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FASIGYN 500MG

Active substance(s): TINIDAZOLE

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Service Développement Fareva Amboise
Produit
Code
Remplace le
Type
Format

FASIGYN TAB

NOIR
PMS 277 U
PMS 541 U

8814503
Couleur:
NA
bobine
Minimum font size: 8 pts
135 x 315 mm
Version: 2
Recto: 4a + spot / Verso: 4b
Préparé par : Karine Duverger
Date: 22/12/2015
Text only is subject to market approval.



PACKAGE LEAFLET:
INFORMATION FOR THE USER

UNITED KINGDOM

Fasigyn®

500mg Tablets
tinidazole
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 Fasigyn is and what it is used
for
2 Before you take Fasigyn
3 How to take Fasigyn
4 Possible side effects
5 How to store Fasigyn
6 Further information

1. What Fasigyn is and what it is
used for
Fasigyn is an anti-infective agent. It
is used to treat a variety of bacterial
infections including:
• infections of the skin, blood, chest,
lung, genitals or womb lining.
• an infection associated with stomach
ulcers in combination with other drugs.
• infections caused by organisms called
protozoa, such as amoebiasis and
giardiasis (stomach infections) and
trichomoniasis (a genital infection).
• vaginal infections (vaginitis) and gum
infections (gingivitis).
It is also used before certain surgical
operations to prevent bacterial infections
developing.
You should ask your doctor if you
are unsure why you have been given
Fasigyn.

2. Before you take Fasigyn
Do not take Fasigyn if:
• you are allergic (hypersensitive) to
tinidazole or any similar drugs or to any
of the other ingredients listed in section
6. An allergic reaction could cause
itching, a skin rash or wheezing.
• you are in the first 13 weeks of
pregnancy or trying to become
pregnant.
• you are breast feeding.
• you have a blood disorder or a history
of blood disorders.
• you have central nervous system (CNS)
disease, including epilepsy.

Taking other medicines with
Fasigyn

Please tell your doctor if you are taking or
have recently taken any other medicines
including those obtained without a
prescription.
You should tell your doctor if you are
currently taking blood thinners such as
warfarin to prevent blood clots as your
doctor may wish to monitor you more
closely.

Taking Fasigyn with food or
drink

You should not drink wine, beer or
spirits during treatment and for 3 days
after stopping treatment with Fasigyn.
The combination may cause flushing,
stomach cramps, vomiting (being sick)
and palpitations (pounding heart).
You should take Fasigyn during or after
a meal.

Pregnancy
You should not take Fasigyn if you are
in the first 13 weeks of pregnancy or are
trying to become pregnant. Always ask
your doctor or pharmacist for advice
before taking Fasigyn or any other
medicine.

Breast-feeding

You should not take Fasigyn if you are
breast feeding as small amounts can
pass into your milk. If you stop breastfeeding during treatment you should
not start again until at least 3 days after
stopping Fasigyn.

Driving and using machines.

Do not drive or use machinery if Fasigyn
makes you feel drowsy or gives you
problems with co-ordination or sensation
(e.g. numbness or weakness).

3. How to take Fasigyn
Always take your tablets exactly as your
doctor has told you and as written on
the label on the pack. Check with your
doctor or pharmacist if you are not sure.
Take Fasigyn with a glass of water during
or after a meal. Swallow the tablets
whole. It is best to take the medicine at
the same time each day.

Use in children under 12 years

For bacterial infections, Fasigyn is not
recommended for use in children less
than 12 years as it has not been tested in
this age group.
For protozoal infections, Fasigyn can be
used in children and has not been shown
to cause any different side effects or
more problems than it does in adults.
The dose and length of treatment
depends upon the infection being
treated. If you are on dialysis, your doctor
may prescribe a different dose.
The doses most commonly used for the
different infections are shown in the table
below:

For treating the infection
associated with stomach ulcers
The usual dose is 1 tablet (500mg) taken
twice a day. Your doctor will probably
prescribe two other medicines to be
taken with Fasigyn. Treatment with the
three medicines together will usually be
for 1 week.

