tarivid
Caution should be taken when using this kind
of medicine.
Check with your doctor, pharmacist or nurse
before having your medicine if:
s You have liver or kidney problems
s You have heart disease or problems with your
heartbeat
s You are taking medicines that can affect your
heart or lower your blood pressure (see section
‘Taking other medicines’)
s You were born with or have family history of
prolonged QT interval (seen on ECG, electrical
recording of the heart)
s You have a salt imbalance in the blood
(especially low levels of potassium or
magnesium in the blood)
s You have a very slow heart rhythm (called
‘bradycardia’)
s You have a weak heart (heart failure)
s You have a history of heart attack (myocardial
infarction)
s You are female or elderly
s You are taking other medicines that result in
abnormal ECG changes (see section ‘Taking
other medicines’)
s You have or have ever had any mental health
problems
s You have porphyria (a rare illness which affects
the metabolism)
s You are going to have an operation under
general anaesthetic whilst being treated with
Tarivid
s You suffer from a condition called
‘myasthenia gravis’ (muscle weakness)
s You have been told by your doctor that
you cannot tolerate some sugars

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If you are not sure if any of the above apply to
you, talk to your doctor, pharmacist or nurse
before having Tarivid.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Tarivid and some other
medicines can affect the way each other work.
In particular, tell your doctor if you are taking
the following medicine:
• Methotrexate used for rheumatism or cancer
Other medicines that can alter your heart rhythm:
• Medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amioderone, sotalol, dofetilide,
ibutilide)
• Tricyclic antidepressants
• Some antimicrobials (that belong to the group
of macrolides)
• Some antipsychotics
The following medicines can change the way
Tarivid works or Tarivid may change the way
some of these medicines work:
• Medicines used to stop your blood from clotting
• Medicines used for high blood pressure or
medicines that lower blood pressure
• Medicines that help put you to sleep
(anaesthetics)
• Water tablets (diuretics) such as furosemide
• Glibenclamide – used for diabetes
• Probenecid – used for gout
• Cimetidine – used for stomach ulcers or
indigestion

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The following medicines, when taken with
Tarivid, can increase the chance of you getting
side effects
• Other antibiotics (such as erythromycin,
azithromycin or clarithromycin)
• Medicines for depression (such as amitriptyline,
clomipramine or imipramine)
• Theophylline – used for breathing problems
• Medicines used to control your heartbeat (such
as amiodarone, quinidine, procainamide, or
disopyramide)
• Non steroidal anti-inflammatory drugs (NSAIDs)
– used for pain relief and inflammation (such
as ibuprofen, diclofenac or indometacin)
• Corticosteroids – used for inflammation
• Antipsychotics – used to treat psychiatric
disorders such as schizophrenia and bipolar
disorder
Having Tarivid with food and drink
Do not drink alcohol while having Tarivid. This is
because it may make you feel dizzy or sleepy.
Pregnancy and breast-feeding
Do not have this medicine if:
• You are pregnant, might become pregnant or
think you may be pregnant
• You are breast-feeding or planning to
breast-feed
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
You may feel sleepy or dizzy or have problems
with your eyesight while having this medicine. If
this happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Tarivid
Tarivid infusion contains sodium. There is 354mg
of sodium per 2mg of infusion. This may be
harmful to people on a low sodium or low salt
diet.

SRZ-Nr.: 508940

3. How Tarivid is given
Having this medicine
• Your doctor or nurse will normally give you
Tarivid. This is because it needs to be given as a
slow infusion (drip) into a vein
• When having Tarivid, avoid strong sunlight and
do not use sun lamps or solaria
If you are not sure why you are receiving Tarivid
or have any questions about how much Tarivid is
being given to you, speak to your doctor,
pharmacist or nurse.
How long you will have Tarivid
• The length of your treatment will depend on
how serious your infection is
• The medicine is usually given for 5 to 10 days
and treatment should not be longer than 2
months
• Once your illness has improved your doctor
may change your medicine to Tarivid tablets
How much will be given to you
• Your doctor will decide on how much Tarivid
you should have
• The dose will depend on the type of infection
you have
The usual dose for adults, including the elderly, is
between 200mg and 800mg each day. The dose
depends on the location and type of infection:
• Kidney or bladder infections
(urinary tract):
200mg each day
• Chest or lung infections:
200mg twice a day
• Blood infections:
200mg twice a day

