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TARIVID 400 MG FILM-COATED TABLETS

Active substance(s): OFLOXACIN

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COMPIÈGNE

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1

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par
modifié le
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23/06/2016
Thill G

Laboratoires
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Sanofi
Grande-Bretagne

Type Article

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Nom du produit
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Dosage
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Tarivid
R778280
200 mg & 400 mg
cprs

Couleur
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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Tarivid® 200 mg
Film-coated Tablets
Tarivid® 400 mg
Film-coated Tablets

ofloxacin

Is this leaflet hard
to see or read?
Phone 0845 372 7101
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
What is in this leaflet:
1. What Tarivid tablets are and what they are
used for
2. What you need to know before you take
Tarivid tablets
3. How to take Tarivid tablets
4. Possible side effects
5. How to store Tarivid tablets
6. Contents of the pack and other information


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1. What Tarivid tablets are and
what they are used for
Tarivid tablets contain a medicine called
ofloxacin. This belongs to a group of medicines
called antibiotics. It works by killling bacteria
that cause infections.
Tarivid tablets are used for infections of the:
• Kidneys or bladder (urinary tract)
• Chest or lungs
• Male or female sex organs (genital tract).
This includes gonorrhoea which is a sexually
transmitted infection that can affect both
men and women
• Skin and soft tissue. Soft tissue is underneath
the skin and includes muscle

2. What you need to know before you
take Tarivid tablets
Do not take this medicine and tell
your doctor if:
 You are allergic (hypersensitive) to ofloxacin
or any of the other ingredients of Tarivid
tablets (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 below)
 You are under 18 years of age or are
still growing
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Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Tarivid tablets.
Warnings and Precautions
Talk to your doctor or pharmacist
before using Tarivid tablets 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 (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 suffer from a condition called
myasthenia gravis, which causes muscle
weakness and excessive muscle fatigue
s You have been told by your doctor that you
can not tolerate some sugars. If you are not
sure if any of the above apply to you, talk
to your doctor or pharmacist before taking
Tarivid tablets.
There have been very rare reports of potentially
life-threatening skin rashes (Stevens-Johnson
Syndrome, Toxic Epidermal Necrolysis) with the
use of Tarivid tablets. Symptoms of which
may include: flu-like symptoms followed
by a painful red or purplish rash that

COMPIÈGNE

Version N°

1

créé le
par
modifié le
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23/06/2016
Thill G

Laboratoires
Pays

Sanofi
Grande-Bretagne

Type Article

Notice double

Nom du produit
Référence article
Dosage
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Tarivid
R778280
200 mg & 400 mg
cprs

Couleur
Nbre/Réf.

spreads and blisters. If you develop any of the
above you must stop taking your medicine and
inform your doctor straight away (see Section 4.)
Tarivid tablets are not recommended if you
have a suspected MRSA infection
While being treated with Tarivid tablets, avoid
strong sunlight and do not use sun lamps or
solariums, as your skin may be more sensitive
to light
If you experience pain in your fingers or toes
whilst being treated with Tarivid tablets, tell
your doctor or nurse immediately.
Other medicines and Tarivid tablets
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 tablets 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 tablets work or Tarivid tablets may
change the way some of these medicines
work:
• Medicines used to stop your blood from
clotting
• Medicines used for high blood pressure

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• Medicines that contain iron (for anaemia)
or zinc
• Medicines that help put you to sleep
(anaesthetics)
• Water tablets (diuretics) such as furosemide
• Antacids that contain magnesium or
aluminium - used for indigestion
• Glibenclamide - used for diabetes
• Probecenid - used for gout
• Cimetidine - used for stomach ulcers or
indigestion
• Sucralfate - used for stomach ulcers
The following medicines, when taken with
Tarivid tablets, 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.
Taking Tarivid tablets with food and drink
Do not drink alcohol while taking Tarivid
tablets. This is because it may make you feel
dizzy or sleepy.
Pregnancy and breast-feeding
Do not take this medicine if:
• You are pregnant, might become pregnant
or think you may be pregnant
• You are breast-feeding or planning to
breast-feed
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Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
Driving and using machines
You may feel sleepy or dizzy or have
problems with your eyesight while
taking this medicine. If this happens,
do not drive or use any tools or machines.
Important information about some of the
ingredients of Tarivid tablets
Tarivid tablets contain lactose. If you have been
told by your doctor that you cannot tolerate
some sugars, talk to your doctor before taking
Tarivid tablets.

3 How to take Tarivid tablets
Always take Tarivid tablets exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• When taking Tarivid tablets, avoid strong
sunlight and do not use sun lamps or solaria
• Medicines containing iron (for anaemia)
antacids (for indigestion or heartburn) or
sucralfate (for stomach ulcers) should be
avoided for two hours before or after taking
Tarivid Tablets
• If you feel the effect of your medicine is
too weak or strong, do not change the dose
yourself, but ask your doctor
• when taking Tarivid tablets, If your eyesight
becomes impaired of if your eyes seem to be
otherwise affected, consult an eye specialist
immediately
When to take your medicine
• The length of your treatment will
depend on how serious your infection is

COMPIÈGNE

Version N°

1

créé le
par
modifié le
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23/06/2016
Thill G

Laboratoires
Pays

Sanofi
Grande-Bretagne

Type Article

Notice double

Nom du produit
Référence article
Dosage
Quantité

Tarivid
R778280
200 mg & 400 mg
cprs

Couleur
Nbre/Réf.