For treating most bacterial
infections

The usual dose is 4 tablets (2g) on the
first day then 2 tablets (1g) once a day or
1 tablet (500mg) twice a day.
The usual length of treatment is 5 to 6
days.

For treating bacterial vaginitis
(a vaginal infection) and acute
ulcerative gingivitis
(a gum infection)

The usual dose is 4 tablets (2g) given as
a single dose.
For vaginitis you may be given 4 tablets
(2g) on two consecutive days.

For preventing bacterial
infections after surgery

Usually 4 tablets (2g) are given as a
single dose about 12 hours before
surgery.

For treating protozoal infections

For treating intestinal amoebiasis (a stomach
infection)
Adult The usual dose is 4 tablets (2g) once
a day for 2 to 3 days.
Child The usual dose is 50 to 60mg/kg of
body weight once a day for 3 days.

For treating amoebic involvement
of the liver (a liver infection)
Adult The usual dose is 3 to 4 tablets (1.5
to 2g) once a day for 3 to 6 days.
Child The usual dose is 50 to 60mg/kg of
body weight once a day for 5 days.

For treating giardiasis (an
abdominal infection) and
trichomoniasis (an infection of the
sex organs in males and females)

Adult The usual dose is 4 tablets (2g)
given as a single dose.
Child The usual dose is 50 to-75mg/kg of
body weight given as a single dose.
Your doctor will calculate the dose required
for a child and may repeat the dose once if
the infection has not cleared up completely.

If you take more Fasigyn than you
should
If you take too much Fasigyn tell your
doctor or contact your nearest hospital
casualty department immediately. Take any
remaining tablets with you.

If you forget to take Fasigyn

If you forget to take Fasigyn take it as soon
as you can. Take your next dose at the right
time. Do not take a double dose to make up
for a forgotten dose.

If you stop taking Fasigyn

If you stop taking Fasigyn too soon, the
infection may return. Take Fasigyn for the
full time of treatment, even when you begin
to feel better.
If you have any further questions about
the use of this product, ask your doctor or
pharmacist for advice.

4. Possible side effects
Like all medicines, this medicine causes side
effects, although not everybody gets them.
Tell your doctor immediately if you
experience any of the following symptoms
after taking this medicine.
Although they are very rare, the symptoms
can be severe.
• Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips or tongue
• fits or seizures
The common side effects (that may affect
up to 1 in 10 people) are listed below. These
may go away during treatment as your body
adjusts to the medicine. Tell your doctor if
any of these side effects continue to bother
you.
• nausea (feeling sick) or vomiting, loss
of appetite, diarrhoea, stomach pain or
cramps
• headache
• vertigo
• skin rash or itching (especially affecting
the whole body).
The frequency of the following side effects
is not known (cannot be estimated from the
available data). You should contact your
doctor if you notice any of the following:
• numbness, tingling, pain or weakness in
hands or feet
• clumsiness or unsteadiness
• fever or chills and painful ulcers in the
mouth
• sore or swollen mouth/tongue
• redness of the face or neck
• dizziness
• tiredness
• dark urine
• tongue discolouration or unpleasant
metallic taste.
Fasigyn can sometimes cause a temporary
reduction in white blood cells which does
not usually give you any symptoms.

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. 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 Fasigyn
Keep out of the reach and sight of children.
Do not take this medicine after the expiry
date stamped on the pack after EXP. The
expiry date refers to the last day of that
month.
Store below 25ºC in a dry place. Store in the
original package to protect from light.
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. Further information
What Fasigyn contains

The active substance is tinidazole (500mg).
The other ingredients are: alginic acid,
hydroxypropyl methylcellulose, magnesium
stearate, maize starch, microcrystalline
cellulose, propylene glycol, sodium lauryl
sulfate and titanium dioxide.

What Fasigyn looks like and
contents of the pack

Fasigyn tablets are round and white with
FAS 500 printed on one side. The tablets
come in blister packs of 16.

Marketing Authorisation Holder

Pfizer Ltd, Ramsgate Rd, Sandwich, Kent,
CT13 9NJ, UK

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route
des Industries, 37530 Pocé-sur-Cisse,
France
This leaflet was last revised in: 12/2015
© Pfizer Limited
Ref: UK FA 7_0

8814503

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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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