Children and Adolescents: This medicine should
not be given to children or adolescents.
If you have more Tarivid than you should
Your doctor will carefully calculate how much
Tarivid you should get. Therefore it is unlikely
your doctor, nurse or pharmacist will give you too
much of this medicine. But, if you think that you
have been given too much or too little Tarivid, tell
your doctor, nurse or pharmacist. The following
effects may happen: confusion, feeling dizzy, loss
of consciousness, convulsion, seizures (fits),
nausea or bleeding in stools.
If you forget to have Tarivid
Your doctor or nurse will have instructions about
when to give you your medicine. It is unlikely that
you will not be given the medicine as it has been
prescribed. If you think that you may have missed
a dose, then talk to your doctor or nurse.
If you stop having Tarivid
Keep having Tarivid until your doctor tells you to
stop. Do not stop having Tarivid just because you
feel better. It is important for you to keep having
Tarivid injections until your doctor decides to stop
them. If you stop, your infection may get worse
again.
Urine Tests
Having Tarivid may affect the results of some
urine tests. If you are going to have a urine test, it
is important to tell your doctor you are having
Tarivid.
If you have any further questions on the use
of this product, ask your doctor, pharmacist
or nurse.

4. Possible side effects
Like all medicines, Tarivid can cause
side effects, although not everybody gets
them.
Tell a nurse or doctor straight away if you have
any of the following serious side effects:
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or
tongue
Very Rare (affects less than 1 in 10,000 people)
• An uneven or fast heartbeat, you may also
feel faint
• Watery diarrhoea, which may have blood in
it, possibly with stomach cramps and a high
temperature
• Fits
• Hearing problems or hearing loss
• Liver problems that may cause your eyes or
skin to go yellow (jaundice)
• Severe skin rashes which may include
blistering or peeling of the skin around the
lips, eyes, mouth, nose and genitals
• Skin rashes caused by strong sunlight
• Feeling faint, light-headed or dizzy, due to
low blood pressure
• Muscle weakness, joint and muscle pains
• Feeling weak or irritable, sweating and/or
trembling. This could be due to lowering of
blood sugar levels
• Feeling thirsty and passing water more often
than usual. This could be due to a rise in
blood sugar levels
• Swelling or discomfort in your tendons, such
as in the achilles tendon

• Skin and soft tissue infections:
400mg twice a day
Kidney or liver problems
If you have any kidney or liver problems you may
be given a lower dose.

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• Severe inflammation of the kidneys, which may
result in your kidneys stopping working. Signs
may include a rash, high temperature and
general aches and pains
• Severe depression or mental illness. Some
people who are depressed think of harming
or killing themselves
Rare (affects less than 1 in 1000 people)
• Numbness or tingling in the hands and feet
or being very sensitive to touch
Frequency Unknown
• Abnormal fast heart rhythm
• Life-threatening irregular heart rhythm
• Alteration of the heart rhythm (called
‘prolongation of QT interval’, seen on ECG,
electrical activity of the heart)
Tell your doctor if any of the following side
effects gets serious or lasts longer than a few
days:
Uncommon (affects less than 1 in 100 people)
• Feeling or being sick, diarrhoea or stomach
pains
• Headaches, sleeping problems, feeling dizzy
or restless
• Skin rash or itching
Rare (affects less than 1 in 1000 people)
• Loss of appetite
• Feeling confused or anxious, nightmares,
seeing things that are not there, depression
and mental illness, feeling drowsy, trembling,
problems walking due to poor muscle control
• Changes in eyesight
• Changes in or loss of your sense of taste or
smell
• Changes in levels of liver enzymes
shown in blood tests

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Format 420 x 148 mm

Erstellt am: 2. Mai 2012 / Version: 3 / Mac

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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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