• The medicine is usually taken for 5 to 10
days and treatment should not be longer
than 2 months
• Doses up to 400 mg are taken as a single
dose in the morning
• Higher doses should be taken in two doses,
one in the morning and one in the evening
How much to take
• Your doctor will decide on how many Tarivid
tablets you should take
• The dose will depend on the type of
infection you have
The usual dose for adults, including the elderly, is
between 200 mg and 800 mg each day. The dose
depends on the location and type of infection:
• Kidney or bladder infections (urinary tract):
200 to 800 mg each day
• Chest or lung:
400 to 800 mg each day
• Male or female sex organ infections
(genital tract):
400 mg each day
• Gonorrhoea
a single dose of 400 mg
• Skin and soft tissue infections:
400 to 800 mg each day
Kidney or liver problems
If you have any kidney or liver problems you
may be given a lower dose.
Children and Adolescents:
This medicine should not be given to children
or adolescents.
Urine Tests
Taking Tarivid tablets 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 taking Tarivid tablets.

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If you take more Tarivid tablets than you
should
If you take more Tarivid tablets than you
should, tell a doctor or go to a hospital
casualty department straight away. Take the
medicine pack with you. This is so the doctor
knows what you have taken. The following
effects may happen: feeling confused or dizzy,
loss of consciousness, fits, feeling sick or blood
in your stools.
If you forget to take Tarivid tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for
the next dose, skip the missed dose.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Tarivid tablets
Keep taking Tarivid tablets until your doctor
tells you to stop. Do not stop taking Tarivid
tablets just because you feel better. If you stop,
your infection may get worse again.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Tarivid tablets can cause
side effects, although not everybody gets them.
Stop taking Tarivid tablets and see a doctor
or go to a hospital straight away if:
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue
Stop taking Tarivid tablets and see a doctor
straight away if you notice any of the
following serious side effects - you may
need urgent medical treatment:


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SCV A1 - 03.10.2005
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V
 ery 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 (Stevens-Johnson
Syndrome, Toxic Epidermal Necrolysis)
which may include blistering or peeling
of the skin around the lips, eyes, mouth,
nose and genitals. Symptoms may include
flu-like symptoms followed by a painful red
or purplish rash that spreads and blisters. If
you develop any of the above you must stop
taking this medicine and inform your doctor
straight away
• 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 raise in
blood sugar levels
• Swelling or discomfort in your tendons, such
as in the achilles tendon
• 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

COMPIÈGNE

Version N°

1

créé le
par
modifié le
par

23/06/2016
Thill G

Laboratoires
Pays

Sanofi
Grande-Bretagne

Type Article

Notice double

Nom du produit
Référence article
Dosage
Quantité

Tarivid
R778280
200 mg & 400 mg
cprs

Couleur
Nbre/Réf.

1

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères

SCV A1 - 03.10.2005
CRGB - V1 - 05/2012
1-606062
606062-1d
150 x 210 mm
9 pts

Code sécurité

778280
Numéro de pages
4/4

Bleu Reflex Blue U


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)
• Indigestion, flatulence (passing wind), constipation
• Fever, pain (back, chest, limbs)
• Severe abdominal pain (pancreatitis)
• Impaired hearing
• Inflammation of the eye (uveitis)
• Skin redness with extensive scaling
(exfoliative dermatitis)
• Loss of appetite, skin and eyes becoming
yellow in colour, dark-coloured urine,
itching, or tender stomach (abdomen). These
may be signs of liver problems which may
include a fatal failure of the liver
• Liver problems
• Problems with eye sight
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
• A general feeling of being unwell


V
 ery 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 bruise more easily than usual. This
could be because of a blood problem called
‘thrombocytopenia’
• Cough or shortness of breath, caused by lung
inflammation
It is possible that Tarivid may trigger an attack
of porphyria (a rare illness which affects the
metabolism) in some patients.
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.
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Tarivid tablets after the expiry date
which is stated on the label. The expiry refers
to the last day of that month.

5 How to store Tarivid tablets
Keep the blister strip in the outer carton in
order to protect from moisture.
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.

6 Contents of the pack and other
information
What Tarivid tablets contain
• Each 200mg tablet contains 200mg of the
active substance, ofloxacin
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• Each 400mg tablet contains 400mg of the
active substance, ofloxacin
• The other ingredients in the tablets are
lactose, maize starch, sodium starch
glycollate (400mg only), hyprolose,
carmellose (200mg only), magnesium
stearate, hypromellose, macrogol 8000, talc,
titanium dioxide (E171), yellow ferric oxide
(E172 - 400mg only), purified water
What Tarivid tablets look like and contents
of the pack
Tarivid 200mg tablets are oblong pale
yellowish-white tablets. They are marked on
each face with ‘MXI’ on one side of the scoreline and the Hoechst logo on the other. They
are supplied in aluminium/PVC blisters in pack
sizes of 10, 20 and 100 tablets. Not all pack
sizes may be marketed.
Tarivid 400mg tablets are oblong pale yellow
tablets. They are marked on each face with
‘MXL’ on one side of the score-line and the
Hoechst logo on the other. They are supplied in
aluminium/PVC blisters in pack sizes of 5, 10 and
50 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie
56, route de Choisy au Bac,
60205 Compiègne, France
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 June 2016
© Sanofi, 2002 – 2016

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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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